最新刊期
      卷 31 ， 期 3 ， 2020
      • WANG Ruoning,HAN Sheng,FAN Di,SHI Luwen,CHEN Jing
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To study the effects of the deregulation of drug price control on drug price ，and to provide reference for policy formulation. METHODS ：The quarterly price data of 46 875 chemical and biological products （measured by fixed Laspeyres index ）were collected from 788 sample hospitals from the database of National Medical Economic Information Network during Jan. 2012 to Jun. 2017. Based on the interrupted time series model ，changes in the prices of overall situation of chemicals and biological products ，as well as the sub-group ，ie. low-cost drugs ，original and imitated drugs were analyzed after the government’s policies of canceling the price limit control and strengthening the price monitoring （including Notice on Printing and Distributing the Opinions on the Supply and Guarantee of Commonly Used Low-cost Drugs in 2014，Notice on Printing and Distributing the Opinions on Promoting the Reform of Drug Prices in 2015，etc.），returning to market competition ；the effects of canceling the price limit control on drug price were put forward. RESULTS & CONCLUSIONS ：After government deregulation for maximum retail price limit of commonly used low-priced drugs ，the price of low-priced drugs increased substantially （β3＝1.11×10－2， P＝0.008）. After the total abolition of drug price control ，there was no significant change in the overall chemical and biological products（β3＝－1.85×10－3，P＝0.175）and sub-group （low-cost drugs ：β3＝1.10×10－3，P＝0.066；original drugs ：β3＝－7.20×10－4， P＝0.549；generic drugs ：β3＝6.78×10－4，P＝0.784）drug prices. Within two years after government deregulation policy in 2015， drug prices and the drug market had remained stable. It can be seen that it is feasible for canceling the government ’s pricing and opening the price control in the mature market so as to make the price formulation return to the market ，combined with the government strengthening the price monitoring.  
        关键词：Government regulation;Deregulation;Drug price;Market;Chemical and biological product   
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        发布时间：2022-06-21
      • YAN Guang
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To provide reference for improving the efficiency of medicine regulation in China. METHODS ：The legal nature and functional scope ，regulatory objectives ，methods and legal elements of UK Medicine and Healthcare Products Regulatory Agency （MHRA），and the implementation and effectiveness of the drug regulatory effectiveness improvement plan in the UK were analyzed to put forward the enlightenment for China. RESULTS & CONCLUSIONS ：MHRA belongs to the enforcement agency of UK Department of Health and Social Care ，and its legal responsibility is borne by the Minister of Health. Its functions include the supervision of medicine ，medical devices ，blood transfusion products. Its objectives include the administrative supervision of medicine and medical devices ，the provision of medical information to patients ，and the encouragement of pharmaceutical enterprises to develop new and effective products. Its supervision methods include the supervision of administrative legislation and regulations ，drug early warning ，admission to market and administrative agreement ；the legal elements as openness ， transparence，cooperation and participation guarantee the legitimacy of regulatory actions. MHRA launched the medicine regulatory performance improvement plan in 2005，aiming to reduce unnecessary medicine regulatory burden and achieve moderate ， risk-based，targeted and cost-effective drug regulation. This plan makes medicine regulatory agencies improve efficiency ，reduce burden of pharmaceutical enterprises and protect patients ’health rights and interests. Our country can learn from the experience of MHRA regulatory practice in the UK ，establish modern regulatory concepts such as from passive regulation to active regulation ， from post supervision to risk supervision ，from administrative guidance to cooperative management ，so as to strengthen regulatory responsibility，make full use of modern information technology and big data technology ，so as to improve the efficiency of drug regulation in China and effectively safeguard the public health rights and interests.  
          
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        发布时间：2022-06-21
      • JIN Jing,HUANG Zhe
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To investigate rationality of existing retail pharmacy layout in Liaoning province ，and to discuss the rationalization of retail pharmacy layout from the perspective of the government. METHODS ：By introducing the concept of coverage radius ，comprehensive use of population ，area，number of retail pharmacies ，average number of people covered by each retail pharmacy ，the difference between the number of pharmacies （calculated according to the coverage radius and area ）and the number of existing pharmacies ，the shortest distance between two retail pharmacies as indicators ，the overall retail pharmacies layout in 14 cities of Liaoning province and the specific layout of retail pharmacies in Shenyang were analyzed to put forward the idea of optimizing the retail pharmacies layout. RESULTS & CONCLUSIONS ：The correlation of the number of existing retail pharmacies in Liaoning province with the population and land area to a certain extent showed no obvious law ，with some degree randomness. The average number of people covered by each pharmacy is 1 917-4 157 in each city ；the average number of people covered by retail pharmacies in the remaining 10 cities like Yingkou is lower than the provincial average. The average number of people covered in Chaoyang and other 3 cities is higher ，with great development space. The number of existing retail pharmacies in 8 districts and counties such as Tiexi district do not meet the actual needs of consumers （the number of existing pharmacies is 2- 3 921 less than the number of due pharmacies ），while the number of existing retail pharmacies in 3 districts such as Shenhe district far exceeds the required number （the number of existing pharmacies is 142-248 more than the number of due pharmacies ）. There is a problem of too small spacing between adjacent retail pharmacies （the minimum distance is less than 500 m）. The distribution of retail pharmacies in Liaoning province is unbalanced ，and there is insufficient demand in some areas. When optimizing of retail pharmacies layout ，the government should establish a double objective evaluation system ，which is fair （measured by the maximum distance between the uncovered demand area and the nearest retail pharmacies ）and efficient （measured by the sum of the number of retail drugstores needed for the existing layout and the number of new retail drugstores ）. It is also necessary to analyze and construct a retail pharmacies location model which is suitable for China ’s national conditions ，and consider the actual conditions of the parameters of the actual constraints and objective constraints ，so as to realize the overall optimization of retail drugstores .  
        关键词：Liaoning province;Retail pharmacy;Layout;Optimization;Government perspective   
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        发布时间：2022-06-21
      • Ayituxun·Abuduwaili,Paerhati·Rouzi,GAO Yanhua,Paiheerding·Mutailifu,Rehebati·Nuerxiati,NING Huixia,Abulimiti·Yili
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To optimize the extractio n technology of Fritillaria pallidiflora polysaccharides（FPSP），and to study its structure. METHODS ：Using the yield of FPSP as response value ，Box-Behnken design-response surface methodology was adopted to optimize solid-liquid ratio ，extraction temperature and extraction time of FPSP extraction technology. Structural properties of FPSP was characterized by UV spectrum ，FTIR，GC-MS，Congo red staining ，SEM，XRD and thermogravimetric analysis. RESULTS：The optimal technology parameters of FPSP were solid-liquid ratio of 1∶28（g/mL），extraction temperature of 94 ℃， extraction time of 2.5 h；the yield of FPSP was 16.25％（n＝3），the error of which to theoretical yield （16.58％）was 0.33％. FPSP contained xylose ，glucose and galactose with a molar ratio of 1∶58.02∶0.73，and trace amount of mannose ；there was a weak absorption peak near the wavelength of 280 nm；belonged to α-configuration pyranopolysaccharide. FPSP was in triple-helical structure. The surface of FPSP was a network structure formed by irregular particles. FPSP had both crystalline and amorphous structures. FPSP had good thermostability. CONCLUSIONS ：The optimized extraction technology of FPSP is reasonable ，and has high extraction yield. The research might provide reference for the further development and utilization of F. pallidiflora .  
          
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        发布时间：2022-06-21
      • SHEN Ying,FAN Jian,MENG Xiangcai
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To explore the medication rul e of Glycyrrhiza uralensis -containing antitussive prescriptions （GUAP）， and to provide reference for the research and development of new antitussive drugs. METHODS ：The GUAP were collected from 2015 edition of Chinese Pharmacopoeia （part Ⅰ）. The information of prescription name ，composition，flavor and meridian tropism，and functional indications were input into Excel 2018 software to establish the database. The frequency of traditional Chinese medicine （TCM）was analyzed statistically. Cluster analysis was performed for high frequency TCM （frequency≥15）in GUAP by using SPSS Statistics 23.0 software；Apriori algorithm and association rules of SPSS Modeler 18.0 software were used to analyze the drug combination of high-frequency TCM in GUAP （support degree ≥15％，confidence degree ≥70％，lift degree ≥1）. New GUAP was sorted. Totally 60 mice were divided into model group （normal saline ），positive group （Codeine phosphate tablet ， 5 mg/kg），New prescription low-dose ，medium-dose and high-dose groups （1.17，5.83，11.67 g/kg，by extractum ），with 12 mice in each group. They were given relevant medicine intragastricaaly once a day ，for consecutive 7 d. 1 h after last medication ，cough was induced by ammonia in mice for 30 seconds；the latent period of cough and the frequency of cough within 2 min were recorded，and the cough inhibition rate was calculated. RESULTS ：Totally 73 prescriptions involved 194 kinds of TCM ，with 11 ingredients of high-frequency TCM （G. uralensis ，Platycodon grandiflorus ，Semen Armeniacae ，Citrus reticulate ，Ephedra sinica ， Gypsum fibrosum ，Scutellaria baicalensis ，Mentha haplocalyx ，Pinellia ternate ，Poria cocos ，Peucedanum praeruptorum ），which were mainly pungent and mostly belonged to lung meridian. High-frequency TCM could be grouped into 5 categories. There were 7 two-item association rules （such as E. sinica →Semen Armeniacae ，G. fibrosum →Semen Armeniacae ）and 10 three-item association rules （such as G. fibrosum -Semen Armeniacae →E. sinica ，C. reticulate -P. grandiflorus →Semen Armeniacae ）. New GUAP contained G. uralensis ，P. grandiflorus ，Semen Armeniacae ，E. sinica ，C. reticulate ，G. fibrosum （mass ratio 1 ∶ 2 ∶ 2 ∶ 2 ∶ 3 ∶ 4）. Compared with model group ，the latent period of cough was prolonged and the frequency of cough within 2 min was decreased significantly in positive group and new prescription low-dose ，medium-dose and high-dose groups （P＜0.01）. Compared with positive group ，latent period of cough was shortened significantly in new prescription low-dose and medium-dose groups ，while the frequency of cough within 2 min was increased （P＜0.05 or P＜0.01）；but there was no significant difference in latent period of cough， the frequency of cough within 2 min， cough inhibitory rate of new prescription high-dose group （P＞0.05）. CONCLUSIONS：The new antitussive prescription was summarized by analyzing the medication rule of GUAP ，and was verified to have good antitussive effect ，which can provide reference for the development of new antitussive drugs.  
        关键词：Glycyrrhiza uralensis;Antitussive;Data mining;Medication rule;New prescription;Mice   
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        发布时间：2022-06-21
      • LIU Pengpeng,ZHANG Fan,SHI Ji,SHAN Guoshun,JIA Tianzhu
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To establish a method for the determination of 8 glycosides（astragaloside Ⅰ，Ⅱ，Ⅲ，Ⅳ and calycosin glucopyranoside ，2′-hydroxy-3′，4′-dimethoxy-isoflavan-glucoside and 9，10-dimethoxy-pterocarpan-glucoside） and 4 aglycones（calycosin，formononetin，7，2′-dihydroxy-3′，4′-dimethoxy-isoflavan and 3-hydroxy-9，10-dimethoxy-pterocarpan） in Astragalus membranaceus ，and to investigate the effects of different processing temperatures on the contents of above 12 components. METHODS ：The contents of 12 components in A. membranaceus and samples processed under different temperatures（120，140，160，180，200 ℃）were determined by UPLC-MS/MS. The determination was performed on ACQUITY UPLC HSS T 3 column with mobile phase consisted of 0.1 mol/L formic acid water solution -0.1 mol/L formic acid acetonitrile solution （gradient elution ）at the flow rate of 0.5 mL/min. The column temperature was 30 ℃. The detection wavel ength was 260 nm，and sample size was 2 μL. Electrospray ion source（ESI）was used under positive ion mode （ESI+）. The mass scanning range was mass ratio （m/z）of 50-1 500，with capillary voltage of 2 000 V and ion source temperature of 100 ℃. The desolvation temperature was 400 ℃；flow rate of atomizing gas （N2） was 40 L/h，and that of desolvation was 800 L/h；collision energy （CE）was 20-30 V；data acquisition rate was 0.5 s/scan. RESULTS：The linear range of astragaloside Ⅰ，astragaloside Ⅱ，astragaloside Ⅲ，astragaloside Ⅳ，calycosin-glucopyranoside， calycosin，ononin，formononetin，2′-hydroxy-3′，4′-dimethoxy-isoflavan-glucoside，7，2′-dihydroxy-3′，4′-dimethoxy-isoflavan，9， 10-dimethoxy-pterocarpan-glucoside and 3-hydroxy-9，10-dimethoxy-pterocarpan were 0.001 16-0.232 0，0.000 276-0.055 2， 0.000 22-0.044 0，0.000 225-0.045 0，0.000 734-0.587 0，0.001 17-0.234 0，0.000 742- 0.148 0，0.001 30-0.260，0.003 98-0.795 0， 0.000 476-0.476 0，0.001 89-0.378 0，0.000 336-0.336 0 μg（all R2≥0.999 2），respectively. The limits of detection were 6.2×10－6， 4.8×10－6，3.8×10－6，3.4×10－6，5.8×10－6，4.8×10－6，4.2×10－6，3.2×10－6，5.8×10－6，2.6×10－6，4.2×10－6，6.4×10－6 μg，respectively. The limits of quantitation were 12.6×10－6，16.2×10－6，14.4×10－6，14.8×10－6，18.8×10－6，16.4×10－6，15.4×10－6，10.8×10－6，20.2×10－6， 12.4×10－6，14.6×10－6，23.4×10－6 μg，respectively. RSDs of precision ，stability（24 h）and repetition tests were all lower than 3.0％（n＝6）. The average recoveries were 99.1％，100.2％，98.7％，101.9％，98.6％，102.1％，99.2％，100.3％，98.7％， 99.2％，99.3％ and 100.8％，with the RSDs of 1.9％，2.2％，2.4％，1.8％，2.1％，1.7％，2.3％，1.9％，2.4％，1.8％，2.2％ and 1.9％（n＝6），respectively. The results showed that the contents of astragaloside Ⅰ，Ⅱ and Ⅲ decreased gradually with the increase of processing temperature ；the content of astragaloside Ⅳ increased gradually with the increase of temperature. The content of flavonoid glycosides ，such as calycosin glucopyranoside ，ononin，2′-hydroxy-3′，4′-dimethoxy-isoflavan-glucoside and 9， 10-dimethoxy-pterocarpan-glucoside decreased with the increase of temperature ；the corresponding aglycone components as flavonoid glycosides ，formononetin，3-hydroxy-9，10-dimethoxy- pterocarpan increased firstly and then decreased with the increase ； the content of 7，2′-dihydroxy-3′，4′- dimethoxy-isoflavan decreased with the increase of temperature. CONCLUSIONS ：Established UPLC-MS/MS method can be used for determination of 12 components in A. membranaceus . After processed under different temperature，the contents of glycosides decreased in general ，while the contents of aglycones increased in general.  
        关键词：Astragalus membranaceus;UPLC-MS/MS;Glycosides;Aglycones;Content det ermination;Directional processing   
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        发布时间：2022-06-21
      • LIU Wenjun,QUE Zuliang,LI Jinzhou,CHEN Zijun,HUANG Zhouyan,PANG Danqing,CHEN Liangni,CHEN Yong
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To inv estigate the tonifying blood effects of different extract parts of Embelia parviflora on blood deficiency model mice ，and to explore its mechanism. METHOD S：Totally 70 mice were randomly divided into blank control group（water），model control group （water），positive control group （Danggui buxue oral liquid ，324 g/kg），petroleum ether ， ethyl acetate ，n-butanol and water parts of E. parviflora groups（4.2，10.64，22.07，5.0 g/kg respectively ，calculated by the extractum），with 10 mice in each group. The mice were given medicine intragastrically ，once a day ，for consecutive 14 d. Except for blank control group ，other groups were given intraperitoneal injection of cyclophosphamide （80 mg/kg）on 12th and 13th day of starting administration to induce blood deficiency model. 30 min after last administration ，automatic hematology analyzer was used to detect the levels of peripheral hemogram indexes （WBC，RBC，HCT，PLT，HGB）；the levels of IL- 2，IL-3，IL-6，EPO， G-CSF，M-CSF and VCAM- 1 were determined by ELISA ；thymus and spleen indexes were calculated. RESULTS ：Compared with blank control group ，peripheral hemogram indexes levels ，serum levels of IL- 2，IL-3，IL-6，EPO，G-CSF，M-CSF，VCAM-1 and thymus index were decreased significantly ，while spleen index was increased significantly （P＜0.01）. Compared with model control group，there was no statistical significance in above indexes of mice in petroleum ether part of E. parviflora group（P＞0.05）. The levels of RBC ，HGB，PLT，the serum levels of IL- 2，IL-6，G-CSF，M-CSF，VCAM-1 and thymus index in ethyl acetate part of E. parviflora group were significantly increased （P＜0.05 or P＜0.01），while there was no statistical significance in other indexes （P＞0.05）. Except for no significant increase of WBC in water part of E. parviflora group，above peripheral hemogram indexes ， serum indexes and thymus index of n-butanol group and water part of E. parviflora group were increased significantly while spleen index was decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS：The ethyl acetate ，n-butanol and water parts of E. parviflora can improve immunological function and the expression of hematopoietic factors in blood deficiency model mice ，and shows certain blood tonifying effects.  
          
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        发布时间：2022-06-21
      • DONG Wenting,HUO Jinhai,SUN Guodong,WANG Weiming
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To investigate th e effects of juglone on brain tissu e of rats and its relationship with the biomarkers related to brain tissue injury. METHODS ：Totally 40 rats were divided into blank group ，juglone high-dose ，medium-dose and low-dose groups （34.832，17.416，8.708 mg/kg），with 10 rats in each group. They were given medicine intragastrically once a day ， for consecutive 4 weeks.After last administration ，the general behavior ，brain index and brain tissue morphology were investigated. UPLC-MRM-MS method was used to determine the serum contents of L-dopa（L-Dopa），L-tyrosine（L-Tyr）and L-tryptophan（L-Trp） in rats. The chromatographic condition included Waters Acquity UPLC BEH C 18 column，mobile phase consisted of ammonium acetate aqueous solution-acetonitrile ，gradient elution ，at the flow rate of 0.3 mL/min，sample size of 5 μL，column temperature of 30 ℃；MS condition include electrospray ion source ，in positive ion mode ，capillary voltage of 3 500 V，desolvent gas flow of 650 L/h，desolvent temperature of 350 ℃，ion source temperature of 110 ℃. RESULTS ：Compared with blank group ，the rats in each dose group showed the behavior of tiredness and weakness of limbs. The brain tissue morphology showed pathological changes ， which contained blood vessel congestion in the cerebral and cerebellar cortex ，partial cell nucleus pyknosis in the pyramidal cell layer，deep staining of nuclei ，irregular shape and unclear boundary and other pathological changes ；the brain index of juglone high-dose group increased significantly （P＜0.05）. The established UPLC-MRM-MS method showed good specificity and the range of L-Dopa，L-Tyr and L-Trp were 31.25-32 000，31.25-32 000，15.625-16 000 ng/mL（r＝0.999 1-0.999 9），respectively. The limits of detection were 6.250，5.625，3.125 ng/mL，respectively. The limits of quantitation were 15.625，18.75，10.00 ng/mL，respectively. RSDs of precision ，accuracy and stability （24 h）tests were all Matrix effects were 95.1％-100.1％ （RSD are not more than 3.25％，n＝3）. Compared with blank group，the contents of L-Dopa were increased significantly injuglone medium-dose and high-dose groups （P＜0.01）. The contents of L-Tyr were increased significantly in juglone lowdose，medium-dose and high-dose gro ups，while the contents of L-Trp were decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ：Juglone has an effect on the general behavior，brain index and brain tissue morphology of rats. It may affect the brain function of rats by increasing the contents of L-Dopa and L-Tyr in serum and decreasing the contents of L-Trp.  
        关键词：Juglone;Brain tissue;Biomarker;UPLC-MRM-MS;Content determination   
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        发布时间：2022-06-21
      • FENG Yiling,LUO Xiaojian,LAI Yanqing,CAI Dayu,RAO Xiaoyong,XU Chunliang
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To establish the method for online rapid detection of related indexes in the concentration process of Huagai san extraction solution ，and to provide reference for judgment of concentration end point. METHODS ：Online diagram of 73 concentrated samples in the concentration process of Huagai san extraction solution were drawn by NIRS online collection equipment. The partial least squares （PLS）method was used to establish the NIRS quantitative calibration model of 5 related indexes （concentration density ， solid content ， the contents of amygdalin ， ephedrine hydrochloride and pseudoephedrine hydrochloride）. Another 15 samples were used to validate the model ，and the correlation of predicted value and measured value was analyzed. RESULTS ：The correlation coefficients （R2）of the concentration density ，solid content ，the contents of amygdalin ， ephedrine hydrochloride and pseudoephedrine hydrochloride in the quantitative calibration model were 0.982 5，0.999 9，0.998 3， 0.999 4 and 0.999 3，respectively；the root mean square errors of calibration （RMSEC）were 0.001 6，0.025 1，0.014 7，0.001 8 and 0.000 9；the root mean square errors of cross validation （RMSECV）were 0.002 1，0.035 8，0.033 6，0.006 3 and 0.001 3， respectively. After validation by 15 samples，root mean square errors of prediction （RMSEP）were 0.003 2，0.024 6，0.021 5， 0.007 7 and 0.005 9，respectively. CONCLUSIONS ：The established quantitative calibration model has good predictability and can provide basis for online judgment of concentration end point of Huagai san extraction solution.  
        关键词：Huagai san;Concentration process;Near-infrared spectro scopy;Online collection   
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        发布时间：2022-06-21
      • LYU Jing,LI Chen,YANG Longfei,GAO Yan,ZHAO Bonian
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To study the heart protective effect of Panax quinquefolium extract of Zebra fish. METHODS ：The drug dosage of P. quinquefolium extract and the optimal modeling dose of terfenadine were determined by tolerance test ；24 hours post fertilization （24 hpf），Zebra fish were divided into control group （0.5％ dimethyl sulfoxide ），model group （2.5 μg/mL terfenadine），positive control group （2.5 μ g/mL terfenadine + 30 μ g/mL resveratrol） and different mass concentration P. quinquefolium extract groups （2.5 μg/mL terfenadine+5，10，25 μg/mL P. quinquefolium extract，by raw material ）. 48 h after incubation，the heart rate and sinus venous-bulbus arteriosus （SV-BA）interval of Zebra fish were used as indexes ，and the heart injury repair rate was calculated to investigate the heart protection of P. quinquefolium extract. Another 24 hpf Zebra fish were divided into blank control group ，model group ，positive control group ，20 batches of P. quinquefolium extract from different producing area groups （5 μg/mL，by raw material ），with same administration route and 48 h of incubation. The heart rate ，SV-BA interval of heart was determined ，heart injury repair rate and heart injury relative repair rate were calculated ；the heart protective effect of P. quinquefolium extract was further validated. RESULTS ：Compared with blank control group ，heart rate was decreased significantly（P＜0.01），while SV-BA interval was increased significantly in model group （P＜0.01）. Compared with model group，heart rate of Zebra fish was increased significantly in positive control group and 5，10，25 μg/mL P. quinquefolium extract groups（P＜0.01），while SV-BA interval of Zebra fish was shortened significantly in 5，10 μg/mL P. quinquefolium extract groups （P＜0.05 or P＜0.01）；heart injury repair rate of Zebra fish in 5 μg/mL P. quinquefolium extract group reached 73.77％. In validation test ，compared with model group ，heart rate was increased significantly （P＜0.01），while SV-BA interval of Zebra fish was decreased significantly in 20 batches of P. quinquefolium extract groups （P＜0.01）；heart injury repair rate ranged 70.45％-85.78％，and heart injury relative repair rate ranged 75.48％-98.12％. CONCLUSIONS ：P. quinquefolium extract has good heart protective effects.  
        关键词：Panax quinquefolium;Zebra fish;Heart protection;Sinus venous-bulbus arteriosus;Interval;Heart rate   
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        发布时间：2022-06-21
      • ZHAO Wenyu,SI Fuchun
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To study the effects and mechanism of water extract and ethanol extract of Muskmelon Pedicel on the proliferation，migration and cloning formation of esophageal carcinoma TE- 1 and EC- 1 cells. METHODS ：TE-1 and EC- 1 cells were cultured in vitro ，and were treated with 0，1.562 5，3.125，6.25，12.5，25，50，100，200 μg/mL of water extract and ethanol extract of Muskmelon Pedicel （calulated by extract powder ）. MTT assay was used to detect the growth inhibitory rate of TE- 1 and EC-1 cells，and calculate IC 50 of them. TE- 1 and EC- 1 cells were divided into TE- 1/EC-1 blank group ，TE-1/EC-1 Muskmelon Pedicel water extract group （IC50 as drug concentration ），and TE- 1/EC-1 Muskmelon Pedicel ethanol extract group （IC50 as drug concentration）. The proliferation and migration of cells in each group were detected by real-time unlabeled cell analysis （RTCA）， and cell proliferation and migration curves were drawn. The morphological changes of cells were observed under microscope ；soft agarose colony forming test was used to analyze the change of colony forming ability of cells in each group ，and the colony forming rate was calculated ；cell cycle and apoptosis rate of cells in each group were detected by flow cytometry ；Western blotting assay was used to detect the relative expression of EGFR and PKC -α in cells in each group. RESULTS ：IC50 of water extract of Muskmelon Pedicel were 49.24，76.38 μg/mL respectively for TE-1 and EC- 1 cells. Those of ethanol extract of Muskmelon Pedicel were 9.08，14.53 μ g/mL respectively for TE-1 and EC- 1 cells. The inhibition effect of water extract and ethanol extract of Muskmelon Pedicel on the cell proliferation were within 30 h. Δ 基金项目：河南省自然科学基金资助项目（No.162300410185） ＊博士研究生。研究方向：肿瘤中医方证。电话：0371-65676778。 The inhibition effect of water extract and ethanol extract of E-mail：zixiangning88@126.com Muskmelon Pedicel on the cell migration were within 60 h. # 通信作者 ：教授，博士生导师 ，博士。研究方向 ：肿瘤中医方 Compared with TE- 1/EC-1 blank group ，the number of cells 证。电话：0371-65676778。E-mail：sifc2000@hotmail.com was decreased significantly in administration groups ， the ·314· China Pharmacy 2020Vol. 31 No. 3 中国药房 2020年第31卷第3期 structure of cell were sloop ，the cell structure was loose ，and most of the cell contour disappeared and became round. The formation rate of cell clone was decreased significantly （P＜0.01）. The percentage of G 2 phase cells increased significantly （P＜ 0.01），while that of G 1 and S phase cells decreased significantly （P＜0.05）. The apoptotic rate of cells increased significantly in early and late stage （P＜0.05）. Relative protein expression of EGFR and PKC- α were decreased significantly （P＜0.01）. Compared with TE- 1/EC-1 Muskmelon Pedicel water extract group ，formation rate of cell clone was decreased significantly in TE- 1/EC-1 Muskmelon Pedicel ethanol extract group （P＜0.05）；cell was increased significantly at G 2 phase（P＜0.05）；relative protein expression of EGFR and PKC- α were decreased significantly （P＜0.01）. The apoptotic rate of cells in early and late stage in TE- 1 Muskmelon Pedicel ethanol extract group was decreased significantly （P＜0.05），the apoptotic rate of cells in early and late stage in EC- 1 Muskmelon Pedicel ethanol extract group was increased significantly （P＜0.05）. CONCLUSIONS ：Water extract and ethanol extract of Muskmelon Pedicel could influence the proliferation ，migration and clone formation ability of TE- 1 and EC- 1 cell，promote cell apoptosis ，the mechanism of which may be associated with the down-regulation of EGFR and PKC-α protein.  
          
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      • WANG Li,WEI Feifei,CHENG Xi,ZHAO Wenlong,JIN Ling
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To study the ecological suitability zoning of Astragalus membranaceus var. mongholicus in Dingxi city. METHODS ：Taking 1 001 batches of A. membranaceus var. mongholicus in Dingxi city as the investigation samples （each natural village with A. membranaceus var. mongholicus cultivation as the collection unit ），the longitude and latitude information of them were obtained from Dingxi economic crop technology promotion station ，and 55 environmental ecological factors （including climate，terrain，soil，etc.）were obtained from the Grid Database of Spatial Information of TCM Resources . Combined with the information of longitude ，latitude and environmental ecological factors ，the maximum entropy model （MaxEnt model ） was established with 75％ samples as the training set ，and the main ecological factors were screened out ，and 25％ samples were set as the validation set for model validation. Then the suitable growing areas of A. membranaceus var. mongholicus were divided by using ArcGIS. RESULTS ：Established MaxEnt model had good prediction （the area under the working characteristic curve of subjects in training set and verification set was 0.970 and 0.968）. Eight main ecological factors ，such as altitude ，precipitation and temperature ， were selected （the total contribution rate was 98.90％）. The comprehensive analysis found that the altitude was 1 800 to 2 650 m， the average precipitation in April was 25 to 50 mm，the lowest temperature of the coldest month was －16 to －8 ℃，the wettest monthly precipitation was 95 to 110 mm，and the seasonal variation of temperature was 70 to 80，the average temperature in December was －6 to －3 ℃ ，the average precipitation in October was 30 to 50 mm，and the average precipitation in December was 0 to 10 mm，which was the suitable environmental parameter for the growth of A. membranaceus var. mongholicus in Dingxi city. Based the results of ArcGIS analysis ，in Dingxi city ，A. membranaceus var. mongholicus was generally suitable for growth ；in the northwest of Lintao county ，the north of Anding district ，the south of Tongwei county ，a small area in the south of Longxi county and the south of Minxian county ，the border between Weiyuan county ，Zhangxian county and Minxian county ，A membranaceus var. mongholicus was not suitable for growth. CONCLUSIONS： Ther results of established model is in E-mail：961308817@qq.com line with the actual investigation ， can provide reference for the planting regional planning of A. membranaceus var. mongholicus in Dingxi city.  
        关键词：Astragalus membranaceus var.mongholicus;Dingxi city;Suitability zoning;Geographic information system   
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      • CHEN Shuai,ZHANG Mei,YUAN Chongjun,LUO Sen,WANG Jia
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To establish the method for content dete rmination of polyphyllin Ⅱ，Ⅵ，Ⅶ in Ypsilandra thibetica ， and to compare the differences of 3 saponins in different parts of Y. thibetica from different producing areas. METHODS ：HPLC method was adopted to determine the contents of polyphyllin Ⅱ，Ⅵ，Ⅶ in whole grass part and underground part of Y. thibetica from 10 producing areas. The determination was performed on Kromasil C 18column with mobile phase consisted of acetonirile-water （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was 35 ℃，and detection wavelength was set at 203 nm；sample size was 10 μL. With the contents of 3 saponins as the index ，20 batches of Y. thibetica were analyzed by cluster analysis and PLS-DA analysis ；the aggregation of samples was analyzed and determined the primary difference components. RESULTS：The linear range of polyphyllin Ⅱ，polyphyllin Ⅵ and polyphyllin Ⅶ were 0.051-2.04，0.007-0.28，0.168-6.72 μg， respectively（r≥0.999 5）；the detection limits were 1.92，1.75，1.87 ng，respectively；and the quantitative limits were 6.40，5.87， 6.23 ng，respectively；RSD of precision ，reproducibility and stability tests （24 h）were all lower than 2％（n＝6）；the average recovery rates were 99.29％，101.38％ and 99.64％，with RSDs of 1.17％，2.64％，0.75％（n＝6），respectively. The content of polyphyllin Ⅱ was 0.615-1.875 mg/g，that of polyphyllin Ⅵ was 0-0.095 mg/g，and that of polyphyllin Ⅶ was 3.158-12.354 mg/g. Cluster analysis showed that 20 batches of samples were clustered into two groups ，batch S 9-S12 were clustered in to one group，and the other 16 batches of samples were clustered into another group. PLS-DA analysis showed that 20 batches of samples were divided into 3 areas，batch S 1，S2，S8，S14，S16，S20 were included in area Ⅰ；batch S 9-S12 included in area Ⅱ；and the rest of the samples included in area Ⅲ. The quality of Y. thibetica from different habitats was different ，and there was no difference in the saponin composition between the whole grass and the underground part. Weight ranking found that mail：cscdtcm@126.com polyphyllin Ⅶ was the main difference component in Y. thibetica，and the content of polyphyllin Ⅶ in Y. thibetica from Pengzhou city and Dayi county was the highest. CONCLUSIONS ：The established method is simple ，convenient and sensitive. It can be used for the content determination of 3 saponins in Y. thibetica . The content of active components is higher and the quality is better in Y. thibetica from Pengzhou city and Dayi county.  
        关键词：HPLC;Ypsilandra thibetica;Polyphyllin Ⅱ;Polyphyllin Ⅵ;Polyphyllin Ⅶ;Cluster analysis;PLS-DA analysis   
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      • XIANG Cuiying,YANG Gang,YANG Bing,ZHENG Chuanbo,ZHOU Jingsi,LI Zhengping
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To study the skin irritation and se nsitization of domestic generic drug Clobetasone butyrate cream ， and to compare it with commercial drug （original drugs ）. METHODS ：The skin irritation test was conducted on rabbits. Totally 24 rabbits were randomly divided into test preparation intact skin group ，test preparation abraded skin group ，commercial drug intact skin group and commercial drug abraded skin group ，with 6 rabbits in each group. 0.5 mL test preparation or commercial drug was administered to the left side of intact or abraded skin and the same amount of excipient on the right side of each rabbit twice a day for consecutive 7 days. The irritation of the drug to the rabbit skin was observed ，and the erythema and edema of the skin were scored；the skin of administration site was taken at 72 h after last administration and the end of 7 d after drug withdrawal for histopathological examination. The skin sensitization test （Buehler test ）was carried out on guinea pigs. Totally 60 guinea pigs were randomly divided into test preparation group （n＝20），commercial drug group （n＝20），positive control group （n＝10）and excipient control group （n＝10）. 0.2 mL test preparation or commercial drug was administrated to the left side of the rib abdomen skin of each guinea pig at the 0，7th，14th day to induce model ，and an equal amount of corresponding preparation was administered to the right side in the same way at the 28th day for stimulation. Hypersensitive response such as erythema and edema were observed and scored at 24 h and 48 h after the stimulation. The incidence of hypersensitive response was then calculated. RESULTS：In skin irritation test of rabbits ，no erythema and edema was caused by the test preparation or commercial drug on intact skin of rabbits ；scores of skin irritation was 0；there was no dermal irritation. Both test preparation and commercial drug caused transient slight erythema on abraded skin of a few rabbits ；scores of intact and abraded skin irritation were 0-0.33；there was no dermal irritation. There was no statistical significance among groups. No dermal pathological changes were observed. In skin sensitization test of guinea pig ，no hypersensitive response such as erythema and edema was found on the skin of guinea pigs in both test preparation and commercial drug groups ；both score and the incidence of hypersensitive response were 0. Compared with excipient control group ，there was no statistical significance of average score and the incidence of hypersensitive response in test preparation group and commercial drug group. CONCLU- SIONS：In skin irritation test of rabbits and skin sensitization test of guinea pigs ， the evaluation results of generic Clobetasone butyrate cream are the same as those of the original drug. It has no irritation to the skin of rabbit ，and no sensitization to the skin of guinea pigs.  
        关键词：Clobetasone butyrate cream;Generic drug;Original drug;Skin irritation;Skin sensitization;Rabbit;Guinea pigs   
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      • WANG Fang,HOU Zili,HAN Bing,XIE Guosheng,ZHANG Yanling
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To study the protection ef fects of mulberry anthocyanin- 3-glucoside on epilepsy model mice and the effect of hippocampal brain derived neurotrophic factor （BDNF）/tyrosine kinase B （TrkB）pathway. METHODS ：Totally 120 C57BL/6 mice were randomly divided into normal group ，model group ，single medication group （mulberry anthocyanin- 3- glucoside），agonist combination group（mulberry anthocyanin- 3-glucoside+TrkB agonist LM 22B-10），with 30 mice in each group. single medication group and agonist combination group were given mulberry anthocyanin- 3-glucoside 600 μg/kg intragastrically once a day ，for consecutive 6 weeks. The agonist combination group was given LM22B-10（5 mg/kg）via the lateral ventricle once a day at 6th week. Normal group and model group were given constant volume of normal saline intragastrically. After last medication，except for normal group ，other groups were given lithium chloride-pilocarpine to establish epilepsy model. After modeling，10 mice in each group were taken to record the latency ，frequency and duration of spontaneous recurrent epilepsy ， observed for 6 hours a day for 4 weeks；EEG was recorded on the 14th，28th and 36th day after modeling ，and the abnormal frequency of EEG in 1 h was counted . On the 6th day of modeling ，other 10 mice in each group were taken to detect the serum calcium level ，and the remaining 10 mice in each group were taken to detect the expressions of BDNF mRNA and protein in the hippocampus. RESULTS ：Compared with normal group ，latency，frequency and duration of spontaneous recurrent epilepsy and the times of abnormal brain wave on the 14th，28th and 36th day after modeling were increased significantly in model group （P＜ 0.05）. The serum calcium level ， mRNA and proteinexpression of BDNF in hippocampus were increased E-mail：wangfang7699@126.com significantly （P＜0.05）. Compared with model group ，the latency，frequency，duration of spontaneous recurrent epilepsy and the times of abnormal brain wave on the 28th and 36th day after modeling were decreased significantly in single medication group（P＜0.05），while serum calcium level ，mRNA and protein expression of BDNF in hippocampus were decreased significantly （P＜0.05）. Compared with single medication group ，the latency，frequency and duration of spontaneous recurrent epilepsy and the times of abnormal brain wave on the 28th and 36th day after modeling were increased significantly in agonist combination group （P＜0.05），while serum calcium level ，mRNA and protein expressions of BDNF in hippocampus were increased significantly （P＜0.05）. CONCLUSIONS ：Mulberry anthocyanin- 3- glucoside has a good protection effect on epilepsy model mice ，the mechanism of which may be associated with inhibiting the activation of hippocampal BDNF/TrkB pathway.  
          
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      • XIONG Lirong,FENG Wei,XIANG Rongfeng,YU Mingjie,DAI Qing,CHEN Yongchuan
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To provide reference for clinical treatment of Acinetobacter baumannii infection and rational use of antibiotics. METHODS ：By retrospective analysis ，64 500 strains of bacteria were isolated from the inpatients of our hospital during Jan. 2015 to Dec. 2018. WHONET 5.6 software was used to analyze the detection rate ，specimen type ，departments of A. baumannii. The resistance of A. baumannii to 18 commonly used antibiotics in 4 years was analyzed by RxC table χ 2 test. RESULTS：A total of 2 072，2 040，2 017 and 2 143 strains of A. baumannii were isolated during 2015-2018，accounting for 12.85％，13.38％，13.60％，11.71％ of positive specimens. The main specimen types of 8 272 strains of A. baumannii were sputum（4 368 strains，52.81％），pus（1 106 strains，13.37％），ascites（804 strains，9.72％）. The main departments were burn department（1 605 strains，19.40％），hepatobiliary department （1 200 strains，14.51％），brain surgery department （977 strains， 11.81％）. The drug resistance rate to 18 kinds of antibiotics showed a wave-like decreasing trend （P＜0.001）. In 2018，drug resistance rate to ampicillin and aztreonam was more than 80％，and that to ampicillin/sulbactam ，ceftazidime，levofloxacin， Compound sulfamethoxazole ，gentamicin，amikacin，tobramycin and tegacyclin was less than 50％ ，among which the drug resistance rate to amikacin and tegacyclin were 14.7％ and 0，respectively. CONCLUSIONS ：There is no significant change in the number of isolates and detection rate of A. baumannii in our hospital between 2015 and 2018. The bacteria mainly cause respiratory tract infection. Amikacin or tegacyclin are recommended for treatment.  
        关键词：Acinetobacter baumannii;Clinical distribution;Antibiotics;Drug resistance;Chongqing   
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      • LIU Chunhe,DENG Li,ZHAO Ying,TAN Lu,ZHU Ruirui,HUANG Yunlin,HUANG Weiqing,CHEN Wenying
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To reference for the rational use of sodium va lproate in clinic. METHODS ：By retrospective analysis，blood concentration monitoring results of sodium valproate and medical record data in 856 patients were collected from the Affiliated Tianyou Hospital of Wuhan University of Science and Technology during Jan. 2016-Dec. 2018. The dosage form of sodium valproate ，monitoring times of therapeutic drugs ，monitoring results of steady-state blood concentration of sodium valproate up to the standard ，dosage adjustment and the combination with carbamazepin ，fluconazol and carbapenem drugs were analyzed. Fisher exact test was used to analyze the factors influencing the steady-state blood concentration of sodium valproate up to the standard. RESULTS ：A total of 1 270 cases of sodium valproate were monitored in 856 patients，involving 407 males and 449 females，with age of （38.2±13.8）years and body mass of （52.3±10.0）kg. Among 1 270 cases of monitoring ，steady-state blood concentration of sodium valproate in 554 cases were in the range of 50-100 µg/mL，and 43.6％ of which reached the standard. The rate of reaching the standard in patients with multiple monitoring was higher than patients with single monitoring ；the dosage of patients with last monitoring reaching the standard was higher than that of patients with the first monitoring reaching the standard. The rate of reaching the standard in Sodium valproate sustained-release tablet group was higher than general Sodium valproate tablet group；the carbamazepin/fluconazol free group was higher than the carbamazepin combination group and fluconazol combination group；the carbapenem free group was higher than the carbapenem combination group （all P＜0.05）. CONCLUSIONS ：Clinical pharmacists should pay attention to the monitoring of sodium valproate treatment drugs ， strengthen the publicity and 3551851542@qq.com education of patients and their families ，and try to use Sodium valproate sustained-release tablets. When patients additionally receive carbapenem drugs like carbamazepin or fluconazol ， the standard level of sodium valproate will be reduced ，then the dosage of sodium valproate should be adjusted.  
        关键词：Sodium valproate;Steady-state blood concentration;Treatment drug monitoring;Rational drug use;Influential   
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      • LIAN Xia,ZHENG Liqun,QIAN Xiaorong,ZHAO Jiali,FEI Yan
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To investigate the correlat ion betwe en N-methyl-D-aspartate（NMDA）receptor subunit gene GRIN2B polymorphism and Han population with epilepsy in south Fujian. METHODS ：In retrospective study ，167 healthy people who had physical examination in the Affiliated Dongnan Hospital of Xiamen University were selected from Jan. 2017 to May 2018 as control group；163 epileptic patients who were monitored the blood concentration of sodium valproate were selected as epilepsy group. The clinical data and peripheral blood of 2 groups were collected. 12 loci of GRIN2B genotype（rs11055514，rs11055515，rs12814951， rs74816802，rs2160517，rs2193149，rs966664，rs1805476，rs1806201，rs1805522，rs3764030，rs1019385） in subjects were genotyped. Haploview 4.2 software was used to perform linkage disequilibrium （LD）analysis，and Pearson correlation was used to analyze haplotype. Distribution differences of wild homozygote （AA），mutant heterozygote （Aa）and mutant homozygote （aa） genotypes at 12 loci of GRIN2B gene between 2 groups were analyzed statistically by using GENO ，TREND，DOM and REC. Logistic regression model was used to analyze the correlation of epilepsy induction among 12 loci of GRIN2B gene. RESULTS ： Totally 12 loci of GRIN2B gene were all in line with Hardy-Weinberg equilibrium in 2 groups（P＞0.05）. There was an obvious LD phenomenon between the block 1 composed of rs 11055514，rs11055515，rs12814951，rs74816802，rs2160517，rs2193149 and rs966664 and the block 2 composed of rs 3764030 and rs 1019385（D’＞0.9，r2＞1/3）. There was a correlation between CGGACAG monoploid in block 1 and the occurrence of epilepsy （P＜0.05）. There was statistical significance in the distribution difference of rs74816802 and rs 2193149 between 2 groups（P＜0.05）. The mutation of rs 2193149 locus may cause epilepsy （addition and effect of alleles ：OR＝1.529，L95＝1.017，P＝0.041）. CONCLUSIONS ：The mutation of GRIN2B gene rs 2193149 locus may be one of the risk factors of epilepsy in Han population from south Fujian.  
        关键词：N-methyl-D-aspartate;GRIN2B;Gene polymorp hism;Epilepsy;Correlation   
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      • ZHANG Mengyuan,LYU Yuan,HONG Xiuqin,YI Shanghui,LIU Taocheng
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To systematically evaluate the effects of phenytoin on 3 kinds of cardiovascular disease-related factors （Folic acid ，vitamin B 12 and homocysteine）in epilepsy patients ，and to provide evidence-based reference for clinical treatment of epilepsy. METHODS ：Retrieved from PubMed ，Google scholar ，CJFD，VIP and Wanfang database ，observational studies about using phenytoin （trial group ） versus using no antiepileptics （control group ） on the levels of folic acid ，vitamin B 12 and homocysteine in serum were collected during Jan. 1991-Jan. 2019. After data extraction of included literatures ，quality evaluation with evaluation criteria for cross-sectional study （AHRQ）scale，Rev Man 5.3 and Stata 11 softwares were used for statistical analysis. RESULTS ：A total of 10 studies were included ，involving 745 patients. Meta-analysis showed that the folic acid level of trial group was significantly lower than control group [SMD ＝－0.90，95％CI（－1.18，－0.62），P＜0.001]；the level of homocysteine in trial group was significantly higher than control group [SMD ＝1.22，95％CI（0.73，1.71），P＜0.001]. There was no significant difference in the levels of vitamin B 12 between 2 groups [SMD ＝－ 0.19，95％ CI（－ 0.39，0.02），P＞0.05]. CONCLUSIONS：Phenytoin can reduce the level of folic acid and increase the level of homocysteine in epilepsy patients.  
        关键词：Phenytoin;Epilepsy;Folic acid;Vitamin B 12;Homocysteine;Meta-analysis   
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      • LI Na,ZHANG Ailing,LIU Nan,TANG Shu,SHI Chengcheng
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To accumulate relevant experience of clinical pharmacists consultation ，and to promote clinical safe and rational drug use. METHODS ：From different approaches ，the clinical pharmacists analyzed and evaluated of drug use in 4 consultation cases ，i.e. a patient of pulmonary infection after liver transplantation was treated with antifungal therapy by voriconazole，which resulted in excessive blood concentration of voriconazole ；a hemoptysis patient with pulmonary infection was found fibrinogen decreased ，after treatmented with anti-infective and hemostatic drugs ；a patient with pulmonary infection after lung transplantation ，followed by the increase of urea and creatinine after anti-infective therapy ；a patient with grand mal epilepsy after kidney transplantation was treated with phenobarbital and diazepam ，the blood concentration of tacrolimus decreased significantly. The pharmaceutical consultation opinion was put forward and the treatment plan was optimized by clinical pharmacists. RESULTS ：Clinical pharmacists put forward pharmaceutical consultation suggestions for four consultation cases ， which were adopted by doctors. Case 1 was stopped voriconazole and omeprazole，and changed to pantoprazole for gastric protection. The steady-state valley concentration of voriconazole decreased from 12.38 μg/mL to 6.86 μg/mL，and the liver function of transaminase and total bilirubin were improved. Case 2 was stopped cefoperazone-sulbactam and hemocoagulase ，given vitamin K1，fibrinogen，cryoprecipitation，plasma for symptomatic treatment. The fibrinogen was gradually increased from 0.74 g/L to 2.88 g/L，and then remained within the normal range. Case 3 was adjusted the dosages of nephrotoxicity-related drugs （meropenem， levofloxacin，ganciclovir and Compound sulfamethoxazole were adjusted to 1 g q 12 h，250 mg qd ，94 mg qd and 2 tablets qd respectively）. The renal function indicators of urea decreased from 37.6 mmol/L to 7.8 mmol/L；creatinine decreased from 173 μmol/L to 68 μmol/L；the renal function returned to normal ，and the infectious indicators also improved. Case 4 adjusted the oral dose of tacrolimus increasing to 2 mg q 12 h，and oral dose of Pentaester soft capsule was increasing to 1 g bid. The blood concentration of tacrolimus increased from 0.8 ng/mL to 5.9 ng/mL，which reached the expected value ，and there was no further fluctuation during hospitalization. CONCLUSIONS ：Clinical pharmacists consultation mainly focuses on the following 66295644。 aspects， such as individual treatment p lan adjustment ， judgment and treatment of ADR ，adjustment of medicationplan for special population ，optimization of treatment plan for drug interactions ，so as to guarantee the safe use of drugs in clinic.  
        关键词：Clinical pharmacist;Consultation;Case analysis;Pulmonary infection;Epilepsy;ADR;Drug interaction   
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      • SHEN Guorong,WANG Yong,JIN Tanghui,HONG Xiao,BAO Jian ’an,MIAO Liyan
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To introduce the development and application of automatic dosing and mixing system of intravenous infusion in PIVAS of our hospital. METHODS ：Based on the bar code management system in PIVAS ，combined with automatic mixing equipment ，our hospital developed and designed automatic dosing and mixing system of intravenous infusion which could realize real-time scanning and charging of drugs ，setting parameters of mixed dispensing and automatic dosing and mixed dispensing of intravenous infusion. Compared with manual dispensing model ，work efficiency of 5 staff who dispensed Coenzyme complex for injection and Carbazochrome sodium s ulfonate for injection 300 bags each as well as the amount of drug residues in empty bottle were investigated to evaluate the effects of the system. RESULTS ：The system realized automatic mixing of intravenous infusion. In manual dispensing model and automatic dispensing model ，the mixing efficiency of Coenzyme complex for injection were （96.6±10.0）and（195.2±10.7）bag/h（P＜0.001）；mixing efficiency of Carbazochrome sodium sulfonate for injection were （83.8±12.9）and（118.8±6.7）bag/h（P＜0.001）. The amount of residual liquid in Coenzyme complex for injection empty bottle were （0.09±0.02）and（0.11±0.01）mL；Carbazochrome sodium sulfonate for injection empty bottle were （0.08± 0.02）and（0.12±0.01）mL，which were all lower than the internal control requirements that injected solvent volume was no more than 5％ （0.15 mL）. CONCLUSIONS ：The automatic dosing and mixing system of intravenous infusion could improve the efficiency of intravenous infusion dispensing and reduce the labor intensity of the staff .  
          
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      • QIU Ji,PAN Aihong,DENG Tingting,LI Rui,YANG Zhangwei,DAI Fu
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To design and upgrade the finished infusion label in P IVAS of Hefei Binhu hospital ，so as to improve the safety and effectiveness of intravenous medication. METHODS ：By investigating the experience and suggestions about the use of infusion labels by pharmacists and clinical nurses in PIVAS ，taking clear ，concise，focused，rational layout ，comprehensive information as improving principle ，the infusion label was designed and upgraded. The effect of upgrading were evaluated by the recognition rate of label scanning ，scanning time and rate on label （94 701，113 759 groups，respectively），and the correct rate ， time and rate of drug delivery checking in 30 days before and after upgrading ，as well as satisfaction degree ，which made among PIVAS pharmacists （30），nurses（50）and patients （49）. RESULTS ：The upgraded label simplified part of the content and optimized the layout structure ，removed redundant content ，focused on the patient safety information that nurses needed to pay attention to when checking ，and added the marking of infusion sequence and precautions. By changing the barcode into two-dimensional code and adding hidden display function ，more information about drugs and rational drug use related to the infusion of patients was provided. Compared with original label ，after upgrading ，the recognition rate of new label scanning increased from 99.27％ to 99.96％，the scanning time reduced from 3 518.75 s/d to 2 110.10 s/d，and the scanning rate increased from 0.57 group/s to 0.95 group/s；the correct rate of drug delivery checking increased from 99.73％ to 99.91％，the time of drug delivery checking decreased from 5 423.55 s/d to 4 818.85 s/d，and the speed of drug delivery checking increased from 0.36 group/s to 0.41 group/s. The satisfaction degree of pharmacists ，nurses and patients were increased from 70.00％ to 93.33％，from 62.00％ to 90.00％，from 20.40％ to 89.80％，respectively. CONCLUSIONS：The design and upgrading of infusion labels can improve the working efficiency of staff ，and improve the quality of pharmaceutical care and nursing care ， and satisfaction， promote the improvement on the safety and effectiveness of intravenous medication for patients.  
        关键词：PVIAS;Finished infusion label;Information display;Design and upgrade;Rational drug use   
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      • MEI Dan,DU Liping,ZHANG Yuxuan
        Vol. 31, Issue 3, (2020)
        摘要：OBJECTIVE：To provide reference for summarize the management and clinical use levels of biosimilar products . METHODS：Related policies and regulations about approval and application of biosimilar products were retrieved from domestic and foreign supervision departments and WHO. The biosimilar products were described from multi-dimensional aspects of whole life cycle of drugs ，generic name and prescription ，indication extrapolation ，clinical drug exchange ，pharmacovigilance，medical insurance payment system ，education and training. RESULTS & CONCLUSIONS ：Biosimilar products refer to therapeutic biological products which are similar to the reference drugs which have been approved for marketing in terms of quality ，safety and effectiveness. In R&D ，production，circulation，use and supervision links，the management of biosimilar products has its own characteristics in different countries/areas/organization. In the R&D stage ，biosimilar products do not need to independently verify their safety and effectiveness ，but only step by step use analytical methods to gradually clarify their high similarity with reference drugs in terms of structure and function. The name of biosimilar products in China is the same as that of the original drugs ，and the general name was used in prescription. For FDA to approve the indication extrapolation of biosimilar products ，it needs to be based on the data and information at the time of application ，the safety and effectiveness information of reference drugs ，and the consideration of relevant scientific elements of indications. It needs to be evaluated and used conditionally under supervision. The standard of FDA approval is strict，that is to say ，the approval standard of realizing interchangeability is higher than that of biological similarity which has no such concept in China. The enterprise community ，regulatory agencies ，academic institutions and hospital drug rooms need to communicate and exchange ，and further strengthen post market risk control and safety monitoring. China’s medical insurance department should establish an appropriate payment system and encourage the use of biosimilar products through the payment system. Meclical workers should learn the characteristics of biosimilar products so that they can make good use of biosimilar products in practice on the basis of understanding their technical evaluation.  
        关键词：Biosimilar products;Drug management;Clinical application   
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