最新刊期
      卷 31 ， 期 24 ， 2020
      • WEI Lin,LI Chunlei
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To pr ovide refe rence for the future research on drug safety legislation and scientific law enforcement and justice. METHODS ：The journal articles published from Jan. 1st，1985 to Dec. 31st，2019 in CNKI were searched by using “subject＝drug crime ，food and drug crime or drug and criminal law ”as retrieval words but without “subject＝drug”. By screening literature，with the emphasis on the content ，with the help of CiteSpace 5.6.R4 software，the legislative dynamics of drug safety and typical drug injury events in China were sorted out and analyzed. The development of the research on drug safety crimes in China were analyzed from four aspects ：research output ，research academic groups ，research discipline perspective and research focus. From the aspects of criminal policy ，criminal legislation ，major drug injury cases ，administrative supervision concept and administrative legislation ，the factors influencing the research changes in each stage were combed and excavated ；on this basis ，the relevant researches on drug safety crime were reviewed and suggestions were put forward for its improvement path. RESULTS & CONCLUSIONS：A total of 852 literatures were retrieved ，and 473 valid literatures were included. The research on crimes against drug safety in China has gone through the exploration period （1985-1996），transition period （1997-2010）and vigorous period （2011-2019）. The number of achievements has been increasing ，and the scale of academic groups has continued to expand ， forming a discipline distribution with criminal law research as the main research ，public security science research as the auxiliary ， and natural science research as the foreign aid ，focusing on the issues of legislation ，judicature and criminal law value ，for example，various academic researches was conducted with major hazardous drug cases as the breakthrough point. Among the influential factors of the researches on drug safety crime ，criminal policy and legislation ，administrative legislation and regulatory evolution were the internal logic ，and the sudden drug injury cases were the important external factors. For this purpose ，to promote theoretical innovation and practical exploration of drug safe ty crime research ，research on drug safety crime in the future should focus on the whole chain of drug safety ， using method and empirical research methods.  
          
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        发布时间：2022-06-21
      • JIANG Rong,GE Wenxia,SHAO Rong
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To improve the willin gness of chinese pharmaceutical enterprises to participate in drug patient assistance programs ，improve the level of drug use and access to innovative drugs in China and fully evaporate the supplementary role of the medical security system. METHODS ：Through grounded theoretical analysis of the interview results ，the theoretical framework of the factors affecting the implementation of drug patient assistance programs by pharmaceutical companies was proposed. The above theoretical framework was empirically studied through questionnaire survey on the personnel who understood or participated in drug patient assistance program in Chinese pharmaceutical enterprises. Based on partial least squares structural equation model ，Smart PLS 3.0 software was used for data processing to analyze the influence of different factors on the willingness of pharmaceutical companies to participate in drug patient assistance programs ，and the relevant suggestions were put forward. RESULTS & CONCLUSIONS ：Economic benefits ，market competition ，social benefits and policy environment have significants impacts on the willingness of pharmaceutical enterprises to implement drug patient assistance programs. The path coefficients were 0.244 （P＜0.01），0.236 （P＜0.01），0.235 （P＜0.05），0.228 （P＜0.01）. Human resource efficiency and cooperation unit have no significant effects on the willingness of pharmaceutical enterprises to implement drug patient assistance programs（P＞0.05）. Economic benefits are in line with the nature of enterprises ’profit-making and have the most close influence. Therefore，the pricing strategy of drugs and the tax policies of government departments are very important for enterprises. Participation in market competition is also an important factor for enterprises to participate in patient assistance programs. The earlier the implementation of patient assistance ，the more opportunities of relevant drugs will be to seize more markets. The social benefits manifest as reducing the economic burden of patients ，improving the quality of life ，and promoting the social and economic development. At the same time ，enterprises have set up good social image and forms a word-of-mouth effect. The policy environment generally includes the legal environment and medical insurance policies. The legal provisions restrict the donations of pharmaceutical enterprises to a certain extent ，but corresponding regulatory measures are still essential. Medical insurance policies are closely related to the establishment and adjustment of patient assistance programs ，and the connection between medical insurance access and patient assistance programs needs to be further improved. Therefore ，from the perspective of enterprises ，it is recommended to establish a cost and benefit calculation system for drug patient assistance programs ，and broaden the publicity channels and increase the publicity intensity of patient assistance programs. From the perspective of the government ，it is recommended that tax incentives for donations should be increased，the patient assistance supervision system should be improved ，the access and adjustment rules for the drugs of patient assistance programs in medical insurance list should be clarified ，so as to promote pharmaceutical enterprises to actively participate in patient assistance programs and improve the drug use level and drug accessibility of patients.  
        关键词：Patient assistance programs;Pharmaceutical enterprises;Behavioral willingness;PLS-SEM   
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        发布时间：2022-06-21
      • LIU Yuyan,ZHANG Xianglin
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To provi de reference for drug admini stration supervision of biosimilars in China. METHODS ： Referring to the authoritative documents of the official websites of National Medical Products Administration of China ，FDA of the United States ，European Drug A dministration and Japan ’s D rug and M edical Devices Agency ，and comparing their regulatory measures on the definition ，effectiveness，safety and clinical application of biosimilars，the suggestions were put forward for the improvement of regulatory measures of biosimilars in China. RESULTS & CONCLUSIONS ：Although the definitions biosimilars in different countries/regions were different ，they all required that biosimilars should have the same drug quality ，safety and effectiveness as their corresponding reference drugs. The United States ，the European Union and Japan required enterprises to provide studies on the similarity of early pharmacy ，non-clinical studies such as pharmacology and toxicology ，and clinical studies on immunogenicity ，pharmacokinetics and pharmacodynamics of biosimilars and reference drugs. However ，the similarity between biosimilars and reference drugs had not been required in China. All countries/regions supported the extrapolation of indications of biosimilars. Among which the United States and the European Union required manufacturers to provide detailed data ；Japan only mentioned the relevant concepts of indications extrapolation of biosimilars，but did not mention the specific data requirements. The relevant description of the conditions for the extrapolation of biosimilars in China was not clear enough ，and its application in China was still facing great challenges. In terms of drug interchangeability ，although the United States allowed the use of interchangeable biosimilars to replace reference drugs under the conditions permitted by state laws ，no relevant biosimilars had been approved；European countries had different regulations on the interchangeability of biosimilars；but there was no document explicitly mentioned in China and Japan on the interchangeability of biosimilars. It is suggested that the principle of comparison should be further improved and strict requirements should be appropriately enforced in ensuring the effectiveness and safety of biosimilars；in the field of indication extrapolation ，more detailed data requirements should be put forward ，and the possible risks after extrapolation should be evaluated scientifically ；in terms of the interchangeability of biosimilars ，it is suggested to try to implement the principle of conversion of biosimilars ，but it should be used after consultation among doctors ，pharmacists and patients，and drug use safety should be monitored timely. Meanwhile ，a sound traceability system should be established to ensure drug safety of patients.  
        关键词：Biosimilars;Effectiveness;Safety;Indication extrapolation;Interchangeability;The United States;Japan;Europe   
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        发布时间：2022-06-21
      • PAN Shumao,ZHANG Xinyou,WU Diyao,GUO Yongkun,DING Liang,TAN Rongzhen
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To estab lish“TCM Data Analysis Platform Based on Strategy Pattern ”（TCMDP），and to analyze the medication rules of TCM prescription against primary hepatic carcinoma （PHC），so as to provide reference for TCM prescription screening. METHODS ：According to the idea of strategy pattern ，TCMDP software was developed ，and the frequency statistics，association，clustering，classification and other methods and the different algorithms covered were encapsulated. Effective TCM prescriptions against PHC were collected and screened from 4 tertiary-grade class-A hospitals in Nanchang city and CNKI ， PubMed. A database of prescriptions for PHC （PDOPHC）was established ，and TCM prescriptions in the data base were put into TCMDP. Clustering algorithm modified by CMC-DD ，modified WD-Get Rules algorithm after merging depth and width search and frequency statistics were used to analyze the distribution of prescription syndrome. Taking phlegm-blood stasis syndrome type （TYPHC）as example ，data mining was carried out on drug efficacy category ，four properties ，five flavors and channel tropism ， drug property combination ，key couplet medicines and key drug combination. RESULTS ：A total of 907 TCM prescriptions against PHC were collected ，mainly involving 10 syndrome types ，such as phlegm-blood stasis syndrome ，deficiency of the vital essential and blood stasis syndrome and liver and spleen blood stasis syndrome. TCM related to TYPHC commonly used in pre- scriptions were tonifying deficiency medicine ， phlegm-re- solving medicine ，promoting blood circulation and removing blood stasi s medicine ，etc．Four properties were mostly cold ，warm and calm ；the five flavors were most ly swe et，bitter and pungent ；channel tropism were mostly spleen ，liver，stomach， lung，heart and kidney ；drug combination were mostly warming-sweet-spleen ，warming-pungent-spleen and cold-bitter-liver ，etc.； there were 36 couplet medicines with frequency ≥30 times；there were 31 strong association rules and 8 key drug combinations in the prescriptions. WD-Get Rules results showed that in the TCM prescriptions against PHC ，Atractylodes macrocephala ，Codonopsis pilosula，Poria cocos and Glycyrrhiza uralensis were in the key position. They were often combined with many kinds of drugs ， which were related to the effect of Sijunzi decoction on strengthening Qi and tonifying spleen. CMC-DD results showed that therapy for TYPHC focused on strengthening the spleen and stomach ，replenishing Qi and blood ；and at the same time ，it treated TYPHC with phlegm-blood stasis syndrome from multiple angles ，such as soothing the liver and regulating Qi ，eliminating phlegm ，clearing heat and detoxification ，promoting blood circulation and nourishing Yin. CONCLUSIONS ：Clinical treatment of TYPHC mainly adopts the methods of invigorating the spleen and replenishing Qi ，soothing the liver and regulating Qi ，promoting blood circulation and removing blood stasis ，which conforms to the medication principle of “strengthening the body and eliminating pathogenic factors”. The application of TCMDP can realize the data mining and analysis of TCM in multi-level and multi-directional way ， which provides a new and effective way for the mining and research of compatibility rules of TCM prescriptions.  
          
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        发布时间：2022-06-21
      • LIU Kedi,DUAN Jialin,SU Jing,TAO Xingru,ZHAO Shi,BAI Yang,WEI Peifeng,XI Miaomiao
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To study the protective effects of butein on oxidative stress injury of PC12 cell and its effects on mitochondrial function. METHODS：Rats PC12 cells were divided into normal control group，model group，solvent control group（1 ‰ dimethyl sulfoxide），butein high，medium and low concentration groups（2，1，0.5 μmol/L）. The latter 4 groups were given relevant reagent/medicine for intervention；24 h later，other groups were given 100 mU/mL glucose oxidase to induce oxidant stress model except for normal control group. After 4 h culture，cell survival rate，apoptosis rate，the levels or activities of ROS，MDA，SOD，CAT，GSH-Px，ATP，IL-1β and TNF-α as well as the change of MMP were detected. RESULTS：Compared with normal control group，cell survival rate，the levels or activities of SOD，CAT，GSH-Px and ATP were all decreased significantly，and apoptotic rate，the content of ROS，the levels of MDA，IL-1β and TNF-α were all increased significantly（P＜0.05 or P＜0.01），while the MMP was decreased significantly. Compared with model group，above indexes of solvent control group had no significant change （P＞0.05），cell survival rates，the levels or activities of SOD （except for medium and low concentration groups），CAT，GSH-Px（except for medium and low concentration groups），ATP（except for low concentration group）were increased significantly in butein high，medium and low concentration groups，while apoptotic rates，the content of ROS，the levels of MDA，IL-1 β and TNF-α were decreased significantly（P＜0.05 or P＜0.01），while the MMP were increased significantly. CONCLUSIONS：Butein can increase the antioxidant enzyme activity， stabilize mitochondrial function， inhibit oxidative stress and inflammationthus， increase energy generation inhibiting neuronal cell apoptosis ultimately exerting a neuroprotective effect.  
        关键词：Butein;PC12 cell;Oxidative stress;Mitochondrial function;Inflammation;Apoptosis;Neuroprotection   
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        发布时间：2022-06-21
      • HAN Xianzhong,SHEN Zhengze,YUAN Wenxiao,HUANG Yingru,DING Jiayu
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To compare the protective effects model mice between the aboveground and underground parts of Astragalus membranaceus on immunosuppression ，and to provide reference for further utilization and development of A. membranaceus. METHODS ：A total of 240 ICR mice were divided into 4 batches，60 mice in each batch ，with half male and half female. Each batch of mice were randomly divided into blank group ，model group ，A. membranaceus aboveground part and undergroud part low-dose and high-dose groups （3，6 g/kg，by crude drug ）according to body weight and sex ，with 10 mice in each group. Blank group and model group were given normal saline intragastrically. A. Membranaceus groups were given corresponding concentration of drug intragastrically ，10 mL/kg，once a day ，for consecutive 30 days. Except for blank group ， other groups were intraperitoneally injected with cyclophosphamide 40 mg/（kg·d）for consecutive 3 days，since 24th day of treatment，to establish immunosuppression model. The levels of serum immunoglobulin （IgG，IgM，IgA），inflammation factors [nitric oxide ，interleukin-2（IL-2），IL-6，tumor necrosis factor-α] and half hemolysis value were detected in each group. Body weight ，thymus index ，spleen index ，phagocytic index ，activity of natural killer （NK）cell，splenic lymphocyte proliferation ability，dinitrofluorobenzene-induced delayed metamorphosis reaction in mice （by weight difference between left and right ears ） and the number of hemolytic plaque were determined. RESULTS ： Compared with blank group ， the serum levels of immunoglobulin，body weight ，thymus index ，spleen index ，phagocytic index ，NK cell activity ，the proliferation ability of splenic lymphocyte，the number of hemdytic plaque and half hemolysis value were decreased significantly in model group （P＜0.05）， while inflammation factor level as well as weight difference between left and right ears were increased significantly （P＜0.05）. Compared with model group ，above indexes of mice in A. membranaceus groups were improved significantly ，in dose-dependent manner（P＜0.05）. Compared with A. membranaceus undergroud part group ，above indexes of A. membranaceus aboveground part group were improved significantly （P＜0.05）. CONCLUSIONS ：Aboveground and underground part of A. membranaceus both have pretective effect on immunosuppression model mice ，and the effect of aboveground part of A. membranaceus is stronger than underground part of A. membranaceus .  
        关键词：Astragalus memb ranaceus;Aboveground part;Underground part;Immunity;Pharmacodynamics   
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        发布时间：2022-06-21
      • LI Yangyang,ZHANG Yiming,WEI Kongxi,ZHOU Ting,HE Jinpeng,DING Nan,ZHOU Gucheng,SHI Tongfan,KE Yicheng,NIU Fan,LIU Yongqi,ZHANG Liying
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To compare the protective effects of different effective components of Astragali radix against DNA damage of human bone marrow mesenchymal stem cells （BMSCs）induced by ionizing radiation. METHODS ：2 Gy X-rays were used to directly irradiate BMSCs to establish a radiation model. CCK- 8 method was used to detect the effects of different mass concentrations（25，50，75，100 μg/mL）of astragalus polysaccharide ，astragalus saponin and astragalus flavonoids for 1 day before radiation + 1 to 5 days after radiation on the proliferation of BMSCs. The dose concentration and the duration of intervention after radiation were selected. The irradiated BMSCs were divided into radiation group ，astragalus polysaccharide group ，astragalus saponin group and astragalus flavonoids group. The last three groups were treated with appropriate dosage of corresponding drugs before and 2 days after radiation ，and a blank groupwas set for comparison. Cytoplasmic division arrest qq.com micronucleus method was used to detect micronucleus cell rate and cell micronucleus rate after appropriate time of was used to detect th e number of 53BP1 foci in cells after appropriare time of intervention following radiation ；the number of 53BP1 foci were compared among different time points （0.5，2，12，24 h）. RESULTS ：Compared with blank group ，OD values of BMSCs were decreased significantly in radiation group （P＜0.05 or P＜0.01）. Compared with radiation group ，the OD values of BMSCs were significantly increased when 50 μ g/mL astragalus polysaccharide，astragalus saponin and astragalus flavonoids continuously intervened radiation for 2-3 days，there was significant difference in other groups at some time point （P＜0.05 or P＜ 0.01）. After consideration ，drug concentration was determined to be 50 μg/mL，and the continuous intervention time was 2 days after radiation. Compared with blank group ，the micronucleus cell rate and cell micronucleus rate of radiation group ，astragalus polysaccharide group ，astragalus saponin group and astragalus flavonoids group increased significantly ，and the number of 53BP1 focus cluster in radiation group and astragalus polysaccharide group increased significantly （P＜0.01）. Compared with radiation group and astragalus flavonoids group ，the micronucleus cell rate ，cell micronucleus rate and the number of 53BP1 focus cluster （continued intervention for 0.5，2，12 h）in the astragalus polysaccharide group and astragalus saponin group were significantly reduced，and the micronucleus cell rate and cell micronucleus rate in the astragalus polysaccharide group were significantly lower than astragalus saponin group （P＜0.05）. 53BP1 focus cluster could not be detected 24 h later （P＜0.05）. CONCLUSIONS ： Astragalus polysaccharide and astragalus saponin both have protective effects on BMSCs DNA damage induced by radiation ，and the protective effect of astragalus polysaccharide is better than that of astragalus saponin ；astragalus flavonoids has no protective effect on radiation-induced DNA damage.  
          
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        发布时间：2022-06-21
      • QIAO Juhui,ZHAO Daqing,LIU Meichen,SUI Bowen,LIU Ying,XING Xin
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To study the improvement effects of total ginsenosides on the senescence of PC 12 cells induced by D-galactose and its mechanism. METHODS ：Rat pheochromocytoma （PC12）cells were treated with D-galactose to establish cell senescence model. CCK- 8 method was used to screen the D-galactose modeling concentration and total ginsenosides concentration. Normal control group ，model group ，total ginsenosides low and high concentration groups were set up. Cell senescence ，cell apoptosis rate ，apoptotic cycle and mitochondrial membrane potential （MMP），cell adenosine triphosphate （ATP）and reactive oxygen species （ROS）levels in each group were detected. The expression of apoptosis related proteins [B lymphoma 2（Bcl-2）and its related egg X protein （Bax），cytochrome C （Cyt-C）] and oxidative damage related proteins [nuclear factor 2 related factor 2 （Nrf2），heme oxygenase 1（HO-1）] were detected. In addition ，positive drug group [ 5 mmol/L N-acetyl-L-cysteine（NAC）] and positive control group [ D-galactose+5 mmol/L NAC] were set up to compare the levels of oxidative damage related proteins. RESULTS：D-galactose could significantly inhibit the survival rate of PC 12 cells，with a critical concentration of 20 mg/mL. The total ginsenosides could significantly increase the survival rate of D-galactose induced senescent cells with a median effective concentration（EC50）of 65 μg/mL，and then the low and high concentrations of total ginsenosides were set at 55 and 65 μg/mL. Compared with normal control group ，the number of aging cells increased ，the apoptotic rate and percentage of G 1 phase were significantly increased i n model group. the percentage of S phase ，MMP and ATP contents ，the protein expression of Bcl- 2 and Cyt-C in mitochondria were decreased significantly ，whileROS content ，the protein expression of Bax ，Nrf2 and Cyt-C protein in endochylema were increased significantly （P＜0.05 or P＜0.01）. Compared with model group ，the number of E-mail：sunqiao150509@163.com aging cells reduced ，the apoptosis rates and percentage of G 1 phase were significantly decreased in total ginsenosides low and high concentration groups ，the percentage of S phase ，the contents of MMP and ATP （except for low concentration group ），protein expression of Bcl- 2，Nrf2 and HO- 1 as well as protein expression of Cyt-C in mitochondria were increased significantly ；ROS level （except for low concentration group ）and Bax protein as well as protein expression of Cyt-C were decreased significantly. The protein expression of Nrf 2 and HO- 1 were increased significantly in positive control group （P＜0.05 or P＜0.01）， but it was lower than that of total ginsenosides groups . CONCLUSIONS：Total ginsenosides can improve D-galactose induced senescence of P 12 cells，the mechanism of which may be related to activating Nrf 2 antioxidant signal pathway to antagonize D-galactose induced oxidative stress and alleviating mitochondrial dysfunction.  
        关键词：Total ginsenosides;D-galactose;PC12 cells;Senescence;Mitochondria;Apoptosis related protein;Oxidative   
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        发布时间：2022-06-21
      • WANG Xiaoyan,CHANG Junmin,GUO Changrun,CHEN Li
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：The establ ish the qu ality standard of Achyranthes bidentata decoction pieces and establish the fingerprint of decoction pieces of different origins. METHODS ：TLC method was used to identify A. bidentata decoction pieces. The contents of water ，total ash and ethanol-soluble extract in A. bidentata decoction pieces were determined according to the method in 2015 edition of Chinese Pharmacopoeia （part Ⅳ）. UV spectrophotometry was used to determine the content of total steroid. The content of β-ecdysterone in A. bidentata decoction pieces was determined by HPLC. HPLC method was used to establish the fingerprint of 10 batches of A. bidentata decoction pieces. Using β-ecdysterone（No. 10 peak）as reference ，similarity evaluation was conducted by using Similarity Evaluation System for TCM Chromatographic Fingerprints （2012 edition），and the common peaks were determined. SPSS 21.0 software was used for cluster analysis and principal component analysis so as to evaluate the comprehensive quality of A. bidentata decoction pieces. RESULTS ：Results of TLC identification showed that the spots with the same color on the corresponding positions of β-ecdysterone and ginsenoside Ro control in chromatogram of test sample. The average water content of 10 batches of A. bidentata decoction pieces was 4.07％ -6.33％ . The total ash content was 5.04％ -6.43％ . The ethanol-soluble extract was 6.57％ -11.12％ . The linear range of total sterone （by β-ecdysterone） and β-ecdysterone were 0.01-0.08 mg/mL and 68.5-479.5 µg/mL （R2＞0.999）， respectively. RSDs of precision ，stability and repeatability tests were all less than 3％. The average recovery rates were 98.85％（RSD＝1.89％，n＝6）and 100.34％（RSD＝ 2.12％，n＝9），respectively. The average contents were 0.34％-0.56％ and 0.07％-0.09％，respectively. There were 24 common peaks in 10 batches of A. bidentata decoction pieces ，and the similarity was all over 0.900. Cluster analysis results showed that 10 batches of A. bidentata decoction pieces could be grouped into 4 categories，among which S 1，S3，S6 and S 10 were one category ， S2，S7 and S 8 were one category ，S4 and S 9 were one category ，and S 5 was one category. The results of principal component analysis showed that the cumulative variance contribution rate of the first four principal components was 86.774％. The order of comprehensive quality is S 8＞S5＞S9＞S4＞S3＞S7＞S6＞S10＞S2＞S1. CONCLUSIONS ：The established quality standard ， content deter mination method and HPLC fingerprint are stable and accurate ，and can be used for the quality evaluation of A. bidentata decoction pieces. Δ 基金项目：国家科技部重点研发计划（No.2018YFC1707105） ＊硕士研究生。研究方向：中药质量控制。E-mail：995354085@  
          
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        发布时间：2022-06-21
      • JIAO Meiyu,TONG Yue,WU Haoshan,KANG Tingguo,ZHANG Hui
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To investigate the internal mechanism of Schisandra sphenanthera and Schisandra chinensis in determining quality by color （“color discrimination grading ”）of medicinal materials ，and to construct a qualitative identification model based on color quantization value. METHODS ：HPLC method was used to determine the contents of 6 active components from 39 batches of samples. The colorimeter was used to determine 3-color spatial value [lightness value （ΔL＊），red-green value （Δa＊），yellow-blue value （Δb＊）]. SPSS 24.0 statistical software was used to analyze the correlation between the contents of 6 active components and 3-color spatial values. Principal component analysis （PCA）was performed by using SIMCA-P 14.1 software. RESULTS：The linear range of schizandrol A ，schizandrol B ，schisandrin A ，schisandrin B ，schisandrin C ，schisantherin A were 0.204 8-2.560 0，0.049 3-0.616 3，0.098 4- 1.230 0，0.046 3-0.578 8，0.010 6-0.132 0，0.100 0-1.500 0 μg（r＞0.999 0）；RSDs of precision ，stability（12 h）and repeatability tests were all less than 3％. The recoveries were 98.14％-101.53％（RSD＝1.08％， n＝6），97.16％-101.05％（RSD＝1.54％，n＝6），98.29％-101.41％（RSD＝1.29％，n＝6），97.17％-100.36％（RSD＝1.20％，n＝ 6），97.32％-102.43％（RSD＝1.77％，n＝6）and 98.02％-100.40％（RSD＝0.84％，n＝6），respectively. Among 39 batches of components were 3.25-7.39，0.96-1.98，0.46-4.74，1.62-2.60， 0.06-0.58，0.48-6.11 mg/g，respectively. Average S. chinensis was － 80.79-－ 70.54， average Δ a ＊ was qq.com # 通 2.54-5.34，average Δb＊ was 5.20-12.83，average ΔE＊ was 71.13-81.23；average ΔL＊ of S. sphe nanthera was －75.90- －69.16，average Δa＊ was 3.77-7.82，average Δb＊ was 8.59-17.23，average ΔE＊ was 69.99-77.92. The results of relationship analysis showed that the contents of schizandrol A ，schizandrol B ，schisandrin A ，schisandrin B and schisantherin A were significantly correlated with ΔL＊，Δa＊，ΔE＊（P＜0.01），with no significant correlation with Δb＊（P＞0.05）. There was a negative correlation of the content of schisandrin C with ΔL＊ and Δa＊（P＜0.05），and there was no significant correlation with Δb＊ and ΔE＊ （P＞0.05）. Results of PCA showed that accumulative variance contribution rate of primary 2 main components was 89.8％，and S. sphenanthera and S. chinensis could be identified significantly. CONCLUSIONS ：The content of schizandrol A in S. chinensis is high relatively ，and content of schisantherin A in S. sphenanthera is high relatively. Schizandrol A ，schizandrol B and schisandrin B were not detected in S. sphenanthera . The 3-color spatial value of S. sphenanthera and S. chinensis are different ，that is ，the brightness of S. chinensis is small and the color is slant black ，while the color of S. sphenanthera is slant red and yellow. The contents of active components of S. sphenanthera and S. chinensis is related to the surface 3-color spatial values ，that is ，the darker the color is ，the weaker the red degree is ，and the higher the contents of schizandrol A ，schizandrol B ，schisandrin B and schisandrin C are ；the brighter the surface color is ，the stronger the red degree is ，and the higher the contents of schisandrin A and schisantherin A are. The established content determination method is precise and stable ，and can be used for the content determination of S. sphenanthera and S. chinensis . The color qualitative identification model can be used for the identification of S. sphenanthera and S. chinensis .  
          
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      • ZENG Zhaojun,HONG Wanmin,ZHONG Rufan,HU Yao,PAN Ling,GAN Li
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To establish an overall quality evaluation model for Agrimonia pilosa based on extract and characteristic spectrum，and to provide evidence for comprehensive quality evaluation of the medicinal material and screening of high-quality provenance. METHODS ：Referring to different extraction method and solvent condition stated in 2015 edition of Chinese Pharmacopoeia （part Ⅳ），using the content and total peak area of HPLC characteristic chromatogram of extract as indexes，and the extraction technology was optimized by weighted comprehensive score. HPLC characteristic spectrum of 15 batches of A. pilosa was established ，and similarity evaluation and characteristic peak identification were performed. SPSS 25.0 software was used to conduct single factor analysis and Pearson correlation analysis for the extract content and total peak area of A. pilosa from different origins. The quality of medicinal materials from different origins were compared. Entropy weight TOPSIS method was adopted to evaluate comprehensive quality of A. pilosa using the extract content and total peak area of 15 batches of A. pilosa . RESULTS ：The extraction technology of A. pilosa extract，which was extracted with hot dip plating using 50％ ethanol as solvent ，was optimized. The similarity of 15 batches of A. pilosa was higher than 0.92，and 4 characteristic components were identified（ellagic acid ，quercetin，apigenin，kaempferol）. There were significant differences in average extract content and total peak area of characteristic chromatogram of A. pilosa from different origins （P＜0.05 or P＜0.01），and there was a certain positive correlation between them （r＝0.86，P＜0.01）. Results of entropy weight TOPSIS evaluation showed that the average Ci values of A. pilosa in Anhui ，Zhejiang，Sichuan，Henan and Jiangsu provinces were 0.689，0.351，0.218，0.308 and 0.361 respectively. CONCLUSIONS：The quality of A. pilosa from Anhui was the best ，that from Zhejiang and Jiangsu was better ，that from Henan was the second ，and that from Sichuan was poor. Established extraction technology and characteristic spectrum determination method of A. pilosa are stable and feasible. The entropy weight TOPSIS model is objective and quantifiable for comprehensive quality evaluation of A. pilosa ，and can effectively evaluate its quality.  
          
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      • ZHANG Dandan,WANG Tianhe,YU Yi,HU Minghua,LI Huijun,XIA Heyuan,LUO Xinyao,YANG Yuying,YE Xiaochuan
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To study “Qi-invigorating”effect and its possible mechanism of total saponins of Astragalus membranaceus on rats with Qi-deficiency ，and to provide reference for elucidating the material basis of “Qi-invigorating”effect of A. membranaceus . METHODS ：Forty male Wistar rats were randomly divided into normal group ，model group ，positive control group [Buzhong yiqi pills ，4.5 g/（kg·d）]，A. membranaceus total saponins high-dose and low-dose groups [ 252，28 g/（kg·d），by the amount of total saponins] according to body weight ，with 8 rats in each group. Except for normal group ，the model of Qi-deficiency was made in other groups by the method of “diet disorder+fatigue ”. At the same time ，administration groups were given relevant medicine intragastrically ，and normal group and model group were given constant volume of water，once a day ，for consecutive 21 days. After last administration ，the general situation of rats was observed ；the body weight ，spleen index and thymus index of rats were detected ；weight-bearing swimming time was recorded ；the levels of spleen T lymphocyte subsets CD 3 and CD 4，the levels of ATP and ADP in liver tissue ，serum levels of ALB ，RBC and HBG in blood as well as the serum levels of SOD，MDA，lactate，LDH，CK，IL-2，IL-12 and TNF-α were all detected. RESULTS：Compared with normal group ，body weight，thymus index ，spleen index ，weight-bearing swimming time ，the level of spleen T lymphocyte subsets CD 3，ATP，ADP， ALB，IL-2 and IL- 12 were decreased or shortened significantly in model group （P＜0.05 or P＜0.01）. The levels of MDA ， lactate，CK and TNF-α were increased significantly （P＜ 0.05）. Compared with model group ，body weight ，spleen index，weight-bearing swimming time ，the level of spleen T lymphocyte subsets CD 3 and the levels of ATP ，ADP，ALB， RBC and IL- 2 were increased significantly or prolonged（P＜0.05）；while the levels of MDA ，lactate，CK and TNF-α were decreased significantly in A. membranaceus total saponins high-dose group（P＜0.05 or P＜0.01）.Weight-bearing swimming time ，the levels of ATP ，ADP and IL- 2 in A. membranaceus total saponins low-dose group were increased significantly or prolonged （P＜0.05 or P＜0.01），while the levels of MDA ，lactate，CK and TNF-α were decreased significantly （P＜0.05 or P＜0.01）. Compared with positive control group ，spleen index ，spleen T lymphocyte subsets CD 3，weight-bearing swimming time and ATP level of A. membranaceus total saponins high-dose group were increased significantly or prolonged （P＜0.05 or P＜0.01），while MDA levels of A. membranaceus total saponins high-dose and low-dose groups were decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ：A. membranaceus total saponins can reduce the body ’s accumulation of blood lactic acid ，the activity of CK ，the level of lipid peroxide and regulate immunity to tonify Qi ，delay fatigue and improve exercise ability.  
        关键词：Astragalus membranaceus total saponins;“Qi-invigorating”effect;Mechanism;Qi-deficiency model;Rat   
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      • ZHANG Yongxin,CAO Chunya,GONG Ming
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To stu dy the improvement effect s of Dantaojin （Salvia miltiorrhiza ，Persicae Semen ，Curcumae Radix）extract on oxidative stress of liver and kidney in chronic lead poisoning model mice. METHODS ：Totally 72 mice were randomly divided into normal control group ，model group ，positive control group （dimercaptosuccinate，70 mg/kg），Dantaojin extract low-dose ，medium-dose and high-dose groups （20，40，60 g/kg），with 12 mice in each group. Except for normal control group，other groups were given intraperitoneal injection of lead acetate solution 20 mg/kg（every other day ，consecutive 20 days） to establish chronic lead poisoning model. After modeling ，administration groups were given relevant medicine intragastrically ， normal control group and model group were given constant volume of water intragastrically ，once a day ，for consecutive 20 days. After last medication ，body weight of mice was weighed ，and organ coefficients （kidney and liver ）were calculated. Serum levels of ALT ，AST，BUN and Scr were determined by automatic biochemical detector. HE staining was used to observe histopathological features of liver and kidney. ELISA method was used to determine the levels of GSH-Px ，SDO and MDA in liver and renal tissue. RESULTS：Compared with normal control group ，body weight （except for high-dose group ），the levels of SOD （except for high-dose group ）and GSH-Px were all decreased significantly in model group and Dantaojin extract groups ，while the renal coefficients（except for high-dose group ），liver coefficients （except for low-dose ，medium-dose and high-dose group ），the levels of BUN （except for high-dose group ），Scr，AST（except for high-dose group ），ALT and MDA were increased significantly （P＜ 0.05 or P＜0.01）. The epithelial cells of glomerulus and renal tubules were atrophied ，the arrang ement of hepatocytes was loose and some cells were necrotic. Compared with model group ，body weight ，the levels of SOD and GSH-Px were increased significantly in positive control group and Dantaojin extract groups，while the renal and liver coefficients ，the levels of BUN，Scr，AST，ALT and M DA were decreased significantly（P＜0.05 or P＜0.01）. Histopathological fea tures of liver and renal tissue were improved significantly in Dantaojin extract medium-dose and high-dose groups. CONCLUSIONS ：Dantaojin extract could improve oxidant stress injury in liver and renal tissue，the mechanism of which may be associated with eliminating reactive oxygen radicals ，inhibiting lipid peroxidation and enhancing antioxidant defense ability.  
        关键词：Dantaojin extract;Chronic lead poisoning;Oxidative stress;Anti-oxidation;Mice   
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      • YAO Jingman,LI Yuanhai
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To o bserve the e fficacy and safety of the application of etomidate combined with propofol in diagnosis and treatment of elderly patients with painless tracheoscope. METHODS ：A total of 124 elderly patients with first selective bronchoscopy under general anesthesia were collected from Anhui Chest Hospital during Oct. 2019-May 2020，and then divided into propofol group （group P ），etomidate and propofol group （group EP ）according to random number table ，with 62 cases in each group. At anesthesia induction ，Sufentanil citrate injection 5 µg was slowly injected into both groups. Based on this base，group P was given Propofol injectable emulsion 2 mg/kg intravenously ；after the eyelash reflex disappeared ，group P was given intravenous infusion of Propofol injectable emulsion 4 mg/（kg·h）to maintain sedation and Remifentanil hydrochloride for injection 0.1-0.2 µg/（kg·min）to maintain analgesia. Group EP was given slow intravenous injection of 0.5％ Propofol injectable emulsion 1 mg/kg+0.1％ Etomidate injectable emulsion 0.2 mg/kg；after the eyelash reflex disappeared ，group EP was given intravenous pump of 0.5％ Propofol injectable emulsion+ 0.1％ Etomidate injectable emulision mixture（1 ∶ 1，V/V）20 mL/h to maintain sedation and Remifentanil hydrochloride for injection to maintain analgesia （same usage and dosage as group P ）；at the same time ，2 groups were given intravenous injection of Cisatracurium besilate for injection 0.1 mg/kg，the laryngeal mask was inserted into the anesthesia machine for mechanical ventilation ，and then the laryngeal mask w as placed into the tracheoscope fordiagnosis and treatment. Heart rate （HR） and mean arterial pressure （MAP） were observed in 2 groups at the time of entering the room （T1）， at the time of eyelash reflex disappearing after anesthesia induction （T2），at the beginning of t racheal intubation examination （T3），10 min after the beginning of the exam ination（T4），at the time of anesthesia recovery （T5），and at the time of leaving the room （T6）；operation time，anesthesia recovery time ，the use of vasoactive drugs ，postoperative 4 h cognitive function and adverse reactions were also observed in 2 groups. RESULTS ：Two patients in each group were excluded. At T 1，there was no statistical significance in MAP and HR between 2 groups（P＞0.05）. There was no statistical significance in MAP of group EP among different time points （P＞ 0.05）. MAP and HR of group P at T 2，MAP of group P at T 4，HR of group EP at T 2 were significantly lower than same group at T1，and MAP of group P at T 2 and T 4 were significantly shorter or lower than those of group EP at the same time （P＜0.05）. The anesthesia recovery time ，the incidence of hypotension and the utilization rate of vasoactive drugs in group EP were significantly lower than group P ；memory ability ，calculation ability and orientation force pass rate of group EP were significantly higher than those of group P of 4 h after operation （P＜0.05）. There was no statistical significance in operation time ，the incidence of injection pain，muscle spasm ，nausea and vomiting ，focus ability ，language ability ，structure ability ，reasoning ability pass rate between 2 groups（P＞0.05）. CONCLUSIONS ：Etomidate combined with propofol shows good therapeutic efficacy and safety for elderly patients with painless tracheoscope.  
        关键词：Propofol;Etomidate;Elderly patients;Tracheoscope;Therapeutic efficacy;Safety   
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      • GUAN Yue,GUO Guiping,WANG Jingwen,WANG Mingming,MOU Fei,QIAO Yi,LI Qiongge
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE： To re-evaluate t he methodology quality of published systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression. METHODS ：Retrieved from Cochrane Library ，PubMed，Embase， SinoMed，CNKI，Wanfang database ，VIP，CBM and other databases ，systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression were collected during the inception to Dec. 2019. After literature screening and data extraction ， methodology quality of included literatures were evaluated by using the AMSTAR scale. RESULTS ：A total of 33 systematic reviews/Meta-analysis were included ，involving 523 RCTs and 41 020 patients. Average score of AMSTAR methodological quality evaluation was 6.76. Citalopram ，duloxetine and paroxetine were effective for the therapy of post-stroke depression ，but the conclusions about the effectiveness among antide-pressants were not consistents. The ADR incidence of Paroxetine was low. It was not clear that sertraline and citalopram may improve the neurological function of patients. CONCLUSIONS ：The methodological quality of systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression is medium ，and the conclusions about the effectiveness of antidepressants ，improvement of daily life ability and the recovery of neurological function are still controversial.  
        关键词：Post-stroke depression;AMSTAR scale;Methodology;Quality re-evaluation;Systematic evaluation;Meta-analysis   
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      • LI Suping,WU Xiuping,LIU Yinli,JI Zhihui,LIU Dongmei
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To management recheck and sorting weight for finished intravenous solutions in PIVAS ，to provide reference for reducing dispensing error and improving the safety and quality of intravenous infusion therapy. METHODS ：The weight analysis method was used to determine the weight of main drug and solvent in the finished intravenous solutions and infusion bottle . The weight maintenance information was added in PIVAS information management system ，and the marked weight of finished intravenous solutions was calculated for the verification of finished intravenous solutions. Average daily check quantity of finished product ，checking time ，average checking time of finished products per bag ，detection rate of dispensing error ，external error and timeliness of finished infusion batch were compared before （Mar.-May，2019，n＝83 006）and after （Jun.-Aug.，2019， n＝83 173）management. The effects of weighting recheck management were evaluated. RESULTS ：Compared with before the implementation of weighting recheck management ，there were no significant differences in the average daily check quantity of finished products ，the detection rate of dispensing errors caused by wrong labeling of liquid ，or the times of delayed drug delivery batches after the implementation of weighting recheck management （P＞0.05）. The checking time of finished products ，average checking time of finished products per bag ，the number of bags added or subtracted error ，detection rate of dose dispensing error ， total error detection rate prolonged or increased significantly （P＜0.05），and the number of external error was decreased significantly（P＜0.05）. CONCLUSIONS ：The weighting recheck management improves the accuracy and safety of PIVAS preparation，effectively improves error detection rate ，reduces the occurrence of external error ，but prolongs the time of checking ， which are urgent to be solved by information and automation means.  
        关键词：Pharmacy intravenous admixture service;Weighting recheck management;Weighting analysis method;Finished   
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      • WEI Zenglin,CHEN Xi,MAO Yanmei,XIAO Yiyun,LIU Fangqun
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To provide reference for performance evaluation of pharmaceutical care for clinical pharmacists. METHODS：Based on literature review ，weighted TOPSIS method was used to formulate a performance evaluation system of pharmaceutical care. The performance of 120 pharmaceutical care work of 5 clinical pharmacists in our hospital from Jan. 2017 to Dec. 2018 was evaluated. RESULTS ：The performance evaluation detailed rules of clinical pharmacists ’pharmaceutical care work were successfully constructed ，including pharmaceutical ward round ，medication education ，medication consultation and pharmacy consultation，with a total of 17 evaluation indicators. Among 120 cases，there were 21 cases with relative approach degree ＞0.6 （17.5％）；73 cases had relative approach degree between 0.5 and ＜0.6（60.8％）；26 cases had relative approach degree between 0.4 and ＜0.5（21.7％）. The major problem was that the participation of clinical pharmacists in muti-disciplinary treatment ，the approval of scientific research fund projects were insufficient and not much paper was written. CONCLUSIONS ：The performance evaluation system of clinical pharmacists ’pharmaceutical care work based on weighted TOPSIS method is normative and reasonable，and it can be used in the evaluation of clinical pharmacists ’pharmaceutical care work . The results suggest that there are some defects in the performance of clinical pharmacists ’pharmaceutical care work in our hospital ，which need to be improved.  
        关键词：Weighted TOPSIS method;Clinical pharmacists;Performance evaluation;Pharmaceutical care   
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      • WU Xiaoyan,WEN Xiaoke,FENG Binbin
        Vol. 31, Issue 24, (2020)
        摘要：OBJECTIVE：To optimize the ant i-infective treatment plan for the super-premature infants and provide reference for the clinical treatment of the super-premature infants and the whole pharmaceutical care. METHODS ：A super-premature infant with gestational age of 25+5 weeks and weight of 400 g was delivered in the second department of neonatology in Hunan Maternal and Child Health Hospital. This child suffered from complex complications. Clinical pharmacists ，relevant medical staff and hospital infection department personnel formed a multidisciplinary treatment team. According to Neonatal Sepsis Treatment Scheme ， Antimicrobial Treatment Guide ，Premature Medicine ，combining with the analysis of infection indicators ，biochemical indicators ， vital signs and other indicators ，a individualized anti-infective diagnosis and treatment plan was developed for the child. After entering the NICU ，this child was given Piperacillin sodium and sulbactam sodium for injection （100 mg/kg，ivgtt，q12 h）for anti-infective treatment ；considering the possibility of sepsis ，clinical pharmacists suggested that Piperacillin sodium and sulbactam sodium for injection should be stopped and Meropenem for injection （40 mg/kg，ivgtt，q12 h）should be used instead. After 7 day of meropenem treatment ，clinical pharmacists suggested adding antifungal Fluconazole injection （5.0 mg/kg，ivgtt，qod）. After 11 days of meropenem treatment ，in order to avoid the aggravation of infection ，according to the drug sensitivity results （sensitive to Ticarcillin sodium and clavulanate potassium for injection ），clinical pharmacists suggested adding Ticarcillin sodium and clavulanate potassium for injection （75 mg/kg，ivgtt，q8 h）for combined anti-infective treatment ，and hospital infection treatment was carried out at the same time. After the infection index was stable ，all antibiotics were stopped. When E. coli infection occurred later，clinical pharmacists suggested that Piperacillin tazobactam sodium for injection （75 mg/kg，ivgtt，q8 h）should be used. After the infection aggravated ，Piperacillin tazobactam sodium for injection was stopped and Imipenem cilastatin sodium forinjection（20 mg/kg，ivgtt，q8 h）was used instead. The child received ladder treatment after the decline of infection index ，and Ceftazidime for injection （50 mg/kg，ivgtt，q12 h）was used. RESULTS ：The doctors adopted the above suggestions. After treatment ，the prognosis of the child was good ，the vital signs were stable ，and the body weight reached 3 000 g at discharge. CONCLUSIONS ：For preterm infants as special group ，before using antibiotics ，clinical pharmacists should focus on the vital signs ，infection indicators and laboratory test results of the child ，so as to help doctors improve the treatment plan and ensure the effectiveness and safety of their medication.  
        关键词：Super-premature infant;Anti-infective treatment;Analysis of drug use;Clinical pharmacist   
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