最新刊期
卷 32 ， 期 16 ， 2021
- 摘要：OBJECTIVE：To provide re ference for scientific management and rational use of antibiotics. METHODS ：Provincial antibiotic classification management lists were retrieved from official websites of provincial health administrative departments ， CNKI and other search engines from Apr. 2012 to Mar. 2020. The difference and adjustment of those lists were analyzed descriptively. RESULTS & CONCLUSIONS ： Since April 2012， 30 provinces released provincial antibiotic classification management lists ，among which only 10 provinces updated the lists. In the provincial classification management lists ，the list of Jiangsu included the most antibiotics （208 kinds），that of Xinjiang involved the least （101 kinds）. Among the 253 antibiotics included in the provincial lists ，134 antibiotics had two management levels ，and 19 antibiotics had three management levels. The 10 antibiotics with the most times of adjustment in the provincial lists mainly include nitimidazoles ，β-lautam compound preparations and quinolones. There was the phenomenon that the same antibiotics were simultaneously included or withdrawn from the lists ，and the grading management level was increased or decreased in the provincial adjustment. Provincial classification management lists updated slowly in China ，and the quantity and classification of drugs selected in the list were quite different. It is suggested that provincial health administrative departments should continuously optimizeand improve classification management list of antibiotics ， and form a long-term mechanism of dynamic adjustment of list and inter-provincial evidence sharing ，so as to promote the rational clinical use of antibiotics ，and curb bacterial resistance.关键词：Antibiotic management;Classification management list;Analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for the drug retailers when making dual-channel pricing decisions in China. METHODS：Based on the analysis of the existing literature and the characteristics of drug supply chain ，taking the dual-channel drug retailers as the research object ，the effects of medical insurance payment policy ，consumers’risk aversion factor and inconvenience cost on consumers ’decision-making behavior were considered ，and dual-channel pricing strategy model for drug retailers was constructed. The reverse induction method was adopted to analyze and solve the model ，obtain the optimal pricing and optimal profit function of the drug retailer. The numerical simulation was adopted to simulate and analyze the effects of consumer medical insurance payment utility ，risk aversion factor and inconvenience cost on drug retailer dual-channel pricing and profits. RESULTS：When the utility of medical insurance payment increased ，the pricing of drugstores and the total profit of dual-channel of drug retailers would increase ；while consumers ’risk aversion factor and inconvenience cost showed a U-shaped trend with retailer ’s dual-channel total profits. In addition ，compared with existing e-commerce platforms ，retailers could make more profits by building their own e-commerce platforms. CONCLUSIONS ：Medical insurance payment policy has a great impact on the profits of dual-channel drug retailers. Drug retailers should continue to pay attention to the trend of relevant national policies and ensure their own profits by adjusting pricing in time. When medical insurance payment utility is in low level ，dual-channel drug retailers can ensure market demand by reducing the retail price of drugstores ，and should use flexible sales strategies to attract consumers. For consumers’risk aversion and inconvenience cost ，drug retailers can adopt strategies such as providing distribution services for consumers with high inconvenience cost.
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To provide refe rence for improving the performance of drug supply chain and sustainable development of the pharmaceutical industry in China . METHODS ：By collecting literatures and combining with the characteristics of drug supply chain ，the questionnaire was designed with Likert 5 scale. After the questionnaire was tested and modified by 10 experts，a preliminary index system framework was formed. The formal questionnaire was prepared by the questionnaire test method；37 experts were consulted by Delphi method ，the index weight was determined by AHP method ，and the index reliability was tested by statistical analysis method ；finally，a pharmaceutical enterprise was taken as an example to measure the index system. RESULTS ：The positive coefficient of the first round of expert consultation was 100％，and that of the second round was 94.59％；average degree of authority of experts was 0.832 6；expert coordination coefficient of the first round was 0.218 2，and that of the second round was 0.396 5. The green supply chain performance indicator system of the pharmaceutical industry included 6 first-level indicators and 26 second-level indicators ，such as drug greenness ，green marketing ，operation process ，drug quality ， drug safety and drug economy. The consistency ratio of the first-level indexes and all second-level indexes were all less than 0.1， the overall Cronbach ’s α coefficient of the index system was 0.892 1. The measured results of a pharmaceutical enterprise showed that the highest score of the pharmaceutical enterprise was the “drug quality ”index，with an absolute score of 3.962 7；the lowest score was the “drug greenness ”index，with an absolute score of 2.297 9. The green supply chain performance evaluation score was 3.167 8，which was at a medium level. CONCLUSIONS ：The established index system has good reliability and validity ，and is expected to provide reference for the performance evaluation of green supply chain in China ’s pharmaceutical industry.关键词：Performance index system;Green supply chain;Pharmaceutical industry;AHP method;Delphi method
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To provi de reference for relevant departments to formulate innovation subsidy policies for pharmaceutical enterprises and enterprises to make their own business strategy decisions. METHODS ：The listed enterprises in China ’s pharmaceutical industry listed before 2012 were selected as the sample enterprises. The annual reports of listed enterprises in pharmaceutical industry and related panel data in CSMAR database during 2012-2019 were colected. Referring to related literatures ， multivariate regression model and threshold model were established to investigate the effects of technology innovation investment ability of sample enterprises ，so as to put forward relevant suggestions. RESULTS & CONCLUSIONS ：A total of 57 sample enterprises were included. The panel data of sample enterprises showed that the technology innovation investment of Chinese pharmaceutical enterprises was basically increasing year by year ，but compared with international standards ，the technology innovation investment of Chinese pharmaceutical enterprises still needed to be improved. The results of multiple regression model showed that the technology innovation investment of pharmaceutical enterprises had no significant impact on their current financial performance and the financial performance of the first and second lags （P＞0.05）. The results of threshold model showed that there was a significant single threshold effect between technology innovation investment and financial performance when enterprise size was taken as the threshold variable （P＜0.05）. When the enterprise size was less than the threshold value of 20.986，the enterprise ’s technology innovation investment had a negative impact on its financial performance （P＜0.05）；when the enterprise size was greater than the threshold value of 20.986，the correlation between the enterprise ’s technology innovation investment and financial performance was not significant （P＜0.05）. It is suggested that China ’s pharmaceutical enterprises should carry out technology innovation activities according to their own strength ，and enterprise managers should formulate different innovation development strategies according to the ac tual situation ，enable enterprises to maintain a reasonable capital structure by broadening financing channels ，identify innovation points according to their own ability ，reduce costs and risks ，and innovate R&D modes，so as to promote the transformation and effective utilization of R&D achievements. Government departments should give full play to the guiding role ，encourage pharmaceutical enterprises to maintain the vitality of R&D and innovation and guide the sustainable innovation and healthy development of the pharmaceutical industry.关键词：Pharmaceutical industry;Technology innovation investment;Financial performance;Threshold effect
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To stud y the mass spec trometry fragmentation regularity and establish rapid identification method of macrocyclic polyamine alkaloids from Tripterygium wilfordii. METHODS ：The determination was performed on Hypersil GOLDTM C18 column with 0.1％ formic acid solution （A）-methanol（B）as mobile phase （gradient elution ）at the flow rate of 0.25 mL/min. The column temperature was 40 ℃，and sample size was 2 μL. The mass spectrometric condition included ESI，positive ion mode ， breakdown voltage of 100 V，collision energy of 35 eV，and scanning range of m/z 100-2 000. UPLC-Q-TOF-MS/MS combined with PeakView 1.2 software were used to analyze mass spectrum of 4 macrocyclic polyamine alkaloids control as celafurine ， celabenzine，celacarfurin，celacinnine and total extract of T. wilfordii ，and summarized the mass fragmentation regularity of alkaloids. According to retention time ，accurate molecular weight and secondary mass fragment ion information ，referring to the above mass spectrometry fragmentation regularity ，macrocyclic polyamine alkaloids in the total extract of T. wilfordii were quickly identified，and whether it was a new compound was determined by consulting Scifinder database and literature comparison. RESULTS：There were three characteristic cleavage fragments of macrocyclic polyamine alkaloids ，i.e. m/z 160.11（base peak ），m/z 188.10 and m/z 100.07 in positive ion mode. According to the precise molecular weight and mass spectrometry fragmentation regularity，10 macrocyclic polyamine alkaloids were identified rapidly ，and compound 1-6，8 were 2-phenyl-1，5，9-triazacy- clotridecan-4-one， 9-acetyl-2-phenyl-1，5，9-triazacyclotridecan-4-one， 9-nicotinoyl-2-phenyl-1， 5， 9-triazacyclotridecan-4-one， celafurine，celabenzine，celacarfurine，celacinnine，respectively. Compounds 3，7，9 and 10 might be new compounds. CONCLUSIONS：The macrocyclic polyamine alkaloids canform three common characteristic fragment ions ，m/z 160.11（base peak ），m/z 188.10 and m/z 100.07，which can be used for the rapid identification of these active components.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide scientifi c evidence for improving the quality standard of Mongolian medicine Juniperus rigida. METHODS ：Totally 10 batches of J. rigida from different places were taken as samples to observe their characters and identify them by microscope ；TLC method was adopted to qualitatively identify isoquercitrin ，quercitrin，amentoflavone， podocarpusflavone A and hinokiflavone ；the contents of total ash ，acid-insoluble ash ，ethanol-soluble extract and heavy metals were determined by related method stated in 2020 edition of Chinese Pharmacopeia （part Ⅳ）. The contents of above 5 components in samples were determined by HPLC. RESULTS ：The powder of J. rigida was green or yellowish green ，polygonal tracheids ， closely arranged in longitudinal with unequal stomatal ；epidermal cells were nearly rectangular ；sclerenchyma cells were quasi rectangular and the wall beadedly thickening. Results of TLC showed that the spots of the same color were found in the corresponding positions of chromatogram for test sample and substance control. The contents of total ash ，acid-insoluble ash and ethanol-soluble extract in 10 batches of samples were 7.37％-11.18％，0.75％-2.98％，16.55％-26.42％，respectively；average contents were 8.51％，1.27％，22.35％. The contents of lead ，arsenic，cadmium，mercury and copper were 2.00-5.44，0.65-1.65， 0.044-0.100，0.034-0.160，4.59-6.79 mg/kg，respectively；average conte nts were 3.73，0.97，0.078，0.061，5.23 mg/kg. The linear ranges of isoquercitrin ，quercitrin，amentoflavone，podocarpus- flavone A and hinokiflavone were 4.98-20.02，49.99-199.96， 19.94-99.96，9.99-40.00，20.20-159.98 μg/mL（all r＞0.999 7）； com RSDs of precision ，repeatability and stability （24 h） tests were all less than 3.00％（n＝6）；the average recoveries were 话：0993-2057878。E-mail：Tanghuishz@qq.com 100.62％-102.96％，RSDs were 1.21％-1.88％（n＝6）. Average contents of the above-mentioned 5 compounds in 10 batches of samples were 0.089-0.379，1.379-4.250，1.077-2.026，0.162-0.423， 0.016 9-0.117 0 mg/g，respectively. CONCLUSIONS ：The qualitative and quantitative analysis methods of Mongolian medicine J. rigida are established. It is preliminarily proposed that the total ash content shall not exceed 10.22％，the acid-insoluble ash content shall not exceed 1.53％，ethanol-soluble extract content shall not be less than 17.88％，heavy metal lead should not exceed 5 mg/kg，arsenic should not exceed 2 mg/kg，cadmium should not exceed 0.3 mg/kg，mercury should not exceed 0.2 mg/kg，copper should not exceed 20 mg/kg.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the f ingerprint of Qinlian runfei decoction，determine the contents of 11 components， and conduct cluster analysis and orthogonal partial least squares discriminant analysis （OPLS-DA）. METHODS ：HPLC method was used. The determination was performed on ZORBAX Eclipse Plus C 18 column with mobile phase consisted of acetonitrile- 0.05％ phosphoric acid solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was set at 260 nm， and column temperature was 30 ℃. The sample size was 10 μL. Using wogonoside as reference，HPLC fingerprints of 10 batches of Qinlian runfei decoction were drawn and the similarity evaluation was conducted with Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition），the common peaks were also confirmed ；the contents of 11 components in Qinlian runfei decoction were determined by the same method. SPSS 21.0 software was used for clus ter analysis ，and SIMCA 14.0 software was used for OPLS-DA to screen marker components affecting quality. RESULTS ：There were 21 common peaks in 10 batches of Qinlian runfei decoction ，and the similarity with control fingerprint was greater than 0.98. A total of 11 common peaks were identified ， which were rutin ， forsythiaside A ， forsythiaside B ， iris， irigenin， baicalin， forsythiaside， wogonoside， baicalein， irisflorentin and wogonin. The line ar ranges of 11 components were 9.960 0-49.800 0，1.974 0-9.870 0，0.672 0-3.360 0，0.960 0-4.800 0，0.549 0- 2.745 0，5.040 0-25.200 0，1.374 0-6.870 0，0.615 0-3.075 0，0.759 9-3.795 0，0.162 0-0.810 0，0.042 0-0.210 0 μg（all r＞ 0.999）； RSDs of precision ， stability （48 h） and repeatability tests were less than 2％ ； the average recoveries were 95.81％-100.29％ with RSDs of 0.43％-1.73％（n＝6）；the contents were 8.924 4-12.820 8，0.352 2-0.868 7，0.435 6-0.711 2， 0.389 8-1.309 0，0.335 8-0.530 1，1.680 5-4.542 3，0.701 8-1.584 2，2.240 2-5.442 5，2.351 0-5.558 9，0.106 0-0.182 2，0.076 8- 0.128 9 mg/g，respectively. The results of cluster analysis showed that when class spacing was 10，it could be divided into two groups，S1-S3 and S 4-S10；when the class spacing was 5，the second class could be divided into two categories ，S6，S7，S9 were clustered into one category ，and S 4，S5，S8，S10 were clustered into one category. The results of OPLS-DA analysis showed that S6，S7 and S 9 were at the top of the figure ，S4，S5，S8 and S 10 were at the lower left side of the figure ，and S 1-S3 were at the lower right side of the figure ，which was consistent with the cluster analysis results ；VIP values of baicalin ，iris，forsythiaside A ， baicalein and wogonoside were all greater than 1. CONCLUSIONS ：Established fingerprint and content determination methods have high precision and good stability. Combined with multivariate statistical analysis ，it can be used for the quality control of Qinlian runfei decoction. Five components as baicalin are the marker components affecting the quality of Qinlian runfei decoction.关键词：Qinlian runfei decoction;HPLC;Fingerprint;Content determination;Cluster analysis;Orthogonal partial least
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To develop a method for simultaneous determination of 5 components in classical formula Huaihua san，including rutin ，naringin，neohesperidin，quercetin and pulegone. METHODS ：HPLC wavelength switching method was adopted. The determination was performed on Cosmosil C 18 column with mobile phase consisted of acetonitrile- 0.05％ phosphoric acid solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelengths were set at 257 nm for rutin ，283 nm for naringin and neohesperidin ，254 nm for quercetin ，252 nm for pulegone ，respectively. The column temperature was set at 30 ℃， and sample size was 10 μL. RESULTS：The linear range was 21.7-2 170 μg/mL for rutin，46-4 600 μg/mL for naringin，22.3- 2 230 μg/mL for neohesperidin，0.96-96 μg/mL for quercetin，2.7-270 μg/mL for pulegone（all r＞0.999），respectively. RSDs of precision，stability（24 h）and reproducibility tests were all lower than 2％（n＝6）. Average recoveries were 100.70％，99.31％， 101.10％，100.03％ and 99.63％（all RSD ＜2％，n＝9）. Among 3 batches of Huaihua san samples ，the contents of above 5 components were 20.055-22.615，25.557-27.806，11.428-13.250，0.350-0.478，2.372-4.011 mg/g，respectively. CONCLUSIONS ： Established method is simple ，accurate and reproducible ，and could be used for the simultaneous determination of 5 components in Huaihua san.
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To establish the fingerprint of the ethanol e xtract from Melastoma dodecandrum ， to study spectrum-effect relationship of its antioxidant activity. METHODS ：HPLC method and Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）were used to establish the fingerprints of 15 batches of ethanol extracts from M. dodecandrum，and heir similarity was evaluated. The common peaks were identified by comparing with substance control. DPPH free radical scavenging method ，ABTS free radical scavenging method and total antioxidant capacity determination method （FRAP） were used to determine antioxidant activity in vitro of 15 batches of ethanol extracts from M. dodecandrum . Principal component analysis，bivariate correlation analysis and partial least squares regression analysis were used to study the spectrum-effect relationship of the antioxidant activity of the ethanol extracts from M. dodecandrum . RESULTS ：Totally 20 common peaks were identified in HPLC fingerprints of 15 batches of ethanol extracts from M. dodecandrum ；its similarity with the control fingerprint was not less than 0.831；it was identified that peak 3 was gallic acid ，peak 13 was vitexin ，peak 17 was rutin and peak 19 was ellagic acid. The IC 50 values of DPPH radical scavenging method of 15 batches of ethanol extracts from M. dodecandrum were 21.98-57.87 μ g/mL，that of ABTS radical scavenging method were 40.94-101.88 μ g/mL，the results of FRAP method were 0.19-0.48 mg/mL. Principal component analysis showed that the contribution rate of IC 50 variance of DPPH was 80.77％. Bivariate correlation analysis showed that the peak areas of peak 2 （positive correlation ） and peak 11 （negative correlation ） were significantly correlated with antioxidant activity （P＜0.05）；partial least squares regression analysis showed that ，the variable projection importance （VIP）in descending order was peak 11＞peak 2＞peak 16＞peak 15＞peak 12＞peak 13＞peak 18，and their VIP values were greater than 1. Peaks 2，13，15，16 and 18 were positively correlated with antioxidant activity ，and peaks 11 and 12 were negatively correlate d with antioxidant activity ，and the absolute value of standardized regression coefficient were greater than 0.1. CONCLUSIONS ：Fifteen batches of ethanol extracts of M. dodecandrum have antioxidant activity in vitro . The compounds corresponding to common peaks 2，11，12， 13，15，16 and 18 may be the material basis of antioxidant activity of M. dodecandrum .
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prepare supersaturated system of lip ophilic aci clovir（ACV）prodrug，and to increase the cutaneous bioavailability of ACV. METHODS ：Three prodrugs of ACV were synthesized by anhydride acylation ，i.e. aciclovir acetate （ACV-Ace），butyrate（ACV-But）and hexanoate （ACV-Hex）. The structures of ACV and three ACV prodrugs were confirmed by 1H-NMR and HRESI-MS ；the concentrations of ACV and three ACV prodrugs were determined by UPLC-triple quadrupole tandem mass spectrometry ，and saturated solubility of them in different volume fractions of propylene glycol-water solution was calculated. The compound with the greatest potential of form supersaturated system was screened out. The supersaturated system of that compound was prepared by co-solvent method. The effect of hydroxypropyl methylcellulose E 3 （HPMC E 3） on its physical stability was observed by light microscope. Vertical Franz diffusion cells were used to study the effects of degree of supersaturation （DS）and HPMC E 3 on the deposited amount of drug in the excised porcine skin after using the supersaturated system for 1 h. The distribution of ACV in the excised porcine skin was determined by frozen slicing stratified quantitative method after using the supersaturated system and marketed aciclovir cream for 1 h. RESULTS ：Three ACV prodrugs were successfully synthesized. The established quantification methods met the requirements of biological sample analysis. Among all of the three ACV prodrugs ， ACV-Hex showed the lowest saturated solubility in water [ （0.5±0.0）mmol/L] a nd the highest saturated solubility in propylene glycol [（53.4 ± 14.2）mmol/L]，which made it potentially feasible to form supersaturated system with high DS. In 10％propylene glycol-water system ，the addition of HPMC E 3 163.com enabled ACV-Hex supersaturated systems ，with DS no morethan 4，to maintain physical stability within 1 h. The total deposited amount （ACV + ACV-Hex ） in skin after the application of ACV-Hex supersaturated system with DS of 4 for 1 h was higher than that after the application of ACV-Hex supersaturated system with DS less than 4 or without HPMC E 3. In addition ，the concentration of ACV in the basal epidermis （skin thickness was 100-160 mm）by supersaturated system was significantly higher than that of the marketed aciclovir cream （P＜0.05）. CONCLUSIONS：ACV-Hex，the lipophilic prodrug of ACV ，can form stable supersaturated system with DS of 4 in 10％ propylene glycol-water system in the presence of HPMC E 3. High concentration of ACV could be accumulated in the basal epidermis after the skin was exposed to supersaturated system for 1 h，which may be valuable for local treatment skin infection of herpes simplex virus .关键词：Aciclovir;Lipophilic prodrug;Supersaturated system;Skin infection;Herpes simplex virus
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish th e fingerp rint and c onduct cluster analysis of Hefu zhiyang decoction （HFZYD），and establish the method for content determination of 8 components，so as to provide reference for the quality control of HFZYD. METHODS：UPLC method was adopted. The determination was performed on ACQUITY UPLC BEH C 18 column with mobile phase consisted of acetonitrile- 0.1％ glacial acetic acid solution （gradient elution ）at the flow rate of 0.25 mL/min. The column temperature maintained at 30 ℃，and detection wavelength was 236 nm. The sample size was 5 μL. The fingerprint of 10 batches of HFZYD was established with Similarity Evaluation System of TCM Chromatographic Fingerprints （2012 edition）. Compared with substance control ，the common peaks were identified. The similarity evaluation was conducted. SPSS 21.0 software was used to conduct cluster analysis of 10 batches of samples. The contents of 8 components such as gallic acid in 10 batches of samples were determined by above UPLC. RESULTS ：There were 34 common peaks in the UPLC fingerprint of 10 batches of HFZYD ， identified as peak 1 was gallic acid ，peak 10 was ferulic acid ，peak 13 was astilbin ，peak 23 was paeonol ，peak 28 was dictamnine，peak 31 was obacunone ，peak 32 was fraxinellone ，and peak 34 was osthole. Its similarity with the control fingerprint was 0.923-0.979. Among 10 batches of samples ，S1，S2，S5，S6，S7，S8 and S 10 were clustered into one category ，and S 3，S4 and S 9 were clustered into one category. The average contents of above 8 components were 0.596-0.714，0.262-0.321，7.647-9.859， 0.113-0.644，0.170-0.202，0.854-1.281，0.631-0.857，3.243-3.548 mg/g，respectively. CONCLUSIONS ：UPLC fingerprint and the method for content determination of 8 components in HFZYD are established successfully.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To optim ize ethanol extraction technology of Mongolian medicine Naru- 3. METHODS ：The L 9（34） orthogonal design was used to optimize ethanol extraction technology of Mongolian medicine Naru- 3 with solid-liquid ratio ，ethanol volume fraction and extraction time as factors ，using comprehensive scores for the contents of benzoylaconitine ，benzoylneoaconitine， benzoylhypoaconitine，aconitine，neoaconitine，hypoaconitine，piperine and gallic acid as indexes. RESULTS ：The optimal ethanol extraction technology was that solid-liquid ratio of 1∶10（g/mL），ethanol volume fraction of 75％，extracting for 1.5 h. After 3 times of validation tests ，average contents of above 8 components in ethanol extract from Naru- 3 were 1.69，1.48，14.69，0.28， 0.05，0.08，26.01，17.33 mg/g（RSDs were 0-4.96％，n＝3），respectively. Average comprehensive score was 19.03（RSD＝1.42％， n＝3）. CONCLUSIONS ：The optimal ethanol extraction technology of Mongolian medicine Naru- 3 is stable and feasible.关键词：Naru-3;Mongolian me dicine;Ethanol extracti on technology;Technology optimization;Comprehensive score
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish a metho d for simultaneous determinat ion of α-pinene，β-pinene，myrcene，limonene， γ-terpinene and α-terpineol in volatile oil from Citrus medica . METHODS ：GC-QAMS method was adopted. The determination was performed on Agilent DB- 17 capillary column. Flame ionization detector was adopted with nitrogen as carrier gas （purity 99.999％） at the flow rate of 0.5 mL/min. The flow rate of nitrogen （make-up gas ）was 25 mL/min，the flow rate of hydrogen was 30 mL/min， and the flow rate of air was 400 mL/min. The inlet temperature was 250 ℃，and the detector temperature was 280 ℃（programmed temperature），and injection volume was 0.5 μL with split ratio of 35 ∶ 1. Using limonene as internal reference ，relative correction factors of α-pinene，β-pinene，myrcene and γ-terpinene were calculated. The contents of 4 components in the samples were calculated according to the relative correction factors. The results were compared between QAMS and internal standard method （ISM，using dodecane as internal substance ，6 components to be determined ）. RESULTS ：The linear range of α-pinene，β-pinene， myrcene，limonene，γ-terpinene and α-terpineol were 0.030 5-0.213 8，0.066 6-0.466 0，0.021 8-0.152 3，0.765 2-5.356 4，0.387 3- 2.710 8，0.034 2-0.239 6 mg/mL（all r＞0.999）. The limits of detection were 4.82，7.89，4.01，4.54，5.53，2.47 µg/mL，and the limits of quantification were 15.34，25.91，13.69，15.70，18.68，8.36 µg/mL，respectively. RSDs of precision ，repeatability and stability tests （24 h）were all less than 2％. The average recovery rates were 96.08％，97.48％，100.90％，101.22％，100.54％， 95.84％（all RSD ＜3％，n＝6）. The average relative correction factors of α-pinene，β-pinene，myrcene and γ-terpinene were 0.997 8， 1.530 7，0.952 4 and 1.025 5 （all RSD ＜1％）. The contents of α-pinene，β-pinene，myrcene，limonene，γ-terpinene and α-terpineol by ISM were 3.296 9-20.994 1，11.300 6-39.440 9，3.684 2-11.291 4，174.857 8-511.611 8，0-285.127 3，0-48.858 6 mg/g， respectively. The contents of α-pinene，β-pinene，myrcene and γ-terpinene determined by QAMS were 3.296 8-20.994 0，11.300 3- 39.439 7，3.684 1-11.291 1，0-285.126 6 mg/g，respectively. Relative content errors of 4 components as α-pinene determined by 2 methods were all less than 1％ . CONCLUSIONS ： The Δ 基金项目：四川省科技厅应用基础研究项目（No.2021YJ0114）； established GC-QAMS method is simple ，rapid，accurate and 泸州市重点科技项目 [No.2011-S-31（3/3）]；合江县人民政府—西南医 科大学战略合作项目（No.2018-HJXNYD-2） repeatable，and can be used for quantitative analysis and ＊硕士研究生 。研究方向 ：中药制备工艺及质量评价 。电话： quality control of volatile oil from C. medica . 0830-3162291。E-mail：493359958@qq.com
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To review the method and results of pharmacoeconomic evaluation of aspirin for cardiovascular disease prevention ，and to provide reference for economic evaluation of aspirin and clinical medication decision. METHODS ： Using“cardiovascular disease ”“cost-effectiveness”“cost-utility”“cost-benefit”“cost effectiveness ”“cost utility ”as the Chinese search terms ，using“cost-effectiveness”“cost-utility”“cost-benefit”“economic analysis ”“pharmacoeconomics”as English search terms，relevant literatures about pharmacoeconomic evaluation of aspirin for cardiovascular disease prevention published during January 1，2000 to January 17，2021 were retrieved from CNKI ，Wanfang database ，VIP，PubMed，Web of Science ，the Cochrane Library. After screening literatures according to inclusion and exclusion criteria ，extracting relevant data ，the quality of included literatures was evaluated with CHEERS scale. The method and results of pharmacoeconomic evaluation of aspirin in the prevention of cardiovascular diseases were analyzed statistically in terms of basic information ，literature quality ，model structure and elements ，health status and utility value ，cost items and sources ，health output ，economic evaluation and sensitivity analysis. RESULTS & CONCLUSIONS ：Nine literatures were included ，and the total coincidence rates of the literatures were all above 80.00％. The pharmacoeconomic evaluation of aspirin in the prevention of cardiovascular disease mainly adopted Markov model ， and the model structure was relatively mature. The cost mainly considered the direct cost ，and the data mainly came from the medical insurance database ；utility was calculated according to the utility value of health state ，which mostly came from the existing literatures. The sensitivity analysis adopted deterministic sensitivity analysis and probabilistic sensitivity analysis ，and the main influential factor was cost. It was economical to use aspirin for cardiovascular disease prevention in most cases ，and aspirin was more economical for primary prevention of cardiovascular disease. It is suggested that domestic scholars can refer to China ’s pharmacoeconomic guidelines to carry out relvant pharmacoeconomic evaluation research more standardized.关键词：Aspirin;Cardiovascular disease;Pharmacoeconomic evaluation;Literature research;Systematic revi ew
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compare th e clinical efficacy and safety of trazodone combined with venlafaxine and venlafaxine in the treatment of major depressive disorder （MDD）. METHODS ：Totally 160 patients with MDD who were treated in our hospital from Sept. 2018 to Oct. 2020 were all enrolled and divided into control group （80 cases）and observation group （80 cases）according to random number table. Control group was treated with V enlafaxine hydrochloride sustained-release tablets 75 mg orally，once every morning. Observation group was additionally treated with Trazodone hydrochloride tablets 25 mg orally ，twice a day，on the basis of control group. The dosage was adjusted according to the efficacy and tolerance. Hamilton depression scale 24 （HAMD-24），Montgomery-Asperger depression scale （MADRS） and Pittsburgh sleep quality index （PSQI） were compared between 2 groups before and after treatment. Clinical efficacies were compared and the occurrence of ADR were recorded. RESULTS：A total of 12 patients were expelled ，and 148 patients were eventually included ，involving 73 cases in control group and 75 cases in observation group. Before treatment ，there was no significant differences in HAMD- 24，MADRS or PSQI scores between 2 group（P＞0.05）. After 1，3，5 and 8 weeks of treatment ，HAMD-24 and MADRS scores of 2 groups were significantly lower than before treatment ，and the observation group was significantly lower than the control group （P＜0.05）. PSQI scores of observation group were significantly lower than before treatment and control group during the same period （P＜0.05），while there was no significant difference in PSQI scores of control group before and after treatment （P＞0.05）. The total response rate of observation group （96.00％）was significantly higher than control group （86.30％）（P＜0.05）. There was no statistical significance in the incidence of ADR between 2 groups（P＞0.05）. CONCLUSIONS ：Trazodone combined with venlafaxine and venlafaxine alone both have good efficacy and similar safety in the treatment of MDD ， but clinical efficacy of trazodone combined with venlafaxine is better.
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To mine and evaluate the post-marketing safety alert signals of pegaspargase （PEG-ASP） and L-asparaginase （L-ASP），and compare the safety differences between them ，so as to provide reference for clinical safe and rational drug use. METHODS ： The adverse drug event （ADE） reports of PEG-ASP and L-ASP issued by FDA adverse event reporting system from Jan. 1st，2004-Jun. 30th，2020 were retrieved. BCPNN method was used to mine the safety signals of these two drugs under the condition that the lower limit of information component （IC－2SD）＞0 and the number of events ≥3. The medium and strong signals of two drugs with IC －2SD≥1.5 were evaluated and compared in 8 system organ class，such as gastrointestinal system ，hepatobiliary system ，blood and lymphatic system ，blood vessels and lymphatic vessels ， nervous system ，immune system ，metabolism and nutrition ，various examinations. IC value of specific ADE signal and its 95％ confidence interval were analyzed by time scanning spectrum. RESULTS & CONCLUSIONS ：The reports of PEG-ASP and L-ASP as suspected drugs were 2 324 and 3 824；67 and 68 medium and strong signals were included ，respectively. In gastrointestinal system，the common strong signal of PEG-ASP and L-ASP was necrotic pancreatitis. In hepatobiliary system ，both of them showed strong signal in venoocclusive liver disease ，and this ADE was not included in the drug instruction. In blood and lymphatic system ， common strong signals of the two drugs were febrile neutropenia ，coagulation disorder ，neutropenia and febrile bone marrow regeneration disorder ；in blood vessels and lymphatic vessels ，in addition to haemodynamic instability ，IC values of other signals of L-ASP were higher than those of PEG-ASP. In nervous system ，IC values of other signals of L-ASP were higher than those of PEG-ASP except for intracranial haemorrhage. In immune system ，anaphylactic reaction was a medium signal for L-ASP but was a strong signal for PEG-ASP. In metabolism and nutritional diseases ，except for tumor lysis syndrome ，IC values of other signals of L-ASP were higher than those of PEG-ASP. The results of time scanning spectrum showed that the signals of necrotic pancreatitis and coagulation disorder of PEG-ASP were stable ，while the signals of veno occlusive liver disease and hypersensitivity were unstable and needed to be observed ；above four signals of L-ASP were stable signals. When using PEG-ASP or L-ASP clinically ， close attention should be paid to the safety problems such as hypersensitivity ，coagulation disorder ，thrombosis，necrotic pancreatitis，venoocclusive liver disease and hypoproteinemia.关键词：Pegaspargase;L-asparaginase;Adverse event;Drug safety;Mining;FDA adverse event reporting system
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explore the regularity and characteristics of adverse drug reactions （ADR）induced by alectinib ， and to provide reference for rational drug use in clinic. METHODS ：Retrieved from CNKI ，Wanfang database ，VIP，PubMed， Web of Science and Embase database during the inception to Mar. 1st，2021，case reports of alectinib-induced ADR were collected ， summarized and analyzed with descriptive statistical analysis method in terms of general information ，occurrence time of ADR ， involved organ/system ，clinical manifestations ，treatment and outcome ，etc. RESULTS ：A total of 17 literatures were included ， involving 17 patients. Among them ，4 cases（23.53％）were males ，and 13 cases（76.47％）were females. The mean age of the patients was （61.82±14.18）years old. The patients were from 5 countries/regions，among which America took the largest ratio （41.18％）. Most ADR occurred within 30 days（52.94％）after therapy. ADR mainly involved skin and its appendants （35.29％）， followed by respiratory system （23.53％），urinary system （11.76％），cardiovascular system （11.76％），gastrointestinal system （11.76％）and blood system （5.87％）；hair loss ，pancreatitis and duodenal perforation belonged to ADRs not recorded in the drug instructions. After 17 patients suffered from ADR ，2 patients still continued to use aletinib ，while 15 patients withdrew aletinib and some patients received symptomatic and supportive treatment ，and their symptoms improved. Among them ，10 patients restarted aletinib treatment after their symptoms improved ，and 8 patients did not suffered from ADR again. CONCLUSIONS ：Female patients and patients over 50 years old are more likely to suffer from ADR after using aletinib ，and most of ADR occur within 1 month after treatment. ADR involves many organs/systems ，mainly skin and its appendants. Special attention should be paid to ADR such as hair loss ，pancreatitis and duodenal perforation.关键词：Alectinib;Adverse drug re action;Case report;Literature analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematically evaluat e the efficacy and safety of different regimens in the treatment of refractory Kawasaki disease ，and to provide evidence-based reference for clinical treatment. METHODS ：Retrieved from PubMed ，Embase， Cochrane Library ， CNKI， VIP， Wanfang database ，randomized controlled trials （RCTs）and cohort studies about different therapeutic regimens in the treatment of refractory 84206032。E-mail：liuyingzryy@163.com Kawasaki disease were collected during the inception to March 2021. After selecting the literature and extracting the data ，the quality of RCT was evaluated by modified Jadad scale ，and the quality of cohort st udy was evaluated by NOS scale. Network Meta-analysis was performed by using Stata 16.0 software. RESULTS ：A total of 29 literatures were included ，involving 15 RCTs and 14 cohort studies. A total of 3 112 patients and 12 therapeutic regimens were involved ，including twice IVIG ，twice IVIG+hormone，twice IVIG+ulinastatin ，first IVIG ，first time IVIG+hormone ，first time IVIG+cyclosporine ，first time IVIG+ etanercept，hormone，hormone+ulinastatin，ulinastatin，infliximab and placebo. The results of network Meta-analysis showed that in terms of the incidence of coronary artery injury （CAL），twice IVIG+hormone was significant lower than hormone ，and first time IVIG +etanercept was significant lower than first time IVIG （P＜0.05）. The sorting results of network Meta-analysis showed that area under cumulative ranking curve of CAL incidence in ascending order was hormone ＜ulinastatin＜twice IVIG ＜first time IVIG＜first IVIG+hormone ＜twice IVIG+hormone ＜infliximab＜first time IVIG+cyclosporin ＜first time IVIG+etanercept. In terms of the incidence of ADR ，compared with twice IVIG+ hormone and hormone ，twice IVIG and first time IVIG+etanercept were decreased significantly ；infliximab was significantly lower than hormone （P＜0.05）. The sorting results of network Meta-analysis showed that area under cumulative ranking curve of ADR incidence in ascending order was hormone ＜twice IVIG+hormone ＜first time IVIG+hormone ＜first time IVIG+cyclosporin ＜first time IVIG ＜twice IVIG ＜first time IVIG+etanercept ＜infliximab. In terms of the serum level of CRP ，compared with twice IVIG ，twice IVIG+hormone ，twice IVIG+ulinastatin and hormone were decreased significantly；twice IVIG+hormone was significantly lower than first time IVIG ；twice IVIG+ulinastatin were all significantly lower than twice IVIG+hormone ，hormone，hormone+ulinastatin，first time IVIG ，first time IVIG+hormone and ulinastatin （P＜0.05）. The sorting results of network Meta-analysis showed that area under cumulative ranking curve of serum CRP level in ascending order was first time IVIG ＜first time IVIG+hormone ＜twice IVIG ＜hormone+ulinastatin＜ulinastatin＜infliximab＜hormone＜twice IVIG+hormone＜twice IVIG+ulinastatin. In terms of improving persistent fever duration ，there was no statistical difference between pairwise treatment measures （P＞0.05）. The sorting results of network Meta-analysis showed area under cumulative ranking curve of persistent fever time in ascending order was first time IVIG ＜placebo＜first time IVIG+cyclosporine ＜hormone＜twice IVIG+ hormone＜twice IVIG ＜ulinastatin＜infamliximab. CONCLUSIONS ：The first time IVIG+etanercept has the best effect in reducing the incidence of CAL. Infliximab possesses a relatively low incidence of ADR and the best antipyretic effect. Twice IVIG + ulinastatin has the best anti-inflammatory effect.关键词：Refractory Kawasaki d isease;Drug therapeutic regimen;Network Meta-analysis;Efficacy;Safety
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explore the effect of clinical pharmacists participating in the therapy of benign prostatic hyperplasia （BPH），and to provide reference for clinical pharmacists participating in the management of chronic diseases. METHODS：Totally 195 BPH patients ，admitted to urology outpatient department of Nanjing Jiangning Hospital during Jan. 2018 to Nov. 2019，were collected and divided into intervention group （98 cases）and control group （97 cases）according to visiting order. Patients in the control group received routine outpatient service of urology surgery . Clinical pharmacists took the initiative to provide individualized pharmaceutical care for intervention group on the basis of routine service ，which mainly included BPH disease education ，healthy lifestyle guidance ，and guidance on rational drug use. International prostate symptom score （IPSS）， quality of life score （QOL），medication adherence and disease progression were compared between 2 groups before intervention and at 2，4，6 and 9 months of follow-up. RESULTS ：Because 15 patients in intervention group lost follow-up ，83 cases were included in the intervention group and 97 cases were included in the control group. Before the intervention ，there was no statistical significance in general information ，IPSS，QOL scores and medication adherence between 2 groups（P＞0.05）. Compared with control group ，IPSS score and QOL score of intervention group were significantly decreased at 2，4，6 and 9 months of follow-up （P＜0.001）；the proportion of patients with high medication adherence in the intervention group increased significantly （P＜ 0.001）；there was no significant difference in disease progression as urinary tract infection between 2 groups （P＞0.05）. CONCLUSIONS：The participation of clinical pharmacists in the treatment of BPH can significantly decrease IPSS score and QOL score，and improve medication adherence and therapeutic effect.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explore the new management model of Good Clinical Practice （GCP）trial drug dispensing . METHODS：Base on the relevant experience of Pharmacy Intravenous Admixture Services （PIVAS）in daytime chemotherapy center（“daytime PIVAS ”for short ）of our hospital ，the nodes and other matters needing attention were discussed in the workflow of confirmation and development of drug dispensing tasks for clinical trials. RESULTS ：After the successful approval of the new clinical trial ，the supervisor of the sponsor and the principal investigator should first confirm whether the drugs involved in the project needed to be centrally dispensed in the daytime PIVAS ，and then submitted the relevant data to PIVAS for filing. Daytime PIVAS pharmacists could participate in trial drug dispensing of relevant projects only after starting training and authorization. After the doctor issued the medical order for the subjects in the hospital information system ，the research nurse took the drugs out of the GCP pharmacy and handed them to the daytime PIVAS drug receiving window. After receiving the drugs ，the pharmacist would check the dispensing ，and then the preparation pharmacist trained and authorized by the project team would mix and dispense the drugs. The reviewed pharmacist would check and label the prepared infusion. In addition ，daytime PIVAS would regularly summarize the feedback information on the trial drug dispensing and fund management in all links of dispensing process ，so as to improve the standardization of the process. CONCLUSIONS ：Daytime PIVAS for clinical trial drug can arrange batches more rationally，ensure smooth and orderly infusion ，and meet different drug stability requirements ，which can improve trial drug dispensing management and further promote the development of drug clinical trial projects in China.关键词：PIVAS;Drug clinical trial project;Trial drug;Workflow
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发布时间：2022-06-21
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