最新刊期
卷 32 ， 期 2 ， 2021
- 关键词：High concentrati on potassium chloride injection;Yunnan;Clinical Use;Management;Expert Consensus
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide sugge stions for improving the variety of pediatric drugs and ensuring the safety of pediatric drug use in China. METHODS ：The historical evolution of laws and regulations on the marketing approval of pediatric drugs in the United States and the implementation results of relevant policies were summarized. Combined with the current situation of the development of pediatric drugs in China ，some suggestions were put forward to ensure the accessibility and safety of pediatric drug use in China. RESULTS & CONCLUSIONS ：Since 1994，the United States had issued a series of laws and regulations to encourage the development of pediatric drugs. At present ，the marketing approval of pediatric drugs were mainly based on the two laws of Best Pediatric Drug Act（BPCA）and Pediatric Research Equality Act （PREA）. From 1998 to 2019，the amount of supplements of pediatric drug information in drug instructions of the United States showed a fluctuating growth. As of April 2020，854 kinds of drugs had been modified in pediatric instructions ，792 of which had been carried out post marketing pediatric clinical research ，and the problem of incomplete pediatric instructions had also been greatly improved. At present ，China’s policies on pediatric drugs mainly included encouraging R&D innovation ，giving priority to review and approval ，and strengthening R&D technical guidance. Although certain achievements had been made ，there were still some problems ，such as imperfect policies and regulations ，and great difficulties carrying out pediatric drug clinical trials. It is suggested that our country should draw lessons from the American regulations on pediatric drugs ，pediatric research and the catalogue of pediatric drugs ，and establish a system and catalogue of ped iatric drug use suitable for China ’s national conditions ，so as to improve the effectiveness ，safety and accessibilityof pediatric drugs.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for improving medical insurance reimbursement for multi-indication drugs based on value-based pricing in China. METHODS：The theory and practice of value-based pricing for multi-indication drugs were sorted out，and the value standards and medical insurance reimbursement strategies based on value-based pricing in France，Germany，UK，Italy and Sweden were analyzed，so as to provide the suggestions for medical insurance reimbursement of multi-indication drugs in China. RESULTS & CONCLUSIONS：The realization of value-based pricing first needed to develop a value framework to define，measure and integrate value，and then established a model to convert the total value into price. The overall idea of value-based pricing for multi-indication drugs was consistent，but there were differences in the value standard. In the UK and Sweden， quality-adjusted life years （QALYs） and incremental cost-effectiveness ratios （ICERs） measured by pharmacoeconomicsare used as the value standard. France，Germany and Italy were more focused on the therapeutic value and clinical benefit improvement. As for medical insurance reimbursement strategies，France adopted single weighting method based on expected volume. Germany adopted combination weighting method based on value and volume. UK introduced the Patient Access Schemes and Italy introduced the Managed Entry reements，both based on the nominal reimbursement standard. Sweden adopted independent reimbursement for different indications by different brand names. It is suggested that China can explore the value-based pricing strategies of multi-indication drugs on the basis of the above international experiences，reference and use these variety of medical insurance reimbursement strategies comprehensively. Simultaneously，the information collection mechanism of patients and drug use should be improved to provide data support for the implementation of China’s value-based pricing and reimbursement strategies for multi-indication drugs.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the synergistic effect and deficiencies between centralized drug quantity purchase policy and medical insurance reimbursement system ，and to provide feasible suggestion to further improve its synergistic effect. METHODS：The literature analysis method and policy evaluation method were adopted to expounds the direct and indirect synergistic effect between the current centralized drug quantity purchase policy and medical insurance reimbursement system in China，and analyze the existing problems so as to put forward the feasible suggestions. RESULTS & CONCLUSIONS ：The centralized drug quantity purchase policy had a direct impact on the payment mode of medical insurance reimbursement system in technical level ，performance evaluation in effect level and process control in management level. The indirect synergy included ： centralized drug quantity purchase policy could promote the adjustment of drug supply security system to adapt to the reform of medical insurance payment ；it could adjust the pharmaceutical market ，and affect the reform of medical insurance reimbursement system. The disadvantages were as follows ：the varieties of selected drugs was still narrow ，and there was room for further improvement in purchasing scope and medical insurance fee reduction ；“one-size-fits-all”payment standard for unselected drug might weaken pharmaceutical companies ’enthusiasm for generic drug research and development. Therefore ，the next step is to significantly expand the variety and scope of procurement ，and appropriately liberalize the medical insurance payment restrictions for drugs with fewer varieties ；coordinate medical insurance reimbursement policies and procurement programs ，and improve the rationality and perfection of medical insurance payment ；guide the medical institutions to change the concept from “price-based medical treatment ”to“value-based medical treatment ”，take into account the interests of all parties in the market ，so as to form a comprehensive coordination adjustment mechanism of drug price and medical insurance reimbursement system.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To construct China ’s Insurance Mode for ADR injury compensation model under marketing authorization holder （MAH）system，and to provide reference for reducing the medical disputes caused by ADR damage and protecting the rights and interests of patients. METHODS ：Using the methods of recommendation and “snowball”，the interviewers were invited to conduct semi-structured interviews to obtain qualitative data ，and the results were analyzed by thematic analysis. According to the results of subject analysis ，the ADR injury compensation model was designed from three aspects of insurance type setting，insurance level division and compulsory insurance protection objects ，and the Fuzzy comprehensive evaluation method based on AHP was used to evaluate the model ；questionnaire and multiple factor Logistic regression analysis was adopted to analyze the influential factors of whether drug related institutions were willing to establish ADR injury compensation system. RESULTS：A total of 40 experts were invited and 34 of them completed the interview ，with a response rate of 85.0％. At present ， the problems of ADR injury compensation in China mainly included the difficulties of third-party identification and adducing evidence of ADR injury ，the difficulty of timely and fair settlement of medical disputes caused by ADR injury ，the high cost and long time of handling ADR injury disputes ，and the uncertainty of compensation mode. More than half of the experts interviewed agreed with the compensation mode of insurance . The overall score of established model was 89.50. A total of 640 questionnaires were distributed and 559 valid questionnaires were recovered （204 drug manufacturers ，172 drug distributors and 183 medical institutions）. The effective rate of the questionnaire was 87.3％. Multiple Logistic regression analysis showed that the factors positively correlated with the approval of establishing ADR injury compensation system after the implementation of MAH system in China included the familiarity of ADR staff in drug manufacturing enterprises with ADR related policies （β＝1.697，P＜0.05），the types of drugs operated by pharmaceutical companies （β＝2.987， P＜0.05），the cognitionlevel of medical staff on ADR （β＝ 2.800，P＜0.05）. The working years of medical staff were negatively correlated with the approval of establishing ADR injury compensation system after the implementation of MAH system （ β ＝－ 2.544，P＜0.05）. CONCLUSIONS ：ADR injury compensation model designed in this study is feasible. It has reference value for reducing the economic burden of ADR patients ， treating patients ’health problems caused by ADR injury in time ，and promoting the development of China ’s drug insurance. Main influential factors for the establishment of ADR injury compensation model under MAH system contain the familiarity of ADR staff in drug manufacturing enterprises with ADR related policies ，the types of drugs operated by pharmaceutical companies ，the cognitionlevel of medical staff on ADR ，the types of drugs operated by pharmaceutical companies ，the cognitionlevel of medical staff on ADR.关键词：Marketing author ization holder;ADR;Injury compensation model;Influential factors
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish fingerprint of Huafengdan yaomu ，and to determine the contents of 7 nucleosides in samples of different fermentation time. METHODS ：HPLC method was adopted. The determination was performed on Pntulips BP-C18 column with mobile phase consisted of methanol-water （gradient elution ）at the flow rate of 0.8 mL/min. The detection wavelength was set at 260 nm，and column temperature was 35 ℃. The sample size was 10 μL. Using xanthine as reference， HPLC fingerprint of 12 batches of Huafengdan yaomu was drawn. The similarity of samples were evaluated with Similarity Evaluation System of TCM Chromatographic Fingerprints （2012 edition）. Common peaks were confirmed. The contents of uracil ， hypoxanthine，xanthine，uridine，inosine，guanosine and thymidine were determined in samples of different fermentation time （0， 1，2，3，4 weeks）by the same method. RESULTS ：There were 8 common peaks in 12 batches of Huafengdan yaomu ，with similarities ranging from 0.712 to 0.954；7 components were identified ，namely uracil ，hypoxanthine，xanthine，uridine，inosine， guanosine and thymidine. The linear ranges of mass concentrations of above 7 components in samples at different fermentation time were 0.87-8.7 μ g/mL （r＝0.999 6）， 4030 1.51-15.1 μg/mL（r＝0.999 7），6.08-60.8 μg/mL（r＝0.999 5）， 号） 1.52-15.2 μg/mL（r＝0.999 6），1.82-18.2 μg/mL（r＝0.999 6）， 1.48-14.8 μg/mL（r＝0.999 6），1.63-16.3 μg/mL（r＝0.999 3）. The limits of quantification were 0.027 4，0.076 3，0.250 4，0.172 3，0.101 1，0.078 3，and 0.084 2 μ g/mL，and the detection limits were 0.008 7，0.025 5，0.007 9，0.084 1，0.035 7，0.026 9，0.027 5 μg/mL，respectively. RSDs of precision ， repeatability and stability tests （12 h）were all less than 3％. The sample recovery rates were 94.16％-100.16％（RSD＝2.24％，n＝ 6），93.87％-100.65％（RSD＝2.67％，n＝6），93.52％-99.66％（RSD＝2.30％，n＝6），93.67％-98.24％（RSD＝1.89％，n＝6）， 96.00％-102.18％（RSD＝1.96％，n＝6），94.62％-101.54％（RSD＝2.82％，n＝6），97.72％-104.56％（RSD＝2.97％，n＝6）. After fermentation for 0-4 weeks，the contents of the above 7 components and total nucleosides were 0.042-0.232，0.027-0.181， 0.039-0.651，0.026-0.225，0.034-0.111，0.009-0.124，0.079-0.099，0.647-1.292 mg/g，respectively. After fermentation for 1-4 weeks，the contents of uracil ，hypoxanthine，xanthine and total nucleosides were significantly increased ，compared with 0 week of fermentation；the contents of uridine ，inosine and guanosine were significantly lower than those in 0 weeks. CONCLUSIONS ：The established fingerprint has strong characteristics and simple to operate ，which can be used for the quality control of Huafengdan yaomu；the content determination method is accurate and reliable ，and can be used to simultaneously determine the contents of 7 active nucleosides ；the content of nucleosides in Huafengdan muyao is affected by fermentation time.关键词：Huafengdan yaomu;HPLC;Fingerprint;Nucleosides;Content determination
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the pharmacokinetics and tissue distribution characteristics of Hydroxycamptothecin （HCPT） nanoparticles in rats ，and to investigate their targeting. METHODS ：Male SD rats were randomly divided into 2 groups，with 6 rats in each group. They were given HCPT nanoparticles and HCPT injection （4 mg/kg based on HCPT ）via tail vein respectively. 500 μL fundus venous plexus blood were sampled at 5，30，60，120，240，360，480，600 and 720 min after administration. The plasma concentration of HCPT in rats were measured by HPLC at different time points. The pharmacokinetic parameters were calculated by DAS 3.0 software. Male SD rats were randomly divided into two groups ，with 24 rats in each group. They were given HCPT nanoparticles and HCPT injection （0.6 mg/kg based on HCPT ）via tail vein ，respectively. Blood was immediately taken from the abdominal aorta ，and heart ，liver，spleen，lung，kidney and brain were removed at 30，60，120，240 min after administration. The plasma and tissue concentration of HCPT in rats were measured by HPLC. The distribution of HCPT ineach tissue and targeting were investigated. RESULTS ：HCPT nanoparticles and its injection conformed to a two-compartment model in rats. Compared with HCPT injection ，AUC0-720 min andAUC0- ∞ increased by 1.89 and 1.87 times respectively ， MRT0-720 min and MRT 0- ∞ increased by 2.74 and 3.00 times respectively， t1/2 β increased by 2.75 times，with statistical significance（P＜0.05）. At 30 min after administration ，HCPT nanoparticles and HCPT injection had the highest concentration in lung；with the passage of time ，the drug gradually accumulated in the liver and reached the highest concentration at 60 min. The relative liver uptake rate of HCPT nanoparticles was the highest （6.28）. Taking liver ad target organ ，and the targeting efficiencies of it in heart ，spleen，lung，kindey，brain and plasma were higher than those of HCPT injection. The selectivity index of HCPT nanoparticles in heart ，lung（except for 30 min after administration ），kidney，brain and plasma were significantly higher than those of HCPT injection at 30-120 min after administration. CONCLUSIONS ：HCPT nanoparticles extend the half-life of the drug ， increase its plasma concentration ，and prolong its action time in vivo ，with significant liver targeting.关键词：Hydroxycamptothecin;Nanoparticles;Pharmacokinetics;Organization distribution;Targeting;Rat
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To comp are the meridian tropism of compatible herbs and compatibility rules of ancient and modern prescriptions containing Eucommia ulmoides ，and to provide theoretical basis for modern clinical application of E. ulmoides . METHODS：Ancient prescriptions containing E. ulmoides were screened from Dictionary of TCM Prescription . The prescriptions containing E. ulmoides were screened from clinical trials which published in CNKI ，Wanfang database and VIP during Jan. 2000 to Jan. 2020. Data mining methods such as frequency statistics and Apriori algorithm were used to analyze the main diseases of ancient and modern prescriptions containing E. ulmoides and the use frequency ，types，meridian tropism and compatibility rules of medical materials. RESULTS ：A total of 84 ancient prescriptions and 188 modern prescriptions of E. ulmoides were included. Ancient prescriptions were mainly used to treat diseases such as back pain ，deficiency，threatened abortion. Modern prescriptions were mainly used to treat osteoarthropathy （mainly lumbar intervertebral disc herniation ），gynecological diseases ，cardiovascular diseases. Cinnamomum cassia ，Angelica sinensis and Achyranthes bidentatawerethe were the high-frequency compatible herbs in ancient prescriptions with E. ulmoides ，and were tonifying medicine ，dispelling wind and dampness medicine and clearing heat medicine；compatible herbs were mainly of warm property ，and the channel tropism was mostly kidney meridian and liver meridian；the five tastes of compatible herbs were mainly sweet and spicy. A. sinensis ，Glycyrrhiza uralensis and Rehmanniae Radix Praeparata were the high-frequency compatible herbs in modern prescriptions with E. ulmoides ，and were mainly tonic medicine，anti-rheumatic medicine ，medicine for promoting blood circulation and removing blood stasis ；compatible herbs were mainly of warm property ，and the channel tropism was mostly liver meridian and kidney meridian ；the five tastes of medicine were mainly bitter and spicy. By analyzing the Apriori association rules of high-frequency herbs ，a total of 10 core herbs combinations were obtained in ancient prescriptions ，including 8 third-order association rules and 2 fourth-order association rules ；a total of 11 core herbs combinations were obtained in modern prescriptions ，including 3 third-order association rules and 8 fourth-order association rules. CONCLUSIONS ： Ancient and modern prescriptions containing E. ulmoides are mainly used to treatlumbar disease ， followed by obstetrics and gynecology com diseases. In addition ，the modern prescriptions can also be #used for the treatment of cardiovascular and cerebrovascular diseases. The ancient prescriptions mainly focus on warming and tonifying ，while the modern prescriptions are more compatible with medicine for dispelling wind and dampness and medicine for promoting blood circulation and removing blood stasis on the basis of tonifying deficiency ；most of the medicines in ancient prescriptions contribute in kidney and liver meridians ，mainly sweet and pungent ，while most of the medicines in modern prescriptions contribute in liver meridian ，and are more compatible with bitter medicines.关键词：Eucommia ulmoides;Ancient prescription;Modern prescription;Apriori algorithm;Compatibility regularity
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish a method for online detection of antioxidant active components in Glycyrrhiza uroalensis decoction pieces ，and to identify it. METHODS ：The free radical scavenging rate of 1，1-diphenyl-2-trinitrobenzene hydrazine （DPPH）was determined to evaluate the antioxidant activity of G. uralensis decoction pieces. HPLC-UV-DPPH method was used to screen the anti oxidant active components of G. uralensis decoction pieces. HPLC-TOF/MS was used to obtain mass spectrum data and Qualitive Analyst B 06.00 Build 6.0.633.0 software was used to analyze data. Through contrast analysis of UV absorption spectrum，online chromatogram ，mass spectrum information of G. uralensis and the retention time of each compound ，accurate molecular weight ，antioxidant active components were identified by referring to relevant literature. Validation test was also conducted. RESULTS ：DPPH free radical scavenging rate in 8 batches of G. uralensis decoction pieces ranged 55.71％-60.17％. Seven antioxidative active compounds ，including avolomotor ，8-isopentenyl naringin ，yellow lupulin weitone ，isoflavone B ，3′， 4′-dimethoxy3-hydroxy-6-methyl flavone ，glycyrrhizin E and glycyrrhizin H ，could be screened from G. uralensis decoction pieces. After validation ，the peak area of inverted peak generated by online reaction was positively correlated with DPPH free radical scavenging rate. CONCLUSIONS ：Established method is simple and accurate ，and can be used to quickly screen and identify the main antioxidant components of G. uralensis decoction pieces ；the peak area of inverted peak can be used to evaluate the antioxidant active components of G. uralensis decoction pieces.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To comprehensi vely evaluate the application progress of network pharmacology methods in TCM compound prescription research ，and to provide reference for modernization of TCM compound prescription research. METHODS ： Taking“network pharmacology ”and“TCM compound prescription ”as keywords ，the literatures were retrieved from CNKI ， Wanfang database and VIP during May 2006 to May 2020. Screening literature ，the databases ，analysis platforms ，and software used of the literature were summarized ；on the basis of quantitative analysis ，the application of network pharmacology in the research of traditional Chinese medicine compound were summarized. RESULTS & CONCLUSIONS ：There were a total of 761 valid literatures ，among which the number of literatures that could be retrieved in 2019 reached 313. In the modernization research of TCM compound prescription ，network pharmacology methods were mainly usedmechanism ，material basis of pharmacodynamics ， compatibility law ，compound optimization ，and“effect-toxic”network. Commonly used databasesand platforms included traditional chinese medicine information database （TCMSP and TCMID ），therapeutic target database （TTD，OMIM），drug targets and target prediction platform （Drugbank，SwissTargetPrediction，TargetNet，PharmMapper），network pharmacology analysis and prediction software and platform （CytoScape），etc. Network pharmacology method was widely used in the field of TCM compound prescription research ，and provided new ideas and methods for the modernization of TCM compound prescription research. In the future，the related research can be combined with the pharmacokinetic parameters ，the efficacy of active compounds and related basic experiments ，use the weighted method to carry out network pharmacology analysis ，and integrate the information of multiple databases to improve the scientificity of research results.关键词：TCM compound prescription;Network ph armacology;Database;Research field;Application;Literature analysi s
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To st udy the effects of Anchang decoction on TLR 4/NF-κB signaling pathway and the expression of fecal calprotectin （FC）in TNBS-induced ulcerative colitis （UC）model rats . METHODS ：SD rats were randomly divided into blank group ，model group ，positive control group [Live Bifidobacterium capsules ，5 mL（containing Bifidobacterium 0.35 g）]， Anchang decoction low -dose，medium-dose and high-dose groups （1，5，10 mL，each milliliter is approximately equivalent to 0.11 g of total crude drug ），with 15 rats in each group. Other groups were given TNBS combined with ethanol enema to establish UC model rat ，except blank group was given normal saline. Two days after successful modeling ，blank group and model group were given normal saline 5 mL，administration groups were given relevant medicine intragastrically ，once a day ，for consecutive 14 d. After last medication ，HE staining was used to observe the pathological change of colon tissue in rats. Western blotting assay was used to detect the protein expression of TLR 4，TRAF6 and NF-κB in colon tissues of rats；Real-time fluorescent quantitative PCR was used to detect mRNA expression of TLR 4，TRAF6，TNF-α and NF-κB；ELISA assay was adopted to detect serum level of TNF-α，IL-6 and FC in stool samples. RESULTS ：Compared with blank group ，the colonic mucosa of model group was severely damaged，and the protein expression of TLR 4，TRAF6 and NF-κB，mRNA expression of TLR 4，TRAF6，TNF-α and NF-κb as well as serum levels of TNF-α，IL-6 and FC level in stool samples were increased significantly （P＜0.05）. Compared with model group，the pathological changes of colon tissue in rats were improved in different administration groups to different extents ，and above indexes were all decreased significantly （P＜0.05）. CONCLUSIONS ：Anchang decoction may relieve the inflammation of UC model rats by regulating the TLR 4/NF-κB signaling pathway and the expression of FC.关键词：Ulcerative colitis;Anchang decoction;TLR4;TRAF6;NF-κB;Fecal calprotectin
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the inhibitor y effects of cajanonic acid A on 5 kinds of cytochrome P 450（CYP）enzyme，in human liver microsomes in vitro . METHODS ：By Cocktail probe substrate method ，50.0，15.0，5.0，1.5，0.5，0.15，0.05 μmol/L cajanonic acid A were added into liver microsomes ， and incubated with mixed probe substrates [including phenacetin ， dextromethorphan，omeprazole，testosterone and toluenesulfonbutylurea （probe substrates of CYP 1A2，CYP2D6，CYP2C19， CYP3A4，CYP2C9，respectively）]. On the basis of setting up blank group and positive control group [ α-naphthalene brass ， quinidine，（+）-N-3-benzyl vanillin ，ketoconazole and sulfabendazole （specific inhibitors of CYP 1A2，CYP2D6，CYP2C19， CYP3A4，CYP2C9，respectively）]，using puerarin as internal standard ，UPLC-MS/MS method was adopted to determine the contents of corresponding metabolites （acetaminophen， dextrophane， 5-hydroxy omeprazole ， 6 β-hydroxytestosterone， hydroxytolbutamide）. The determination was performed on ACQUITY UPLC ® BEH C 18 column，with mobile phase consisted of 0.01％ formic acid aqueous solution- 0.01％ acetonitrile formic acid （gradient elution ）at the flow rate of 0.4 mL/min. The column temperature was 40 ℃，and the sample size was 2 μL. An electrospray ionization source was used to conduct positive and negative ion scanning in the multiple reaction monitoring mode. The data acquisition range was m/z 100-1 200，the collision gas was argon ， the atomized gas was nitrogen ，the gas flow rate of the cone hole was 50 L/h，the desorption gas flow rate was 800 L/h，the capillary voltage under positive and negative mode was 2.0， 1.5 kV，and the ion source temperature was 120 ℃，110 ℃， respectively. The desolvent temperature were 400 ℃ and 450 ℃ ， respectively. Non linear regression analysis was performed by using Graphpad Prism 5.0 software and IC 50 wascalculated. RESULTS ：The linear ranges of above metabolifes were 0.26-8.35，0.36-34.56，0.10-3.09, 3.67-117.37，0.15-4.88 μmol/L（R2＞0.99）. The limits of quantitation were 0.26，0.36， 0.10，3.67，0.15 μmol/L，respectively. The IC 50 values of specific inhibitors in positive control group to CYP 1A2，CYP2D6， CYP2C19，CYP3A4 and CYP 2C9 in human liver microsomes were all within the acceptable range reported in the literature. The IC50 values of cajanonic acid A to CYP 1A2，CYP2D6 and CYP 3A4 in human liver microsomes were all more than 50 μmol/L，and the IC 50 values of CYP 2C9 and CYP 2C19 were 4.94 and 18.00 μmol/L，respectively. CONCLUSIONS ：Cajanonic acid A has no inhibitory effect on CYP 1A2，CYP2D6 and CYP 3A4，but has a certain inhibitory effect on CYP 2C9 and CYP 2C19.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish fingerprint of Paliurus ramosissimus total triterpenes ，and to conduct cluster analysis and principal component analysis ，and to determine the content of the main component paliurusene. METHODS ：HPLC method was adopted. The determination was performed on Agilent PheHex column with mobile phase consisted of methanol- 0.05％ phosphoric acid solution （gradient eluetion ） at the flow rate of 1 mL/min. The detection wavelength was set at 320 nm，and column temperature was 30 ℃. The sample size was 5 μL. Using paliurusene as reference，HPLC fingerprints of 10 batches of P. ramosissimus total triterpenes were drawn. Similarity evaluation was performed by using TCM Chromatographic Fingerprint Similarity Evaluation System （2012 edition），and the common peaks were confirmed. Cluster analysis and principle component analysis were performed by using SPSS 26.0 software. The content of paliurusene was determined by same HPLC method. RESULTS：There were totally 6 common peaks in HPLC fingerprint of 10 batches of P. ramosissimus total triterpenes. The similarity was more than 0.990；one of six common peaks was identified as paliurusene. The results of cluster analysis showed that 10 batches of samples could be clustered into 4 categories，including S 1，S2，S3-S6 and S 7-S10. The results of principal component analysis showed that the accumulative variance contribution rate of primary 2 principal components was 99.430％. Comprehensive score ranking was S 1＞S9＞S8＞S7＞S10＞S2＞S3＞S5＞S6＞S4. The linear range of paliurusene concentration was 33.7-844.0 μg/mL（r＝0.999 9）. RSDs of precision ，reproducibility and stability （24 h）tests were all lower than 2％. Average recovery was 99.75％（RSD＝1.13％，n＝6）. The average contents of paliurusene in 10 batches of P. ramosissimus total triterpenes was 0.576％-0.712％. CONCLUSIONS ：Established HPLC fingerprint and content d etermination method are reliable and stable ， and can be used for the quality control of P. ramosissimus .
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish characteristic chromatogram of Cornus officinalis and its different wine-processedproducts，investigate the differences of chromaticity values，and analyze them with chemical pattern recognition technology.METHODS：UPLC method was adopted. Using loganin as reference，UPLC characteristic chromatograms were drawn for 10batches of C. officinalis and 20 batches of different wine-processed products （stewing with wine，steaming with wine）. TCMFingerprint Similarity Evaluation System（2012A edition）was used for similarity evaluation，and common peaks were confirmed.The chromaticity values [lightness（L），red and green tone value（a），yellow and blue tone value（b），color difference value（ΔE）]were determined by spectrophotometer. SPSS 20.0 and SIMCA 14.0 software were used for cluster analysis，principal componentanalysis and partial least squares-discriminant analysis；taking the area of characteristic peak and chromaticity value as indexes，andthe variable importance projection greater than 1 as the standard，the difference markers affecting its quality were screened.RESULTS：There were 6 common peaks in the chromatograms for decoction piece of C. officinalis，7 common peaks forwine-processed C. officinalis（stewing with wine）and wine-processed C. officinalis（steaming with wine）. Four components wereidentified as gallic acid，5-hydroxymethylfurfural，morroniside，loganin. 5-hydroxymethylfurfural was produced after processing.The similarity between C. officinalis and different wine-processed products （stewing and steaming with wine） was low（0.869-0.937，0.845-0.944），but the similarity between different wine-processed products was higher than 0.99. ΔL，Δa，Δb and ΔEof C. officinalis decoction pieces and wine-processed C. officinalis decoction pieces（stewing in wine）were －9.42-－3.58，－24.92- －15.00，－11.33- －7.00 and 17.01-28.12，respectively. ΔL，Δa，Δb and ΔE of C. officinalis decoction pieces and wine-processed C. officinalis（steaming in wine）decoction pieces were －8.58-－2.42，－25.08-－13.83，－10.92-－6.08，15.58-28.67. ΔL，Δa，Δb and ΔE of wine-processed C. officinalis decoction pieces（stewing and steaming with wine）were －2.17-3.00，－0.75-2.50， 0.25-1.42 and 1.25-3.83，respectively. Results of cluster analysis showed that 30 batches of sample were clustered into two categories，S1-S10 were clustered into one category，and S11-S30 were clustered into other category. Principal component analysis showed that cumulative contribution rate of former two main components was 83.147％. Results of partial least squares-discriminant analysis showed that morroniside，No.5 peak and chromaticity values（L，a，b）were the difference markers affecting its quality. CONCLUSIONS：Established UPLC characteristic chromatogram is stable and feasible，and can be used to rapidly identify C. officinalis and its different wine-processed products. Established chemical mode can be used to identify different wine-processed products.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To stud y the correlatio n between the contents of active ingredients and the color of Morus alba ，to establish fingerprint and conduct cluster analysis of samples from different producing areas ，so as to provide reference for its quality control and evaluation. METHODS ：HPLC and HCl-Mg reaction colorimetry were used to determine the contents of morusin and total flavonoids in M. alba . The color of M. alba was observed by naked eye ，and chromaticity values （L＊，a＊，b＊） were measured by color difference meter and color aberration （E＊ab）were calculated. Pearson correlation of the contents of morusin and total flavonoids with color indicators （L＊，a＊，b＊，E＊ab）were analyzed by SPSS 21.0 software. HPLC method was used to establish the fingerprint of 20 batches of M. alba from 3 different producing areas ，and the similarity analysis was carried out. K-means cluster analysis （based on the contents of morusin and total flavonoids and corlor index ）and hierarchical cluster analysis （based on relative peak area of common peaks in fingerprint ）were performed for 20 batches of samples by SPSS 21.0 software. RESULTS：The average contents of morusin and total flavonoids in M. alba were 0.096 0-0.618 6 mg/g，0.48％-1.51％，which were significantly correlated with each color index （P＜0.01）. The smaller L＊，b＊，E＊ab and the larger a＊were，the higher the content of morusin was ；the higher the value of L＊，b＊，E＊ab and the smaller the value of a＊were，the higher the content of total flavonoids was. The similarity between the fingerprints of 20 batches of samples and the control ranged from 0.883 to 0.983；13 common peaks were demarcated ，and No. 1 peak was identified as chlorogenic acid. K-means cluster analysis showed that 20 batches of samples could be divided into 2 categories. Category Ⅰ were mainly from Anhui province with higher content of morusin，lower content of total flavonoids ，darker and yellowish brown color ；category Ⅱ were mainly from Sichuan province and Guizhou province ，with lower content of morusin ，higher content of total flavonoids ，lighter and yellowish white color. The results of hierarchical cluster analysis were consistent with the results. CONCLUS IONS：The color of M. alba is closely related to the contents of morusin and total flavonoids. The content of morusin in yellow-brown M. albais is higher ，while the content of total flavonoids in yellow-white M. albais is higher.关键词：Morus alba;Color;Morusin;Total flavonoids;Fingerprint;Color difference of principle;Cluster analys is
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the antioxidan t activity and lipid-lowering effect of ethanol extract and its different solvent extracts from the stems and leaves of Scutellaria amoena . METHODS ：The stem and leaves of S. amoena was extracted with 95％ ethanol to obtain ethanol extract ，and then extracted with petroleum ，ethyl acetate and n-butanol to obtain corresponding different solvent extracts. Using vitamin C （Vc）as positive control ，the antioxidant activities of ethanol extract ，petroleum ether extract ， ethyl acetate extract and n-butanol extract from the stems and leaves of S. amoena were determined by hydroxyl radical ，superoxide anion radical and DPPH radical scavenging method ，and the IC 50 was calculated. Steatosis L 02 hepatocyte model was established with fat emulsion. Using fenofibrate （20 μg/mL）as positive control ，the effects of high and low concentration （100 and 50 μg/mL） ethanol extract ，ethyl acetate extract and n-butanol extract from the stems and leaves of S. amoena on the contents of TC and TG in cells were investigated. RESULTS ：The order of scavenging ability to hydroxyl radicals was n-butanol extract ＞ethyl acetate extract＞Vc＞ethanol extract ＞petroleum ether extract ；IC50 of them were 0.15，0.17，0.35，0.75，1.17 mg/mL，respectively. The order of scavenging ability to superoxide anion radical was Vc ＞n-butanol extract ＞ethyl acetate extract ＞ethanol extract ＞ petroleum ether extract ；IC50 of them were 0.034，0.55，0.75，3.32，3.73 mg/mL，respectively. The order of DPPH scavenging ability to DPPH radical was Vc ＞n-butanol extract ＞ethyl acetate extract ＞ethanol extract ＞petroleum ether extract ；IC50 of them were 0.003 2，0.028，0.033，0.048，0.057 mg/mL， respectively. The ethanol extract ，ethyl acetate extract and n-butanol extract from the stems and leaves of S. amoena could significantly decrease the contents of TC and TG in steatosis L 02 hepatocytes （P＜0.01）. The order of lipid-lowering ability was n-butanol extract （low dose ）≈fenofibrate＞ethyl acetate extract （high dose ）＞ethanol extract （high dose ）＞ n-butanol extract （high dose ）＞ethyl acetate extract （low dose ）＞ethanol extract （low dose ）. CONCLUSIONS ：The ethanol extract ， petroleum ether extract ，ethyl acetate extract and n-butanol extract from the stems and leaves of S. amoena show good antioxidant activity and lipid-lowering effect （except for petroleum ether extract ）. Ethyl acetate extract and n-butanol extract possess the strongest antioxidant activity and lipid-lowering effect.关键词：Stem and leaves of Scutellaria amoena;Ethanol extract;Antioxidant activity;Lipid-lowering activity
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the method for content determination of 6 components in Fuzheng guben granules ，such as 2，3，5，4′-tetrahydroxystilbene glucoside ，baicalin，icariin，scutellarin，baicalein and wogonin. METHODS ：HPLC method was adopted. The determination was performed on Dikma Diamonsil C 18 column with mobile phase consisted of acetonitrile- 0.1％ phosphoric acid aqueous solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelengths were set at 275 nm （0-8 min），320 nm（8-9 min）and 275 nm（9-33 min）. The column temperature was set at 25 ℃，and sample size was 10 μL. With baicalin as reference material ，the relative corr ection factors （fk/s） of other five components were calculated by multi-point correction method and slope correction method ；the retention time difference method was used to locate the chromatographic peaks ； the calculation values obtained by above 2 QAMS were compared with measured values of external standard method. RESULTS ： The linear range of 2，3，5，4′-tetrahydroxystilbene glucoside ，baicalin，icariin，scutellarin，baicalein and wogonin were 0.053-2.12， 0.163-6.52，0.059-2.36，0.021 6-0.864，0.03-1.2，0.021-0.84 μg（r＞0.999），respectively. RSDs of precision ，stability（12 h）and reproducibility tests were all lower than 3％. Average recoveries were 98.72％-99.82％（RSDs were 0.89％-1.24％，n＝9）. Using baicalin as reference material ，fk/s of multi-point correction method for 2，3，5，4′-tetrahydroxystilbene glucoside ，icariin，scutellarin， baicalein and wogonin were 1.172，0.528，1.479，1.820 and 2.534，respectively；fk/s of slope correction method were 1.234， 0.550，1.559，1.939，2.664. RSDs of 6 components in 10 batches of Fuzheng guben granules by 3 methods were 0.29％-2.77％ （n＝10），respectively. Pearson correlation coefficient was not lower than 0.999 9（P＜0.001）in measured values between QAMS and external standard method. CONCLUSIONS ：QAMS method is established successfully for simultaneous determination of 6 components in Fuzheng guben granules.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the protec tive effects of scoparone on acute liver injury induced by CCl 4 in mice and its potential molecular mechanism. METHODS ：Fifty male Kunming mice were randomly divided into normal control group ，model group，silymarin group （positive control ，120 mg/kg），scoparone high-dose and low-dose groups （60，30 mg/kg），with 10 mice in each group. Administration groups were given relevant medicine intragastrically. Normal control group and model group were given constant volume of 0.5％ sodium carboxymethyl cellulose solution ，once a day ，for 7 days. Two hours after last medication ， except normal control group was intraperitoneally injected constant volume of olive oil ，other groups were intraperitoneally injected 0.1％ CCl4 olive oil solution （10 mL/kg）at one time to establish the acute liver injury model. The pathological changes of liver tissues in mice were observed by HE staining ；the activity of AST ，ALT，SOD and CAT and the contents of IL- 1β，IL-6，TNF-α and MDA in serum were measured by ELISA ；the phosphorylation of nuclear factor κB（NF-κB）pathway related proteins （NF-κB p65，IκBα）in liver tissue were detected by Western blotting assay. RESULTS ：Compared with normal control group ，serum activities of AST and ALT ，the contents of MDA ，IL-1β，IL-6 and TNF-α were significantly increased in model group，the activities of SOD and CAT were decreased significantly （P＜0.05）；obvious pathological changes were observed in liver tissues ； phosphorylation levels of NF-κB p65 and IκBα protein in liver tissues were significantly increased（P＜0.05）. Compared with model group ，the activities or contens of related factors in serum of mice were significantly reversed in silymarin group and scoparone high-dose and low-dose groups （P＜0.05）；the pathological changes of liver tissues were significantly reduced ；the phosphorylation levels of NF-κB p65 and IκBα protein in liver tissues were significantly reduced（P＜0.05）. CONCLUSIONS ： Scoparone has a protective effect on CCl 4-induced acute liver injury in mice ，which is related to reducing oxidative stress levels and blocking the activation of NF-κB pathway，thereby inhibiting inflammatory response.关键词：Scoparone;Acute liver injury;NF-κB pathway;Oxidative stress;Inflammation;Mice
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To initially evaluate the safety of ceritinib after it is marketed ，and to provide reference for the rational use of drug. METHODS The report odd ratio method and proportional reporting ratio method were used to mine the signals of ceritinib-related adverse events from FDA adverse event reporting system （FAERS）during the second quarter of 2014 to the third quarter of 2019. The patients ’gender，age，body weight ，daily dose and course of treatment were collected. SPSS 26.0 software was used to test the number of ADR cases of this system group and other system groups by chi square test. RESULTS ：A total of 10 318 ADR reports with ceritinib as the first suspicious drug were collected ， and 236 ADR signals of seretinib were excavated. After excluding the ineffective treatment ，187 ADR signals were obtained ，involving 16 systems. Inaddition to those mentioned in the drug instructions ，the signals also included various nervous disease ，blood and lymph system disease ，infections and infectious disease ，etc.，such as hand-foot-genital syndrome ，mutation of anaplatic lymphoma kinase gene. Among them ，the ADR reports of gastrointestinal diseases were the most （576 cases）. Compared with ADR of other systems ，gender，age，body weight，daily dose and treatment course had significant effects on ADR of gastrointestinal diseases （P＜0.05）. Most of the patient with gastrointestinal ADR after using ceritinih were female （59.9％），45 years old and above （70.3％），body weight ≤65 kg （68.1％），daily dose 451-750 mg/d（50.2％），and medication duration less than 3 months（75.7％）. CONCLUSIONS ：The risk of gastrointestinal ADR in female patients over 45 years old and with body weight less than 65 kg after using seretinib is relatively high. This kind of ADRs are also related to daily dose ，and most of which occur within 3 months. Therefore ，great importance should be attached to drug monitoring during clinical use.关键词：Ceritinib;Signal mining;ADR
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To rapidly evaluate the effectiveness ，safety and economy of evolocumab in the treatment of hypercholesterolemia so as to provide evidence-based reference for clinical drug selection and decision. METHODS ：Retrieved from PubMed，Cochrane Library ，CNKI，Wanfang database and HTA relative official website ，HTA reports ，systematic evaluation/ Meta-analysis and pharmacoeconomic studies about evolocumab alone or combined with standard plan versus standard plan or placebo or ezetimibe in the treatment of hypercholesterolemia were collected during the inception to Jan. 2020. Based on literature screening and data extraction ，HTA checklist ，system evaluation measurement tool AMSTAR- 2 scale，comprehensive healthy economic evaluation report standard scale were used to evaluate the quality of included HTA reports ，systematic evaluation/ Meta-analysis and pharmacoeconomic literatures. Quantitative description was performed for effectiveness and safety results ，and qualitative description was performed for economic evaluation results. RESULTS ：A total of 13 literatures were included ，involving 6 Meta-analysis and 7 economic studies. The quality of Meta-analysis literatures was low ，and the quality of economic research was good. In terms of effectiveness ，compared with placebo or ezetimibe ，evolocumab significantly reduced the levels of LDL-C ，TC， TG and VLDL-C ，the incidence of cardiovascular events ，myocardial infarction ，coronary ischemia and stroke ，while increased the level of HDL-C （P＜0.05）. There was no statisti cal significance in the risk of hospitalizatio n，cardiac mortality or cardiovascular disease mortality in patients with unstable angina pectoris between placebo and evolocumab （P＞0.05）. In terms ofsafety，there was no significant difference in the incidence of 6237545。E-mail：zhangxu1130@163.com any adverse events ，any treatment emergency adverse events and back pain ，musculoskeletal and connective tissue diseases between evolocumab and placebo （P＞0.05）. In terms of economy，additional use of evolocumab ，based on standard plan ，had a cost-effectiveness advantage for patients with high-risk atherosclerotic cardiovascular disease （ASCVD）whose blood lipids were still not up to standard. CONCLUSIONS ：Evolocumab has good effectiveness and safety in the treatment of hypercholesterolemia. For high-risk patients with ASCVD whose blood lipids are still not up to standard after standard plan ，evolocumab has certain economy and can be used as an alternative.关键词：Evolocumab;Effectiveness;Safety;Economy;rHTA
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the effects of the third batc h of Shanghai drug quantity purchasing and national “4+7” drug quantity purchasing in a Shanghai hospital and its impact on the use of statins. METHODS ：Consumption amount （tablets） and sum of statins were collected from information system of this hospital before （Feb. 10th-Aug. 31th，2018）and after （Sept. 1th，2018-Mar. 19th，2019）the implementation of the third batch of Shanghai drug quantity purchasing ，after the implementation of national “4+7”drug quantity purchasing （Mar. 20th-Oct. 9th，2019）. The defined drug frequency （DDDs）and average defined daily cost （DDC） of above 3 periods were calculated according to drug defined daily dose （DDD） recommended by New Pharmacology and related drug instructions ，so as to analyzethe influence of the third batch of Shanghaidrug quantity purchasing and national “4+7”drug quantity purchasing on the use of statins in this hospital and predict the market share trend of each specification in this hospital. RESULTS & CONCLUSIONS ：Before the implementation of the third batch of Shanghaidrug quantity purchasing，there were 5 varieties and 8 specifications of statins in this hospital ；after the implementation of quantity purchasing ，it was adjusted to 5 varieties and 9 specifications. The amount of Simvastatin tablets was small in general ，and its consumption sum also continued to decline after the implementation of quantity purchasing. The amount of Rosuvastatin calcium tablets accounted for 49.49％ before the implementation of quantity purchasing ，ranking the first ；after the implementation of 3 batches of Shanghai drug quantity purchasing ， the amount proportion decreased to Δ 基金项目：上海市科学技术委员会科研计划项目（No.19ZR1450- 600） below 30％，and consumption sum proportion decreased from ＊本科 。研究方向 ：医药市场研究与分析 。电话 ：021- 37.82％ to 18.77％；after the implementation of national “4+ 54237308。E-mail：2123398711@qq.com 7”drug quantity purchasing ，the consumption sum proportion # 通信作者 ：副主任药师 ，博士。研究方向 ：临床药学 。电话： continued to decline to 17.38％ .The amount of Atorvastatin 021-65690520。E-mail：Hongjun.chen@tongji.edu.cn calcium tablets increased significantly after the implementation 中国药房 2021年第32卷第2期 China Pharmacy 2021Vol. 32 No. 2 ·247· of the thi rd batch of Shanghaidrug quantity purchasing ，from 41.55％ to 54.09％，and decreased slightly after the implementation of the national “4+7”drug quantity purchasing ，but the amount proportion was still as high as 53.06％，ranking the first ；before and after the implementation of quantity purchasing ，the proportions of its consumption sum were ranked the first ，which remained at about 50％，being 52.87％，61.18％ and 46.50％，respectively. Compared with the amount before the implementation of the third batch of Shanghaidrug quantity purchasing ，the amount of its generic drugs increased by 40.32％，but the consumption sum decreased by 78.18％. Any one type of Pravastatin sodium tablets and Pitavastatin calcium tablets was not selected ；the proportion of them was increased continuously ，but the overall proportion was relatively small. The price of statins decreased significantly after included in quantity purchasinglist. It is expected that the market share of simvastatin in thise hospital will continue to shrink ，and that of atorvastatin may continue to expand. Due to more adverse reactions ，rosuvastatin has limited room to expand ，and pravastatin accounts for a small proportion ，but there is still a demand for patients. Because pitavastatin is a new drug ，its application in this hospital needs more clinical data support.
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发布时间：2022-06-21
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