最新刊期
      卷 31 ， 期 20 ， 2020
      • ZHANG Xiaoyu,YAN Jianzhou,SHAO Rong
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To provide reference for further standardizing and improving the selection of essential medicine in China. METHODS ：The selection mode of essential medicine in South Africa was introduced ，involving organizational structure and responsibilities ，selection criteria ，selection procedure ，dynamic adjustment mechanism and implementation effect. The suggestions were put forward for improving selection mode of essential medicine in China. RESULTS & CONCLUSIONS ： Pharmaceutical and Therapeutics Committees at all levels in South Africa were responsible for collecting applications for essential medicine and submitting them to the Rational Selection Group for preliminary screening ，which was finally decided by the National Essential Drugs List Committee ；the selection criteria was mainly based on WHO essential medicine selection criteria ；the selection basis of essential medicine in South Africa was based on standard treatment guidelines ；a bottom-up normalized user feedback mechanism was established to dynamically adjust the list ，and more attention was paid to drug evidence and evidence level in the review process ；the review points tended to focus on evidence and the level of evidence. In general ，the selection of essential medicines in South Africa had high recognition and good application. It is recommended that China appropriately refer to the practice of South Africa ，take clinical guideline as one of the selection criteria ，establish daily gradual feedback channels ， strengthen the review of evidence ，unify Chinese evidence grading system ，and combine Chinese national conditions to finally explore a selection model for essential medicine with Chinese characteristics.  
        关键词：South Africa;Essential medicine;Selection;Evidence level;Enlightenment   
        99
        |
        2
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27614024 false
        发布时间：2022-06-21
      • CHENG Zhaogen,HUANG Huang,LIN Mengyao
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To study FDA data standards program in the United States ，and to provide reference for constructing medicine data standards in China. METHODS ：By analyzing the governance organization and policy system of FDA data standards program in the United States ，the experience were summarized for data standards development mode and development procedure ， and relevant suggestions were put forward for medicine data standards construction in China. RESULTS & CONCLUSIONS ：The organization of FDA data standards program is led by the Chief Scientist Office of FDA ，coordinated by the Data Standards Advisory Board ，specifically responsible by the Data Standards Program Board under the center for Drug Evaluation and Research ， and participated by other regulatory centers and offices under FDA. FDA data standards program is composed of 4 subsystems as data standards strategy ，data standards program action plan ，data standards catalog and data standard communication plan. According to the federal laws and regulations of the United States ，the demand of FDA and pharmaceutical industry for data standards and the importance of data standards ，the strategic objectives of data standards development are proposed ，and the strategic objectives are refined into specific projects through the data standards program action plan. These programs strictly follow the“data standards development process ”and gradually advance quarterly ，and new data standards will be included in the Data Standards Catalog . At the same time ，FDA strengthen the cooperation and communication with internal and external stakeholders through the data standards program communication plan. It is suggested that China should learn from the experience of FDA data standards program construction ，establish a medical and health data standards program management mode ，strengthen the participation of internal and external stakeholders ，establish data standards committee ，formulate data standards catalog ，and provide clear and unified data standards for the pharmaceutical industry ，so as to promote the construction of medicine data standards in China.  
        关键词：US FDA;Data standards;Data standards strategy;Data standards program   
        91
        |
        7
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27614015 false
        发布时间：2022-06-21
      • XI Xiaoyu,LU Mengqing,HUANG Yuankai,SHAO Rong
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To provide reference for improving th e availability of clinical medication for children in China. METHODS：Based on the current laws and regulations of China ，referring to the relevant excellent experience and mode of foreign countries，the definition and regulatory attributes of intermediate products and final small-sized children ’s preparations were analyzed，and the feasible regulatory pathway of children ’s medicine preparedby intermediate products entering medical institutions were discussed. RESULTS & CONCLUSIONS ：According to the clinical dosage and characteristics of medication ，small-sized preparations for children in medical institutions could be divided into preparations for children ’s medical institutions and personalized preparations for children. From the analysis of foreign experience ，legal policies and technical conditions ，it was feasible for medical institutions to use intermediate products to formulate children ’s small-sized preparations ，but they also faced certain difficulties as the difficulty to supervise ，unclear quality standards ，vague subject and scope of use ，etc. In terms of supervision，it wa s suggested that intermediate products should be taken as the main quality management object when children ’s small-sized preparations prepared by intermediate products entered medical institutions. Meanwhile ，quality risk management should be paid attention to it. In the management of small-sized preparations for children in medical institutions ，it is necessary to formulate the preparation specifications of small-sized preparations for children in medical institutions ，prepare guidelines for the use of excipients and improve the quality inspection standards of preparations ；in the aspect of preparation supervision ，the small-sized preparations for children in medical institutions with large clinical demand are strictly controlled ，and those with high personalized degree in medical institutions are under loose supervision ；in terms of registration and approval ，technical evaluation should be carried out at the same time as the implementation of registration/filing management ；in terms of price setting ，appropriate profit margins should be formulated according to the innovation degree ，clinical demand ，children’s family affordability and public opinion feedback of price of children ’s small-sized preparations in medical institutions. Indiviclualized preparations are forma- lated ased on the price of preparations inmedical institutions ， with reference to the differential price comparice rules. Mean- while，pharmaceutical service fees are charged to compensate pharmacists’time and labor ；in terms of medical insurancepayment，the drugs are classified and managed according to whether they are included in the medical insurance list ，so as to ensure the same drug availability for children and adults .  
        关键词：Children’s small-sized preparations;Intermediate products;Medical institution;Feasibility;Supervision strategy   
        115
        |
        1
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27614004 false
        发布时间：2022-06-21
      • WANG Huiling,ZHANG Taozhi,YIN Xuxu,WANG Yanwen,LI Meng,XIN Hongxia,LIU Wei
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To compare the similarities and differences of antiepileptic drugs between 2019 edition of WHO Model List of Essential Medicines for Children （called“WHO-EMLc”for short ）and 2018 edition of the National Essential Medicines List （called“NEML”for short ），and to provide reference for the improvement of national essential medicines list and formulation of essential medicines list for children. METHODS ：By means of descriptive analysis ，the differences in the varieties ， dosage forms ，specifications and marker symbols of antiepileptic drugs were compared between WHO-EMLc and NEML. The marketing status of antiepileptic drugs included in WHO-EMLc and NEML were analyzed statistically. RESULTS & CONCLUSIONS：There were 9 kinds of antiepileptic drugs included in WHO-EMLc ，all of which were under the category of anticonvulsant/antiepileptic drugs. There were 6 kinds of antiepileptic drugs in NEML of China ，and the other three kinds of drugs included in WHO-EMLc were included in the category of psychotherapy drugs in NEML. Eight kinds of antiepileptic 126 drugs were shared by NEML and WHO-EMLc ， namely 109614043@qq.com carbamazepine， valproic acid ， phenytoin sodium ， pheno- barbital，lamotrigine，diazepam，lorazepam and midazolam. The special antiepileptic drug in NEML was ocazepine ，and edu.cn the special antiepileptic drug in WHO-EMLC was ethylsu c- cinate. Oral dosage forms involved in WHO-EMLc included oral solution ，ordinary tablet，enteric-coated tablet ，dispersed tablet ， etc.，while oral dosage forms involved in NEML included ordinary tablet ，dispersed tablet and oral solution. In terms of dosage form of a single drug ，the drug specifications in WHO-EMLc were more comprehensive than those in NEML. In WHO-EMLc ， lorazepam was labeled with “□”，indicating that it was more effective and safe in similar drugs . Lamotrigine ，midazolam injection and phenytoin （25 mg∶5 mL and 30 mg∶5 mL）were labeled with “*”，indicating that there were special precautions for the drug or dosage form and specification. In NEML ，diazepam was marked with “*”，and diazepam injection was marked with “△”， indicating that diazepam appeared repeatedly under different classifications ；diazepam injection should be used under the guidance of doctors with corresponding prescription qualifications or under the guidance of specialists ，and the use monitoring and efficacy evaluation should be strengthened. In addition ，most of the antiepileptic drugs included in WHO-EMLc had been marketed in China，but the dosage forms on the market were relatively simple ，which could not meet the drug demand of children. Our country could learn from WHO-EMLc selection method to further improve the national essential medicine list ，formulate essential medicine list for children which was suitable for Chinese national conditionsas soon as possible on the basis of disease spectrum and drug clinical comprehensive evaluation. At the same time ，the government should also encourage the development and production of children’s medicines to ensure that children fairly access to drugs.  
        关键词：WHO Essential Medicine List for Childre n;National Essential Medicine List;Antiepileptic drugs   
        185
        |
        3
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613992 false
        发布时间：2022-06-21
      • LI Jixin,YE Jianghai,ZOU Juan,PAN Lutai,ZHANG Jingjie
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To st udy the chemical constituents of diterpenoids from Buyi medicine Isodon coetsa ，and to provide reference for the development and utilization of the medicinal resources. METHODS ：The 95％ methanol extract of Buyi medicine I. coetsa were isolated and purified with silica gel column ，Sehadex LH- 20 gel column and MCI column. The structures of the compounds were obtained by spectral analysis （mass spectrum ，hydrogen spectrum and carbon spectrum ），and then compared with active components of Miao medicine “Isodon flavidus ”. RESULTS & CONCLUSIONS ：Ten diterpenoids were obtained from I. coetsa，including rabdocoetsin B （Ⅰ），megathgrin B （Ⅱ），rabdocoetsin A （Ⅲ），enanderianin N （Ⅳ），rabdocoetsin D （Ⅴ）， megathyrin A （Ⅵ），lophanic acid （Ⅶ），rubesanolide D （Ⅷ），excisanin D （Ⅸ），excisanin K （Ⅹ）. The compounds Ⅶ，Ⅸ and Ⅹ were isolated from this specie for the first time. Compound Ⅶ（lophanic acid ）is a common active component in the Buyi medicine I. coetsa and Miao medicine “I. flavidus ”.  
        关键词：Buyi medicine;Isodon coetsa;Diterpenoids;Chemical constituents;Identification   
        115
        |
        3
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613980 false
        发布时间：2022-06-21
      • SUN Pingping,GUO Zhenghong,YANG Wude,YANG Bo,SHEN Chengjun,SHEN Xiangchun,TAO Ling,XIAO Ting
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To establish the fingerprint of crude/vinegar-processed Corydalis yanhusuo decoction pieces and their dispensing granules，and to determine the contents of five alkaloids （protopine，tetrahydropalmatine，corydaline，berberine hydrochloride，palmatine hydrochloride ）. METHODS ：HPLC method was adopted. The determination was performed on Agilent TC-C18 column with mobile phase consisted of 0.1％ phosphoric acid solution-methanol （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was set at 280 nm，and the column temperature was 30 ℃. The sample size was 10 μL. Using palmatine hydrochloride as reference ， Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition） was used to establish the fingerprint of 11 059） batches of C. yanhusuo decoction pieces ，7 batches of crude . yanhusuo dispensing granules ， 12 batches of vinegar- processed C. yanhusuo decoction pieces and 11 batches of vinegar-processed C. yanhusuo dispensing granules. The same HPLC method was adopted to determine the contents of protopine， tetrahydropalmatine， corydaline， berberine hydrochloride and palmatine hydrochloride in 41 batches of crude/ vinegar-processed C. yanhusuo decoction pieces and their dispensing granules. RESULTS ：There were 12 and 20 common peaks for crude C. yanhusuo decoction pieces and its dispensing granules ，and 14 and 16 common peaks for vinegar-processed C. yanhusuo decoction pieces and its dispensing granules. The similarity of each batch of same type were 0.529-0.981，0.342-0.985， 0.711-0.999，0.437-0.998，respectively. The linear range of protopine ，tetrahydropalmatine，corydaline，berberine hydrochloride and palmatine hydrochloride were 1.9-38.0，2.0-40.0，2.2-44.0，2.6-52.0，2.3-46.0 μg/mL（R2＞0.999 0）. The recoveries were 100.12％-100.98％（RSD＝1.05％-1.90％，n＝9）. RSDs of precision ，reproducibility，stability（24 h）and durability tests were all lower than 2.0％. The average contents of five alkaloids in different batches of crude/vinegar-processed C. yanhusuo decoction pieces and its dispensing granules were 0.24-0.46，0.37-0.82，0.24-0.58，0.07-0.75，0.24-0.76 mg/g. RSDs were 12.27％-147.48％. CONCLUSIONS：The fingerprint of crude/vinegar-processed C. yanhusuo decoction pieces and its dispensing granules is established successfully. The similarities of fingerprint are different before and after processing with vinegar ，and the contents of five alkaloids in C. yanhusuo decoction pieces and its dispensing granules are greatly different.  
        关键词：Corydalis yanhusuo;Vinegar-procession;HPLC;Alkaloids;Fingerprint;Content determination   
        98
        |
        8
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613964 false
        发布时间：2022-06-21
      • DENG Bili,DONG Nana,WANG Xulan,LUO Chengyue,CHEN Xiaolan
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To establish and optimize a extraction method of Fructus Gleditsiae Abnormallis ，and to analyze and identify chemical components of the extract simultaneously. METHODS ：Fructus Gleditsiae Abnormallis was extracted with CO 2 supercritical fluid extraction （SFE）method. Based on single factor tests ，using extraction yield as index ，extraction temperature ， extraction pressure and extraction time as investigation factors ，SFE technology was optimized with orthogonal test ，and validation test was performed. Chemical components in the extract were identified by GC-MS. Relative percentage of each component was calculated with area normalization method. RESULTS ：The optimal SFE extraction technology of Fructus Gleditsiae Abnormallis was extraction temperature of 60 ℃，extraction pressure of 300 MPa and pression time of 15 min. Average extraction of 3 times of validation tests was 1.73％（RSD＝1.78％，n＝3）. The 48 components in the extracts of Fructus Gleditsiae Abnormallis were identified，which accounted for 98.31％ of the total amount of the extracts. The extracts of Fructus Gleditisae Abnormalis mainly included organic acids ，accounting for 36.99％，followed by alkaloids ，accounting for 12.59％ in total. Main components were palmitic acid （16.62％），oleic acid （14.12％），N-aminotetrahydropyrrole（9.79％），2，6-dimethyloctane-1，7-dien-3-ol（5.95％）， tetrahydropyran（3.83％），vanillin（3.39％），etc. CONCLUSIONS ：SFE method of Fructus Gleditisae Abnormalis is established successfully，and the extract is mainly organic acids.  
        关键词：Fructus Gleditisae Abnormalis;CO2 supercritical fluid extraction;Single factor test;Orthogonal test;GC-MS   
        99
        |
        8
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613952 false
        发布时间：2022-06-21
      • LIU Xiaomei,YANG Yuanyuan,HU Jing,REN Hui,CUI Xiaomin,TAO Hongxun,CHEN Zhiyong
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To identify t he chemical constituents of Fengliaoxing fengshi dieda wine. METHODS ：An ultra-high performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry （UPLC-Q-Exactive- MS）technique was used for identifying chemical constituents of Fengliaoxing fengshi dieda wine. The determination was performed on Thermo Accucore aQ RP 18 column with mobile phase consisted of 0.1％ formic acid-methanol （gradient elution ）at the flow rate of 0.3 mL/min. The column temperature was 30 ℃，and the sample size was 2 μL. HESI source was adopted，ion mode was positive and negative ion mode ，nitrogen as sheath gas and auxiliary gas. The positive ion mode had spray voltage of 3.5 kV， capillary heating temperature of 350 ℃，sheath gas pressure of 35 psi，auxiliary gas pressure of 15 arb，and ion source heating temperature of 320 ℃. The negative ion mode had spray voltage of 3.2 kV，capillary heating temperature of 350 ℃， sheath gas pressure of 35 psi，auxiliary gas pressure of 15 arb，and ion source heating temperature of 300 ℃. The mass axis was calibrated by external standard method （mass error less than 5 ppm）. The scanning range of the first mass spectrometry was m/z 80.0-1 200.0 （the resolution was 70 000），the scanning range of secondary mass spectrometry was m/z 80.0-1 200.0（the resolution was 17 500），and the collision voltage was 20，40，60 eV. Retrieved from CNKI ，VIP，PubMed and other database ，the chemical constituents information of each Chinese traditional medicine in Fengliaoxing fengshi dieda wine were collected to establish chemical constituents database. The structure of the compounds was identified on the basis of above constituents database ，the relevant literature ，retention time of reference substance and MS fragmentation regularity. RESULTS & CONCLUSIONS ： Fifty-nine compounds were identified in Fengliaoxing fengshi dieda wine ，including 12 flavones（e.g. neoeriocitrin ，hesperidin.），8 alkaloids （e.g. baogongteng C or erycibellin ， ephedrine，pseudoephedrine）， 9 organic acids （e.g. chlorogenic acid ， cryptochlorogenic acid ，neochlorogenic acid ），7 coumarins（e.g. xanthotoxol）， 4 esters， 4 amino acids ， and 15 other categories（including volatile oils ，terpenes，amides）. UPLC- 5103YX11SF37（17）] Q-Exactive-MS technology can quickly and accurately identify the chemical constituents in Fengliaoxing fengshi dieda wine.  
          
        141
        |
        1
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613939 false
        发布时间：2022-06-21
      • LUO Yuan,WANG Changquan,GONG Zipeng,LI Yueting,WANG Aimin,CHEN Siying,HUANG Yong,ZHENG Lin
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To estab lish a method that can comprehensively and rapidly analyze the chemical compositions of Miao medicine Caesalpinia decapetala，and to providing reference for quality control and pharmacodynamic material basis study of C. decapetala . METHODS ：UPLC-Q-TOF-MS/MS was adopted . The determination was performed on Agilent SB-C 18 column with mobile phase consisted of 0.1％ formic acid solution- 0.1％ formic acid acetonitrile （gradient elution ）at the flow rate of 0.25 mL/min. The column temperature was 30 ℃，and sample size was 2 µL. ESI source was applied in negative and positive scanning ion mode and data collection range of m/z 50-1 500. The capillary voltage was 4.5 kV，the atomizing gas （nitrogen）pressure was 1.2 Bar， the solvent removal gas was nitrogen ，the flow rate of solvent removal gas was 8 L/min and the solvent removal gas temperature was 200 ℃. Data Analysis 4.2 software was adopted to analyze fragment ion information of each peak ，and identify chemica l compositions on the basis of relevant literature and mass spectograms of reference substance. RESULTS ：Under positive ion mode ， 9 chemical compounds were identified ；peak 1，2，3，4，5，6，7，8，9 were catechin ，protohematoxylin B ，epicatechin，ethyl gallate，quercetin，luteolin，3-deoxy-hematoxylin chalcone ， isoliquiritigenin and linoleic acid. Under negative ion mode ， U1812403）， totally 21 peaks were confirmed and 13 compounds were identified；peak 3，4，5，6，7，8，9，10，11，12，13，15， 21 were catechins ， brevifolin carboxylic acid ， proto- hematoxylin B ，epicatechin，ethyl gallate ，epicatechin gallate ， quercetin，resveratrol，hematoxylin，luteolin，3-deoxy-hema- toxylin， isoliquiritigenin， linoleic acid. CONCLUSIONS UPLC-Q-TOF-MS/MS method is established successfully for analysis of chemical compositions in C. decapetala .  
        关键词：Miao medicine;Caesalpinia decapetala;UPLC-Q-TOF-MS/MS;Chemical composition;Analysis and   
        100
        |
        7
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613924 false
        发布时间：2022-06-21
      • ZHANG Huijie,REN Xiaoliang,SUN Hao,WANG Yaqi,LIANG Ying
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To establish UPLC fin gerprint of 32 compatible herb pairs with Polygonum multiflorum as the core ， and to conduct multivariate statistical analysis. METHODS ：UPLC method was adopted. Using P. multiflorum and single decoction pieces of compatible herb as reference ，UPLC fingerprints of 32 compatible herb pairs of P. multiflorum were drawn. Common peaks were confirmed by relative retention time and UV absorption spectrum. Non-supervised PCA and supervised OPLS-DA were conducted by using SPSS 19.0 software and SIMCA 13.0 software. RESULTS ：There were totally 12 common peaks in UPLC fingerprints of 32 compatible herb pairs of P. multiflorum . The results of non-supervised PCA showed that the accumulative variance contribution rate of primary 6 principal components was 84.633％. The results of cluster analysis of PCA comprehensive score showed that single decoction piece of P. multiflorum ，compatible herb pairs of P. multiflorum with Lycium barbarum ，Rehmannia glutinosa，Paeonia lactiflora ，Codonopsis pilosula ，Eclipta prostrate ，Angelica sinensis ，Glycyrrhiza uralensis ，Astragalus membranaceus and Ophiopogon japonicus were clustered into one category ；others were clustered into one category. Results of supervised OPLS-DA analysis showed that eigen values of 4 principal components were 2.32，2.61，1.58 and 0.90，respectively. There were differences in the contents of 12 common components in the compatibility of P. multiflorum with tonic medicine and non-tonic medicine. The changes of the content of the components after compatibility with tonic medicine were similar. Common peak 7，4，6，3 were main reasons for the differences （variable importance projection value were all higher than 1）. CONCLUSIONS：Established fingerprint is simple in operation ，and can be combined with multivariate statistical analysis to evaluate the content changes of common components of 32 compatible herb pairs with P. multiflorum as the core.  
        关键词：Polygonum multiflorum;Compatible herb pairs;UPLC;Fingerprint;PCA;OPLS-DA   
        71
        |
        4
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613911 false
        发布时间：2022-06-21
      • PU Yanpeng,ZHOU Jiaming
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To investigate the regulation effects of volatile oil from Angelica sinensis on autophagy of myocardial cell H 9C2 in rats with hypoxia and reoxygenation （H/R）injury. METHODS ：Using myocardial cell H 9C2 as subject ，CCK-8 method was used to screen the optimal concentration and administration time of volatile oil from A. sinensis. The acitivity of LDH in cell supernatant was determined after treated with volatile oil from A. sinensis by ELISA. Using autophagy inhibitors （3-methyladenine，5 mmol/L） as positive control ，MDC method and Western blotting assay were used to detect average fluorescence intensity of MDC and the expression of autophagy related proteins [Beclin- 1，microtubule associated protein light chain 3Ⅱ（LC3Ⅱ），LC3Ⅰ] in H 9C2 cells after treated with medicines. RESULTS ：After treated with 0.6 μmol/L violate oil from A. sinensis for 6 h，compared with blank group ，LDH activity in cell supernatant ，average fluorescence intensity of MDC ，the expression of Beclin- 1，LC3Ⅱ/LC3Ⅰ ratio in cells were increased significantly in H/R group ，while the expression of p 62 was decreased significantly （P＜0.05 or P＜0.01）. Compared with H/R group ，the activity of LDH in cell supernatant of H/R+drug group as well as average fluorescence intensity of MDC ，the expression of Beclin- 1，LC3Ⅱ/LC3Ⅰratio in cells in H/R+drug group and H/R+autophagy inhibitor group were decreased significantly ，while the expression of p 62 were increased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ：The volatile oil from A. sinensis can reduce the autophagy level of H/R injury myocardial cells by regulating the expression of autophagy related proteins.  
        关键词：Volatile oil from Angelica sinensis;Hypoxia/reoxygenation;Myocardial cell H 9C2 of rats;Autophagy   
        49
        |
        3
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613903 false
        发布时间：2022-06-21
      • MIAO Yanyan,XU Banghui,XU Jian,ZHANG Yongping,LIU Jie,LIU Yao
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To establish fingerprint of Lonicera japonica ，and to study its anti-inflammatory spectrum-effect relationship. METHODS ：HPLC was adopted. The determination was performed on Diamonsil C 18 column with mobile phase consisted of 0.1％ formic acid solution-acetonitrile （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was 30 ℃，and detection wavelength was 238 nm. The sample size was 10 μL. Using chlorogenic acid as reference，HPLC fingerprint of 10 batches of L. japonica from different production areas was established according to TCM Chromatographic Fingerprint Similarity Evaluation System （2012 edition）. By comparing with reference substance ，chemical constituents corresponding to common peaks were identified ，and the similarity analysis was conducted. Acute and chronic inflammatory models of mice induced by xylene ，carrageenan and cotton ball were used to evaluate inhibition rate of 10 batches of L. japonica to ear，foot and granuloma swelling； the average value was calculated as the comprehensive pharmacodynamic index. The spectrum-effect relationship with HPLC fingerprint of L. japonica and anti-inflammatory effect was analyzed by grey relational analysis （GRA）and partial least squares regressiosn （PLSR）based on common peak area and comprehensive pharmacodynamic index . Chromatographic peaks with correlation＞0.7 and regression coefficient of PLSR model ＞0 were characteristic peaks. The percentage of peak areas of characteristic peaks to peak areas of common peak was calculated in 10 batches of L. japonica （e.g.“peak ratio ”）. RESULTS ： There were 25 common peaks in HPLC fingerprints of 10 batches of L. japonica ，with similarity of 0.775-0.994. Totally 9 peaks were confirmed ，i.e. rutin （peak 18），hyperoside（peak 20），isochlorogenc acid B （peak 22），galuteolin（peak 21），chlorogenc acid（peak 9），loganin（peak 10），neochlorogenic acid （peak 2），isochlorogenic acid C （peak 25），isochlorogenic acid A （peak 23）. All 10 batches of L. japonica had inhibitory effects on ear swelling ，foot swelling and granuloma ，with average inhibitory rate of 47.95％-56.52％. The correlation by GRA was peak 8＞12＞18＞16＞3＞11＞20＞22＞19＞21＞1＞9＞10＞13＞24＞14＞2＞ 17＞25＞23＞5＞4＞15，and all of correlations were greater than 0.7. The regression coefficient of PLSR for peaks 2，4，5，7，8， 10，12，13，14，15，16，17，18，20，21，22，24 were all greater than 0；those peaks were positively correlated with anti-inflammatory effect and were characteristic peaks except for peak 7； among them ，VIP values of peaks 5，8，10，16，18， 20，24 were greater than 1. The peak ratio of 10 batches of L. japonica was 58.61％-71.19％. CONCLUSIONS ：HPLC fingerprint of 10 batches of L. Japonica is successfully established. 10 batches of samples have similar components ，and the content of anti-inflammatory components is relatively high. The proportion of characteristic peaks to common peaks should not be less than 51.8％.  
          
        101
        |
        7
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613888 false
        发布时间：2022-06-21
      • WANG Bin,LIANG Weilong,LIN Qinxian,KANG Zhiying,WANG Qifeng
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To optimize the microwave processing technology of yellow wine-processed Corydalis yanhusuo . METHODS：The contents of opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine in C. yanhusuo processed with yellow wine were determined by HPLC. The contents of the extracts were determined by hot dipping method. Based on the single factor tests ，using the appearance of yellow wine-processed C. yanhusuo with microwave processing technology ，the contents of extract，opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine as indexes ，with the amount of yellow wine ，wetting time，microwave power and microwaving time as factors ，the processing technology was optimized with orthogonal test combined with comprehensive weighted scoring method ，and then validated and compared with traditional yellow wine-processed C. yanhusuo . RESULTS：The linear ranges of opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine were 0.100-1.500 μg（R2＝0.999 6）， 0.012-0.188 μg（R2＝0.999 5），0.050-0.750 μg（R2＝0.999 8）. RSDs of precision ，stability（12 h）and repeatability tests were all less than 2％ . The recoveries were 99.15％ -100.34％（RSD＝0.54％ ，n＝6），99.52％ -100.78％（RSD＝0.69％ ，n＝6）， 99.26％-99.79％（RSD＝0.28％，n＝6）. The optimum microwave processing technology included that the amount of yellow wine was 4 g（about 20％ of medicinal material amount ），microwave power was 40％，wetting time was 3 hour，processing time was 3 min. The results of three verification tests showed that the contents of extract ，opioid alkaloid ，berberine hydrochloride and tetrahydropalmatine were 15.7％-16.1％，0.061％-0.063％，0.003％-0.004％ and 0.061％-0.063％. The comprehensive scores were 97.916，94.730 and 97.217，and RSD were 0.42％，0.38％，0.46％（n＝3），respectively. Compared with traditional yellow wine processing technology ，there was no significant difference in the contents of opioid alkaloid and other components ，but no scorched spot and crumbs was found in yellow wine-processed C. yanhusuo with microwave processing technology. CONCLUSIONS：Established method for content determination is simple ，accurate，reliable and reproducible ，and can be used for quantitative analysis of active components in yellow wine-processed C. yanhusuo . Optimized microw ave processing technology is stable and feasible ，and can be used for the processing of yellow wine-processed C. yanhusuo .  
          
        148
        |
        1
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613873 false
        发布时间：2022-06-21
      • ZHOU Xiangde,HUANG Xiaolan,YANG Wenwu,LI Hailing,ZHOU Nong,ZOU Longqiong,WANG Li
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To estab lish a me thod for simultaneous determination of morroniside ，loganin，echinacoside and acteoside in Huanshao capsules. METHODS ：HPLC method was adopted. The determination was performed on Zhongpuhong RD-C18 column with mobile phase consisted of acetonitrile- 0.1％ formic acid solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was set at 240 nm （morroniside，loganin） and 330 nm （echinacoside，acteoside）. The column temperature was set at 35 ℃，and sample size was 10 μL. RESULTS：The linear range were 5.29-105.80 μg/mL for morroniside， 4.49-89.88 mg/L for loganin ，16.26-325.25 mg/L for echinacoside and 16.31-326.25 mg/L for acteoside ，r values were 0.999 9. RSDs of precision ，stability （24 h），reproducibility and durability tests were all lower than 2.0％ . The recoveries were 94.34％ -96.23％（RSD＝0.81％ ，n＝6），97.04％ -98.89％（RSD＝0.73％ ，n＝6），96.23％ -98.08％（RSD＝0.82％ ，n＝6）， 95.40％-98.47％（RSD＝1.23％，n＝6），respectively. The contents of above 4 components in 11 batches of Huanshao Capsules were 0.190-0.704，0.439-0.857，2.723-4.475 and 0.589-1.035 mg/g，respectively. CONCLUSIONS ：Established method is specific ， precise and can be used for content determination of 4 components in Huanshao capsules.  
        关键词：Huanshao capsules;HPLC;Morroniside;Loganin;Echinacoside;Acteoside;Content determination   
        122
        |
        8
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613857 false
        发布时间：2022-06-21
      • SUO Caixian,QIU Yunjing,WU Wenping,SUN Dongmei,LI Xiuzhi,PAN Liye,LI Guowei
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To provide reference for the identification of Chebulae Fructus and Chebulae Fructus Immaturus . METHODS：UPLC method was adopted. The determination was performed on Waters Cortecs T 3 C18 column with mobile phase consisted of acetonitrile- 0.2％ phosphoric acid solution （gradient elution ）at the flow rate of 0.35 mL/min. The column temperature was 30 ℃，and the detection wavelength was set at 270 nm. The sample size was 1 μL. Using gallic acid as reference，UPLC fingerprints of 17 batches of Chebulae Fructus and 14 batches of Chebulae Fructus Immaturus were established and their similarity was evaluated by TCM Chromatographic Fingerprint Similarity Evaluation System （2012 edition）. By comparing substance control ， UV absorption spectrum and related literaturs ，common peaks were identified. PCA and PLS-DA were performed by using SPSS 20.0 and SIMCA 14.1 software. The contents of main difference components in Chebulae Fructus and Chebulae Fructus Immaturus were determined by above UPLC method and compared. RESULTS ：There were 8 common peaks in UPLC fingerprint of Chebulae Fructus and Chebulae Fructus Immaturus ，i.e. chebulic acid （peak 1），gallic acid （peak 2），punicalagin A （peak 3），punicalagin B （peak 4），corilagin（peak 6），chebulagic acid （peak 7）and chebulinic acid （peak 8）. The similarities of 17 batches of Chebulae Fructus were from 0.92 to 0.99，while 14 batches of Chebulae Fructus Immaturus were all above 0.99. The similarity of control fingerprint between Chebulae Fructus and Chebulae Fructus Immaturus was 0.909. PCA demonstrated the differences between Chebulae Fructus and Chebulae Fructus Immaturus . The results of PLS-DA were consistent with those of PCA ，and the variable importance in projection （VIP）values of peak 5，4，7，3 and 2 were above 1 in the PLS-DA model. In 31 batches of samples ，the contents of gallic acid （peak 2），punicalagin A（peak 3），punicalagin B （peak 4）and chebulagic acid （peak 7）were 2.63-10.31， 5.37-44.63，8.02-60.77，44.07-162.98 mg/g；RSDs were 40.14％， 47.91％ ，53.97％ ，36.22％（n＝31）. There was statistical significance in the differences of the mentioned 4 components between Chebulae Fructus and Chebulae Fructus Immaturus 719412818@qq.com （P＜0.05）. CONCLUSIONS ：There are significant differences between Chebulae Fructus and Chebulae Fructus Immaturus gallic acid ，punicalagin A ，punicalagin B and chebulagic acid are the main difference components for identification.  
          
        124
        |
        4
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613841 false
        发布时间：2022-06-21
      • XUE Di,LIU Yuchao,JIA Yongming,WANG Na,LIU Xuewei
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To investigate the mechanism of sinapic acid （SA）against PC 12 cell injury induced by Amyloid β1-42 protein（Aβ1-42）based on PI 3K/Akt/GSK3β signaling pathway. METHODS：PC12 cells of rats were randomly divided into control group，Aβ group（Aβ1-42 2 μmol/L），Aβ+SA group（Aβ1-42 2 μmol/L+SA100 μmol/L），Aβ+SA+LY group [Aβ1-42 2 μmol/L+SA 100 μmol/L+LY294002（PI3K inhibitor ）10 μmol/L]，Aβ+LY group（Aβ1-42 2 μmol/L+LY294002 10 μmol/L）and LY group （LY294002 10 μmol/L）. Except for control group and LY group ，the cells of other groups were replicated the damage model with Aβ1-42. After 24 hours of culture ，the morphology of cells was obsened in each group with a microscope ，and MTT assay was adopted to determine the cell viability of PC 12 cells in each group. Western blotting assay was used to detect the expression of PI 3K，p-PI3K， Akt，p-Akt，GSK3β and p-GSK3β in cells of each group. RESULTS：Compared with control group ，the number of cells decreased and some synaptic breaks disappeared in Aβ group while cell viability，ratio of p-PI 3K/PI3K，p-Akt/Akt and p-GSK 3β/GSK3β in Aβ group were decreased significantly（P＜0.05 or P＜0.01）. Compared with Aβ group，the cells became round and synapses became more in Aβ+SA group while cell viability，the ratio of p-PI 3K/PI3K，p-Akt/Akt and p-GSK 3β/GSK3β were increased significantly（P＜0.05）. Compared with Aβ+SA group，some synaptic breaks occurred in Aβ+SA+LY group while cell viability， the ratio of p-PI 3K/PI3K，p-Akt/Akt and p-GSK 3β/GSK3β were decreased significantly（P＜0.05）；Aβ+LY group had more cell debris，and t he cell viability was decreased ，but the difference was not significant ，and the ratio of p-PI 3K/PI3K，p-Akt/Akt and p-GSK3 β/GSK3 β had no significant change （P＞0.05）; LY294002 alone had no significant effect on morphology ，cellviability and the ratio of p-PI 3K/PI3K，p-Akt/Akt or p-GSK 3β/ GSK3 β （P＞0.05）. CONCLUSIONS ： SA may play aprotective role against PC 12 cell injury induced by A β 1-42 through activating PI 3K/Akt/GSK-3β.  
          
        198
        |
        1
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613830 false
        发布时间：2022-06-21
      • LIU Shimeng,LI Shunping,YANG Yi,TANG Chengxiang,CHEN Yingyao
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To provide reference for the clinical treatment and pharmacoeconomics research of type 2 diabetes patients. METHODS ：Using“Discrete choice ”“Discrete ranking ”as Chinese keywords ，“Discrete choice ”“Discrete ranking ” “Conjoint analysis ”“Diabetes mellitus ”“Type 2”“Type 2 diabetes mellitus ”“Non-insulin-dependent diabetes mellitus ”as English keywords，Chinese and English literatures were retrieved from domestic and foreign databases as CNKI ，Wanfang database ， PubMed，Web of Science during the inception to Dec. 2019. The application status of discrete choice experiment （DCE）was analyzed and summarized from the aspect of attributes and levels ，DCE choice sets ，DCE data quality ，sample size ，econometrics analysis and the preference results. RESULTS & CONCLUSIONS ：A total of 295 related literatures were retrieved ，involving 30 valid literatures. The attributes as drug administration ，glucose control and hypoglycemic events were included more frequently. D-efficient/ D-optimal and orthogonal experiment designs were used more frequently to create the DCE choice sets. DCE data quality could be checked by the internal validity tests. The rules of thumb was usually used to calculate the sample size. Conditional Logit model ，multinomial Logit model or mixed Logit model were used more frequently to analyze the preference data. ZH187） Compared with mild hypoglycemic events ，patients’treatment E-mail：19111020032@fudan.edu.cn choices were more likely to be affected by blood glucose control. However ， when hypoglycemic events occurred at：yychen@shmu.edu.cn night or the degree of hypoglycemia was serious ， the ·treatment preference of patients would change. Although most studies included the drug administration related attributes ，they were not major factors influencing patients ’treatment preferences and were closely related to patients ’previous medication history. DCE had been widely used in the study of type 2 diabetes in foreign countries ，but there were few relevant studies in China. The data quality of DCE was difficult to control. Although the trend of building complex econometric models was gradually rising ，most studies had not fully introduced the design details such as sample size determination method ，option set design principle and quality control option. In addition ，there were some deficiencies such as too many attributes ，too large or too small horizontal spacing. It is suggested that the ten criteria of related research in ISPOR report by Bridges JF and other soholars can be used for reference in DCE design to improve the rigor of design and ensure the credibility of preference results.  
        关键词：Type 2 diabetes;Patients;Treatment preferences;Discrete choice experiment   
        251
        |
        7
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613819 false
        发布时间：2022-06-21
      • HUANG Yanhua,YU Fang,LI Qingyan,SHEN Lei
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To evaluate the safety of PARP inhibitors in hematological system ，and to provide evidence-based evidence for rational drug use in the clinic. METHODS ：Retrieved from PubMed ，Embase，Cochrane Library ，ScienceDirect， CNKI，CBM，VIP and Wanfang data from May 2014 to June 2019，randomized controlled trials （RCTs）about PARP inhibitors or PARP inhibitors combined with chemical treatment drugs （trial group ）versus chemical treatment drugs alone ，placebo alone or chemical treatment drugs combined with placebo （control group ）were collected. After literature screening ，data extraction and quality evaluation with bias risk assessment tool recommended by Cochrane systematic evaluator manual 5.1.0，and Meta-analysis was performed by using Rev Man 5.3 software，and sensitivity analysis and publication bias analysis. RESULTS ：A total of 10 RCTs were included ，involving 3 129 patients. Meta-analysis showed that the incidence of anemia ≥grade 3 [RR＝7.27，95％CI （2.74，19.27），P＜0.000 1]，neutropenia≥grade 3 [RR＝2.46，95％CI（1.43，4.24），P＝0.001]，and leukopenia ≥grade 3 in trial group [RR ＝1.71，95％CI（1.15，2.54），P＝0.008] in trial group were significantly higher than control group. There was no statistically significant difference in the incidence of thrombocytopenia ≥grade 3 between two groups [RR ＝3.54，95％CI（0.66， 19.05），P＝0.14]. Results of sub-group analysis showed that the incidence of an emia≥grade 3 and neutropenia ≥grade 3 in the patients receiving PARP inhibitors alone ，PARP inhibitors combined with chemical treatment dr ugs as well as the incidence of leukopenia≥grade 3 in the patients receiving PARP inhibitors （No.2018FH001-096） combined with chemical treatment drugs were significantly higher than those receiving placebo alone ，chemical treatment com drugs alone or chemical treatment drugs combined with placebo （P＜0.05）. Sensitivity analysis supported the above results howerer，publication bias was possibility. CONCLUSIONS ：PARP inhibitor in the treatment of cancer can cause hematological system adverse drug reaction ，mainly manifesting as anemia ，neutropenia and leukopenia. These results should be interpreted with caution.  
        关键词：PARP inhibitor;Hematologic system;Adverse drug reaction;Meta-analysis   
        258
        |
        9
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613809 false
        发布时间：2022-06-21
      • CHEN Liangjiang,WO Tian,CHEN Lei,XI Xiaoyu
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To p rovide reference for th e development and application of the pediatric quality of life inventory （PedsQL）. METHODS ：Using“PedsQL”as keyword ，retrieved from foreign databases as Medline ，ScienceDirect，Cochrane Library，ISI Web of Science ，SpringerLink and Embase ，Chinese databases as CNKI ，Wanfang database ，VIP and SinoMed ， research literatures about the application of PedsQL at home and abroad were collected during Jan. 1999-Dec. 2019. RESULTS & CONCLUSIONS：A total of 2 117 literatures were included ，including 1 836 foreign literatures and 281 domestic literatures （242 in Chinese，39 in English ）. The number of published literatures was increasing year by year. PedsQL had a wide range of applications and divided into 4 main areas according to purpose ，including analysis of health influencing factors （63 items），assessment of diseases burden （1 720 items），evaluation of intervention measures （285 items），theoretical study of other scales （49 items）. The application of PedsQL in clinical trials had made fast progress ，but there were still some problems in China ，such as improper selection and use of the scale ，less application in pediatric clinical practice ，and insufficient evaluation of intervention measures. It is suggested that future researcher should consider both universality and disease specificity ，self-administered and parental surrogate version of PedsQL when selecting tools ，and apply PedsQL to perform routine clinical health-related quality of life screening to optimize the utilization efficiency of pediatric health 一 resources，and construct PedsQL mapping function based on Chinese population preference to realize the economic evaluation of drug intervention measures.  
          
        133
        |
        8
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613799 false
        发布时间：2022-06-21
      • LIAO Yufang,ZOU Ze,YUE Jiannong
        Vol. 31, Issue 20, (2020)
        摘要：OBJECTIVE：To investigate the role of clinical pharmacists in the therapy of gefitinib-caused liver injury complicated with cholecystitis in a patient with lung adenocarcinoma ，and to provide reference for the therapy of similar type of patients. METHODS ： Clinical pharmacists participated in the treatment for gefitinib-caused liver injury complicated with cholecystitis in a patient with lung adenocarcinoma. The patient took Gefitinib tablets orally for a long time for anti-tumor treatment，and was hospitalized due to abnormal increase of transaminase. The doctors gave intravenous infusion of tiopronin sodium+ acetylcysteine+reduced glutathione+citicoline to protect liver ，but the effect was not good. After consulting the literature and analyzing the patient ’s condition ， clinical pharmacists suggested that gefitinib should be stopped ， and Magnesium isoglycyrrhizinate injection 0.2 g+5％ Glucose injection 250 mL，ivgtt，qd for liver protection treatment. After discharge ，the patient took Gefitinib tablets orally and was admitted to hospital again due to abnormal increase of transaminase ，and suffered from non-infectious and non-calculous cholecystitis. Clinical pharmacists suggested continuing intravenous drip of Magnesium isoglycyrrhizinate injection 0.2 g+5％ Glucose injection 250 mL，qd for liver protection treatment ，oral administration of Danshu capsules 0.9 g，tid for conservative treatment ；at the same time ，closely monitoring the changes of related indicators. After discharge，clinical pharmacists instructed patients to stop gefitinib ，and take Icotinib hydrochloride tablets 0.125 g，tid+Compound Taxus capsules 0.6 g，tid for anti-tumor treatment. RESULTS ：The doctors adopted the opinions of clinical pharmacists ，and the transaminase levels returned to normal ，and the symptoms of cholecystitis basically subsided. CON CLUSIONS：In the treatment of gefitinib-caused liver injury complicated with cholecystitis in patients with lung adenocarcinoma ， clinical pharmacists 135） assisted doctors to improve the treatment plan and ensure the effectiveness of drug use.  
          
        162
        |
        15
        |
        0
        <HTML>
        <L-PDF><Meta-XML>
        <引用本文> <批量引用> 27613789 false
        发布时间：2022-06-21
      0