最新刊期
      卷 31 ， 期 14 ， 2020
      • LIU Wen,ZHU Jiong,HU Jun,WANG Chong,HU Zengyao
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To provide re ference for the relevant personnel of drug quality sampling and testing to understand and implement the new requirements in the Management of Drug Quality Sampling and Testing . METHODS ：The test and retest requirements were compared between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing. The revised and newly added contents were analyzed ，and the recommendations for implementation were put forward. RESULTS & CONCLUSIONS ：Referring to drug regulation need ，related requirements of test and retest in the Management of Drug Quality Sampling and Testing were modified and supplemented on the basis of the Regulation of Drug Quality Sampling and Testing . In the requirements for test ，the requirements for test items were revised ，the requirements for test time limit were confirmed ，the requirements for test report ，original record and quality management system ，the definition of “serious risk ” and its reporting requirements were added newly. The requirements for exploratory research were put forward for test institutions， as well as new requirements for test institutions and inspectors ’behaviors. In the requirements for retest ，the materials to be submitted for retest were revised ，and the identity certificate of the manager and time limit certificate were added ；the situation of no-retest were revised ，and the treatment method were added when obviously visible foreign matters were detected ；transfer requirements for retest report were added newly. It is suggested that the relevant personnel should pay more attention to the above changes，strengthen the construction of test capacity a nd the management of tes t time and quality ，attach importance to serious quality risks ，actively carry out exploratory research ，and mind their own test behaviors ；strictly review retest materials ， pay attention to the newly revised no-test and comprehensively transfer the retest report according to the requir ements and actual situation ，conduct and implement the Management of Drug Quality Sampling and Testing actively.  
        关键词：Management of drug quality sampling and testing;Test;Retest;Comparative analysis   
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        发布时间：2022-06-21
      • CAO Yunchun,LIN Haonan
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE： To invest igate the intraction between China ’s foreign economic trade and pharmaceutical manufacturing industry ，in order to provide the reference for China ’s foreign economic trade growth and pharmaceutical manufacturing industry development in the future. METHODS ：By collecting the data of China ’s foreign economic trade and pharmaceutical manufacturing industry during 1998-2018 issued by National Bureau of Statistics ，China Statistics Yearbook on High Technology Industry and China Statistics Yearbook on Scientific Technology ，referring to relevant literature method ，index system was established that includes the foreign economic trade system and the pharmaceutical manufacturing system. CRITIC method was adopted to assign the weight of data index and calculate comprehensive evaluation data. VAR model was used to analyze the interaction between China ’s foreign economic trade and pharmaceutical manufacturing industry and put forward the suggestions. RESULTS & CONCLUSIONS ：From the results of cointegration test ，foreign economic trade development played a strong role in promoting and driving pharmaceutical manufacturing industry development （correlation coefficient was 0.432 198）；from the results of Granger causality test ，the development of foreign economic trade was the Granger cause for pharmaceutical manufacturing industry development （confidence probability was lower than 0.001），but the pharmaceutical manufacturing industry development was not the Granger ’s reason for foreign economic trade （confidence probability was 0.358）. By the results of impulse response and variance decomposition ，it reflected an interrelationship between the two ，but the contribution of foreign economic trade to the development of pharmaceutical manufacturing is relatively small. It is suggested that China ’s pharmaceutical manufacturing enterprises should grasp the market demand and trade opportunities in time ，and further expand the scale of business by providing high quality pharmaceutices products ；make full use of new trade mode and speed up the circulation of pharmaceutical products in economic and trade activities so as to further expand the domestic and foreign markets of pharmaceutical products ；the state should formulate and improve the preferential and supporting policies for pharmaceutical manufacturing industry as soon as possible to reduce the burden for pharmaceutical manufacturing enterprises. In addition ，from the national level and the enterprise level ，we should appropriately increase the investment in scientific research of pharmaceutical manufacturing industry and increase industry cultiration，so as to promote the rapid development of pharmaceutical manufacturing industry and realize a virtuous circle of mutual promotion of foreign economic trade and pharmaceutical manufacturing industry.  
        关键词：Foreign economic trade;Pharmaceutical manufacturing industry;Interaction;Empirical study;Vector   
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        发布时间：2022-06-21
      • LIU Fusong,CHEN Cuisha,SUN Pei,LIU Sha,WEI Zhonglan,LIU Xiaoqi,WU Faming
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To establish a method for simultaneous determination of the contents of codonopatin ，syringin， atractylenolide Ⅰ，atractylenolide Ⅱ and atractylenolide Ⅲ，and to compare the contents of above 5 components in different varieties and harvesting periods of Codonopsis Radix. METHODS ：HPLC method was used. The column was Inertsil ODS- 3 with mobile phase consisted of acetonitrile-water （gradient elution ）at the flow rate of 0.8 mL/min. The detection wavelengths were 210 nm （codonopatin），220 nm （syringin，atractylenolide Ⅱ ，atractylenolide Ⅲ），276 nm （atractylenolide Ⅰ）. The column temperature was set at 30 ℃ ，and the sample size was 20 μ L. RESULTS：The linear range of codonopatin ，syringin， atractylenolide Ⅰ，atractylenolide Ⅱ and atractylenolide Ⅲ were 44.30-886.00 μg/mL（r＝0.999 7），6.50-130.03 μg/mL（r＝0.999 6）， 4.47-89.46 μg/mL（r＝0.999 5），2.53-50.50 μg/mL（r＝0.999 4），5.64-112.80 μg/mL（r＝0.999 5）；the limits of quantification were 2.446 0，0.168 0，0.248 1，0.065 7，0.099 8 μg/mL，and detection limits were 1.352 0，0.067 2，0.005 4，0.006 3，0.007 3 μ g/mL；RSDs of precision ，stability（24 h），repeatability and durability tests were all less than 2％；the recoveries were 98.87％-100.62％（RSD＝0.73％，n＝6），98.46％-101.54％ （RSD＝1.15％，n＝6），98.32％-101.12％（RSD＝1.19％，n＝ 96.83％-104.16％（RSD＝2.62％，n＝6），97.87％-100.99％ （RSD＝1.07％，n＝6）. The average contents were 33.78-431.82， 0-20.60，0.44-3.68，0-10.83，0.27-73.40 μ g/g. The content of 1271985629@qq.com codonopatin was in descending order was as follows as Codonopsis pilosula ＞C. tangshen ＞C. pilosula Nannf. var. modesta （Nannf.） L. T. Shen ＞ecotypic variety of C.·1677· tangshen. The content of syringin in descending order was C. pilosula ＞C. pilosula Nannf. var. modesta（Nannf.）L. T. Shen ＞C. tangshen，but it was not detected in ecotypic variety of C. tangshen . The content of atractylenolide Ⅰ in descending order was C. pilosula Nannf. var. modesta（Namf.）L. T. Shen ＞ecotypic variety of C. tangshen ＞C. pilosula ＞C. tangshen . The content of atractylenolide Ⅱ in C. pilosula was higher than C. pilosula Nannf. var. modesta（Nannf.）L. T. Shen ，but was no detected in C. tangshen and ecotypic variety of C. tangshen . The content of atractylenolide Ⅲ in descending order was C. pilosula ＞C. pilosula Nannf. var. modesta（Nannf.）L. T. Shen ＞ecotypic variety of C. tangshen ＞C. tangshen . In Codonopsis Radix collected from Jul. to Oct. ，the content of codonopatin was the highest ；the content of atractylenolide Ⅰ was lower in sample collected from Jun. to Oct.；atractylenolide Ⅱ was not detected in sample collected in Aug. ；the contents of atractylenolide Ⅰ and atractylenolide Ⅱ were the lower in sample collected in Sept. ，and syringin and atractylenolide Ⅱ were not detected in some samples. CONCLUSIONS ： The established HPLC method is simple ，accurate，highly sensitive and reproducible. It can be used to simultaneously determine 5 active ingredients contents of Codonopsis Radix ；there are great difference in contents of 5 active ingredients in different varieties and harvesting periods of Codonopsis Radix.  
          
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        发布时间：2022-06-21
      • XUE Cun,WU Dan,GONG Zipeng,CHEN Siying,TANG Juan,LI Yueting,WANG Aimin,LI Yongjun,LAN Yanyu,WANG Yonglin
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To explore the metabolic charact eristics of Miao medicine Laportea bulbifera extract in isolated human intestinal flora. METHODS ：L. bulbifera was extracted with 70％ ethanol reflux extraction. After concentration，extraction with n-butanol and drying ，L. bulbifera extract was obtained. Taking 0.05 g/mL L. bulbifera extract 1 mL mixed with isolated human intestinal flora fluid 10 mL and cultured for 36 h in anaerobic environment （setting up blank control without drugs or human intestinal bacterial solution ），so as to simulate the metabolic process of the extract in human intestine. The metabolites were detected by UPLC-Q-TOF/MS. The determination was performed on Agilent Eclipse Plus C 18 RRHD column with mobile phase consisted of 0.01％ formic acid water solution- 0.01％ formic acid acetonitrile solution （gradient eluetion ）at the flow rate of 0.25 mL/min. The column temperature was set at 40 ℃，and the sample size was 1 µL. ESI detection was adopted and scanned by negative ion mode （ESI－）；the capillary voltage was 4.5 kV，the ion source temperature was 120 ℃，the collision energy was 15-32 V，and the scanning range was m/z 50-1 000. The “Strip”module of MassLynx V 4.1 software was used to analyze the differential chromatograms between the reaction solution and the blank control of L. bulbifera extract. Mass spectrum data and UNIFI so ftware were used to predict relative molecular weight and formula ；based on the information of substance control and related literature reports ， the structure and biotransformation pathway of L. bulbifera metabolites in isolated human intestinal flora were predicted and analyzed. RESULTS & CONCLUSIONS ： A total of 3 prototype ： products（rutin，quercetin，kaempferol-3-O-rutinoside）and 22metabolites （mainly the metabolites of quercetin ，mono- caffeoylquinic acid ，isoquercitrin，etc.） were detected after metabolized in isolated human intestinal flora. Itsbiotransformation pathway is phase Ⅰ reaction，which mainly consisted of reduction ，oxidation and hydrolysis.  
        关键词：Laportea bulbifera;Isolated human intestinal flora;Metabolism;UPLC-Q-TOF/MS;Identification   
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        发布时间：2022-06-21
      • LIU Wei,LIU Wen,SONG Xinli,WANG Guanhua,WANG Yunxia,LI Yunkai
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To prepar e Breviscapine gastric adhesive tablets ，to optimize the formulation and to evaluate the quality. METHODS ：HPMC K 100M and carbomer 934P were used as bioadhesives and skeleton materials ，and lactose was used as filler，and magnesium stearate was used as glidant and lubricant to prepare Breviscapine gastric adhesive tablets by direct powder pressing method. The comprehensive scores of scores of accumulative release rate of Breviscapine gastric adhesive tablets in pH 6.8 PBS at 2，6，12 h（Q2 h，Q6 h，Q12 h，with scutellarin meter ，by HPLC method ）and in vitro adhesion force of gastric tissue were evaluated by weighting method. Taking this scores as indexes，L9（34）orthogonal test design was used to optimize the amount of HPMC K 100M，carbomer 934P and lactose in Breviscapine gastric adhesive tablets and validation tests were conducted. The properties，identification，weight difference ，fragility，release and the content of scutellarin of the gastric adhesive tablets were determined. RESULTS ：The optimal prescription of Breviscapine gastric adhesive tablets were 42％ breviscapine，10％ HPMC K100M，3％ carbomer 934P and 45％ lactose. The verification test results show that the Q2 h，Q6 h，Q12 h of 3 batches of Breviscapine gastric adhesive tablets were 20.36％，48.55％，and 87.00％ ；the average in vitro adhesion force of gastric tissue was 31.36 g/cm2；the average comprehensive score was 70.23（RSD＝1.84％，n＝3）. The gastric adhesive tablets were light yellow，tasteless or slightly salty ；the peak time was consistent with that of scutellarin control ；its weight difference were ±6％， the fragility was 0.54％，and the Q12 h was 83.51％（RSD＝2.14％，n＝6）. The content of scutellarin was 288.47 mg/g（RSD＝ 0.70％，n＝3）. CONCLUSIONS ：Breviscapine gastric adhesive tablets is prepared successfully ，and its quality evaluation conforms to the requirements of Chinese Pharmacopoeia （2015 edition）.  
        关键词：Breviscapine;Gastric adhesive ta blets;Formulation optimization;Quality evaluation   
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        发布时间：2022-06-21
      • PU Jian,YAN Ting,KUAI Qingye,WANG Aimin,ZHENG Lin,LI Yongjun,HUANG Yong
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To compare the volatile components extracted from the roots ，stems and leaves of Gaultheria yunnanensis. METHODS ：Steam distillation method was used to extract the volatile oils from roots ，stems and leaves of G. yunnanensis. Chemical constituents were analyzed by GC-MS. NIST 2011 standard mass spectral library was adopted to select the chromatographic peak with a matching degree higher than 80，and combined with relevant literatures for identification. Relative percentages of chemical constituents were calculated by peak area normalization. RESULTS ：Totally 95 chromatographic peaks were detected in valatile oil from the roots of G. yunnanensis and 54 chemical constituents were identified ，accounting for 82.35％ of the total content of root volatile components. The constituents with relatively high content were methyl salicylate （20.30％）， n-hexadecanoic acid （19.86％），（Z，Z）-9，12-octadecadienoic acid （9.26％），phenanthrene（4.37％）and so on. Totally 69 chromatographic peaks were detected in volatile oil from the stems and leaves of G. yunnanensis and 46 chemical constituents were identified，accounting for 97.10％ of the total content of volatile components in stems and leaves. The constituents with relatively high content were methyl salicylate （86.72％），n-hexadecanoic acid （2.60％），（Z，Z，Z）-9，12，15-octadecatrienoic acid （1.25％） and so on. Both of them contained 16 common constituents such as alkenes esters ，acids and so on. CONCLUSIONS：The chemical constituents of volatile oils extracted from the roots ， stems and leaves of G. yunnanensis are mainly esters and acids. The components are similar to each other ，but the contents of acids in the roots and esters in the leaves and stems are higher.  
          
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        发布时间：2022-06-21
      • HUANG Yuxin,MA Ling,LI Miao,ZHENG Guobao,MA Xiaorong
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To establish the content determination method of betaine in Lycium barbarum ，and to optimize the extraction method. METHODS ：HPLC method was used to determine the content of betaine in L. barbarum . The determination was performed on Waters Spherisorb NH 2 column with mobile phase consisted of acetonitrile- 0.01 mol/L monopotassiun phosphate aqueous solution （75∶25，V/V）at the flow rate was 0.7 mL/min. The detection wavelength was 195 nm，and column temperature was 30 ℃. The sample size was 10 μL. Using the content of betaine as index，on the basis of single factor tests ，L（9 34）orthogonal test design were used to select the methanol volume fraction ，extraction time and solid-liquid ratio of betaine in L. barbarum by ultrasonic extraction. The contents of betaine in 10 batches L. barbarum were determined ，and compared with the results of TLC included in 2015 edition of Chinese Pharmacopeia . RESULTS ：The linear range of betaine was 2.035-2 035.04 μg/mL（R2＝0.999 3）. The limits of detection and quantification were 0.410 μ g/mL and 2.051 μ g/mL，respectively. The average recovery were 97.41％-98.86％（RSDs were 0.8％-1.4％，n＝3）. RSDs of precision ，reproducibility and stability （24 h）tests were not higher than 1.2％. The optimal extraction method included solid-liquid ration of 1∶30（g/mL），ultrasonic extraction with methanol for 45 min. The average content of betaine in the extract from the three validation tests was 2.30％（RSD＝0.43％，n＝3）. The contents of betaine in 10 batches L. barbarum were 1.91％ -2.55％ ，which was no significantly different from the results of TLC （1.88％-2.60％）（RE were －1.92％-2.79％）. CONCLUSIONS ：The content determination method of betaine in L. barbarum was established successfully ，and the extract ion process was optinized.  
        关键词：Lycium barbarum;Betaine;HPLC;Content determination;Extraction method   
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        发布时间：2022-06-21
      • YANG Jiajia,LI Wanrong,PENG Jianqing,XIAO Ting,WU Linjing,ZHOU Xue,YANG Zengqiu,JIANG Feng,DING Yang,SHEN Xiangchun,TAO Ling
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To optimize the p reparation technology of citronellol submicroemulsion. METHODS ：The content of citronellol in Citronellol submicroemulsion was determined by HPLC. Citronellol submicroemulsion by high-speed shearing dispersion-high pressure homogenization method ，with centrifugation stability constant （ke） and particle size were used as evaluation indexes. Its formulation and preparation technology were optimized and validated. Drug-loading amount and encapsulation rate of the preparation were detected. RESULTS ：The linear range of citronellol were 4-64 μg/mL（R 2＝0.999 9）. RSDs of precision ，stability（24 h）and reproducibility tests were all lower than 3％. The recoveries were 97.64％-101.97％（RSD＝ 2.28％，n＝3），97.71％-99.50％（RSD＝1.29％，n＝3），96.87％-101.48％（RSD＝2.86％，n＝3）. The optimal formulation included that total weight of soybean oil and medium chain triglycerides （1 ∶ 1，g/g）was 3.75 g，1.2％ soybean phospholipid was 0.6 g， cholesterol was 0.06 g，citronellol was 1.25 g，0.6 ％ sodium oleate was 0.3 g，15-hydroxystearic acid polyethylene glycol ester was 0.75 g，poloxamer 188 was 0.75 g，water added to 50 mL. After prepared by optimal technology at 4 ℃ which contained shearing speed of 13 000 r/min，lasting for 5 min， primary emulsion was adjusted to pH 7 with dilute hydro- chloric acid ，and homogenized with 600 Bar high pressure for 1434412440@qq.com 5 min. The parameters of Citronellol submicroemulsion accor- ding to optimal formulation and technology contained mean particle size of （91.05±0.26）nm，PDI of （0.20±0.01）， Zeta-potential of （－30.86±0.39）mV，average content of 649511230@qq.com citronellol（100.21±0.01）％，the drug-loading amount was （2.481 7 ± 0.000 7） mg/mL，the encapsulation rate was （99.27 ± 0.03）％ . CONCLUSIONS ：The optimal formulation and technology is stable and feasible.  
          
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        发布时间：2022-06-21
      • SHI Tinglan,ZHANG Li,HUANG He,MEI Xiaoli,TU Ruxia,WU Silan,LAN Bo,LI Henghua
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To study the toxic effect of the extract from Tripterygium hypoglaucum on pregnant animal and embryo-fetal development . METHODS ：Successfully mated New Zealand female rabbits were randomly divided into solvent control group，positive control group （cyclophosphamide，20 mg/kg）and T. hypoglaucum extract high-dose ，medium-dose and low- dose groups（15.0，7.50，3.75 g/kg，by the amount of crude drug ）according to their body weight ，with 18 rabbits in each group at least. The female rabbits in solvent control group and T. hypoglaucum extract groups were given water or the corresponding T. hypoglaucum extract solution from 6th to 18th day of pregnancy ，5 mL/kg，once a day. Positive control group was given cyclophosphamide subcutaneously into the neck from 10th to 13th day of pregnancy ，1 mL/kg，once a day. According to the related requirements of Technical Guidelines for the Study of Drug Reproductive Toxicity ，the general situation ，body weight ，body weight increase and food intake of female rabbits were observed and recorded during the experiment ，and euthanasia was carried out on 28th day of pregnancy ；the relative indexes of main organs ，fetal uterus ，placenta uterus ，placenta，ovary，implantation gland ， absorption fetus ，stillbirth，live fetus and corpus luteum were observed and recorded after anatomy ；the relative indexes of body weight，appearance，visceral and skeletal alterations of the fetus were detected . RESULTS ：Compared with solvent control group ， the body weight ，body weight increase ，food intake ，main organs ，pregnancy of pregnant rabbits ，as well as reproductive function，embryo formation ，fetal growth and development ，appearance，visceral and skeletal development indexes in T. hypoglaucum extract groups had no significant abnormal changes （P＞0.05）；above indexes in the positive control group had significant changes （P＜0.05），and significant maternal toxicity and embryotoxicity were found. CONCLUSIONS ：T. hypoglaucum extract 15.00-3.75 g/kg（by the amount of crude drug ）have no significant maternal toxicity ，embryotoxicity or fetal development toxicity to New Zealand rabbits.  
        关键词：Tripterygium hypoglaucum;Extract;New Zealand rabbits;Embryo;Fetal;Reproductive toxicity   
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        发布时间：2022-06-21
      • GONG Xinghua,ZHENG Lei,LI Juan
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To establish a method for sim ultaneous determination of 7-hydroxycoumarin，6，7-dimethoxy- coumarin，5，7-dimethoxycoumarin，imperatorin and bergaptene in Shugan hewei pills. METHODS ：Samples were extracted by Soxhlet extraction and separated by using D 101 macroporous adsorption resin ；HPLC method was used to determine the contents of above 5 components. The determination was performed on Venusil MP C 18 column with mobile phase consisted of methanol- 0.1％ phosphoric acid water solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was 270 nm and the column temperature was 30 ℃ . The sample size was 10 μ L. RESULTS：The linear ranges were 1.875-187.5 μ g/mL for 7-hydroxycoumarin（r＝0.999 9），1.075-107.5 μg/mL for 6，7-dimethoxycoumarin（r＝0.999 9），1.261-126.1 μg/mL for 5， 7-dimethoxycoumarin（r＝0.999 9），0.875-87.5 μg/mL for imperatorin（r＝0.999 9），2.033-203.3 μg/mL for bergaptene（r＝0.999 8）， respectively. RSDs of precision ，stability（24 h），reproducibility and durability tests were lower than 2.0％. Average recoveries were 95.18％ -98.44％ （RSD＝1.27％ ，n＝6）， 95.35％ -98.14％ （RSD＝1.16％ ，n＝6），95.21％ -97.32％ （RSD＝0.83％ ，n＝6）， 95.43％-97.14％（RSD＝0.76％，n＝6），95.12％-98.75％（RSD＝1.35％，n＝6），respectively. The average contents of the above five components in 3 batches of shugan hewei pills were 0.424，0.239，0.305，0.180，0.459 mg/g（n＝2）.CONCLUSIONS：A method for simultaneous determination of five components in Shugan hewei pills was established.  
          
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        发布时间：2022-06-21
      • HUANG Lei,LIU Meiqiong,ZHANG Xiaoman,SU Shaofeng,ZOU Xiaoqin,ZHONG Xiaobin,FENG Jie
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To investigate the anti-inflammatory activity of 70％ ethanol extracts from Garcinia oblongifolia （GOEE）on LPS-induced RAW 264.7 cells and its potential molecular mechanism. METHODS ：GOEE was obtained after the fresh G. oblongifolia epicarp refluxed with 70％ ethanol. The contents of total phenol and total flavonoids were determined by Folin-Ciocalteau assay and UV spectrophotometer. MTT assay was used to detect the cytotoxicity of different doses of GOEE. The inflammatory model was induced in RAW 264.7 cells by lipopolysa- ccharide （LPS）. Using dexamethasone and N-acetyl-L-cysteine as positive control ，Griess assay and 2′，7′-dichloro- fluorescein assay were used to detect the contents of NO in cell culture medium and ROS in cells. The levels of TNF-α，IL-6，and IL- 1β in cell culture medium were measured by ELISA. The protein expression of p 65，p-p65，IκBα，p-IκBα，HO-1 in cells and NRF 2 in nucleus were determined by using Western blotting assay. RESULTS：The contents of total phenol and flavonoids in GOEE were （20.191±1.264）and（12.571±0.020）mg/g，respectively. At the concentration below 500 μ g/mL， GOEE had no significantly effect on survival rate of RAW 264.7 cells（P＞ 294043）0.05）. Compared with control group ，the contents of NO and ROS，the levels of TNF-α，IL-6 and IL- 1β，ratio of p-p 65 top65，ratio of p-IκBα to IκBα，protein expression of NRF 2 were increased significantly in LPS model group （P＜0.05 or P＜0.01）. Compared with LPS model group ，the contents of NO（except for GOEE 50 μg/mL group）and ROS ，the levels of TNF-α，IL-6 and IL- 1β，ratio of p-p 65 to p 65 and ratio of p-IκBα to IκBα were decreased significantly in GOEE groups and positive control groups ，while protein expression of HO- 1 and NRF 2 were increased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS：GOEE attenuates LPS-induced macrophages inflammation injury by inhibiting the inflammatory response and the phosphorylation of NF-κB pathway，promoting NRF 2 protein transportation to the nucleus.  
          
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        发布时间：2022-06-21
      • CHEN Fangchao,GAO Shouhong,WANG Zhipeng,YANG Hong,SHUN Qingsheng,SONG Xinhua,XU Yixin
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To identi fy chemical components of Actinidia chinensis root rapidly ，and to provide reference for further material basis and quality control study of the crude medicine. METHODS ：UHPLC-Q-TOF-MS/MS technique was used to detect chemical components of A. chinensis root. The separation was performed on Waters XSelect HSS T 3 column with mobile phase consisted of 0.1％ formic acid acetonitrile solution- 0.1％ formic acid water solution （gradient elution ）at the flow rate of 0.3 mL/min. The column temperature was set at 40 ℃，and sample size was 3 μL. Electrospray ion source was adopted，the data was collected under negative ion mode ；the scanning range was m/z 50-1 500；the drying gas temperature was 350 ℃，the atomizing air pressure was 45 psi，the capillary voltage was 3 500 V，and sheath gas temperature was 350 ℃. According to the information of excimer ion and secondary fragment ion ，the chemical components were identified by combining with the relevant literature ，the retention time of the reference substance and the law of mass spectrometry cracking. RESULTS & CONCLUSIONS ：Totally 58 chemical components was identified ，which included 16 pentacyclic triterpenes （such as hydroxyasiatic acid ，asiatic acid ，maslinic acid，corosolic acid ，oleanic acid ，ursolic acid ，etc.），12 flavonoids（such as rutin ，quercitrin，cynaroside，astragalin，etc.），17 organic acids （such as cryptochlorogenic acid ，chlorogenic acid ，isochlorogenic acid A ，isochlorogenicacid C ，etc.）. There were 9 components（such as procydanidin B 1，B2 and luteolin ，etc.）identified for the first time in A. chinensis root. UHPLC-Q-TOF-MS/ MS technique can be used for the rapid identification of chemical components in A. chinensis root.  
        关键词：Actinidia chinensis root;UHPLC-Q-TOF-MS/MS;Chemical component;Identification   
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      • MA Liuchun,MA Shengjun,ZHU Jinfang,YANG Jianbo,ZHOU Mingcong,SONG Xiaoyu
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To es tablish the HPLC fingerprint of Arnebia euchroma ，analyze them with chemical pattern recognition technology ， and determine the contents of 3 components. METHODS ： HPLC method was adopted. Using acetylshikonin as reference ，HPLC fingerprint of 34 batches of A. euchroma from different sources were drawn. Similarity Evaluation System for TCM Chromatographic Fingerprint （2012A edition ）was used to evaluate the similarity of the samples ，and common peaks were determined. SPSS 19.0 and SIMCA 14.1 statistical software was used for cluster analysis ，principle component analysis and orthogonal partial least squares-discriminate analysis. According to the standard of the variable importance in the project greater than 1，the differential markers affecting the quality difference of A. euchroma were screened. Meanwhile ，the contents of 3 components were determined by the same HPLC method. RESULTS ：There were 12 common peaks in HPLC fingerprints for 34 batches of A. euchroma . The similarity of other samples were more than 0.86，except that t he three （No.2016A3005-5） batches of medicinal herbs on the market were less than 0.72；3 common peaks were identified ， such as shikonin ，acetylshikonin， β ，β ′-dimethylacrylic acanine. These 34 batches of samples could be classified into two categories . S 1， qq.com S4-S6，S13，S15-S20，S22，S26-S34 were clustered into one category，and others clustered into the other category. By principal component analysis ，the contribution rates of three principle components were 52.834％ ，18.600％ and 8.387％ . Accumulative contribution rate was 79.821％ . Six constituents，such as shikonin，acetylshikonin and β，β'-dimethylacrylic acanine were screened as differential markers，representing the major differences of A. euchroma . The linear range of above three components were 0.72-90，2.05-410，2.50-500 µg/mL（r all more than 0.999）， respectively. The limits of quantification were 0.132，0.135，0.118 µg/mL，respectively. The limits of detection were 0.040，0.041， 0.036 µg/mL，respectively. RSDs of precision ，stability（24 h），reproducibility and durability tests were all lower than 3％. Recoveries were 95.959％-100.201％（RSD＝1.669％，n＝6），97.818％-102.698％（RSD＝1.788％，n＝6），95.831％-99.344％ （RSD＝1.600％，n＝6）. The contents of above three components were 0.002％-0.134％，0.025％-1.388％，0.022％-0.881％. CONCLUSIONS：Established HPLC fingerprint and content determination method are simple and stable ，can be used for quality evaluation and quantitative analysis of A. euchroma . Shikonin ，acetylshikonin and β，β'-dimethylacrylic acanine are different in the content and are differential markers of A. euchroma from different source.  
          
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      • DENG Lihong,ZHANG Zhipeng,TIAN Qingqing,CHENG Xueren,LU Yun,LIU Liaoyuan
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To e stablish UPLC characteristic chrom atograms of Euodia rutaecarpa ，processed E. rutaecarpa decoction piece ，water decoction and formula granules ，and to compare its relationship and difference. METHODS ：UPLC method was used. The determination was performed on YMC Triart C 18 column with mobile phase consisted of acetonitrile- 0.1％ phosphoric acid water solution （gradient elution ）at the flow rate of 0.3 mL/min. The detection wavelength was set at 254 nm，and column temperature was 30 ℃. The sample size was 1 μL. Using limonin as reference，the characteristic chromatograms of E. rutaecarpa ， processd E. rutaecarpa decoction piece ，water decoction and formula granules （each 10 batches，totally 60 batches）were drawn. The similarity was evaluated with TCM Chromatographic Fingerprint Similarity Evaluation System （2012 edition），and to determine the common characteristic peak. The differences of ratio of common characteristic peak area were evalucoted according to variance analysis. Meanwhile ，the cluster analysis and principal component analysis （PCA） were performed to research the differences of E. rutaecarpa ，processed E. rutaecarpa decoction piece ，water decoction and formula granules by using SPSS 20.0 software. RESULTS ：Totally 16 and 17 common peaks were respectively confirmed in characteristic chromatograms of E. rutaecarpa samples and processed E. rutaecarpa samples（decoction piece ，water decoction and formula granules ）. No. 8，9，11， 17 peaks were identified as limonin ，evodiamine，rutaecarpine and glycyrrhizic acid. Compared with decoction piece ，the similarities of characteristic peak between water decoction and formula granules were lower than 0.55，while those between water decoction and formula granule were higher than 0.95. Cluster analysis and PCA results showed that E. rutaecarpa decoction piece and processed E. rutaecarpa decoction piece could be clustered into one category ；E. rutaecarpa water decoction and formula granules could be clustered into one category ；processed E. rutaecarpa water decoction and formula granules could be clustered into one category. CONCLUSIONS ：Compared with E. rutaecarpa ，processed E. rutaecarpa additionally contain glycyrrhizic acid ； main che mical components of decoction piece ，water decoction and formula granules are basically the same ，but the contents of the components between decoction piece to water decoction and formula granules are different.  
          
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      • LI Shihuan,LI F an,HUANG Yidi,XU Zhixin
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To investigate the effects of parecoxib sodium ，flurbiprofen axetil and lornoxicam combined with patient controlled intravenous analgesia （PICA） on postoperative analgesia in patients undergoing gynecological laparoscopic surgery and its effect on serum related factors. METHODS ：A total of 280 patients who underwent gynecologic laparoscopic surgery in the Second Affiliated Hospital of Hainan Medical University from Mar. 2017 to Mar. 2019 were randomly divided into control group （group C ），parecoxib sodium group （group P ），and flurbiprofen axetil group （group F ）and lornoxicam group （group L ）acording to random number table ，with 70 patients in each group. Four groups of patients received Sodium chloride injection 5 mL，Parecoxib sodium for injection 40 mg，Flurbiprofen axetil injection 50 mg and Lornoxicam for injection 8 mg （added 8 mg when the effect was not good ）intravenously at 30 min before the end of surgery. At the end of surgery ，they were given PICA of Sufentanil citrate injection and Dizosin injection for analgesia. The situation of pain and nausea symptom were evaluated at 6，12，24 and 48 h after surgery by using numerical rating scale （NRS）. The levels of serum CRP ，IL-6，SP and PGE 2 were detected by chemiluminescence method and ELISA. The times of pressing PICA pump and the dosage of analgesic were recorded in 4 groups within 24 h after surgery. The ADRs of patients within 48 h after surgery were recorded ，such as bloating ， dizziness，itchy skin ，respiratory depression and urinary retention. RESULTS ：At different time points ，the NRS scores of pain of group P ，F and L were significantly lower than those of group C ；and 48 h after surgery ，NRS score of pain of group L was significantly lower than those of group P and F （P＜0.05）. There was no statistical significance in the level of CRP ，IL-6，SP and PGE2 of 4 groups before surger （P＞0.05）. The CRP ，IL-6，SP and PGE 2 levels at each time point after surgery of group P ，F and L were significantly lower than those of group C ；compared with group P ，serum level of SP at 48 h after surgery as well as serum levels of PGE 2 at 12，24 and 48 h after surgery were significantly decreased in group F ，and serum level of IL- 6 at 48 h after surgery，serum levels of SP at 24 and 48 h after surgery ，serum levels of PGE 2 at 12，24，48 h after surgery were decreased significantly in group L ；compared with group F ，serum level of SP at 48 h after surgery as well as serum levels of PGE 2 at 12， 24，48 h after surgery were all decreased significantly in group L （P＜0.05）. There was no statistical significance in the incidence of anausea and vomiting among 4 groups（P＞0.05）. CONCLUSIONS ：Parecoxib sodium ，flurbiprofen axetil and lornoxicam combined with PICA can effectively relieve the pain of patients after gynecological laparoscopic surgery and reduce the levels of serum related factor ，and lornoxicam has the most obvious effect.  
          
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      • TIAN Xiaojiang,JIA Yuntao,WANG Kejing,CHEN Lin
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To eva luate the risk of abno rmal female reproductive system haemorrhage induced by novel oral anticoagulants （NOACs）. METHODS ：The abnormal female reproductive system haemorrhage reports induced by 4 kinds of NOACs as “dabigatran etexilate ”，“rivaroxaban”，“apixaban”and“edoxaban”were used as the first suspected dugs to collected from FDA adverse event reporting system （FAERS）database during Jan. 1st，2004-May 31st，2019. The report odd ratio （ROR） method was used to detect the signal of abnormal female reproductive system haemorrhage induced by NOACs. RESULTS ：A total of 2 658 adverse events related to abnormal female reproductive system haemorrhage were collected from FAERS database ， involving 330 reports of dabigatran etexilate ，2 049 reports of rivaroxaban ，267 reports of apixaban ，and 12 reports of edoxaban. The abnormal female reproductive system haemorrhage caused by dabigatran etexilate ，apixaban and edoxaban mainly occurred in patients aged 75 and older ，accounting for 37.27％，36.70％ and 58.33％ respectively；that of rivaroxaban mainly occurred in patients with 45-64 years old ，accounting for 33.04％. The incidence of severe adverse events （SAE）induced by dabigatran etexilate，rivaroxaban，apixaban and edoxaban were 96.36％，84.53％，47.19％ and 58.33％，respectively. All of patients in the included reports were mainly hospitalized and hospitalization stay wa s prolonged ，accounting for 64.78％，90.01％，86.51％ and 71.43％ ，respectively. A total of 12 suspected signals were detected，involving cervix uteri ，fallopian tube ，ovary，pelvis cavity，uterus，vagina，urinary tract ，etc. Among them ，there were 11 positive signals of rivaroxaban ，and the bleeding events were concentrated in vaginal hematoma [ROR ＝12.07， 药。95％CI（8.51，17.12）]，postmenopausal hemorrhage [ROR ＝ 9.89，95％CI（8.31，11.77）]，pelvic hematoma [ROR ＝7.68，95％CI（5.66，10.43）]. There were 4，4 and 2 suspicious signals for dabigatran etexilate ，apixaban and edoxaban. The main bleeding events of both apixaban [ ROR＝5.18，95％CI（1.81，5.85）] and edoxaban [ROR ＝48.19，95％CI（6.76，343.77）] were vaginal hematoma ；dabigatran etexilate-induced pelvic hematoma [ROR ＝ 12.56，95％CI（8.92，17.70）] had the strongest signal ，followed by urinary tract bleeding [ROR ＝5.41，95％CI（3.34，8.76）] and pelvic hemorrhage [ ROR＝2.53，95％CI（1.88，3.40）]. CONCLUSIONS ：Totally 4 kinds of NOACs can cause abnormal female reproductive system haemorrhage ，and the incidence of SAE is high ，of requiring hospitalization or prolonging hospitalization time. The risk of haemorrhage in rivaroxaban is the highest ，usually manifesting as vaginal hematoma ，postmenopausal hemorrhage and pelvic hematoma. Dabigatran etexilate mainly induce pelvic hematoma ，while apixaban and edoxaban are mainly cause vaginal hematoma.  
          
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      • WANG Hengsheng,TANG Yaoping,DENG Kaifeng,FENG Jiaoqun,WEI Xiawei,LIU Ruoya
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To systematically evaluate the efficacy and safety of Kuanxiong aerosol in the treatment of coronary heart disease angina ，and to provide evidence-based reference for climical drug use . METHODS ：Retrieved from Cochrane Library，PubMed，Embase，CKNI，Wanfang data ，VIP，and CBM ，randomized controlled trials （RCTs）about Kuanxiong aerosol （trial group ）versus nitroglycerin （control group ）in the treatment of coronary heart disease angina were collected during the inception to Mar. 20th，2020. After literature screening and data extraction ，quality assessment was performed using the bias risk assessment tool recommended by the Cochrane System Evaluator Manual 5.1.0. Meta-analysis was performed by using Rev Man 5.3 statistical software. Sensitivity analysis was conducted for the stability of the result ，and trial sequential analysis （TSA）was performed by using TSA 0.9 software. RESULTS ：A total of 11 RCTs were included ，with a total of 1 847 cases. Meta-analysis showed that improvement rate of angina pectoris （within 3 min）[RR＝1.11，95％CI（1.02，1.22），P＝0.02] and total response rate of angina pectoris （within 5 min）[RR＝1.04，95％ CI（1.01，1.07），P＝0.01] in trial group were significantly higher than control group；the incidence of ADR [RR＝0.44，95％CI（0.35，0.57），P＜0.000 01] in trial group was significantly lower than control group. There was no statistical significance in total response rate of ECG [RR＝1.02，95％CI（0.97，1.09），P＝0.42] or the level of NO after treatment [SMD ＝－0.08，95％CI（－0.61，0.45），P＝0.76] between 2 groups. The results of sensitiv ity analysis and TSA showed that the efficacy evidence of Kuanxiong aerosol in the treatment of coronary heart disease pectoris was not accurate ，but the evidence of safety was accurate. CONCLUSIONS ：Kuanxiong aerosol can improve the efficacy in patients with coronary heart disease angina ，and the safety is better ，but the conclusions of efficacy needs to be further confirmed by enlarging sample size.  
        关键词：Kuanxiong aerosol;Coronary heart disease angina;Nitroglycerin;Meta-analysis;Efficacy;Safety   
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      • XIAO Xiao,ZHOU Jing,YANG Min,LAI Weihua,ZHONG Shilong,ZENG Yingtong
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To provide evidence-based reference for c linical drug selection and decision by rapidly evaluating the effectiveness，safety and economy of treprostinil in the treatment of pulmonary arterial hypertension （PAH）. METHODS ：Retrieved from Chinese and English database such as PubMed ，Embase，Web of Science ，the Cochrane Library ，Epistemonikos，HTA database（University of York ），CNKI and Wanfang databases ，included the health technology assessment （HTA）report，systematic/ Meta-analysis and pharmacoeconomic evaluation of treprostinil compared with placebo or other drugs in the treatment of PAH. The search time limit is from the construction of the database to May 1st，2020. HTA checklist ，AMSTA and CHEERS were applied to evaluate the quali ty of the literatures about HTA ，systematic review/Meta-analysis analysis a nd pharmacoecono mic evaluation and the inclusion studies was analyazed by descriptive summary. RESULTS：A total of 18 literatures were included ，involving 1 HTA report ，12 systematic review/Meta-analysis ，5 pharma- coeconomic studies. The analysis results of effectiven- ess mail： showed that compared with placebo ，treprostinil could signifi- cantly increase 6-MWD while decrease Borg dyspnea score of PAH p atients（P＜0.05），but had no significant effect on mortality，the rate of clinical deterioration ，WHO functional grading ，the rate of hospitalization ，mPAP，PVR，cardiac index and mRAP（P＞0.05）. In addition ，compared with placebo combined with endothelin receptor antagonist and/or phosphodiesterase inhibitors，oral administration of treprostinil combined with endothelin receptor antagonist and/or phosphodiesterase inhibitors could extend 6-MWD significantly. Compared with riociguat ，treprostinil could significantly reduce Borg dyspnea score of patients. The analysis results of safety displayed that ，although the incidence of drug withdrawal due to can ’t tolerate ADR increased in patients receiving treprostinil ，there was no significant difference in the incidence of serious adverse events compared with placebo or other treatments，and it was better tolerated when administered by inhalation or intravenous injection. The analysis results of pharmacoeconomic studies showed that ICER of treprostinil was higher than the willingness payment threshold ，although the willingness payment threshold was different in different countries and different payers. CONCLUSIONS ：Treprostinil treatment is effective for PAH. Patients may stop taking it due to can ’t tolerate ADR ，but the risk of serious adverse events are not increase. Although the price is high ，it is still an important alternative for PAH patients with clinical progress or poor prognosis.  
        关键词：Treprostinil;Effectiveness;Safety;Economy;Rapid healt h technology assessment   
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      • LIU Kefeng,QIAO Gaoxing,ZHANG Xufeng,ZHU Qiyue,LIU Yu,ZHAO Jie
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To systematically evaluate the effects of CYP1A2 gene polymorphisms on blood concentrations of antipsychotic drugs （haloperidol，clozapine，olanzapine），and to provide evidence-based reference for the clinical drug use . METHODS：Retrieved from Cochrane Library ，PubMed，Embase，CBM，CNKI and Wanfang data ，during the inception to Nov. 2019，cross-sectional study was conducted to investigate the effects of CYP1A2 gene polymorphisms on blood concentrations of antipsychotic drugs （haloperidol，clozapine，olanzapine）were collected. After screening the literature ，extracting the data and quality evaluation with Q-Genie tool ，Meta-analysis was performed by using Rev Man 5.3 software. RESULTS ：A total of 11 cross-sectional studies were included ，with a total of 914 patients. Of these ，haloperidol was used in 2 studies，clozapine was used in 5 studies，and olanzapine was used in 4 studies. Meta-analysis showed that there was no statistically significant difference in the blood concentration of haloperidol between CYP1A2（－2964G＞A）G/G type and G/A+A/A type [SMD ＝－0.22，95％CI（－0.66， 0.23），P＝0.35]. The blood concentration of clozapine in CYP1A2（－163C＞A）A/C type was significantly lower than C/C type [SMD ＝0.31，95％CI（0.01，0.62），P＝0.04]；there was no statistical significance in blood concentration of clozapine between A/A type and C/C type [SMD ＝0.09，95％CI（－0.21，0.40），P＝0.56]，between A/A type and A/C type [SMD ＝－0.22，95％CI（－0.55， 0.10），P＝0.18]，between CYP1A2（－2467delT）delT/delT type and T/T type [SMD ＝－0.11，95％CI（－0.75，0.52），P＝0.72]， between delT/T type and T/T type [SMD ＝0.01，95％CI（－0.33，0.34），P＝0.97]，between delT/delT type and delT/T type [SMD ＝ －0.15，95％CI（－0.80，0.05），P＝0.66]. The blood concentration of olanzapine in CYP1A2（－163C＞A）A/A type was signifi- cantly lower than A/C type [SMD ＝－0.31，95％CI（－0.55， － 0.08），P＝0.009]；there was no statistically significant difference in the blood concentration of olanzapine between A/A liukefeng-num.1@163.com type and C/C type [SMD ＝－0.20，95％CI（－0.61，0.21），P＝ 0.34]，between A/C type and C/C type [SMD ＝0.06，95％CI E-mail：hnmuzj@163.com （－0.35，0.47），P＝0.77]，between CYP1A2（－2467delT）delT/T type and T/T type [SMD ＝0.28，95％CI（－0.15，0.71），P＝0.20]. CONCLUSIONS：CYP1A2（－163C＞A）A/C type is related to the reduction of clozapine blood concentration ，and A/A type is related to the reduction of olanzapine blood concentration. CYP1A2 （－163C＞A）gene polymorphism is significance for guiding individualized medication of schizophrenia patients.  
        关键词：CYP1A2;Gene polymorphism;Antipsychotic drugs;Blood concentration;Meta-analysis   
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      • ZHU Ji,WANG Lei,CHEN Ge,LU Juanyi,MA Qiayi
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To know about the management status and problems of TCM pharmaceutical administration in Community Health Service Centers （CHS）in Shanghai ，and provide referrence for improving the level of TCM pharmaceutical administration in primary health institutions. METHODS ：From March to May 2019，a questionnaire survey was conducted on the current situation of TCM pharmaceutical administration in 243 CHS of Shanghai ，including the basic situation of the surveyed institutions，management of TCM decoction pieces ，review of TCM prescription and situation of hospital-made TCM preparations ， etc. A total of 243 questionnaires were issued ，237 valid ones were recovered ，with an effective recovery rate of 97.5％. RESULTS ： 233 CHS had established and implemented a standardized pharmaceutical administration. In 2017，the average number of outpatient prescriptions for TCM decoction pieces was 15 814.7，while that of decocting prescription was 2 898.9. In 2018，the average number of outpatient prescriptions for TCM decoction pieces was 15 256.5，while that of decocting prescription was 3 552.1. 211 CHS had established and implemented the working system of TCM decoction pieces prescription review ，and 220 CHS could carry out the work of TCM prescription review regularly. 3 CHS had hospital-made TCM preparations. CONCLUSIONS ：There is # high coverage rate of TCM decoction pieces service in CHS in Shanghai， and a relatively perfect and standardized management system of TCM prescription review has been established. However ，there are still some problems ，such as the supervision of Chinese medicine decocting enterprises still needing to be strengthened ，the quality of personnel for TCM prescription review needing to be improved ，and the development and use of hosipital-made TCM preparations being relatively weak. It is suggested that the level of TCM pharmaceutical administration in primary medical institutions should be improved by formulating regional standard documents ，establishing quality supervision system with multiple participation ，strengthening the training of clinical pharmacists of TCM ，and providing policy support for hosipital-made TCM preparations.  
          
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      • YANG Chunsong,YANG Yaya,ZHANG Lingli,LIN Yunzhu
        Vol. 31, Issue 14, (2020)
        摘要：OBJECTIVE：To investigate the status quo and influential factors for scientific research training of pharmacists （nurses）in PIVAS of China ，to provide direction and reference for the development of PIVAS. METHODS ：The survey method was used to conduct a questionnaire survey of PIVAS pharmacist （nurses）from 29 tertiary and secondary hospitals in 24 provinces， autonomous regions ， municipalities from eastern ， western and central China through the i nternet by using self-designed questionnaire. The survey period was from Mar. to Apr. 2019. The survey content included the basic information （gender，region， hospital level ，professional and technical title ，education background ，employment nature ）of the survey participants and the status quo of scientific research training （frequency and content of scientific research training ，degree of need for scientific research ， degree of interest in scientific research ，etc.）and status quo of scientific research output （publication and application of the project）. Main influential factors for scientific research training were analyzed. RESULTS ：A total of 504 questionnaires were sent out，and 501 valid questionnaires were collected ，with effective response rate of 99.40％ . Totally 63.1％（316/501）of the respondents had scientific training ，and the frequency of scientific training was mainly less than one time/month （26.1％，131/501） and 1-2 times/month（25.0％，125/501）；72.1％（361/501）of the respondents have medium or above scientific research needs ， 82.4％（413/501）of the respondents have medium or above interest in scientific research ，only 6.0％（30/501）of the respondents had mastered the major scientific research methods ， only 5.4％（27/501）of the respondents thought that their scientific research ability were strong. The pharmaceutical re search - direction was mainly related to clinical rational use of drugs ， song_123@126.com less to precision medicine ，new drug and new dosage form： development， therapeutic drug monitoring research ， 028-85503220。E-mail：linyunzhu99@163.com translational medicine ， etc. Only 16.6％ （83/501） of the respondents had published articles after working in PIVAS ，and 9.0％（45/501）had applied for projects. There were statistical significances in the scientific research training among the respondents with different regions ，professional and technical titles ， educational backgrounds and employment natures （P＜0.05）. CONCLUSIONS ：The scientific research training of PIVAS pharmacist（nurses）in China is inadequate and the research output is low. Main influential factors for scientific research training include region ，professional and technical title ，educational background and employment nature .  
        关键词：PIVAS;Pharmacist（nurse）;Scientific research training;Influence factor;Questionnaire survey;China   
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