最新刊期

    卷 32 , 期 21 , 2021
    • YOU Li,BIAN Jing,XU Yangui,WANG Zhuo,ZHAO Qingchun,HUANG Xin,LIU Jing,LU Jin,ZHEN Jiancun
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To interpret the new version of the Implementation Plan for Enrollment and Assessment of Clinical Pharmacist Teacher Training Project of Chinese Hospital Association (Trial)(hereinafter referred to as the “New Plan ”)officially announced by the Chinese Hospital Association in Sept. 2021,in order to provide guidance and reference for smoothly promoting the implementation of the New Plan and realizing the original intention of the reform. METHODS :The New Plan was interpreted from four aspects ,including the background of the formulation of the New Plan ,the main features presented ,the innovations and the issues that need to be paid attention to in the next implementation. RESULTS & CONCLUSIONS :The formulation and release of the New Plan marks the beginning of a new round of reform of the clinical pharmacist teacher training program of the Chinese Hospital Association. It is mainly based on the actual problems encountered in the operation of the current clinical pharmacist teacher training system ,the importance of clinical pharmacistteacher training itself ,and the opportunities and challenges that the development of the times has brought to our country ’s 163.com clinical pharmacy business. Research foundation , problem orientation and professional demonstration present important characteristics. Compared with the old plan ,the New Plan adds a substantive selection mechanism for majors ,which intends to achieve the necessary “strictness”in the enrollment process ;it reconstructs the overall training goal of the benchmarking project and the three-in-one assessment system ,which intends to achieve a reasonable “lax”of assessment link ;it removes restrictions on off-site training ,advocates wide-ranging professional docking,and improves the flexibility of the training system and process management. The implementation of the New Plan is a complex work involving multiple parties and is affected by many factors. It requires multiple teams to perform their duties and promote together. The teacher training base and expert team must understand the spirit of reform and achieve the stable implementation of the New Plan ;at the same time ,the communication between the project working group and the teaching base and experts should be strengthened ,and finally realize the original intention of the reform of cultivating more high-quality clinical pharmacy teachers.  
      关键词:Clinical pharmacist;Teacher training;Enrollment;Assessment;Implementation plan;Interpretation   
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      发布时间:2022-06-21
    • LIANG Yun,YUE Xiaoxiao,SHAO Rong
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To provide reference for furthe r promoting the high-quality development of the biomedical industry in Guangdong-Hong Kong-Macao Greater Bay Area. METHODS :Through summarizing the development status and development environment of the biomedical industry in the Guangdong-Hong Kong-Macao Greater Bay Area ,the construction experience of foreign advanced biomedical industrial park was introduced ,and the problems and challenges faced by the biomedical industry in the Guangdong-Hong Kong-Macao Greater Bay Area were sorted out so as to put forward relevant countermeasures and suggestions. RESULTS & CONCLUSIONS :Guangdong-Hong Kong-Macao Greater Bay Area has received multiple policy support,which is conducive to the development of biomedical industry. The industrial chain is complete ,and the scale advantage of biological industry is showing day by day. Biological industry has achieved fruitful innovation achievement ,and its R&D investment is in the leading position in the country. The pharmaceutical manufacturing industry is developed and the total amount of medical resources is large. The financial advantages are obvious ,and institutional innovation is conducive to the development of biomedical industry. The process of internationalization takes the leading place ,which is conducive to continuously promoting foreign cooperation. However ,compared with foreign advanced biomedical industrial parks ,Guangdong-Hong Kong-Macao Greater Bay Area still has some deficiencies in management mode ,service mode and “industry-university-institute”cooperation. It also faces the following problems that the legal systems and industry norms of the three places need to be further connected ;there is a talent gap ;the industrial chain is not perfect ;the support for new drug R&D is insufficient ;the“industry-university-institute” cooperation needs to be strengthened ;the level of financial support needs to be improved. Accordingly ,it is recommended to break down institutional barriers ,and promote the connection between the legal system and industry norms ;innovate talent policies ,and continue to attract excellent R&D talents ;introduce leading companies ,and improve the industrial chain ;open up clinical trial channels and promote the transformation efficiency of scientific research achievements ;strengthen“industry-university-institute” cooperation,and promote the improvement of biomedical innovation ability ;make good use of financial support to help the rapid rise of biomedical industry enterprises ,so as to promote the high-quality development of biomedical industry in Guangdong-Hong Kong-Macao Greater Bay Area.  
      关键词:Guangdong-Hong Kong-Macao Greater Bay Area;Biomedical industry;Development;Suggestion   
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      发布时间:2022-06-21
    • LIU Wen,WANG Chong,ZHU Jiong,HU Zengyao
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To provide a reference for further improvi ng the quality risk reminder mechanism of the drug sampling and testing (called“the Reminder ”as for short )in China ,and strengthening the drug quality management. METHODS : The quality risk management situation of the drug sampling and testing were summarized ,and the legal nature ,main content and working procedures of the Reminder were analyzed. The latest data of the Reminder in 2020 were taken as an example to analyze the role of the Reminder in the investigation of potential drug quality risks ,and made the suggestions for existing problems. RESULTS & CONCLUSIONS :Based on legal standards ,China’s drug regulatory departments had carried out exploratory research on drugs that may have quality and safety risks due to drug quality control blind spots or deviations of manufacturing enterprises , and divided them into serious risks and general risks according to the severity of the problems found ,and implemented hierarchical management. The Reminder was an administrative measure for general drug quality risks based on the principle of persuasion first , and did not have sanctions. Its main content covered all the information required for risk investigation and rectification (basic drug information, suggested risk information , contact information , risk discovery methods , troubleshooting and rectification requirements,and responsibilities of local provincial drug regulatory departments ). It involved five responsible parties ,ie. the inspection institution ,China Institute for Food and Drug Control ,National Medical Products Administration ,the provincial food and drug administration of the relevant manufacturing enterprises and the relevant manufacturing enterprises. Through the mode of closed-loop management ,the benign interaction between regulatory authorities and manufacturing enterprises could been realized. In 2020,National Medical Products Administration issued 312 reminders to 286 manufacturers,with an accuracy of 87.91%,which was scientific and targeted. The manufacturer had carried out a series of rectification measures for the contents of the Reminder , including carrying out process verification ,revising internal control standards and strengthening production process control. However, there were also some problems , such as the rationality of the prompt contents being questioned by the manufacturer and the i nsufficient investigation of the manufacturer. It is suggested that the manufacturers correctly understand the nature and value of the Reminder. The inspection agency should further improve the scientific pertinence of the problems found ,while the drug regulatory department should focus on the troubleshooting of the problems found ,so as to jointly promote the improvement of drug quality.  
      关键词:Drug sampling and testing;Risk management;Reminder;Persuasion first   
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      发布时间:2022-06-21
    • LIU Yanli,LU Tao,WANG Yong
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To provi de reference for improvin g the quality assurance system of clinical pharmaceutical talent training and promoting the development of clinical pharmaceutical education in China. METHODS : The background of pharmaceutical education reform and accreditation in Japan was introcuded ;the development of clinical pharmaceutical professional accreditation standards in Japan and the main changes of current standards were analyzed so as to put forward the enlightenment to the development of clinical pharmaceutical education in China. RESULTS & CONCLUSIONS :Japan officially started the six-year clinical pharmaceutical education in 2006,which stipulated that only graduates of six-year clinical pharmaceutical education can be qualified to participate in the national examination for pharmacists. Japan Accreditation Borad of Pharmaceutical Education (JABPE)is responsible for the professional accreditation of clinical pharmacy in Japan. Its accreditation standards experienced the development of three versions in 2006,2012 and 2018. The main changes in the latest accreditation standards in Japan (2018 edition)are reflected in the innovation of index system framework ,accreditation concept and training requirements. For example , its system framework integrates 57 benchmarks and 176 viewpoints in 2012 edition of accreditation standard into 19 benchmarks and 53 viewpoints in 2018 edition of accreditation standard ,with prominent focus ,clarity and simplification. Our country should learn from the development experience of clinical pharmaceutical professional accreditation in Japan ,perfect laws and regulations to ensure the healthy and orderly development of accreditation system ;establish an independent third-party certification body ;explore the mechanism of organic connection between professional certification and professional qualification ;attach importance to the application of self-evaluation and qualitative indicators ; explore and construct a training mode of clinical pharmaceutical talents based on national conditions and in line with international standards.  
      关键词:Clinical pharmacutical education;Professional accreditation;Japan;Enlightenment   
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      发布时间:2022-06-21
    • AN Zhenxiang,HE Yuanli,TANG Dongxin,HUANG Dan,WANG Min,WANG Fang
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To study the mechanism of improvement effects of Fupi rougan granule (FRG)on hepatic fibrosis model rats. METHODS :The rats were randomly divided into blank group ,model group ,Colchicine tablet group (chemical positive control ,0.2 mg/kg),Fuzheng huayu capsule group (TCM positive control ,0.415 g/kg),FRG low-dose ,medium-dose and high-dose groups (20,40,80 g/kg),with 10 rats in each group ,except for 11 rats in blank group and model group (one rat was used to judge whether the modeling was successful ). Except for blank group ,other groups were given intraperitoneal injection of 50% CCl4 olive oil solution and intragastric administration of 30% ethanol to induce hepatic fibrosis model. After modeling , administration groups were given relevant medicine intragastrically ;blank group and model group were given constant volume of normal saline intragastrically ,once a day ,for consecutive 4 weeks. After last administration ,morphology changes of liver tissue in rats were observed. The serum levels of HA ,LN,PCⅢ and Col Ⅳ in rats were detected ,and protein expression of Beclin- 1 and LC3-Ⅱin liver tissue were also determined. mRNA and protein expression of Akt ,AMPK,mTOR,p70S6K were detected in liver tissues of rats. RESULTS :Compared with blank group ,the structure of hepatic lobules in the model group was disordered ,the proliferation of fibrous tissue was obvious ,and some pseudolobules were formed ;the serum levels of HA ,LN,PCⅢ and Col Ⅳ, the protein expression of Beclin- 1 and LC 3-Ⅱ in liver tissue as well as mRNA and protein expression of Akt ,AMPK,mTOR and p70S6K were increased significantly (P<0.01). Compared with model group ,the liver injury of rats in FRG groups was significantly relieved ,and the levels of the above indexes in serum and liver tissue (except for LN and PC Ⅲ in FRG low-dose group) were significantly reduced (P<0.05 or P<0.01). CONCLUSIONS :FRG can improve hepatic fibrosis in rats ,the mechanism of which may be associated with down-regulating the expression of autophagy associated protein and Akt/AMPK/mTOR/ p70S6K signaling pathway related protein.  
      关键词:Fupi rougan granule;Hepatic fibrosis;Autophagy;Akt/AMPK/mTOR/p70S6K signaling pathway;Rats   
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      发布时间:2022-06-21
    • LIAO Xiaohong,ZHANG Yijing,TANG Hongmei,QIU Zhen wen,LUO Dandong,YANG Liuliu,YANG Li ’e,LUO Qian
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To study the improvement effects of Weijing deco ction on AECOPD model rats and its possibile mechanism. METHODS :Totally 55 male SD rats were randomly divided into normal group ,model group ,Weijing decoction low-dose and high-dose groups (8.37,16.74 g/kg,by crude drug ),dexamethasone group (positive control group ,0.09 mg/kg),with 11 rats in each group. Except for normal group ,AECOPD model was induced by cigarettes combined with lipopolysaccharide in other groups. After modeling ,normal group and model group were given constant volume of water intragastrically ,and other groups were given relevant medicine intragastrocally ,twice a day ,for 14 days. After last intragastric administration ,the serum level of IL- 1 β was determined,and pathological changes of lung tissue and bronchus were observed in each group ;mRNA expression of MMP-9 and TIMP- 1 genes in lung tissue were detected ;protein expression of Ras homologous gene family member (RhoA), dishevelled associated activator of morphogenesis- 1(DAAM1)and hyperplasic suppress gene (HSG)in lung tissue were also determined. RESULTS :Compared with normal group ,the levels of IL- 1β in serum,mRNA expression of MMP- 9 and TIMP-1 as well as protein expression of RhoA and DAAM 1 in lung tissue were increased significantly in the model group(P<0.05),while protein expression of HSG in lung tissue was decreased significantly (P<0.05);there were many chronic inflammatory cells infiltrating around the bronchus ,some airway mucosa epithelium exfoliating ,alveolar compensatory dilation,pulmonary septal capillary dilation and hyperemia. Compared with model group ,the levels of IL- 1β in serum,mRNA expression of MMP- 9 and TIMP- 1 in lung tissue were decreased significantly in Weijing decoction high-dose group (P<0.05);the protein expression of RhoA and DAAM 1 in lung tissue were decreased significantly in Weijing decoction low-dose and high-dose groups(P<0.05),while the protein expression of HSG in lung tissue was increased (P<0.05);the pathological changes of Weijing decoction high-dose group ,such as inflammatory cells infiltrating around the bronchus and shedding of airway mucosa , were improved significantly , and there was complete alveolar epithelium structure but no obvious pulmonary dilation. CONCLUSIONS:Weijing decoction can improve AECOPD model rats to certain extent ;its mechanism may be associated with down-regulating mRNA expression of MMP- 9 and TIMP -1 as well as protein expression of RhoA and DAAM 1 in lung tissue , up-regulating protein expression of HSG in lung tissue so as to inhibit the airway remodeling.  
        
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      发布时间:2022-06-21
    • LIU Lei,MA Wei,WU Xiuhong,YANG Dayu,ZHANG Xiaoyan,NIU Lulu,ZHANG Shuxiang
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To stud y the effects of “green removing ”processing technology of fresh fruit of Schisandra chinensis after harvested on the quality of medicinal material ,and to provide new ideas for the scientific and rational processing of Chinese medicinal material. METHODS :Fifteen fresh fruits of S. chinensis were used as samples ,with 3 samples in each group. The sample were processed preliminarily by 5 methods,such as drying at 50 ℃,drying in the sun ,drying at 50 ℃ after“green removing”processing with microwave ,drying at 50 ℃ after“green removing ”processing with blanching ,drying at 50 ℃ after “green removing ”processing with steaming. HPLC fingerprints of 15 batches of dried S. chinensis products were established and similarity evaluation was conducted according to Similarity Evaluation System of TCM Chromatographic Fingerprints (2012 edition). Cluster analysis was used to evaluate the similarity of dried S. chinensis products with different processing methods. At the same time ,HPLC method was adopted to determine the content changes of seven lignans in dried products ,such as schisandrol A , schisandrol B ,schisantherin A ,schisantherin B ,schizandrin A ,schisandrin B and schisandrin C. RESULTS :A total of 7 common peaks were obtained in the fingerprints of 15 batches of dried S. chinensis products. Except that the similarity between the chromatograms of dried samples in the sun and the control fingerprint was relatively low ,the similarities of chromatograms of dried products by other processing methods were greater than 0.900. Cluster analysis showed that 6 samples dried at 50 ℃ after“green removing”processing with microwave and dried at 50 ℃ after“green removing ”processing with blanching were grouped into the first category ;3 samples dried at 50 ℃ after“green removing”processing with steaming were grouped into the second category ;6 samples dried at 50 ℃ and dried in sun were grouped into the third category. The content determination results showed that there was no significant difference in the total content of seven lignans in the samples dried at 50 ℃ and dried in the sun (P>0.05). The total contents of seven lignans in the samples dried at 50 ℃ after“green moving ” processing with microwave ,blanching and steaming were significantly higher than those dried at 50 ℃ and dried in sun (P<0.01). CONCLUSIONS:The quality of S. chinensis samples dried after “green moving ”processing with microwave and blanching is better than those directly dried in sun and dried in oven.  
        
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      发布时间:2022-06-21
    • LU Yun,HONG Wanmin,YAO Xiaoxuan,JI Yuhua,LIANG Lijin,ZHONG Wenfeng,LIU Liaoyuan
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To analysis the correlation between chrom aticity value and quality index of Atractylodis chinensis decoction piece powder stir-fired with bran ,and to determine its processing time. METHODS :The processed samples of 16 batches of A. chinensis decoction piece stir-fired with bran (S0-S15,S0 is the raw product of A. chinensis )were prepared ,and chromaticity values of all samples were determined ,such as lightness value (L*),yellow blue value (b*),red green value (a*). UPLC fingerprint of sample were analyzed ,and the contents of extract and volatile oil were also determined. Pearson correlation was used to analyze the correlation between the chromaticity value and quality index (relative peak area of each chromatographic peak in UPLC fingerprint ,water-soluble extract content ,alcohol-soluble extract content and volatile oil content ). Multivariate statistical analysis (principal component analysis ,cluster analysis ,partial least squares discriminant analysis )was carried out with chromaticity value and quality index ,and the processing time of A. chinensis decoction piece stir-fired with bran was determined by grey correlation method. RESULTS :In the process of bran frying ,with the extension of processing time ,L* and b* of decoction pieces powder decreased ,and a* increased first and then decreased ;relative areas of peak 1 and peak 2 increased first and then decreased,while relative areas of peak 3(5-hydroxymethyl furfural )increased,and the areas of the other peaks decreased. The content of the extract did not change significantly with time ,and the content of the volatile oil decreased. The results of correlation analysis showed that the relative peak area of peak 2-27,alcohol-soluble extract content and volatile oil content had a certain correlation with the chromaticity value ,while the relative peak area of peak 1 and water-soluble extract content had no linear correlation with the chromaticity value. Results of multivariate statistical analysis showed that the samples were divided into mild (S0-S5),excessive (S12-S15),moderate (S6-processing time of 18-33 min). The results of grey correlation method showed that the processing time of A. chinensis decoction piece stir-fired w ith bran should be controlled in the range of 18-24 min,and the optimal processing time was 18 min. CONCLUSIONS :There is a correlation between chromaticity value of A. chinensis decoction piece powder stir-fired with bran and the relative peak area of 27 chromatographic peaks ,and content of extract and volatile oil. It is suggested that the processing time should be 18 min.  
        
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    • WU Yanxue,CHEN Tianli,HOU Xiaolin,YAN Yan,FANG Jing,WANG Mengcong,WENG Lili
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To optimize the processing technology of Paeonia lactiflora stir-baked with wine ,and to investigate its in vitro anticoagulant effect. METHODS :The weight coefficient of each index was determined and the comprehensive score was calculated with analytic hierarchy process (AHP),Criteria Importance Though Intercrieria Correlation (CRITIC)and AHP-CRITIC weighting method ,using the contents of oxypaeoniflorin ,albiflorin,paeoniflorin,benzoic acid and water-soluble extract as index. Box-Behnken response surface methodology was used to optimize the parameters of P. lactiflora stir-baked with wine ,such as moistening time ,frying time and frying temperature. Then in vitro anticoagulant experiment was used to investigate the pharmacodynamics of P. lactiflora stir-baked with wine prepared according to the optimal processing technology. RESULTS :The weight coefficients of albiflorin ,oxypaeoniflorin,paeoniflorin,benzoic acid and water-soluble extract determined by AHP-CRITIC weighting method were 0.233 9,0.131 7,0.183 3,0.078 9,0.372 3,respectively;the optimal processing technology of P. lactiflora stir-baked with wine included moistening time of 35 min,frying time of 20 min and frying temperature of 120 ℃. The results of in vitro anticoagulant test showed that P. lactiflora and P. lactiflora stir-baked with wine could significantly prolong the time of thrombin time ,prothrombin time ,activated partial thrombin time of plasma ;the effects of P. lactiflora stir-baked with wine were significantly better than those of P. lactiflora (P<0.05). CONCLUSIONS :The optimized processing technology of P. lactiflora stir-baked with wine is stable and feasible. The in vitro anticoagulant effect of P. lactiflora stir-baked with wine prepared by this tehcnology is better than that of raw products.  
      关键词:Paeonia lactiflora;Paeonia lactiflora stir-baked with wine;Anticoagulation;Technology optimization;Box-Behnken   
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    • ZHENG Xiaoyuan,YU Zhijie,WANG Xuan,ZHOU Shiwen
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To study the hepatotoxicity of main components of Polygonum multiflorum ,and investigate its toxic mechanism based on metabolic enzymes. METHODS :ADMETlab 2.0 platform was used to forecast the toxic or carcinogenic effects of emodin ,physcion,rhein,stilbene glycoside and gallic acid on liver ,skin and heart. The effects of those components on cytochrome P 450 enzyme system (CYP1A2,CYP2C9,CYP2C19,CYP2D6,CYP3A4)were evaluated. The effects of different concentrations of emodin ,rhein,stilbene glycoside and gallic acid (10,20,40,80 μmol/L)on the survival rate of normal hepatocyte L 02 were detected. The effects of major components of P. multiflorum on the activity of UGT 1A1 enzyme were studied by in vitro reaction system ,using bilirubin as substrate. RESULTS :Main components of P. multiflorum ,ie. emodin ,physcion, rhein and gallic acid ,showed strong toxic effects on the liver ,while stilbene glycosides possessed weak toxic effects on the liver. Emodin and physcion had strong inhibitory effects on CYP 1A2 and medium inhibitory effects on CYP 2C9,CYP2D6 and CYP3A4;rhein showed medium inhibitory effects on CYP 1A2 and CYP 2C9,while stilbene glycoside and gallic acid possessed weak inhibitory effects on the above enzymes. Emodin (40,80 μmol/L)and gallic acid (40,80 μmol/L)could significantly reduce the survival rate of L 02 cells(P<0.01). The inhibition rate of 5,10,20,40,80 μmol/L emodin and gallic acid(except for 5 μmol/L emodin)on UGT 1A1 enzyme increased significantly (P<0.01),and the inhibition effect of emodin on UGT 1A1 enzyme was reversible competitive inhibition. CONCLUSIONS :The main components of P. multiflorum ,ie. emodin ,rhein and physcion , are hepatotoxic ;the mechanism of it may be associated with inhibiting the activity of CYP 1A2 and CYP 2C9 and competitively blocking rate-limiting enzyme UGT 1A1 in the process of bilirubin metabolism.  
        
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      发布时间:2022-06-21
    • HUANG Jianyou,HU Xiaoxi,TAN Xiao,QU Xincheng,LU Guoshou,HUANG Zhoufeng
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To establi sh the quality standard of Yao medicine Pileostegia tomentella,and to provide reference for its quality control. METHODS :Totally 10 batches of P. tomentella were collected from Guangxi area. The properties of P. tomentella were observed and microscopic identification was conducted for the transverse section of its stems ,roots and powder. TLC method was established by using 7-hydroxycoumarin as reference. The contents of water ,total ash ,acid-insoluble ash and alcohol-soluble extract in P. tomentella were determined. The contents of skimmin ,7-hydroxycoumarin and 7-hydroxy-8- methoxycoumarin in P. tomentella were determined by HPLC. RESULTS :The root and stem surface of P. tomentella possessed obvious wrinkles ,hard texture ,slight smell and bitter taste ,and there were secretory cells and needle crystal cells in the cross section. The medicinal powder contained calcium oxalate needle crystal ,calcium oxalate square crystal ,sclerotic cell and starch granules. The results of TLC showed that the spots of the same color were found in the corresponding positions of chromatograms of test samples and 7-hydroxycoumarin control. In the 10 batch of P. tomentella ,the contents of water were 9.1%-11.8%;those of total ash were 3.6%-6.7%;those of acid-insoluble ash were 0.10%-0.44%;those of alcohol-soluble extract were 8.9%-14.0%.The linear range of skimmin ,7-hydroxycoumarin and 7-hydroxy-8-methoxycoumarin were 6.088-182.640,1.568-47.040 and 1.096- 32.880 μg/mL(all r not less than 0.999 7). The average recoveries were 99.47%,101.07% and 99.89%(RSD were all less than 2%). RSDs of precision ,stability(24 h),reproducibility and durability tests were all lower than 2% . The contents of 3 components such as skimmin were 1.337-9.534,0.348-2.236, 0.083-1.088 mg/g,respectively. CONCLUSIONS :It is preli- 201705) minarily proposed that the content of water in P. tomentella is not more than 12.0% ;that of total ash is not more than 7.0%;that of alcohol-soluble extract is not less than 8.0%; E-mail:luguoshou@foxmail.com that of ski mmin is not less than 1.30 mg/g;that of 7-hydroxy- coumarin is not less than 0.30 mg/g;that of 7-hydroxy-8-methoxycoumarin is not less than 0.06 mg/g.  
        
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      发布时间:2022-06-21
    • ZHANG Weiqi,WANG Qian,HE Yan,WANG Xueqin
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE: To establish GC-MS method for the content determination of three toxic impurities in glycerophosphorylcholine raw materials ,such as epichlorohydrin ,glycidyl,3-chloro-1,2-propanediol. METHODS :Four batches of glycerophosphorylcholine raw materials were used as test samples. The determination was performed on ZB-WAXplus TM column, and the injector temperature was 200 ℃;the sample injection adopted splitless injection mode ,using helium (He)as carrier gas , in constant current mode ;the temperature program for the column was initially heating at 30 ℃ for 1 min,rising to 220 ℃ at a speed of 30 ℃/min then remaining 5 min. The ion source was electrospray ion source (EI),the ion source temperature was 200 ℃,and the ionization energy was 70 eV;transmission interface temperature was 250 ℃,and mass spectrum monitoring mode was selected ion (SIM). Detection ions were epichlorhydrin [mass charge ratio (m/z)49,57,62],glycidyl(m/z 31,43,44), 3-chloro-1,2-propanediol(m/z 44,61,79). The solvent delay time was 3 min. RESULTS :The linear range of epichlorhydrin , glycidyl and 3-chloro-1,2-propanediol were 29.86-746.48,172.91-922.18,21.18-211.85 ng/mL,respectively(all r>0.999 0). The detection limits were 19.91,115.27,10.59 ng/mL,respectively. The limits of quantitation were 29.86,172.91,21.18 ng/mL, respectively. RSDs of precision (n=6),reproducibility (n=6) and stability (placed at room temperature for 12 h,n=8) tests were all lower than 10%. The average recoveries were 93.88%,91.45%,91.86%,and RSDs were 5.10%,3.10%,2.49% (n=9),respectively. In the 4 batches of glycerophosphorylcholine raw materials ,three toxic impurities were all not detected. CONCLUSIONS:Established GC-MS method is simple ,efficient,accurate and repeatable ,and it can be used to determine the contents of three toxic impurities in glycerophosphorylcholine raw materials ,such as epichlorohydrin ,glycidyl,3-chloro-1, 2-propanediol.  
      关键词:GC-MS method;Glycerophosphorylcholine;Epichlorhydrin;Glycidyl;3-chloro-1;2-propanediol   
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      发布时间:2022-06-21
    • TAN Xiaoxi,SHI Weiwen,JIANG Anrong,LIU Wei,LI Shigang,YU Lingling
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To stu dy the improvement effects o f Trillium tschonos kii total sapo nins(TTM)on adjuvant-induced arthritis model rats and its mechanism. METHODS :SD rats were randomly divided into model group (n=44)and blank group (n=6). Model group was given Complete Freund ’s adjuvant to induce the adjuvant-induced arthritis model ;blank group was given constant volume of normal saline with same method. Model group were divided into model group ,Tripterygium wilfordii polyglycoside tablets group (40 mg/kg),TTM low-dose ,medium-dose and high-dose groups (50,100,200 mg/kg),with 6 rats in each group. Administration groups were given relevant medicine intragastrically ;blank group and model group were given normal saline intragastrically ,once a day ,for consecutive 9 days. After last intragastric administration ,the body weight and foot swelling degree (bilateral)were detected ,and arthritis score was performed. The contents of tumor necrosis fator α(TNF-α), interleukin 1β(IL-1β)and IL- 6 were detected ;the pathomorphological changes of rat ankle were observed ;protein expression of NOD-like receptor protein 3 (NLRP3),apoptosis associated spot-like protein (ASC),caspase-1 were detected ;the protein expression of NLRP 3 in synovial tissue of ankle joint were also determined. RESULTS :Compared with blank group ,foot swelling degree,serum contents of TNF-α,IL-1β and IL-6,the protein expression of NLRP 3,ASC and caspase- 1 in knee tissue as well as the protein expression of NLRP 3 in synovial tissue of ankle joint were increased significantly in model group (P<0.05 or P< 0.01),while the body weight was decreased significantly (P<0.05). The obvious proliferation of synovial cells ,the congestion and inflammatory cell infiltration of synovial tissue were all observed. Compared with model group ,most of the above indexes were all reversed significantly in TTM groups (P<0.05 or P<0.01);the pathological changes such as synovial cell proliferation , congestion of synovial tissue and chondrocyte destruction were all relieved ,and inflammatory cell infiltration was alleviated.CONCLUSIONS:TTM can improve rheumatoid arthritis of rats, the mechanism of which may be associated with 用。E-mail:yulingling@ctgu.edu.cn inhibiting the activity of NLRP 3/caspase-1 signaling pathway and decreasing the expression of inflammatory factors TNF-α,IL-1β,IL-6.  
      关键词:Trillium tschonoskii total saponins;Arthritis;NOD-like receptor protein 3;Anti-inflammation;Rats   
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    • SUN Bo,LIU Danna,LIU Xun,ZHANG Erfeng,MA Huanqing,ZHAO Xiaoli,CHEN Lu,KONG Tiandong
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To explore t he risk factors that may lead to the ineff ectiveness of using palonosetron combined with dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV),and to provide a reference for the rational choice and use of antiemetic drugs. METHODS :In a retrospective case-control study ,871 patients who used palonosetron combined with dexamethasone to prevent CINV in a tertiary cancer hospital from 2016 to 2020 were selected as the object. Totally 32 related data such as demographic data ,living habits ,medical history ,examination information and treatment information were counted as variables. Combined with single factor regression ,multi-factor regression, likelihood ratio forward or backward stepwise 163.com regression were used to comprehensively screen the factors for many times. The standard target factors screened by stepwise E-mail:kongtiandong@126.com regression were included in the multivariate Logistic regression analysis,and the regression model was evaluated by the ROC c urve. RESULTS :The multivariate Logistic regression model fitted well(AUC in ROC was 0.83,but 0.82 after screening ). The results showed that there were 15 statistically significant independent influential factors ,including 12 independent risk factors ,ie. poor nutritional status (OR=2.11,95%CI(1.05,4.22),P=0.036), history of gastrointestinal disease (OR=2.76,95%CI(1.87,4.07),P<0.001),abnormal electrolyte level (OR=2.54,95%CI (1.74,3.69),P<0.001),nausea and vomiting 24 h before chemotherapy (OR=8.47,95%CI(3.28,21.91),P<0.001),history of chemotherapy-induced vomiting (OR=3.20,95% CI (2.18,4.71),P<0.001),high risk level of vomiting caused by chemotherapy(OR=3.16,95%CI(2.38,4.20),P<0.001),application of opioid combined with non-steroidal analgesics (OR= 4.18,95%CI(2.06,8.49),P<0.001),the use of other drugs that stimulate the intestine and stomach (OR=2.49,95%CI(1.28, 4.83),P=0.007),history of surgery (OR=1.88,95%CI(1.34,2.63),P<0.001),high level of albumin (OR=1.05,95%CI (1.01,1.08),P=0.015),multiple days of single chemotherapy (OR=1.69,95%CI(1.11,2.56),P=0.014),and opioid analgesia medicine (OR=1.71,95%CI(1.15,2.53),P=0.007);and the following 3 independent protective factors included long time of diagnosis (OR=0.65,95%CI(0.46,0.93),P=0.019),non-first chemotherapy (OR=0.52,95%CI(0.33,0.83),P= 0.006),and drugs combined chemotherapy (OR=0.55,95%CI(0.34,0.90),P=0.018). CONCLUSIONS :Patients with the following conditions are more likely to experience CINV prevention ineffectiveness ,ie. single long-term chemotherapy ,application of chemotherapy plan with a higher risk of emesis ,history of chemotherapy-induced vomiting ,history of gastrointestinal diseases , nausea and vomiting 24 hours prior to chemotherapy ,history of surgery ,within 1 year of diagnosis ,chemotherapy for the first time,use of opioids ,use of 5-HT3 reuptake inhibitors ,malnutrition and electrolyte disorders.  
      关键词:Palonosetron;Dexamethasone;CINV;Prevention failure;Risk factors   
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    • ZHANG Jianhua,KANG Bingyao,LI Dan,LUO Dan,YANG Chunsong,CHEN Jing
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To overview and analyze the current evidence of systematic reviews of drug treatment for children with tic disorder (TD),and to provide evidence-based reference for clinical practice. METHODS :Retrieved from Medline ,Embase, CBM,CNKI,VIP and Wanfang database ,and so on ,systematic reviews about the efficacy and safety of drug treatment for TD were collected. AMSTAR- 2 tools were used to evaluate the quality of included studies ;the intervention measures ,diagnosis standard,outcome index ,the types of included studies ,main conclusion ,control measures ,effect sizes of different drug treatment were also extracted and analyzed descriptively. RESULTS :A total of 27 systematic reviews were included ,of which 5 were medium-quality,8 low-quality and 14 very-low-quality. Meta-analysis showed that although typical psychiatric drugs could control tic symptoms ,ADR were prominent and the safety was not good ;risperidone and aripiprazole as atypical psychiatric drugs had good efficacy and safety ,and the research evidence was relatively sufficient. Clonidine as α2 adrenergic agonist could effectively control tic symptoms with fewer ADR ,especially for patients with affention deficit and hyperactivity disorder (ADHD),and research evidence was sufficient. Tiapride could effectively improve tic symptoms ,and the overall tolerance was better. Tomoxetine and methylphenidate could significantly improve the tic symptoms of tic patients with ADHD. CONCLUSIONS :In the clinical treatment of TD in children ,ADR induced by typical antipsychotics are prominent and the safety is not good ;risperidone, aripiprazole,clonidine and tiapride have good efficacy and safety. Clonidine ,tomoxetine and methylphenidate could significantly improve tic symptoms of TD patients with ADHD. But the quality of systematic review methodology for tomoxetine and methylp- henidate is not good and further improvement is needed.  
        
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    • DONG Weizheng,DONG Min,CHEN Haiyan,XU Mengyan
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To systematically evaluate the c linical efficacy and safety of misoprostol versus oxytocin in preventing postpartum hemorrhage ,and to provide evidence-based reference for clinical drug use. METHODS :Retrieved from CNKI,VIP,Wanfang database ,CBM,PubMed,Embase and the Cochrane Library ,randomized controlled trials (RCTs) published at home and abroad about clinical efficacy and safety of misoprostol and oxytocin in preventing postpartum hemorrhage were collected during the inception to Feb. 15th,2021. According to the inclusion and exclusion criteria ,the included studies were screened and evaluated. RevMan 5.3 software was used for Meta-analysis. RESULTS :A total of 14 RCTs involving 25 732 lying-in women were included. The results of Meta-analysis showed that compared with oxytocin group ,there was no difference in the mean blood loss (MD=14.96,95%CI(-2.62,32.54),P=0.10),the time of the third stage of labor (MD=-0.03,95%CI (-0.19,0.13),P=0.69),the incidence of blood transfusion (RR=0.91,95%CI(0.74,1.12),P=0.37)or the incidence of nausea(RR=1.06,95%CI(0.85,1.31),P=0.60)in misoprostol group ;but the incidence of shivering(RR=2.99,95%CI (2.22,4.04),P<0.000 01),the incidence of fever (RR=4.31,95%CI(2.79,6.67),P<0.000 01),the incidence of vomiting (RR=2.16,95%CI(1.63,2.88),P<0.000 01)and the incidence of diarrhea (RR=2.67,95%CI(1.79,3.98),P<0.000 01)in misoprostol group were higher. CONCLUSIONS :The effect of misoprostol in the prevention of postpartum hemorrhage is similar to oxytocin ,but the incidence of ADR is higher. It is necessary to pay close attention to the adverse reactions during use. Due to the limitation of included studies ,multi-center,large-scale and high-quality RCTs are needed for further validation.  
        
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    • PENG Huaidong,ZHANG Jianpan,WU Xiaoli,ZHONG Yi,WANG Zhaotao,WANG Ruolun
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To provide reference for the participation of clinical pharm acists in outpatient antibiotics management so as to promote the rational use of antibiotics in outpatient department. METHODS :The pharmacist reset medication rules , classified irrational medication levels ,formulated warning contents ,and established a diagnosis database of mild to moderate non- complex infections ,according to the problems found in the post review of outpatient antibiotics prescription through sorting out the previous rules of antibiotics use in the Yiyao Rational Drug Use Management Software (called“review software ”for short )in our hospital. The special pre-review was performed by using combination of system review and manual review. Pharmacists used the review saftware to count the data of outpatient antibiotics prescriptions before (the first quarter of 2020)and after (the second , third and fourth quarters of 2020)the implementation of special pre-review. The post review for antibiotics prescriptions in Dec. 2019(before the implementation of special pre-review )and Dec. 2020(after implementation of special pre-review )were performed by pharmacists to evaluate the impact of the implementation of special pre-review on promoting rational use of outpatient antibitics. RESULTS:Comared with before the implementation of special pre-review in the first quarter of 2020,the prompt rate of the review software for antibiotics prescriptions was decreased ,and the interception rate was increased after the implementation of special pre-review in the second quarter of 2020(P<0.05). Compared with before the implementation of special pre-review in Dec. 2019,the proportion of outpatient antibiotics prescriptions in all outpatient prescriptions ,the ratio of bi-antibiotics prescriptions in all antibiotics prescriptions in the same month ,the ratio of prescriptions with unsuitable indications in all antibiotics prescriptions in the same month were all decreased E-mail:phdloveyou@163.com significantly (P<0.01), while the ratio of prescriptions with rational antibiotics use in all antibiotics prescriptions in the same month was increased significantly (P<0.01). CONCLUSIONS:Pharmacists establishing a rule for rational use of antibiotics in outpatient department b ased o n the hospital ’s situation,implementing a special pre-review for antibiotics prescriptions with the help of review software ,can promote the rational use of antibiotics in outpatient department.  
      关键词:Antibiotics;Special pre-review;Outpatient department;Pharmacist   
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    • LYU Yanxia,HU Meng,XU Aijun
      Vol. 32, Issue 21, (2021)
      摘要:OBJECTIVE:To investigate the influ ential factors of traditional Chinese medicine (TCM)service utilized by outpatients in Jiangsu province ,and to provide reference for scientific utilization of TCM service. METHODS :Based on the data of Jiangsu province in National Sixth Health Service Survey in 2018,descriptive analysis was performed for the general situation and population characteristics of 1 617 outpatients in Jiangsu province. Single factor analysis and multivariate binary Logistic regression model analysis were used to analyze the influential factors of TCM service utilized by outpatients. RESULTS :Of the 1 617 respondents,145 patients(9.0%)applied TCM services at outpatient visits. Results of single factor analysis showed that age , education degree ,annual income ,whether to participate in basic medical insurance ,self-perceived illness severity ,hypertension, diabetes,other chronic diseases ,and the first diagnose institutions were significant influential factors for TCM service utilized by outpatients in Jiangsu province (P<0.05). Results of binary Logistic regression showed that the elderly aged 65 years and over , the patients who participated in the basic medical insurance for urban workers ,the patients with hypertension ,primary medical institutions as first diagnosis institutions ,the middle-income population ,and other chronic diseases were significant influential factors for TCM service utilized by outpatients in Jiangsu province (P<0.05). CONCLUSIONS :Age,annual income ,whether to participate in basic medical insurance ,hypertension and other chronic diseases ,and first diagnosis institutions are significant infleutial factors for TCM service utilized by outpatients in Jiangsu province. The utilization of TCM health services for outpatients in Jiangsu province is in relatively low level ,and middle-aged and elderly patients and patients with chronic diseases show high acceptance for TCM services. Outpatients first diagnosed in primary medical institutions are more willing to accept TCM services.  
      关键词:Traditional Chinese medicine service;Influential factors;Outpatients;Logistic regression model;Jiangsu province   
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