《美国药典》《欧洲药典》《日本药典》与《中国药典》中中药饮片微生物限度检查及标准的比较研究  

Comparative Study of Microbial Limit Test and Criteria of TCM Decoction Pieces among United States Pharmacopeia,European Pharmacopeia,Japanese Pharmacopeia and Chinese Pharmacopeia

作　　者：范一灵[1] 李琼琼[1] 秦峰[1] 刘浩[1] 杨美成[1] FAN Yiling;LI Qiongqiong;QIN Feng;LIU Hao;YANG Meicheng(Shanghai Institute for Food and Drug Control/NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验所/国家药品监督管理局药品微生物检测技术重点实验室,上海201203

出　　处：《中国药房》2020年第22期2695-2700,共6页China Pharmacy

基　　金：国家药典委员会科研课题。

摘　　要：目的:比较《美国药典》43版(USP43)、《欧洲药典》10.0版(EP10.0)、《日本药典》17版(JP17)与《中国药典》2020年版(ChP2020)中中药饮片微生物限度检查方法及标准的差异,为我国中药饮片相关微生物标准的修订和完善提供参考。方法:比较USP43、EP10.0、JP17和ChP2020在中药饮片的微生物计数法(包括抽样与取样、菌种和培养基选择、微生物和耐热菌计数等)、控制菌检查(包括样品前处理、增菌、分离、鉴定等)、微生物相关限度标准等方面的差异。结果与结论:在中药饮片微生物的检查方法上,USP43、EP10.0、JP17都有各自独立的规定,ChP2020则新增了"通则1108"。在检验项目上,除需氧菌总数、霉菌和酵母菌总数外,ChP2020与EP10.0规定了3种控制菌(耐胆盐革兰阴性菌、大肠埃希菌、沙门菌)的检查方法;在此基础上,JP17补充了金黄色葡萄球菌的检查方法;USP43增加了梭菌的检查方法,并最早提出不可接受微生物风险评估理念;ChP2020还新增了耐热菌计数方法。在微生物限度标准上,USP 43对中药饮片的分类最为细致,要求较为严格且高于EP10.0、JP17;ChP2020仍未对中药饮片控制菌检查设立统一的限度标准。虽然,ChP2020对"中药提取物及中药饮片的微生物限度标准"进行了修订,但相较于美国、欧洲和日本药典的规定还不完善。建议根据我国中药饮片微生物污染和控制现状,逐步完善药典对中药相关产品的微生物检验和限度标准,合理细化相应产品的微生物限度水平。OBJECTIVE:To compare the difference of microbiological limit test and criteria of TCM decoction pieces among43 edition of United States Pharmacopeia(USP43),10.0 edition of European Pharmacopeia(EP10.0),17 edition of Japanese Pharmacopeia(JP17)and 2020 edition of Chinese Pharmacopeia(ChP2020),and to provide refernce for the revision and improvement of microbiological standards for TCM decoction pieces in China.METHODS:The differences in the microbial enumeration tests method(including sampling and sample preparation,selection of bacteria and culture medium,count of microorganisms and heat-resistant bacteria,etc.),tests for specified microorganisms(including sample pretreatment,enrichment,separation and identification,etc.)and microbial related limit criteria were compared among USP43,EP10.0,JP17 and ChP2020.RESULTS&CONCLUSIONS:In terms of microbiological examination of TCM decoction pieces,USP43,EP10.0,JP17 had their own independent provisions.Chp2020 added"general rule 1108".In terms of inspection items,in addition to the total aerobic bacteria count and total combined yeasts and molds count,ChP2020 and EP10.0 provided three methods for the inspection of control bacteria(bile-resistant Gram-negative bacteria,Escherichia coli,Salmonella).On the basis,JP17 supplemented Staphylococcus aureus test;However,USP43 added Clostridium test method and put forward the concept of objectionable microorganisms risk assessment;ChP2020 also added a new method for counting heat-resistant bacteria.In terms of microbial limit criteria,USP43 was the most detailed in the classification of TCM decoction pieces,which was more strict than EP10.0 and JP17;ChP2020 had not set up a unified limit for the inspection of control bacteria of TCM decoction pieces.ChP2020 revised the"microbial limit standard for TCM extracts and TCM decoction pieces",but it was not perfect compared with the Pharmacopoeia of the United States,Europe and Japan.It is suggested that according to the current situation of microbial contamination and control of TCM decoc

关 键 词：中药饮片 药典 微生物检查 限度标准 比较研究 

分 类 号：R921[医药卫生—药学] R927.1