50种中药煎煮类饮片微生物检查方法研究及污染情况分析  

Microbiological Examination Method of 50 Kinds of Chinese Medicine Decoction Pieces and Their Microbial Contamination

作　　者：张平 石春红 胡亚英 任丽君 顾芙蓉 ZHANG Ping;SHI Chunhong;HU Yaying;REN Lijun;GU Furong(Shanghai Songjiang Institute for Food and Drug Control,Shanghai,China 201600;Shanghai Yutiancheng Traditional Chinese Medicine Co.,Ltd.,Shanghai,China 201600;Shanghai Songjiang District Market Supervision Administration,Shanghai,china 201600)

机构地区：[1]上海市松江食品药品检验所,上海201600 [2]上海余天成中药饮片有限公司,上海201600 [3]上海市松江区市场监督管理局,上海201600

出　　处：《中国药业》2021年第3期40-44,共5页China Pharmaceuticals

基　　金：上海市松江区科学技术攻关项目[18SJKJGG51]。

摘　　要：目的考察50种中药煎煮类饮片的微生物污染情况,分析不同炮制方法、不同类别饮片对微生物生长的影响。方法参考2020年版《中国药典》微生物通则修订草案相关检查方法,建立50种共150批次中药煎煮类饮片的微生物检查方法,并进行微生物限度检查。结果5个品种具有抑菌性,需采用消除抑菌的方法,其余45个品种采用常规平皿倾注法测定;150批次样品需氧菌总数计数结果介于10~10~7 cfu/g,霉菌和酵母菌总数计数结果介于10~10~5 cfu/g,耐热菌数计数结果介于10~10~4 cfu/g;耐热菌和耐胆盐革兰阴性菌检出率均为50.67%,均未检出大肠埃希菌和沙门菌。结论中药饮片易受微生物污染,需开展更深入的风险评估,完善《中国药典》关于中药饮片微生物的检查方法和限度标准,保障用药安全。Objective To investigate the microbial contamination of 50 kinds of Chinese medicine decoction pieces,and to analyze the effects of different processing methods and different varieties of decoction pieces on microbial growth.Methods With reference to the relevant inspection methods of the Revised Draft Microbiological Principles of the Chinese Pharmacopoeia(2020 edition),a microbiological inspection method for 50 kinds of Chinese medicine decoction pieces(a total of 150 batches)was established,and the microbial limit test was carried out.Results Five varieties have bacteriostatic properties,and the method of eliminating bacteriostatic properties needs to be adopted.The remaining 45 varieties can be determined by the conventional dish pouring method.In the 150 batches of samples,the range of total aerobic microbial count was 10-10~7 cfu/g,the range of total yeasts and molds count was 10-10~5 cfu/g,the range of heat-resistant strains count was 10-10~4 cfu/g.The detection rate for heat-resistant strains and bile-tolerant Gram-negative bacteria(MPN method)was 50.67%.However,other pathogens such as Escherichia coli and Salmonella were not detected.Conclusion Chinese medicine decoction pieces are susceptible to microbial contamination,so it is necessary to carry out a more in-depth risk assessment,improve the microbial inspection methods and limit standards of Chinese medicine decoction pieces in the Chinese Pharmacopoeia to ensure the people’s medication safety.

关 键 词：中药饮片 煎煮类 微生物 检查方法 污染情况 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]