9种中药口服制剂微生物限度与控制菌检查法的建立及方法学验证

摘要

目的：建立9种中药口服制剂微生物限度与控制菌检查的方法并进行验证。方法：按2010年版《中国药典》，用大肠埃希菌、枯草芽胞杆菌、金黄色葡萄球菌、黑曲霉和白色念珠菌对健胃清肠合剂等9个中药口服制剂进行微生物限度检查方法学验证，采用直接接种法进行控制菌检查方法验证。结果：按供试品制备方法，各阳性菌样品的回收率均高于70%。结论：健胃清肠合剂、复方萱草颗粒、健胃消食合剂、健胃止泻合剂、健胃止血合剂、痛风平颗粒可按常规法进行细菌、霉菌及酵母菌的检查；通窍鼻渊丸、清热解毒合剂可用培养基稀释法(0.5 mL/皿)进行细菌检查，姜石肠炎康颗粒可用培养基稀释法(0.2 mL/皿)进行细菌检查，霉菌及酵母菌的检查均可按常规法进行。各品种控制菌均可用常规法进行检查。%Objective: To establish the methods of microbial limit and control germ for nine kinds of oral preparations of Chinese medicine, and to test the methods. Methods:According to 2010 edition of Chinese Pharma-copoeia, microbial limit checking methods for nine kinds of oral preparations of Chinese medicine were testified by observing Escherichia coli, bacillus subtilis, Staphylococcus aureus, Aspergillus niger and Candida albicans, control germ by direct inoculation method. Results:The recovery rates of positive bacteria samples were higher than 70%according to sample preparation methods. Conclusion:Conventional method could be used to check bacteria, mold and yeast in JianWei QingChang mixture, compound XuanCao Granules, JianWei XiaoShi mixture, JianWei ZhiXie mixture, JianWei ZhiXue mixture, TongFengPing granules;culture medium dilution (0.5 mL/medium) could be ap-plied to test bacteria in TongQiao BiYuan pills and QingRe JieDu mixture, culture medium dilution (0.2 mL/medium) to examine bacteria in JiangShi ChangYanKang granules while conventional methods for mold and yeast. Conven-tional method could be used for all varieties of control germs.