六种中药制剂微生物限度检查方法验证

目的:建立6种中药制剂微生物限度的检查方法。方法:参照《中国药典》(2015年版)微生物限度检查法,进行各品种的微生物限度检查方法验证。结果:复方黄连灌肠液、蒲地灌肠液、复方茵陈合剂和气血双补口服液无抑菌作用,回收率均在0.5~2.0范围内,可采用常规法进行微生物计数;复方大黄灌肠液对枯草芽孢杆菌有抑菌作用,可采用培养基稀释法进行微生物计数;五味子酊需采用薄膜过滤法进行微生物计数;所有品种的控制菌检查均可采用常规法测定。结论:确立了6种中药制剂微生物限度检查方法,可有效控制其质量。

Validation of Microbial Limit Test Method of Six Kinds of Traditional Chinese Medicine Preparations

Objective: To establish the microbial limit test for six kinds of traditional Chinese medicine preparations. Methods: Microbial limit tests for six kinds of traditional Chinese medicine preparations were validated by consulting the microbial limit tests in Chinese Pharmacopoeia (2015 edition). Results: Compound berberine enema, PuDi enema, compound YinChen mixture and Qi-blood ShuangBu oral liquid had no bacteriostasic activity, recovery rate was ranged from 0.5 to 2.0, and the routine method could be used to determine the number of bacteria; com-pound berberine enema showed antibacterial activity to Bacillus subtilis, culture medium dilution method could be used for bacterial counting; membrane-filter procedure could be used for microbial counting of WuWeiZi tincture;the tests for control bacteria in all the preparations could be tested by routine method. Conclusion: Microbial limit tests for six kinds of traditional Chinese medicine preparations are confirmed, which could effectively control the quality of the preparations.