摘要
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。
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.
出处
《西部中医药》
2017年第11期59-61,共3页
Western Journal of Traditional Chinese Medicine
