复方土茯苓胶囊微生物限度检查方法验证

目的：为提高制剂质控标准，建立复方土茯苓胶囊的微生物限度检查方法。方法：按《中国药典》2015年版四部通则微生物限度检查法中的微生物计数法和控制菌检查法进行验证。结果：对3个批次的样品用常规法检测五种菌回收率，范围均在50%~200%内，采用常规法即可检出大肠埃希菌。结论：建立满足《中国药典》2015年版要求的复方土茯苓胶囊的微生物限度检查方法，需氧菌总数、霉菌和酵母菌总数及控制菌检查均采用常规法。

Validation of Microbial Limit Test of Compound Glabrous Greenbrier Rhizome Capsule

Objective: To improve the internal control standards for preparations and establish a method for the determination of microbial limits in compound Glabrous Greenbrier Rhizome capsules. Methods: A validation on the microbial limit test was conducted in accordance with the counting method of aerobic bacteria, mycetes & yeasts and the control bacteria test stated in the general rule of China Pharmacopoeia (2015 edition). Results: The recoveries of five bacteria for three preparations were in the range of 50%-200% when conventional methods were used. Escherichia coli could be detected by the conventional method. Conclusions: The method of microbial limit test for compound Glabrous Greenbrier Rhizome cap-sules, meeting the requirement of Chinese Pharmacopoeia 2015, has been established. Conventional methods can detect the quantity of aerobic bacteria and the amount of molds respectively. And the routine means can detect the controlled bacteria.