妇科洗剂微生物限度检查法的适用性考察

Applicability Research on Microbacteria Limit Determination Method for Gynecological Lotion

目的:根据中国药典2015年版的要求,建立妇科洗剂的微生物限度检查方法。方法:采用常规法、供试液稀释法、薄膜过滤法对妇科洗剂进行方法适用性试验,通过比较试验菌的回收率,选择供试液稀释法和薄膜过滤法对本品进行需氧菌总数、霉菌及酵母菌总数的测定,采用常规法进行控制菌检查。结果:薄膜过滤法和供试液稀释法均可消除妇科洗剂的抑菌作用,使微生物计数试验中6种试验菌的回收率在0.5~2.0范围内。最终选择薄膜过滤法作为妇科洗剂的微生物计数检查法,冲洗液为p H 7.0氯化钠-蛋白胨缓冲液,分3次冲洗,每次100 ml。控制菌验证中,试验组均有菌落生长,菌落形态均呈现试验菌相应的反应特征,且生长良好,阴性对照组无菌生长。结论:妇科洗剂微生物限度检查法经验证符合中国药典2015年版要求。

Objective： To establish a microbial limit test method for gynecological lotion according to the requirement in Chinese Pharmacopoeia （2015 edition）. Methods： The applicability of the methods was performed respectively for the routine method, the tes- ting solution dilution method and the membrane filtration method. Using the recovery ratio of test bacteria as the index, the testing solu- tion dilution method and the membrane filtration method were used for the total aerobic microbial count and the total yeasts and molds count, and the routine method was used for the control bacteria detection. Results： The membrane filtration method and the testing so- lution dilution method could eliminate the bacteriostasis of gynecologic lotion, and the recovery ratio of each testing bacteria was within the range of 0.5-2.0. Finally, the membrane filtration method was selected as the microbial counting method for gynecological lotion, and the flushing fluid was sodium chloride-peptone buffer solution with pH of 7.0 for three times rinsing with 100ml for each time. In the verification test of the control bacteria, the test groups all had colonies with promising growth, the morphology was consistent with the reaction characteristics of the experimental bacteria, and the negative control group was without bacteria. Conclusion： The microbiological examination methods for gynecological lotion meet the requirements in Chinese Pharmacopoeia （2015 edition）.