两种瑶药酊剂微生物限度检查方法适用性试验及结果分析

Experimental Study on Applicability of Microbial Limit Test for 2 Kinds of Yao Medicine Tinctures and Result Analysis

目的:按照《中国药典》2020年版对两种瑶药酊剂抗风湿骨痛酊和抗骨质增生酊的微生物限度检查进行适用性试验,为有较强抑菌作用冲洗量较大的酊剂提供适用性试验的方法参考。方法:对有较强抑菌作用的抗风湿骨痛酊、抗骨质增生酊,按照《中国药典》2020年版四部中相关的规定,采用稀释法结合薄膜过滤法进行需氧菌总数、霉菌和酵母菌总数的计数方法适用性试验。控制菌采用增菌液常规法、增菌液稀释法和薄膜过滤法循序、科学、合理地进行适用性研究试验。结果:采用优选的方法进行微生物限度检查验证时,两种酊剂的计数方法回收比值均在0.5~2.0范围内,控制菌适用性试验中试验组均能检出所加试验菌相应的反应特征。结论:所采用的方法符合《中国药典》2020年版四部通则的有关规定。

Objective According to the Chinese Pharmacopoeia 2020 edition,the applicability of Microbial Limit Test for two kinds of Yao medicine tinctures was studied and the results were analyzed,it provides a reference for the establishment of the method of microbial limit test for Chinese Patent Medicine Capsules,reduces the Times of test and improves the efficiency of test.Methods In accordance with the relevant provisions of the 2020 edition of the Chinese Pharmacopoeia in four volumes,the anti-rheumatic Gutong tincture and anti-bone Hyperplasia tincture,which have strong bacteriostatic effect,the count method of aerobic bacteria,mould and yeast was carried out by dilution method and membrane filtration method.In order to control bacteria,routine method,dilution method and membrane filtration method were used to study the applicability of the control bacteria.Results The recovery ratios of the two tinctures were all in the range of 0.5-2.0,in the control bacteria suitability test,the test group could detect the corresponding response characteristics of the tested bacteria.Conclusion The method adopted is in accordance with the relevant provisions of the four general principles of the 2020 edition of the Chinese Pharmacopoeia.