复方伤痛胶囊的微生物限度检查及适用性研究

Microbial limit test and applicability research of Fufang Shangtong Jiaonang (复方伤痛胶囊)

目的建立复方伤痛胶囊的微生物限度检查方法并进行方法适用性研究。方法按照2015年版《中华人民共和国药典》(四部)制剂通则1105,1106中的方法进行试验。对复方伤痛胶囊各试验菌进行回收率试验,并采用常规法检查控制菌。结果分别采用平皿法、培养基稀释法检测需氧菌总数、霉菌和酵母菌总数,验证试验中各菌的回收比值均符合2015年版《中华人民共和国药典》规定,采用常规法控制菌检查方法可行。结论培养基稀释法适用于复方伤痛胶囊的微生物限度计数方法的检查,常规法可用于控制菌的检查。

Objective To establish a method for microbial limit test of Fufang Shangtong Jiaonang(复方伤痛胶囊)and to carry on the applicability research of this method.Methods The test was conducted according to the methods of general principles 1105 and 1106 of the Pharmacopoeia of the People’s Republic of China(Part IV)in the 2015 edition.The recovery rate of each test bacteria in Fufang Shangtong Jiaonang was tested,and the control bacteria was checked by routine method.Results The recovery ratios of the sum of aerobic bacteria,mycete and saccharomycetes in the verification test by the plating and culture medium dilution method conformed to the provisions of the Pharmacopoeia of the People’s Republic of China in 2015.It was feasible to control bacteria by routine method.Conclusion The dilution method is suitable for the microbial limit counting method of Fufang Shangtong Jiaonang,while the routine method can be used for the check of the control bacteria.