摘要
目的:建立甲状腺片的微生物限度检查方法。方法:按照《中国药典》2015年版四部通则1105和1106中方法适用性试验的方法进行。结果:对3个厂家的甲状腺片分别进行计数法和控制菌的适用性试验,一个厂家需氧菌总数需采用1∶50的供试液进行,另外两个厂家需氧菌总数可采用常规法;三个厂家的霉菌和酵母菌总数和控制菌检查都可采用常规法。结论:该方法适用于甲状腺片的微生物限度检查。
Objective:To establish a microbial limit test method for Thyroid Tablets.Method:The suitability of microbial limit test methods of microbial count and control bacteria for Thyroid Tablets was verified according to general chapter 1105 and 1106 in Chinese Pharmacopoeia 2015 Volume IV respectively.Results:The suitability test of microbial count and control bacteria was performed with 3 manufacturers′Thyroids Tablets.The 1∶50 test solution was used for total aerobic count for the sample from one manufacturer,and the conventional method was used for total aerobic count of the samples from other two manufacturers.The conventional method was used for moulds and yeasts count,and control bacteria for 3 manufacturers samples.Conclusion:The established method is suitable for microbial limit test of Thyroid Tablets.
作者
房霞
刘晋
王芳芳
FANG Xia;LIU Jin;WANG Fangfang(Liaocheng Institute for Drug and Food Control,Liaocheng 252000,China)
出处
《中国药品标准》
CAS
2020年第5期459-463,共5页
Drug Standards of China
基金
2019年山东省药品质量风险监测项目甲状腺片专项。
