护肝片和护肝胶囊的微生物限度检查方法研究及质量分析  

Validation of Microbial Limit Test Method and Quality Analysis of Hugan Tablets and Capsules

作　　者：袁力 孙新皓 陶明[1] 杨淑先[1] YUAN Li;SUN Xin-hao;TAO Ming;YANG Shu-xian(Henan Provincial Institute of Food and Drug Control,Henan Zhengzhou 450018,China;Henan Kangyixing Biological Technology Company Limited,Henan Zhoukou 466000,China)

机构地区：[1]河南省食品药品检验所,河南郑州450018 [2]河南康益兴生物科技有限公司,河南周口466000

出　　处：《中国药物评价》2021年第3期213-218,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:建立护肝片和护肝胶囊的微生物限度检查方法,并对样品的污染菌进行分离、鉴定,评价其微生物学质量。方法:按《中国药典》2015年版四部通则1105和1106规定,取代表性的护肝片和护肝胶囊分别进行方法适用性试验,建立微生物计数和控制菌检查方法,对抽验样品进行微生物限度检查,并采用VITEK2全自动微生物分析系统对分离得到的细菌进行鉴定。结果:167批次样品的需氧菌总数、霉菌和酵母菌总数以及控制菌均符合药典规定,鉴定显示分离得到的污染菌主要为芽孢杆菌属。结论:该法可用于护肝片和护肝胶囊的微生物限度检查,国产护肝类药品微生物学质量总体良好。Objective:To establish the microbial limit test method of hugan tablets and capsules,isolate and identify the contamination bacteria of samples,and evaluate the microbiological quality.Methods:According to general chapter 1105 and 1106 of Chp2015 VolumeⅣ,the suitability tests were performed with representative hugan tablets and capsules respectively,the established method of microbial count and control bacteria was used for all samples,then the isolated bacteria were identified by VITEK2 strain identification system.Results:The total aerobic count,moulds and yeasts count,and control bacteria of 167 batch samples were complied with the pharmacopoeia requirements.The isolated bacteria were mainly Bacillus genus.Conclusion:The established method is suitable for microbial limit test of hugan tablets and capsules,the microbiological quality of domestic liver-protecting drugs are generally good.

关 键 词：护肝片 护肝胶囊 微生物限度检查 方法适用性试验 分离鉴定 

分 类 号：R927.33[医药卫生—药学]