摘要
目的通过比较不同厂家活血止痛胶囊的微生物限度检查结果,探讨引起菌数差异的特点及规律,为提高中成药产品质量提供参考。方法按照《中国药典》2010年版一部附录微生物限度检查法对活血止痛胶囊进行验证实验,并测定其细菌、霉菌和酵母菌数以及进行控制菌的检查。结果不同企业来源活血止痛胶囊检测出的细菌数有很大差异。结论应加强对生产单位的监督管理,完善中成药微生物限度标准。
Objective To investigate the occurrence characteristics and regularities of bacterial count differences through the comparison of the microbial limit test results of Huoxue Analgesic Capsules from different enterprises,and to provide a reference for the quality control of Chinese patent drugs.Methods The verification test was carried out in accordance with the microbial limit testing method recorded in the appendix of China Pharmacopeia（2010 edition,VolumeⅠ）,and the count of bacteria,mould and yeast in these capsules was determined.Meanwhile,the microbiotic control for these capsules was evaluated.Results There were significant differences in bacterial counts between Huoxue Analgesic Capsules from different enterprises.Conclusion Inspection and management of pharmaceutical enterprises should be reinforced.And the microbe limitation standard should be improved for traditional Chinese patent medicines.
出处
《中国药事》
CAS
2012年第10期1112-1114,共3页
Chinese Pharmaceutical Affairs
