芪苈强心胶囊微生物限度检查方法学验证  

VALIDATION METHOD USED FOR MICROBIAL LIMIT TEST OF QILIQIANGXIN CAPSULES

作　　者：王刚[1] 李素霞[2] 李喆[1] 周莹君[1] 范文成[1] 王丽环[1] 

机构地区：[1]石家庄以岭药业股份有限公司,石家庄050035 [2]河北化工医药职业技术学院

出　　处：《中国消毒学杂志》2013年第8期720-721,共2页Chinese Journal of Disinfection

摘　　要：目的建立芪苈强心胶囊的微生物限度检查法。方法采用微生物限度检查方法,对该胶囊微生物检验方法进行验证。结果混入芪苈强心胶囊中的枯草芽孢杆菌、金黄色葡萄球菌、白色念珠菌和黑曲霉用常规检验法细菌回收率均比较低,表现出一定抑菌作用,但大肠埃希菌回收率符合要求。混入该胶囊中的枯草芽孢杆菌、金黄色葡萄球菌、白色念珠菌和黑曲霉采用稀释法检测,其回收率明显提高。结论该药物胶囊对细菌和真菌均有一定的抑制作用,可以通过培养基稀释法来消除。Objective To establish the method to determine the microbial limit tests for Qiliqiangxin Capsules.Methods By using validation method,the microbial limit test for the capsules was validated.Results Using the conventional test method,the bacterial recovery rates of the Bacillus subtilis,Staphylococcus aureus,Candida albicans,and Aspergillus niger were lower.The recovery rates of the Escherichia coli could meet the requirements.The Bacillus subtilis,Staphylococcus aureus,Candida albicans and Aspergillus niger could be tested by culture medium dilution method,the recovery rate has been significantly improved.Conclusion Qiliqiangxin Capsules showed inhibition effect on the bacteria and fungus.The effect could be eliminated by culture medium dilution method.

关 键 词：芪苈强心胶囊 微生物限度检查 稀释法 抑菌 

分 类 号：R197.21[医药卫生—卫生事业管理]