复方红景天口服液微生物限度检查方法的验证  

Validation of microbial limit tests for compound Hongjingtian oral liquid

作　　者：陈雅琳[1] 冯旭[1] 陈虹[2] 栾洁[1] 赵龙[2] 汪家春[1] 

机构地区：[1]海军医学研究所,上海200433 [2]天津科技大学,天津300457

出　　处：《药学实践杂志》2016年第2期177-178,共2页Journal of Pharmaceutical Practice

基　　金：全军医药卫生科研基金项目(14TG0294)

摘　　要：目的建立复方红景天口服液的微生物限度检查方法。方法按照《中华人民共和国药典》(2010年版)附录微生物限度检查法中细菌、霉菌及酵母菌数计数方法和控制菌检查方法进行验证。结果金黄色葡萄球菌采用培养基稀释法,大肠杆菌、枯草芽孢杆菌、白念珠菌、黑曲霉采用常规法,回收率>70%;控制菌检查中,各阳性实验菌均检出,阴性对照无菌生长。结论经验证,复方红景天口服液微生物限度采用培养基稀释法检查金黄色葡萄球菌;采用常规法检查大肠杆菌、枯草芽孢杆菌、白念珠菌、黑曲霉等。Objective To establish a method of microbial limit tests for compound Hongjingtian oral liquid and to perform the validation of the method.Methods The validation on the microbial limit test method was conducted according to the counting method of bacteria,mycetes and yeasts and the control bacteria test method stated in the appendix of China pharmacopoeia（2010edition）.Results The recoveries were over 70% when culture diluting method was used for staphylococcus aureus and routine test method was used for Escherichia coli,Bacillus subtilis,Candida albicans and Aspergillus niger.In the test of positive control bacteria,the growth was detected,while the negative control was no growth detected.Conclusion The microbial limit test for compound Hongjingtian oral liquid is validated in this study.The amount of staphylococcus aureus can be determined using diluted culture method;while the amounts of Escherichia coli,Bacillus subtilis,Candida albicans,Aspergillus niger can be determined by conventional method.

关 键 词：复方红景天口服液 微生物限度检查 方法学验证 

分 类 号：R927.33[医药卫生—药学]