芪贞慢咽宁颗粒微生物限度检查法的建立及方法学验证  

Establishment and Validation of Microbial Limit Method for Qizhenmanyanning Granules

作　　者：何倩灵[1] 郭峰[1] 谭琴[1] 赵静[1] 姚仲青[1] 

机构地区：[1]扬子江药业集团有限公司,泰州225321

出　　处：《海峡药学》2017年第6期49-51,共3页Strait Pharmaceutical Journal

摘　　要：目的建立芪贞慢咽宁颗粒微生物限度检查的方法并进行验证。方法按2015年版《中国药典》,以金黄色葡萄球菌、枯草芽孢杆菌、铜绿假单胞菌、白色念珠菌,黑曲霉菌和大肠埃希菌,对芪贞慢咽宁颗粒进行微生物限度检查方法学验证试验。结果规定条件下培养,3个批次制剂五种阳性菌回收率均高于70%,证明无抑菌现象。3个批次制剂试验组和阳性对照组有菌生长,而阴性对照未出现。结论本品对需氧菌和霉菌、酵母菌计数方法为平皿法;控制菌检查可采用常规法检验。该方法用于芪贞慢咽宁颗粒的质量控制有效、可行。OBJECTIVE To establish the validation of microbial limit test method for Qizhenmanyanning Gran- ules. METHODS According to Chinese Pharmacopoeia 2015, the microbial limit test method of Qizhenmanyanning Granules was validated using Pseudomonas aeruginosa, Staphylococcus aureus, Bacillu Subtilis, Candida albicans ,As- pergillus niger and Escherichia coli. RESULTS To cultivate in specified conditions, recoveries of Five kinds of posi- tive organisms were higher than 70% in three batches preparation and Proving no bacteriostasis phenome- non. Experimental group and positive control group had colonies and negative control did not appear. CONCLUSION The routine method were used with count of aerobe, countsmold and yeasts＇ Pathogenic bacteria can be tested by general method. The method is cogent, effective and can be used to the quality concrol of the Qizhenmanyanning Granules.

关 键 词：芪贞慢咽宁颗粒 微生物限度检查 验证 

分 类 号：R927[医药卫生—药学]