摘要
目的:建立陈香露白露片微生物限度检查方法。方法:根据该样品的微生物限度标准,按《中国药典》2005年版一部附录微生物限度检查法的验证试验指导原则,用委托厂家3个批号的陈香露白露片进行验证试验,以考察确定陈香露白露片微生物限度的检查方法。首先用常规法进行预试验,初步考察该样品对试验菌检测的影响,然后根据预试验结果,用离心沉淀集菌法进行再试验。结果:常规法试验时,大肠埃希菌、白色念珠菌的回收率均大于70%,而金黄色葡萄球菌、枯草芽孢杆菌的回收率小于70%,控制菌检查检出试验菌。采用离心沉淀集菌法试验时,可以有效消除抑菌作用,使金黄色葡萄球菌、枯草芽孢杆菌的回收率大于70%。结论:采用离心沉淀集菌法可以有效消除抑菌作用,简便、准确。
Objective： To establish a microbial limit test method for Chenxianglubailu tablets. Methods： The microbial limit test for Chenxianglubailu tablets was studied according to the guidance of the microbial limit standard for this product and the principle of the validation of microbiological test in ＂Chinese Pharmacopoeia＂ （2005）, and tested in three batches of Chenxianglubailu tablets. The test was conducted with routine and centrifugal precipitation methods. Results： When doing routine test the rate of recovery of escherichia coli and candida albicans was over 70%, but the rate of recovery of staphylococcus aureus and bacillus subtilis was below 70%. Test organism was obtained by controlled bacteria detection test. The results showed that centrifugal precipitation test could eliminate bacteriostasis effectively. Conclusions： Centrifugal precipitation test could eliminate bacteriostasis effectively and the test was simple and accurate.
出处
《儿科药学杂志》
CAS
2009年第2期47-49,共3页
Journal of Pediatric Pharmacy
关键词
微生物限度检查
验证试验
离心沉淀集菌法
Microbial limit test
Verification test
Centrifugal precipitation methods
