胃安颗粒微生物限度检查方法的验证  

Weian granules in verification of microbial limit test method

作　　者：郑兆银 陈延晶[1] 贺蕾[1] 

机构地区：[1]天津市静海县药品检验所,天津301600

出　　处：《天津药学》2012年第4期1-3,共3页Tianjin Pharmacy

摘　　要：目的:建立胃安颗粒微生物限度检查方法。方法:按《中国药典》2010年版一部附录微生物限度检查法及应用指导原则[1],考察确定胃安颗粒微生物限度的检查方法。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,根据结果,用培养基稀释法进行再试验。结果:常规法试验,大肠埃希菌、白色念珠菌、黑曲霉的回收率均大于70%,而金黄色葡萄球菌、枯草芽孢杆菌的回收率均小于70%,控制菌检查采用常规法。采用培养基稀释法试验时,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:采用培养基稀释法可以有效消除抑菌作用,简便、准确。Objective ： to establish microbial Weian granules limit inspection Methods. Methods ： according to the China Pharma- copeia （2010 edition a microbial limits inspection and application appendix guiding principle）, the investigation to determine the microbial limits stomach Ann particle inspection Methods. With conventional method on the test, a preliminary study samples of the experimental fungus effect on detecting, according to the results, with culture medium diluted method to test. Results： the nor- mal method of test, escherichia coli, candida albicans, aspergillus are larger than the recovery rate of 70%, and staphylococcus aureus and bacillus subtilis were less than the recovery rate of 70% , the conventional method check control bacteria. The culture medium diluted method test, can effectively eliminate the bacteriostatic action, make staphylococcus aureus, bacillus subtilis re- covery rate of more than 70%. Conclusion： the culture medium diluted method can effectively eliminate the bacteriostatic action, is simple and accurate.

关 键 词：微生物限度检查 验证试验 培养基稀释法 

分 类 号：R927.11[医药卫生—药学]