胃安颗粒微生物限度检查方法的验证

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。

Weian granules in verification of microbial limit test method

Objective: to establish microbial Weian granules limit inspection Methods.Methods: according to the China Pharmacopeia(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 normal 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 recovery rate of more than 70%.Conclusion: the culture medium diluted method can effectively eliminate the bacteriostatic action,is simple and accurate.