丹参益心片微生物限度检查法方法学验证试验研究

Verification Test on the Technology of Microbial Limit Test for Danshen Yixin Tablet

目的:建立丹参益心片微生物限度检查方法。方法:采用低速离心沉淀集菌与培养基稀释联用方法、常规法。结果:经用低速离心沉淀集菌与培养基稀释联用方法验证,金黄色葡萄球菌、枯草芽孢杆菌的回收率在80%以上,用常规法验证,大肠埃希菌、白色念珠菌、黑曲霉菌回收率大于80%,控制菌可检出大肠埃希菌。结论:丹参益心片的微生物限度检查,可采用低速离心沉淀集菌法与培养基稀释法联用检查细菌数:常规法检查霉菌、酵母菌数和控制菌。

Objective： To establish microbial limit test method for Danshen Yixin Tablet. Methods：Verification test was carries out by integrated two methods, collecting bacteria with low-speed centrifugation and nutrient medium dilution method; the recovery rates of staphylococcus aureus and bacillus subtilis were more than 80%, verification with common method, the recovery rates of escherichia coil, blastomyces albicans and aspergillus niger were also more than 80%, escherichia coil could be examined out in control bacteria. Conclusion： the microbial limit tese of Danshen Yixin Tablet can examine the count of bacteria by collecting bacteria with low-speed centrifugation and nutrient medium dilution method; examine mycetes, yeast count and control bacteria.