三乌胶及三乌胶丸的微生物检查方法验证

Validation of Determination Methods for Microbacteria Limit in Sanwujiao and Sanwujiaowan

目的建立三乌胶及三乌胶丸微生物限度检查方法。方法通过接种代表性的阳性菌株,采用常规法及稀释法进行方法学验证。结果三乌胶丸常规法接种5株阳性试验菌株回收率均高于70%,三乌胶常规法对金黄色葡萄球菌、大肠埃希菌、白色念珠菌、黑曲霉菌回收率高于70%,三乌胶及三乌胶丸由于剂型不同,所采用的检查方法也不同。结论三乌胶丸细菌数、霉菌数及控制菌均可采用常规法进行检验,三乌胶细菌数需采用稀释法进行检验,霉菌数及控制菌可采用常规法进行检验。

Objective To establis a method of the microbial limit test in Sanwujiao and Sanwujiaowan. Methods Validation of methods was performed through inoculation of representative positive strain and was used test of recovery rate. Results For different dosage form of medicine, their detection limit are different. Conclusion The amount of bacteria, molds and controlled bacteria can be determined with conventional method in Sanwujiaowan. In Sanwujiao, the amount of bacteria was determined with diluted culture method, the amount of molds and controlled can be determined with conventional method.