复方青香胶囊微生物限度检查方法的建立和验证

目的:建立医院制剂复方青香胶囊的微生物限度检查方法。方法:按照2015版《中国药典》四部制剂通则1105,1106中的方法对复方青香胶囊各试验菌进行回收率试验,并采用常规法检查、选择分离和培养控制菌。结果:复方青香胶囊对金黄色葡萄球菌有一定的抑制作用,采用供试液稀释法(1∶20)进行需氧菌计数方法适用性试验,常规平皿法-倾注法进行霉菌和酵母菌计数方法适用性试验,常规法进行控制菌的检查。结论:所建方法准确可靠,可用于对复方青香胶囊的微生物限度检查。

Establishment and Validation of Microbial Limit Test Methods for Compound Qingxiang Capsules

Objective:To establish a microbial limit test method for compound Qingxiang Capsules.Methods:According to the fourth volume of Chinese Pharmacopoeia(the 2015 edition),general rule 1105 and 1106,the recovery rate of each experimental bacteria of compound Qingxiang capsules was tested,and the conventional method was used to check,isolate and cultivate the control bacteria.Results:Compound Qingxiang capsules had a certain inhibitory effect on Staphylococcus aureus.The test solution dilution method was used for the applicability test of the aerobic bacteria counting method,the conventional plate-pour method was used for the applicability test of the mold and yeast counting method,and the conventional method was used to check the control bacteria.Conclusion:The established methods were accurate and reliable,which can be used for the microbial limit test of compound Qingxiang capsules.