离心弃沉淀处理对药品微生物限度检查结果影响的考察

The study on the results of microbial limit test after centrifugation

目的:通过对供试液经500r/min离心5min后,考察细菌、霉菌和酵母菌在上清液及沉淀中的分配情况及对药品微生物限度检查结果的影响。方法:采用药用淀粉为供试品制备供试液,分别加入各验证菌,将其离心后对上清液和沉淀物分别进行细菌、霉菌和酵母菌的计数并与未经离心处理的供试液进行对比。结果:离心后分布在上清液中的细菌、霉菌和酵母菌数少于沉淀物中,细菌的回收率小于40%,霉菌和酵母菌回收率小于5%。结论:供试液经500r/min离心5min后取上清液弃沉淀的处理方式影响药物菌落计数的准确性,使结果明显偏低,是一种需改进的方法。

Objective：To study the distribution of bacteria, fungi and yeasts in the supernatant and precipitation after pretreated preparation was centrifuged at 500r/min for 5 minutes.Methods：Bacteria, fungi and yeasts were added into starch respectively. To count bacteria, fungi and yeasts respectively in the supernatant and precipitation after centrifugation.Results：Bacteria, fungi and yeasts in the supernatant were less than those in the precipitation after centrifugation. The recovery of bacteria was below 40%. The recoveries of fungi and yeasts were below 5%.Conclusion：It is unsuitable to count bacteria, fungi and yeasts in the supernatant by the method of centrifugation at 500r/min for 5minutes.