抗真菌药固体制剂微生物限度检查方法的建立

目的建立抗真菌药固体制剂微生物限度检验方法。方法采用平皿法和薄膜过滤法测定样品污染试验菌的回收率来确定适宜的检验方法。结果采用平皿法中的培养基稀释法测定样品人工污染3株细菌代表菌株的菌回收率均大于70％，采用薄膜过滤法在冲洗1000ml时，测定样品人工污染2株真菌代表菌株的菌回收率均大于70％。结论可采用平皿法中的培养基稀释法测定抗真菌药片剂中的细菌数，采用薄膜过滤法测定抗真菌药片剂中的霉菌和酵母菌数。

Establishment of method for limit test of microbial contamination of anti-fungus medicine solid preparations

Objective To establish a microbiological test method for Anti - fungus medicine solid preparation, Methods Plate - count methods and membrane filtration methods were used to confirm the suitable test method through determining the bacterial recovery rate. Results The recovery rate of three representative bacteria determined by the culture media dilution method, were more than 70% and the recovery rate of two representative mold and fungus determined by the membrane filtration methods with 1000 ml washed, were more than 70% . Conclusion The total aerobic microbial count of Anti - fungus medicine solid preparation can be determined by the culture media dilution method of Plate - count methods and the total combined molds and yeasts count was determined by membrane filtration methods.