口服β-内酰胺类抗生素药品的微生物限度检查方法

Microbial Limit Test of β-Lactam Antibiotics for Oral Administration

采用平皿法、培养基稀释法和薄膜过滤法考察3个品种5个剂型的β-内酰胺类抗生素药品的试验菌回收率,以期建立适合口服β-内酰胺类抗生素药品的一般微生物限度检查方法。结果显示,采用缓冲液和培养基中均添加青霉素酶的薄膜过滤法,各药品的试验细菌回收率均高于70%;采用平皿法和培养基稀释法,各药品的试验真菌回收率均高于70%。

The plating method, dilution method and the membrane filtration method were used for the investigation of the recoveries of the tested microorganisms in the buffer containing three kinds of β-lactam antibiotics. It was designed to find a method which was suitable for the microbial limit test of the β-lactam antibiotics for oral administration. The results showed that the recoveries of bacteria from the membrane filtration method in which the penicillinase was added to the buffer and the culture medium was higher than 70 %, and the recoveries of fungi by plating method and dilution method were higher than 70 %.