β-内酰胺类抗生素无菌检查方法学研究

Studies on Test for Sterility of β-Lactam Antibiotics

关键词:  β-内酰胺类抗生素  无菌检查法(薄膜过滤法)  方法验证

Key words:  β-lactam antibiotics  sterility test (Membrane filtration method)  testing and verifying of the method

摘要:

目的建立β-内酰胺类抗生素的无菌检查方法。方法采用薄膜过滤法，以不同冲洗量，联合加入β-内酰胺酶以消除抗生素的抑菌活性。结果样品、阴性对照无菌生长，所有阳性对照及试验组菌在2 d内生长良好。结论针对β-内酰胺类抗生素做无菌检查时，无论品种、规格，均可配成约20 mg·mL-1后按薄膜过滤法操作，根据抗生素对β-内酰胺酶的稳定性适量加入β-内酰胺酶可减少冲洗液用量，以获得最佳的无菌检查方法。

Abstract:

OBJECTIVE To establish methods to detect the microbial contamination of β-lactam antibiotics. METHODS Membrane filtration method was used by modifying the amount of rinsing fluid and adding β-lactamase to inactivate the antibiotic. RESULTS All of positive strains and test strains revealed growth of microorganism in two days and the substance control and negative control gave no evidence of growth. CONCLUSION β-lactam antibiotics, whatever the kind or specification, can be dissolved into about 20 mg·mL-1 and then we can do its sterility test according to membrane filtration method. Adding some β-lactamase in thioglycollate medium for the antibiotics which are sensitive to it can decrease the amount of rinsing fluid and the most effective sterility test method is gained.