84种注射用药品细菌内毒素检查法的方法学研究

Study of Bacterial Endotoxin Test on 84 Drugs for Injection

目的对2000年版《中国药典》二部中有热原检查项的注射剂类药品进行细菌内毒素检查法的方法学研究,以确定热原检查法改为内毒素检查法的可行性,以及其检查限值的定值。方法通过28个省市药检所药理室的协作研究,采用细菌内毒素凝胶法,对每个品种抽取的样品进行干扰实验。结果确定了每个品种的不干扰浓度或稀释倍数,并以此判断该品种能否使用细菌内毒素法进行检验。结论84个品种可采用内毒素检查法,16个品种暂不能采用内毒素检查法。

OBJECTIVE To screen the drug for injection with Pyrogen test in Ch. P（2000 ）Vol Ⅱ , to evaluate the possibility for the replacement with bacterial endotoxin test; and to investigate the methodology of the bacterial endotoxin test for all kinds of injections required for Pyrogen test in Ch. P（2000） Vol Ⅱ. METHODS Interference tests were done on each sample of injections by using bacterial endotoxin gel-method. The samples were provided by the collaboration of Pharmacology Divisions of Institute for Drug Control in 28 provinces or cities. RESULTS Determined the no interference concentration or the minimum no interference dilution of each drug and whether the drug is valid for bacterial endotoxin test. CONCLUSION 84 drugs for injection are valid for bacterial endotoxin test, and 16 drugs for injection are not suitable for bacterial endotoxin test.