注射用盐酸吡硫醇细菌内毒素检查法的建立及方法学研究

The establishment of a bactetial endotoxin test method of pyritinol hydrochloride for injection and its methodology study

目的建立注射用盐酸吡硫醇的细菌内毒纱检查法。方法采用《中国药典》2005年版二部附录细菌内毒素检查法,确定注射用盐酸吡硫醇的细菌内毒素限值,并分别用两个厂家的鲎试剂对3批供试品进行干扰试验。结果注射用盐酸吡硫醇浓度为0.5 m g/m l时可排除对鲎试剂的干扰作用。结论注射用盐酸吡硫醇的细菌内毒素检查法是可行的。

Objective To establish a bacterial endotoxin method for pyritinol hydrochloride for injection. Methods The researcher adopted the bacterial endotoxin test method from Ch. p（2005） Vol Ⅱ to fix on the bacterial endotoxin limit of the samples. The interference test to three samples was conducted with limulus lysate agent from two factories. Results The test showed that the reaction to limulus lysate agent was not disturbed when the sample concentration was 0. 5 mg/ml. Conclusion The bacterial endotoxin test method of pyritinol hydrochloride for injection is feasible.