注射用硫酸链霉素及其原料的细菌内毒素检查

Determination of Endotoxin in Streptomycin Sulfate for Injection and Its Raw Materials

目的建立硫酸链霉素细菌内毒素检查法,以代替热原检查法。方法按中国药典2000年版二部附录E方法(1)用两个厂家的鲎试剂对3个厂家的3批原料和6批注射用硫酸链霉进行干扰实验考察。结果硫酸链霉素最大不干扰浓度为4mg·ml-1,其细菌内毒素限值可定为0.25EU·mg-1。结论注射用硫酸链霉素及其原料采用细菌内毒素检查法是可行的。

Objective：To set up the method of test for bacterial endotoxins in Streptomycin Sulfate. Methods：The interfering test is carried out on 6 batches of Streptomycin Sulfate for Injection and 3 batches of its material with 2 products of Taehypleus Amebocyte Lysate reagent according to the appendix XI E of Chinese pharmacopeia （2000） vol I . Results：Maximum concentration of no inhibition for baeterlal endotoxin test was 4mg . ml^-1. The limit of endotoxin was supposed as 0.25EU . mg^-1. Conclusion：Limulus test can be used to replace the method of test for pyrogen in Streptomycin Sulfate.