一次性使用无菌注射器和玻璃注射器的细菌内毒素检查法

Asepetic Syringe for Single Use and Glass Syringe TEsted by Bacterial Endotoxin Test

目的:探讨细菌内毒素检查法在一次性使用无菌注射器和玻璃注射器检查中应用的可行性。方法:根据中国药典2000年版二部收载的细菌内毒素检查法的要求进行实验。结果:通过干扰实验证明,供试品提取液对鲎试剂的凝集反应无干扰作用,用标示灵敏度为(λ)0.25 EU·ml^(-1)的鲎试剂检查细菌内毒素的方法可行、有效。结论:该法可用于一次性使用无菌注射器和玻璃注射器的细菌内毒素检查。

Objective:to explore a feasibility of asepetic syringe for sngle use and glass syringe to be tested by a test Methods;an experment was conducted acoording to the bacterial endotoxin test provided rom the 2nd. edition of 《Cinese Pharmacopeia》2000.Resultthe test result showed that the extracted liquid of expermental supplies did not experience and interference of TAL.Conclusion;0.25 EUml-1 of TAL as sensitivity to test bacterial endotoxin is feasible ,and can be used for asepetic syringe for single use and glass syringe to be tested by the bacterial endotoxin test.