摘要
目的:建立利巴韦林注射液细菌内毒素的检查方法。方法:用两个生产厂家的鲎试剂至5批样品,把中国药典2000年版二部附录ⅪE方法进行干扰试验考察。结果:利巴韦林注射液最大非干扰浓度为20mg·ml-1,其细菌内毒素限值可定为0.125EU·mg-1。因此可选用灵敏度(λ)为0.5EU·ml-1的鲎试剂,将样品稀释至4mg·ml-1后进行细菌内毒素检查。结论:可以用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制其热原。
Objective:To set up the endotoxin determination method for monitoring pyrogen of Ribavirin Injection. Methods:The disturb test is carried out on 5 lots of Ribavirin Injection with two products of Tachypleus Amebocyte Lysate (TAL) reagent according to the appendix Ⅺ E of Chinese Pharmacopeia (2000) vol Ⅱ . Results: Maximum concentration of no inhibition and enhancement action for bacterial endotoxin test was 20mg·ml-1. The limit was supposed as 0.125EU · mg-1. The bacterial endotoxin test can be made with λ0. 5EU · ml-1 of TAL, when preparation was diluted to 4mg · ml-1. Conclusions: TAL method can be used in place of rabbit method for pyrogen monitoring of Ribavirin Injection.
出处
《中国药品标准》
CAS
2004年第3期26-28,共3页
Drug Standards of China
