摘要
目的:建立脑精素注射液的细菌内毒素检查法。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:将脑精素注射液稀释30倍,以标示灵敏度为0.5EU·mL^(-1)的鲎试剂检查是有效的。结论:鲎试验法取代家兔法对脑精素注射液进行热原检查是可行的。
OBJECTIVE: To establish the inspection method of endotoxin in cerebrolysin injection. METHODS: The experiment is implemented according to the request of endotoxin inspection method colledted in China Pharmacopeia(Ⅱ ,2000Ed). RESULTS:The experiment showed that the interference elements can be excluded by diluting cerebrolysin injection 30 times, and it is effective that endotoxin can be tested by amebocyte lysate with accuracy of 0. 5EU·mL-1. CONCLUSION: For daily pyrogon test of cerebrolysin injection, enotoxin inspection method can be used instead of domestic rabbit method.
出处
《药学实践杂志》
CAS
2003年第2期82-83,共2页
Journal of Pharmaceutical Practice
关键词
脑精素注射液
细菌内毒素检查
干扰试验
Cerebrolysin injection
endotoxin experiment
interference experiment
