苄星青霉素细菌内毒素检查法的标准修订  

Revision of the criterion for bacterial endotoxinins test of Benzathine Benzylpenicillin

作　　者：刘雪莉[1] 张敏[1] 陈汝红[1] 崔晓燕[1] 

机构地区：[1]河北省药品检验所,河北石家庄050011

出　　处：《中国医药导报》2012年第10期141-142,147,共3页China Medical Herald

基　　金：河北省科技计划项目(项目名称:苄星青霉素的质量研究;项目编号:06276425)

摘　　要：目的修订苄星青霉素及注射用苄星青霉素细菌内毒素检查法的质量标准。方法按《中国药典》2005年版二部附录,研究本品对细菌内毒素检查试验的干扰情况。结果苄星青霉素及注射用苄星青霉素600单位/mL浓度对鲎试剂无干扰,可将细菌内毒素检查限值由"每1 000单位小于0.25 EU"提高至"每1 000单位小于0.10 EU"。结论修订的标准可行,利于有效控制产品中的致热物质。Objective To revise the criterion for bacterial endotoxins test of Benzathine Benzylpenicillin and Benzathine Benzylpenicillin for injection.Methods The experiment was carried according to the Appendix of Chinese Pharmacopoeia 2005 Vol.Ⅱ.Interference test for bacterial endotoxins test was done.The feasibility of improving the limit for bacterial endotoxins in the products was discussed.Results The concentration of 600 units/mL for Benzathine Benzylpenicillin and Benzathine Benzylpenicillin for injection had no interference to bacterial endotoxins test.The endotoxins test could be improved from ＂it contains less than 0.25 EU per 1 000 Penicillin Units＂ to ＂it contains less than 0.10 EU per 1 000 Penicillin Units＂.Conclusion The criterion revised is feasible,which can be used to control effectively pyrogenic substances in the products.

关 键 词：苄星青霉素 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]