西咪替丁注射液的细菌内毒素检查方法研究

Study on the bacterial endotoxin inspection method of Cimetidine Injection

目的建立西咪替丁注射液的细菌内毒素的检查方法。方法按照《中国药典》2010年版附录细菌内毒素检查法进行试验,用两个不同厂家的鲎试剂对西咪替丁注射液进行干扰试验。结果西咪替丁注射液在2.0mg.mL-1浓度时对细菌内毒素检查无干扰。其细菌内毒素限值定为0.5 EU.mg-1。结论本方法快速、灵敏,可以用于西咪替丁注射液的细菌内毒素限度检查。

Objective To establish a bacterial endotoxin inspection method of Cimetidine Injection. Methods Inter- ference tests of Cimetidine Injection were performed with TAL from two manufacturers according to bacterial endotoxin in- spection test method in Appendix of Chinese Pharmacopoeia （2010 Edition}. Results No interference was found when Cim- etidine Injection with concentration of 2.0 mg · mL-1. The limit value of bacterial endotoxin was 0.5 EU · mg- 1. Conclu- sion The method was rapid,sensitive,and it can be used for the bacterial endotoxin limit test of Cimetidine Injection.