盐酸法舒地尔注射液细菌内毒素检查法建立及方法学研究  

The study on bacterial endotoxin test of Fasudil Hydrochloride Injection

作　　者：翁一玲[1] 李鸣[2] 陈松旺 

机构地区：[1]福建中医药大学附属第二人民医院药剂科,福州350003 [2]福建省药品检验所,福州350001 [3]福建省福州市药品检验所,福州350001

出　　处：《海峡药学》2012年第4期57-59,共3页Strait Pharmaceutical Journal

摘　　要：目的建立盐酸法舒地尔注射液细菌内毒素检查法。方法按照《中华人民共和国药典》2005年版二部附录细菌内毒素检查法〔1〕和2005年版《药品标准操作规范》细菌内毒素检查法〔2〕,确定盐酸法舒地尔注射液细菌内毒素限值,用2个厂家鲎试剂对3个批次的盐酸法舒地尔注射液进行干扰试验考察。结果盐酸法舒地尔注射液的浓度稀释到0.05mg·mL-1时进行细菌内毒素检查无干扰作用。结论盐酸法舒地尔注射液采用细菌内毒素检查法检查是可行的。OBJECTIVE To establish a method of bacterial endotoxin test for Fasudil Hydrochloride Injection.METHODS The test was conducted according to the bacterial endotoxin test in Appendix Ⅱ of China Pharmaciopeia（2005 Edition） and the bacterial endotoxin test in the Drug Standard Operation Intruction（2005 Edition） to make sure the bacterial endotoxin limitation of Fasudil Hydrochloride Injection,and then reagents from two factories were used to conduct the interferential tests of three batch Fasudil Hydrochloride Injection RESULTS When the Fasudil Hydrochloride Injection was diluted to the concentration of 0.05mg·mL-1,the interference of Fasudil Hydrochloride Injection to limulus test were eliminated efficiently.CONCLUSION It is feasible to detect the bacterial endotoxin of Fasudil Hydrochloride Injection by the method of etermination of bacterial endotoxin.

关 键 词：盐酸法舒地尔注射液 鲎试剂 细菌内毒素检查法 干扰试验 

分 类 号：R969.4[医药卫生—药理学]