盐酸奥普力农注射液细菌内毒素检查方法的研究

Research on the bacterial endotoxins test of olprinone hydrochloride injection

目的建立盐酸奥普力农注射液的细菌内毒素检查方法,以控制产品质量,确保临床用药安全。方法按照《中华人民共和国药典》2015年版四部通则"9301"里规定的注射剂安全性检查法应用指导原则和"1143"里规定的细菌内毒素检查方法进行实验,分别用湛江博康海洋生物有限公司和湛江安度斯生物有限公司两个不同厂家生产的鲎试剂对1批盐酸奥普力农注射液进行了干扰实验和细菌内毒素检查。结果盐酸奥普力农注射液浓度稀释至0.04 mg/ml,使用灵敏度为0.125 EU/ml的鲎试剂,本品对鲎试剂和细菌内毒素反应无干扰作用,并对盐酸奥普力农注射液进行细菌内毒素检查,结果符合规定。结论盐酸奥普力农注射液的细菌内毒素检查方法可行,能控制产品质量,保证临床用药安全。

Objective To establish bacterial endotoxins test method for olprinone hydrochloride injection,so as to control the product quality and ensure the safety of clinical medication.Methods The experiment was carried out according to the application guiding principle of injection safety test method specified in"9301"and bacterial endotoxins test method specified in"1143"of General Principles in PartⅣof Chinese Pharmacopoeia(2015 Edition).The interference test and bacterial endotoxins test were carried out on a batch of olprinone hydrochloride injections with limulus reagent produced by Zhanjiang Bokang Marine Biology Co.,Ltd.and Zhanjiang A&C Biological Co.,Ltd.Results The concentration of olprinone hydrochloride injection was diluted to 0.04 mg/ml,and limulus reagent with sensitivity of 0.125 EU/ml was used.This product had no interference on the reaction between limulus reagent and bacterial endotoxin.The bacterial endotoxins test of olprinone hydrochloride injection was carried out,and the results met the requirements.Conclusion The bacterial endotoxins test for olprinone hydrochloride injection is feasible,which can control the product quality and ensure the safety of clinical medication.