苯巴比妥钠注射液细菌内毒素检查法标准研究  

Study on Bacterial Endotoxin Test of Phenobarbital Sodium Injection

作　　者：甄晓兰 崔晓燕 郭永辉 

机构地区：[1]河北省药品检验研究院,石家庄市050011

出　　处：《中国药品标准》2017年第5期394-400,共7页Drug Standards of China

基　　金：河北省科技计划项目(编号16272610);项目名称:苯巴比妥钠注射液的质量标准提高研究

摘　　要：目的:苯巴比妥钠注射液现有检验标准"国家药品标准WS1-XG-058-2011"无细菌内毒素或热原检查项目,一方面给临床用药造成很大的安全隐患,另一方面也不符合《中国药典》2015年版四部9301"注射剂安全检查法应用指导原则"。建立该品种的细菌内毒素检查方法非常必要。方法:依照《中国药典》2015年版四部1143检查法,采用凝胶限量法和动态浊度法进行干扰试验,并参考USP 40-NF 35.2017苯巴比妥钠注射液细菌内毒素检验,拟定细菌内毒素检查限值;另取两个厂家8个批次的苯巴比妥钠注射液按拟定细菌内毒素检查限值对其进行定性和定量检验,验证方法的可行性。结果:拟定苯巴比妥钠注射液细菌内毒素限值为每1 mg苯巴比妥钠中含细菌内毒素的量应小于0.3 EU。采用凝胶法和动态浊度法对两个厂家8个批次的苯巴比妥钠注射液进行验证,结果均符合规定。结论:本文建立的细菌内毒素检查法适用于苯巴比妥钠注射液细菌内毒素检查。Objective ： There is no bacterial endotoxin or pyrogen test item in the current specification of Phenobar- bital Sodium Injection ＂national drug standards WS1-XG-058-2011＂ That would make the potential safety hazards happen in the clinical medication. On the other hand, that does not comply with the ＂guideline on application of the injection safety tests＂ in ChP 2015 Vol Ⅳ. It is necessary to establish the bacterial endotoxin test method of Pheno- barbital Sodium Injection. Methods： The test was performed as per ChP 2015. Vol Ⅳ： 1143, and the interference test conducted by the gel clot method and kinetic turbidimetric method. The limit of bacteria endotoxin was set by referring to the bacterial exdotoxin test method of Phenobarbital Sodium Injection in USP 40-NF 35.2017. 8 batches of Phenobarbital Sodium Injection from 2 manufacturers were used to validate the suitability of the established test method of bacterial endotoxin. Results： The limit was set as 1 mg Phenobarbital Sodium containing less than 0. 3 EU of endotoxin, the gel clot method and kinetic turbidimetric methods were validated with 8 batches of samples from 2 manufacturers and the good results were obtained. Conclusion： The established method was applicable to test of bacterial endotoxin in Phenobarbital Sodium Injection.

关 键 词：苯巴比妥钠注射液 热原物质 细菌内毒素 

分 类 号：R921.2[医药卫生—药学]