基于国家药品评价性抽验的盐酸奈福泮注射液质量分析及研究  

Quality analysis of nefopam hydrochloride injection based on national drug evaluation sampling inspection

作　　者：刘慧颖 马惠钟 陈默 LIU Hui-ying;MA Hui-zhong;CHEN Mo(Liaoning Institute for Drug Control,Liaoning Inspection,Testing and Certification Center,State Key Laboratory of Chemical Drug Quality Research and Evaluation,Shenyang 110036;College of Pharmacy,Liaoning University,Shenyang 110036)

机构地区：[1]辽宁省药品检验检测院,辽宁省检验检测认证中心,化学药品质量研究与评价国家重点实验室,沈阳110036 [2]辽宁大学药学院,沈阳110036

出　　处：《中南药学》2022年第11期2616-2621,共6页Central South Pharmacy

摘　　要：目的 对全国盐酸奈福泮注射液的质量现状和问题进行分析,为盐酸奈福泮注射液质量标准的提高提供科学依据,为药品监管部门提供技术支撑。方法 依据法定标准对国家药品评价性抽验的60批盐酸奈福泮注射液进行检验,并对结果进行统计分析,从质量标准、产品安全性等方面开展探索性研究。结果 按法定标准检验的合格率为100%,探索性研究发现产品渗透压存在风险隐患,检验标准尚需完善。结论 盐酸奈福泮注射液整体质量良好,生产企业需考察处方的合理性,产品的质量标准需要统一和完善。Objective To analyze the quality status and problems of nefopam hydrochloride injection in China,and to provide scientific basis for the quality standard improvement and technical support for drug regulatory departments.Methods According to the legal standards,60 batches of nefopam hydrochloride injection were tested,the results were analyzed,and exploratory research was conducted concerning the aspects of quality standards and product safety.Results The qualified rate of the inspection according to the legal standard was 100%.The exploratory study found that the osmotic pressure had potential risks and dangers,and the inspection standard needed to be improved.Conclusion The overall quality of nefopam hydrochloride injection is good.Manufacturers need to investigate the rationality of the prescription,and the quality standard of the product needs improvement.

关 键 词：盐酸奈福泮注射液 评价性抽验 质量分析 探索性研究 

分 类 号：R927.11[医药卫生—药学]