小牛血去蛋白提取物注射液质量分析  

Investigation on the quality of deproteinized calf blood extractives for injection

作　　者：薛巧如[1] 陈宇堃[1] 杨承勇[1] 蒋玉辉[1] 邓锋[1] 梁蔚阳[1] XUE Qiaoru;CHEN Yukun;YANG Chengyong;JIANG Yuhui;DENG Feng;LIANG Weiyang(Guangdong Institute for Drug Control,NMPA Key Laboratory of Quality Control of Blood Products,Guangdong Drug Administration Key Laboratory of Quality Control and Research of Blood Products,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局血液制品质量控制重点实验室,广东省药品监督管理局血液制品质量控制研究重点实验室,广州510663

出　　处：《中国药品标准》2020年第4期360-364,共5页Drug Standards of China

摘　　要：目的:评价国内不同企业生产的小牛血去蛋白提取物注射液系列品种的质量现状及存在问题。方法:采用法定检验方法和探索性研究进行样品检验,探索性考察样品的活力测定,肽段分析、降压物质、钾、钠含量等。结果:按照法定检验,总合格率为81.6%,不合格项目主要为总固体、可见异物、呼吸活性等。结论:目前国内小牛血去蛋白提取物注射液系列产品的质量标准及产品质量均存在一定缺陷,需进一步完善。Objective:To evaluate the quality status and exsiting issues of the series products of the deproteinized calf blood extractives injection from the different domestic manufacturers.Methods:The statutory test methods and exploratory study methods were used for samples test.The exploratory studies included bioactivity,depressor substances,peptide segment analysis,K,Na contact and so on.Results:76 batches of samples were tested by the statutory test methods,and the qualified rate was 81.6%.The main nonconforming items were total solid content,visible particles and respiratory bioactivity,etc.Conclusion:The current statutory standards and quality of series products of deproteinized calf blood extractives injection are defective and need improvemant.

关 键 词：小牛血去蛋白提取物注射液 质量分析 

分 类 号：R921.2[医药卫生—药学]