国内外人血白蛋白产品的渗透压摩尔浓度抽验结果及质量分析  

Determination of Osmotic Pressure and Quality Analysis of Human Albumin at Home and Abroad

作　　者：罗立 但晓梦 LUO Li;DAN Xiao-meng(Department of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430022,China;Hubei Institute for Drug Control,Hubei Wuhan 430064,China)

机构地区：[1]华中科技大学同济医学院附属协和医院药剂科,湖北武汉430022 [2]湖北省药品监督检验研究院,湖北武汉430064

出　　处：《中国药物评价》2019年第2期103-110,共8页Chinese Journal of Drug Evaluation

基　　金：国家药品监督管理局关于2018年国家药品抽验计划(项目编号:47

摘　　要：目的:采用冰点降低法考察国内外人血白蛋白产品的渗透压现状,为提高该品种的质量标准和工艺水平提供数据参考。方法:按照《中国药典》2015年版四部通则,采用冰点降低法测定抽样的33家国内外企业生产的153批人血白蛋白的渗透压摩尔浓度。结果:浓度为10%的人血白蛋白渗透压摩尔浓度范围在240～253 mOsmol·kg^(-1)之间;浓度为20%的人血白蛋白渗透压摩尔浓度范围在218～337 mOsmol·kg^(-1)之间;浓度为25%的人血白蛋白仅抽到1批,渗透压摩尔浓度为258 mOsmol·kg^(-1);国产人血白蛋白渗透压摩尔浓度范围在237～337 mOsmol·kg^(-1)之间;进口人血白蛋白渗透压摩尔浓度范围在218～333mOsmol·kg^(-1)之间。结论:国内外企业生产的人血白蛋白均符合2015年版《中国药典》相关要求,国产人血白蛋白中渗透压摩尔浓度整体质量控制较好,接近正常人体液渗透压摩尔浓度平均水平;由于人血白蛋白中渗透压摩尔浓度与钠离子含量呈显著相关,而我国药典及企业注册标准均未规定钠离子含量下限,致使不同生产企业间的渗透压差别较大,有必要进一步调整人血白蛋白质量标准中渗透压摩尔浓度限度范围,促使企业进一步提高人血白蛋白生产工艺。Objective:To determine osmotic pressure of human albumin with freezing point osmometer,which could provide experimental basis for improving the quality standard and technology.Methods:Based on the volume four-general rules of Chinese pharmacopoeia 2015 edition,the osmotic pressure of 153 batches of human albumin was detected by freezing point osmometer,which were produced by 32 manufacturers.Results:Osmotic pressure molar concentration of 10%human albumins was about 240~253 mOsmol·kg^-1,Osmotic pressure molar concentration of 20%human albumins was about 218~337 mOsmol·kg^-1,Osmotic pressure molar concentration of 25%human albumins was 258 mOsmol·kg^-1.Osmotic pressure molar concentration of human albumins made in China was about 237~337 mOsmol·kg^-1,Osmotic pressure molar concentration of human albumins made in China was about 237~337 mOsmol·kg^-1,and the imported products was 218~333 mOsmol·kg^-1.Conclusion:The human albumin produced by both domestic and foreign enterprises meet the requirements of the volume three of the Chinese pharmacopoeia 2015 edition.The overall quality control of the osmotic molar concentration of domestic human albumin was closer to the average level of osmotic molar concentration of normal body fluid.Since the osmotic molar concentration in human albumin was significantly correlated with the content of sodium ions,and the lower limit of sodium ion content was not stipulated in the Chinese pharmacopoeia 2015 and the enterprise registration standards.However,the difference in osmotic pressure between different manufacturing enterprises was still large,so it was necessary to adjust the limit range of osmotic molar concentration in human albumin quality standard,so as to improve the production process of human albumin.

关 键 词：人血白蛋白 冰点降低法 渗透压摩尔浓度 

分 类 号：R927.11[医药卫生—药学]