脑蛋白水解物注射液的渗透压分析  

Measurement of the osmotic pressure of cerebroprotein hydrolysate injection

作　　者：梁成罡[1] 吕萍[1] 丁晓丽[1] 杨化新[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第9期1582-1584,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家科技支撑计划重点项目-药品注射剂检测技术体系研究(课题编号:2008BA155B04)

摘　　要：目的:对不同企业的脑蛋白水解物注射液进行渗透压分析,为提高该品种的国家标准提供实验依据。方法:利用渗透压测定仪对国内32个生产厂家的103批脑蛋白水解物注射液进行测定。结果:脑蛋白水解物注射液渗透压在421～677mOsM之间,其中420～520mOsM有72批,占69.9%;521～600mOsM有28批,占27.2%;600mOsM以上的有3批,占2.9%。结论:国内不同厂家产品的渗透压差异较显著,有必要在脑蛋白水解物质量标准中增设渗透压检查项。Objectlve：The osmotic pressure of cerebroprotein bydrolysate injection was measured in order to im- prove its quality standard. Methods： The osmotic pressure of 103 batches of cerebroprotein hydrolysate injection from 32 pharmaceutical factories were measured on osmotic pressure analyzer. Results：The range of measured os- motic pressure of cerebroprotein hydrolysate injection was 421 -677 mOsM. There were 72 batches（69.9% of 103 batches） which osmotic pressure fell within 420 -520 mOsM, and 28 batches（27.2% of 103 batches） within 521 -600 mOsM,and 3 batches（2. 9% of 103 batches） with osmotic pressure of more than 600 mOsM. Conclusion： The difference of osmotic pressure from various pharmaceutical factories is obvious in some degree. It is necessary to test the osmotic pressure in the quality standard of cerebroprotein hydrolysate injection.

关 键 词：脑蛋白水解物注射液 渗透压 

分 类 号：R917[医药卫生—药物分析学]