胸腺肽注射剂降压物质检查及其限值的确定  

Test for depressor substance and establishment of its limit to depressor substances in thymosin injections

作　　者：邓利娟[1] 闫安庄[1] 范慧红[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》2010年第8期1493-1498,共6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:确定合理的胸腺肽注射剂降压物质检查限值,建立降压物质检查法。方法:采用猫血压法确定胸腺肽注射剂降压物质检查限值,并对不同厂家的胸腺肽注射剂进行考察。结果:胸腺肽注射剂降压物质检查限值确定为0.27mg·kg-1较为合理。结论:胸腺肽注射剂按限值0.27mg·kg-1进行降压物质检查结果安全可靠。Objective：To set up reasonable limit of test for depressor substances for thymosin injections and establish a method for examining depressor substances.Method：The limit of test for depressor substances for thymosin injections was determined with cats.And the test for depressor substances was conducted by using samples from different factories.Results：The most suitable limit of test for depressor substances for thymosin injections was 0.27 mg·kg-1.Conclusion：This method for examining depressor substances in thymosin injections was proved to be safe and reliable.

关 键 词：胸腺肽 降压物质 限值 

分 类 号：R917[医药卫生—药物分析学]