摘要
目的:建立人血白蛋白不溶性微粒检测的方法,保障医院临床用药安全。方法:将人血白蛋白用微粒检查用水(经0.2μm滤膜滤过的注射用水)稀释成5%质量分数的溶液,采用光阻法,用GWF-8JA激光微粒分析仪对不溶性微粒进行测定。结果:测定了每瓶人血白蛋白含10μm以上的不溶性微粒,其平均回收率为101.1%(n=9),RSD为1.3%,含25μm以上的不溶性微粒,其平均回收率为101.3%(n=9),RSD为1.5%。并运用此方法考察了4个人血白蛋白生产企业所生产的12批样品中所含的不溶性微粒。结论:本方法准确、灵敏、重复性好,为医院临床用药安全提供了保障。
OBJECTIVE To establisha testing method for measuring the particulate matter in human albumin and to ensure the safety of clinical drug use in hospital. METHODS To produce a solution of 5% human albumin with water for the test of particulate matter（the water should be filtered through a filter with a porosity of 0. 2μm）, and use the method of light obscuration particle count test to test particulate matter with GWF-8JA laser particle size analysers. RESULTS Established a testing method for measuring the particulate matter in human albumin, the average recoveries（n = 9） of each bottle of human albumin contains particulale matters that were greater than 10μm was 10/. 1 % and with RSD of 1.3% ; the average recoveries（n= 9） of each bottle of human albumin contains particulate matters that were greater than 25 μm was 101.3% and with RSD of 1.5%, and tested particulate matter in human albumin of 12 batches which was produced by 4 manufacturer. CONCLUSION The method is specific, sensitive and accurate, reliable for the quality control of human albumin, and can ensure the safety of clinical drug use in hospital.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2010年第14期1197-1200,共4页
Chinese Journal of Hospital Pharmacy
关键词
人血白蛋白
不溶性微粒
光阻法
human albumin
particulate matter
light obscuration particle count test
