光阻法检测人血白蛋白、静注人免疫球蛋白中的不溶性微粒  

Study on Determination of Subvisible Particles in Human Albumin and Human Immunoglobulin by Light Obscuration Particle Count Test

作　　者：蒋玉辉[1] 梁蔚阳[1] 

机构地区：[1]广东省药品检验所,广州510180

出　　处：《中国药事》2010年第11期1112-1114,共3页Chinese Pharmaceutical Affairs

摘　　要：目的对人血白蛋白、静注人免疫球蛋白中的不溶性微粒进行检查研究。方法按照《中国药典》2010年版三部中不溶性微粒检查法-光阻法进行检测。结果样品不经稀释,即可用于检测。液体制剂混匀后静置2min即可消除气泡,冻干制剂则需静置2~4h方可脱气。10μm粒子的回收率为98.5%,25μm粒子的回收率为100.1%。共检测人血白蛋白130批、静注人免疫球蛋白（pH 4）103批、冻干静注人免疫球蛋白（pH 4）44批,均符合规定。结论《中国药典》2010年版三部附录中的＂不溶性微粒检查法＂可用于人血白蛋白、静注人免疫球蛋白的检测,抽检的样品均能达到新版药典的要求。Objective The determination of subvisible particles in human albumin and human immunoglobulin for intravenous injection（IVIG） was studied and discussed.Methods Samples were detected by light obscuration particle count test in CHP 2010.Results Samples could be detected directly without dilution.Eliminate gas bubbles in liquid samples by allowing to stand for 2 min,but in freeze-dried IVIG by allowing to stand for 2~4 h.The average recovery of light obscuration test for human albumin were 98.5% for 10 μm and 100.1% for 25μm.130 batches of human albumin,103 batches of IVIG（pH 4） and 44 batches of freeze-dried IVIG（pH 4） were determinated and all conformed to the rules formulated by CHP 2010.Conclusion The particulate contamination of human albumin and IVIG can be detected by the subvisible particle count test in CHP 2010 Volume Ⅲ,and the results of all samples comply with the requirements.

关 键 词：人血白蛋白 静注人免疫球蛋白 血液制品 不溶性微粒 光阻法 

分 类 号：R927.12[医药卫生—药学] R392.115