冻干及静注人免疫球蛋白类制品中不溶性微粒含量测定研究  

Quality Investigation of Insoluble Particles in Freeze-Dried and Liquid Human Immunoglobulin for Intravenous Injection

作　　者：王敏力[1] 王威[1] 侯继锋[1] 

机构地区：[1]中国食品药品检定研究院,卫生部生物技术产品检定方法及标准化重点实验室,北京100050

出　　处：《中国药学杂志》2012年第12期993-996,共4页Chinese Pharmaceutical Journal

摘　　要：目的选取全国14个企业报验的冻干、液体2种剂型的静注人免疫球蛋白(pH 4)及冻干、液体2种剂型的静注乙型肝炎人免疫球蛋白(pH 4)制品,考察其不溶性微粒含量。方法按2010年版《中国药典》三部不溶性微粒光阻法,检测19批静注人免疫球蛋白(pH 4)、5批冻干静注人免疫球蛋白(pH 4)、5批静注乙型肝炎人免疫球蛋白(pH 4)和3批冻干静注乙型肝炎人免疫球蛋白(pH 4),计算≥10和≥25μm两个粒径通道的不溶性微粒含量。遇光阻法结果不符合规定时,采用显微计数法复测。样本均为随机抽取,并比较测定结果与自检结果的一致性。结果抽验的32批供试品的不溶性微粒含量合格率为90.6%(29/32),其中3批冻干静注人免疫球蛋白的不溶性微粒检查结果不符合2010年版《中国药典》三部光阻法的相关要求,但显微计数法复验结果符合规定。结论目前国内冻干及静注人免疫球蛋白类制品中不溶性微粒质量总体情况较好,不同实验室间测定结果趋势一致;冻干、静注人免疫球蛋白(pH 4)不溶性微粒光阻法与显微计数法检查结果有呈现差异现象。OBJECTIVE To determine the insoluble particles in human immunoglobulin （pH 4） for intravenous injection and human hepatitis B immunoglobulin （pH 4） for intravenous injection in both liquid and freeze-dried forms from 14 domestic manufactur- ers. METHODS Thirty-two batches of human immunoglobulin products including 19 batches of human immunoglobulin （ pH 4） for intravenous injection, 5 batches of human immunoglobulin （pH 4） for intravenous injection （freeze-dried）, 5 batches of human hepa- titis B immunoglobulin （ pH 4） for intravenous injection, and 3 batches of human hepatitis B immunoglobulin （ pH 4） for intravenous injection （freeze-dried） were tested by light obscuration particle count test method recommend by appendix of 2010 CHP by GWF-8JA laser particle size analyzers. Insoluble particles greater than 10 and 25 μm were counted, respectively. Microscopy counting was car- ried out if the test results from light blockage method did not meet the qualification criteria in 2010 ChP. Trend analysis and comparison of the results from NIFDC and enterprises were done. RESULTS The test results of insoluble particles in 32 batches of human immu- noglobulin products indicate that 90. 6% （29/32） of the products complied with the requirement of 2010 ChP and the results were in a- greement between NIFDC and enterprises. Unfortunately, 3 batches of human immunoglobulin （pH 4 ） for intravenous injection （freeze-dried） failed in light obscuration particle count test, however, they met the requirement of 2010 ChP when microscopy counting method was used. CONCLUSION The quality control of human immunoglobulin products in China market is generally fine, and the test results from different laboratories are basically consistent. Test result of insoluble particles in freeze-dried IVIG by microscopy counting method and light obscuration particle count test method show significant difference.

关 键 词：静注人免疫球蛋白 静注乙型肝炎人免疫球蛋白 不溶性微粒 光阻法 显微计数法 血液制品 冻干剂型 

分 类 号：R973[医药卫生—药品]