全层析工艺制备10%静注人免疫球蛋白及检测分析

发布时间：2018-08-06 22:14

【摘要】：目的试验研究全层析法结合超滤透析等步骤,并辅以3步病毒灭活/去除工艺制备10%静注人免疫球蛋白的可行性。方法运用全层析工艺纯化制备10%IVIG,计算工艺回收率,并参照《中华人民共和国药典》及《欧洲药典》8.0静注人免疫球蛋白质量标准对其关键指标进行了检测;用散射比浊法对终产品Ig A、Ig M杂质蛋白及Ig G亚类等指标进行检测分析。结果 Ig G总回收率平均值为60.86%,变异系数为0.7%表明工艺具有良好的重复性;纯度、分子大小分布等关键指标到达《中华人民共和国药典》及《欧洲药典》8.0要求;杂质蛋白Ig A、Ig M含量较低,Ig A2.87 mg/L、Ig M0.15 mg/L;4个亚类构成比(%)分别为55.1±2.5、35.8±2.3、5.39±0.93和3.66±0.16。结论本公司全层析工艺能高效制备满足国际标准的10%IVIG产品。
[Abstract]:Objective to study the feasibility of 10% intravenous injection of human immunoglobulin by complete chromatography combined with ultrafiltration dialysis and three steps of virus inactivation / removal. Methods 10IVIGs were purified by full chromatography, and the recoveries were calculated, and the key indexes were determined by referring to the quality standards of human immunoglobulin (Ig) injected intravenously in the PRC Pharmacopoeia and the European Pharmacopoeia 8.0. The impurity protein and Ig G subclass of the final product were detected and analyzed by scatter turbidimetry. Results the average recovery of IgG was 60.86, and the coefficient of variation was 0.7%, which indicated that the process had good reproducibility, and the key indexes, such as purity and molecular size distribution, reached the requirements of the Pharmacopoeia of the people's Republic of China and the Pharmacopoeia of Europe. The content of impurity protein IgA2.87 mg / L Ig M0.15 mg / L was lower than that of impurity protein IgA2.87 mg / L, and the composition ratios of four subgroups (%) were 55.1 卤2.5ng / L, 35.8 卤2.3n, 5.39 卤0.93 and 3.66 卤0.16, respectively. Conclusion the whole chromatographic process of our company can efficiently prepare 10%IVIG products that meet the international standards.
【作者单位】：国药集团武汉血液制品有限公司;
【基金】：国家863计划《重组血液制品等相关产品及关键技术研发》(2012AA021904) 重大科技创新计划(产业化类)项目《特异性免疫球蛋白系列产品产业化》(2013ACC001) 武汉市国际科技合作计划《血浆蛋白层析分离中试研究》(2015030809020360)
【分类号】：R392-33

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