16批人血白蛋白多聚体含量测定及分析

POLYMERS CONTENT DETERMINATION AND ANALYSIS OF 116 BATCH OF HUMAN ALBUMIN PRODUCTS

目的探索提高人血白蛋白制品质量和收率的方法。方法用凝胶层析法测定１１６批人血白蛋白制品中多聚体的含量并对结果进行统计分析。结果３４批复制批（因半成品热原不合格而经过重新处理过的制品）和１９批回收批（灯检工序中被剔出的有异物产品，经重新除菌后再分装的制品）中白蛋白多聚体的含量均明显高于正常批（生产工艺流程中各工艺段一次通过的产品）白蛋白多聚体含量。（Ｐ＜００１）。结论本次研究提示提高制品的一次合格率和改进复制及回收的工艺是降低制品中多聚体含量，提高产品质量和经济效益的有效途径和方法。

Objictive To research the method of improving the quality and recovery of the human albumin products.Method The polymers content in 116 batch of the human albumin products was determined by gelchromatography and the results were analysed by statistical method.Results The results indicated the polymers content in 34 duplicated batch and 19 rclaimed batch that were reprocessed was significantly higher than that in normal batch(P<001).Condusion The results show that the effective method is to improve the first qualified rate and reform the manufacture technology for decreasing the polymers content in human albumin products.