血液制品生产中药用辅料麦芽糖质量可比性研究

Quality of medicinal maltose as a excipient in the production of blood products:a comparative study

目的通过全面比较2家国内厂家(B、C)与1家国外厂家(A)的药用辅料麦芽糖质量、过滤效果,并作为静注人免疫球蛋白产品辅料对产品质量进行可比性研究,确定不同厂家麦芽糖作为静注人免疫球蛋白辅料的可行性和可替代性。方法对不同厂家麦芽糖进行质量检验和质量比对、进行小规模过滤试验、静注人免疫球蛋白(pH4)生产后产品质量进行可比性研究。结果比对结果发现,国内厂家B与国外厂家A药用级麦芽糖质量上无显著差异,生产的静注人免疫球蛋白(pH4)质量上也无显著性差异。国内厂家C质量不符合要求。结论国内厂家B与国外厂家A生产的药用级麦芽糖质量无统计学差异,可用于静注人免疫球蛋白(pH4)的生产。

Objective To comprehensively compare the quality and filtration efficiency of medicinal maltose between two domestic manufacturers(B,C)and one foreign manufacturer(A),compare their product quality as an excipient for intravenous immunoglobulin(IVIG),so as to determine the feasibility and substitutability of maltose as an excipient for IVIG from different manufacturers.Methods Quality inspection and comparison of maltose from different manufacturers,small-scale filtration tests,and product quality comparision of IVIG(pH4)were conducted.Results The comparis on results showed that there was no significant difference in the quality of medicinal maltose between manufacturer B and A,and there was no significant difference in the quality of IVIG(pH4)produced.The quality of manufacturer C did not meet the requirements.Conclusion There is no significant difference in the quality of medicinal maltose produced by manufacturer B and A,which can be used for the production of IVIG(pH4).