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

VernacularTitle:血液制品生产中药用辅料麦芽糖质量可比性研究
Author: Zhiru DU ¹ ; Jie HUANG ; Yingqiu TAO ; Hui ZHANG ; Chao LUO ; Yaling DING
Author Information

1. 成都蓉生药业有限责任公司,四川成都 610200
Keywords: intravenous immunoglobulin(IVIG); maltose; quality analysis
From: Chinese Journal of Blood Transfusion 2024;37(5):580-585
CountryChina
Language:Chinese
Abstract: 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 in-travenous 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 require-ments.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).