Quality of medicinal maltose as a excipient in the production of blood products: a comparative study
10.13303/j.cjbt.issn.1004-549x.2024.05.015
- 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
1
;
Yingqiu TAO
1
;
Hui ZHANG
1
;
Chao LUO
1
;
Yaling DING
1
Author Information
1. Chengdu Rongsheng Pharmaceuticals Co., LTD., Chengdu 610200, China
- Publication Type:Journal Article
- 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 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).
