Quality evaluation and research on the pharmaceutical excipient soluble starch
10.19778/j.chp.2024.02.012
- VernacularTitle:药用辅料可溶性淀粉质量评价与研究
- Author:
Shujun HU
1
;
Xiujin YE
;
Yi LI
;
Jiazhe HU
;
Min CHEN
Author Information
1. 广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州 510663
- Keywords:
soluble starch;
quality evalution;
reducing sugar;
functionality;
clarity of the solution
- From:
Drug Standards of China
2024;25(2):181-186
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the quality status and problems of pharmaceutical excipient soluble starch,and to evaluate its quality attributes.Methods:A total of 28 batches of samples from 5 manufacturers were tested accord-ing the current quality standard.Exploratory research were carried out and the quality differences of soluble starch were evaluated.Results:According to the current standard,2 batches of samples were unqualified,accounting for 7.1％of the total.The exploratory research have found that some differences in soluble starch were due to the differ-ent plant sources.The contents of mycotoxin were higher in soluble starch derived from the maize.Attention should be paid to its risk.The powder flowability was related to the particle sizes of soluble starch.The particle sizes of solu-ble starch derived from the potatoes were bigger and the flowability was better than soluble starch from maize and tapi-oca.The dynamic moisture adsorption of potato derived soluble starch was higher.Conclusion:The quality of soluble starch was evaluated as general.A example has been set for the follow-up preparation research through the quality evaluation and research.It is significance for the development of traditional Chinese medicine preparation.
