药用辅料可溶性淀粉质量评价与研究  

Quality evaluation and research on thepharmaceutical excipient soluble starch

作　　者：胡淑君 叶秀金[1] 李艺 胡佳哲 陈旻[1] HU Shujun;YE Xiujin;LI Yi;HU Jiazhe;CHEN Min(Guangdong Institute for Drug Control,CFDA Key Laboratory of Quality Control and Evaluation of Pharmaceutical Excipients,Guangzhou 510663,China)

机构地区：[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

出　　处：《中国药品标准》2024年第2期181-186,共6页Drug Standards of China

基　　金：广东省药品监督管理局科技创新项目(2022ZDZ03)。

摘　　要：目的:考察药用辅料可溶性淀粉的质量现状及存在问题,分析评价其质量属性。方法:按现行质量标准对5个厂家28批样品进行检验,并开展探索性研究试验,分析评价可溶性淀粉的质量差异。结果:按现行标准检验,2批样品不合格,占总数的7.1%。探索性研究发现,不同植物来源的可溶性淀粉存在差别。真菌毒素多存在于玉米来源的可溶性淀粉,含量较高,应关注其风险;可溶性淀粉的粉体流动性与粒度有关,马铃薯来源的可溶性淀粉颗粒较大,流动性比玉米和木薯来源的要好;动态水分吸附马铃薯来源的较高。结论:可溶性淀粉产品质量评价一般。通过质量评价与研究,为后续制剂研究提供参考,对于中药制剂的发展具有重要意义。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 according 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 different 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 soluble starch derived from the potatoes were bigger and the flowability was better than soluble starch from maize and tapioca.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.

关 键 词：可溶性淀粉 质量评价 还原糖 功能性 溶液的澄清度 

分 类 号：R921.2[医药卫生—药学]