药用辅料糊精的质量评价
Quality evaluation of pharmaceutical excipient dextrin
叶秀金 1胡淑君 1李艺 1郭雅娟 1胡佳哲 1王彩媚 1林嗣翔 1陈旻1
作者信息
- 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,广东广州 510663
- 折叠
摘要
目的 考察药用辅料糊精的质量现状及存在问题.方法 按现行质量标准,对18个厂家167批样品进行检验,并开展探索性试验,分析评价糊精的质量.结果 按现行标准检验,1批样品不合格.产品中真菌毒素的含量较高,并存在质量不均一的情况,应重视,以免带来质量风险.结论 按现行质量标准和探索性研究项目检验,糊精的合格率为85.6％.为后续制剂研究提供参考,对中药制剂的发展具重要意义.
Abstract
OBJECTIVE To investigate the current situation of the quality status and the existing problems of the pharmaceutical excipient dextrin.METHODS A total of 167 batches of samples from 18 manufacturers were tested based on the current quality standard.Exploratory research were carried out and the quality differences of dextrin were evaluated.RESULTS According to the current standard,1 batch of sample was unqualified.The exploratory research is found that the high contents of mycotoxins in dextrin and the quality was inhomogeneous.Attention should be paid to avoid the quality risks.CONCLUSION The acceptance rate of dextrin is 85.6％according to the current quality standard and the exploratory research.An example has been set for the following pharmaceutical preparation research.It is of great significance for the development of traditional Chinese medicine preparation.
关键词
糊精/质量评价/均匀性/真菌毒素/溶液的澄清度/元素杂质/还原糖/农药残留Key words
Dextrin/Quality evaluation/Homogeneity/Mycotoxin/Clarity of the solution/Elemental impurities/Reducing sugar/Pesticide residue引用本文复制引用
基金项目
广东省药品监督管理局科技创新项目(2022ZDZ03)
出版年
2024
NETL
NSTL
万方数据