中药生产中回收乙醇的质量风险分析及实例研析  

Quality risk analysis and case study of recovered ethanol in Chinese materia medica production

作　　者：胡实凯 黄艳 HU Shikai;HUANG Yan(Department of Quality,Shanghai Yudan Pharmaceutical Co.,Ltd.,Shanghai 201601,China)

机构地区：[1]上海玉丹药业有限公司质量部,上海201601

出　　处：《中国医药科学》2023年第16期179-182,共4页China Medicine And Pharmacy

摘　　要：中药生产中溶剂使用问题日益得到重视。本文通过文献回顾分析不同应用情况下影响乙醇回收质量的关键因素,还通过对参桂胶囊生产验证试验的实例数据和文献数据进行比较,证明乙醇的回收次数与质量之间无明显关联,建议研究重点应关注杂质或有害成分与限度的比值关系。The use of solvents in the production of Chinese materia medica has been paid more and more attention.In this paper,the key factors impacting the quality of ethanol recovery in different application scenarios were reviewed and analyzed by referring to the literature.By comparing the case data of Shengui Capsule production verification test with the literature data,it was proved that there was no obvious correlation between the times of ethanol recovery and its quality.Therefore,it is suggested that the research focus should be on the ratio correlation between impurities or harmful components and limits.

关 键 词：中药提取 回收乙醇 交叉污染 累积 质量风险 

分 类 号：R28[医药卫生—中药学]