国家药品计划抽检品种麸炒薏苡仁质量问题分析及评价

Quality Analysis and Suggestion on Bran Fried Coicis Semen based on National Drug Plan Sampling

目的:通过国家药品计划抽检工作,对药食两用中药材麸炒薏苡仁的质量进行考察,了解麸炒薏苡仁饮片质量现状及存在的问题,完善麸炒薏苡仁检验标准,为药品监管部门提供技术支持。方法:从全国24个省(市、自治区)的生产和使用环节抽取麸炒薏苡仁样品,按照《中华人民共和国药典》2020年版一部进行性状、水分、灰分、浸出物及含量测定项检验,分析检验数据以评价麸炒薏苡仁饮片的质量状况,并针对检验中发现的问题,开展探索性研究。结果与结论:本次抽验的麸炒薏苡仁样品共计98批次,按现行质量标准检验合格率均为100%。经探索性研究,发现麸炒薏苡仁存在炮制不到位的问题,33批次样品中4批次玉米赤霉烯酮超标;此外,甘油三油酸酯含量测定项限度偏低。通过探索性研究发现麸炒薏苡仁饮片和标准中的问题,结合标准提高工作完善麸炒薏苡仁检验标准。建议增加安全性控制指标及炮制控制指标,并提高含量测定限度。

Objective:In order to put forward data support for the improvement of quality standards and market supervision on bran fried Coicis Semen,the quality status and the quality problems of bran fried Coicis Semen were analyzed through the national drug plan sampling.Methods:Bran fried Coicis Semen were sampled from 24 provincial administrative regions in China.The characteristics,moisture,ash content,extract,and content determination tests were carried out by using the method for bran fried Coicis Semen in Volume I,Chinese Pharmacopoeia(2020 edition).Exploratory research was carried out on the problems found in the statutory inspection.Results and Conclusion:A total of 98 batches of bran fried Coicis Semen were tested.According to the current quality standards,the qualified rate was 100%.Through exploratory research,it was found that the processing of prepared bran fried Coicis Semen was not standardized,and 4 out of 33 batches of samples exceeded the pharmacopoeia standard of zearalenone.In addition,the limit of content determination was unreasonable.Through the drug sampling and testing in China,the problems in the inspection standard of bran fried Coicis Semen were found.The inspection standard of bran fried Coicis Semen needs to be further improved combined with the improvement of the standard.It is recommended to add safety control and processing control indicators,and increase the content determination limit.