基于国家药品评价性抽检的巴戟天饮片质量分析与研究

Quality Analysis and Study on Morindae Officinalis Radix Decoction Pieces Based on National Drug Sampling and Testing

目的:通过国家药品评价性抽检工作,了解市场上的巴戟天饮片质量及存在的问题,为巴戟天的质量标准提高和市场监管提供数据支持。方法:从全国24个省级行政区抽取巴戟天饮片,按照《中华人民共和国药典》2015年版(一部)巴戟天性状项和薄层鉴别项方法开展检验工作,并进行DNA条形码技术、指纹图谱、环烯醚萜含量测定、真菌毒素残留量共4项探索性研究,分析检验结果以评价巴戟天饮片的市场情况。结果:本次抽检的88家企业的巴戟天饮片共计108批,按照国家法定标准检验的合格率为100%。DNA条形码技术可以有效区分巴戟天及其混伪品。指纹图谱研究结果显示,正品巴戟天指纹图谱相似度均超过95%,混伪品相似度均低于70%。含量测定结果显示,不同巴戟天炮制品中环烯醚萜从种类和含量上具有显著性差别。真菌毒素筛查试验结果显示,有1批样品的黄曲霉毒素G1超出药典限度。结论:按标检验结果显示,市场上巴戟天饮片质量基本合格。根据探索性研究结果,建议标准增加环烯醚萜含量测定和黄曲霉毒素限量检查。

Objective:To analyze the quality and the problems of Morindae Officinalis Radix decoction pieces in the market through national drug sampling and testing in order to put forward data support for the improvement of quality standards and market supervision on Morindae Officinalis Radix decoction pieces.Methods:Morindae Officinalis Radix decoction pieces were sampled from 24 provincial administrative regions in China.The test work was carried by using the method of character item and TLC identification item for Morindae Officinalis Radix decoction pieces in Volume I,Chinese Pharmacopoeia(2015 edition),and four exploratory studies on DNA barcoding technology,fingerprints,content detection of cycloid,and mycotoxin residues were carried out.The test results were analyzed to evaluate the market situation of Morindae Officinalis Radix decoction pieces.Results:A total of 108 batches of Morindae Officinalis Radix decoction pieces from 88 enterpriseswere tested andthe qualified rate was 100%according to the national legal standards.Morindae Officinalis Radix decoction pieces and the fakes can be distinguished effectively based on the method of DNA barcoding technology.The results of fingerprint analysis showed that the similarity of Morindae Officinalis Radix was more than 95%and the similarity of adulterants was less than 70%.The results of content determination showed the iridoids in different processed products of Morinda Officinalis have significant difference in species and content.Mycotoxin screening test results showed that afl atoxin G1 in 1 of 30 batches of samples exceeded the limit of pharmacopoeia.Conclusion:According to the standard test results,the quality of Morinda Officinalis Radix decoction pieces in the market was basically qualified.Based on the exploratory research results,it is suggested that standard determination of iridoid content and afl atoxins limit should be added.