基于国家药品评价性抽验的全国重楼饮片质量情况分析与研究

目的：通过全国中药材饮片专项抽验工作，了解重楼饮片市场整体质量现状及存在的问题，完善重楼检验标准，为监管部门提供技术支持，保障公众用药安全有效。方法：从全国19个省级行政区抽取重楼饮片样品，按照《中国药典》2015年版一部重楼项下规定开展检验工作，出具检验报告，分析检验数据以评价重楼饮片市场情况。针对检验中发现的问题，采用实地调研等方法开展探索性研究。结果与结论：本次抽验的重楼样品共计55批次，部分批次样品存在薄层色谱鉴别不合格和含量不合格问题，经探索性研究发现部分批次存在混伪品问题以及疑似为被提取后的重楼饮片问题。现行重楼标准存在薄层鉴别与含量测定指标不合理等问题。

Quality Analysis and Study on Paridis Rhizoma Pieces Based on National Drug Evaluation Sampling Inspection

Objective:To analyze the overall quality status and related quality problems of Paridis Rhizoma pieces through national special sampling inspection of Chinese herbal medicine pieces in order to improve inspection standards, provide technical supports for relevant regulatory departments and ensure the safety of public medication. Methods:According to the current statutory standard of Paridis Rhizoma in the Chinese Pharmacopoeia (2015 edition) Volume I, the quality inspection and data analysis was carried out to evaluate the quality of Paridis Rhizoma pieces which were sampled from 19 provinces in China. Moreover, on-site investigation and other methods were used in exploratory study in solving the problems found in the inspection. Results and Conclusion:A total of 55 batches of Paridis Rhizoma piece samples were tested. Some batches failed to meet the thin layer chromatography (TLC) and determination standards. The exploratory study found out that some batches mixed with adulterants and the unqualified samples were speculated to extracted pieces. There exist some problems such as unreasonable indicators for TLC identification and content determination in current standard of Paridis Rhizoma pieces.