基于国家药品评价性抽验的鹅不食草质量问题分析

目的： 通过国家药品评价性抽验工作,对常用中药材鹅不食草的质量进行考察,分析影响鹅不食草质量的主要问题及对策,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29个省（市、自治区）的生产和流通领域抽取鹅不食草样品,按照《中华人民共和国药典》2015年版一部进行检验,并采用分子生物学技术进行了探索性研究。结果： 本次抽验的鹅不食草样品共计126批次,按现行质量标准检验合格116批,不合格10批,均为杂质项不合格;经探索性研究鉴定,发现正品符合药典规定,掺杂的杂质主要为"白鳞莎草"和"阿拉伯婆婆纳"。结论： 鹅不食草样品的总体质量状况为"一般",存在的问题主要为杂质问题。

Analysis of Quality Problems of Centipeda minima Based on National Drug Evaluation Surveillance

Objective: Through the national drug evaluation sampling test, the quality of Centipeda minima, the commonly used Chinese medicinal materials were studied, and the main problems and countermeasures affecting the quality of Centipeda minima were analyzed. Technical support was provided for the regulatory authorities and the safety and effectiveness for public using were ensured. Methods: According to the current pharmacopeia standard of Centipeda minima, the quality inspection and data analysis were carried out to evaluate the quality of Centipeda minima which were sampled from 29 provinces in China. Moreover, molecular biology techniques were employed to identify adulteration. Results: 126 batches of samples collected nationwide were tested, among which 116 batches were qualified while impurities of 10 batches failed to meet the standards. In exploratory research, the qualified samples were in accordance with the regulations, while the impurities were identified to be Cyperus nipponicus Franch. et Savat. and Veronica persica Poir. Conclusion: The overall quality of C. minima samples was "medium". The main problem was impurity.