基于国家药品抽检的全国益心酮片质量情况分析与研究

Quality Analysis and Study on Yixintong Tablets Based on National Drug Sampling

目的:通过国家药品抽检工作,了解益心酮片市场整体质量现状及存在的问题,为监督管理部门提供技术支撑,以保障公众用药安全有效。方法:从全国24个省级行政区抽取益心酮片样品,按照《中华人民共和国药典》2015年版一部益心酮片薄层鉴别项与含量测定项方法开展检验工作,并进行指纹图谱、农药残留、显微鉴别、非法添加化学药品四项探索性研究,分析检验结果以评价益心酮片的市场情况。结果:本次抽验的益心酮片样品共计78批次,依《中华人民共和国药典》法定标准检验的合格率为100%。指纹图谱研究结果显示,不同企业不同批号的产品批间一致性较好;农药残留研究结果显示,农药自身的性质、稳定性及提取工艺对制剂中农药残留量影响很大;显微鉴别以及非法添加化学药品的研究表明,不存在原粉入药以及非法添加化学药品的现象。结论:建议各企业对原材料进行严格控制,并对工艺进行优化,以保障产品安全有效;相关企业修改标示规格,与现行《中华人民共和国药典》标准保持一致。

Objective: To analyze the overall quality status and the current problems of Yixintong tablets through national drug sampling in order to provide technical support to the relevant regulatory departments and ensure the safety and effectiveness of public medication. Methods: Yixintong tablets were sampled from 24 provinces in China. By using the method of TLC identification and content detection for Yixintong tablets in Volume I, Chinese Pharmacopoeia(2015 edition), four exploratory studies on fingerprints, pesticide residues, microscopic identification and illegal addition of chemical drugs were carried out. The test results were analyzed to evaluate the market of Yixintong tablets. Results: A total of 78 batches of Yixintong tablets were tested, and the qualified rate was 100% according to the standard of Chinese Pharmacopoeia. The results of fingerprint analysis showed that the consistency of products of different batch numbers from different enterprises was good. The research on pesticide residues indicated that the properties, stability and extracting process of pesticides had great influence on the residue contents in the preparations. The researches on microscopic identification and illegal addition of chemicals suggested that there was no phenomenon of raw powder used as extracts or illegally added chemicals. Conclusion: It is suggested that enterprises should strictly control the raw materials and optimize the extracting process so as to ensure the safety and effectiveness of the products. It is also suggested that the related enterprises should modify the specification to be consistent with the current standards of Chinese pharmacopoeia.