药品补充检验方法在中成药质量监管中的应用

Application of Supplementary Drug Testing Methods in Quality Supervision of Proprietary Chinese Medicine

目的:回顾药品补充检验方法的实施,探讨其在中成药质量监管和质量标准提高中的作用和意义,并对补充检验方法的研究方向提出建议。方法:对2006年1月至2022年3月涉及中成药的补充检验方法进行梳理,通过细叙实施情况,分析其变化趋势与中成药质量情况的相关性。结果:我国已公布实施了120个涉及中成药的通用补充检验方法,主要包括涉及处方药味掺伪使假和增重、涉及非法添加化学物质、涉及染色以及未按批准生产工艺生产4个方面。通过对补充检验方法的公布实施时间进行统计,发现不同类型补充检验方法的颁布时间具有一定的规律性。结论:补充检验方法的实施有力打击了中成药掺伪使假违法行为,并助力中药质量标准的提升。建议开展多品种同一指标或多指标检查项通用补充检验方法的研究,药检部门可以根据在市场上发现的药材存在的问题,开展包含此药味的中成药相关检查方法的研究,对市场上相应品种的中成药主动开展筛查工作,进而申报补充检验方法,打击中成药中存在的掺伪使假行为。

Objective: To review the implementation of supplementary testing methods(STM), discuss the role and significance in quality supervision and standards improvement of proprietary Chinese Medicine, and put forward suggestions on the research direction of supplementary testing methods. Method: From January 2006 to March 2022, the STM involved in proprietary Chinese Medicine were sorted out, and the correlation between the content of STM and the quality of proprietary Chinese medicine was analyzed by detailing the implementation situation. Result: China has published and implemented 120 generic supplementary testing methods involving proprietary Chinese medicines, mainly involving prescription drug fl avor falsifi cation, weight gain, illegal addition of chemical substances, staining, and failure to produce according to approved production processes. Through the statistics of the promulgation time of supplementary testing methods, it is found that the promulgation time of different types of supplementary testing methods has certain regularity. Conclusion: The implementation of supplementary inspection methods has effectively cracked down on the adulteration and counterfeiting of proprietary Chinese medicine, and helped improve the quality standards of traditional Chinese medicine.Suggestions to develop more varieties of the same or more indicators to check general complement testing method of research, testing departments could according to the problems found in the market of medicinal materials,contains the ingredients of traditional checking method of related research, corresponding to the market varieties of proprietary Chinese medicine screening work actively, and subsequently declare added inspection method, and crack down on the adulteration of proprietary Chinese medicine.