| 邓继敏,陶冶,袁杰,翟宏焱,张亚中.基于2022年专项抽检工作探讨中药配方颗粒的质量控制[J].中国药事,2023,(11):1290-1295 |
| 基于2022年专项抽检工作探讨中药配方颗粒的质量控制 |
| Discussion about Quality Control of Traditional Chinese Medicine Formula Granules Based on 2022 Special Sampling Inspection |
| 投稿时间：2023-03-30 |
| DOI：10.16153/j.1002-7777.2023.11.009 |
| 中文关键词: 中药配方颗粒 质量控制 标准修订 问题与对策 抽检 |
| 英文关键词: traditional Chinese medicine formula granules quality control standard revision problems and countermeasures sampling inspection |
| 基金项目:安徽省药品监督管理局科技创新项目（编号 AHYJ-KJ-202102） |
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| 中文摘要: |
| 目的：通过专项抽检工作，了解中药配方颗粒的整体质量状况及存在的问题，为后续质量监管与国家标准的制修订及执行提供参考。方法：基于安徽省2022年配方颗粒专项抽检工作，就抽样检验过程中出现的与质量控制相关的问题进行研究。结果：本次抽检的中药配方颗粒质量情况总体较好，不合格率为1.7%。存在部分企业原料使用不当、卫生控制不严、制粒工艺欠佳等问题，且国家标准在落地执行中也存在部分项目检验方法不合理、对仪器设备要求高等问题。结论：建议通过落实生产企业主体责任、提升检验机构的检测能力、标准制修订部门优化标准可行性等措施，提升中药配方颗粒产品质量， 保障配方颗粒产业健康有序发展。 |
| 英文摘要: |
| Objective: To understand the overall quality status and the current problems of traditional Chinese medicine formula granules (TCMFGs) through the special sampling inspection, so as to provide a solid reference for the subsequent quality supervision, as well as revision and implementation of national standard. Methods: Based on the 2022 special sampling inspection of TCMFGs in Anhui Province, the issues related to quality control in the sampling inspection process were reviewed. Results: The quality of the TCMFGs was good in general, and the unqualified rate was 1.7%. There were some problems such as improper use of raw materials, lax health control, poor granulation process, and unreasonable inspection methods for some projects and high requirements for instruments and equipment in the implementation of national standards. Conclusion: It is suggested to improve the quality of TCMFGs products and ensure the healthy and orderly development of TCMFGs industry by implementing the main responsibility of production enterprises, improving the testing ability of inspection institutions, and optimizing the feasibility of standards by the department of standards revising. |
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