<span style="font-family:&quot;font-size:medium;">基于市场抽检情况探讨中药配方颗粒质量标准问题</span>

杨园珍, 朱作为, 赖章婷, 洪挺, 许妍

doi:magtech-2024-08-16-00001

中国药物评价 >

2025 , Vol. 42 >Issue 5: 399 - 399-402

DOI: https://doi.org/magtech-2024-08-16-00001

管理研究

基于市场抽检情况探讨中药配方颗粒质量标准问题

展开

1. 江西省药品检验检测研究院/国家药品监督管理局中成药质量评价重点实验室/江西省药品与医疗器械质量工程技术研究中心，江西南昌 330029；
2.江西省医疗器械检测中心，江西南昌 330029

杨园珍，女，主管中药师，研究方向：中药质量分析。

收稿日期: 2024-08-16

录用日期: 2025-01-23

网络出版日期: 2025-12-15

基金资助

江西省药品监督管理局科研项目(2023JS04)；江西省重大科技研发专项“揭榜挂帅”企业需求类项目（20233AAE02018）

收起

Discussion on the Quality Standard of Traditional Chinese Medicine Formula Granules Based on Sampling Inspection

Expand

1.Jiangxi Institute For Drug Control/NMPA Key Laboratory for Quality Evaluation of Traditional Chinese
Medicine/Jiangxi Provincial Engineering Research Center of Drug and Medical Device Quality， Nanchang， Jiangxi， 330029， China；
2.Jiangxi Medical Device Testing Center， Nanchang， Jiangxi， 330029， China

Received date: 2024-08-16

Accepted date: 2025-01-23

Online published: 2025-12-15

Fold

摘要

目的：对2022—2023年江西省中药配方颗粒抽检情况进行分析，找出中药配方颗粒质量标准存在的问题，为中药配方颗粒的标准提高及质量监管提供依据。方法：对所抽检的中药配方颗粒按照相应的标准进行检验，在性状、鉴别、指纹（特征）图谱、浸出物、检查、含量测定等方面进行质量评价及分析。结果：所抽检的548批中药配方颗粒，涉及317个品种，均符合规定，并阐述中药配方颗粒质量标准存在的问题。结论：通过分析近两年江西省中药配方颗粒的检验情况，发现其总体质量较好，但质量标准有待完善，提示需提升中药配方颗粒质量控制水平及标准，并加强其质量监管。

关键词： ; font-size:medium; ">中药配方颗粒；质量标准；问题与建议；抽检

本文引用格式

杨园珍, 朱作为, 赖章婷, 洪挺, 许妍 . 基于市场抽检情况探讨中药配方颗粒质量标准问题[J]. 中国药物评价, 2025 , 42(5) : 399 -399-402 . DOI: magtech-2024-08-16-00001

Abstract

Objective： Based on the analysis of the sampling inspection of traditional Chinese medicine formula granules (TCMFGs) in Jiangxi Province from 2022 to 2023， the problems existing in the TCMFGs standard were found， providing the standard improvement and quality supervision of TCMFGs. Methods： The sampled TCMFGs were inspected according to the corresponding standards， and the quality evaluation was carried out in terms of characteristics， identification， fingerprint (characteristic) map， leachable， inspection and content determination. Results： A total of 548 batches of TCMFGs were sampled， involving 317 varieties， were in compliance with the regulations and elaborated on the problems with the quality standards of TCMFGs. Conclusion： By analyzing the inspection of TCMFGs in the past two years， it is found that the overall quality of TCMFGs in Jiangxi Province is quite good， but the inspection standards need to be improved， and it is suggested to continue to improve the quality standard and strengthen the quality supervision of TCMFGS.

Key words： ; font-size:medium; ">Traditional Chinese medicine formula granules (TCMFGs)； Quality standards； Problems and recommendations； Sampling inspection

Options

文章导航

模态框（Modal）标题

摘要

本文引用格式

Abstract