| 接恒博,李文瀚,张翠莲,左玮.对国家药品监督管理局公布的复方丹参片质量抽检不合格问题的分析和建议[J].中国药事,2024,38(9):1001-1007 |
| 对国家药品监督管理局公布的复方丹参片质量抽检不合格问题的分析和建议 |
| Data Analysis and Suggestions on Unqualified Compound Danshen Tablets from Drug Sampling based on NMPA Drug Quality Announcement |
| 投稿时间：2024-05-15 |
| DOI：10.16153/j.1002-7777.20240385 |
| 中文关键词: 复方丹参片 药品抽检 质量分析 |
| 英文关键词: Compound Danshen Tablets drug sampling quality analysis |
| 基金项目:中央高水平医院临床科研业务费资助（编号 2022-PUMCH-B-060） |
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| 中文摘要: |
| 目的：提取和整理国家药品监督管理局（NMPA）2016-2022年发布的复方丹参片抽检数据，梳理其质量不合格问题特点和趋势，为促进中成药提升质量提供参考。方法：在NMPA官网数据查询系统 “全国药品抽检”界面，以“复方丹参片”作为关键词检索并提取抽检不合格相关信息。通过归类分析，统计复方丹参片质量不合格数据，并对涉事药品生产企业产品的不合格批次等进行分析。结果： 共检索到54条本品不合格记录，涉及24家生产企业的46批产品，含量测定与重量差异未达标的批次占比分别为63.0%和34.8%。在含量测定未达标的29批产品中，主要不合格项目依次为三七含量（34.5%）、 丹参酮IIA含量（20.7%）与丹酚酸B含量（20.7%）。药品不合格现象集中于某些生产企业，在涉及到的24家企业中，有6家（25.0%）出现3批或以上不合格产品，涉及不合格产品24批，占总不合格批次的 52.17%。结论：自2017年至2022年，复方丹参片质量抽检不合格的批次与项目呈下降趋势，表明本品质量整体向好，但质量风险仍然存在，提示生产企业应持续加强内部质量控制，经销商应完善药品运输和储存过程管理，避免湿度等环境因素引起的质量变化。建议药品监督管理部门继续加强本品抽检与探索性研究，进一步提升复方丹参片的质量标准，保障公众用药质量。 |
| 英文摘要: |
| Objective: To provide references for further quality improvement of traditional Chinese patent medicines by extracting and analyzing the unqualified information of Compound Danshen Tablets released by the National Medical Products Administration (NMPA) from 2016 to 2022. Methods: The data were extracted from the interface of “National Drug Sampling Database” on the NMPA official website. The research keyword was “Compound Danshen Tablets”. Through classification analysis, the data of unqualified quality of Compound Danshen Tablets and unqualified batches of products from the involved pharmaceutical production enterprises were statistically analyze. Results: A total of 54 unqualified records of this product were retrieved, involving 46 batches of products from 24 manufacturing enterprises. 63.0% of the batches were unqualified due to assay of content and 34.8% of them were unqualified due to weight variation. Among the 29 batches which were unqualified due to assay of content, the top unqualified items were content of Panax notoginseng (34.5%), content of Tanshinone IIA (20.7%) and content of Salvianolic acid B (20.7%). The phenomenon of unqualified products was concentrated in certain production enterprises. Among the 24 enterprises involved, 6 (25.0%) of the enterprises had 3 or more batches of unqualified products, involving 24 batches of unqualified products which accounted for 52.17% of the total unqualified batches. Conclusion: The number of unqualified batches and items of Compound Danshen Tablets has been decreasing from 2017 to 2022, indicating that the overall quality of Compound Danshen Tablets was gradually improving. However, quality risks still exist. It is still necessary to remind the enterprises to continue strengthening internal quality control and improve the management of transportation and storage processes to avoid quality issues caused by environmental factors such as humidity. It is recommended that the regulatory authorities should strengthen the sampling and exploratory work and further improve the quality standard of Compound Danshen Tablets to ensure the safety of public medication. |
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