| 张翠莲,许婷婷,安鹏姣,接恒博,左玮.基于国家药品监督管理局公布藿香正气水质量抽检不合格问题的分析与提示[J].中国药事,2023,(12):1408-1415 |
| 基于国家药品监督管理局公布藿香正气水质量抽检不合格问题的分析与提示 |
| Data Analysis and Alerts of Unqualified Huoxiang Zhengqi Shui from DrugSampling Based on NMPA Drug Quality Announcement |
| 投稿时间：2023-05-31 |
| DOI：doi:10.16153/j.1002-7777.2023.12.010 |
| 中文关键词: 药品抽检 藿香正气水 项目 不合格 批次 |
| 英文关键词: drug sampling Huoxiang Zhengqi Shui items unqualifi ed batche |
| 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：通过对国家药品监督管理局（NMPA）2017-2022年发布的藿香正气水抽检不合格信息进行汇总分析，梳理主要问题，为促进其高质量发展与提升用药安全提供参考。方法：登陆NMPA官网“全国药品抽检数据库”，以“藿香正气水”为关键词进行查询。经提取信息，按生产批号、检验依据、不合格项目、标示生产企业名称(来源、产地)、抽检类别与抽样环节等进行统计、分析，并提出建议。结果：2017-2022年共发布本品不合格信息43条35批次，源自11个省市的20家制药企业；2020-2022年抽检不合格批次与2017-2019年相比减少52.2%。在43条不合格信息中，抽样环节覆盖12个省市自治区，包括地抽38条（88.4%）、国抽5条（11.6%），其中，抽自社会药店、药品生产企业、经销商与医院的占比分别为37.2%、27.9%、20.9%与14.0%。在35批次不合格产品中，装量、乙醇、甲醇、微生物与含量测定不符合规定的批次占比分别为40.0%、28.6%、20.0%、5.7%与25.7%；甲醇未达标的7批产品集中于2022年；含量测定未达标的9批产品集中于2017-2019年，其中，涉及“装量+含量”与“乙醇+含量”同时未达标的占比分别为33.3%与44.4%。结论：藿香正气水总体质量呈逐步向好趋势。虽然在2020-2022年本品不合格批次与未达标项目减少，但基于装量与乙醇风险问题，仍需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、储存过程管理，避免产品质量受损。建议药品管理部门进一步加强本品抽检，保障公众用药安全。 |
| 英文摘要: |
| Objective: To summarize and analyze the unqualifi ed information of Huoxiang Zhengqi Shui releasedby the National Medical Products Administration (NMPA) from 2017 to 2022, identify the main problems, andprovide reference for promoting high-quality development and improving drug safety. Methods: Log in to theinterface of “National drug sampling database” on the NMPA official website, and search using the keywordHuoxiang Zhengqi Shui. Then, information was extracted and categorized by production batch number, inspectionbasis, unqualified items, label manufacturer (source, place of origin), sampling type and sampling source, etc.The proportion is calculated for data of unqualified items and batches, some suggestions are put forward byanalysis. Results: The 35 batches products of 43 items unqualifi ed information was released from 2017 to 2022.These unqualified products were from 20 pharmaceutical manufacturing enterprises in 11 provinces or cities.The number of unqualifi ed batches (11 batches) in 2020-2022 decreased by 52.2% compared with that in 2017-2019 (23 batches). Among the 43 items, the proportion of items for samples extracted from social pharmacies,drug manufacturers, business enterprises and hospitals was 37.2%, 27.9%, 20.9%and 14.0%, respectively. The 43items for drug sampling were covered from supply chain in 12 provinces and cities, including 38 items (88.34%)provincial-level drug sampling and 5 items (11.6%) of national sampling. Among the 35 batches unqualifiedproducts, the Proportion of unqualified batches of Minimum Fill, Content of Ethanol, Content of Methanol,Microbial Limit Test and Assay was 40.0%, 28.6%, 20.0%, 5.7% and 25.7%, respectively. In particular, therewere 7 batches of unqualifi ed “Content of Methanol” released by NMPA in the 2022, and there were 9 batchesof unqualifi ed Assay from 2017 to 2019. Among the 9 batches unqualifi ed Assay, the Proportion of MinimumFill+Assay and Ethanol+Assay was 33.3% and 44.4% respectively. Conclusion: The overall quality of HuoxiangZhengqi Shui is gradually improving. Although the number of unqualifi ed batches and items were reduced from2020 to 2022, it is suggested that manufacturing enterprises should continue to strengthen quality tracking andinternal quality control based on risk of Minimum Fill, Content of Ethanol, and business enterprises shouldimprove the management of drug transportation and storage process to avoid product damage. It is suggested fordrug regulatory authorities to further expand Sampling supervision to ensure the quality of public medication. |
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