| 张翠莲,许婷婷,王彪,李文瀚,左玮,刘建茹.基于国家药品监督管理局药品质量公告发布不合格软膏与乳膏类药品的数据分析与提示[J].中国药事,2022,36(9):1078-1086 |
| 基于国家药品监督管理局药品质量公告发布不合格软膏与乳膏类药品的数据分析与提示 |
| Data Analysis and Alerts of Unqualified Ointments and Creams Released by NMPA Drug Quality Announcement |
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| DOI：10.16153/j.1002-7777.2022.09.014 |
| 中文关键词: 药品抽检 软膏 乳膏 不合格 发生率 |
| 英文关键词: drug sampling ointments creams disqualification incidence rate |
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| 中文摘要: |
| 目的：分析2017-2021年国家药品监督管理局(NMPA)发布的软膏与乳膏剂的抽检不合格信息，通过梳理凸显问题，为确认改进目标与提升药品质量提供参考。方法：在NMPA数据查询库的“全国药品抽检”界面，以“乳膏”与“软膏”作为关键词分别进行查询。经提取信息，用Excel进行梳理。 再按药品品名、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归类，并按占批次百分比统计，分析涉及的市售药品与医院制剂占比，以及项目不合格发生率。结果：39批不合格乳膏产品中，有市售药品21批，占53.85%；医院制剂18批，占46.15%。其中， 市售不合格乳膏21批中的国抽样品占61.90%、地抽样品占38.10%，“含量测定”项目不合格发生率占 42.86%、“装量差异”占23.81%；而18批不合格乳膏类医院制剂均系地抽，其“含量测定”项目不合格发生率占37.50%、“装量差异”占55.56%。8批次不合格软膏包括市售2批、医院制剂6批。两剂型的项目不合格发生率以“含量测定”占比最高，乳膏与软膏类分别为38.46%、37.50%。结论：制药企业与医院生产的软膏与乳膏剂型的不合格项目分布与发生率趋于一致，且共性风险集中在含量控制项目；而医院制剂凸显风险还包括最低装量不合格的批次占55.56%。提示制药企业与医疗机构应进一步改进设备与包装、加强生产过程管理，全面提升产品质量。 |
| 英文摘要: |
| Objective: To analyze the unqualified list of ointments and cream drugs released by the National Medical Products Administration (NMPA) from 2017 to 2021 and sort out the prominent problems in order to provide references for confirming improvement goals and improving drug quality. Methods: In the interface of “National Drug Sampling” of NMPA database, “cream” and “ointment” were used as keywords to query respectively. After extracting information, Excel was used to sort out the data. Then, the drugs were classified according to their names, production batch number, inspection basis, unqualified items, label manufacturers (source, place of origin), sampling types and sampling source, etc. In addition, statistics were performed according to the percentage of batches to analyze the proportion of incidence of unqualified items from commericial drugs and hospital preparations. Results: Among 39 batches of unqualified cream samples, 21 batches came from commericial drugs and 18 batches from hospital preparations, accounting for 53.85% and 46.15%, respectively. Among the 21 batches of unqualified cream samples, 61.90% were extracted from national drug sampling and 38.10% from provincial-level drug sampling. As for the incidence of unqualified issue, 42.86% were due to “content determination” and 23.81% to “loading difference”. 18 batches of unqualified cream preparations in hospital all came from provincial-level drug sampling, among which the incidence of unqualified “Assay” and “Minimum Fill” accounted for 37.50% and 55.56%, respectively. Among the 8 batches of unqualified ointment samples, 2 batches were produced by pharmaceutical enterprises and 6 batches were hospital preparations. As for the incidence of unqualified of cream and ointment samples, “Assay” accounted for the highest proportion, of which creams and ointments accounted for 38.46% and 37.50%, respectively. Conclusion: The distribution and incidence of unqualified ointments and creams produced by pharmaceutical enterprises and hospitals tend to be consistent, and the common risks were focused on the content control items. However, the prominent risk of hospital preparations included the unqualified “Minimum Fill” for containers labelled by weight, and the batch proportion was 55.56%. It is suggested that pharmaceutical enterprises and medical institutions should further improve equipment and packaging so as to strengthen production process management and comprehensively improve product quality. |
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