| 沈薇,吕栋,王奕匀,梁一博,马迎春.基于国家药品评价性抽验的全国脑苷肌肽注射液质量情况分析与研究[J].中国药事,2021,35(3):281-288 |
| 基于国家药品评价性抽验的全国脑苷肌肽注射液质量情况分析与研究 |
| Quality Analysis and Study on National Cattle Encephalon Glycoside and Ignotin Injection Based on National Drug Evaluative Sampling Inspection |
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| DOI：10.16153/j.1002-7777.2021.03.007 |
| 中文关键词: 脑苷肌肽注射液 国家药品评价性抽验 质量分析 标准改进 探索研究 |
| 英文关键词: Cattle Encephalon Glycoside and Ignotin Injection national drug evaluative sampling inspection quality analysis standard improvement exploratory research |
| 基金项目: |
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| 中文摘要: |
| 目的：了解全国脑苷肌肽注射液的质量状况及存在的问题，完善脑苷肌肽注射液检验标准，为药品监管部门提供技术支撑。方法：从全国 25 个省级行政区抽取脑苷肌肽注射液样品，依据其现行法定标准进行检验，分析检验数据以评价质量状况；针对检验中发现的问题，开展探索性研究。结果：本次抽验的脑苷肌肽注射液样品共 59 批，依据国家标准检验未出现不合格样品。探索性研究对其过敏检查法进行改进，并增加环境温度稳定性实验及溶血检验。结论：脑苷肌肽注射液整体质量良好；现行质量标准需要改进，以减少不良反应发生率；应加强从原辅料、生产工艺、储运、使用环节等各个环节的全过程监管。 |
| 英文摘要: |
| Objective: To analyze the quality status and the current problems of Cattle Encephalon Glycoside and Ignotin Injection in order to improve the inspection standards and to provide technical support for relevant regulatory departments. Methods: According to the current statutory standards of Cattle Encephalon Glycoside and Ignotin Injection, the quality inspection and data analysis were carried out to evaluate the quality of Cattle Encephalon Glycoside and Ignotin Injection, the samples of which were collected from 25 provinces in China. Moreover, an exploratory study was conducted to address the problems found in the inspection. Results: A total of 59 batches of Cattle Encephalon Glycoside and Ignotin Injection samples were tested. According to the national standards, no unqualified samples were found. In the exploratory study, the allergic test was improved, and the stability test on the environmental temperature and hemolysis test were added. Conclusion: The overall quality of Cattle Encephalon Glycoside and Ignotin Injection is good. The current quality standard needs to be improved so as to reduce the incidence of adverse reactions and the whole process supervision on raw materials, production, storage, transportation, use and other links should be strengthened. |
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