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| 基于维生素B12的引湿性研究探讨国家药品标准物质的管理方法 |
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| 投稿时间：2024-04-24 修订日期：2024-07-18 |
| DOI： |
| 中文关键词: 国家药品标准物质 维生素B12 引湿性 管理 |
| 英文关键词: national drug reference standards vitamin B12 hygroscopicity management |
| 基金项目: |
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| 摘要点击次数: 74 |
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| 中文摘要: |
| 目的:通过探讨有引湿性化学对照品的管理办法,进一步完善和提高国家药品标准物质的管理工作。方法:通过分析维生素B12对照品的引湿性研究结果,从研制、分装、包装、标签和说明书、稳定性考察等方面探讨有引湿性的国家药品标准物质管理办法。结果:根据引湿性研究的结果,分析了有引湿性化学对照品的影响因素和使用方法,为提高该类国家药品标准物质的管理提供依据。结论:通过完善和优化有引湿性的国家药品标准物质管理办法,全面提升国家药品标准物质的管理和质量,为药品质量标准的实施和用药安全提供保障。 |
| 英文摘要: |
| Objective: Improve the management of national drug reference standards through exploring the management methods for chemical reference standards with hygroscopicity. Methods: By analyzing the research results of the hygroscopicity study of vitamin B12 reference standard, discuss the management methods of hygroscopic national drug reference standards from the aspects of development, packaging, packages, labels and instructions, stability inspection, etc. Results: Analyze the influencing factors and usage methods of hygroscopic chemical reference standards according to the results of hygroscopicity sdudy, so as to provide a basis for improving the management of such national drug reference standards. Conclusion: Comprehensively enhance the management and quality of national drug reference standards by improving and optimizing the management methods of hygroscopic national drug reference standards, in order to provide guarantees for the implementation of drug quality standards and medication safety. |
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