首页|橡胶类药包材国际标准概况及进展

橡胶类药包材国际标准概况及进展

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橡胶类药包材是一种重要的药品包装材料,本文旨在研究和分析橡胶类药包材国际标准的概况,为我国橡胶类药包材国家标准体系的建立和优化提供参考。通过对各国药典和行业标准中橡胶类药包材的标准体系进行梳理,对《美国药典》《欧洲药典》等国际标准中橡胶类的标准进行讨论分析,对各标准相互联系和差异进行比较分析。本文总结了国内外橡胶类药包材标准的框架、质量控制要点以及最新进展情况。结合橡胶类药包材国际标准的特点和形式,提出了基于关联审评和国家标准体系构建需求的建议,有助于我国药包材标准体系建设和提升,以满足产业发展和监管需求。
Overview and progress of international standards for rubber pharmaceutical packaging materials
Rubber pharmaceutical packaging materials are essential components in drug packaging.This paper aims to investigate and analyze the overview of international standards for rubber pharmaceutical packaging materials,providing insights for the establishment and optimization of China's national standards system for rubber pharmaceutical packaging materials.Through a systematic review of the standard systems for rubber pharmaceutical packaging materials in various national pharmacopeias and industry standards,the standards for rubber in international standards such as the United States Pharmacopeia and the European Pharmacopoeia are discussed and analyzed.A comparative analysis is conducted to examine the interconnections and differences among these standards.This study summarized the standard formats,key points in quality control,and the latest developments in different rubber pharmaceutical packaging materials standards.Considering the characteristics and forms of international standards for rubber pharmaceutical packaging materials,recommendations are proposed based on the requirements for correlated assessments and the construction of national standards systems.These suggestions aim to contribute to the development and enhancement of China's pharmaceutical packaging materials standards,aligning with industry growth and regulatory demands.

Pharmaceutical packaging materialsRubberInternational standards

贾菲菲、赵霞、杨会英

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中国食品药品检定研究院,北京 100050

药包材 橡胶 国际标准

中国食品药品检定研究院中青年发展研究基金

2023C7

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(5)
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