目的: 介绍以促进制剂创新应用为导向的二氧化硅药典标准修订思路和过程,并对收集到的样品进行质量评价。方法: 从促进应用的角度详细解读二氧化硅标准制定过程及理念,具体包括应用调研、样品收集、标准比对、项目制修订过程以及质量评价。结果: 建立的二氧化硅药典标准可有效控制及评价制剂创新应用所需要的不同规格不同型号二氧化硅的质量。结论: 以应用为导向的标准研究与质量评价思路适用于制定规格型号多样化的二氧化硅药用辅料质量标准,标准的制定过程及理念体现了中国药典标准的严谨性与科学性,促成“以标准促进技术创新,以先进技术带动标准进步,以先进标准促进产业发展”的共生效应,与现行的审评审批制度适应,可为其他药用辅料的标准制定提供参考。
Objective: To introduce the idea and processes of revising pharmacopoeia standard for silicon dioxide guided by promoting the innovative application of preparations, and evaluates the quality of collected samples. Methods: A detailed interpretation of the silicon dioxide standard development process and philosophy from the perspective of promoting application, including application research, sample collection, standard comparison,project revision process and quality evaluation. Results: The pharmacopoeia standard for silicon dioxide could effectively control and evaluate the quality of different specifications and models of silicon dioxide required for innovative application of preparations. Conclusion: The idea of application-oriented standard research and quality evaluation is suitable for formulating the quality standards of silicon dioxide with diversified specifications. The formulation process and idea of standards present the preciseness and scientificity of pharmacopoeia standards, promote the symbiotic effect of “promoting technological innovation with standards, promoting standard progress with advanced technology, and promoting industrial development with advanced standards”, adapt to the current review and approval system. It can provide references for the formulation of standards for other pharmaceutical excipients.
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