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.
YU Shao-wen, WU Wei-cong, HU Shujun, YE Xiu-jin, LI Yi, CHEN Ying
. Research and quality evaluation of silicon dioxide pharmacopoeia standards guided by promoting innovative application of preparations*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(6)
: 1080
-1089
.
DOI: 10.16155/j.0254-1793.2023.06.20
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