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高分子材料制品与医药和食品工业的液体制品在生产和储运过程中长时间接触后的材料溶出程度和溶出物质的安全性越来越受到国内外学者的关注。对于溶出物试验而言,如何根据实际液体制品的成分确定合适的模拟试剂体系显得十分重要。本文从溶出物试验的试剂选择原则和溶剂分类理论角度入手,提出了基于两种不同理论依据的模拟试剂选择方案,为之后研究人员在撰写和评估溶出物试验方案时提供了模拟试剂体系的设计思路和参考意见。
Polymer materials and pharmaceutical and food industry liquid products during the production and storage of long-term contact after the dissolution of the material and the safety of dissolved substances more and more attention by scholars at home and abroad. For the dissolution test, it is very important how to determine the suitable simulation reagent system according to the composition of the actual liquid product. Based on the principle of reagent selection and the theory of solvent classification, this paper proposed a simulation reagent selection scheme based on two different theoretical bases. After that, the researchers designed the simulation reagent system when writing and evaluating the experimental program Ideas and reference views.