Selection Principle and Solution for Simulation Solvent Used in Extractables Tests for Medical, Pharmaceutical and Food-grade Polymer Materials

Jun-wei ZHANG; Jing-ke ZHU; Xue-wei WEN; Yi-qing ZHOU; Yin-ying CAO

doi:10.14028/j.cnki.1003-3726.2016.012.009

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Selection Principle and Solution for Simulation Solvent Used in Extractables Tests for Medical, Pharmaceutical and Food-grade Polymer Materials

更新时间：2022-09-12

- Selection Principle and Solution for Simulation Solvent Used in Extractables Tests for Medical, Pharmaceutical and Food-grade Polymer Materials
- Polymer Bulletin Vol. 29, Issue 12, Pages: 59-65(2016)
- 作者机构：
  
  1.杭州安诺过滤器材有限公司, 杭州 311404
  2.浙江大学化学工程与生物工程学院, 杭州 310027
- 作者简介：
- 基金信息：
- DOI：10.14028/j.cnki.1003-3726.2016.012.009
  CLC：
- Published：20 December 2016，
  
  Received：16 June 2016，
  
  Revised：28 August 2016，
扫描看全文
Jun-wei ZHANG, Jing-ke ZHU, Xue-wei WEN, Yi-qing ZHOU, Yin-ying CAO. Selection Principle and Solution for Simulation Solvent Used in Extractables Tests for Medical, Pharmaceutical and Food-grade Polymer Materials. [J]. Polymer Bulletin 29(12):59-65(2016)
DOI：

Jun-wei ZHANG, Jing-ke ZHU, Xue-wei WEN, Yi-qing ZHOU, Yin-ying CAO. Selection Principle and Solution for Simulation Solvent Used in Extractables Tests for Medical, Pharmaceutical and Food-grade Polymer Materials. [J]. Polymer Bulletin 29(12):59-65(2016) DOI： 10.14028/j.cnki.1003-3726.2016.012.009.

摘要

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。

Abstract

The safty and degree for the extractable and leachable of polymer material used in storage and transportation of the process liquid in medical

pharmaceutical and food industry have attracted more and more attention by public. For extractalbe test

it is important to determine simulation solvent system based on actual liquid product ingredients. After explaining the principle of solvent selection and theory of solvent classification

the review propose the two solutions for selection simulation solvent in extractable experiment

based on the Induction and summary of reported article and literature. It can provide researchers with ideas and advice for design and evaluation simulation solvent system in extraction experiment in the future.

关键词

溶出物模拟试剂溶剂强度极性

Keywords

ExtractableSimulation solventSolvent strengthPolar

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