高准确度快速溶出取样器的设计与评价  

Design and qualification of a dissolution sampler with high-speed and high-accuracy

作　　者：邵锋伟 任兴发 何旭鸿 赵桂芝 程楚楚 张维冰 Shao Fengwei;Ren Xinfa;He Xuhong;Zhao Guizhi;Cheng Chuchu;Zhang Weibing(Instrument Department of Welch Materials(Zhejiang)INC.,Jinhua 321000,China;Welch Materials(Shanghai)INC.,Shanghai 201613,China;School of Chemical and Molecular Engineering,East China University of Science and Technology,Shanghai 200237,China;Zhejiang QingLong Tapes,Co.LTD.,Jiaxing 314005,China)

机构地区：[1]浙江月旭材料科技有限公司仪器部,金华321000 [2]月旭科技(上海)股份有限公司,上海201613 [3]华东理工大学化学与分子工程学院,上海200237 [4]浙江青龙胶带有限公司,嘉兴314005

出　　处：《现代仪器与医疗》2023年第1期37-42,共6页Modern Instruments & Medical Treatment

基　　金：国家重点研发计划项目(2021YFF0701900);上海市2020年度“科技创新行动计划”科学仪器领域项目(20142200900)。

摘　　要：溶出度试验是药物研发与生产过程中一项重要的检验指标,对于考察药品生产的批间差异,对确保药品处方和生产工艺变更后的质量和疗效一致性等具有重要意义。溶出仪是进行溶出度实验的主要工具,其与自动化取样器连用不仅可以提高检测效率,也能够减少人为因素的干扰。本文基于双泵驱动单通道技术设计了一种新型溶出仪用高准确度自动取样器,为解决高准确度快速取样提供了新的解决方案。新型取样器的平均取样速度可以达到48ml/min,1ml介质体积的取样准确度在±0.007ml范围内,并具有自动过滤、自动原位稀释和系统监测的功能,对其进行的性能评价显示具有良好的应用前景。Dissolution is an important testing parameter during the research & development and pharmaceutical production, it is significant to evaluate the quality consistency among pharmaceutical preparation lots, and qualify the change of prescription or production process by dissolution test. Dissolution tester is the main tool applied for dissolution analysis, with an auto-sampler to sample the dissolution medium, in order to improve the test efficiency and reduce the error of human factor. We reported a new designed auto-sampler in this paper, which is a double-pumps-driving one channel technology, it is a new solution on high-speed liquid sampling by high-accuracy. The average sampling speed of the new auto-sampler reaches to 48mL/min, the accuracy is within ±0.007mL when sampling 1mL liquid, meanwhile the auto-sampler has the function of automatically immediate filtration, onsite dilution and system monitor. This auto-sampler has an ideal application prospect according to the evaluation test.

关 键 词：溶出取样器 快速取样 即时精滤 原位稀释 

分 类 号：TH788[机械工程—仪器科学与技术]