一种基于仿制药质量和疗效一致性评价的溶出系统研究
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摘要
溶出系统是由溶出度实验仪(溶出仪)和自动取样器2种仪器组成的。溶出仪是专门检测固体制剂溶出度的药物实验仪器。它是一种控制药物制剂质量的体外检测方法。它能模仿人体胃肠消化运动过程,配合紫外分光光度计等仪器检测药物的溶出度。自动取样器是配合溶出仪用于药物溶出实验取样、收集的仪器。本文介绍一种基于仿制药质量和疗效一致性评价的溶出系统,概述溶出仪、自动取样器的结构组成、工作原理、验证、实验和结果分析,并对影响溶出度的因素进行了讨论。
The dissolution system consists of two instruments,a dissolution tester( hereinafter referred to as a dissolution apparatus) and an autosampler. The dissolution apparatus is a drug testing instrument that specifically detects the dissolution of solid preparations. It is an in vitro assay for controlling the quality of pharmaceutical preparations. It can imitate the process of human gastrointestinal digestion and movement,and detect the dissolution of the drug cooperate with ultraviolet spectrophotometer. The autosampler is an instrument for sampling and collecting the drug dissolution test with a dissolution apparatus. This paper describes a dissolution system based on the consistency of generic drug quality and efficacy evaluation,and summarizes the composition,working principle,verification,test and results analysis of the dissolution apparatus and autosampler. Finally,the factors which affect the dissolution are discussed.
The dissolution system consists of two instruments,a dissolution tester( hereinafter referred to as a dissolution apparatus) and an autosampler. The dissolution apparatus is a drug testing instrument that specifically detects the dissolution of solid preparations. It is an in vitro assay for controlling the quality of pharmaceutical preparations. It can imitate the process of human gastrointestinal digestion and movement,and detect the dissolution of the drug cooperate with ultraviolet spectrophotometer. The autosampler is an instrument for sampling and collecting the drug dissolution test with a dissolution apparatus. This paper describes a dissolution system based on the consistency of generic drug quality and efficacy evaluation,and summarizes the composition,working principle,verification,test and results analysis of the dissolution apparatus and autosampler. Finally,the factors which affect the dissolution are discussed.
引文
[1]国务院办公厅.关于开展仿制药质量和疗效一致性评价的意见[EB/OL].[2016-03-05]. http://www. gov. cn/zhengce/content/2016-03/05/content_5049364. htm.
[2]国家药品监督管理局.关于仿制药质量和疗效一致性评价有关事项的公告[EB/OL].[2018-12-28]. http://www.nmpa. gov. cn/WS04/CL2138/334161. html.
[3]国家食品药品监督管理总局.药物溶出度仪机械验证指导原则[EB/OL].[2016-04-29]. http://samr. cfda. gov. cn/WS01/CL0087/151716. html.
[4] 2016年溶出度技术及体内外相关性研讨会. 2016年溶出度技术及体内外相关性研讨会论文集[C].天津:2016.
[5]宁保明,何兰,张启明,等.国内外溶出度试验用标准片的研究及应用[J].药物分析杂志,2012,32(8):1509-1515.
[2]国家药品监督管理局.关于仿制药质量和疗效一致性评价有关事项的公告[EB/OL].[2018-12-28]. http://www.nmpa. gov. cn/WS04/CL2138/334161. html.
[3]国家食品药品监督管理总局.药物溶出度仪机械验证指导原则[EB/OL].[2016-04-29]. http://samr. cfda. gov. cn/WS01/CL0087/151716. html.
[4] 2016年溶出度技术及体内外相关性研讨会. 2016年溶出度技术及体内外相关性研讨会论文集[C].天津:2016.
[5]宁保明,何兰,张启明,等.国内外溶出度试验用标准片的研究及应用[J].药物分析杂志,2012,32(8):1509-1515.