溶出度在药品评价中的作用探讨

发布时间：2018-03-19 01:01

本文选题：溶出度　切入点：有区分力的溶出方法　出处：《中国新药杂志》2015年14期 　论文类型：期刊论文

【摘要】：本文通过对3个仿制药在研发中与原研药溶出曲线对比及体内生物等效性试验结果的分析,阐述溶出度若要作为评价口服固体制剂的重要指标,选择合适的测定方法非常关键。溶出度方法可分为无区分力、有区分力及有体内预测力的溶出方法(即临床相关的溶出方法)。只有经人体药代数据证明具有体内预测能力的溶出度测定方法,才能用体外溶出曲线对比研究结果来预测仿制药与原研药在体内是否等效或变更前后的产品是否等效。而有区分力的溶出度方法一般仅用于监测同一企业的产品在日常生产中是否会在原辅材料质量与制剂生产工艺等方面发生不可预测的变化,如果用于比较不同企业产品质量则应慎重。
[Abstract]:In this paper, by comparing the dissolution curves of three generic drugs with those of the original one and analyzing the results of bioequivalence test in vivo, the dissolution of three generic drugs is described as an important index for evaluating oral solid preparations. It is very important to select the appropriate method of determination. The dissolution method can be classified as nondiscriminant. Dissolution methods with distinguishing and in vivo predictive power (I. e., clinically relevant dissolution methods). Only dissolution methods that are proven to have in vivo predictive capacity by human pharmacological data, In order to predict whether the generic drug is equivalent to the original drug in vivo or whether the product before and after the change is equivalent or not, the dissolution curve in vitro can be used to predict whether the product is equivalent or not. The discriminative dissolution method is generally only used to monitor the products of the same enterprise. Whether there will be unpredictable changes in the quality of raw and auxiliary materials and in the production process of preparations in daily production, If used to compare the quality of different enterprises, we should be careful.
【作者单位】：国家食品药品监督管理总局药品审评中心;上海安必生制药技术有限公司;
【分类号】：R95;F203

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