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通过记录pH值来表征酸酐-酸共聚物及其盐衍生物的组成并监测其溶解曲线的方法。

Recording pH method of characterizing composition and monitoring dissolution profile of an anhydride-acid copolymer and its salt derivatives.

作者信息

Mo Y, Peck G E, Heyd A, Banker G S

出版信息

J Pharm Sci. 1977 May;66(5):713-7. doi: 10.1002/jps.2600660527.

Abstract

A sensitive potentiometric monitoring method was developed that permits the continuous measurement of the disolution profiles of methyl vinyl ether-maleic anhydride-acid copolymers and salt derivatives. Three distinct rate periods were observed in the dissolution rate of the anhydride copolymer, expressed as percent anhydride dissolved, was independent of sample weight over the weight range studied. The acid form of the copolymer showed only one dissolution rate period, with dissolution being very rapid. The rapid initial pH decrease observed during the first stage of dissolution for a series of anhydride-acid copolymer powder samples correlated closely with the anhydride-acid ratio, permitting chemical characterization of the copolymer functionality simultaneously with the analysis of dissolution profiles. Similarly, the extent of copolymer alkaline salt conversion was inversely proportional to the initial maximum pH increase observed during the first stage of dissolution of these salts. Mechanisms of dissolution of copolymer powder materials are discussed and compared to the dissolution of compressed disks and films reported previously.

摘要

开发了一种灵敏的电位监测方法,该方法能够连续测量甲基乙烯基醚-马来酸酐-酸共聚物及其盐衍生物的溶出曲线。在酸酐共聚物的溶解速率中观察到三个不同的速率阶段,以溶解的酸酐百分比表示,在所研究的重量范围内,其与样品重量无关。共聚物的酸形式仅显示一个溶解速率阶段,溶解非常迅速。在一系列酸酐-酸共聚物粉末样品溶解的第一阶段观察到的初始pH值快速下降与酸酐-酸比例密切相关,从而在分析溶出曲线的同时能够对共聚物官能团进行化学表征。同样,共聚物碱性盐的转化程度与在这些盐溶解的第一阶段观察到的初始最大pH值升高成反比。讨论了共聚物粉末材料的溶解机制,并与先前报道的压缩盘和薄膜的溶解情况进行了比较。

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