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片剂中药物的溶出曲线

Dissolution profiles of drugs from tablets.

作者信息

Kitamori N, Iga K

出版信息

J Pharm Sci. 1978 Oct;67(10):1436-9. doi: 10.1002/jps.2600671030.

Abstract

A theoretical equation to describe the drug dissolution from a tablet was derived by combining and equation for the disintegration rate of a tablet with an equation for the dissolution of particles. The theory is based on the assumptions that: (a) dissolution occurs only from the particles released in a medium by tablet disintegration, (b) the number of particles released into a medium obeys the equation N = NO(T/Td)m, and (c) the dissolution of particles, which are spherical in shape, is represented by the equation previously given by Brooke. Tablet dissolution versus time plots, obtained by calculating the equation with a computer, gave an S-shaped curve between the dissolution curve for particles starting at time zero and the curve for particles starting at the tablet disintegration time. The joint influences of disintegration and particle dissolution on the overall tablet dissolution profile also were examined. When dissolution of powders was rapid, disintegration of a tablet directly influenced its dissolution. When powders intrinsically dissolved slowly, the effect of disintegration on the tablet dissolution profile was slight.

摘要

通过将片剂崩解速率方程与颗粒溶解方程相结合,推导出了一个描述片剂药物溶解的理论方程。该理论基于以下假设:(a) 溶解仅发生在片剂崩解后释放到介质中的颗粒上;(b) 释放到介质中的颗粒数量服从方程N = NO(T/Td)m;(c) 形状为球形的颗粒的溶解由布鲁克先前给出的方程表示。通过计算机计算该方程得到的片剂溶解与时间关系图,在从时间为零开始的颗粒溶解曲线和从片剂崩解时间开始的颗粒溶解曲线之间给出了一条S形曲线。还研究了崩解和颗粒溶解对整体片剂溶解曲线的联合影响。当粉末溶解迅速时,片剂的崩解直接影响其溶解。当粉末本身溶解缓慢时,崩解对片剂溶解曲线的影响很小。

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