水渗透对速崩制剂崩解作用的研究

Contribution of water uptake on disintegration of rapidly disintegrating tablets

目的 :探讨崩解剂以及速崩片的吸水动力学过程对片剂崩解的影响。方法 :按照文献设计吸水装置 ,分别测定各种崩解剂以及它们用于微晶纤维素 /乳糖片的吸水过程 ,并进行统计学处理 ,得到吸水特性常数 ,与片剂崩解时间进行比较 ,以确定水渗透与崩解的关系。结果 :崩解剂的亲水性对高硬度片剂的崩解有显著影响 ,而对低硬度片剂的崩解影响不显著。结论 :崩解剂以及片剂的吸水滞后时间是影响片剂崩解效果的主要因素之一。

OBJECTIVE:To study the role of water uptake of disintegrants and rapidly disintegraing tablets on disintegration.METHODS:The measurement of water uptake by disingtegrants or microcrystalline cellulose/lactose tablets was designed according to a reference.The kinetic constant of water uptake which was determined by statistics analysis was compared to the disintegrated time of tablets to define the relationship between water uptake and disintegration.RESULTS:The disintegration of low hardness tablets would mostly depend on the porosity (pore size and distribution) of tablets,And the disintegration of highhardness tablets would mostly depend on the hydrophilicity of tablet ingredients.The correlation existed between the disintegrated time and the lag time of water uptake of tablets.CONCLUSION:The lag time of water uptake of disintegrants of tablets could be helpful in evaluating disintegrated effect of disintegrants.