硝苯地平长效缓释片释放度的试验研究

Studied on the release rate of long action nifedipine sustained release tablet

目的：采用固体分散法制备了硝苯地平长效缓释片，并测定体外释放度。方法：比较了０．１ｍｏｌ·Ｌ－１ＨＣｌ，ｐＨ６．８磷酸缓冲液，体积分数为２．５％，５％和１０％乙醇溶液对本品释放度的影响。用紫外分光光度法，在３４０ｎｍ波长处测定吸光度。结果：试验结果表明，介质ｐＨ的改变对释放度没有影响，本品在体积分数为５％乙醇溶液中的释放度较合适，２４ｈ累计释放度达９３．１％，本品在体积分数为５％乙醇介质中以５０ｒ·ｍｉｎ－１速度释药与体内吸收速度有较好的相关性（ｒ＝０．９９１７）。

OBJECTIVE:Nifedipine long action sustained release tablet was prepared with solid dispersion,dissolution rate was determined.METHODS:Compared with release rate of the tablet in different dissolution medium,for example 0.1mol·L -1 HCl,pH6.8 PBS,2.5%,5% and 10% alcohol solution.RESULTS:The results showed that 5% alcohol was suitable among the five dissolution mediums,being less affected by pH value of the dissolution medium to release rate of nifedipine from the tablet.The relationships between in vitro dissolution and in vivo absorption indicated that there were good correlations.The correlation coefficients of precent dissolution vs absorption was 0.9917.