脱卷积法对盐酸普罗帕酮缓释微丸体内外相关性

Evaluation of in vitro/in vivo correlation for propafenone hydrochloride sustained release pellets using deconvolution method

目的采用脱卷积法进行盐酸普罗帕酮缓释微丸体内外相关性的研究。方法以盐酸普罗帕酮普通片的犬体内血药质量浓度数据为权函数,根据自制盐酸普罗帕酮缓释微丸试验犬体内血药质量浓度数据,采用脱卷积法计算体内释药特性,与相应的体外释药特性进行比较,考察体内外相关性。结果用脱卷积法计算自制盐酸普罗帕酮缓释微丸的体内外释药相关性良好。结论脱卷积法适用于自制盐酸普罗帕酮缓释微丸的体内外相关性研究。

Objective To evaluate the in vitro/in vivo correlation for propafenone hydrochloride sustained release pellets using deconvolution method. Methods The percentage of absorption was calculated by deconvolution method using data of plasma concentration from propafenone hydrochloride sustained release pellets in healthy dogs, which the in vivo dutu of propafenone hydrochloride tablets after oral administration to dogs was used as weight function. It was compared with data of in vitro release to assess the in vitro/in vivo correlations. Results The good correlations of in vitro/in vivo were shown for propafenone hydrochloride sustained release pellets by deconvolution method. Conclusions The deconvolution method exhibits advantage in evaluation of in vitro/in vivo correlation for propafenone hydrochloride sustained release pellets.