脱卷积法进行自制尼群地平缓释制剂体内外相关性研究

Evaluation of in vitro/in vivo correlation for three kinds of self-designed sustained-release nitrendipine formulations using deconvolution method

目的 用脱卷积法进行自制尼群地平缓释制剂体内外相关性的研究。方法 以自制尼群地平口服溶液剂的犬体内血药浓度数据为权函数,根据3种自制尼群地平缓释制剂试验犬体内血药浓度数据,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3种尼群地平缓释制剂的体内外释药相关性良好。结论 脱卷积法适用于自制尼群地平缓释制剂的体内外相关性研究。

Aim To evaluate the in vitro/in vivo correlation for three kinds of self-designed sustained-release nitrendipine formulations using deconvolution method. Methods The characteristics of in vivo release were calculated by deconvolution method using the data of plasma concentration of three kinds of self-designed sustained-release nitrendipine formulations in healthy dogs, in which the in vivo results of nitrendipine solution after oral administrated to dogs were used as weight function. It was the compared with characteristics of in vitro release to assess the in vitro/in vivo correlations. Results The good correlations of in vitro/in vivo were shown in three kinds of self-designed sustained-release nitrendipine formulations using deconvolution method. Conclusion The deconvolution method exhibited advantage in evaluation of in vitro/in vivo correlation for self-designed sustained-release nitrendipine formulations.