己酮可可碱缓释胶囊的研制及其体外释药特性考察

Pentoxifylline Modified Release Capsules' Preparation and Its in Vitro Drug Release Characteristics

目的:制备己酮可可碱(PTX)缓释胶囊,并考察其体外释药特性。方法:运用正交设计法对处方组成及制备工艺进行筛选 和优化;采用紫外分光光度法测定制剂中PTX的含量。结果:优选出的最佳处方及制备工艺为PTX200mg、羟丙基甲基纤维素 90mg、硬脂酸60mg、硬脂醇50mg、80℃流化25min;PTX检测浓度在1．0-10．0μg／ml范围内与吸收度呈良好线性关系 (r=0．9 995),平均回收率为101．24％,RSD=1．27％(n=6)。结论:优选得到的工艺简便易行,所制备的PTX缓释胶囊稳定性 好,体外试验具有明显的缓释特性。

OBJECTIVE： To prepare pentoxifylline（PTX） modified release capsule and to investigate its in vitro drug release characteristics. METHODS： The orthogonal design was adopted to optimize the formula and the preparation technics; and the contents of PTX were determined by UV spectrophotometry. RESULTS： The optimized formula and preparation technics were as follows： PTX 200mg, hydroxy propyl methylcellulose 90mg, stearic acid 60mg, octadecyl alcohol 50mg, fluidization for 25min at 80℃ ;PTX assumed linear relationship with absorbability at the range of 1.0-10.0μg/ml（ r = 0.9 995）, the average recovery was 101.24% , RSD = 1.27% （n = 6） . CONCLUSION： The optimized technics is simple and easy to handle; PTX modified release capsules prepared in the technics were of good stability and which have an obvious in vitro slow - release property.