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目的:研制己酮可可碱缓释胶囊,确定其体外释放度测定方法。方法:采用挤出滚圆法制取含药小丸,再对小丸进行缓释包衣,制得缓释小丸。采用紫外分光光度法测定其体外释放度,并进行方法验证。结果:自制缓释胶囊粒间、批间差异小;采用紫外分光光度法测定其体外释放度,线性范围4～20μg·ml~(-1),线性方程:A=0.036 1C+0.0009(r=1.0000)。平均回收率为98.8%,RSD=1.4%(n=6)。结论:采用紫外分光光度法测定其体外释放度方便、快速、准确。
Objective: To develop pentoxifylline sustained-release capsules and to determine its in vitro release. Methods: Drug-containing pellets were produced by extrusion-spheronization method, then the pellets were coated with sustained-release tablets to prepare sustained-release pellets. The in vitro release was determined by UV spectrophotometry and the method was validated. Results: The self-made sustained-release capsules showed a small difference between the two groups. The in vitro release was determined by ultraviolet spectrophotometry with a linear range of 4 ~ 20μg · ml -1. The linear equation was A = 0.036 1C + 0.0009 (r = 1.0000). The average recovery was 98.8%, RSD = 1.4% (n = 6). Conclusion: It is convenient, rapid and accurate to determine the in vitro release by ultraviolet spectrophotometry.