自制单硝酸异山梨酯缓释胶囊的体外释放度考察

Study on in vitro Release of Self-made Isosorbide Mononitrate Sustained-release Capsules

目的：建立自制单硝酸异山梨酯缓释胶囊释放度测定方法并与对照品比较释放行为。方法：采用篮法，以水500ml为释放介质，转速为50r／min；采用高效液相色谱法测定含量，色谱柱为VenusilMP C18，流动相为甲醇．水（37：63），检测波长为220nm;以相似因子法评价自制品与对照品的释放相似性，同时对两种制剂进行释放模型的拟合。结果：单硝酸异山梨酯检测质量浓度线性范围为20～140μg／ml（r=0．9999），平均回收率为99．86％（RSD=0．17％，n=3）；两种制剂相似因子大于50，体外释放模型拟合更接近Higuchi方程。结论：建立的释放度测定方法操作简便、准确；自制品与对照品比较具有相似的体外释放特征。

OBJECTIVE： To establish a determination method for release rate of self-made Isosorbide mononitrate sustained-re- lease capsules, and compare release behavior with reference preparation. METHODS： Basket method was adopted with water 500 ml as dissolution medium and rotation speed of 50 r/min. HPLC method was carried out on venusil MP C18 column using metha- nol-water （37：63） as mobile phase. The detection wavelength was set at 220 nm. Similar factor method was used to evaluate the similarity of release between self-made preparation and reference preparation; release model of two preparations were fitted. RE- SULTS： The linear range of isosorbide mononitrate were 20-140 μg/ml （r=0.999 9） with an average recovery of 99.86% （RSD= 0.17%, n=3）; similar factorfi of two preparations was greater than 50; the fitting of in vitro release model was close to Higuchi equation. CONCLUSIONS： Established method is simple and accurate; self-made preparation is similar to reference preparation in release characteristics in vitro.