结核灵分散片的制备及其溶出度测定

Preparation and Dissolution of Jieheling Dispersible Tablets

目的：制备结核灵分散片并建立测定其狼毒乙素溶出度的方法。方法：采用高效液相色谱法测定结核灵分散片中狼毒乙素的溶出度。色谱柱为Kromasil C18（250 mm×4.6 mm,5μm）,流动相为乙腈-水（40∶60）,检测波长为290 nm,流速为1.0 ml·min-1,柱温为30℃,进样量为100μl。结果：狼毒乙素在0.005～0.057μg（r=0.999 6）范围内与峰面积有良好的线性关系,平均回收率均在95%～105%之间。采用p H 6.8磷酸盐溶液为结核灵分散片溶出度的测定介质。结论：结核灵分散片溶出度测定方法简便、准确、专属性强,可用于该制剂的质量控制。

Objective：To prepare Jieheling dispersible tablets and establish the dissolution determination method. Methods：The dissolution of fischeriana B in the tablets was determined by HPLC. The column was Kromasil C18（250 mm ＆#215;4.6 mm,5μm）with ace-tonitrile-water （40∶60） as the mobile phase at a flow rate of 1. 0 ml＆#183;min-1 . The detection wavelength was at 290nm. The column temperature was 30℃ and the sample size was 100 μl. Results： The linear range of fischeriana B was 0. 005-0. 057 μg （ r =0. 999 6）. The average recovery was between 95% and 105%. Phosphate solution with pH of 6. 8 was used as the dissolution medi-um. Conclusion：The method is simple, accurate and specific, and can be used in the quality control of Jieheling dispersible tablets.