论文部分内容阅读
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 tacrolimus dispersible tablets and establish a method for the determination of its dissolution. Methods: The dissolution of tangtsenin B in nogosulin dispersible tablets was determined by high performance liquid chromatography. The column was Kromasil C18 (250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-water (40:60), the detection wavelength was 290 nm, the flow rate was 1.0 ml · min-1 and the column temperature was 30 ℃. The amount is 100 μl. Results: Stevioside had a good linear relationship with the peak area in the range of 0.005-0.057 μg (r = 0.999 6), and the average recoveries ranged from 95% to 105%. The p H 6.8 phosphate solution was used as the dissolution medium for dissolution of tuberculin dispersible tablets. Conclusion: The method for the determination of dissolution rate of TBL dispersible tablets is simple, accurate and specific. It can be used for the quality control of this preparation.