越多索茶碱干糖浆的制备及质量控制

目的:制备多索茶碱干糖浆并建立质量控制方法。方法:以多索茶碱为主要成分制备制剂,测定pH、干燥失重,以及用HPLC法测定有关物质和含量。结果:所制备的干糖浆为白色颗粒,检查符合中国药典2010年版相关规定,多索茶碱检测浓度线性范围10～83μg/ml(r=0.9999),在低、中、高3个浓度(n=3)的回收率分别为99.50%、100.03%和99.52%。RSD分别为0.41%、0.56%和0.31%。结论:该制剂制备工艺可行,质量可控。

Objective:To prepare doxofylline Dry Syrup and primarily discuss to its quality contro1.Methods:The Dry Syrup were prepared with doxofylline and the pH,Loss on drying etc were determined,The related substances and content was determined by high performance liquid chromatography.Results:The preparation was White particles with its property up to the standard stated in Chinese pharmacopeia(2010 Edition).The linear range of doxofylline was 0.01～0.08mg/ml(r=0.9999) and its average recoveries of high,middle and low concentrations were99.52 %,100.03% and 99.50% with RSD were 0.49%,0.22% and 0.30% respectively.Conclusion:The preparation process was proved to be feasible and the quality of the preparation was controllable.