[关键词]
[摘要]
目的 建立清咽滴丸中没食子酸溶出度的测定方法。方法 采用高效液相色谱法对没食子酸进行测定,遴选溶出条件,计算并绘制出没食子酸累积溶出曲线。采用桨法,转速100 r/min,以蒸馏水为溶出介质。结果 没食子酸在0.01~0.20 μg线性关系良好(r=0.999 9),样品回收率为100.50%,RSD为1.60%。结论 本方法灵敏准确,专属性强,为该制剂的质量控制提供了良好保证。
[Key word]
[Abstract]
Objective To establish a method of dissolution determination of gallic acid in Qingyan Dropping Pills. Methods The content of gallic acid was determined by HPLC. The determination conditions of dissolution were selected, results were calculated, and cumulative dissolution curves were drawn. By slurry method, distilled water was taken as dissolution medium, at speed of 100 r/min. Results The linear range was of 0.01—0.20 μg for gallic acid and the correlation coefficient was 0.999 9. The average recovery was 100.50% with RSD 1.60%. Conclusion: The method is simple, accurate, and could provide good guarantee for the quality control of the preparation.
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[基金项目]
天津市高等学校科技发展基金计划项目(20060302)