石杉碱甲片溶出度方法的建立

Study on Dissolution Method of Huperzine A Tablets

目的：建立石杉碱甲片的溶出度检查方法。方法：以盐酸溶液（9→1000）100mL为溶出介质，转速为50r·min^-1，取样时间为30min。采用溶出度第三法测定。结果：石杉碱甲在0．13—1．02μg·mL^-1的浓度范围内，线性关系良好。线性方程为：A=103．95C-0．15（γ=1．0）；平均回收率为99．0％（RSD=2．0％）；6批样品30min平均溶出度均在80％以上。结论：本方法简便、准确、重现性好，可用于石杉碱甲片的质量控制。

Objective ：To establish a method for the determination of dissolution of Huperzine A Tablets. Methods： Hydrochloric acid solution（9→1000） was taken as solvent with the rotating speed at 50 r·min^-1, and the sampling time was 30 min. The dissolution of Huperzine A Tablets was determined by dissolution test method 3. Results：The standard curve of Huperzine A as a good linear rela- tionship in the range of 0. 13- 1.02μg · mL^- 1 （ r = 1.0, n = 6）. The average recovery was 99. 0% （ RSD = 2. 0%, n = 9 ）. The mean cumulative dissolutions of six batches of samples were above 80%. Conclusion：The method is simple, accurate and reproducible, and can be used for the quality control of this preparation.