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石杉碱甲片溶出度方法的建立
引用本文:郑国钢,李会林.石杉碱甲片溶出度方法的建立[J].中国药品标准,2010,11(4):251-253.
作者姓名:郑国钢  李会林
作者单位:浙江省食品药品检验所,杭州,310004
摘    要: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。

关 键 词:石杉碱甲片  溶出度  高效液相色谱法

Study on Dissolution Method of Huperzine A Tablets
Authors:Zheng Guo-gang and Li Hui-lin
Institution:( Zhejiang Institute for Food and Drug Control, Hangzhou 310004 )
Abstract: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.
Keywords:Huperzine A Tablets  Dissolution  HPLC
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