石杉碱甲片溶出度方法的建立 |
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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. |
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作者姓名: | 郑国钢 李会林 |
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作者单位: | 浙江省食品药品检验所,杭州,310004 |
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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。
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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 |
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Authors: | Zheng Guo-gang and Li Hui-lin |
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Institution: | ( Zhejiang Institute for Food and Drug Control, Hangzhou 310004 ) |
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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. |
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Keywords: | Huperzine A Tablets Dissolution HPLC |
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