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速效抗晕胶囊质量标准研究

         

摘要

Objective To establish quality specifications for Suxiaokangyun Capsules. Methods Zingiber was identified by thin layer chromatography. The content of D-amphetamine sulfate and dimentydrinate was determined by high performance liquid chromatography. Results Zingiber could by specifically identified by thin layer chromatography. The aniount of inlet D-amphetamine sulfate had a good linearity with the response value of the peak area in the range of 244-366 μg/ml( r =0.9999) . The average recovery of D-amphetamine sulfate was 99.54%,RSD was 0.81%. For dimentydrinate, the range was of 0.32-0.48 mg/ml( r = 0. 9999), and the average recovery was 99.56% while RSD was 1.06%. Conclusion The method is reliable,simple,reproducible, and can be used for the quality control of Suxiaokangyun Capsules.%目的 确定速效抗晕胶囊的质量检测标准.方法 采用薄层色谱法定性鉴别干姜提取物,用高效液相色谱法测定硫酸右旋苯丙胺和茶苯海明含量.结果 薄层色谱法鉴别专属性强;高效液相色谱法中,硫酸右旋苯丙胺在244~366μg/ml范围内浓度与吸收度呈良好线性关系(r=0.9999),平均回收率为99.54%,RSD为0.81%;茶苯海明在0.32~0.48mg/ml范围内浓度与吸收度呈良好线性关系(r=0.9999),平均回收率为99.56%,RSD为1.06%.结论 该方法操作简便、可靠、重复性好,可用于速效抗晕胶囊的质量控制.

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