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复方杜仲片质量标准研究

Quality standard of Fufanduzhong tablet

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【作者】 梁建宁李波

【Author】 Liang Jian-ning, Li Bo ( Institute of Drug Control of Hunan Province, Changsha 410001; Institute of Drug Management and Supervision of Hunan Province, Changsha 410006)

【机构】 湖南省药品检验所湖南省食品药品监督管理局 长沙 410001长沙 410006

【摘要】 目的 完善复方杜仲片的质量标准。方法 对方中的牛膝、益母草进行TLC鉴别,对黄芩采用HPLC法定量,色谱条件为Kromasil-C18柱,以甲醇-水-磷酸(45;55:0.2)为流动相;检测波长为315 nm;流速1.0 mL·min-1。结果 在选定的薄层条件下,牛膝、益母草的薄层图谱清晰,分离度好。黄芩苷在0.537 66~2.688 μg范围内具有良好的线性关系,其回归方程为:A=39 094.51 C-800.14,r=0.9999。平均回收率为96.5%,RSD=2.1%。结论 实验方法操作简单,可以用来控制本制剂质量。

【Abstract】 OBJECTIVE To improve the quality standard of Fufanduzhong tablet. METHODS Radix achyranthis bidentatae and Herba Leonuri were identified by TLC and the content of Baicalin in Fufanduzhong tablet was determined by HPLC. The chromatographic condition was Kromasil-C18 colume, the mobile phase was methanol-water-phosphoric acid (45 : 55 : 0. 2); the flow rate was 1. 0 mL · min-1; the determined wavelength was 315 nm. RESULTS Radix achyranthis bidentatae and Herba Leonuri were identified successfully by TLC. The standard Baicalin showed a good linear correlation within the concentration of 0. 537 66 - 2. 688 μg, the regress equation was A = 39 094. 51 C-800. 14, r=0. 999 9; the average recovery was 96. 5%, and RSD=2. 1%. CONCLUSIONS The method is simple and able to control the quality of Fufanduzhong tablet.

  • 【文献出处】 中南药学 ,Central South Pharmacy , 编辑部邮箱 ,2004年04期
  • 【分类号】R286
  • 【被引频次】5
  • 【下载频次】276
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