姜香安胃软胶囊质量标准研究

Quality Standard Study on Jiangxiang Anwei Soft Capsules

    摘要
  • 摘要: 目的 建立中药复方制剂姜香安胃软胶囊（高良姜、木香、干姜）的质量标准控制方法。方法 采用薄层色谱法对本品中的高良姜、干姜、木香进行定性鉴别；用高效液相色谱法测定制剂中木香烃内酯、去氢木香烃内酯的含量。结果 木香烃内酯在0.103～1.030 μg(r=0.999 5，n=7）范围内线性良好，平均回收率为97.27%，RSD=1.10%；去氢木香烃内酯在0.126～1.260μg(r=0.999 6，n=7）范围内线性良好，平均回收率为97.90%，RSD=1.05%。结论 该方法准确、可靠，可用于控制姜香安胃软胶囊的质量。

     

    Abstract: OBJECTIVE To establish the controlling methods for quality standard of jiangxiang Anwei Soft Capsules(Rhizoma Alpiniae Officinari， Rhizoma Zingiberis， Radix Aucklandiae).METHODS Rhizoma Alpiniae Officinari， Rhizoma Zingiberis， Radix Aucklandiae were identified by thin-layer chromatography(TLC). The contents of costunolide and dehydro-costunolide were determined by High Performance Liquid Chromatography (HPLC) together. RESULTS Consimilitude showed a good linear relationship at the range of 0.103～1.030 μg( r=0.999 5，n=7），the average recovery was 97.27%， RSD was 1.10%;Dehydro-costunolide showed a good linear relationship at the range of 0.126～1.260 μg(r=0.999 6，n=7）， the average recovery was 97.90%，and RSD was 1.05%.CONCLUSION This method is accurate， reliable， and can be used for quality control of Jiangxiang Anwei Soft Capsule.

     

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