溃结灵片的制备工艺及质量标准研究

    Study on preparation technology and quality standard of Kuijieling tablet

    • 摘要: 目的:研究溃结灵片的制备工艺及质量标准。方法:单因素试验考察溃结灵片的制备工艺;通过薄层色谱法对处方中五味药材进行定性鉴别;高效液相色谱法对白术内酯Ⅰ和Ⅲ进行定量测定。结果:确定溃结灵片的处方:崩解剂为L-HPC和PVPP各8%,黏合剂为95%的乙醇溶液,润滑剂为0.25%硬脂酸镁。薄层鉴别图谱斑点清晰,分离度好。白术内酯Ⅰ和Ⅲ分别在0.012 5~0.112 5 μg/mL和0.024 5~0.220 5 μg/mL内线性关系良好。溃结灵片成品各项检查均符合药典要求。结论:该处方工艺科学、合理,建立的质量标准方法可行。

       

      Abstract: Objective: To study the prescription,preparation technology and quality standard of Kuijieling tablet.Methods: Single factor experiments were used to investigate the important factors affecting the process of tablet forming;the five herb medicine in this prescription were identified by thin layer chromatography(TLC) and atractylenolide Ⅰand atractylenolide Ⅲ were quantitatively determined by high performance liquid chromatography.Results: The formula for determining the core of Kuijieling was as follows:Disintegration agent was L-HPC and PVPP each 8%,the binder was 95% ethanol solution,and the lubricant was 0.25% magnesium stearate;spots in the TLC chromatogram for qualitative identification of the five herb medicine were clear and the resolution was high.AtractylenolideⅠshowed a good linear relationship in the range of 0.024 5-0.220 5 μg/mL and atractylenolide Ⅲ showed a good linear relationship in the range of 0.012 5-0.112 5 μg/mL.The results of the various examinations on Kuijieling colon specific tablets were all in line with the requirements of the Pharmacopoeia.Conclusions: The prescription process is scientific and reasonable.The established quality standard method is feasible.

       

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