元胡止痛分散片的制备及质量标准研究

目的:制备元胡止痛分散片并制订制剂的质量标准。方法:用二氧化碳超临界流体萃取法(CO2-SFE)提取元胡和白芷药材的有效成分,加入适当辅料制备元胡止痛分散片;以薄层色谱鉴别元胡和白芷药材,以高效液相色谱法测定有效成分的含量。结果:确立了CO2-SFE提取药材的工艺指标及分散片的制备方法,建立了药材鉴别的薄层色谱条件及延胡素乙素和欧前胡素含量测定的高效液相色谱方法。结论:药材提取方法先进,分散片制备工艺稳定、可控,质量标准可行。

Study on Preparation and Quality Standard of Yuanhuzhitong Dispersible Tablet

Objective: To prepare the Yuanhuzhitong dispersible tablet and establish its quality control standard. Method; Coryd alis yanhusuo W. T. wang and angelica dahurica were extracted by CO2 supercritical fluid extraction (CO2-SFE) , then the extractions were prepared into Yuanhu Zhitong Dispersible Tablet. The herbs were idenfiticated by TLC and the contents were determined by HPLC. Result: The methods were established, including CO2-SFE of herbs, preparation technology of dispersible tablets,TLC identification of herbs and content determination methods of tetrahydropalmatine and imperator. Conclusion: The extractions methods of herbs are advanced, the preparation technology is stable and controllable, the quality standard is praticable.