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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。
Objective: To prepare Yuanhu analgesic dispersible tablets and formulate quality standards for the preparations. Methods: The active ingredients of Yuanhu and Baizhi were extracted by CO2-SFE, and the appropriate excipients were added to prepare the Yuanhu Zhitong dispersible tablets. The thin-layer chromatography was used to identify the herbs of Yuanhu and Baiji for high performance liquid chromatography. Method to determine the content of active ingredients. RESULTS: The technical index of CO2-SFE extracted medicinal materials and the preparation method of dispersible tablets were established. The thin-layer chromatographic conditions for the identification of medicinal herbs and the high performance liquid chromatography method for the determination of the content of Yanhurin B and imperatorin were established. Conclusion: The extraction method of medicinal materials is advanced, and the preparation process of dispersible tablets is stable, controllable, and the quality standards are feasible.