五味骨疽拔毒散质量标准研究

Study on the quality standard of Wuwei Guju Badu powder

目的:建立五味骨疽拔毒散的质量评价方法。方法:采用显微鉴别法观察方中山药、生天南星的显微特征;采用薄层色谱法(TLC)对方中冰片和山药进行定性鉴别;采用返滴定法测定方中白矾的含量。结果:五味骨疽拔毒散中山药、生天南星的草酸钙针晶显微特征显著;冰片和山药的TLC斑点清晰,分离良好,阴性对照无干扰;返滴定法测定白矾含量的方法学考察符合规范要求,平均回收率为98.90%,相对标准偏差为1.29%(n=6)。结论:建立的显微鉴别、TLC及返滴定法,操作简便、准确、重复性好,可用于五味骨疽拔毒散质量的控制。

Objective:To establish the quality evaluation method of Wuwei GuJu Badu powder.Methods:The microscopical identification was used to observe the microscopical characteristics of Dioscoreae Rhizoma and unprocessed Arisaematis Rhizoma.Thin layer chromatography(TLC)was applied to qualitatively identify Borneolum Syntheticum and Dioscoreae Rhizoma.Residual titration was employed to determine the content of Alumen.Results:The microscopical characteristics of needle-like calcium oxalate crystals in Dioscoreae Rhizoma and unprocessed Arisaematis Rhizoma were obvious.The TLC spots of Borneolum Syntheticum and Dioscoreae Rhizoma were clear and separated well,and the negative control had no interference.The method evaluation of residual titration for Alumen content met the requirements of the standards,with average recovery rate of 98.90%and relative standard deviation of 1.29%(n=6).Conclusions:The established method of microscopical identification,TLC and residual titration is simple,accurate and reproducible,which can be used for the quality control of Wuwei GuJu Badu powder.