蜜炙化橘红饮片的质量标准研究

The Study on the Quality Standard of Honey-processed Citri Grandis Exocarpium

目的:建立蜜炙化橘红饮片的质量标准。方法:按2015年版《中国药典》(四部)相关方法对10批蜜炙化橘红饮片进行性状、显微、薄层鉴别和水分、灰分、浸出物测定,采用高效液相色谱法(HPLC),测定蜜炙化橘红饮片中的柚皮苷和野漆树苷含量。结果:各项鉴别方法专属性强,薄层色谱斑点清晰,分离度良好;拟定蜜炙化橘红水分不得超过8.8%,总灰分不得超过3.2%,水溶性浸出物不得少于53.2%,柚皮苷含量不得少于7.4%,野漆树苷含量不得少于0.9%。结论:该方法稳定性强、专属性高、重现性好,能够用于蜜炙化橘红饮片的质量控制。

objective To establish the quality standard of honey-processed Citri Grandis Exocarpium(CGE).Method:Samples of 10 batches honey-processed CGE from different sources were identified by character,microscopy,TLC and the contents of water,total ashes,extracts were tested according to 2015 edition of Chinese Pharmacopoeia.Then the content of naringin and rhoifolin were measured by HPLC.Results The identification methods have strong specificity.The formulate standard of water and total ashes for honey-processed CGE were no more than 8.8%and 3.2%,respectively.It’s content of water-soluble extracts,naringin and rhoifolin were no less than 53.2%,7.4%and 0.9%,respectively.Conclusion:The method is stable,specific and reproducible,which can be used for quality control of honey-processed CGE.