清热养胃合剂的质量标准

Quality Standards of Qingre Yangwei Mixture

目的：建立清热养胃合剂质量控制方法。方法：采用薄层色谱法对制剂中牛至、金莲花进行鉴别,其中牛至的薄层色谱鉴别采用咖啡酸为对照品,以甲苯-乙酸乙酯-甲酸（10∶7.5∶1）为展开剂;金莲花的薄层色谱鉴别采用芦丁为对照品和金莲花对照药材,以乙酸乙酯-甲酸-水（8∶1∶0.8）为展开剂。采用紫外分光光度法测定总黄酮的含量,高效液相色谱法测定芦丁的含量。结果：清热养胃合剂中的牛至、金莲花的薄层色谱具有鉴别特征、斑点清晰,与相应对照品均呈相同的鉴别反应;总黄酮含量测定中芦丁在0.134~0.670 mg线性关系良好（r=0.999 9）,平均回收率98.42%,RSD 1.2%。含量测定中芦丁在0.400~4.000μg有良好的线性关系（r=0.999 9）,平均加样回收率为98.91%,RSD 1.2%。结论：鉴别方法专属性强、灵敏度高;定量方法简便快速、结果准确且重复性好,可用于控制清热养胃合剂的质量。

Objective： To establish the method for quality control of Qingre Yangwei mixture. Method：The ingredients of Origani Herba and Trollii altaici Flos were identified by thin layer chromatography（ TLC）.Methylbenzene-ethyl aceate ethyl ethanoate-formic acid（ 10 ∶ 7. 5 ∶ 1） was used as developing solvent in the TLC identification of Origani Herba,with caffeic acid as the control product; ethyl aceate ethyl ethanoate-formic acidwater（ 8∶ 1∶ 0. 8） was used as developing solvent in the TLC identification of T. altaici Flos,with rutin and crude T. altaici Flos as the control products. The content of total flavonoids was determined by ultraviolet spectroscopy,and the content of rutin was determined by high performance liquid chromatography（ HPLC）. Result： The TLC method of Origani Herba and T. altaici Flos from Qingre Yangwei mixture had identification characteristics with clear spots,and showed the same identifying reaction with the control products. In the determination of total flavonoids content,the good linear range was 0. 134-0. 670 mg for rutin（ r = 0. 999 9）,with an average recovery rate of 98. 42% and RSD of 1. 2%. In the contents determination,the good linear range was 0. 400-4. 000 μg for rutin（ r = 0. 999 9）,with an average recovery rate of 98. 91% and RSD of 1. 2%. Conclusion： This identification method is selective and sensitive. The quantitative method is simple,rapid,accurate and reproducible,and can be used to control the quality of Qingre Yangwei mixture.