清热凉血标准汤剂质量标准研究

Study on Quality Control of Qingre Liangxue Decoction

目的测定清热凉血标准汤剂中两种指标性成分的含量,建立相应标准用于评价该标准汤剂的质量和制备工艺。方法含量测定采用HPLC法,采用Waters Xbridge C_(18)色谱柱(4.6×250mm,5μm),0.1%磷酸水溶液(v/v)-乙腈为流动相,梯度洗脱,流速1.0mL·min^(-1),柱温30℃,进样量10μL,检测波长300nm;以黄芩苷和绿原酸为指标性成分,对10批次药材制备的标准汤剂进行含量测定研究,确定上述成分的含量限度范围并对标准汤剂的煎煮时间、煎煮次数和水量进行评价,以优选制备工艺。结果 10批标准汤剂中,绿原酸的含量范围为0.811～0.974mg·mL^(-1),黄芩苷的含量范围为1.303～1.664mg·mL^(-1);标准汤剂采用30倍水(相当于药重)煎煮2次,1次60min时,提取效率最佳。结论本研究所用方法快速、科学、高效,能够准确评价清热凉血标准汤剂的质量和制备工艺。

OBJECTIVE To determine contents of two index compounds in QingreLiangxue standard decoction,and establish standard to evaluation its quality and preparation technique.METHODS Content determination used HPLC method,an Waters Xbridge C18 column(4.6×250 mm,5μm)was applied,with a mobile phase containing 0.1%phosphoric acid and acetonitrile in gradient elution,the flow rate was 1.0 mL·min^-1,column temperature was 30℃,the injection volume was 10μL and the detection wavelength was 300 nm;baicalin and chlorogenic acid were used as indexes;10 batches of standard decoction prepared by different batches ingredients were determined to establish content limits of the above mentioned compounds,as well as evaluate parameters such asduration,cycle and water volume of the decoction.RESULTS In 10 batches of standard decoctions,chlorogenic acidcontent was in the range of 0.811-0.974 mg·mL^-1,and that of baicalin was 1.303-1.664 mg·mL^-1;its preparation obtained optimum efficiency using 15 times of water(vs ingredient weight)for 2 cycles and 60 min per cycle.CONCLUSION The method used in this study was fast,scientific and efficient,which was capable of evaluating quality and preparation technique of Qingre Liangxue standard decoction.