和胃颗粒质量标准研究

Quality standards for Hewei granules

目的建立和胃颗粒的质量标准。方法采用TLC法定性鉴别处方中半夏、甘草、人参、黄连、干姜含量;采用HPLC法测定黄芩苷的含量。色谱柱为Agilent TC-C18（4.6 mm×250 mm,5μm）;以乙腈为流动相A、0.1%磷酸溶液为流动相B,按规定进行梯度洗脱;检测波长为280 nm;流速1.0 m L/min;柱温25℃。结果 5种成分的薄层定性鉴别分离、专属性均较好;黄芩苷在0.070 26-1.053 86μg范围内线性关系良好（r=0.9999）,平均加样回收率为99.7%,RSD为1.01%（n=6）。结论本方法可以较好地控制该制剂的质量。

Objective To establish the quality standard for Hewei granules.Methods Pinellia ternata Liquorice,Ginseng,Coptis chinensis and Rhizoma zingiberis were identified by TLC and the contents of baicalin were determined by RP-HPLC.The chromatography conditions were as follows：Agilent TC-C_（18） column（4.6 mm × 250 mm,5 μm）;the mobile phase consisted of A（acetonitrile） and B（0.1%phosphoric acid） with the column temperature being 25 ℃ and gradient elution;UV detection wavelength was set at 280 nm with the flow rate of 1.0 mL/min.The sample injection was 10μL.Results The method of TLC had good resolution with clear spots,and negative control showed no interference.The good linearity was obtained within the range of 0.070 26 ~ 1.053 86 μg（r =0.999 9） for baicalin,and the average recovery was 99.7%（RSD = 1.01%,n =6）.Conclusion The established method is simple,accurate and sensitive for the the quality control of Hewei granules.