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中文摘要：
目的为新制剂毒热清颗粒建立质量标准。方法对制剂中连翘、紫花地丁、甘草采用薄层色谱（TLC）法进行定性鉴别;采用高效液相色谱法（HPLC）测定毒热清颗粒中黄芩苷、绿原酸的含量。色谱柱为Agilent ZORBAX XDB-C18柱（4.6mm×150mm,5μm）,流动相甲醇-0.4%磷酸（梯度洗脱）,流速1.0mL/min,检测波长为316nm,柱温25℃。结果连翘、紫花地丁、甘草的TLC图斑点清晰,分离度好。黄芩苷、绿原酸检测进样量线性范围分别为0.4764-2.382μg（r=0.9999）,0.4216-2.108μg（r=0.9999）,加样回收率分别为98.8%（RSD=1.5%）,99.1%（RSD=1.1%）,精密度、重复性、稳定性实验的RSD〈2%,n均为6。结论所建质量控制方法科学合理,可作为毒热清颗粒的质量标准。
英文摘要：
Objective To establish quality standard of new preparations of dureqing granule. Methods Forsythia,Violet,Licorice in dureqing granule were identified by TLC.The contents of baicalin and chlorogenic acid were determined by HPLC,which was performed on an Agilent ZORBAX XDB-C18 column（4.6mm×250mm,0.45μm）with a mobile phase methanol-0.4% phosphoric acid（gradient elution）,at a flow rate of 1.0mL/min.The detection wavelength was 316 nm,with column temperature 25℃. Results Chromatographic characteristics of qualitative identification were evident.The linear range of baicalin was 0.4764 - 2.382μg（r=0.9999） and the average recovery rate was 98.8%（RSD=1.5%）.The linear range of chlorogenic acid was 0.4216 - 2.108μg（r=0.9999） and the average recovery rate was 99.1%（RSD=1.1%）. RSDs of precision, stability and reproducibility tests were lower than 2.0%（n=6）. Conclusion The method of qualitative and quantitative analysis is accurate,feasible and suitable for effective quality control of dureqing granule.
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