目的：建立感冒热毒清合剂的质量标准。方法采用薄层色谱（TLC）法对感冒热毒清合剂中的主要药味连翘、金银花、板蓝根、熟地黄进行定性鉴别。采用高效液相色谱（HPLC）法测定制剂中连翘苷及绿原酸的含量，连翘苷测定时色谱柱为 C18柱(250 mm ×4．6 mm，5μm )，流动相为乙腈－水(76：24)，流速为1．0 mL/min，柱温为30℃，检测波长为277 nm；绿原酸测定时色谱柱为C18柱(250 mm ×4．6 mm，5μm )，流动相为乙腈－0．4%磷酸(88：12)，流速为1．0 mL/min，柱温为40℃，检测波长为327 nm。结果连翘、金银花、板蓝根与熟地黄的TLC图斑点清晰、分离较好，阴性对照无干扰。连翘苷质量浓度在6．88~137．6μg/mL范围内与峰面积呈良好的线性关系（ r=0．9992），绿原酸质量浓度在5．02~100．4μg/mL范围内与峰面积呈良好的线性关系（ r=0．9995）。连翘苷的平均回收率为99．30%，绿原酸的平均回收率为101．93%（ n=9）。结论该方法简便，结果准确，重复性好，可作为感冒热毒清合剂的质量评价方法。%Objective To establish the quality standard of Ganmaoreduqing Mistura. Methods The chief components of the preparation, Forsythiae fructus, Lonicerae japonicae flos, Isatidis radix, Rehmanniae radix were identified by TLC qualitatively. The content of phillyrin and chlorogenic acid in mistura was determined by HPLC with a SHISEIDO CAPCELL PAK MG-C18 column(250 mm×4.6 mm,5 μm), acetonitrile-water ( 76:24 ) was used as mobile phase and the flow rate was 1. 0 mL/min. The columm temperature was set at 30℃and the wavelength of the detector was set at 277 nm. The content of chlorogenic acid in mistura was determined by HPLC with a SHISEIDO CAPCELL PAK MG-C18 column ( 250 mm × 4. 6 mm, 5 μm ) , acetonitrile-0. 4% phosphoric acid ( 88:12 ) was used as mo-bile phase and the flow rate was 1. 0 mL/min. The columm temperature was set at 40 ℃ and the wavelength of the detector was set at 327 nm. Results The spots in the TLC figure of the Arabesques of forsythia, flos lonicerae, radix isatidis and rehmannia glutinosa were clear, better separated, and no negative control interference. The linear range for phillyrin was 6. 88-137. 6 μg/mL ( r=0. 999 2 ) , and the linear range for chlorogenic acid was 5. 02-100. 4 μg/mL ( r=0. 999 5 ) . The average recovery for phillyrin were 99. 30%, and the average recovery for chlorogenic acid were 101. 93% ( n=9 ) . Conclusion The method is accurate, reproducible and suitable, which can be used for quality assessment of Ganmaoreduqing Mistura.
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