目的 采用HPLC-VWD同時測定清肺湯市售制劑中綠原酸、苦杏仁苷、梔子苷、橙皮苷、黃芩苷、漢黃芩苷、甘草酸銨、五味子醇甲等指標(biāo)成分的含量并建立清肺湯的指紋圖譜，表征與區(qū)分不同來源的清肺湯市售制劑。方法 采用Agilent Technologies Zorbax SB-C₁₈（250 mm×4.6 mm，3.5 μm）色譜柱，以乙腈-0.1%磷酸水溶液為流動相，梯度洗脫，柱溫35℃，體積流量0.6 mL/min，進樣量10 μL，同時對指標(biāo)成分的含量和指紋圖譜進行檢測。采用指紋圖譜相似度評價、熱圖聚類分析等方法，表征與區(qū)分不同來源清肺湯市售制劑。結(jié)果 8種成分專屬性、線性關(guān)系（r²>0.999 8）、精密度（RSD≤1.85%，n=6）、重復(fù)性（RSD≤1.82%，n=6）、穩(wěn)定性（RSD≤1.49%，48 h）均良好；加樣回收率為（93.19±1.93）%～（102.36±4.17）%（n=6）。含量測定結(jié)果顯示清肺湯市售制劑中指標(biāo)成分的每日服用量在不同廠家中波動較大，如黃芩苷的波動范圍59.85～224.05 mg；但在相同廠家的不同劑型中波動不明顯，如港香蘭藥廠2種制劑中黃芩苷質(zhì)量為140.00～142.47 mg；同時指紋圖譜相似度計算結(jié)果均大于0.945，表明不同來源的清肺湯市售制劑指紋圖譜相似度較高。結(jié)論 該方法準確可靠、具有良好的重復(fù)性，可用于測定清肺湯市售制劑中8種成分的含量及建立清肺湯的指紋圖譜，通過成分每日服用量熱圖聚類分析與相似度評價，能表征與區(qū)分不同來源的清肺湯市售制劑。

Objective To simultaneously determinate the content of chlorogenic acid, amygdalin, gardenoside, hesperidin, baicalin, wogonoside, ammonium glycyrrhizate and schisandrin in Qingfei Decoction by HPLC-VWD, and establish the fingerprint of Qingfei Decoction. The results can be applied to characterize and distinguish commercially available Qingfei Decoction preparations from different manufacturers. Methods Agilent Technologies Zorbax SB-C₁₈ (250 mm×4.6 mm, 3.5 μm) column was used, with acetonitrile (A)-0.1% phosphoric acid aqueous solution (B) as the mobile phase for gradient elution, column temperature of 35℃, flow rate of 0.6 mL/min, injection volume of 10 μL. The content of the indicator components and the fingerprints were simultaneously assayed by the above method. Fingerprint similarity evaluation, heat map cluster analysis and other methods were used to characterize and distinguish the commercially available Qingfei Decoction preparations from different sources. Results The specificity, linear relationship (r²>0.999 8), precision (RSD ≤ 1.85%, n=6), repeatability (RSD ≤ 1.82%, n=6), stability (RSD ≤ 1.49%, 48 h) of eight components were good; The recovery rate of the sample was in the range of (93.19±1.93)% to (102.36±4.17)% (n=6). The results of content determination showed that the daily dosage of the indicator ingredients in the marketed Qingfei Decoction preparations fluctuated greatly in different manufacturers, such as baicalin, which fluctuated from 59.85 to 224.05 mg, but the fluctuation was not obvious in different dosage forms of the same manufacturer, for example, the content of baicalin in the two preparations of KPC Herbs was 140.00 to 142.47 mg. At the same time, the similarity calculation results of fingerprints were all greater than 0.945, which indicated that the fingerprints of Qingfei Decoction from different sources were highly similar. Conclusion The method is accurate and reliable with good repeatability. It can be used to determine the content of eight components in the commercial Qingfei Decoction preparations and establish the fingerprint of Qingfei Decoction. The commercial Qingfei Decoction preparations can be characterized by heat map clustering analysis of the daily dosage of the eight components and the fingerprint similarity evaluation to distinguish the commercially available preparations of Qingfei Decoction from different sources.

R283.6

天津市科技計劃項目（18ZXXYSY00140）