目的 建立银菊解毒口服液（YJOL）药材原液-半成品-成品的指纹图谱，并进行多成分定量分析，为产品及其生产工艺过程质量控制提供有效方法与依据。方法 采用岛津Inert Sustain C₁₈色谱柱（250 mm×4.6 mm，5 μm），以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱，体积流量1.0 mL/min，波长240、327、334、280 nm，柱温30 ℃。对12批药材原液、半成品、成品进行测定，分别建立相应的HPLC指纹图谱，并对三者间进行全谱的相似度评价及共有图谱拟合，同时对指纹图谱中特征共有峰进行指认及定量分析。结果 各批次药材原液（共有峰15个）、半成品（共有峰15个）、成品（共有峰13个）各自相似度均在0.9以上，质量稳定；药材原液与半成品及成品三者间相似度大于0.9，相关性较好；YJOL成品指纹图谱中，1号峰主要来源于板蓝根药材；2~7号峰来源于川银花和野菊花药材；8、9号峰主要来源于野菊花药材；10、11号峰来源于玄参药材；12、13号峰主要来源于补骨脂药材。通过比对特征峰保留时间，指认出6种主要成分，分别为R，S-告依春（1号峰）、绿原酸（3号峰）、蒙花苷（10号峰）、哈巴俄苷（11号峰）、补骨脂素（13号峰）、异补骨脂素（14号峰），6种成分在药材原液中质量分数平均值分别为39.21、15.43、2.14、0.53、7.21、6.51 mg/g，在半成品中质量分数平均值分别为35.31、11.54、1.83、0.37、4.95、4.74 mg/g，在成品中质量分数平均值分别为32.87、10.58、1.72、0.31、4.58、4.48 mg/g。结论 同时对YJOL药材原液-半成品-成品进行指纹图谱和6个指标成分分析，可有效地用于YJOL生产过程的质量控制和产品的质量评价。

Objective To establish the HPLC fingerprint of liquid of raw material-intermediate product-Yinju Jiedu Oral Liquid (YJOL), and to determine the multi-components in YJOL, thus to provide an approach and basis for the quality control in production. Methods The separation was performed on Shimadzu Inert Sustain C₁₈ columin (250 mm × 4.6 mm, 5 μm) with mobile phase composed of acetonitrile-0.1% phosphoric acid solution (gradient elution) at the flow rate of 1.0 mL/min, the column temperature was set at 30 ℃ and the detection wavelengths were set at 240, 327, 334, and 280 nm. HPLC fingerprints of the extracts from 12 batches of raw material, intermediate product, and YJOL were established and compared. The content was determined and the common peaks were identified, and some of the characteristic peaks were analyzed. Results Fifteen common peaks of intermediate product and liquid of raw material and 13 common peaks in YJOL were determined. The similarities of YJOL were over 0.9, the same with the similarities of the liquid of raw material and intermediate product. The correlation was good between the extracts from the liquid of raw material, intermediate product and YJOL. Peak 1 was from Isatidis Radix, peaks 2-7 were from Honeysuckle of Sichuan and Chrysanthemum indicum, peaks 8 and 9 were from Chrysanthemum indicum, peaks 10 and 11 were from Scrophulariae Radix, peaks 12 and 13 were from Scurfpea fruit. Based on the retention time of master compounds, six components [R,S-epigoitrin (peak 1), chlorogenic acid (peak 3), linarin (peak 10), harpagoside (peak 11), psoralen (peak 13), and psoralen (peak 14)] were identified and quantified. The average contents of six components were 39.21, 15.43, 2.14, 0.53, 7.21, and 6.51 mg/g in raw material, were 35.31, 11.54, 1.83, 0.37, 4.95, and 4.74 mg/g in intermediate product, and were 32.87, 10.58, 1.72, 0.31, 4.58, and 4.48 mg/g in YJOL. Conclusion This validated method is suitable for the quality evaluation and quality control of YJOL.

四川省科技支撑项目（2014SZ0140）