目的 建立小儿退热洗剂HPLC指纹图谱，并测定其中10种成分（新绿原酸、绿原酸、隐绿原酸、咖啡酸、连翘酯苷A、异绿原酸B、异绿原酸A、异绿原酸C、迷迭香酸、连翘苷）的含量。方法 采用Kromasil 100-5 C₁₈（250 mm×4.6 mm，5 μm）色谱柱，以0.1%磷酸水溶液-乙腈为流动相，梯度洗脱，体积流量1 mL/min，柱温35℃，检测波长330 nm，以连翘酯苷A为参照峰，建立11批样品的HPLC指纹图谱；基于指纹图谱色谱条件，在330、280 nm检测波长下测定10种主要成分含量，并对11批制剂进行多指标含量测定。结果 建立了HPLC指纹图谱，共标定22个共有峰，指认出13个色谱峰，11批制剂相似度在0.987～0.999。新绿原酸、绿原酸、隐绿原酸、咖啡酸、连翘酯苷A、异绿原酸B、异绿原酸A、异绿原酸C、迷迭香酸、连翘苷分别在14.18～141.78、20.53～205.63、14.38～143.78、5.62～56.19、22.22～222.22、8.40～83.98、5.70～57.02、7.46～76.36、16.95～169.48、8.59～85.94 μg/mL线性关系良好，平均加样回收率分别为109.51%、98.73%、99.41%、90.63%、92.73%、95.39%、91.87%、106.50%、95.23%、108.71%。11批制剂中新绿原酸、绿原酸、隐绿原酸、咖啡酸、连翘酯苷A、异绿原酸B、异绿原酸A、异绿原酸C、迷迭香酸、连翘苷质量浓度分别在306.38～457.85、607.67～854.71、306.81～469.02、95.65～170.64、484.41～819.44、234.28～322.01、145.42～226.85、219.11～292.21、347.94～507.74、201.35～261.94 mg/mL。结论 该方法准确简单，稳定可靠，可用于小儿退热洗剂质量控制。

Objective To establish HPLC fingerprint of antipyretic lotion for children and determine the content of 10 components (neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, forsythiae A, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C, rosmarinic acid and forsythin). Methods The analysis of antipyretic lotion for children was performed on the Kromasil 100-5 C₁₈ (250 mm×4.6 mm, 5 μm) chromatographic column, with mobile phase comprising of 0.1% phosphate acid-acetonitrile flowing at 1 mL/min in a gradient elution manner, and the column temperature was 35℃, and detection wavelength was set at 330 nm. With forsythia A as reference peak, HPLC fingerprint of 11 batches of preparations was established; Based on the conditions of fingerprint chromatogram, the content of 10 components was determined at the detection wavelength of 330 and 280 nm and the multi-index content of 11 batches of the preparation was determined. Results HPLC fingerprint was established, a total of 37 peaks were selected as the common peaks, of which 22 peaks were identified, and the similarities of 11 batches of preparations were between 0.987 and 0.999. The linear relationships of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, forsythiae A, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C, rosmarinic acid, and forsythioside were good in the range of 14.18-141.78, 20.53-205.63, 14.38-143.78, 5.62-56.19, 22.22-222.22, 8.40-83.98, 5.70-57.02, 7.46-76.36, 16.95-169.48, 8.59-85.94 g/mL, respectively. The average recoveries were 109.51%, 98.73%, 99.41%, 90.63%, 92.73%, 95.39%, 91.87%, 106.50%, 95.23%, and 108.71%. The content of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, forsythiae A, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C, rosmarinic acid, and forsythin in the 11 batches were in the range of 306.38-457.85, 607.67-854.71, 306.81-469.02, 95.65-170.64, 484.41-819.44, 234.28-322.01, 145.42-226.85, 219.11-292.21, 347.94-507.74, 201.35-261.94 mg/mL, respectively. Conclusion The method is accurate, simple, stable and reliable, which can be used for the quality control of antipyretic lotion for children.