目的 建立小儿七星茶口服液HPLC 指纹图谱,表征小儿七星茶口服液的化学成分信息。方法 采用HPLC 法建立指纹图谱并用液质联用仪鉴定指纹图谱主要色谱峰。采用Ultimate AQ-C₁₈ 色谱柱(150 mm×4.6 mm,5 μm);以乙腈-0.1%冰醋酸溶液为流动相进行梯度洗脱;检测波长为300 nm;柱温为30℃;体积流量为1.0 mL/min。结果 建立了小儿七星茶口服液HPLC 指纹图谱,确认并鉴别出共有特征峰12 个,21 批样品的相似度达0.89 以上;方法学考察的精密度、重复性相似度均达1.0,36 h 内样品稳定性相似度达0.98。结论 所建立的方法稳定、可靠、重复性好,可用于小儿七星茶口服液质量控制。

Objective To establish HPLC fingerprint for Xiaoer Qixing Cha Oral Liquid and analyze its chemical constituents. Methods RP-HPLC method was performed on an Ultimate AQ-C₁₈ (150 mm×4.6 mm, 5 μm) column with a gradient elution composed of acetonitrile-aqueous solution containing 0.5% acetic acid at the flow rate of 1.0 mL/min. The column temperature was set at 30℃, while the detective wavelength was set at 300 nm. HPLC-MS was used to identify the main chromatographic peaks of the fingerprint. Results The chromatographic fingerprint common pattern was established. Twelve mutual peaks were obtained and identified from the chromatograms of 21 batches of samples and the similarity of the sample was over 0.89. Conclusion The method has good precision, stability, and repeatability and can be used for the quality control of Xiaoer Qixing Cha Oral Liquid.

2012 年度中山市科技计划项目(20123A275)