目的 建立小兒化痰止咳顆粒的HPLC特征圖譜，考察其主要組成原料吐根酊的投料情況，評價其質(zhì)量。方法 采用高效液相色譜法，色譜柱為Inertsil ODS-SP（250 mm×4.6 mm，5 μm），乙腈-0.4%磷酸溶液為流動相，梯度洗脫，體積流量為1 mL/min，檢測波長210 nm，柱溫35℃。結(jié)果 建立了41個廠家181批樣品的HPLC特征圖譜，確定其中來自原料鹽酸麻黃堿、吐根酊和桑白皮流浸膏的6個特征色譜峰；利用該特征圖譜，發(fā)現(xiàn)部分廠家存在投入不合格吐根酊原料的情況。結(jié)論 該方法建立的小兒化痰止咳顆粒HPLC特征圖譜專屬性強，重復(fù)性好，可有效的控制該產(chǎn)品的質(zhì)量。

Objective To establish the HPLC typical chromatogram, investigate the input amounts of main crude material ipecac tincture, and evaluate the quality of Xiaoer Huatan Zhike Granule. Methods The HPLC typical chromatogram was performed on an Inertsil ODS-SP column (250 mm×4.6 mm, 5 μm) with a gradient mobile phase of acetonitrile-0.4% phosphoric acid aqueous solution system at a flow rate of 1 mL/min. The detection wavelength was 210 nm and the column temperature was 35℃. Results The HPLC typical chromatograms of 181 batches of samples from 41 manufacturers were obtained, in which six typical chromatographic peaks from ephedrine hydrochloride, ipecac tincture, and liquid extract of Mori Cortex were identified. And it was found that the unqualified materials of ipecac tincture were applied in some manufactures using the established HPLC typical chromatograms. Conclusion The established methods have high specificity and good repeatability, and can be used for the quality control of these products.