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[摘要]
目的 建立小儿化痰止咳颗粒的HPLC特征图谱,考察其主要组成原料吐根酊的投料情况,评价其质量。方法 采用高效液相色谱法,色谱柱为Inertsil ODS-SP(250 mm×4.6 mm,5 μm),乙腈-0.4%磷酸溶液为流动相,梯度洗脱,体积流量为1 mL/min,检测波长210 nm,柱温35℃。结果 建立了41个厂家181批样品的HPLC特征图谱,确定其中来自原料盐酸麻黄碱、吐根酊和桑白皮流浸膏的6个特征色谱峰;利用该特征图谱,发现部分厂家存在投入不合格吐根酊原料的情况。结论 该方法建立的小儿化痰止咳颗粒HPLC特征图谱专属性强,重复性好,可有效的控制该产品的质量。
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[Abstract]
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.
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