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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,5μm),乙腈-0.4%磷酸溶液为流动相,梯度洗脱,体积流量为1 m L/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。
OBJECTIVE To establish HPLC profile of Xiaoer Huatanzituke Granule, investigate the feeding situation of its main components, Ipomoea tincture, and evaluate its quality. Methods High performance liquid chromatography (HPLC) was performed on a column with Inertsil ODS-SP (250 mm × 4.6 mm, 5 μm) and acetonitrile-0.4% phosphoric acid as mobile phase with gradient elution at a volume flow rate of 1 mL / 210 nm, column temperature 35 ℃. Results HPLC profiles of 181 batches of samples from 41 factories were established and six characteristic chromatographic peaks were obtained from the raw materials of ephedrine hydrochloride, tincture of Ipomoea officinalis and mulberry bark extract. Using this characteristic map, it was found that some of the manufacturers were not involved Qualified Tuitou tincture of raw materials. Conclusion The method established pediatric Huatanzituo particles HPLC profile specificity, good repeatability, which can effectively control the quality of the product.