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目的:建立了中药制剂治咽茶的HPLC指纹图谱,用于控制治咽茶的质量。方法:采用HPLC法,色谱柱为Zorbax Extend-C18柱(250mm×4.6mm,5μm);流动相为甲醇:1‰磷酸水,梯度洗脱,流速为1mL.min-1;检测波长为270nm。采用中药色谱指纹图谱相似度评价系统的操作规范(版本2004A)计算。结果:该制剂10批的指纹图谱相似度都达到0.910以上,制剂生产工艺稳定可行。结论:本法可作为治咽茶质量控制方法。
OBJECTIVE: To establish a HPLC fingerprint of traditional Chinese medicine preparation for pharyngeal tea for controlling the quality of tea for treating pharynx pharynx. Methods: The HPLC method was used on a Zorbax Extend-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol: 1% phosphoric acid and eluted with a gradient of 1 mL · min-1. The detection wavelength was 270 nm. Using the Chinese medicine chromatographic fingerprint similarity evaluation system operating specifications (version 2004A) calculation. Results: The fingerprints similarity of 10 batches of the preparation reached above 0.910, the preparation process was stable and feasible. Conclusion: This method can be used as a quality control method of regulating pharynx tea.