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目的:建立清凉含片的定性定量方法,更好地控制产品质量。方法:采用薄层色谱法对处方中的薄荷、薄荷脑和葛根进行鉴别,采用气相色谱法测定薄荷脑的含量,以聚乙二醇(PEG)-20M为固定相,在140℃柱温下检测。结果:薄层色谱鉴别方法专属性好,斑点清晰,分离度好,阴性样品无干扰;气相色谱法测定,薄荷脑在0.099～2.106μg范围内线性关系良好(r=1.000 0);平均回收率为96.4%,RSD=1.8%(n=6)。结论:本方法能准确地进行定性、定量,且专属性强,灵敏度高,重复性好,可用于清凉含片的质量控制。
OBJECTIVE: To establish a qualitative and quantitative method of cooling tablets for better control of product quality. Methods: Peppermint, menthol and Pueraria lobata were identified by thin-layer chromatography. Menthol content was determined by gas chromatography. Polyethylene glycol (PEG) -20M was used as the stationary phase. Detection. Results: The method of identification by TLC was of good specificity, clear spots, good separation and no interference with the negative samples. Gas chromatography showed that the linear relationship of menthol in the range of 0.099 ~ 2.106μg was good (r = 1.000 0); the average recovery 96.4%, RSD = 1.8% (n = 6). Conclusion: The method can be accurately qualitative, quantitative, and specificity, high sensitivity, good reproducibility, can be used for quality control of cool lozenges.