实脾消水凝胶贴膏的薄层色谱鉴别和含量测定研究

TLC identification and quantitative determination of Shipi Xiaoshui gel plaster

目的 建立实脾消水凝胶贴膏的薄层色谱鉴别和含量测定方法。方法 采用薄层色谱法(TLC)对制剂中的黄芪、车前子、莪术、桂枝、猪苓、预知子进行鉴别;采用超高效液相色谱-串联质谱法(UPLC-MS)对制剂中君药黄芪所含成分黄芪甲苷进行含量测定。结果 TLC鉴别图斑点清晰,分离度好,阴性对照无干扰;黄芪甲苷的质量浓度在2.75~33μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 9,n=6),精密度、重复性、稳定性实验的RSD<3%,平均加样回收率为100.49%(RSD=1.98%,n=6)。结论 本研究所建立的方法准确可靠、专属性强,可用于实脾消水凝胶贴膏的质量控制。

Objective To establish the method of thin layer chromatography(TLC)for identification and quantitative determination of Shipi Xiaoshui gel plaster.Methods TLC was adopted to qualitatively identify astragalus radix,plantaginis semen,curcumae rhizome,cinnamomi ramulus,polyporus umbellatus and akebia quinata.UPLC-MS was used to determine the content of astragalosideⅣ.Results TLC spots were clear and well-separated;RSDs of precision,reproducibility and stability tests were all lower than 3%,the linear range of astragalosideⅣwas 2.75-33μg/ml(r=0.9999,n=6),and the average recovery was 100.49%(RSD=1.98%,n=6).Conclusion The established method in this study is accurate,reliable and specific,which could be used for the quality control of Shipi Xiaoshui gel plaster.