复方茶多酚搽剂质量标准的研究

Study on quality standard for compound tea polyphenols liniments

目的：建立复方茶多酚搽剂质量控制方法。方法：采用薄层色谱法，以硅胶G为固定相，氯仿-醋酸乙酯-乙醚-甲酸（9：7：3：3）为展开剂，对茶多酚搽剂中2种主要活性成分表没食子儿茶素没食子酸酯（EGCG）和表儿茶素没食子酸酯（ECG）进行定性鉴别；采用反相高效液相色谱法，以Kromasil—C18为色谱柱，乙腈-0．1％构橼酸溶液（15：85）为流动相，测定茶多酚搽剂中EGCG和ECG的含量。结果：薄层色谱斑点清晰，Rf值分别为0．38（EGCG）和0．52（ECG）。高效液相色谱定量方法达到基线分离，EGCG和ECG的保留时间分别为10．192和22．149min。线性范围分别为18．75—300μg·mL^-1（r=0．9997），3．125～50μg·mL^-1（r=0．9998），平均回收率分别为98．8％和98．0％。精密度RSD分别为2．7％和2．4％。结论：首次建立了茶多酚搽剂中EGCG和ECG的定性定量方法。该法准确、专属性及重现性好且快速简便，可作为该制剂质量控制方法。

Objective： To develop a quality standard for compound tea polyphenols （TP） liniment. Methods：TLC was used to qualitatively identify the two main ingredients of EGCG and ECG in TP liniment using silica gel as a stationary phase, CHCL3-EtoAC-ether-HCOOH （9： 7： 3：3） as a developing agent. HPLC was used to quantitatively determine EGCG and ECG content using CH3CN-0.1% citric acid （15： 85） as a mobile phase, Kromasil-C18 as a chromatographic column. Results：TLC showed two clear spots with Rf of 0.38 and 0.52 corresponding to EGCG and ECG, respectively. HPLC resulted in a base-line separation of EGCG, ECG and other components,with no interference from blank sample. Good linearity over the range of 18.75 - 300μg·mL^ - 1 （ r = 0. 999 7 ） for EGCG and 3. 125 - 50μg· mL^ - 1 （ r = 0. 999 8） for ECG were achieved with average recovery being 〉 95% , precision （RSD） 〈 3% for both ingredients. Conclusion ：The method developed in the present study is highly specific, precise, accurate. It is suitable for the quality control of the liniment.