复方广金钱草颗粒质量标准研究

Study on Quality Standard for Fufang Guangjinqiancao Granules

目的建立复方广金钱草颗粒的质量标准。方法采用TLC法鉴别方中广金钱草、车前子、泽泻、牛膝及穿破石;采用超高效液相色谱（UPLC）法对制剂中夏佛塔苷进行含量测定,ACQUITY UPLC BEH SHIELD RP18色谱柱（21 mm×50 mm,1.7μm）,流动相为甲醇-水（32∶68,v/v）,检测波长为271 nm,流速为0.2 m L/min,柱温为35℃;采用超高效液相色谱（UPLC）法对制剂中23-乙酰泽泻醇B进行含量测定,ACQUITY UPLC BEH SHIELD RP18色谱柱（21 mm×150 mm,1.7μm）,流动相为乙腈-水溶液（73∶27,v/v）,检测波长为211 nm,流速为0.2 m L/min,柱温为35℃。结果在TLC色谱中,可检测出广金钱草、车前子、泽泻、牛膝及穿破石的特征斑点,清晰,易于观察。通过超高效液相色谱法测得制剂中夏佛塔苷的线性关系为Y=8848.2X＋13306（r=0.999 0）,表明夏佛塔苷在1.5625-400μg/m L范围内有良好的线性关系;23-乙酰泽泻醇B的线性关系为Y=3 077.65X-17 298.15（r=0.999 8）,表明23-乙酰泽泻醇B在25.3-227.7μg/m L范围内有良好的线性关系。结论该方法简便、准确、稳定且无干扰,可作为该制剂的质量控制方法。

Objective To establish quality standard of Fufang Guangjinqiancao granules. Methods TLC was used to identify Desmodium Styracifolium,plantain seed,Alisma orientalis（ Sam） Juzep,Achyranthes bidentata BL,Ventilago leiocarpa Benth in Fufangguangjinqiancao granules. The UPLC method for schaftoside was used for determination of Diamonsil C18 column The UPLC method for schaftoside was used for determination of ACQUITY UPLC BEH SHIELD RP18column（ 21mm×50 mm,1. 7 μm）,the mobile phase was consisted of methyl alcohol-water（ 32 ∶68,v / v）,and the flow rate was 0. 2m L / mi,the UPLC method for 2,3-acetylalisol was used for determination of ACQUITY UPLC BEH SHIELD RP18column（ 21 mm × 150 mm,1. 7 μm）,the mobile phase for 2,3-acetylalisol was consisted of acetonitrile-water（ 73 ∶27,v/v）,and the flow rate was 0. 2 m L / min. Results Desmodium Styracifolium, plantain seed, Alisma orientalis（ Sam） Juzep,Achyranthes bidentata BL,Ventilago leiocarpa Benth,Glycyrrhiza uralensis Fisch could be detected by TLC and easily to observe. The liner relationship of schaftoside in the preparation measure by UPLC was Y = 8 848. 2 X ＋13 306,r = 0. 9990,showing that the liner range of schaftoside was 1. 562 5-400 μg / m L. The liner relationship of alisol B 23-acetate in the preparation measure by UPLC was Y = 3 077. 65X-17 298. 15,r = 0. 999 8,showing that the liner range of alisol B 23-acetate was 25. 3-227. 7 μg / m L. Conclusion The methods are reliable,reproducible and with strong specificity,which can be used to control the quality of Fufang Guangjinqiancao granules.