藏降脂胶囊质量标准研究

Quality standard for Zangjiangzhi Capsules

目的研究制定藏降脂胶囊(藏锦鸡儿、余甘子、短管兔耳草、紫檀香、印度獐牙菜、诃子、沙棘膏、大黄、塞北紫荆、甘青青兰、干姜)的质量标准。方法采用薄层色谱(TLC)法对藏降脂胶囊中齐墩果酸、大黄、甘青青兰进行定性鉴别;采用高效液相色谱(HPLC)法同时对藏降脂胶囊中大黄的有效成分芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚同时进行了定量测定,采用Waters C18柱(250 mm×4.6 mm,5μm)色谱柱,柱温为25℃,流动相为甲醇-0.1%磷酸水溶液(80∶20,V/V),体积流量为1.0 mL/min,检测波长设定为430 nm。结果 TLC鉴别方法专属性强,齐墩果酸、大黄、甘青青兰的特征斑点清晰,阴性对照无干扰;HPLC测定大黄中芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚质量浓度的线性范围分别为0.75～7.5μg/mL(r=0.999 9,n=5)、0.41～4.1μg/mL(r=0.999 8,n=5)、0.98～9.8μg/mL(r=0.999 9,n=5)、2.56～25.6μg/mL(r=0.999 6,n=5)、1.48～14.8μg/mL(r=0.999 8,n=5),平均加样回收率分别为98.63%、98.77%、99.04%、98.69%、98.57%,RSD分别为1.04%(n=6)、1.15%(n=6)、0.93%(n=6)、0.76%(n=6)、1.17%(n=6)。结论所建立的定性、定量分析方法简便易行,重复性好,准确度高,能够有效控制藏降脂胶囊的质量。

AIM To study and establish the quality standard for Zangjiangzhi Capusles（Caragana jubata（pall.） Poir.,Phyllanthi Fructus,Lagotis brevituba Maxilm.,Pterocarpus indicus Willd.,Swertia chirayita（Roxb.ex Flemi） Karsten,Chebulae Fructus,Hippophae Fructus,Rhei Radix et Rhizoma,Corydalis impatiens（Pall.） Fisch.,Dracocephalum tanguticum Maxim.,Zingiberis Rhizoma）.METHODS Oleanolic acid,Rhei Radix et Rhizoma and Dracocephalum tanguticum Maxim.in Zangjiangzhi Capusles were identified by TLC.The contents of aloeemodin,rhein,emodin,chrysophanol and physcion in Rhei Radix et Rhizoma were determined by HPLC on a Waters C18 column（250 mm×4.6 mm,5 μm） with the column temperature at 25 ℃.The mobile phase consisted of methanol and 0.1% H3PO4（80∶ 20,V/V） with flow rate of 1.0 mL/min,and the detection wavelength was set at 430 nm.RESULTS The identification method was exclusive.The TLC sports were fairly clear,and the blank test showed no interference.The determination of aloeemodin,rhein,emodin,chrysophanol and physcion kept the good linear relation in the concentration ranges of 0.75-7.5 μg/mL（r=0.999 9,n=5）,0.41-4.1 μg/mL（r=0.999 8,n=5）,0.98-9.8 μg/mL（r=0.999 9,n=5）,2.56-25.6 μg/mL（r=0.999 6,n=5）,1.48-14.8 μg/mL（r=0.999 8,n=5）,respectively.The average recoveries of aloeemodin,rhein,emodin,chrysophanol and physcion were 98.63%,98.77%,99.04%,98.69% and 98.57%,respectively.The RSDs were 1.04%（n=6）,1.15%（n=6）,0.93%（n=6）,0.76%（n=6） and 1.17%（n=6）,respectively.CONCLUSION The established qualitative and quantitative methods are simple,accurate with good reproducibility,which can be used for the quality control of Zangjiangzhi Capsules.