人参鳖甲煎丸质量标准的提高研究

Improvement in quality standard for Renshen Biejiajian Pills

目的提高完善人参鳖甲煎丸(白芍、大黄、人参、鳖甲胶等)质量标准。方法建立了牡丹皮、黄芩、白芍、厚朴的薄层鉴别法;采用反相液相色谱法,在C18色谱柱上以甲醇-0.1%磷酸溶液(75∶25)为流动相,检测波长430 nm,同时测定了芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚5个成分。结果芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚进样量分别在6.37～1274ng、12.6～1260 ng、11.4～2280 ng、23.9～4780 ng、7.84～1 568 ng范围内线性关系良好。平均回收率(n=9)分别为98.3%、96.9%、101.2%、96.1%、99.5%;RSD分别为1.2%、1.2%、1.5%、0.9%、1.8%。薄层图谱斑点清晰,空白无干扰。结论本法操作简便、快速,结果可靠,重复性好,可作为该产品质量控制的方法。

AIM To improve the quality standard for Renshen Biejiajian Pills （Paeoniae Radix alba, Rhei Radix et Rhizoma, Ginseng Radix et Rhizorna, Trionycis Carapax, etc. ）. METHODS Moutan Cortex, Scutellariae Radix, Paeoniae Radix alba and Magnoliae officinalis Cortex in the preparation were identified by TLC. The contents of aloe-emodin, rhein, emodin, chrysophanol and physcion were determined by RP-HPLC on a C18 column with a mobile phase of methanol-0. 1% phosphoric acid solution （72 ： 25 ） at 430 nm wavelength. RESULTS The linear ranges of aloe-emodin, rhein, emodin, chrysophanol and physcion were 6.37-1 274 ng, 12.6-1 260 ng, 11.4-2 280 ng, 23.9-4 780 ng and 7.84-1 568 ng, respectively. The average recoveries （ n = 9 ） were 98.3% （RSD of 1.2%）, 96. 9% （RSD of 1.2%）, 101.2% （RSD of 1.5%）, 96. 1% （RSD of 0.9%）, 99.5% （ RSD of 1.8% ）, respectively. The spots on TLC chromatograms were clear and accurate. CONCLUSION The methods are convenient, reliable and accurate for the quality control of Renshen Biejiajian Pills.