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目的:建立野牡丹止痢片的质量标准。方法:采用TLC法对野牡丹进行鉴别;用HPLC法对野牡丹中没食子酸进行含量测定,色谱柱:Thermo BDS HYPERSIL C_(18)(250mm×4.6mm,5μm),流动相:甲醇-0.1%甲酸(5:95),检测波长:272nm,流速:1.0ml·min~(-1)。结果:本品鉴别薄层色谱特征明显;没食子酸线性范围0.12~1.6μg(r=0.999 9),平均回收率为100.6%(RSD=1.3%,n=9)。结论:鉴别和含量测定方法准确可行,重复性好,可作为药品标准控制野牡丹止痢片的质量。
Objective: To establish the quality standard of wild Peony Zhijing tablets. Methods: The wild peony was identified by TLC method. Gallic acid was determined by HPLC method. Column: Thermo BDS HYPERSIL C_(18)(250mm×4.6mm, 5μm), mobile phase: methanol -0.1% Formic acid (5:95), detection wavelength: 272 nm, flow rate: 1.0 ml·min -1 . RESULTS: The characteristics of the identification of thin-layer chromatography of this product were obvious; the linear range of gallic acid was 0.12 to 1.6 μg (r=0.999 9), and the average recovery was 100.6% (RSD=1.3%, n=9). Conclusion: The method of identification and content determination is accurate and feasible, and the repeatability is good. It can be used as a drug standard to control the quality of wild Peony Zhijing tablets.