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目的:对复方虎杖颗粒进行质量标准研究,建立该制剂的定性、定量检测方法。方法:采用薄层色谱法(TLC)对复方虎杖颗粒中主要药味虎杖、黄柏、茵陈、五味子进行定性分析;采用高效液相色谱法(HPLC)对方中君药虎杖中虎杖苷进行含量测定,色谱条件为色谱柱:Alltima C18(4.6 mm×250 mm,5μm),流动相:乙腈-水溶液(20∶80),流速:1.0 m L·min~(-1),柱温:35°C,进样量20μL,检测波长306 nm。结果:TLC定性鉴别中,虎杖、黄柏、茵陈、五味子的薄层鉴别分别在对应位置斑点清晰,阴性无干扰,专属性强。HPLC含量测定中,虎杖苷在0.070~0.700μg范围内,峰面积与进样量有良好的线性关系(r=0.999 5);平均加样回收率为99.90%(RSD=1.2%,n=6)。结论:所建立的定性、定量方法操作简单、重复性好、专属性强,可用于复方虎杖颗粒的质量控制。
OBJECTIVE: To study the quality standard of compound Polygonum cuspidatum and to establish the qualitative and quantitative test methods of the preparation. Methods: The main medicinal compounds of Polygonum cuspidatum, Polygonum cuspidatum, Phellodendron amicula, Capillaris and Schisandra chinensis were identified by TLC. The content of cediid catalase in Polygonum cuspidatum was determined by high performance liquid chromatography (HPLC) The chromatographic conditions were as follows: Alltima C18 (4.6 mm × 250 mm, 5 μm), mobile phase of acetonitrile-water (20:80), flow rate of 1.0 m L · min -1, column temperature of 35 ° C, Injection volume 20μL, detection wavelength 306 nm. Results: TLC qualitative identification, Polygonum cuspidatum, Phellodendron, capillaris, Schisandra TLC identification of the corresponding spots were clear spots, negative non-interference, special and strong. In the determination of HPLC, there was a good linear relationship between the peak area and the injection volume in the range of 0.070 ~ 0.700μg (r = 0.999 5); the average recovery was 99.90% (RSD = 1.2%, n = 6 ). Conclusion: The established qualitative and quantitative methods are simple, reproducible and specific, and can be used for the quality control of compound Polygonum cuspidatum granules.