复方虎杖颗粒质量控制方法研究

Quality Control for Compound Huzhang Granules

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 establish the quality standard for Compound Huzhang Granules based on the qualitative and quantitative analysis methods. Methods ： TLC was used to identify the quality of raw Polygoni Cuspidati Rhizome et Ra- dix, Schisandrae Chinensis Fructus, Artemisiae Scopariae Herba and Phellodendri Chinensis Cortex. HPLC was used to determine the content of polydatin and the method was developed with the condition as follows ： Alhima Cls （4.6 mm x 250 mm,5 μm） , mobile phase acetonitrile - water （ 20 ： 80 ） ; flow rate 1.0 mL · min - 1 ; column temperature 35 ℃ ; detection wavelength 306 nm;the injection volume 20 μL. Results： The TLC spots of Polygoni Cuspidati Rhizome et Radix, Schisandrae Chinensis Fruetus, Artemisiae Seopariae Herba and Phellodendri Chinensis Cortex were clear on correspond- ing positions without negative interference and had strong specificity. Polydatin showed a good linear relationship within a range of 0. 070 ~ 0. 700 g （ r = 0.999 5 ）. The average recovery was 99.90% （ RSD = 1.2% , n = 6）. Conclusion ： This qualitative and quantitative analysis method is simple, special and repeatable and can he used for quality control of Com- pound Huzhang Granules.