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目的:建立六味颈康胶囊质量标准。方法:用TLC法对处方中白芍、甘草、续断、粉葛进行定性鉴别;用HPLC法测定其主要活性成分葛根素、芍药苷、甘草苷、甘草酸铵的含量,色谱柱为ZORBAX SB-C18柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.1%磷酸水溶液,进行梯度洗脱;流速为1.0 ml·min~(-1);柱温为30℃;检测波长为0~7 min、在250 nm波长下检测葛根素,7~10 min在232 nm波长下检测芍药苷,10~14 min在276 nm波长下检测甘草苷,14 min在250 nm波长下检测甘草酸铵;进样量为10μl。结果:TLC法可鉴别白芍、甘草、续断、粉葛的特征斑点且阴性样品无干扰,4个有效成分的线性范围分别为:葛根素2.644~26.440μg·ml~(-1)(r=0.999 9)、芍药苷65.200~652.000μg·ml~(-1)(r=0.999 2)、甘草苷12.620~126.200μg·ml~(-1)(r=0.999 9)、甘草酸铵13.280~132.800μg·ml~(-1)(r=0.998 9),平均加样回收率分别为98.74%,99.24%,98.69%,98.19%,RSD分别为0.71%,0.40%,0.78%,0.84%(n=6)。结论:该方法简便、准确、灵敏度高、重复性好,可有效控制六味颈康胶囊的产品质量。
Objective: To establish Liuweikangkang capsule quality standard. Methods: The prescriptions of Radix Paeoniae Alba, Glycyrrhiza uralensis, Dipsacus and Powdergrass were identified qualitatively by TLC method. The content of puerarin, paeoniflorin, glycyrrhizin and ammonium glycyrrhizinate was determined by HPLC. The chromatographic column was ZORBAX SB (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution with gradient elution. The flow rate was 1.0 ml · min -1. The column temperature was 30 ℃. The detection wavelength was 0 ~ 7 min, puerarin at 250 nm, paeoniflorin at 232 nm at 7-10 min, glycyrrhizin at 276 nm at 10-14 min and ammonium glycyrrhizinate at 250 nm at 14 min ; Injection volume of 10μl. Results: TLC method could identify the characteristic spots of white peony root, licorice root, dipsaci root and powder root, and the non-interference of the negative samples. The linear ranges of the four active ingredients were as follows: puerarin 2.644 ~ 26.440μg · ml ~ (-1) = 0.999 9), paeoniflorin 65.200 ~ 652.000μg · ml -1 (r = 0.999 2), glycyrrhizin 12.620 ~ 126.200μg · ml -1 (r = 0.999 9), ammonium glycyrrhizinate 13.280 ~ The average recoveries were 98.74%, 99.24%, 98.69% and 98.19%, respectively, with RSD of 0.71%, 0.40%, 0.78% and 0.84% (r = 0.998 9, n = 6). Conclusion: The method is simple, accurate, sensitive and reproducible, which can effectively control the product quality of Liuwei Jingkang Capsules.