一测多评法测定昆仙胶囊中10种黄酮类成分

目的建立一测多评法同时测定昆仙胶囊中10种黄酮类成分的含量,并验证此方法在昆仙胶囊中应用的可行性和适用性。方法采用HPLC法,以金丝桃苷为内参物,建立朝藿苷A、朝藿苷C、朝藿苷B、淫羊藿苷、木犀草素、槲皮素、川陈皮素、山柰酚和宝藿苷I的相对校正因子(fs/i),并利用fs/i计算昆仙胶囊样品中成分的含量,同时用外标法计算各成分的含量,比较两种方法的差异,采用t检验法比较分析昆仙胶囊中10种黄酮类成分的含量。结果朝藿苷B、朝藿苷A、朝藿苷C、淫羊藿苷、木犀草素、槲皮素、川陈皮素、山柰酚和宝藿苷I的fs/i分别为0.756 5、2.199 4、1.232 7、1.008 5、0.635 7、0.576 0、0.487 5、0.545 6、0.675 8。采用一测多评法与外标法得到的10批昆仙胶囊样品含量测定结果 RSD2.0%,无显著差异。结论以金丝桃苷为内参物建立fs/i准确、可行,一测多评法可用于昆仙胶囊的质量评价。

Determination of ten flavones in Kunxian Capsules with quantitative analysis of multi-components by single marker

Objective To establish quantitative analysis of multi-components by single marker (QAMS) method for simultaneous determining the content of ten flavonoids in Kunxian Capsules (KC), and evaluate the adaptation and application of QAMS method in the quality control of KC. Methods The relative factor (f_s/i) of epimedin A, epimedin C, epimedin B, icariin, luteolin, quercetin, nobiletin, kaempferol and baohuoside I were established by HPLC method with hyperoside as internal standard, which were used to calculate the content of ten flavonoids in the samples of KC. Meanwhile, external standard method (ESM) was used to calculate the content of ten flavonoids. The difference between QAMS and ESM were analyzed to evaluate the accuracy of QAMS. T-test was used to compare the content of ten flavonoids in KC. Results The f_s/i of epimedin A, epimedin C, epimedin B, icariin, luteolin, quercetin, nobiletin, kaempferol, and baohuoside I were 0.756 5, 2.199 4, 1.232 7, 1.008 5, 0.635 7, 0.576 0, 0.487 5, 0.545 6, 0.675 8. The content determination results of ten batches of KC samples were calculated by the method of QAMS and ESM, with no significant difference in RSD < 2.0%. Conclusion The f_s/i established in the QAMS method with hyperoside as the internal reference substance is accurate and feasible. The QAMS method can be used for the quality evaluation of KC.