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目的建立同时测定心脑康片中11种成分(丹参酮IIA、葛根素、β-蜕皮甾酮、甘草苷、芍药苷、斯皮诺素、阿魏酸、山柰素、大黄素、细叶远志皂苷和23-乙酰泽泻醇B)的HPLC分析方法。方法采用HPLC法测定心脑康片中丹参酮IIA、葛根素、β-蜕皮甾酮、甘草苷、芍药苷、斯皮诺素、阿魏酸、山柰素、大黄素、细叶远志皂苷和23-乙酰泽泻醇B。色谱柱为Inert Sustain C18柱(250 mm×4.6 mm,5μm);甲醇-乙腈(1∶1,A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱:0~10.0 min,80%B;10.0~20.0 min,80%~70%B;20.0~35.0 min,70%~50%B;35.0~50.0 min,50%~30%B;体积流量0.9 m L/min;柱温40℃;进样量10μL。结果丹参酮IIA、葛根素、β-蜕皮甾酮、甘草苷、芍药苷、斯皮诺素、阿魏酸、山柰素、大黄素、细叶远志皂苷和23-乙酰泽泻醇B分离度良好,分别在28.24~282.42、15.89~158.90、20.53~205.26、4.09~40.94、12.08~120.76、40.03~404.30、4.08~40.75、2.13~21.25,7.91~79.14、20.30~202.96、4.10~40.96μg/m L线性关系良好,r均大于0.999 0,平均加样回收率为98.15%~101.84%(RSD在0.62%~1.71%)。6批样品中丹参酮IIA、葛根素、β-蜕皮甾酮、甘草苷、芍药苷、斯皮诺素、阿魏酸、山柰素、大黄素、细叶远志皂苷和23-乙酰泽泻醇B分别在0.870~0.887、6.321~6.329、0.857~0.866、0.171~0.179、0.369~0.377、2.128~2.136、0.088~0.099、0.148~0.155、0.113~0.121、0.371~1.380、0.101~0.109 mg/g。结论本法快速、灵敏度高、准确度高、专属性好,为心脑康片的质量控制提供依据。
Objective To establish a method for the simultaneous determination of eleven components of tangtokang tablet (tanshinone IIA, puerarin, β-ecdysterone, glycyrrhizin, paeoniflorin, spinosin, ferulic acid, kaempferol, emodin, Saponins and 23-Acetoxynil B) HPLC analysis method. Methods Tanshinone IIA, puerarin, β-ecdysterone, liquiritin, paeoniflorin, spinosin, ferulic acid, kaempferol, emodin, Acetyl alisol B. The mobile phase consisted of Inert Sustain C18 column (250 mm × 4.6 mm, 5 μm) and methanol-acetonitrile (0.1%, A) -0.1% phosphoric acid solution (B) B, 10.0-20.0 min, 80-70% B, 20.0-35.0 min, 70-50% B, 35.0-50.0 min, 50-30% B, volumetric flow rate 0.9 m L / min, ; Injection volume 10μL. Results Tanshinone IIA, puerarin, β-ecdysterone, glycyrrhizin, paeoniflorin, spinosin, ferulic acid, kaempferol, emodin, Saponin and 23-acetyl alisol B were well separated , Respectively, at 28.24 ~ 282.42,15.89 ~ 158.90, 20.53 ~ 205.26, 4.09 ~ 40.94, 12.08 ~ 120.76, 40.03 ~ 404.30, 4.08 ~ 40.75, 2.13 ~ 21.25, 7.91 ~ 79.14, 20.30 ~ 202.96, 4.10 ~ 40.96μg / m L The linearity was good, r was greater than 0.999 0, the average recovery was 98.15% ~ 101.84% (RSD 0.62% ~ 1.71%). Tanshinone IIA, puerarin, β-ecdysterone, glycyrrhizin, paeoniflorin, spinosin, ferulic acid, kaempferol, emodin, saponin and 23- Respectively, ranging from 0.870 to 0.887, 6.321 to 6.329 and from 0.857 to 0.866, from 0.171 to 0.179, from 0.369 to 0.377, from 2.128 to 2.136, from 0.088 to 0.099, from 0.148 to 0.155 and from 0.113 to 0.121, from 0.371 to 1.380 and from 0.101 to 0.109 mg / g, respectively. Conclusion This method is rapid, sensitive, accurate and specific. It provides the basis for the quality control of Xinnaokang tablets.