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作 者:张海弢[1] 付娟[1] 李曼曼[1] 柏伟荣[1] 王振中[1] 萧伟[1]
机构地区:[1]江苏康缘药业股份有限公司,中药制药过程新技术国家重点实验室,江苏连云港222047
出 处:《中成药》2017年第5期968-971,共4页Chinese Traditional Patent Medicine
摘 要:目的建立HPLC法同时测定情之怡片(葛根、余甘子、丹参等)中4种成分的含有量。方法该药物50%甲醇提取液的分析采用Kromasil C_(18)色谱柱(4.6 mm×250 mm,5μm);以0.1%甲酸-甲醇-乙腈为流动相,梯度洗脱;体积流量1.0 m L/min;柱温30℃;检测波长270 nm。结果没食子酸、葛根素、丹酚酸B、丹参酮ⅡA分别在11.95~382.48、14.23~455.28、10.77~344.68、3.89~124.32μg/m L范围内呈良好的线性关系,平均加样回收率分别为99.96%、100.92%、98.87%、97.67%,RSD分别为1.09%、1.30%、1.11%、1.22%。结论该方法灵敏、简便、准确,可用于情之怡片的质量控制。AIM To establish an HPLC method for the simultaneous content determination of four constituents in Qingzhiyi Tablets (Puerariae lobatae Radix, Phyllanthi Fructus, Salviae miltiorrhizae Radix et Rhizoma, etc. ). METHODS The analysis of 50% methanol extract of this drug was performed on a 30 ℃ thermostatic Kromasil Cls column (4.6 mm ×250 mm, 5 μm) , with the mobile phase comprising of 0. 1% formic acid-methanol-acetoni- trile flowing at 1.0 mL/min in a gradient elution manner, and the detection wavelength was set at 270 nm. RESULTS Gallic acid, puerarin, salvianolie acid B and tanshinone II A showed good linear relationships within the ranges of 11.95 - 382. 48, 14.23 - 455.28, 10.77 - 344.68 and 3.89 - 124.32μg/mL whose average recoveries were 99.96% , 100. 92% , 98.87% and 97.67% with the RSDs of 1.09% , 1.30% , 1.11% and 1.22% , respectively. CONCLUSION This sensitive, simple and accurate method can be used for the quality control of Qingzhiyi Tablets.
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