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高效液相色谱法测定肝复颗粒中6种成分含量

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目的 建立高效液相色谱法(HPLC)法,同时测定肝复颗粒中栀子苷、西红花苷Ⅰ、丹参酮Ⅰ、隐丹参酮、虎杖苷、丹参酮ⅡA 6 种成分的含量.方法 采用COSMOSILC18 色谱柱,以乙腈-0.1%磷酸为流动相,流速为 0.8 ml/min,进行梯度洗脱,检测波长为 205 nm.结果 6 种成分均实现较好的分离,在一定的浓度范围内各成分均呈良好的线性关系,平均回收率为 97.92%~99.67%,相对标准偏差(RSD)为 0.28%~1.51%.定量数据经统计学软件分析,可知栀子苷和西红花苷Ⅰ是影响批次样品差异的主要因素.结论 建立HPLC法同时测定肝复颗粒中栀子苷、西红花苷Ⅰ、丹参酮Ⅰ、隐丹参酮、虎杖苷、丹参酮ⅡA 6 种成分的含量,有利于对肝复颗粒成分的质量控制.
Determination of Six Components in Ganfu Granules by High Performance Liquid Chromatography
Objective To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of six components in Ganfu granules,including geniposide,crocin Ⅰ,tanshinone Ⅰ,cryptotanshinone,polygonatum cuspidatum glycoside,and tanshinoneⅡA.Methods Used a COSMOSILC18 chromatographic column,with acetonitrile 0.1%phosphoric acid as the mobile phase and a flow rate of 0.8 ml/min,for gradient elution with a detection wavelength of 205 nm.Results Six components all achieved good separation,and within a certain concentration range,each component showed a good linear relationship.The average recovery rate was from 97.92%to 99.67%,and the RSD was from 0.28%to 1.51%.Quantitative data was analyzed by statistical software,and it was found that geniposide and crocinⅠ were the main factors affecting the differences in batch samples.Conclusion Establishing a high-performance liquid chromatography(HPLC)method to simultaneously determine the content of six components in Ganfu granules,including geniposide,crocinⅠ,tanshinoneⅠ,cryptotanshinone,polygonatum cuspidatum glycoside,and tanshinoneⅡA,is beneficial for the quality control of Ganfu granules.

Ganfu Granules6 componentsContent determinationHigh performance liquid chromatography

吴国军、徐惠玲、龚艳珍

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江西省人民医院(江西南昌 330006)

肝复颗粒 6种成分 含量测定 高效液相色谱法

江西省中医药局科技项目

2022B1056

2024

医疗装备
国家食品药品监督管理局北京医疗器械质量监督检验中心 北京市医疗器械检验所

医疗装备

影响因子:0.339
ISSN:1002-2376
年,卷(期):2024.37(5)
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