论文部分内容阅读
目的:建立不同生产企业心脑健胶囊的HPLC特征图谱及其6个指标成分含量的测定方法。方法:利用HPLC法,采用Agilent-C18色谱柱(100 mm×4.6 mm,2.7μm);流动相为乙腈-0.05%磷酸溶液,梯度洗脱;流速0.4m L/min;检测波长280 nm;柱温40℃。结果:在特征图谱研究中,以表没食子儿茶素没食子酸酯为参照峰,共标定了11个共有峰,分析的26批次心脑健胶囊与共有模式对照图谱之间有良好的相似性,相似度均在0.99以上;6个指标成分没食子酸、没食子儿茶素、表没食子儿茶素、咖啡因、表没食子儿茶素没食子酸酯和表儿茶素没食子酸酯分离良好,r均大于0.9990,平均加样回收率在95.29%~102.3%之间。结论:所建立的特征图谱及含量测定分析方法灵敏度高,专属性强,可用于心脑健胶囊的质量控制。
OBJECTIVE: To establish HPLC profiles of Xinnaojian Capsules from different manufacturers and to determine the content of 6 components of them. Methods: The mobile phase consisted of acetonitrile-0.05% phosphoric acid solution with a gradient of 0.4 m L / min using Agilent-C18 column (100 mm × 4.6 mm, 2.7 μm) Temperature 40 ℃. Results: In the characteristic map study, epigallocatechin gallate as the reference peak, a total of 11 common peaks were calibrated, analysis of 26 batches of Xinnao Jian Capsule and the common pattern of control maps have a good similarity , The similarity is above 0.99; 6 indicator components gallic acid, gallocatechin, epigallocatechin, caffeine, epigallocatechin gallate and epicatechin gallate separation is good, r Greater than 0.9990, the average recovery rate was between 95.29% ~ 102.3%. Conclusion: The established characteristic maps and determination of content of the method of high sensitivity, specificity, and can be used for the quality control Xinnao Jian Capsules.