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作 者:程清[1] 陈丹[1] 黄群[1] 曾令军[1] 任瑞琴[1] 郑利[1] 黄庆德[1] 白韵雪[1]
出 处:《中国医院药学杂志》2013年第14期1134-1137,共4页Chinese Journal of Hospital Pharmacy
基 金:福建省自然科学基金项目(编号:2012J01386;2010J01189);建省科技计划重点项目(编号:2010Y0030);建省科技计划项目(编号:2010Y2004);建省发展和改革委员会产业技术开发项目[编号:闽发改高技(2011)1598号]
摘 要:目的:建立玳玳黄酮自微乳化软胶囊中指标性成分新橙皮苷和柚皮苷的含量测定方法。方法:采用高效液相色谱法,色谱条件:色谱柱250-4 lichrocart C18;流动相乙腈-0.1%磷酸水溶液(22∶78);流速1.0mL.min-1;检测波长284 nm,与一测多评法(柚皮苷为参照物)进行比较。结果:柚皮苷在4.080~20.440μg.mL-1(r=0.999 1)、新橙皮苷在6.384~31.920μg.mL-1(r=0.999 2)范围内分别与峰面积成良好的线性关系。高效液相色谱法与一测多评法所得到的含量值之间的Pearson相关系数为0.999,含量间的相对误差在0.5%以内。结论:一测多评法与高效液相色谱法比较,二者含量测定结果无显著性差异,可以用于玳玳黄酮自微乳化软胶囊的质量控制。OBJECTIVE To set up a method for determination of naringin and neohesperidin of Daidai flavones SMEDDS soft capsule. METHODS The column was 250-4 lichrocart Cla. The mobile phase was acetonitrile: water with 0. 1 % phos phoric acid (22:78). The flow rate was 1.0 mL.min I and detection wavelength was set at 284 nm. Multi- components quantitation by one marker was used to determine neohesperidin with naringin as the reference object and compare it with the method of HPLC. RESULTS The naringin calibration curve was linear over the range of 4. 080 - 20. 440 μg · mL- 1 with the r = 0. 999 1. The neohesperidin calibration curve was linear over the range of 6. 384 - 31. 920μg,mL 1 with the r= 0. 999 2. Pear- son correlation coefficient between the method of HPLC and multi-components quantitation by one marker was 0. 999 while the relative error was less than 0. 5 %. CONCLUSION The result of determination by multi-components quantitation by one marker is consistent with determinnation by HPLC without significant difference. The method of multi-components quantitation by one marker can be used for quality control of Daidai flavones SMEDDS soft capsule.
关 键 词:玳玳黄酮自微乳化软胶囊 含量测定 一测多评 质量控制
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