原创中药新药红珠胶囊质量标准的研究

摘要

为建立红珠胶囊（其内容物为化橘红有效部位）的质量标准，采用薄层色谱法对红珠胶囊中柚皮苷、野漆树苷进行定性鉴别，紫外分光光度法测定红珠胶囊中总黄酮含量并进行溶出度考察，高效液相色谱法测定其中柚皮苷含量。结果显示薄层鉴别专属性强；总黄酮质量浓度在0～27μg/mL 范围内呈良好的线性关系， r＝0.9998，平均回收率为99.63％，RSD为1.95％（n＝9）；柚皮苷在0.2012～2.0120μg范围内呈良好的线性关系，r＝0.9999，平均回收率为97.92％，RSD为2.80％（n＝9）。表明该质量标准方法简便、准确，重复性好，可用于红珠胶囊的质量控制。%The quality standard for Hongzhu Capsule (Citrus Grandis active fraction)was established. Naringin and rhoifolin were identified by TLC.The TLC identification was specific.The assays of the total flavonoids were determined by UV.The linear range of flavonoids was from 0 ~27 μg/mL (r=0.999 8)with an average recovery of 99.63% (RSD was 1.95%,n=9).Naringin was determined by HPLC.The linear range of naringin was from 0.201 2~2.01 2 0 μg (r=0.999 9)with an average recovery of 97.92% (RSD was 2.80%,n=9 ).The methods in quality standard were simple,accu-rate and reproducible.The established standard can be used for quality control of Hongzhu Capsule.