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目的:建立运脾颗粒的质量标准。方法:采用薄层色谱法(TLC)(或称薄层层析)对处方中主要药材进行定性鉴别;采用高效液相色谱法(HPLC)测定运脾颗粒中柚皮苷与橙皮苷的含量。结果:TLC鉴别方法专属性强、重现性好,阴性对照无干扰。高效液相色谱法测出柚皮苷和橙皮苷分别在0.0296~0.296、0.0174~0.174mg/m L范围内与峰面积呈良好的线性关系,R分别为1(N=6)、1(N=6),平均回收率分别为98.50%、99.03%,RSD分别为0.56%(N=6)、0.45%(N=6)。结论:所建立的方法简便、快速、准确,能有效控制运脾颗粒剂的质量。
Objective: To establish the quality standard of Yunpi granule. Methods: TLC (or TLC) was used to qualitatively identify the main herbs in the prescription. The contents of naringin and hesperidin in Yunpi granule were determined by high performance liquid chromatography (HPLC) . Results: TLC identification method specificity, good reproducibility, negative control without interference. The results of HPLC showed that naringin and hesperidin had a good linear relationship with the peak area in the range of 0.0296 ~ 0.296 and 0.0174 ~ 0.174 mg / mL, respectively, with R values of 1 (N = 6), 1 N = 6). The average recoveries were 98.50% and 99.03%, respectively. The RSDs were 0.56% and 0.45%, respectively. Conclusion: The established method is simple, rapid and accurate, which can effectively control the quality of Yunpi granule.