运脾通便合剂质量标准研究  

Study on Quality Standard for Yunpitongbian mixture

作　　者：刘顺[1,2] 邹恺平 周琴妹[1] 施敏[1] 

机构地区：[1]南京中医药大学附属医院,江苏南京210029 [2]南京中医药大学,江苏南京210023

出　　处：《现代中药研究与实践》2017年第3期58-61,共4页Research and Practice on Chinese Medicines

基　　金：江苏省中医院2016院级课题(Y16022);国家自然科学基金青年科学基金项目(81603310)

摘　　要：目的建立运脾通便合剂的质量标准。方法采用薄层色谱法对制剂中白术和枳实进行定性鉴别。采用高效液相色谱法同时对制剂中橙皮苷和白术内酯Ⅲ进行含量测定。结果薄层色谱法鉴定专属性强,阴性无干扰。橙皮苷的线性范围为10.5~210μg/L,回归方程为Y=15.5X+55.135(r=0.999 7),平均加样回收率为97.60%,RSD为1.28%;白术内酯Ⅲ的线性范围为0.51~10.19μg/L,回归方程为Y=22.682X+37.492(r=0.999 9),平均加样回收率为101.12%,RSD为2.07%。结论本方法准确、快速、稳定、可靠,重复性好,可用于运脾通便合剂的质量控制及评价。Objective To establish the quality standard of Yunpitongbian mixture. Methods Thin layer chromatography（TLC） was used to identify atractylodes and Fructus Aurantii Immaturus in Yunpitongbian mixture. The content of hesperidin and atractylenolide were determined by high performance liquid chromatography（HPLC）. Results The TLC spots were clear with strong specificity and free of interference of negative samples. The HPLC results showed that the linear range of hesperidin and atractylenolide were 10.5 ~ 210 μg/L, 0.51 ~ 10.19 μg/L. The regression equations were Y = 15.5X ＋ 55.135（ r = 0.999 7）, Y= 22.682 X ＋ 37.492（ r = 0.999 9）. The average recovery of hesperidin and atractylenolide were 97.60% with RSD = 1.28%, 102.12% with RSD = 2.07%, respectively. Conclusion The method was accurate, rapid, reliable, stable and with good repeatability. This method could be used in establishing the quality standard and evaluation of Yunpitongbian mixture.

关 键 词：运脾通便合剂 质量标准 薄层色谱法 高效液相色谱法 橙皮苷 白术内酯Ⅲ 

分 类 号：R284[医药卫生—中药学]