基于高效液相色谱法和薄层色谱法的消食健胃片质量标准提升研究  

Study on quality improvement of Xiaoshi Jianwei Pian based on HPLC and TLC

作　　者：王军 董恒岳 袁永健 WANG Jun;DONG Heng-yue;YUAN Yong-jian(Bozhou City Food And Drug Inspection Center,Bozhou 236800,China)

机构地区：[1]亳州市食品药品检验中心,安徽亳州236800 [2]安徽华鼎堂中药饮片科技有限公司,安徽亳州236800

出　　处：《中国处方药》2024年第8期26-29,共4页Journal of China Prescription Drug

摘　　要：目的通过科学的分析方法提高消食健胃片的质量标准。方法采用薄层色谱法(TLC)对消食健胃片中的麦芽和槟榔进行鉴别;同时,高效液相色谱法(HPLC)对制剂中山楂的主要成份熊果酸和齐墩果酸的含量进行精确测定。实验条件包括:色谱柱DiKMAC_(18)(4.6 mm×250 mm,5μm)、流动相为乙腈-甲醇-0.5%乙酸铵溶液(67∶12∶21)、流速1.0 ml/min、柱温30℃、检测波长为210 nm。结果TLC结果显示,麦芽和槟榔的斑点清晰,阴性对照溶液无干扰。HPLC结果显示,熊果酸的含量测定在36.84312~368.4312μg/ml范围内,线性回归方程为Y=4.5874 X+24.042,相关系数R^(2)=0.9995,平均回收率为99.23%;齐墩果酸的含量测定在10.36~103.6μg/ml范围内,线性回归方程为Y=5.7897 X+8.5658,相关系数R^(2)=0.9992,平均回收率为98.99%。结论本研究所建立的方法准确度高,可靠性强,可以对消食健胃片质量标准的提高提供依据。Objective To improve the quality standard of Xiaoshi Jianwei Pian through scientific analytical methods.Methods Malt and betel nut in the Xiaoshi Jianwei Pian were identified by thin layer chromatography(TLC);the main contents of ursolic acid and onolic acid in the hawthorn extract were precisly determined by high-performance liquid chromatography(HPLC).Experimental conditions included:DiKMAC_(18) column(4.6 mm×250 mm,5μm),mobile phase of acetonitrile-methanol-0.5%ammonium acetate solution(67∶12∶21),flow rate of 1.0 ml/min,column temperature of 30℃,and the detection wavelength of 210 nm.Results TLC results showed that the spots of malt and betel nut were clear,with no interference from the negative control solution.HPLC results indicated that the content determination of ursolic acid at 36.84312~368.4312μg/ml had a linear regression equation of Y=4.5874 X+24.042,with a correlation coefficient R^(2)=0.9995 and an average recovery rate of 99.23%.The content determination of onolic acid at 10.36 to 103.6μg/ml had a linear regression equation of Y=5.7897 X+8.5658,with a correlation coefficient R^(2)=0.9992 and an average recovery of 98.99%.Conclusion The established method in this study has high accuracy and strong reliability,which can provide a basis for improving the quality standard of Xiaoshi Jianwei Pian.

关 键 词：消食健胃片 麦芽 槟榔 熊果酸 齐墩果酸 

分 类 号：R286.0[医药卫生—中药学]