复方新会陈皮含片质量控制研究  

Experimental Study on QualityControl of Compound Xinhui Citri Reticulatae Pericarpium Buccal Tablets

作　　者：昌水平[1] 梁志云[1] 张明[1] 张俊杰 余香[1] 陈观凤 张军[2] CHANG Shuiping;LIANG Zhiyun;ZHANG Ming;ZHANG Junjie;YU Xiang;CHEN Guanfeng;ZHANG Jun(Jiangmen Xin Hui Hospital of Traditional Chinese Medicine,Jiangmen 529100,China;Guangzhou University of Chinese Medicine,Guangzhou 510006,China)

机构地区：[1]广东省江门市新会区中医院,广东江门529100 [2]广州中医药大学,广东广州510006

出　　处：《中国民族民间医药》2023年第12期24-29,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：广东省中医药局科研项目(编号:20221434)。

摘　　要：目的:建立复方新会陈皮含片的质量控制方法。方法:采用TLC鉴别含片中新会陈皮、蛇胆汁、甘草;采用高效液相色谱法同时测定含片中甘草苷、甘草酸铵、橙皮苷、川陈皮素和橘皮素的含量,以十八烷基硅烷键合硅胶为填充剂(Kromasil C_(18)柱长为250 mm,内径为4.6 mm,粒径为5μm);以乙腈(A)-0.05%磷酸溶液(B)为流动相,梯度洗脱;检测波长为237 nm、254 nm;流速为1.0 mL/min;柱温为30℃。结果:复方新会陈皮含片色谱中,与新会陈皮的橙皮苷、川陈皮素、橘皮素及甘草的甘草苷、甘草酸铵对照品色谱相应的位置上有相同保留时间的色谱峰,阴性对照试验无干扰。各对照品峰面积与进样质量呈良好的线性关系,其回归方程分别为橙皮苷:y=267.92x+10.046,r=0.9992;川陈皮素:y=2771.4x-15.586,r=1;橘皮素:y=1692.3x+4.7767,r=0.9999;甘草苷:y=1684.6x+8.3101,r=0.9991;甘草酸铵:y=347.97x+12.726,r=0.9993。平均加样回收率分别为94.93%(RSD=0.76%),101.10%(RSD=1.39%),102.36%(RSD=0.91%),101.75%(RSD=1.98%),102.33%(RSD=1.60%)。结论:复方新会陈皮含片质量控制实验研究建立了药材的TLC定性鉴别方法和含片中橙皮苷、川陈皮素、橘皮素、甘草苷、甘草酸铵的含量测定方法,能有效地控制复方新会陈皮含片制剂的质量。Objective To establish the quality control method for compound Xinhui citri reticulatae pericarpium buccal tablets.Methods TLC was used to identifycitri reticulatae pericarpium,snake bile and licorice.The contents of liquiritin,ammonium glycyrrhetate,hesperidin,nobiletin and tangeretin in lozenges were determined by high performance liquid chromatography.Octadecylsilane bonded silica gel was used as filler(Kromasil C_(18) column length 250 mm,inner diameter 4.6 mm,particle size 5μm).Acetonitrile(A)-0.05%phosphoric acid solution(B)was used as mobile phase in gradient elution.The detection wavelength was 237 nm and 254 nm.The flow rate was 1.0 mL/min.The column temperature was 30℃.Results In the chromatogram of compound Xinhui citri reticulatae pericarpium buccal tablets,there were chromatographic peaks with the same retention time corresponding to the chromatographic positions of hesperidin,nobiletin,tangeretin,liquiritin and ammonium glycyrrhetate,and the negative control test had no interference.There was a good linear relationship between the peak area of each reference substance and the injection quality,and the regression equations were as follows:hesperidin:y=267.92x+10.046,r=0.9992.nobiletin:y=2771.4x-15.586,r=1.Tangeretin:y=1692.3x+4.7767,r=0.9999.liquiritin:y=1684.6x+8.3101,r=0.9991.ammonium glycyrrhetate:y=347.97x+12.726,r=0.9993.The average recovery rates respectively were 94.93%(RSD=0.76%),101.10%(RSD=1.39%),102.36%(RSD=0.91%),101.75%(RSD=1.98%),102.33%(RSD=1.60%).Conclusion The TLC method for qualitative identification and determination of hesperidin,nobiletin,tangeretin,liquiritin and ammonium glycyrrhetate in lozenges were established,which can effectively control the quality of compound Xinhui citri reticulatae pericarpium buccal tablets.

关 键 词：复方新会陈皮含片 质量控制 实验研究 

分 类 号：R282[医药卫生—中药学]