通降汤质量标准研究  

Study on Standard of Tongjiang Tang

作　　者：赵万隆 程伟 陈剑 ZHAO Wan-long;CHENG Wei;CHEN Jian(Shanghai Qingpu Institute for Food and Drug Control,Shanghai 201799,China;Xinyang Institute for Food and Drug Control,Xinyang 464000,China)

机构地区：[1]上海市青浦食品药品检验所,上海201799 [2]信阳市食品药品检验所,河南信阳464000

出　　处：《中国现代中药》2019年第7期960-964,共5页Modern Chinese Medicine

摘　　要：目的:建立通降汤的院内制剂质量标准。方法:采用TLC薄层色谱法对处方中大黄进行定性鉴别;采用高效液相色谱法测定该药中阿魏酸、丹酚酸B、甘草酸铵和大黄素的含量。结果:TLC斑点较为清晰且分离良好,阴性无干扰,专属性良好。HPLC方法中阿魏酸、丹酚酸B、甘草酸铵和大黄素分别在3.13~62.68、4.71~94.24、2.92~58.40、2.07~41.36μg·mL^-1与峰面积线性关系较好;平均回收率分别为97.6%(RSD=2.3%)、98.6%(RSD=1.0%)、97.7%(RSD=1.7%)和98.1%(RSD=1.3%)。结论:此方法专属性强、精密度高、重复性好,可为建立通降汤院内制剂的质量标准提供参考。Objective:To establish the quality control standard of TongjiangTang. Methods:Radix et Rhizoma Rhei in the prescription was identified by TLC.Ferulic acid,salvianolic acid B,ammonium glycyrrhizinate and emodin in TongjiangTang were determined by HPLC. Results:The spots in TLC were clear and could be well separated,the negative samples showed no interference.In HPLC the linear range of schisandrin and geniposide were 3.13-62.68,4.71-94.24,2.92-58.40,2.07-41.36 μg · mL^-1 ,respectively,and the average recovery rate were 97.6%(RSD=2.3%),98.6%(RSD=1.0%),97.7%(RSD=1.7%)and 98.1%(RSD=1.3%),respectively. Conclusion:The methods were good in repeatability and reliable,and the study provides a reference for establishing the quality control method of TongjiangTang.

关 键 词：通降汤 大黄素 阿魏酸 丹酚酸B 甘草酸铵 高效液相色谱法 

分 类 号：R944.61[医药卫生—药剂学]