丹参滴注液中果糖、丹参酸B含量的检测方法  

Content Detection Methods of Fructose and Salvianolic Acid B in Salvia Miltiorrhiza Infusion

作　　者：刘将 周仓 LIU Jiang;ZHOU Cang(Shanghai Huayuan Anhui Jinhui Pharmaceutical Co.,Ltd.,Fuyang 236018;Bozhou University,Bozhou,Anhui 236800)

机构地区：[1]上海华源安徽锦辉制药有限公司,安徽阜阳236018 [2]亳州学院,安徽亳州236800

出　　处：《怀化学院学报》2020年第5期21-25,共5页Journal of Huaihua University

基　　金：安徽省校企合作实践教育基地“亳州学院安徽九洲方圆制药有限公司实践教育基地”(2019sjjd66).

摘　　要：目的:建立一种适用于丹参滴注液中果糖、丹酚酸B含量的检测方法.方法:采用HPLC-RID法检测丹参滴注液中的果糖成分含量;HPLC-UV法检测丹参滴注液中的丹酚酸B含量.结果:HPLC-RID法的果糖浓度检测范围为0.6273~20.0740 mg/mL,平均回收率为100.15%,RSD=0.77%,连续测得3批丹参滴注液果糖含量为633.68~643.50 mg/瓶(250 mL);HPLC-UV法的丹酚酸B浓度检测范围为2.7~43.2μg/mL,平均回收率为100.3%,RSD=1.51%,连续测得3批丹参滴注液丹酚酸B含量为3.07~3.29 mg/瓶(250 mL).结论:HPLC-RID法能够快速地对丹参滴注液中所含果糖成分进行准确的检测;HPLC-UV法能够快速地对丹参滴注液制剂中所含丹酚酸B成分进行准确的检测.[Objective]To better control the quality of salvia miltiorrhiza infusion,explore and establish an analyzing method for the content of fructose and salvianolic acid B in salvia miltiorrhiza infusion.[Methods]The analysis of fructose was performed on Phecda-NH2 column with refractive index detector(RID),and the salvianolic acid B content was determined with HPLC-UV.[Results]The data showed that the detection range of fructose concentration is from 0.6272 to 20.0740 mg/mL,and the mean recovery of fructose is 100.15%,with RSD of 0.77%,the fructose contents in three samples were from 633.68 to 643.50 mg/bottle(250 mL).The detection range of salvianolic acid B concentration is from 2.7 to 43.2μg/mL,and mean recovery of salvianolic acid B is 100.3%,with RSD of 1.51%,the salvianolic acid B content in three samples were from 3.07 mg/bottle to 3.29 mg/bottle(250 mL),respectively.[Conclusion]The HPLC-RID and HPLC-UV methods are reliable,reproducible,and can be used for the quality control of salvia miltiorrhiza infusion.

关 键 词：丹参滴注液 果糖 HPLC-RID法 丹酚酸B HPLC-UV法 

分 类 号：R917[医药卫生—药物分析学]