HPLC法测定丹参类注射液中4种水溶性成分含量Simultaneous determination of 4 water-soluble components in danshen-containing injections by HPLC
潘英妮,袁丹,付文卫,王爱萍,鹿野美弘
PAN Ying-ni 1; YUAN Dan 1; FU Wen-wei 1; WANG Ai-ping 1; KANO Yoshihiro 2 (1. School of Traditional Chinese Materia Medica;
摘要(Abstract):
目的采用HPLC法同时测定香丹注射液 (复方丹参注射液 )及丹参注射液中 4种水溶性成分丹酚酸B、迷迭香酸、丹参素和原儿茶醛含量。方法采用HypersilC18(2 5 0mm× 4 6mm ,5 μm)色谱柱 ;以甲醇 水 二甲基甲酰胺 冰醋酸为流动相梯度洗脱 ;流速为 1 0mL/min ;柱温为 35℃ ;检测波长 2 80nm。结果丹参素、原儿茶醛、迷迭香酸和丹酚酸B线性范围分别在 0 0 194~0 194 0 g·L-1、0 0 0 4 0 4~ 0 0 4 0 4 g·L-1、0 0 0 80 8~ 0 0 80 8g·L-1和 0 0 2 6 0~ 0 2 6 0 0 g·L-1内 ,线性关系良好 (r≥ 0 9998) ;加样回收率分别为 10 4 % ,98 3% ,10 1% ,10 3% ,RSD <2 0 %。结论本研究为丹参类注射液的质量综合评价和控制提供了简单、准确、可行的分析方法。
Objective To develop a reversed-phase HPLC method for the simultaneous determintion of 4 water-soluble components,danshensu,protocatechuic aldehyde,rosmarinic acid and salvianolic acid B,in commercial compound danshen(traditional Chinese medicine,Salvia miltiorrhiza Bge.)injections and danshen injection.Method A gradient HPLC system was used in the quantitative analysis of the above 4 water-soluble components,including the ODS reversed-phase column of Hypersil C 18 (4.6 mm× 250 mm, 5 μm),the mixed solvents of methanol-water-dimethyl formamide-acetic acid at the flowrate of 1.0 mL·min -1.The eluate was monitored with UV absorption at 280 nm.Result The linear ranges of danshensu,protocatechuic aldehyde,rosmarinic acid and salvianolic acid B were 0.019 4~ 0.194 0 g·L -1, 0.004 04~ 0.040 4 g·L -1, 0.008 08~ 0.080 80 g·L -1 and 0.026 0~ 0.260 0 g·L -1( r≥ 0.999 8),respectively.The RSD were less than 2.0%,and the recoveries were from 98.3% to 104%.Conclusion The method is of good accuracy and a simple procedure.It may be practical to evaluate and control the quality of danshen-containing injections.
关键词(KeyWords):
丹参;丹酚酸B;迷迭香酸;丹参素;丹参类注射液;反相高效液相色谱法;含量测定;香丹注射液
Salvia miltiorrhiza Bge.; salvianolic acid B; rosmarinic acid; danshensu; danshen-containing injections; RP-HPLC; quantitative analysis; xiangdan injection
基金项目(Foundation):
作者(Authors):
潘英妮,袁丹,付文卫,王爱萍,鹿野美弘
PAN Ying-ni 1; YUAN Dan 1; FU Wen-wei 1; WANG Ai-ping 1; KANO Yoshihiro 2 (1. School of Traditional Chinese Materia Medica;
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- 丹参
- 丹酚酸B
- 迷迭香酸
- 丹参素
- 丹参类注射液
- 反相高效液相色谱法
- 含量测定
- 香丹注射液
Salvia miltiorrhiza Bge. - salvianolic acid B
- rosmarinic acid
- danshensu
- danshen-containing injections
- RP-HPLC
- quantitative analysis
- xiangdan injection
- 潘英妮
- 袁丹
- 付文卫
- 王爱萍
- 鹿野美弘
PAN Ying-ni 1 - YUAN Dan 1
- FU Wen-wei 1
- WANG Ai-ping 1
- KANO Yoshihiro 2 (1. School of Traditional Chinese Materia Medica
- 潘英妮
- 袁丹
- 付文卫
- 王爱萍
- 鹿野美弘
PAN Ying-ni 1 - YUAN Dan 1
- FU Wen-wei 1
- WANG Ai-ping 1
- KANO Yoshihiro 2 (1. School of Traditional Chinese Materia Medica