摘要
目的建立同时测定丹参注射液中丹参素、原儿茶醛、迷迭香酸、丹酚酸B的方法,并用此法研究其指纹特征。方法采用高效液相色谱法同时测定丹参注射液中4种成分,色谱条件:以Hedera ODS-2(250 mm×4.6 mm,5μm)柱为分析柱;0.05%磷酸水-乙腈为流动相进行梯度洗脱;检测波长286 nm;柱温30℃;体积流量为1.0 mL/min。结果测定了丹参注射液中4种成分,丹参素、原儿茶醛、迷迭香酸、丹酚酸B分别在0.876～5.254μg(r=1.000)、0.424～2.544μg(r=1.000)、0.081～0.486μg(r=0.999 9)、0.084～0.506μg(r=0.999 9)范围内线性关系良好,平均回收率分别为96.09%、104.77%、98.55%、101.52%。并用此法建立了共有指纹图谱,包含20个共有峰,个峰分离度好,指认出5种特征水溶性有效成分。结论本试验同时对丹参注射液的4种成分和指纹图谱进行分析,快速、简便、准确,可作为全面评价该制剂质量的有效方法之一。
AIM To establish an HPLC method for simultaneously determing the level of danshensu,protocatechuic aldehyde,rosmarinic acid and salvianolic acid B in Danshen Injection and fingerprint chromatography.METHODS HPLC was used to determine the contents of four constituents.The analytical column was Hedera ODS-2 column（250 mm × 4.6 mm,5μm）.The mobile phase was composed of 0.05% orthophosphoric acid（A） and acetonitrile（B） with gradient elution.The flow rate was 1.0 mL/min,the detection wavelength was set at 286 nm and the column temperature was maintained at 30 ℃.RESULTS The fingerprint chromatography included 20 mutual peaks,and in which,five characteristic components were recognized.The linear ranges were in the range of 0.876-5.254 μg（r = 1.000）、0.424-2.544 μg（r = 1.000）、0.081-0.486 μg（r = 0.999 9）、0.084-0.506 μg（r =0.999 9）for danshensu,protocatechuic aldehyde,rosmarinic acid and salvianolic acid B,respectively.The average recoveries were 96.09% 、104.77% 、98.55% and 101.52%,respectively.CONCLUSION The method is rapid、simple and accurate and can be used for the quality control of Danshen Injection.
出处
《中成药》
CAS
CSCD
北大核心
2011年第4期553-556,共4页
Chinese Traditional Patent Medicine
关键词
丹参注射液
多成分
定量测定
指纹图谱
Danshen Injection
main constituents
determination
fingerprint chromatography
