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作 者:丁宁[1] 郑云枫[1] 程建明[1] 李贺敏[1] 彭国平[1]
机构地区:[1]南京中医药大学,南京210029
出 处:《中国药房》2012年第8期744-746,共3页China Pharmacy
摘 要:目的:建立丹参滴注液中丹酚酸D的分离及同时测定其中丹参素、原儿茶醛、丹酚酸D和丹酚酸B含量的方法。方法:采用反相高效液相色谱法分离及含量测定。色谱柱为Kromasil C18柱,流动相为乙腈-1%冰乙酸(梯度洗脱),流速为1.0mL·min-1,进样量为10μL,柱温为30℃,检测波长为281nm。结果:从制剂中分离并鉴定出丹酚酸D标准品。丹参素、原儿茶醛、丹酚酸D、丹酚酸B的检测浓度分别在60.9~975.0、8.7~139.0、11.0~175.8、2.7~43.2μg·mL-1范围内与其峰面积积分值呈良好的线性关系;平均加样回收率分别为99.1%、100.2%、98.3%,100.4%、102.5%、101.1%,101.4%、97.0%、102.1%,100.6%、99.2%、101.3%,RSD分别为0.94%、0.97%、2.78%、1.07%。结论:该方法简单、快速、专属性好,可用于丹参滴注液的质量控制。OBJECTIVE:To establish the method for the isolation and identification of salvianolic acid D and simultaneous determination of tanshinol,protocatechuic aldehyde,salvianolic acid D and B in Danshen infusion.METHODS:RP-HPLC method was adopted for isolation and content determination.The determination was performed on Kromasil C18 column with mobile phase consisted of acetonitrile-1% glacial acetic acid at the flow rate of 1.0 mL·min-1.The injection volume was 10 μL and column temperature was 30 ℃.The detection wavelength was set at 281 nm.RESULTS:Salvianolic acid D had been succeddfully isolated and indentified.The linearities of tanshinol,protocatechuic aldehyde,salvianolic acid D,salvianolic acid B were 60.9~975.0,8.7~139.0,11.0~175.8,2.7~43.2 μg·mL-1.The average recoveries rate were 99.1%,100.2%,98.3%,100.4%,102.5%,101.1%,101.4%,97.0%,102.1%,100.6%,99.2%,101.3%,and the RSDs were 0.94%,0.97%,2.78%,1.07%.CONCLUSION:The method is simple,rapid and specific.It may be suitable for the quality control of Danshen infusion.
关 键 词:丹参滴注液 丹参素 原儿茶醛 丹酚酸D 丹酚酸B 反相高效液相色谱法
分 类 号:R917[医药卫生—药物分析学]
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