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KromasilC18柱,流动相为乙腈-1％冰乙酸(梯度洗脱),流速为1.0 mL·min-1,进样量为10μL,柱温为30℃,检测波长为281 nm.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、2.7～43.2 μg·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 °C. The detection wavelength was set at 281 run. 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 ng·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.
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