离子排斥色谱法测定生脉注射液中的有机酸

Determination of Organic Acids in Sheng-mai Injection by Ion Exclusion Chromatography

1引言 生脉注射液是由红参、麦冬和五味子3种药材经提取后制成的灭菌水溶液,为国家中药保护品种,具有益气养阴,复脉固脱的功效。前期的分析实验表明,生脉注射液中含有有机酸类成分。根据生脉注射液的生产工艺和3种药材的的化学成分研究报道,分析生脉注射液中的有机酸主要来源于五味子。五味子含有柠檬酸、苹果酸、琥珀酸等多种有机酸成分。目前,有机酸的分析方法有气相色谱法[1]、高效液相色谱法[2]、毛细管电泳法[3]及离子色谱法[4]。

A method was developed for the separation and determination of three organic acid,viz citric acid,malic acid and succinic acid in Sheng-mai Injection by ion exclusion chromatography with suppressed conductivity detection.The chromatographic separation was performed on a Transgenomic Sep-ION-300 column（300 mm length ×7.8 mm i.d.,8 μm） at 70 ℃ and eluted with a mixture of 5 mmol/L sulphuric acid and acetone（95 ∶ 5） at the flow rate of 0.4 mL/min.The effects of the concentration of sulphuric acid,the volume ratio of acetone and column temperature were investigated and optimized.The calibration curve for citric acid,malic acid and succinic acid was in a good linearity in the range of 7.45-476.5 mg/L,14-521.0 mg/L and 3.47-222.0 mg/L,respectively.The average recovery for citric acid,malic acid and succinic acid was 97.12% with RSD 2.7%,96.9% with RSD 2.3%,and 95.09% with RSD 1.9%,respectively.The validated method was successfully applied to determination of organic acids in 15 batches of Sheng-mai Injection.