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 1300 mm length × 7. 8 mm I. D. , 8 μim) 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 97.1Z% 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.%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].这些方法专属性差或样品制备繁琐,而离子排斥色谱法( IEC)样品前处理简单[5],准确度高,重现性好,适合于同时定量分析多种有机酸.本研究利用离子排斥色谱法对生脉注射液中的主要水溶性有机酸进行了分析,结果稳定可靠.
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