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有机酸广泛分布在植物及相关产品中,其参与多种代谢途径(如三羧酸循环),并表现出多种药理活性。参附注射液作为广泛使用的中药注射剂,不良反应时有报道。因而,应深入阐明参附注射液的化学组成,并制定严格的质量标准,进而保障其临床使用安全有效。参附注射液由红参及黑顺片经现代工艺提取制备而成,有机酸为其主要成分类别之一。该研究通过建立HILIC-LC-MS,同时测定参附注射液中肉桂酸、阿魏酸、4-羟基苯甲酸、乳酸、己二酸、延胡索酸、咖啡酸、琥珀酸、马来酸、丙二酸、苹果酸、莽草酸、酒石酸和金鸡纳酸等14种有机酸成分的含量。14种有机酸类成分在HILIC色谱柱上均获得较好的保留和分离。除肉桂酸(231μg·L~(-1))、乳酸(113μg·L~(-1))和丙二酸(32.5μg·L~(-1))外,其余11个化合物的定量限均小于10μg·L~(-1)。定量结果表明,苹果酸、丙二酸、奎尼酸、乳酸和肉桂酸在参附注射液中含量较高(>1.89 mg·L~(-1)),而10批样品中均未检测到咖啡酸和己二酸。该方法适用于参附等中药注射液中多种有机酸含量的同时测定。
Organic acids are widely distributed in plants and related products and are involved in a variety of metabolic pathways (eg, tricarboxylic acid cycles) and exhibit various pharmacological activities. Shen Fu injection as a widely used traditional Chinese medicine injection, adverse reactions have been reported. Therefore, the chemical composition of Shenfu Injection should be thoroughly elucidated and strict quality standards should be formulated to ensure its clinical use is safe and effective. Shenfu injection by the red ginseng and black tablets prepared by modern technology extracted from organic acids as one of its main component categories. In this study, HILIC-LC-MS was used to determine the contents of cinnamic acid, ferulic acid, 4-hydroxybenzoic acid, lactic acid, adipic acid, fumaric acid, caffeic acid, succinic acid, maleic acid, Acid, malic acid, shikimic acid, tartaric acid and cinchona 14 kinds of organic acid content. Fourteen organic acids were well retained and separated on HILIC columns. Except cinnamic acid (231μg · L -1), lactic acid (113μg · L -1) and malonic acid (32.5μg · L -1), the limits of quantification Less than 10μg · L -1. Quantitative results showed that malic acid, malonic acid, quinic acid, lactic acid and cinnamic acid were higher in Shenfu injection (> 1.89 mg · L -1), but none of the 10 batches of samples Caffeic acid and adipic acid. The method is suitable for simultaneous determination of various organic acids in Shenfu and other Chinese traditional medicine injection.