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目的我国糖肽类药物国家标准采用比色法测定多糖含量,游离单糖或二糖会影响含量测定结果,本实验建立了糖肽类药物中游离糖含量测定方法。方法固相萃取小柱去除样品基体,高效阴离子交换-脉冲安培检测法,Carbo PacPA20阴离子交换柱,200 mmol·L-1氢氧化钠溶液和1 mol·L-1醋酸钠溶液梯度洗脱,脉冲安培检测器,金工作电极,Ag/Ag Cl参比电极,四电位糖检测波形。结果测定薄芝糖肽、甘露聚糖肽、云芝胞内糖肽原料及制剂20批样品,结果 8批样品中检出较高含量游离单糖,包括葡萄糖、蔗糖、甘露糖和果糖。与其他糖检测方法相比,该方法有专属、灵敏、快速、应用范围广等特点。结论该方法适用于各种糖类化合物的分析,有良好的应用和发展前景;我国糖肽类药物标准中含量测定方法亟待改进。
Objective To determine the content of polysaccharides in Chinese glycopeptide drugs by colorimetric method, the content of free polysaccharides or disaccharides will affect the assay results. The method of determining free sugars content in glycopeptide drugs was established in this experiment. Methods Solid phase extraction cartridges were used to remove the sample matrix. High performance anion exchange-pulsed amperometric detection, Carbo PacPA20 anion exchange column, gradient elution with 200 mmol·L-1 sodium hydroxide solution and 1 mol·L-1 sodium acetate solution , Pulsed ampere detector, gold working electrode, Ag / Ag Cl reference electrode, four-potential sugar detection waveform. Results The results showed that the higher content of free monosaccharides, including glucose, sucrose, mannose and fructose, were detected in 8 batches of samples. Compared with other sugar detection methods, the method has its own characteristics, such as sensitivity, speediness and wide application range. Conclusion The method is suitable for the analysis of various carbohydrate compounds, and has good application and development prospects. The determination of the content of glycopeptide drugs in our country needs to be improved urgently.