药用辅料聚山梨酯80的质量研究

为了完善并提高聚山梨酯80的现行质量标准,为《中华人民共和国药典》(2015版)四部聚山梨酯80的质量标准修订提供理论参考,对国内外6个生产企业共16批聚山梨酯80样品进行质量研究,优化部分杂质的检测方法;调整环氧乙烷和二氧六环检查项分流比,并适当提高对照品溶液配制浓度,更换溶剂;提高乙二醇和二甘醇检查项对照品溶液及内标溶液浓度;增加红外光谱法鉴别及三甘醇检查项。对改进的方法进行相应的方法学考察。实验结果表明,改进后的方法专属性、精密度、线性关系以及回收率等均良好,提高后的质量标准更适用于聚山梨酯80的质量检测,并从安全性和规范性上提高了聚山梨酯80的质量标准。

Quality study of pharmaceutical excipient polysorbate 80

To improve the current quality standards of polysorbate 80 and provide reference recommendations for the revision of the quality standards of polysorbate 80 in the fourth part of China Pharmacopoeia(2015 Edition). A total of 16 batches of polysorbate 80 samples from 6 domestic and foreign production companies were studied, optimize the detection method for some impurities. Adjust the split ratio of the ethylene oxide and dioxane check items, and appropriately increase the concentration of the reference solution solution and change the solvent. In the ethylene glycol and diethylene glycol items, the concentration of the reference solution and the internal standard solution were appropriately increased. The infrared identification and the triethylene glycol check items were added to the quality standards, and we carry out corresponding methodological investigation on the improved method. The results showed that the improved methods had good specificity, precision, linearity and recovery rate. The improved quality standard is more suitable for the detection of polysorbate 80, and can increase the quality standards of polysorbate 80 from safety and standardization.