摘要
目的:以聚山梨酯80的色泽与脂肪酸组成作为考察指标,探求可提高其品质的有效途径。方法:参考《欧洲药典》建立聚山梨酯80脂肪酸组成的检测方法并对市售样品进行测定,后围绕浊点萃取法、三相分离法以及基于其制备原料(油酸)纯度控制这3种方法展开聚山梨酯80的精制工艺研究。结果:当选用高纯度油酸作为聚山梨酯80制备的起始原料时,产品的脂肪酸组成可达到《欧洲药典》要求,并且聚山梨酯80经浊点萃取法和三相分离法两种方法精制后,尤其经三相分离法精制后,产品的色泽可接近无色。结论:应当选用高品质起始原料进行聚山梨酯80的制备,并配合三相分离法的使用,可实现聚山梨酯80产品外观与内在品质的共同提高。
Objective： To improve the quality of polysorbate 80 by monitoring its color and fatty acid. Methods： This paper established a method to detect the fatty acids composition of polysorbate 80 with reference to the European Pharmacopoeia and used this method to detect the polysorbate 80 from markets.,.Based on the cloud point extraction, three phase partitioning and purification control of the starting material （oleic acid）, we studied the refining technology of polysorbate 80. Results： The outcomes demonstrate that if oleic acid with high quality was used as raw material, the fatty acid composition of / polysorbate 80 will meet the standard of European Pharmacopoeia. Besides, after being refined with the two methods, especially with three phase partitioning, the quality of polysorbate 80 will get further improved through making the products nearly colorless. Conclusion： Utilizing three phase partitioning accompanied with high-quality starting materials, the outlook and quality of the products were both improved.
出处
《药学与临床研究》
2010年第1期46-49,共4页
Pharmaceutical and Clinical Research
关键词
聚山梨酯80
脂肪酸组成
精制
浊点萃取法
三相分离法
olysorbate 80
Fatty acids composition
Refining
Cloud point extraction
Three phase partitioning
