差示扫描量热法评价聚山梨酯80质量  

Quality Evaluation of Polysorbate 80 by a Differential Scanning Calorimetry

作　　者：韩荣[1] 李蒙[1] 张海燕[2] 齐云[1] 杨明[2] 廖永红[1] 

机构地区：[1]中国医学科学院北京协和医学院药用植物研究所,100193 [2]江西中医学院现代中药制剂教育部重点实验室,南昌330004

出　　处：《医药导报》2011年第11期1481-1484,共4页Herald of Medicine

基　　金：科技部国家科技重大专项资助项目(基金编号:2009ZX09103-351);国家中医药管理局中医药行业专项资助项目(基金编号:200708006)

摘　　要：目的研究差示扫描量热法(differential scanning calorimetry,DSC)作为聚山梨酯80质量评价方法的可行性。方法采用DSC对8个不同品牌的聚山梨酯80进行表征,分析DSC图谱中熔点和峰型;采用酶标法测定聚山梨酯80对家兔体外溶血的影响;采用肌酸激酶(creatine kinase,CK)试剂盒测定聚山梨酯80对L6细胞的刺激性。结果同一品牌同一批聚山梨酯80熔点相对标准偏差(relative standard deviation,RSD)在5%以内,重复性良好。DSC热分析图具有较好的灵敏度,可甄别批次间成分存在的一定差异。DSC热分析图的差异和品质有直接的相关性,不同品牌的聚山梨酯80呈现差异较大的热分析图,表明这些样品成分差异较大,这一结果得到了体外溶血性和骨骼肌刺激性实验结果的证实。结论 DSC技术可以作为聚山梨酯80质量评价的一种半定量方法。Objective To investigate the applicability of differential scanning calorimetry（DSC） to evaluate the quality of polysorbate 80. Methods Eight different brands of polysorbate 80 were characterized by DSC,and the melting points and peak shape of polysorbate 80 were analyzed.The hemolysis of rabbit in vitro induced by polysorbate 80 was determined with ELISA at 540 nm,whilst the muscle irritation was tested by using creatine kinase（CK） kit following exposure of L6 cells with polysorbate 80. Results DSC thermograms showed an excellent reproducibility for the same brand and same batch of polysorbate 80 with the RSD of melting points within 5%.In addition,they were sensitive and distinguished difference between batches or brands of polysorbate 80.DSC thermograms was directly related to the quality.Different batches of polysorbate 80 presented different DSC thermograms,demonstrating differences within constituents of samples,which was confirmed by the results of hemolysis and muscle irritation. Conclusion DSC has the potential to be utilized as a semi-quantitative means for the quality evaluation of polysorbate 80.

关 键 词：聚山梨酯80 溶血性 刺激性 差示扫描量热法 质量评价 

分 类 号：R94[医药卫生—药剂学] R927.1[医药卫生—药学]