不同来源聚山梨酯80对多西他赛注射液质量的影响

以《中国药典》(2010年版)为质量标准,对10种不同来源的聚山梨酯80的质量进行比较,并评价聚山梨酯80对多西他赛注射液质量的影响。以真空溶剂蒸发法制备多西他赛注射液,以含量、单个有关物质及总杂质为指标,运用期望值分析法研究多西他赛注射液的综合质量。结果显示不同来源聚山梨酯80的质量存在差异,多西他赛注射液的稳定性受聚山梨酯80的影响较大,其中聚山梨酯80的过氧化值与多西他赛含量呈负相关。因此,应严格控制聚山梨酯80的过氧化值,以保证多西他赛注射液的产品质量。

Effects of polysorbate 80 of different sources on the quality of docetaxel injection

This investigation was carried out for the quality comparison of ten kinds of polysorbate 80 from different sources according to Chinese Pharmacopoeia(ChP 2010)and evaluated the effect of polysorbate 80 on the quality of docetaxel injection.Docetaxel injections were prepared by solvent vacuum evaporation method,the content of docetaxel,individual impurity and total impurity content were chosen as the index,a comprehensive quality evaluation of docetaxel injection was conducted by desirability analysis.The results showed that polysorbate 80 from different sources had quality differences,and peroxide value of polysorbate 80 affected the quality of docetaxel injection.It should be emphasized that controlling the peroxide value of polysorbate 80 would be very important for qualified docetaxel injection.