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聚山梨酯80致多西紫杉醇注射液异常现象的初步分析

  

  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2012-01-25

Preliminary Analysis of Polysorbate 80 Induced Docetaxel Injection's Abnormal Phenomenon

  • Received:1900-01-01 Revised:1900-01-01 Online:2012-01-25

摘要: 目的:确定引起多西紫杉醇注射液异常现象的原因,并给予建议.方法:综合分析原辅料、生产工艺、储藏等因素,找出主要影响因素,并通过实验明确关键指标以及其限度.结果:与聚山梨酯80质量及凝点密切相关的脂肪酸是油酸和棕榈油酸,油酸含量越高、棕榈油酸含量越低,聚山梨酯80的质量越好,凝点越低.结论:多西紫杉醇注射液异常现象为辅料聚山梨酯80质量所致,关键指标为聚山梨酯80的脂肪酸组成及凝点,建议限度分别为油酸含量>80%,棕榈油酸含量<0.1%,凝点<-5℃.

Abstract: Objective:To determine the cause of Docetaxel injection’s abnormal phenomenon and give advice.Methods:Find out the major influence factor by comprehensive analysis of the supplementary materials,processing technique,storage and so on.In addition,via the designed experiment,determine the crucial standards and qualifications.Results:The fatty acids closely related to polysorbate 80’s quality and solidifying point are oleic acid and palmitoleic acid.The higher content of oleic acid,and the lower content of palmitoleic acid,polysorbate 80’s quality will be better,and solidifying point will be lower.Conclusion:Docetaxel injection’s abnormal phenomenon was induced by the quality of polysorbate 80,whose fatty acid composition and solidifying point are the crucial standards.The qualifications could be oleic acid content more than 80%,palmitoleic acid content less than 0.1%,solidifying point less than-5℃.