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《Chinese Journal of Medicinal Guide》 2012-01
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Preliminary Analysis of Polysorbate 80 Induced Docetaxel Injection's Abnormal Phenomenon

Zhang Weidong(General Hospital of Beijing Military District,Beijing 100700,China)  
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℃.
【CateGory Index】: R943
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