【摘 要】
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该文对新型紫杉醇给药系统--“聚乙二醇-氨基酸-紫杉醇”型前药的特性进行了研究,测定了前药的水溶性和紫杉醇含量.结果表明,此类前药的水溶性良好（达紫杉醇的200～400倍）.在体外
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该文对新型紫杉醇给药系统--“聚乙二醇-氨基酸-紫杉醇”型前药的特性进行了研究,测定了前药的水溶性和紫杉醇含量.结果表明,此类前药的水溶性良好（达紫杉醇的200～400倍）.在体外模拟体内环境（pH7.4的磷酸缓冲溶液,37℃）对前药进行药物释放测定,采用累计释放法通过高效液相色谱检测紫杉醇浓度.利用自行合成的多西紫杉醇,并参照Aventis公司产品处方,进行了多西紫杉醇注射浓缩液制备工艺的研究,最终研制了多西紫杉醇注射液.对多西紫杉醇原料药及注射浓缩液建立了高效液相色谱分析检测方法.为多西紫杉醇原料药和注射浓缩液质量标准的拟订提供了必要的依据.建立了鲎试剂检测多西紫杉醇注射浓缩液中的细菌内毒素的方法.
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