聚乙二醇化盐酸多柔比星脂质体注射液药代动力学的对比研究

发布时间：2018-04-28 22:00

本文选题：盐酸多柔比星脂质体注射液 + 药代动力学　；参考：《中国医药工业杂志》2017年11期

【摘要】：为了评价盐酸多柔比星脂质体受试制剂(S)和进口同规格参比制剂(R)的一致性,对比研究了2种制剂单次静脉注射后,在SD大鼠和荷人卵巢癌A-2780肿瘤裸鼠的血清和不同组织内的药物浓度。建立了HPLC-FLD法,用于测定SD大鼠血清、荷瘤裸鼠血清和肿瘤中多柔比星(1)总含量(即游离1和PEG化脂质体中1的含量总和)和PEG化脂质体中1含量,以及大鼠不同组织中1的总含量。结果显示,两种制剂以5 mg/kg的剂量,尾静脉注射给予SD大鼠,给药后1 h、24 h和72 h,分别对9个组织脏器中的1总含量进行双单侧检验分析,在P=0.05水平上2种制剂的差异不显著;2种制剂以10 mg/kg的剂量,尾静脉注射给予荷瘤裸鼠,给药后1 h、24 h和72 h分别对瘤内1总含量和PEG化脂质体中1含量进行双单侧检验分析,在P=0.05水平上2种制剂的差异也不显著。由此推断,受试制剂与参比制剂在动物体内的分布无统计学差异。
[Abstract]:In order to evaluate the consistency of doxorubicin liposome (S) and imported standard reference preparation (R), the drug concentration in serum and different tissues of SD rats and human ovarian cancer A-2780 tumor nude mice after 2 kinds of single intravenous injection was compared and studied. A HPLC-FLD method was established to determine the serum of SD rats and nude mice bearing tumor. The total content of doxorubicin (1) in serum and tumors (the total of 1 in free 1 and PEG liposomes) and 1 in PEG liposomes, as well as the total content of 1 in the different tissues of the rats. The results showed that the two preparations were given to SD rats at 5 mg/kg doses with the tail vein, 1 h, 24 h, and 72 h, respectively, for 1 in 9 tissues and organs, respectively. The analysis of double unilateral test showed that there was no significant difference between the 2 preparations at the level of P=0.05; the 2 kinds of preparations were given 10 mg/kg of the dose, the tail vein was given to the nude mice with tumor, 1 h, 24 h and 72 h respectively, and the total content of 1 in the tumor and the 1 content in the liposome were analyzed by double unilateral test, and the difference of the 2 preparations at the P=0.05 level was not significant. It was concluded that there was no significant difference in the distribution of the tested preparations and reference preparations in animals.

【作者单位】：中国医药工业研究总院上海医药工业研究院创新药物与制药工艺国家重点实验室/上海市生物物质成药性评价专业技术服务平台;上海复旦张江生物医药股份有限公司;
【分类号】：R965

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