加热处理阿霉素碘油制剂临床意义的实验研究  

The Experiment Study on Clinical Significance of Heated Lipiodol-doxorubicin Pharmaceutics

作　　者：杨利[1] 王执民[1] 吴道澄[2] 张洪新[1] 李晓晔[2] 郭卫平[1] 吴智群[1] 吴红[2] 李文献[1] 王义清[1] 曹玮[1] 刘毅勇[1] 陈岚[1] 王敏[1] 谢劲波[1] 刘宇峰[1] 

机构地区：[1]第四军医大学唐都医院介入放射科,陕西西安710038 [2]第四军医大学基础部化学教研室

出　　处：《实用放射学杂志》2004年第4期293-297,共5页Journal of Practical Radiology

摘　　要：目的　研究普通阿霉素碘油乳剂和阿霉素碘油混悬剂热处理后的物理性状改变的临床意义。方法　用“泵法”(pumpingtechnique)制成普通阿霉素碘油乳剂 (UFL -ADMEmulsion ,UAE)和阿霉素碘油混悬剂 (UFL -ADMSuspension ,UAS) ,分别在 2 5℃、40℃、5 0℃、60℃水浴箱中加热 2h后 ,观察乳析和分层时间 ,测定相对粘度 ,在显微镜下观察制剂微粒的状况 ,用紫外分光光度法(ultravioletspectrophotometicmethod)测定释放到透析液中阿霉素的浓度 ,计算释放率。结果　混悬剂和普通乳剂在加热后层析 /沉淀出现早 ,显微镜下大颗粒 /油滴增多。从 2 5℃到 60℃ ,相对粘度和相对粘度比下降了近 2倍 ,溶出速率明显降低 (Ρ <0 .0 5 ) ;2 5℃、40℃、5 0℃处理组间释放速率近乎相等 (Ρ >0 .0 5 ) ;60℃条件下 ,混悬剂组和普通乳剂组与作为对照组的生理盐水组中的阿霉素浓度几近相等 (Ρ >0 .0 5 )。结论　阿霉素碘油混悬剂和普通乳剂在热处理后 ,物理稳定性下降 ,粘度减小 ,阿霉素释放速度减慢 。Objective To investigate the clinical significance of the physicochemical properties of two types of Lipiodol-Adriamycin pharmaceutics after heated. Methods Ultra-fluid lipiodol Adriamycin emulsion (UFL-ADM Emulsion, UAE) and ultra-fluid lipiodol Adriamycin suspension (UFL-ADM Suspension, UAS) was prepared by 'pumping technique'.After heated up at different temperature of 25℃,40℃,50℃,60℃ for two hours, the time of delamination and sediment of pharmaceutics was counted, the viscosity was measured, the form of the particle was observed by the microscope, the concentration of ADM in liquid of dialysis was measured by ultraviolet spectrophotometic method for the ADM releasing rate.Results After heated up,the delamination and sediment of UAS and UAE was speeded up. In the sight of the microscope, the heated pharmaceutics had more big particulate/oil-drop. In comparison with the degree of 25℃, both the relative viscosity and the relative viscosity ratio of the two pharmaceutics reduced about two times at the degree of 60℃, the releasing rate was lower(Ρ<0.05). Among the groups at the degree of 25℃,40℃,50℃, each pharmaceutics had nearly the same releasing rate(Ρ>0.05). In the group at the degree of 60℃, the releasing rate of UAS, USE and Adriamycin-Saline solution almost had no difference(Ρ>0.05). Conclusion After heated, the physical stability of UAE and UAS is reduced, the viscosity become lower, ADM releasing rate is fell. The heated Lipiodol-Adriamycin pharmaceutics had advantage in the interventional embolization chemotherapy of the neoplasm.

关 键 词：阿霉素 碘油制剂 乳剂 混悬剂 肿瘤 介入性热化疗 并发症 

分 类 号：R454.5[医药卫生—治疗学] R815[医药卫生—临床医学]