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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 ,具有一定的临床应用价值
Objective To study the clinical significance of the change of physical properties of common doxorubicin lipiodol emulsion and doxorubicin lipiodol suspension after heat treatment. Methods Urap-ADME emulsion (UAE-UME) and UFL-UAS (UAS) were prepared by pumpingtechnique at 25 ℃, 40 ℃ , 50 ° C, 60 ° C water bath for 2 h, the lactation and delamination time were observed, the relative viscosity was measured, the state of the preparation particles was observed under a microscope, and the solution was released into the dialysate by ultravioletspectrophotometry method The concentration of mycotoxin, calculate the release rate. Results The suspensions and the common emulsions appeared early after heating and the large particles / oil droplets increased under the microscope. From 25 ℃ to 60 ℃, the relative viscosity and relative viscosity decreased nearly 2-fold and the dissolution rate decreased significantly (P <0. 05). The release rates were nearly equal between the treatments at 25 ℃, 40 ℃ and 50 ℃ (P> 0.05). At 60 ℃, the concentrations of doxorubicin in the suspension group and the normal emulsion group were nearly equal to those in the saline group (P> 0.05). CONCLUSION: Adriamycin lipiodol suspension and common emulsion have lower physical stability, lower viscosity and slower release of doxorubicin after heat treatment, which has some clinical value