注射用紫杉醇(白蛋白结合型)调配方法的改进

Improvement of blending method for paclitaxel for injection(albumin-bound)

目的比较说明书指导的调配方法及改进的4种不同静置溶解方法对注射用紫杉醇(白蛋白结合型)平均溶解耗时及起泡率的影响,为提高注射用紫杉醇(白蛋白结合型)调配效率提供参考与借鉴。方法选取复旦大学附属中山医院厦门医院2021年8—12月注射用紫杉醇(白蛋白结合型)冲配医嘱,在注射用紫杉醇(白蛋白结合型)说明书中已提及的调配方法基础上,结合文献及自身调配经验改进调配方法,按照调配方式的不同细分为4种(整体浸湿、西林瓶竖直;整体浸湿、西林瓶水平横放;底面浸湿、西林瓶竖直;底面浸湿、西林瓶水平横放),主要涉及药品溶解及药液转移等过程,通过科学的统计学方法比较不同溶解方法的起泡率及溶解耗时,总结出起泡率低、溶解耗时短的调配方法。结果改进的4种调配方法较说明书指导的调配方法平均溶解耗时分别降低10.82、9.98、16.84、12.42 min,起泡率分别降低21.05%、32.31%、62.04%、65.10%,溶解耗时与起泡率均显著下降(P<0.05)。结论静置溶解时只浸湿冻干块状物底面且西林瓶竖直放置的起泡率低,溶解耗时最短。改进后的精细调配方法可操作性强,可有效减少药品在溶解、转移过程中产生泡沫,从而缩短调配耗时,提高工作效率,保障药物稳定性及给药剂量准确性,保障用药安全。

Objective To compare the effects of the instructional blending method and four different methods of static dissolution on the average dis solution time and foaming rate of paclitaxel for injection(album in-bound),so as to provide a reference for improving the blending efficiency of paclitaxel for injection(albumin-bound).Methods The blending instructions of paclitaxel for injection(albumin-bound)in Zhongshan Hospital,Fudan University(Xiamen Branch)from August to December 2021 were selected for the improvement according to the literature and hospital-specific blending experience,based on the bl ending method mentioned in the instructions for paclitaxel for injection(albumin-bound).And four types of improved blending methods were concluded according to the different blending methods(whole wetted,with vial placed vertically;whole wetted,with vial placed horizontally;bottom wetted,with vial placed vertically;bottom wetted,with vial placed horizontally),mainly involving the process of drug dissolution,liquid medicine transfer,etc.The blending methods with low foaming rate and short dissolution time were screened out by comparing the foaming rate and dissolution time of different blending methods with scientific statistical methods.Results The average dissolution time of the four improved blending methods was reduced by 10.82 min,9.98 min,16.84 min and 12.42 min,respectively,and the foaming rate was reduced by 21.05%,32.31%,62.04%and 65.10%,respectively,co mpared with those of the instructional method,with significant reduction in the dissolution time and foaming rate(P<0.05).Conclusion The foaming rate is low and the dissolution time is the shortest when only the bottom surface of the lyophilized block is wetted and the vial is placed vertically during static dissolution.The improved fine blending methods are highly operable and can effectively reduce the foaming rate during the dissolution and transfer of drugs,thus shortening the blending time,improving the work efficiency,gu aranteeing the stability of drugs and the accuracy of drug dosing,and further ensuring the safety of drug adminis tration.