紫杉醇注射液的制备及其物理稳定性的初步评价

目的制备紫杉醇注射液 ,初步评价其物理稳定性。方法采用混合表面活性剂和混合溶剂对紫杉醇进行增溶 ,制备了紫杉醇注射液。选择适当的等渗液稀释后 ,用激光NICOMP3 80 /ZLS系统测不同时间下相应动态光散射光谱的体积分布频率、散射强度分布频率图谱。结果与结论注射液稀释后的动态光散射光谱 6h内无明显差别 ,粒径大小及分布均符合静脉滴注要求。该制剂制备工艺简单 ,室温放置 1 5a后注射液外观澄清 ,稀释后测定粒径与粒径分布无明显变化 ,物理稳定性良好。

Preparation and preliminary evaluation of physical stability of the paclitaxel injection

Objective To prepare the paclitaxel injection, and evaluate the physical stability of the drug.Methods The solubility of paclitaxel was enhanced by co-surfactant and co-solvent, and the paclitaxel injection was prepared.A suitable injection diluent was selected.After diluting it, their volume-weighted particle size distribution (PSDV) and the corresponding intensity-weighted (PDSI) were measured by the Nicomp 380/ZLS system.Results and Conclusions The process of the preparation was easy.The PSD of the paclitaxel injection was not different for 6 h after dilution.The particle size and distribution accorded with the specification of the injection for i.v.administration.After 1.5year's saving, the particle size and distribution of the injection didn't change after dilution, which indicates that the system is an ideal case of a uniform distribution with a good physical stability.