激光散射法分析异丙酚纳米乳剂的粒径大小与分布

Analysis of the particle size and distribution of propofol nanoemulsion by the laser diffraction method

目的制备异丙酚纳米乳剂 ,以激光散射光谱分析其粒径大小与分布 ,为微粒分散药物制剂物理稳定性的研究提供简便、快速、有效的方法。方法制备 3种处方不同 ,工艺相同的异丙酚纳米乳剂 (分别为Ⅰ、Ⅱ及Ⅲ ) ,以激光NICOMP3 80 /ZLS系统测得相应动态光散射光谱的体积为权重的重量平均粒径分布、散射强度为权重的重量平均粒径分布。结果 3个制剂动态光散射光谱有显著差别。纳米乳剂Ⅰ ,两种图谱示单峰 (davg=2 64 2nm) ;纳米乳剂Ⅱ和Ⅲ ,两种图谱示双峰 ,纳米乳剂Ⅱ中大粒子 (davg=3 1 5 5nm)占 5 4 3 % ,而小粒子 (davg=73 6nm)占 45 7% ;纳米乳剂Ⅲ示小粒子 (davg=87 1nm)占 74 9% ,而大粒子 (davg=2 3 2 7nm)占 2 5 1 %。结论 3种纳米乳剂激光光散射光谱有显著差别 ,纳米乳剂Ⅰ粒径与Ⅱ、Ⅲ相比虽稍大 ,但均匀 ,该处方制得的制剂室温放置 3年外观透明 。

Objective To prepare and assess propofol nanoemulsion using the laser diffraction (LD) which provides a convenient,rapid,and effective method of physical stability study for ultra-fine dispersion.Methods Three preparations named as nanoemulsion Ⅰ,nanoemulsion Ⅱ and nanoemulsion Ⅲ respectively, were prepared by the same procedure while different recipes had been made.Their volume-weighted particle size distribution,PSD V,the corresponding intensity-weighted,PSD I and ELS spectra were measured by the Nicomp 380/ZLS system.Results Three preparations have differences clearly in PSD Figures.Singer- peak appeared for emulsionⅠnot only in PSD V,but also in PSD I,with the mean diameter of 264 2 nm.Double-peak occurred in nanoemulsion Ⅱ and nanoemulsion Ⅲ individually.The large-size partical of which average diameter is 315 5 nm,accounted for 54 3%.The small-size partical of which the average diameter is 73 6 nm,accounted for 45 7% in nanoemulsionⅡ.In nanoemulsion Ⅲ, 232 7 nm,25 1%,while 87 1 nm,74 9%.Conclusions Although the particle size in nanoemulsionⅠis larger compared with that of Ⅱ and Ⅲ,it is uniform.The change of droplets for the formulaⅠhaven't been observed in 3-year saving,it indicates that the system is the ideal case of a uniform distribution with a good physical stability.