激光散射法分析异丙酚纳米乳剂的粒径大小与分布

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 ,物理稳定性良好

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

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.