目的: 建立激光散射法用于测定氟米龙滴眼液的粒度分布。方法: 采用Mastersizer 3000激光粒度分析仪和Hydro MV型湿法进样器,样品折射率为1.70;样品吸收率为0.001;分散介质为0.000 1 g·mL-1吐温-80,其折射率为1.33;搅拌速率为1 000 r·min-1;测量次数为5次;测量时间为5 s;背景时间为5 s;遮光率为5%~15%。结果: 方法学精密度考察结果d(0.5)和d(0.9)的RSD均＜2%,5批氟米龙滴眼液样品d(0.5)均＜4 μm,d(0.9)均＜8 μm。结论: 该方法操作简便,准确度高,耐用性好,适用于氟米龙滴眼液的粒度检测。
Objective: To establish a laser light scattering method for the determination of particle size distribution of fluorometholone eye drops. Methods: The Master sizer 3000 laster size analyzer with the Hydro MV wet autosampler was used. The measurement conditions: sample refractive index was 1.70, sample absorbency was 0.001, dispersing medium was 0.000 1 g·mL-1 of Tween 80 with refractive index of 1.33, stirring rate was 1 000 r·min-1, measurement was conducted for 5 times, measuring time for back ground and samples was 10 s, and laser obscuration was 5.0%-15.0%. Results: RSD of d(0.5) and d(0.9) were both lower than 2%. All the d(0.5) of 5 batches of fluorometholone eye drops were less than 4 μm, and the d(0.9) were less than 8 μm. Conclusion: The method is simple, accurate and robust.It is suitable for the particle size detection of fluorometholone eye drops.
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