本文選題：激光散射法 + 粒度測定�。� 參考：《藥物分析雜志》2017年11期

【摘要】：目的:建立激光粒度散射濕法測定曲安奈德注射液粒度及粒度分布的方法。方法:Malvern Mastersizer 2000激光粒度分析儀,Hydro 2000SM進樣器;背景及樣品的掃描時間為15 s,攪拌速率為850 r·min~(-1);分散液為水,分散助劑為聚山梨酯80和磷酸二氫鈉;顆粒折射率為1.50;顆粒的吸收率為0.001;遮光度為5%~15%。結果:激光散射法可以測定曲安奈德注射液的粒度及其分布,由體積平均粒徑D[4,3]可以直觀的表征不同批號的曲安奈德注射液顆粒的大小差異,由d(0.1)、d(0.5)、d(0.9)數值表示其粒度分布的特征。方法學考察結果和樣品測定結果的d(0.1)、d(0.5)和d(0.9)的RSD均小于6%。結論:本方法適合曲安奈德注射液的粒度及粒度分布的測定。
[Abstract]:Objective: to establish a method for the determination of triamcinolone acetonide injection particle size and distribution by laser particle size scattering wet method. Methods: a Hydro 2000 SM sampler was developed by using a: Malvern Mastersizer 2000 laser particle size analyzer, the scanning time of background and sample was 15 s, the stirring rate was 850 r min ~ (-1), the dispersion solution was water, the dispersing agent was polysorbate 80 and sodium dihydrogen phosphate. The refractive index of the particles is 1.50, the absorptivity of the particles is 0.001, and the shading degree is 5 / 15. Results: the particle size and distribution of triamcinolone acetonide injection could be measured by laser scattering method. The size difference of triamcinolone acetonide injection with different batches of triamcinolone acetonide injection could be visualized by the volume average particle size D [4N3], and the particle size distribution of triamcinolone acetonide injection was characterized by d (0.1) d (0.5) d (0.9). The RSD of the results of methodological investigation and sample determination were less than that of 0. 1%, 0. 5% and 0. 9%, respectively. Conclusion: this method is suitable for the determination of particle size and distribution of triamcinolone acetonide injection.
【作者單位】： 廣州市藥品檢驗所;
【分類號】：R927.1

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