激光粒度散射法测定曲安奈德注射液粒度

发布时间：2018-07-09 12:20

本文选题：激光散射法 + 粒度测定　；参考：《药物分析杂志》2017年11期

【摘要】：目的:建立激光粒度散射湿法测定曲安奈德注射液粒度及粒度分布的方法。方法:Malvern Mastersizer 2000激光粒度分析仪,Hydro 2000SM进样器;背景及样品的扫描时间为15 s,搅拌速率为850 r·min~(-1);分散液为水,分散助剂为聚山梨酯80和磷酸二氢钠;颗粒折射率为1.50;颗粒的吸收率为0.001;遮光度为5%~15%。结果:激光散射法可以测定曲安奈德注射液的粒度及其分布,由体积平均粒径D[4,3]可以直观的表征不同批号的曲安奈德注射液颗粒的大小差异,由d(0.1)、d(0.5)、d(0.9)数值表示其粒度分布的特征。方法学考察结果和样品测定结果的d(0.1)、d(0.5)和d(0.9)的RSD均小于6%。结论:本方法适合曲安奈德注射液的粒度及粒度分布的测定。
[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.
【作者单位】：广州市药品检验所;
【分类号】：R927.1

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