激光粒度散射法测定曲安奈德注射液粒度

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。

Objective: To establish a method for determination of the particle size distribution of triamcinolone acetonide injection.Methods: The Malvern Mastersizer 2000 laser size analyzer with a Hydro 2000SM wet auto sampler were used.The determination conditions were as follows, measurement time for background and samples:15 s, pump speed:850 r·min^-1, obscuation:5%-15%, dispersion solvent:water, dispersant:polysorbate 80 and sodium dihydrogen phosphate;particle RI:1.50, particle AI:0.001.Results: A variety of triamcinolone acetonide injection products could be analyzed by laser light scatting method.The D[4, 3]could show the size difference between different patch products.The profile of the particle size distribution could be reflected by the d(0.1)、d(0.5) and d(0.9).The RSDs of methodological study and sample results for d(0.1)、d(0.5) and d(0.9) values were lower than 6%.Conclusion: The method was simple, accurate and producible, which was suitable for the particle size control of triamcinolone acetonide injection.

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