激光粒度仪测定环索奈德粒度分布的应用研究  

Application of the laser particle analyzer to determine the laser particle size of ciclesonide

作　　者：沈丹丹 曾令高 许娟 肖波 Shen Dan-dan;Zeng Ling-gao;Xu Juan;Xiao Bo(Chongqing Research Academy of Pharmaceutical Industry, Chongqing 401121;Collaborative Innovation Center for Chemical Medicine Quality Control and Evaluation, Chongqing 401121;Chongqing Rennzar Pharmaceutical Technology Co.,Ltd, Chongqing 400021)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121 [2]重庆市化学药品质量控制与评价产业技术协同创新中心,重庆401121 [3]重庆仁泽医药科技有限公司,重庆400021

出　　处：《中国抗生素杂志》2019年第8期946-952,共7页Chinese Journal of Antibiotics

摘　　要：目的建立激光粒度仪测定环索奈德粒度分布的测定方法。方法采用马尔文2000激光粒度仪,以浓配法配制供试品溶液,表面活性剂浓度为0.01%(W/W)吐温20,分散介质水500mL,遮光度界限为10%~15%,泵转速为2000r/min,超声能量为12.5,超声定时120s,样品测量时间10s,样品测量快照10000,背景测量时间10s,背景测量快照10000。结果3批样品中环索奈德粒径分布特征值d0.1、d0.5和d0.9平均值分别为1.215、2.726和5.734μm,平均标准差分别为0.086、0.186和0.251μm,测定结果与显微镜法基本一致。结论本法快速、简便、重现性好、精密度高,适用于微粉化活性成份环索奈德的粒度测定。Objective To establish a method for the determination of the particle size distribution of ciclesonide. Methods The Malvern Mastersizer 2000 laser size analyzer was used. The conditions of determination were as follows: The test solution was prepared with 0.01%(W/W) Tween 20 as a concentrated solution, and disperse the sample in 500mL water, the pump of Malvern laser particle size analyzer was set at 2000r/min, laser obscuration was set between 10%~15%, ultrasonic energy and ultrasonic time were 12.5 and 120s, sample measurement time and sample measurement snapshot were 10s and 10,000, and background measurement time and background measurement snapshot were 10s and 10,000. Results The d0.1, d0.5 and d0.9 average of particle size distribution of three batches were 1.215, 2.726 and 5.734μm, respectively. The average standard deviations were 0.086, 0.186 and 0.251μm, respectively. The results were generally consistent with the microscopy method. Conclusion The method is simple, accurate, reproducible, and with high precision, which is suitable for the particle size control of micronized ciclesonide.

关 键 词：环索奈德 马尔文激光粒度仪 粒度及粒度分布 

分 类 号：R943[医药卫生—药剂学]