摘要
目的建立测定微粉化非诺贝特粒度的方法。方法进样前用5号标准药典筛进行预分散,检测仪器为Mastersizer 3000型激光粒度仪,检测方法为干法,颗粒类型为非球形,进样量为0.20 g,折射率为1.53,颗粒吸收率为0.01,背景测试时间为10 s,样品测试时间为8 s,测量次数为1次,遮光度为1%~5%,分散气压为1.50 bar,振动进样速率为50%,文丘里管类型为标准文丘里管,料斗间隙为1.00 mm,分析模型为通用型。结果重复性、耐用性试验结果的RSD均小于8%。3批样品的累积粒度分布达到10%,50%,90%时对应的粒径(D_(10),D_(50),D_(90))分别为2.30~2.36μm、5.33~5.35μm、10.56~10.69μm。结论所建立的方法操作简单、快捷,能满足微粉化非诺贝特生产过程中的快速检测,且重复性、耐用性均良好,适用于该产品的粒度控制。
Objective To establish a method for the determination of the particle size of micronized fenofibrate.Methods Pre-dispersion was performed by the No.5 standard pharmacopoeia sieve before injection.The detection instrument was Mastersizer 3000 laser particle size analyzer,and the detection method was dry.The particle type was non-spherical,the injection volume was 0.20 g,the refractive index was 1.53,the particle absorption rate was 0.01,the background testing time was 10 s,the sample testing time was 8 s,the measurement frequency was one time,the light shielding degree was in the range of 1%-5%,the dispersion pressure was 1.50 bar,the vibration injection rate was 50%,the Venturi tube type was a standard Venturi tube,the hopper gap was 1.00 mm,and the analysis model was universal.Results The RSDs of the repeatability and durability test results were both lower than 8%.When the cumulative distribution particle size of the three batches of samples reached 10%,50%,and 90%,the corresponding particle sizes(D_(10),D_(50),D_(90))were 2.30-2.36μm,5.33-5.35μm,and 10.56-10.69μm,respectively.Conclusion The established method is simple and fast,which can meet the rapid detection requirements in the production process of micronized fenofibrate.It has good repeatability and durability,which is suitable for particle size control of the product.
作者
付志玲
杨楠楠
刘佩
白秀秀
尚斌
李霞
FU Zhiling;YANG Nannan;LIU Pei;BAI Xiuxiu;SHANG Bin;LI Xia(Xi′an Hanfeng Pharmaceutical Co.,Ltd.,Xi′an,Shaanxi 710500,China;Shaanxi Institute for Food and Drug Control,Xi′an,Shaanxi 710065,China)
出处
《中国药业》
2026年第1期83-85,共3页
China Pharmaceuticals
基金
陕西省科学技术厅秦创原“科学家+工程师”队伍建设项目[2022KXJ-110]。
关键词
非诺贝特
微粉化
激光粒度仪干法
粒度分布
fenofibrate
micronization
laser particle size analyzer dry method
particle size distribution
