超临界溶液快速膨胀法制备盐酸氟桂利嗪微粒的研究  

Micronization of Flunarizine Hydrochloride via Rapid Expansion of Supercritical Solution

作　　者：胡国勤[1] 孙芳星 刘景辉 陈鹏丽 HU Guoqin;SUN Fangxing;LIU Jinghui;CHEN Pengli(School of Chemical Engineering and Energy,Zhengzhou University,Zhengzhou 450001,China)

机构地区：[1]郑州大学化工与能源学院

出　　处：《郑州大学学报（工学版）》2019年第6期57-61,67,共6页Journal of Zhengzhou University（Engineering Science）

基　　金：河南省科技攻关重点项目(152102310148)

摘　　要：采用超临界溶液快速膨胀法制备盐酸氟桂利嗪药物微粒,研究了该方法使盐酸氟桂利嗪微粒化过程中萃取温度、萃取压力、膨胀室温度、喷嘴温度、喷嘴直径以及夹带剂用量对药物微粒的粒径大小以及形态的影响,并用正交实验法对该工艺条件进行优化.结果表明:采用超临界溶液快速膨胀法成功制备了粒径小且分布均匀的球型或类球型盐酸氟桂利嗪微粒,平均直径为1.285~6.893μm,经正交实验优化得到该工艺的最佳条件为:萃取温度35℃,萃取压力25 MPa,喷嘴温度140℃,夹带剂用量0.3 m L/min,此时得到微粒的平均粒径为1.386μm.采用扫描电镜、红外光谱、X射线衍射、热重分析对药物微粒进行了分析表征,超临界溶液快速膨胀前后盐酸氟桂利嗪药物微粒物理化学性质、晶体结构基本保持稳定.Flunarizine hydrochloride(FH)was micronized via rapid expansion of supercritical solution(RESS).The effects of the process parameters such as the extraction temperature,the extraction pressure,the temperature of the expansion chamber,the nozzle temperature,the nozzle diameter,and the dosage of the entrainer on the size and morphology of the drug particles were investigated.And the orthogonal test method was used to optimize this process.The experimental results showed that micro-particles of FH were successfully prepared by RESS which the average particle size was in the range of 1.285μm to 6.893μm.The optimum conditions were obtained through orthogonal test:The extraction temperature was 35℃,the extraction pressure was 25 MPa,the dosage of entrainer was 0.3 m L/min,the nozzle temperature was 140℃,and the diameter of the particle was 1.386μm.FH microparticles were characterized by scanning electron microscope,Fourier transform infrared,X-ray diffraction and thermogravimetric analysis and its crystal habit was not modificated at the experimental conditions tested.

关 键 词：盐酸氟桂利嗪 微粒化 超临界溶液快速膨胀过程 正交实验 表征 

分 类 号：R944.9[医药卫生—药剂学]