摘要
目的:对盐酸特比萘芬醇类脂泡囊的制备工艺条件进行优化并进行药剂学性质评价。方法:采用乙醇注入法制备盐酸特比萘芬醇类脂泡囊;以包封率为评价指标,采用单因素试验考察不同因素对包封率的影响并采用正交试验筛选最佳制备工艺条件;采用0.22μm微孔滤膜考察醇类脂泡囊的变形性;采用马尔文激光粒度仪测定粒径及Zeta电位。结果:最佳制备工艺条件为:囊材主药比为17∶12,搅拌时间为25 min,醇相含量为30%;醇类脂泡囊包封率为96.79%,变形性测定结果为86.67%,平均粒径为226.1 nm,Zeta电位为-4.78 m V。结论:制备的盐酸特比萘芬醇类脂泡囊的包封率高,变形性好,粒径小。
Objective: To optimize the preparation conditions and evaluate the pharmaceutical properties of tabinafine hydrochloride lipid vesicles.Methods: Terbinaphenols hydrochloride lipid vesicles were prepared by ethanol injection.Taking the encapsulation efficiency as the evaluation index,the effects of different factors on the encapsulation efficiency were investigated by single factor test.The deformation of lipid bubbles was investigated by means of 0.22 μm microporous membrane.The particle size and zeta potential were measured by a Malvin laser granularity analyzer.Results: The optimum preparation conditions were as follows: the main drug ratio to the capsule was 17∶ 12,the stirring time was 25 min,and the alcohol phase content was 30 %.The encapsulation efficiency of lipid vesicles was 96.79%,the determination of deformability was 86.67%,the average particle size was 226.1 nm,and the zeta potential was-4.78 m V.Conclusion: The preparation of terbinafinol hydrochloride lipid vesicles is successful with high encapsulation efficiency,good deformation and small particle size.
作者
刘宝
罗国平
闫梦茹
孟会宁
薛倩倩
申宇梅
张孟丽
Liu Bao;Luo Guoping;Yan Mengru;Meng Huining;Xue Qianqian;Shen Yumei;Zhang Mengli(Pharmaceutical Institute, Xi’an Medical University,Xi’an 710021,China;Shandong Buchang Medicine Co. Ltd.)
出处
《中国药师》
CAS
2019年第8期1538-1542,共5页
China Pharmacist
基金
西安医学院药学省级重点学科建设项目(编号:2016YXXK10)
2018年西安医学院校级大创项目(编号:2018DC-64)
关键词
盐酸特比萘芬
醇类脂泡囊
乙醇注入法
工艺优化
包封率
Terbinafine hydrochloride
Alcohol lipid vesicles
Ethanol injection method
Process optimization
Encapsulation efficiency
