环孢素眼用乳剂体外释放方法研究
IVRT study on cyclosporine ophthalmic emulsion
董双涛 1李宝霞 1马郑2
作者信息
- 1. 山西药科职业学院,太原 030030
- 2. 浙江亚瑟医药有限公司,嘉兴 314001
- 折叠
摘要
目的:建立环孢素眼用乳剂体外释放方法.方法:采用Franz扩散池,聚偏氟乙烯膜滤膜,以缓冲盐-无水乙醇(40∶60)为接收液,时间点为60、125、190、255、320、385 min.结果:方法学验证表明,体外释放方法的滤膜惰性、专属性、灵敏度、选择性均符合规定.测定方法的定量限为0.07 μg·mL-1,在0.07～44.62 μg·mL-1范围呈现良好的线性关系,回收率为98.9％.依据FDA的判定原则,自研制剂与参比制剂体外释放行为一致.结论:本法适合环孢素眼用乳剂的体外释放度评价.
Abstract
Objective:To develop a method for characterizing in vitro release of cyclosporine ophthalmic emul-sion.Methods:The Franz diffusion cell and the polyvinylidene fluoride membrane were adopted with buffer-eth-anol(40∶60)as receiving media.The sampling time was set at 60,125,190,255,320,385 min,respectively.Results:The in vitro release method showed that the inertia of membrane,specificity,sensitivity and selectivity met the requirements.The validation of HPLC showed that the quantitative limit of the method was 0.07 µg·mL-1 and a good linear relationship between the concentration range of 0.07-44.62 μg·mL-1.The average re-covery was 98.9％.Compared with the original preparation by FDA guideline,the in vitro release of the self-de-veloped preparation was the same as the reference preparation.Conclusions:This method is suitable for the in vitro release evaluation of cyclosporine eye drops.
关键词
环孢素眼用乳剂/体外释放(IVRT)/参比制剂/自研制剂/方法学验证Key words
cyclosporine ophthalmic emulsion/in vitro release(IVRT)/reference preparation/self-developed preparation/method validation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据