环孢素眼用乳剂体外释放方法研究  

IVRT study on cyclosporine ophthalmic emulsion

作　　者：董双涛 李宝霞 马郑 DONG Shuang-tao;LI Bao-xia;MA Zheng(Shanxi Pharmaceutical Vocational College,Taiyuan 030030,China;Zhejiang Arthur Pharmaceutical Co.,Ltd.,Jiaxing 314001,China)

机构地区：[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

出　　处：《药物分析杂志》2024年第6期1082-1088,共7页Chinese Journal of Pharmaceutical Analysis

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0.07μg·mL^(-1),在0.07~44.62μg·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。Objective:To develop a method for characterizing in vitro release of cyclosporine ophthalmic emulsion.Methods:The Franz diffusion cell and the polyvinylidene fluoride membrane were adopted with buffer-ethanol(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 0.07μg·mL^(-1) and a good linear relationship between the concentration range of 0.07-44.62μg·mL^(-1).The average recovery was 98.9%.Compared with the original preparation by FDA guideline,the in vitro release of the self-developed 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 

分 类 号：R917[医药卫生—药物分析学]