丝裂霉素C眼用凝胶的制备及质量控制  

Preparation and Quality Control of Mitomycin C Ophthalmic Gel

作　　者：毕宏生[1,2] 苏卫华[2] 郭俊国[1] 刘大美[2] 吴建峰[2] 

机构地区：[1]山东中医药大学,济南250355 [2]山东中医药大学眼科研究所,济南250002

出　　处：《生物医学工程研究》2011年第3期181-183,共3页Journal Of Biomedical Engineering Research

基　　金：山东省中医药科学技术研究项目(2009HZ091)

摘　　要：制备丝裂霉素C眼用凝胶剂并建立其质量控制方法。以丝裂霉素为主药,以卡波姆和羧甲基纤维素(HPMC K4M)为基质制备眼用凝胶,采用HPLC法测定制剂中丝裂霉素C的含量。所制得的眼用凝胶为淡紫色透明状,丝裂霉素C在21-210μg/ml范围内呈良好的线性关系,A=0.482C+0.009,精密度RSD为0.049%,稳定性RSD为1.28%。该法制备工艺简单,质量可控,有关项目符合眼用凝胶的质量要求。To prepare mitomycin C ophthalmic gel and the establishment of its quality control methods.Eyegel was prepared based on mitiomycin medicine and taking Carbomer and carboxymethyl cellulose（HPMC K4M） as a substrate.Mitonycin c content was determinated wing HPLC.The obtained eye gel is transparent lavender,within the scope of mitomycin C in 21~210μg/ml good linear relationship,A=0.482C＋0.009,precision RSD of 0.049%,stable of the RSD is 1.28%.The preparation process is simple,quality control,the project meets the quality requirements of the eye gel.

关 键 词：丝裂霉素 眼用凝胶 制备 高效液相色谱 质量控制 

分 类 号：R318[医药卫生—生物医学工程]