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

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.