重组人白介素-2鼻用凝胶剂的制备和性质研究

Study on Preparation and Characterization of rhIL-2 Nasal Gel

筛选重组人白介素-2鼻用凝胶剂的处方及辅料用量,建立其质量控制方法。采用水溶胀性卡波姆-980为凝胶基质,以乙醇、甘油、苯扎溴铵等为辅料,采用高效液相色谱法测定重组人白介素-2含量,测定波长为205 nm。该凝胶剂处方制备工艺稳定,重现性好,质量稳定。

Through the optimization of the formulation parameters such as excipient contents of rhIL-2 nasal gel, and in order to establish its quality control method, this nasal gel formulation consisting of water-swelling carbomer-980 as the basic gel matrix, and of ethanol, glycerin and benzalkonium bromide as additional excipients. The content of rhIL-2 in the formulation was determined using a high performance liquid chromatography （HPLC） at 205 nm in UV detecting wavelength. The results demonstrated both targeting and control release effect. Thus the formulation process was simple and feasible to provide reproducible formulations of acceptable quality and stability.