溶菌酶眼用膜剂的制备及相关性质考察

摘要

Objective To prepare and evaluate the lysozyme ocular film as a novel therapy for infectious eye diseases. Methods Various preparations were evaluated based on their attachment,detachment,flexibility and film per-formance. Lysozyme ocular film was prepared with coating method,and in vitro drug release characteristics and eye irri-tation were assessed. Results Using PVA124 as film-forming material and glycerol as plasticizer,we found that cumu-lative drug release reached more than 80% at 8 hours. According to evaluation standard,the scores were both 0 for sin-gle and multiple dosing in eye irritation experiment in rabbits. Histopathologic examination revealed that multiple dosing of ocular film resulted in slight hyperemia of iris in the rabbit. Conclusion The preparation process of lysozyme ocular film is simple and in accordance with the standard of ophthalmic drug.%目的：制备溶菌酶眼用膜剂,为感染性眼部疾病提供新的药物治疗。方法以脱膜性、粘附性、柔韧度、膜性能等相关指标为依据,筛选处方,采用涂膜法制备了溶菌酶眼用膜剂,并考察眼用膜剂的体外释放特性及眼部刺激性。结果以PVA124为膜材、甘油为增塑剂制备的眼用膜剂,8 h时累计释放量达到80%以上,对家兔眼部单次及多次给药后,根据评分标准,评分均为0,多次给药后的组织病理切片表明,给药组家兔虹膜有轻微充血。结论溶菌酶眼用膜剂制备工艺简单,符合眼部用药标准。