利奈唑胺滴眼液的制备、质量控制和眼刺激性实验  

Preparation and Quality Control of Linezolid Eye Drops and Eye Irritation Test

作　　者：姚向超[1] 王延东[1] 曾夏芸 

机构地区：[1]中山大学中山眼科中心,广州510060 [2]广东宏盈科技有限公司,广东佛山528531

出　　处：《中国药房》2014年第21期1961-1963,共3页China Pharmacy

基　　金：广东省部产学研合作引导项目(No.2010B090400081)

摘　　要：目的：制备利奈唑胺滴眼液,并对其进行质量控制和眼刺激性考察。方法：以玻璃酸钠、氯化钠、泊洛沙姆407和依地酸二钠为辅料,采用新型眼用释药系统纳米分子罩系统α（NMHSα）制备利奈唑胺滴眼液,采用高效液相色谱法测定滴眼液中利奈唑胺的含量,考察滴眼液的兔眼刺激性和稳定性。结果：所制滴眼液为类白色黏稠液体,规格为10 ml∶20 mg,含药量为0.2%;利奈唑胺检测质量浓度的线性范围为0.025～0.8 mg/ml（r=0.999 9）,平均回收率为101.08%,RSD=0.71%（n=3）。该滴眼液对兔眼无刺激性,室温环境下12个月内稳定性良好。结论：本制剂制备方法简单、可行,质量可控,无眼刺激性。OBJECTIVE：To prepare Linezolid eye drops,and to control the quality and inspect the eye irritation.METHODS：Linezolid eye drops were prepared by Nano Molecular Hood System（NMHS）using sodium hyaluronate,sodium chloride,poloxamer 407 and natrium adetate as excipients.The content of linezolid in eye drops was determined by HPLC.Irritation to rabbits＇ eyes and stability of linezolid eye drops were observed.RESULTS：The prepared eye drops were off-white color viscous liquid with specification of 10 ml ∶ 20 ml,content of linezolid was 0.2%.The calibration curve linear range of linezolid were 0.025-0.8 mg/ml（r= 0.999 9）with an average recovery of 101.08%（RSD=0.71%,n=3）.The eye drops had no irritation to rabbits＇ eyes and its stability was relatively good at room temperature within 12 months.CONCLUSIONS：The method is simple,feasible and controllable in quality without irritation.

关 键 词：利奈唑胺 滴眼液 质量控制 刺激性实验 稳定性实验 

分 类 号：R943[医药卫生—药剂学] R944.12[医药卫生—药学]