魟鱼软骨多糖眼用纳米乳的质量评价  

Quality evaluation of ray cartilage glycosaminoglycans ocular nanoemulsion

作　　者：曹见敏[1] 张蕾[1] 郭斌[2] 

机构地区：[1]辽宁医学院研究生院,辽宁锦州121001 [2]辽宁医学院附属第一医院药剂科,辽宁锦州121001

出　　处：《山东大学学报（医学版）》2010年第5期157-160,共4页Journal of Shandong University:Health Sciences

基　　金：2008年辽宁省教育厅高等学校科研项目(2008393)

摘　　要：目的建立魟鱼软骨多糖眼用纳米乳的质量评价方法及纳米乳中多糖的含量测定方法。方法制备魟鱼软骨多糖纳米乳,观测纳米乳的载药量、外观形状、pH值、粒径等指标,采用硫酸-咔唑法测定纳米乳中多糖的含量,检测波长为529.0nm。结果纳米乳平均粒径为51nm,澄清度、稳定性良好,无眼刺激性。在8.024～40.120mg/L浓度,A=0.0129c+0.008,r=0.9999,方法平均回收率为100.2%,RSD为0.92%;纳米乳载药量为50.03g/L。结论魟鱼软骨多糖眼用纳米乳制剂质量稳定,符合《中国药典》(2005版)关于眼用制剂的标准;硫酸-咔唑法测定多糖含量简单、快速、准确,可用于控制纳米乳制剂质量。Objective To evaluate the qualities of RCG ocular nanoemulsion and to determine RCG content in nanoemulsion.Methods A RCG ocular nanoemulsion was prepared and the RCG content in the nanoemulsion was determined with the sulfate carbazole colorimetry method at a detection wavelength of 529.0 nm.The appearance,pH values and average droplet diameter of the nanoemulsion were observed and measured.Results The RCG ocular nanoemulsion was stable and transparent,with an average droplet diameter of 51 nm,and no irritation existed.The linear range was 8.024～40.120 mg/L,and the regression equation was A=0.0129c＋0.008（r=0.999 9）.The average recovery of the method was 100.2%,and RSD was 0.92%.The RCG content in the nanoemulsion was 50.03 g/L.Conclusion The RCG ocular nanoemulsion is stable and accordant with the eye preparation standard of Ch.P（2005）.The assay is simple,rapid and accurate,and suitable to control the quality of the ocular nanoemulsion.

关 键 词：魟鱼软骨多糖 纳米乳 质量评价 稳定性 

分 类 号：R283.6[医药卫生—中药学]