吲哚美辛羟丙基-β-环糊精包合物滴眼液的制备  

Preparation of Indomethacin Hydroxypropyl-β-Cyclodextrin Inclusion Complex Eye Drops

作　　者：蔡永豪[1] 张晓碧[1] 刘小飞 郁引飞[1] 

机构地区：[1]温州医学院附属眼视光医院,浙江温州325000 [2]浙江海康生物制品有限责任公司,浙江温州325000

出　　处：《中国药业》2009年第9期38-39,共2页China Pharmaceuticals

摘　　要：目的建立吲哚美辛(IDM)羟丙基-β-环糊精包合物滴眼液的制备方法。方法采用饱和水溶液法制备,以紫外分光光度法测定制剂中IDM的含量并考察制剂的稳定性。结果IDM质量浓度在5～25μg/m L范围内与吸收度有较好的线性关系(r=0.9998),平均回收率为97.63%,RSD=0.61%(n=6),日内、日间精密度RSD分别小于1.93%和2.34%(n=5);制剂稳定性良好。结论该制备工艺简单,质量控制方法可靠,适合于眼科临床用药。Objective To establish the preparation method of Indomethacin Hydroxypropyl-β-Cyclodextrin Inclusion Complex Eye Drops. Methods The saturated aqueous solution was used to prepare Indomethacin Hydroxypropyl- β- Cyclodextrin Inclusion Complex Eye Drops, Indomethacin （IDM） was detected by UV and the stability was observed. Results The IDM curve had good linear relationship in the range of 5-25 μg/mL （r=0. 999 8）, the average recovery rate was 97.63%.The inter-day and intra-day RSD were less than 1.93%, 2.34% （ n = 5）, respectively, with good stability. Conclusion The preparation method of Indomethacin Hydroxypropyl - β - Cyclodextrin Inclusion Complex Eye Drops is simple in technology, reliable in quality control, so it is suitable for clinical usage in ophthalmology.

关 键 词：吲哚美辛 羟丙基-Β-环糊精 滴眼液 制备 

分 类 号：R945[医药卫生—微生物与生化药学] R988.1[医药卫生—药剂学]