盐酸丁卡因壳聚糖滴眼液的制备与质量控制  

Preparation and quality control of tetracaine hydrochloride chitosan eye drops

作　　者：蔡永豪[1] 刘小飞 

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

出　　处：《海峡药学》2009年第8期56-58,共3页Strait Pharmaceutical Journal

摘　　要：目的制备盐酸丁卡因壳聚糖滴眼液并建立其质量控制方法。方法以壳聚糖为增稠、增效剂，盐酸丁卡因为主药制备滴眼液；采用紫外分光光度法测定制剂中盐酸丁卡因的含量。并对其稳定性及兔眼刺激性进行考察。结果盐酸丁卡因在2．5—12．5μg·mL^-1。范围内线性关系良好（r=0．9999）。含量测定平均回收率为101．54％，RSD=0．69％（n=6）；制剂稳定性良好。结论本制备工艺简单。质量控制方法可靠．可满足眼科临床用药。OBJECTIVE To prepare tetracaine hydrochloride chitosan eye drops and establish its quality control methods. METHODS Chitosan as a means of thickening, synergist, tetraeaine hydrochloride is as the principle mcim in eye drops preparation; using UV agents in the determination of tetraeaine hydroehloride content, and its stability and eye irritation in rabbits inspection. RESULTS Tetraeaine hydroehloride in the range of 2.5 12.5μg· mL^-1has a good linear relationship （r = 0. 9999）, determination of the average recovery was 101.54 %, RSD= 0.69 % （n = 6） ; the preparation has good stability. CONCLUSION The preparation of Tetraeaine hydrochloride chitosan eye drops is easy in process, reliable in quality control, so it is suitable for ophthalmology clinical use.

关 键 词：盐酸丁卡因 壳聚糖 滴眼液 

分 类 号：R942[医药卫生—药剂学]