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.
出处
《海峡药学》
2009年第8期56-58,共3页
Strait Pharmaceutical Journal
关键词
盐酸丁卡因
壳聚糖
滴眼液
Tetraeaine hydrochloride
Chitosan
Eye drops
