伏立康唑磺丁基醚-β-环糊精滴眼液的研制及兔眼刺激性试验
Studies on voriconazole sulfobutyl ether beta cyclodextrin eye drops and eye irritation test
蔡永豪 1徐雪姑 1陈文斐 1郁引飞1
作者信息
- 1. 温州医科大学附属眼视光医院,浙江 温州 325000
- 折叠
摘要
目的 制备1%伏立康唑滴眼液,建立质量控制方法并进行眼刺激性试验.方法 以SBE-β-CD为增溶剂来制备伏立康唑滴眼液,采用高效液相色谱法测定主药含量,考察滴眼液的稳定性及兔眼刺激性.结果 所得制剂为无色澄明液体,规格为5 mL:50 mg,含药量为1.0%;鉴别、检查结果均符合2015版中国药典中的相关规定,伏立康唑检测浓度的线性范围为20~800μg/mL(r=0.9999,n=6),平均回收率为100.13%(RSD=0.78%,n=9),日内和日间精密度RSD均小于2%(n=5),该滴眼液对兔眼无刺激性,稳定性良好.结论 本制剂处方及工艺简单、质量可控,无眼部刺激性,适用于医院配制使用.
Abstract
Objective To prepare 1% voriconazole eye drops, establish its method of quality control and inspect the eye irritation. Methods Voriconazole was solubilizing by SBE-β-CD in order to prepare voriconazole eye drops. The content of voriconazole was determined by HPLC, observed stability and irritation to rabbits'eyes of voriconazole eye drops. Results The eye-drops was colorless and transparent liquid, specification of 5 mL: 50 mg, content of voriconazole was 1%. Its identification and test conformed to the related standards stated in Ch.P(2015). There was a good linear relationshop with the concentration range of 20~800μg/mL(r=0.9999, n=6)for voriconazole, and its average recovery was 100.13%(RSD=0.78%, n=9). Both intra- and inter-day precision RSD were less than 2%(n=5). The eye drops had no irritation to rabbits'eyes, accelerated stability test is good. Conclusion The preparation process of voriconazole eye drops is simple, its quality control method is reliable.
关键词
伏立康唑/滴眼液/SBE-β-CD/质量控制/刺激性试验Key words
voriconazole/eye drops/SBE-β-CD/quality control/irritation test引用本文复制引用
基金项目
温州市公益性科技计划项目(Y20150372)
出版年
2017
NETL
NSTL
维普
万方数据