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5mL:50mg，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。
Objective To prepare1%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 of5mL:50mg,content of voriconazole was1%.Its identification and test conformed to the related standards stated in Ch.P(2015).There was a good linear relationshop with the concentration range of20～800μg/mL(r=0.9999,n=6)for voriconazole,and its average recovery was100.13%(RSD=0.78%,n=9).Both intra-and inter-day precision RSD were less than2%(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.
作者
蔡永豪
徐雪姑
陈文斐
郁引飞
CAI Yong-hao;XU Xue-gu;CHEN Wen-fei;YU Yin-fei(The Affiliated Eye Hospital of Wenzhou Medical University,Wenzhou 325000, China)
出处
《中国生化药物杂志》
CAS
2017年第11期20-23,共4页
Chinese Journal of Biochemical Pharmaceutics
基金
温州市公益性科技计划项目(Y20150372)
