中国药房2012,Vol.23Issue(5):430-433,4.DOI:10.6039/j.issn.1001-0408.2012.05.17
伏立康唑滴眼液的处方优化及质量控制
Formula Optimization and Quality Control of Voriconazole Eye Drops
刘美欣 1高翔 2刘彤 1闫瑾 1张毅1
作者信息
- 1. 天津市眼科医院天津市眼科学与视觉科学重点实验室,天津300020
- 2. 天津医科大学药学院,天津300070
- 折叠
摘要
Abstract
OBJECTIVE: To design the formula of Voriconazole eye drops and to establish its method of quality control. METHODS: The formula was optimized by L9(34) orthogonal test for 3 times with comprehensive score of osmotic pressure of eye drops as index using the amount of propylene glycol, PEG400 and Tween-80 as factors. The preliminary stability of preparations (4 weeks) and its stimulation to rabbits were investigated, and the quality of preparation was evaluated. RESULTS: The added amounts of propylene glycol, PEG400 and Tween-80 were 0, 25, 125 mL, and the osmotic pressure of the preparation was 0.230~ 0.320 Osmol. The index of stability test had no significant change in 4 weeks. Irriation score was 0 (not irritant). In quality evaluation, pH value of sample was 5.5-6.5 and labblled amounts were 96.38%~102.61%. CONCLUSION: The preparation of Voriconazole eye drops is simple in technology process and controllable in quality, and it is worthy of promoting in clinic.关键词
伏立康唑滴眼液/处方设计/优化/质量控制Key words
Voriconazole eye drops/ Formula design/ Optimization/ Quality control分类
医药卫生引用本文复制引用
刘美欣,高翔,刘彤,闫瑾,张毅..伏立康唑滴眼液的处方优化及质量控制[J].中国药房,2012,23(5):430-433,4.