夫西地酸涂膜剂的制备工艺与透皮吸收研究
Preparation process and transdermal absorption of fusidic acid film
陈慧 1蔡丽 1宁琳 2骆春梅1
作者信息
- 1. 成都东软学院健康医疗科技学院,成都 611844
- 2. 成都东软学院健康医疗科技学院,成都 611844;电子科技大学医学院药学系,成都 610054
- 折叠
摘要
目的 优选夫西地酸涂膜剂处方并研究其透皮吸收行为.方法 以涂膜剂成膜时间、韧性、可揭性、黏性作为综合评价指标,在单因素试验的基础上,采用响应面设计试验法优化处方;采用HPLC法对涂膜剂进行质量控制;采用改良Franz扩散装置研究夫西地酸涂膜剂的透皮吸收行为.结果 响应面设计试验法得到以4.8％聚乙烯醇缩丁醛、1.9％羟丙基纤维素MF、2.0％柠檬酸三乙酯、89.3％无水乙醇的处方制备涂膜剂具有良好性质;24 h累积透过率达87.74％,显著优于市售夫西地酸乳膏剂.结论 试验筛选出夫西地酸涂膜剂处方最优配比与用量,新剂型质量稳定可控,可为夫西地酸涂膜剂的临床用药提供依据.
Abstract
Objective To optimize the prescription of fusidic acid film and study its transdermal absorption behavior. Methods The fusidic acid film was evaluated comprehensively based on the film-forming time,toughness,peelability,and viscosity. On the basis of single-factor experiments,response surface design experiments were used to optimize the prescription. HPLC was used for quality control of the fusidic acid film. The improved Franz diffusion cell apparatus was used to study the transdermal absorption behavior of the fusidic acid film. Results The response surface design experiments yielded a prescription with good properties,consisting of 4.8％ polyvinyl butyral,1.9％ hydroxypropyl methylcellulose MF,2.0％ triethyl citrate and 89.3％ anhydrous ethanol. The 24-hour cumulative permeation rate was 87.74％,which was significantly better than that of commercially available fusidic acid cream. Conclusion This experiment identified the optimal ratio and dosage of the prescription for fusidic acid film. The new formulation is of stable and controllable quality,providing a basis for the clinical use of fusidic acid film.
关键词
夫西地酸涂膜剂/制备工艺/响应面分析法/透皮吸收/高效液相色谱法Key words
Fusidic acid film/Preparation process/Response surface methodology/Transdermal absorption/High-performance liquid chromatography引用本文复制引用
出版年
2024
NETL
NSTL
万方数据