目的:研制酮洛芬巴布剂并研究其体外释药性能和经皮吸收特点。方法:以水溶性高分子材料为辅料制备酮洛芬巴布剂,用HPLC法测定酮洛芬的经皮吸收量,按《中华人民共和国药典》2005年版方法进行体外释放度测定,利用改良Franz扩散池研究巴布剂的经皮吸收特点。结果:酮洛芬巴布剂含膏量均匀,含量稳定,体外释药符合Weibull分布方程。巴布剂中的酮洛芬24h内以零级动力学经皮渗透,体外经皮释药方程为Q=10.196t-7.9547(r=0.9988),24h累积渗透量为244.70μg/cm^2结论:酮洛芬巴布剂为一种新型控释型经皮给药制剂。
Objective: To study the preparation of ketoprofen cataplasm and its characteristics of release in vitro. Methods: Ketoprofen cataplasm was prepared with some macromolecular water-soluble materials as base. The content of ketoprofen was determined by HPLC method. Its release test in vitro was carried out according to the method of Chinese Pharmacopoeia 2005 edition. The BLAB/c mouse skin penetration test in vitro was performed by modified Franz diffusion cell. Results: The ketoprofen cataplasm was homogeneous and had constant content of ketoprofen. Its release property in vitro conformed to Weibull equation. The penetration of ketoprofen in the cataplasm through the BLAB/c mouse skin followed zeroorder dynamics in 24 h. Its release equation in vitro was Q= 10. 196 t- 7. 954 7 (r=0. 998 8). The cumulative permeation quantity in 24 h was 244.70 μg/cm^2 through BLAB/c mouse skin in vitro. Conclusion: The ketoprofen cataplasm is a new transdermal agent of sustained release property.