PGE1-ethyl Ester 함유 발기부전 치료용 요도주입 액제의 제조 및 평가

Abstract

[ PGE1 ]-ethyl ester intraurethral solutions were prepared in ethanol/propylene glycol mixture with penetration enhancer and viscosity-enhancing agent. The stability of PGE1-ethyl ester in intraurethral solution was investigated at various temperature. Simultaneous determination of PGE1-ethyl ester and PGE1 was performed using a validated HPLC technique. In pentobarbital anesthetized cats, increase in intracavernous pressure(ICP), increase in penile length and duration of erectile response were determined after intraurethral application of PGE1-ethyl ester solutions. PGE1-ethyl ester solutions, when instilled into the eyes of rabbits, produces no noticeable irritation, or slight transient conjunctival irritation. From these results, ocular irritation of this solutions was judged as practically non-irritating. The stability study indicates that the therapeutically effective content in solution is well maintained for 46 weeks or longer when they are stored at 4∘C. After intraurethral application of PGE1-ethyl ester, ICP was increased and penile erection was induced. PGE1-ethyl ester intraurethral solutions for erectile dysfunction could be developed and evaluated by employing feline erection model.