CAJ | 학술논문

目的：制备盐酸布替萘芬涂膜剂，考察处方组成并对质量控制进行研究。方法以成膜时间和外观质量作为评价指标，考察盐酸布替萘芬涂膜剂的处方组成，并依据2010年版《中国药典》二部附录对涂膜剂的检查要求进行质量控制。结果盐酸布替萘芬涂膜剂的处方为：盐酸布替萘芬1％（w／w）、甘油10％（v／w）、卡波姆971PNF3％（w／w）、对羟基苯甲酸乙酯0．1％（w／w）、无水亚硫酸钠适量作为pH调节剂、溶媒为95％的乙醇。该制剂性状为无色透明、黏稠的半固体，pH为4．5，采用高效液相色谱法测定药物含量，结果稳定、可靠。结论本文制备的盐酸布替萘芬涂膜剂制备工艺简单、性质稳定、使用方便并且质量可控，是一种具有开发潜力的制剂。
목적：제비염산포체내분도막제，고찰처방조성병대질량공제진행연구。방법이성막시간화외관질량작위평개지표，고찰염산포체내분도막제적처방조성，병의거2010년판《중국약전》이부부록대도막제적검사요구진행질량공제。결과염산포체내분도막제적처방위：염산포체내분1％（w／w）、감유10％（v／w）、잡파모971PNF3％（w／w）、대간기분갑산을지0．1％（w／w）、무수아류산납괄량작위pH조절제、용매위95％적을순。해제제성상위무색투명、점주적반고체，pH위4．5，채용고효액상색보법측정약물함량，결과은정、가고。결론본문제비적염산포체내분도막제제비공예간단、성질은정、사용방편병차질량가공，시일충구유개발잠력적제제。
Objective To prepare butenafine hydrochloride plastics,investigate the prescription composition and make a quality control standard for the preparation.Methods Film-forming time and appearance quality as the evaluation index,the quality control standard of butenafine hydrochloride according to the Chinese pharmacopoeia two section ( 2010 edition ) was made.ResuIts The prescription of butenafine hydrochloride plastics was identified as:1%butenafine hydrochloride(w/w),10%glycerol(w/w),3%carbomer 971PNF(w/w),0.1% ethyl p-hydroxybenzoate(w/w),moderate anhydrous sodium sulfite(pH adjusting agent) and 95% ethanol (solution).The preparation was colorless,transparent and viscous semi-solid with pH4.5.A content determination method of butenafine hydrochloride with HPLC was established and the result was stable and reliable .ConcIusion The butenafine hydrochloride has several advantages such as preparation simply , stable property,application convenience and quality control.It is a potential preparation to develop.