Investigation of preparation and quality control for butenafine hydrochloride plastics / 中国生化药物杂志

ABSTRACT

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 as1%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.