Formula optimization of dyclonine hydrochloride thermosensitive gel by Box-Behnken response surface methodology
Objective To prepare dyclonine hydrochloride thermosensitive gel(DH-Gel),and to determine its stability,in vitro release and irritation.Methods The gelation temperature was taken as the evaluation index.The formula of DH-Gel was optimized by single factor test and Box-Behnken response surface methodology.The changes in character,pH,gelation temperature and drug content were used as evaluation indexes,and the stability of DH-Gel under different conditions was measured.The drug release behavior of the gel was determined by diffusion pool method.The irritation of DH-Gel was investigated by rabbit eye irritation test.Results The best formula of DH-Gel was dyclonine hydrochloride 1％,poloxamer 407 19.39％,poloxamer 188 1.96％,hydroxypropyl methyl cellulose 0.30％,and sodium benzoate 0.01％.The preparation was stable under both high and low temperature.The drug release was in compliance with Ritger-Peppas equation.Dyclonine hydrochloride release from the thermosensitive gel displayed the Fick's diffusion.The irritation degree of the DH-Gel group was lower than that of dyclonine hydrochloride solution group.Conclusion DH-Gel prepared in this experiment has an ideal gelation temperature,which can make the drug adhere to the drug site more persistently and effectively,facilitating the administration.
NETL
NSTL
万方数据
