Study On Preparation And Application Of Compound Estriol Vaginal Bioadhesive Film

Objective Using chitosan(CS) as main film-forming material,compound estriol vaginal bioadhesive film loaded estriol, ciprofloxacin hydrochloride and dexamethasone acetate was studied. The preparation of compound estriol vaginal bioadhesive film was optimized using orthogonal test. Using the optimized method prepared the film. Study it's adhesion ability irritation and the clinical efficacy in the treatment to senile vaginitis. Methods Using classical method prepare compound estriol vaginal bioadhesive film. The vertical force and tangential force were investigated as evaluation index by adhesion force measuring device. The composition of prescription was optimized according to orthogonal design. The contents of the 3 ingredients were determined by HPLC. Study the irritation of compound estriol vaginal bioadhesive film to vaginal mucosa in rabbits. And observe the clinical efficacy of compound estriol vaginal bioadhesive film using suppositoria Baofukang in the treatment to senile vaginitis as control. Results The preparation was semitransparent yellowish film. The influence factors were sequenced from strong to weak as follows:chitosan concentration(A)>concentration of glycerol (C)>drug content(D)> gelatin concentration(B). The optimum prescription wasA2B2C2D3:1.0% chitosan,1.5% gelatin, 8.0% glycerol and 1.0% drug. The film fitted the description of China Pharmacopeia(2010 edition) in identification and test of items. Estriol, ciprofloxacin hydrochloride and dexamethasone acetate were linear in the ranges of 1.56～77.8,15.97～798.4, and1.66～83.2μg·mL-1, respectively (r=0.9999) with average recoveries at 98.44% (RSD=0.87%),99.67%(RSD=0.54%) and 98.54% (RSD=0.42%), respectively. The compound estriol vaginal bioadhesive film was non-irritative to vaginal mucosa in rabbits. The effective rate in the treated group was 92.31%, and the rate of the control group was 88.0%. There was no significant difference between the two groups(P>0.05). Conclusion The compound estriol vaginal bioadhesive film loaded estriol,ciprofloxacin hydrochloride and dexamethasone acetate could be used as bioadhesive drug delivery system in the treatment of senile vaginitis. It could release drugs slowly in vaginal to supply estrogen. The compound estriol vaginal bioadhesive film has good effect on the treatment of senile vaginitis.