Preparation and Quality Evaluation of Shenhuang Vaginal Thermosensitive in situ Gels / 中国药师

ABSTRACT

Objective:To prepare and evaluate Shenhuang vaginal thermosensitive in situ gels. Methods:Shenhuang vaginal ther-mosensitive in situ gels( SHV-TISG)were prepared with poloxamer 407 and poloxamer 188 as the materials. The viscosity change at different temperatures and the gelation temperature of SHV-TISG and SHV-TISG diluted by stimulant vaginal fluid were measured,the in vitro drug release of the preparation was evaluated by a membraneless diffusion method,and the safety of SHV-TISG was detected by vaginal irritation test. Results:The preparation showed the vaginal injectability and gelationability in vivo without vaginal irritation. Gel erosion was the principal mechanism of the drug release from the gels. Conclusion:The preparation of SHV-TISG is feasible in tech-nique,and the properties meet the requirements of vaginal topical use.