CAJ | 학술논문

目的：制备参黄阴道用温敏原位凝胶并对其进行评价。方法：以泊洛沙姆407和泊洛沙姆188为基质，制备参黄阴道用温敏原位凝胶。考察原位凝胶经模拟阴道液稀释前后的黏度随温度变化曲线和胶凝温度，采用无膜释放法评价凝胶的体外释放，通过阴道刺激性试验观察原位凝胶的安全性。结果：所得制剂满足阴道可注入性和体内凝胶性能，对阴道无刺激性，药物释放由凝胶溶蚀来决定。结论：参黄阴道用温敏原位凝胶工艺可行，符合临床阴道局部用药物要求。
목적：제비삼황음도용온민원위응효병대기진행평개。방법：이박락사모407화박락사모188위기질，제비삼황음도용온민원위응효。고찰원위응효경모의음도액희석전후적점도수온도변화곡선화효응온도，채용무막석방법평개응효적체외석방，통과음도자격성시험관찰원위응효적안전성。결과：소득제제만족음도가주입성화체내응효성능，대음도무자격성，약물석방유응효용식래결정。결론：삼황음도용온민원위응효공예가행，부합림상음도국부용약물요구。
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.