参黄阴道用温敏原位凝胶的制备及质量评价  

Preparation and Quality Evaluation of Shenhuang Vaginal Thermosensitive in situ Gels

作　　者：李燕[1] 赵利刚[2] 王春艳[1] 于桂兰[1] 张立新[1] 

机构地区：[1]唐山市妇幼保健院药剂科,河北唐山063000 [2]河北联合大学药学院

出　　处：《中国药师》2015年第4期655-659,共5页China Pharmacist

基　　金：河北省自然科学基金石药联合基金项目(编号:H2013209098)

摘　　要：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。Objective： To prepare and evaluate Shenhuang vaginal thermosensitive in situ gels. Methods： Shenhuang vaginal thermosensitive 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 technique,and the properties meet the requirements of vaginal topical use.

关 键 词：参黄温敏原位凝胶 制备 质量评价 

分 类 号：R283.649[医药卫生—中药学]