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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 a thermosensitive in-situ gel for the reference of yellow vagina and evaluate it. Methods: A temperature-sensitive in-situ gel was prepared from Poloxamer 407 and Poloxamer 188. The in vitro gel viscosity was simulated and the gelation temperature was measured before and after dilution with simulated vaginal fluid. The in vitro release of the gel was evaluated by the film-free release method. The safety of the in-situ gel was observed by the vaginal irritation test. RESULTS: The resulting preparations met vaginal injectability and gel properties in vivo, and were non-irritating to the vagina. Drug release was determined by gel erosion. Conclusion: The temperature-sensitive in-situ gel technique for yellowing vagina is feasible and meets the requirements of clinical vaginal topical drugs.