口腔溃疡原位凝胶的研制及体外质量评价  

Preparation and in vitro Quality Evaluation of Oral Ulcer in Situ Gels

作　　者：王宏[1] 汪燕[1] 齐腊梅[1] 王芳[2] Wang Hong;Wang Yan;Qi Lamei;Wang Fang(Anqing Hospital Affiliated to Anhui Medical University,Anhui Anqing 246003,China;Nanjing Tech University)

机构地区：[1]安徽医科大学附属安庆医院,安徽安庆246003 [2]南京工业大学

出　　处：《中国药师》2020年第8期1487-1491,共5页China Pharmacist

基　　金：国家自然科学基金项目(编号:21878156)。

摘　　要：目的:优化口腔溃疡原位凝胶的制备工艺,研究口腔溃疡不同剂型体外释药规律及机制。方法:以泊洛沙姆188(P188)和泊洛沙姆407(P407)为凝胶基质,胶凝温度为考察指标,采用星点设计-效应面法优选凝胶处方。采用改良桨法,研究口腔溃疡原位凝胶的经皮渗透过程,探索口腔溃疡原位凝胶的缓释机制。结果:口腔溃疡原位凝胶的最优处方为:P188用量为4.0%,P407用量为12.5%,形成凝胶相转变温度范围为33~37℃。口腔溃疡原位凝胶体外释药行为遵循一级动力学方程。结论:口腔溃疡原位凝胶的制剂处方设计合理,质量可控,具有一定的缓释性,是可替代口腔溃疡液用于临床的一种新剂型。Objective: To optimize the preparation process of oral ulcer in situ gels and to study the release law and mechanism of different dosage forms of oral ulcer in vitro. Methods: Poloxamer 188( P188) and Poloxamer 407( P407) were used as the gel matrix and the gelation temperature was applied as the index,and the gel formulation was determined by central compsite design-response surface method. The transdermal osmotic process of oral ulcer in situ gels was studied by modified oar method,and the sustained release mechanism of oral ulcer in situ gels was explored. Results: The optimal formulation of oral ulcer in situ gels was 4.0% P188 and12.5% P407,and the phase transition temperature of gel formation was 33-37℃ . The drug release behavior of oral ulcer in situ gels followed the first-order kinetic equation. Conclusion: The formulation of oral ulcer in situ gels is reasonable and the quality is controllable with certain slow release. It is a new dosage form which can be used as a substitute for oral ulcer liquid in clinic.

关 键 词：口腔溃疡原位凝胶 星点设计-效应面法 胶凝温度 制备工艺 缓释性 

分 类 号：R944.15[医药卫生—药剂学]