黄体酮阴道缓释凝胶的处方及工艺的研究

Study on Formulation and Preparation Technology of Progesterone Vaginal Sustained-release Gel

制备黄体酮阴道缓释凝胶,以处方的外观性状、流变学和体外溶出为评价标准,采用单因素实验优化处方的制备工艺。以自制制剂与市售制剂Crinone体外溶出曲线的相似因子作为主要评价指标,使用单因素法考察处方因素对黄体酮阴道缓释凝胶的体外溶出的影响。结果表明,甘油、粒径以及聚卡波非与粒径的交互作用显著影响黄体酮缓释凝胶的体外释放。最优处方与市售制剂相似因子f2=64.23,外观性状及流变学等行为也相似,为后期体内研究奠定了基础。

Progesterone vaginal sustained-release gelwas prepared,taking the appearance properties,rheology and in vitro dissolution of the preparations as the evaluation criteria,the preparation process of the gel by using single factor experimentswas optimized.Single factor method was used to investigate the factors affectingin vitro dissolution of the progesterone vaginal sustained-release gel.The similar factors ofin vitro dissolution curves of self-made preparations and commercial preparations Crinone were used as the main evaluation indicators.The result showed thatglycerin,particle size and the interaction of polycarbophil and particle size significantly affected in vitro release of progesterone sustained-release gel.The similar factor of optimal preparation was 64.23 and theappearance and rheology results were relatively close,laying the foundation for later in vivo studies.