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制备释放50μg/d黄体酮的宫内节育器(IUD),供体外释放速度研究、动物实验及临床研究。IUD的贮药管内填充黄体酮与硅油的混悬剂,由多聚物管壁限制释放速度。硅油又作为药物的载体。本给药系统在“漏槽”状态下测定释放速度,经短时间的较快释放后可维持长期的零级速度。属于精密给药系统。释药速度是管壁厚度及/或的函数。放入家兔子宫内同样以零级速度释放,并求得体内外的相关性。推导了释放速度方程式,并研究了各种因素与释放速度的关系。实验结果初步表明本系统属于骨架控制释放机理。本IUD已提供临床试用。
Intrauterine device (IUD) releasing 50 μg / d progesterone was prepared for in vitro release rate studies, animal experiments and clinical studies. IUD storage tube filled with progesterone and silicone oil suspension, limiting the release rate by the polymer wall. Silicone oil and as a drug carrier. The delivery system determines the release rate in the “drain” state and maintains a long-term zero-order speed after a short release. Belong to precision drug delivery system. Drug release rate is a function of tube wall thickness and / or thickness. Into the rabbit uterus the same speed of zero-speed release, and obtained in vitro and in vivo relevance. The release velocity equation was derived and the relationship between various factors and release rate was studied. The experimental results show that the system belongs to the framework of controlled release mechanism. This IUD has been clinically tested.