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报告复方左炔诺孕酮避孕环(CVR)的制备及体外释药研究。CVR以医用硅橡胶作贮药管,内装左炔诺孕酮(LNG)、雌二醇(E_2)和载体制成的混悬剂,在“漏槽状态”下测定CVR药管的体外释药速度。结果表明:不同的硅橡胶、载体和管壁厚度对释药速度有显著影响,温度与释药速度的关系符合Arrhenius关系式,释药速度与厚度的倒数呈线性相关。实验结果提示,LNG为零级释放,其释放机理为膜控制释放;E_2的释放速度与时间的平方根呈线性相关,可能为骨架型释放。本CVR经兔体内释放试验,证明体内外释药相关。
Preparation of levonorgestrel (CP) contraceptive ring (CVR) and its drug release in vitro. CVR used medical silicon rubber as medicine storage tube, contained levonorgestrel (LNG), estradiol (E_2) and carrier made suspension, measured in “drain state” CVR tube in vitro release speed. The results show that different silicone rubber, carrier and wall thickness have significant influence on the drug release rate. The relationship between temperature and drug release rate accords with the Arrhenius relationship, and the drug release rate is linearly related to the reciprocal of the thickness. The experimental results suggest that LNG is a zero-order release and its release mechanism is membrane-controlled release. The release rate of E 2 is linearly related to the square root of time and may be a skeleton-type release. The CVR release test by the rabbit in vivo proved that drug release in vitro and in vivo.