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本文依据雌性家兔及人体内使用9%乙烯醋酸乙烯(9%Ethylene Vinyl Acetate,简称EVA)共聚物作为释药系统,含一定量孕酮的宫内节育器,经过使用不同时间后分别取出测定剩余的孕酮量,观察本释药系统在体内的药物释放情况。测定结果证明家兔体内释放符合零级动力学,即恒速释放,释放速度为46.6μg/cm~2/天。在人体内也达到恒速释放,释药速度为29μg/cm~2/天。此外对四名育龄妇女进行上环前一个周期及上环后九个月至一年的基础体温、宫颈粘液、阴道脱落细胞成熟指数及血清促黄体生成激素、促卵泡激素、雌二醇和孕酮的放射免疫测定的系统纵向观察,结果证明受试者上环后每个周期均有排卵,释放孕酮量为29μg/cm~2/天的宫内节育器对机体垂体-卵巢轴无显著影响。
This article based on the female rabbits and the human body using 9% ethylene vinyl acetate (9% Ethylene Vinyl Acetate, referred to as EVA) copolymer as a drug delivery system, containing a certain amount of progesterone IUD were taken after different time were measured The remaining amount of progesterone, the release of the drug system to observe the release of the body. The results show that rabbits released in line with zero-order kinetics, that is, constant release, the release rate of 46.6μg / cm ~ 2 / day. In the human body also achieve constant release, release rate of 29μg / cm ~ 2 / day. In addition, basal body temperature, cervical mucus, vaginal exfoliated cell maturation index and serum luteinizing hormone, follicle stimulating hormone, estradiol and progesterone of four women of childbearing age in the previous cycle of Sheung Wan and nine months to 1 year after Sheung Wan, Longitudinal observation of the radioimmunoassay results showed that the subjects ovulation every cycle after the ring, the release of progesterone dose 29μg / cm2 / day IUD no significant effect on the body pituitary - ovarian axis .