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左炔诺孕酮宫内节育器的研制

DEVELOPMENT OF LEVONORGESTREL-RELEASING INTRAUTERINE DEVICE

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【作者】 徐鹤良金昭英林晓红庄澜

【Author】 XU He-Liang;JIN Zhao-Ying;LIN Xiao-Hong;ZHUANG Lan (Department of Pharmaceutics, Shanghai Medical University, Shanghai 200032)

【机构】 上海医科大学药剂学教研室

【摘要】 制备一种每天释放10μg左炔诺孕酮(LNG)的宫内节育器(IUD)。在硅橡胶制成的控制释药管中填入LNG和硫酸钡混合细粉,并与乙烯-醋酸乙烯共聚物(EVA)铸成的横臂粘接成钥匙形IUD,体外释药速度测定表明本品释放符合零级动力学。测得的标化速度为1.67μg·mm/cm ̄2·d。其释药速度(q)与药管壁厚度(h)的倒数呈良好线性关系,并表明本品释药过程符合骨架控制释放机理。

【Abstract】 A noval key-shaped levonorgestrel (LNG)-releasing intrauterine device(IUD) was developed with a release rate of 10μg/d of LNG, which was considered clinically to be appropriate to Chinese women for contraception. Silicone eiastomer was selected as the rate-controlling membrane material by its greater diffusion coefficient and permeability of LNG than that of ethylene-vinyl acetate copolymer employed before. The reservoir contained a mixture of LNG and barium sulfate which served as an X-ray contrast medium.The in vitro release investigation showed its constant rate for more than 50 days and a normalized flux of 1.67±0.12μg·mm/cm ̄2·d.In addition,the release rate(q)was founded to be a linear function of the reciprocal thickness(1/h) of silicone elastomer tube.

  • 【文献出处】 中国医药工业杂志 ,CHINESE JOURNAL OF PHARMACEUTICALS , 编辑部邮箱 ,1995年01期
  • 【分类号】R979.21
  • 【被引频次】1
  • 【下载频次】54
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