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本文研究了国产18-甲基炔诺酮硅橡胶长效皮下埋植剂的药物体外释放,并与进口Norplant进行了比较。释放试验采用水平振荡法,实验条件符合“漏槽”状态的要求。用紫外分光光度法在240 nm波长处测定18-甲基炔诺酮每天的体外释放量。二年多体外释放试验的实验结果表明:国产埋植剂的药物体外释放无爆破效应,释药速度稳定,为零级速度。平均每天释放量为85μg。体外释放的重现性好。进口Norplant则有明显的爆破效应,经10天释放,才趋于稳定,平均每天释药量为68μg。
In this paper, the in vitro release of domestic 18-norgestrel silicone rubber long-acting subcutaneous implants was studied and compared with the imported Norplant. Release test using horizontal oscillation method, the experimental conditions in line with the “drain” state requirements. The daily in vitro release of 18-norgestrel was determined by UV spectrophotometry at a wavelength of 240 nm. Two years of in vitro release test results show that: domestic implants released in vitro drugs without blasting effect, drug release rate stable, zero-speed. The average daily release was 85μg. Good reproducibility of in vitro release. Imported Norplant has obvious blasting effect, after 10 days of release, it tends to be stable, the average daily dose of 68μg.