活性元宫型药铜365宫内节育器体外释放吲哚美辛的研究

Study on Indomethacin Release in vitro of Active Yuangong Type 365 Drug-releasing Copper-bearing Intrauterine Contraceptive Device

目的:建立国产活性元宫型药铜365宫内节育器中吲哚美辛体外释放度测定方法。方法:以模拟宫腔液为释放介质,控制温度(37.0±0.1℃),匀速磁力搅拌,控制速度为70r/min,采用紫外分光光度法测定药物含量及释放量。结果:吲哚美辛的吸收度与浓度呈良好的线性关系,吲哚美辛的释放于d3达到平衡。结论:建立的吲哚美辛释放度测定方法简便、准确,可用于质量控制。

Objective：To establish a method for the determination ofindomethacin release of domestic drug-releasing copper-bearing intrauterine contraceptive device in vitro and assess its release performance. Methods： The simulated uterine fluid was used for releasing media and the release was performed at 37.0 ± 0.1℃ with magnetic stirring at 70 r/min. Ultraviolet spectrophotometry was used for the determination of drug contents and release amounts with the detection wavelength of 232 nm. Results： The linear correlation between absorbability and concentration of indomethacin was favorable. Indomethacin release of the IUD achieved steady state after three days. Conclusion： The established indomethacin release measure method in vitro can be used in the quality control.