含吲哚美辛硅橡胶宫内节育器中吲哚美辛的载药量及在模拟宫腔液中的释放研究

Determination of Indomethacinin in the Intrauterine Device of Indomethacin Containing Silicone Rubber and Its Release in the Uterine Cavity Fluid Simulation Test

目的测定含吲哚美辛硅橡胶宫内节育器中吲哚美辛的载药量及其在模拟宫腔液中的释放量。方法采用高效液相色谱（HPLC）法,色谱柱为SB-C18柱（150 mm×4.6 mm,5μm）,流动相为0.1 mol/L冰醋酸-乙腈（1∶1）,流速为1.0 m L/min,检测波长为228 nm,检测温度为37℃。结果吲哚美辛载药量均在标示量的±10%范围内;吲哚美辛在模拟宫腔液中的释放速率起初较快,3～14 d后逐渐递减,最后基本趋于缓慢、平稳释放,且在同一数量级（20～85μg/d）。结论 HPLC法用于测定含吲哚美辛硅橡胶中吲哚美辛的载药量及其在模拟宫腔液中的释放量,测定结果准确、可靠,可满足相关产品的质量检测与控制。

Objective To determine the content of indomethacin in the intrauterine device of indomethacin containing silicone rubber and its release in the uterine cavity fluid simulation test. Methods HPLC method was used. The chromatographic column was SB- C18 column（ 4. 6 mm × 150 mm,5 μm）,acetonitrile- 0. 1mol / L glacial acetic acid（ 1 ∶ 1） was used as the mobile phase at rate of 1. 0 m L / min.The detection wavelength was 228 nm and the column temperature was 37 ℃. Results The drug loading of indomethacin in indomethacin rubber used for IUD was in the range of ± 10% of labelled amount. The initial rate of release in simulated uterine fluid was faster,after 3 to 14 d,the initial rate was gradually decreased,released slowly and steadily in the same order of magnitude（ 20- 85 μg / d）.Conclusion The established method is accurate,reliable,and can satisfy the detection of the most forms of products on the market.