消炎痛缓释系统的基础研究及新型T型铜药宫内节育器临床应用的初步研究

将消炎痛掺入SYZ-1医用加成型硅橡胶制成长21mm,直径为2.4mm含消炎痛40mg的均质型缓释药棒,通过体外消炎痛释放量测定,得出消炎痛缓释系统为非零级释放,释放时间至少持续360天,其生物安全性能评价结果全部合格,其经γ射线,环氧乙烷消毒后,无新物质产生,消炎痛释放规律不变。将该缓释系统应用于新型T型铜药宫内节育器,通过半年的临床观察有效地防止了放器后引起的月经过多,并随机选择10例放器后的妇女于分泌期吸取宫颈粘液测消炎痛含量,结果为7.44μg/ml粘液,5例妇女于分泌期吸取宫颈粘液测铜含量,结果为0.46μg/ml粘液湿重。选择15例妇女于放器前月经干净3～7天及放器1月月经干净3～7天对子宫内膜细胞后150个进行定量测定,结果示放器后1月子宫内膜细胞较放器前明显增大。

The Basic Research and Preliminary Clinical Observation of T-Cu-i IUD.

The indomethacin- releasing system containing 40mg indomethacin with the length of 21mm,diameter of 2. 4mm was prepaired by mining indomethain and SYZ ?1 medical additional silastic elastomer. The releasing experiment in vitro demonstratred that its releasing pattern was non ?yero ?order type and its effective releasing could last 360 days at least. Resuits of biosafety studies wrer satisfactory. There were no changes in the quality and releasing pattern of the releasing system after steriliyation with γ—ray or cyclooxyethane. The newly designed medicated IUD is "T " shaped stainless steel IUD with pure copper wire of 200mm2 and indomethacin releasing system. Clinical observation for 6 months showed that the menstrual blood loss was distinctly reduced after insertion of the newly designed IUD. Indomethacin and copper ion were determined with the cervical secretion at 1, Sand Gmonths after insertion. The quantitative measurement of the endome-trial cells before and 1 month after insertion showed that the sizes of the endometrial cells were larger than those of before.