每周一次经皮雌二醇控释系统在中国绝经后女性中的药代动力学
Pharmacokinetics of weekly transdermal estradiol controlled delivery system in postmenopausal Chinese.
作者信息
Chen G S, Zhang M Y, Wang Q, Ye J C
机构信息
Institute of Materia Medica, Zhejiang Academy of Medical Sciences, Hangzhou, China.
出版信息
Zhongguo Yao Li Xue Bao. 1996 Sep;17(5):407-10.
AIM
To study Pharmacokinetical profile of weekly transdermal estradiol controlled delivery system (E2-WTCDS) in 18 Chinese postmenopausal women.
METHODS
Single and multiple daily doses of E2-WTCDS were applied to an area of intact skin on the lower abdomen, using Estraderm TTS (E2-TTS) from Ciba-Geigy Company as control. E2 concentration in serum was measured by RIA.
RESULTS
Cmax 38 +/- 5 ng.L-1, Tmax 22 +/- 5 h, AUC 5651 +/- 386 ng.h.L-1, Cmax(SS) 44 +/- 7 ng.L-1, Cmax(SS) 35 +/- 4 ng.L-1, Fl 0.22 +/- 0.10. The relative bioavailability of E2-WTCDS was comparable to E2-TTS during the same period of system application.
CONCLUSION
E2-WTCDS maintained relatively constant and effective serum estradiol concentrations and is suitable for once-weekly application.
目的
研究每周一次经皮雌二醇控释系统（E2-WTCDS）在18名中国绝经后妇女中的药代动力学特征。
方法
将单次和多次每日剂量的E2-WTCDS应用于下腹部完整皮肤区域，使用汽巴-嘉基公司的雌二醇透皮贴剂（E2-TTS）作为对照。采用放射免疫分析法测定血清中E2浓度。
结果
Cmax为38±5 ng.L-1，Tmax为22±5小时，AUC为5651±386 ng.h.L-1，稳态Cmax为44±7 ng.L-1，谷浓度Cmax为35±4 ng.L-1，波动度为0.22±0.10。在系统应用的同一时期，E2-WTCDS的相对生物利用度与E2-TTS相当。
结论
E2-WTCDS可维持相对恒定且有效的血清雌二醇浓度，适用于每周一次给药。
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