Oschmann R, Biber A, Lang F, Stumpf H, Kunz K
Dr. Willmar Schwabe Arzneimittel, Karlsruhe, Germany.
Pharmazie. 1996 Aug;51(8):577-81.
With a specific radioimmunoassay the pharmacokinetics and relative bioavailability of escin was measured after administration of different formulations containing Aesculus-extract. Of special interest was the relative bioavailability of escin after administration of a newly developed film-coated tablet with sustained release in comparison to a reference formulation. In a cross-over steady-state study in 24 volunteers bioequivalence of test and reference preparation could be demonstrated. The 90% confidence interval of the AUC (O-tau) was 98.3 to 120.9%.
采用特定的放射免疫分析法,在给予含七叶树提取物的不同制剂后,测定了七叶皂苷的药代动力学和相对生物利用度。特别令人感兴趣的是,与参比制剂相比,给予新研制的缓释薄膜包衣片后七叶皂苷的相对生物利用度。在一项针对24名志愿者的交叉稳态研究中,证实了试验制剂和参比制剂的生物等效性。AUC(0-tau)的90%置信区间为98.3%至120.9%。