公开(公告)号：EP1229917B1

公开(公告)日：2008-12-17

申请号：EP00971847.9

申请日：2000-10-20

申请人： YUYU Pharma, Inc.

发明人： KANG, Sung An ,  LEE, Kyung Hee ,  KWAK, Chung Shil ,  KIM, Chang Jong ,  LEE, Yong, Oh

IPC分类号： A61K31/59 ,  A61K31/66

CPC分类号： A61K31/66 ,  A61K9/1623 ,  A61K9/2077 ,  A61K9/2866 ,  A61K9/4858 ,  A61K9/5084 ,  A61K31/59 ,  A61K2300/00

摘要： The present invention relates to a pharmaceutical composition for the treatment of metabolic bone disease and the method of preparation thereof, and more particularly, to an improved pharmaceutical composition for the therapeutic treatment of metabolic disease and the method of preparation thereof, wherein said composition is prepared as a composite pharmaceutical agent which comprises calcitriol; which reduces the rate of spine fractures and increases bone density; alendronate, a bone resorption inhibitor, as two main active ingredients in an optimal mixing ratio to exert the greatest synergistic therapeutic effect; and adequate amount of other additives such as a resorption fortifier of alendronate. Therefore, the pharmaceutical composition according to the present invention can inhibit hypercalcemia caused when administered by calcitriol alone, compensate the inhibitory activity of bone remodeling caused by alendronate due to the presence of calcitriol, and improve drug compliance associated with the usual difficulty in administration as well as a side effect in esophagus, thus effectively preventing the occurence of osteoporosis.