| 摘要 |
PROBLEM TO BE SOLVED: To provide a sustained release matrix preparation containing tramadol or its pharmaceutically permissible salt as an active ingredient for therapy. SOLUTION: This stabilized sustained release tramadol preparation is obtained by hardening the stabilized sustained release oral administering medicine containing an effective amount of tramadol dispersed in a matrix of a hydrophobic material containing a wax like substance which is melted or softened during the preparation of the matrix, at an approximately 35-approximately 65°C temperature for spending approximately 4-approximately 72 hrs, while setting conditions so that in the case that the preparation is dissolved in vitro after exposing at least for 1 month under an accelerating preservation condition of 40°C/75 % RH, the preparation releases the tramadol in an amount not exhibiting a change approximately by >20 % of the total released amount of the tramadol at an optional dissolving time point as compared with the in vitro dissolution performed before exposing the preparation to the accelerating preservation condition. COPYRIGHT: (C)2004,JPO
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