| 摘要 |
PROBLEM TO BE SOLVED: To stabilize a composition containing amlodipine maleate and provide a stabilized pharmaceutical composition having excellent shelf life. SOLUTION: An acid (e.g. maleic acid, phosphoric acid, ascorbic acid or sorbic acid) having >=1.5 pK1 is added to amlodiphine maleate in order to prevent unnecessary formation of Michael adduct and further, a carrier (e.g. mannitol, cellulosic substance or starch) or a disintegrator (e.g. magnesium stearate) is added thereto to provide a stabilized pharmaceutical composition of amlodiphine maleate, which is stable both during formulation and throughout the life of the product, in which stabilizing action by the acid is enhanced.
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