| 摘要 |
The present invention relates to a pharmaceutical composition in the form of coated tablets containing as an active substance clopidogrel hydrogen bromide. This composition, containing as active substance clopidogrel hydrogen bromide in an amount of 75 mg, based on clopidogrel base, further contains a. filling agent being selected from the group consisting of anhydrous lactose, mannitol or a mixture thereof in an amount of 40 to 70 percent by weight, based on the tablet total weight, b. a coating the main component of which is hydroxypropylmethyl cellulose, whereby the amount of the total coating ranges within 1 to 7 percent by weight, based on the tablet total weight, c. is free of cellulose of any kind and silica, d. release rate of the active components being as follows: Time [min] .tab. Released active component%.para.5.tab..tab..tab.30 to 95.para.10.tab..tab..tab.50 to 100.para.15.tab..tab..tab.70 to 100.para.20.tab..tab..tab.80 to 100.para.25.tab..tab..tab.90 to 100.para.30.tab..tab..tab.90 to 100.para.45.tab..tab..tab.90 to 100.para..para., wherein the release rate remains stable for a period of at least 3 month provided the composition is maintained under both natural conditions (25 degC/60 percent relative humidity), accelerated stability conditions i.e. 30 degC/65 percent relative humidity. |
