| 摘要 |
The invention relates to a three-phase pharmaceutical form with constant and controlled release for single daily application and to the process for preparing the same. The three-phase pharmaceutical form with constant and controlled release for single daily application comprises 0.05...300 mg of amorphous active ingredient, 1...40% by weight a water-soluble polymer polyvinylpyrrolidone having the molecular weight of 2,000...1,100,000 g/mole, 0.1...220% by weight a surface-active agent, 10...70% by weight a cellulose ether having the average molecular weight of 5,000...50,000 g/mole, the second phase consisting of 5...40% by weight cellulose ether having the molecular weight of 50,000...300,000 g/mole, up to 10% by weight a mixture of mono-, di- and triglycerides, usual adjuncts and a coating representing the third phase and comprising 2...10% by weight an esther of hydroxypropylmethylcellulose with phthalic anhydride having the molecular weight of 2,000...100,000 g/mole or 2...15% by weight a copolymerizate of the methacrylic acid with ethyl acrylate. The process for preparing the three-phase pharmaceutical form with constant and controlled release for single daily application consists in dissolving 0.05...3% by weight active ingredient, 0.1...20% by weight surface-active agent, 1...40% by weight polyvinylpyrrolidone in organic solvent, at a temperature ranging from 30 to 70 degree C, the resulting solution being atomized in a granulator with fluidized bed on a cellulose ether, the resulting granulate being afterwards mixed with cellulose ether and pharmaceutically acceptable adjuncts to homogenize, at the ambient temperature, and finally the granulate being compressed as tablets which are coated with a film or conditioned as capsules.
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