| 摘要 |
1. Controlled release pharmaceutical preparation in the form of doses, i.e. tablets or capsules which contains multi-particles of the size between 0.1-3.0 mm, and which contains an active component included in the matrix of pharmaceutically permissible adjuvants. Characterized in that: the active component is tramadol or its pharmaceutically permissible salt, where a dose contains from 50 mg to 800 mg of tramadol (per tramadol hydrochloride), and the matrix is a hydrophobic fusible carrier selected from among the following substances: hydrogenated vegetable oil, particularly castor oil, microcrystalline wax, beeswax, carnauba wax, glyceryl monostearate; possibly with the addition of a release modifying agent selected from among the following substances: polyethylene glycol, dicalcium phosphate or lactose, where the total amount of the active component in the preparation is between 10 and 90 percent by weight. 4. A method of producing controlled release pharmaceutical preparation in the form of doses, i.e. tablets or capsules, whereby the mixture of the active component and particles of a hydrophobic fusible carrier is placed in a known high-speed agitator and the mixture is processed. Characterized in that: Tramadol or its pharmaceutically permissible salt in the form of particles and a hydrophobic fusible carrier in the form of particles, which is selected from among the following substances: hydrogenated vegetable oil, particularly castor oil, microcrystalline wax, beeswax, carnauba wax, glyceryl monostearate, are applied, and possibly a release-modifying agent, selected from among the following substances: polyethylene glycol, dicalcium phosphate or lactose, is added to the mixture, where the total amount of the active component in the preparation is between 10 and 90 percent by weight and from 50 gm to 800 gm of the active component per each dose. During the processing in the high-speed agitator, such speed and energy is applied, by means of a heating jacket or microwave radiation, so that the temperature of the bed is at least 40 degrees C, the mixture is melted or softened and agglomerates with a cohesive granular structure and irregular shape and appearance, are obtained; further the agglomerates are broken into a mixture of a powder and small particles, and next the mixture is further processed in the high-speed agitator until particles sized from 0.1 to 0.3 mm are obtained; such particles are further used to fill capsules according to a known method, or are pressed to form tablets.
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