FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to pharmaceutics. A pharmaceutical granule is spherical or spheroidal and has volume density 0.6-1.3 g/ml and disintegration 0.5-5 minutes. Active pharmaceutical ingredients are preparations of Traditional Chinese Medicine, herbal preparations or their extracts with a nucleus made of an extract of Traditional Chinese Medicine or herbal preparations, and a pharmaceutically acceptable carrier. The content of the pharmaceutically acceptable carrier with respect to total granule weight makes 10-60 wt %. The granule diameter can be equal to 700-1500 mcm. The granule nucleus diameter can be equal to 200-750 mcm. The granule can be also coated with a layer of 2-5 wt % with respect of total granule weight. A method for making the granules consists in introducing initial granules into a layer of a fluidised material as an excipient; the active pharmaceutical ingredients are prepared in the form of a suspension or a solution of the viscosity controlled within 6.0-9.8 MPa·s with using a viscosity-control agent; then they are sprayed over a surface of the initial granule for making a finished granule.
EFFECT: granules possess fast disintegration, contain a small amount of the carrier and contain a low single dose.
12 cl, 5 ex
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Authors
Dates
2012-07-27—Published
2007-06-22—Filed