MEDICINE OF SEDATIVE AND ANTISPASMODIC EFFECT AND METHOD OF PREPARATION (VERSIONS) Russian patent published in 2009 - IPC A61K36/534 A61K36/185 A61K31/515 A61K31/22 A61K47/40 A61K47/38 A61K9/20 A61J3/06 A61P25/20 A61P9/08 

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention concerns medicine, particularly medical drugs with organic active components, medicines with sedative, vasodilating and antispasmodic effect, and methods of medicine obtainment, an can be applied in treatment of neuroses with high irritability, increased agitation, insomnia, neurocirculation dystonia, early stage of hypertension, non-acute cardiovascular spasm, digestive organ spasms related to neurovegetative disorders. Medicine of sedative and antispasmodic effect includes ethyl ether of α-bromisovaleric acid, Phenobarbital, peppermint oil, microcrystalline cellulose auxiliary substances for solid formulation obtainment in pellet form at the following component ratio, wt %: ethyl ether of α-bromisovaleric acid 1.37-8.2; Phenobarbital 1.25-7.5; peppermint oil 0.16-0.58; microcrystalline cellulose 2-15; the rest is auxiliary substances; pellets are covered with shell composed of β-cyclodextrin in amount of 10% of dry coating weight. First version of method of obtaining medicine with sedative and antispasmodic effect involves initial mixing of ethyl ether of α-bromisovaleric acid with peppermint oil, so that the mix comprises over 4.5% of total pellet, core pellet or capsule content weight, adding the mix to humid β-cyclodextrin taken in amount of up to 70% of total pellet core weight, stirring for 1-2 minutes, drying and pelletising of obtained mix, mixing granulate with Phenobarbital and microcrystalline cellulose powders and auxiliary filler, fluffer and slider substances, pellet compression and coating with shell containing β-cyclodextrin in amount of up to 10% of dry coating weight. Second version of method involves initial mixing Phenobarbital with auxiliary filler substance, separate preparation of mix of ethyl ether of α-bromisovaleric acid with peppermint oil, so that the ether oil mix comprises less than 4.5% of total pellet, core pellet or capsule content weight, adding microcrystalline cellulose powder, powders with extensive crystal surface area, auxiliary fluffer and slider substances, adding obtained mix to Phenobarbital and filler mix, pellet compression and coating with shell containing β-cyclodextrin in amount of up to 10% of dry coating weight.

EFFECT: medicine of sedative and antispasmodic effect in solid pellet form, with sedative and antispasmodic action matching that of drops with similar effect, ensuring stability of volatile components.

20 cl, 8 ex, 11 tbl