FIELD: pharmaceutical chemistry, in particular crystal form of pravastatine sodium salt.
SUBSTANCE: invention relates to new crystal form of pravastatine sodium salt known under chemical name of 1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobubutoxy)-haphtaleneheptane acid monosodium salt, obtained by a) preparation of solution containing pravastatine and sodium cations in lower aliphatic C1-C4-alcohol; b) addition ethylacetate to said solution; c) cooling of obtained alcohol/ethylacetate mixture; and d) crystallization. Characteristics of new crystal form of pravastatine sodium salt such as crystallogram and melting point (170-1740C) also are disclosed. The subject invention also pertains to method for pravastatine production as well as pharmaceutical composition containing the same. Pravastatine, its derivatives and analogs are well-known HMG-CoA reductase inhibitors and are useful as anticholesterenemic agents in treatment of hypercholesterenemia and hyperlypemia.
EFFECT: crystal form of pravastatine sodium salt and pharmaceutical composition with improved therapeutic action.
29 cl, 5 ex, 4 dwg
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