FIELD: medicine; pharmaceuticals.
SUBSTANCE: present invention relates to solid pharmaceutical compositions containing biopterin derivatives, as well as methods for preparing such solid pharmaceutical compositions. Composition according to invention contains 4-amino-5,6,7,8-tetrahydro-L-biopinterin (I) and/or 4-amino-7,8-dihydro-L-biopinterin (II) and two different phosphate salts of sodium NaH2PO4⋅2H2O and Na2HPO4⋅2H2O. Molar ratio as NaH2PO4⋅2H2O and Na2HPO4⋅2H2O to compound (I) or compound (II) ranges from 0.02 to 0.5. Composition can additionally contain auxiliary substance NaCl. Also described is a method for preparing a solid pharmaceutical composition in the form of a lyophilizate and using said composition for treating traumatic brain injury and secondary cerebral injury. Also described is a method of producing an injection solution.
EFFECT: compositions according to the invention provide no oxidation of biopsyderin derivatives and are stable during storage.
42 cl, 3 dwg, 6 tbl, 3 ex
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Year |
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