SALFAPRODIL CRYSTAL FORM, PREPARATION METHOD, AND STERILE POWDER CONTAINING SALFAPRODIL CRYSTAL

摘要

Disclosed is a salfaprodil crystal form I, belonging to a triclinic system. A space group is P1(1); cell parameters: a=7.5286(13)Å, b=7.5754(12)Å, c=28.2018(13)Å, α=82.54(1)º, β=83.48(1)º, γ=84.16(2)º, and Z=2; the cell volume V=1578(2)Å3; and the salfaprodil crystal form I is obtained through an anti-solvent solventing-out crystallization method, a cooling crystallization method, and an evaporative crystallization method. Further disclosed is a salfaprodil crystal form II, belonging to a monoclinic system. A space group is P2/c(13); cell parameters: a=29.6080(7)Å, b=7.3204(7)Å, c=7.4624(8)Å, α=90.0º, β=96.64(8)º, γ=90.0º, and Z=2; the cell volume V=1607(1)Å3, and the salfaprodil crystal form II is obtained by dissolving salfaprodil in water, stirring and raising temperature, completely dissolving, and concentrating under reduced pressure until being dried. Further disclosed are a sterile powder formed by a mixture of the salfaprodil crystal form I or the crystal form II and amorphous salfaprodil and a preparation method thereof. The sterile powder is used for treating cerebral apoplexy or myocardial infarction of people or animals.