| 摘要 |
A ziprasidone hydrogen sulfate dehydrate is provided to ensure excellent stability, solubility, and non-hygroscopicity and have equal or more elution rate with a ziprasidone hydrochloride in formulation. A manufacturing method of ziprasidone hydrogen sulfate dehydrate comprises: a step of adding ziprasidone in inert solvent to produce ziprasidone solution; a step of adding diluted sulfuric acid and stirring; a step of cooling the mixture to -10 ~ 10°C, adding distilled water, and stirring to form crystalline; and a step of filtering the precipitated crystalline and washing with inert solvent. The inert solvent is acetone, ethyl acetate, methanol, ethanol, isopropanol, acetonitrile, isopropyl ether, methyl ethyl ketone, dichloromethane, tetrahydrofuran or their mixture. A therapeutic composition for schizophrenia or bipolar disorder-related mania comprises ziprasidone hydrogen sulfate dehydrate and pharmaceutically allowable carrier.
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