lansoprazole monohydrate crystal and crystal preparation method thereof

2017 
The invention relates to relates to iansoprazole monohydrate crystal; TGA (thermal gravimetric analysis) results show that the iansoprazole monohydrate crystal has characteristic peaks at 76+/-2 DEG C and 174 DEG C-2 DEG C, weight at the 76+/-2 DEG C is reduced by 4.6+/-0.5%, the decomposition temperature if 174+/- DEG C, and the appearance of needle shape. Under room temperature and stirring action, solid iansoprazole is added into a mixed solvent of acetonitrile-water or acetonitrile-acetone, and a solution having a concentration of 0.01-0.04 g/ml is prepared; a surfactant is added into the solution, and the solution is stirred until clarification; adsorbing is performed with activated carbon before filtering; system temperature is lowered to 0-5 DEG C, and grain is grown for 5-10 h; washing filter cakes with saturated sodium carbonate solution is performed, and vacuum suction filtering is performed to obtain a suspension that is a wet product; the wet product is dried to obtain the finished iansoprazole monohydrate crystal. The process is stable, the energy consumption is low, the product yield is up to 90% and above, the product purity reaches 99% and above, and the iansoprazole monohydrate crystal is suitable for the manufacture and long-term storage of pharmaceutical preparations.
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