Tebipenem pivoxil crystal and preparation method thereof
A technology of tipipenem and pivoxil, which is applied in the field of drug synthesis, can solve the problems of unstable amorphous products and difficulty in meeting medicinal requirements for crystalline products
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Embodiment 1
[0042] Add 10g of amorphous tipipenem pivoxil into 20ml of absolute ethanol solution, heat to 40°C, stir until completely dissolved, then cool the reaction system to 5-15°C, stir and crystallize, and crystals precipitate , continue to keep warm and stir to crystallize for 3h, filter, and dry the filter cake at 40-45°C for 8h under reduced pressure to obtain 7.6g of tebipenem pivoxate crystalline sample, yield 76.0%, HPLC 99.7%, melting point 134.1-134.8°C .
Embodiment 2
[0044] Add 10g of amorphous tipipenem pivoxil into a mixture of 30ml of absolute ethanol and 10ml of n-hexane, heat to 40°C, stir to dissolve, then cool down to 10-15°C, stir to crystallize, and crystals precipitate out Afterwards, continue to keep warm and stir to crystallize for 3 hours, filter, and dry the filter cake under reduced pressure at 40-45°C for 8 hours to obtain 7.9 g of tebipenem pivoxate crystalline samples, with a yield of 79.0%, HPLC of 99.5%, and a melting point of 133.6-134.1°C .
Embodiment 3
[0046] Add 10g of amorphous tipipenem pivoxil into 30ml of ethyl acetate, stir at 20°C to completely dissolve, then cool down to 10-15°C, stir and crystallize, after crystals are precipitated, continue to stir and crystallize for 3h, filter , and the filter cake was dried under reduced pressure at 40-45° C. for 8 hours to obtain 8.3 g of a crystalline sample of tebipenem pivate, with a yield of 83.0%, HPLC of 99.8%, and a melting point of 134.3-134.8° C.
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