Cangrelor monohydrate crystal and preparation method thereof
A monohydrate and crystal technology, applied in the field of medicine, can solve the problems of high impurity content, moisture absorption and weight gain, difficulty in purification, etc.
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Embodiment 1
[0045] In a 1L reaction flask equipped with stirring, thermometer, and condenser, add 50 g of cangrelor, 300 ml of water, and 1.2 ml of dichloromethane, stir for 30 minutes, filter, and cool the filtrate to 8°C for later use.
[0046] Cool 350ml of ethyl acetate mixed solution to 8°C, add it into the above standby solution with stirring, keep it warm for 15 hours, crystals precipitate out, filter and dry to obtain 52.5 grams of white crystals. Measured 3 times by Karl Fischer method, take the average value, containing 2.25% (weight ratio) of water. Purity 99.9% (HPLC normalization method), optical purity 99.97ee (chiral HPLC).
Embodiment 2
[0048] Injections containing cangrelor monohydrate
[0049] Prescription: cangrelor monohydrate 2.5% by weight, mannitol 13.2%, lactose 18.4%, water for injection 65.7%, made into 1000 sticks.
[0050] Process: Take cangrelor monohydrate, mannose, lactose, and water for injection and stir to dissolve, then add 5g of activated carbon, stir at room temperature for 10 minutes, filter out the activated carbon, use microporous membrane to filter and sterilize, and pack the filtrate into 1000 tubes. After pre-freeze-drying for 3 hours, freeze-dry under reduced pressure for 20 hours, then warm up to room temperature, and seal it.
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