A stable rabeprazole sodium compound
The technology of rabeprazole sodium and compound is applied in the field of rabeprazole sodium compound and preparation thereof, and can solve the problems of rabeprazole sodium having large number of impurities, high total amount of impurities, low optical purity and the like
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Embodiment 1
[0067] Add 60 grams of rabeprazole sodium and 300 milliliters of water into a 500ml reaction flask equipped with stirring, thermometer and condenser, add 0.5 grams of dimethylformamide (DMF) to the above aqueous solution, stir for 30 minutes, filter, The filtrate was cooled to 12°C and set aside.
[0068] Cool 1150ml of acetonitrile-methyl ethyl ketone = 5:5 mixture to 13°C, add the above standby solution while stirring, keep warm for 18 hours, crystals precipitate, filter, and dry to obtain 53.3 grams of white crystals. Measured 3 times by Karl Fischer method, get the average value, contain 2.40% (weight percent) moisture. Purity 99.9% (HPLC normalization method), optical purity 99.96% ee (chiral HPLC).
[0069] Elemental Analysis Results:
[0070] Measured value (calculated value), C: 56.68 (56.68), H: 5.29 (5.29), N: 11.02 (11.01),
[0071] O: 12.58 (12.60) , S: 8.41 (8.40).
[0072] The X-ray diffraction pattern of the crystal is shown in figure 1 . Instrument model...
Embodiment 2
[0074] Capsules containing rabeprazole sodium compound
[0075] Prescription: 20 grams of rabeprazole sodium compound, 100 grams of mannitol, 140 grams of lactose, 50 grams of calcium carbonate, 5 grams of magnesium stearate, appropriate amount of 8% ethyl cellulose solution, 1000 enteric-coated capsules, made into 1000 grain.
[0076] Process: Mix rabeprazole sodium compound, mannitol, lactose, and calcium carbonate evenly; add an appropriate amount of binder 8% ethyl cellulose solution to make a soft material, granulate with a 20-mesh screen, and dry at 40°C±2°C , granulated, added externally mixed with magnesium stearate, mixed evenly, packed into capsules, and obtained.
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