Omeprazole sodium crystalline compound, preparation method and medicine composition thereof
A technology for omeprazole sodium and crystallization, which is applied in the field of crystallization preparation and pharmaceutical preparations, can solve the problems such as complicated preparation method, disadvantage, increase cost, etc., and achieve the effects of simple preparation method, low hygroscopicity and easy handling.
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Embodiment 1
[0038] Add 5.0 g of omeprazole sodium to 20 ml of water to dissolve, then add 95 ml of a mixed solution of isoamyl alcohol and 2-butanone at a volume ratio of 1:6, and then stir the mixture at 18°C for 1 hour, and then in Stir at 5°C for 2 hours. Then stand still for 6 hours, filter the obtained crystals with suction, wash with 20 ml of propanol, and dry to obtain 4.15 g of V-type crystals.
[0039] The X-ray diffraction analysis figure and infrared spectrum figure of this crystal are respectively figure 1 and figure 2 .
[0040]
Embodiment 2
[0042] Add 10.0 g of omeprazole sodium to 50 ml of water to dissolve, then add 135 ml of a mixed solution of isoamyl alcohol and 2-butanone at a volume ratio of 1:8, and then stir the mixture at 16°C for 1.5 hours, then in Stir at 8°C for 2 hours. Then stand still for 8 hours, filter the obtained crystals with suction, wash with 50 ml of propanol, and dry to obtain 8.45 g of V-type crystals.
[0043] The X-ray diffraction analysis figure and infrared spectrogram of the crystal are basically the same as those in Example 1.
[0044]
Embodiment 3
[0046] Add 13.0 g of omeprazole sodium to 55 ml of water to dissolve, then add 140 ml of a mixed solution of isoamyl alcohol and 2-butanone at a volume ratio of 1:9, and then stir the mixture at 18°C for 2 hours, and then in Stir at 8°C for 3.5 hours. Then stand still for 10 hours, filter the obtained crystals with suction, wash with 60 ml of propanol, and dry to obtain 11.12 g of V-type crystals.
[0047] The X-ray diffraction analysis figure and infrared spectrogram of the crystal are basically the same as those in Example 1.
[0048]
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