RU96102079A - Magnesium Omeprazole Salt - Google Patents

Magnesium Omeprazole Salt

Info

Publication number
RU96102079A
RU96102079A RU96102079/04A RU96102079A RU96102079A RU 96102079 A RU96102079 A RU 96102079A RU 96102079/04 A RU96102079/04 A RU 96102079/04A RU 96102079 A RU96102079 A RU 96102079A RU 96102079 A RU96102079 A RU 96102079A
Authority
RU
Russia
Prior art keywords
salt
omeprazole
paragraphs
magnesium
salt according
Prior art date
Application number
RU96102079/04A
Other languages
Russian (ru)
Other versions
RU2139868C1 (en
Inventor
Оке Кельстрем Ларс
Аннелие Нюгрен Моника
Original Assignee
Астра Актиеболаг
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from SE19939302396A external-priority patent/SE9302396D0/en
Application filed by Астра Актиеболаг filed Critical Астра Актиеболаг
Publication of RU96102079A publication Critical patent/RU96102079A/en
Application granted granted Critical
Publication of RU2139868C1 publication Critical patent/RU2139868C1/en

Links

Claims (29)

1. Магниевая соль омепразола, отличающаяся тем, что имеет степень кристалличности более 70%, определенную порошковой рентгенографией.1. Magnesium salt of omeprazole, characterized in that it has a degree of crystallinity of more than 70%, determined by powder x-ray. 2. Соль по п.1, отличающаяся тем, что степень ее кристалличности составляет более 75%. 2. The salt according to claim 1, characterized in that the degree of crystallinity is more than 75%. 3. Соль по п.1, отличающаяся тем, что средний диаметр массы частиц, определенный методом лазерной дифракции, составляет менее 30 мкм, предпочтительно менее 20 мкм. 3. The salt according to claim 1, characterized in that the average particle mass diameter determined by laser diffraction is less than 30 microns, preferably less than 20 microns. 4. Соль по п. 1, отличающаяся тем, что плотность ее имеет величину в интервале 1,33 - 1,35 г/см3, определенную порошковым пикнометром.4. The salt according to claim 1, characterized in that its density has a value in the range of 1.33 - 1.35 g / cm 3 determined by a powder pycnometer. 5. Соль по п.1, отличающаяся тем, что имеет гигроскопичность, при которой после хранения в течение одного месяца при относительной влажности атмосферы менее 94% увеличение массы составляет менее 2%, как определено гравиметрически. 5. The salt according to claim 1, characterized in that it has hygroscopicity, in which after storage for one month at a relative humidity of less than 94%, the mass increase is less than 2%, as determined gravimetrically. 6. Соль по п.1, отличающаяся тем, что содержание воды составляет 5 - 10 мас.%, по определению методом титрования Карла Фишера. 6. The salt according to claim 1, characterized in that the water content is 5 to 10 wt.%, As determined by Karl Fischer titration. 7. Соль по п.1, содержащая менее 0,1 мас.% растворителя, как определено методом газовой хроматографии. 7. The salt according to claim 1, containing less than 0.1 wt.% Solvent, as determined by gas chromatography. 8. Соль по п.1, отличающаяся тем, что содержит менее 0,05 мас.% растворителя по определению методом газовой хроматографии. 8. The salt according to claim 1, characterized in that it contains less than 0.05 wt.% Solvent, as determined by gas chromatography. 9. Способ получения магниевой соли омепразола, отличающийся следующими последовательными стадиями: обрабатывают омепразол или его соли алкоголятом магния в растворе, отделяют неорганические соли от реакционной смеси, проводят кристаллизацию магниевой соли омепразола, выделяют полученную кристаллическую магниевую соль омепразола; и необязательно очищают и сушат кристаллическую магниевую соль омепразола с использованием общеизвестных методов. 9. A method of producing omeprazole magnesium salt, characterized by the following successive stages: treating omeprazole or its salts with magnesium alcoholate in a solution, inorganic salts are separated from the reaction mixture, crystallization of the omeprazole magnesium salt is carried out, the obtained crystalline magnesium salt of omeprazole is isolated; and optionally, crystalline magnesium salt of omeprazole is purified and dried using well-known methods. 10. Способ по п. 9, отличающийся тем, что алкоголятом магния является метилат магния. 10. The method according to p. 9, characterized in that the magnesium alcoholate is magnesium methylate. 11. Способ по п. 9, отличающийся тем, что растворителем является метанол. 11. The method according to p. 9, characterized in that the solvent is methanol. 12. Способ по п. 9, отличающийся тем, что кристаллизацию проводят добавлением воды. 12. The method according to p. 9, characterized in that the crystallization is carried out by adding water. 13. Способ по п. 9, отличающийся тем, что выделение магниевой соли омепразола выполняют при помощи центрифугирования кристаллов. 13. The method according to p. 9, characterized in that the selection of the magnesium salt of omeprazole is performed by centrifugation of crystals. 14. Способ по п. 9, отличающийся тем, что выделение магниевой соли омепразола выполняют посредством кристаллизации с последующей фильтрацией кристаллов. 14. The method according to p. 9, characterized in that the selection of the magnesium salt of omeprazole is performed by crystallization, followed by filtering the crystals. 15. Способ по п. 9, отличающийся тем, что очистку кристаллов магниевой соли омепразола выполняют посредством промывки кристаллов раствором полярных растворителей. 15. The method according to p. 9, characterized in that the purification of crystals of the magnesium salt of omeprazole is performed by washing the crystals with a solution of polar solvents. 16. Способ по п. 9, отличающийся тем, что кристаллы магниевой соли омепразола сушат предпочтительно при пониженном давлении. 16. The method according to p. 9, characterized in that the crystals of the magnesium salt of omeprazole are dried, preferably under reduced pressure. 17. Способ по п. 9, отличающийся тем, что сушку кристаллов магниевой соли омепразола выполняют посредством выпаривания оставшегося растворителя при нагревании. 17. The method according to p. 9, characterized in that the drying of the crystals of the magnesium salt of omeprazole is performed by evaporating the remaining solvent with heating. 18. Соль по п. 1, отличающаяся тем, что представляет собой продукт, полученный способом по любому из пп. 9 - 17. 18. The salt according to claim 1, characterized in that it is a product obtained by the method according to any one of paragraphs. 9-17. 19. Фармацевтическая композиция, отличающаяся тем, что в качестве активного ингредиента содержит магниевую соль омепразола по любому из пп. 1 - 8. 19. A pharmaceutical composition, characterized in that the active ingredient contains the magnesium salt of omeprazole according to any one of paragraphs. 18. 20. Композиция по п. 19, отличающаяся тем, что ее используют для орального введения. 20. The composition according to p. 19, characterized in that it is used for oral administration. 21. Композиция по п. 19, отличающаяся тем, что представляет собой таблетки. 21. The composition according to p. 19, characterized in that it is a tablet. 22. Соль по любому из пп. 1 - 8, отличающаяся тем, что ее используют в терапии. 22. Salt according to any one of paragraphs. 1 to 8, characterized in that it is used in therapy. 23. Соль по любому из пп. 1 - 8, отличающаяся тем, что ее используют для ингибирования секреции желудком кислоты у животных и человека. 23. Salt according to any one of paragraphs. 1 to 8, characterized in that it is used to inhibit the secretion of acid by the stomach in animals and humans. 24. Соль по любому из пп. 1 - 8, отличающаяся тем, что ее используют в качестве агента с защитой активностью в отношении слизистой оболочки желудка млекопитающих и человека. 24. Salt according to any one of paragraphs. 1 to 8, characterized in that it is used as an agent with protection activity against the gastric mucosa of mammals and humans. 25. Соль по любому из пп. 1 - 8, отличающаяся тем, что ее используют для лечения заболеваний, связанных с секрецией желудочной кислоты у млекопитающих и человека. 25. Salt according to any one of paragraphs. 1 to 8, characterized in that it is used to treat diseases associated with the secretion of gastric acid in mammals and humans. 26. Соль по любому из пп. 1 - 8, отличающаяся тем, что ее используют для получения лекарственного средства для ингибирования секреции желудком кислоты. 26. Salt according to any one of paragraphs. 1 to 8, characterized in that it is used to obtain a medicinal product for inhibiting the secretion of acid by the stomach. 27. Соль по любому из пп. 1 - 8, отличающаяся тем, что ее используют для получения лекарственного средства для защитной активности слизистой оболочки желудка. 27. Salt according to any one of paragraphs. 1 to 8, characterized in that it is used to obtain drugs for the protective activity of the gastric mucosa. 28. Соль по любому из пп. 1 - 8, отличающаяся тем, что ее используют для лекарственного средства для лечения заболеваний, связанных с секрецией кислоты в желудке. 28. Salt according to any one of paragraphs. 1 to 8, characterized in that it is used for a medicinal product for the treatment of diseases associated with acid secretion in the stomach. 29. Способ лечения заболеваний, связанных с секрецией желудочной кислоты у млекопитающих и человека, отличающийся тем, что пациенту, которому это необходимо, вводят терапевтически эффективную дозу магниевой соли омепразола по любому из пп. 1 - 8. 29. A method of treating diseases associated with the secretion of gastric acid in mammals and humans, characterized in that the patient who needs it is administered a therapeutically effective dose of the omeprazole magnesium salt according to any one of claims. 18.
RU96102079A 1993-07-09 1994-07-08 Omeprazole magnesium salt, method of its preparing, pharmaceutical composition, method of treatment RU2139868C1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE19939302396A SE9302396D0 (en) 1993-07-09 1993-07-09 A NOVEL COMPOUND FORM
SE9302396-8 1993-07-09
PCT/SE1994/000680 WO1995001977A1 (en) 1993-07-09 1994-07-08 Magnesium omeprazole

Publications (2)

Publication Number Publication Date
RU96102079A true RU96102079A (en) 1998-05-20
RU2139868C1 RU2139868C1 (en) 1999-10-20

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RU96102079A RU2139868C1 (en) 1993-07-09 1994-07-08 Omeprazole magnesium salt, method of its preparing, pharmaceutical composition, method of treatment

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EP (2) EP1164132A3 (en)
JP (2) JP3635432B2 (en)
KR (1) KR100353783B1 (en)
CN (1) CN1064680C (en)
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AU (1) AU679766B2 (en)
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CA (1) CA2166794C (en)
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DE (2) DE69429774T2 (en)
DK (1) DK0707580T3 (en)
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EE (1) EE03127B1 (en)
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SA (1) SA94150058B1 (en)
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WO (1) WO1995001977A1 (en)
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GB2189698A (en) * 1986-04-30 1987-11-04 Haessle Ab Coated omeprazole tablets
DE4035455A1 (en) * 1990-11-08 1992-05-14 Byk Gulden Lomberg Chem Fab ENANTIOMER SEPARATION
SE9302396D0 (en) * 1993-07-09 1993-07-09 Ab Astra A NOVEL COMPOUND FORM

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