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Esomeprazole sodium hemihydrate
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A technology of esomeprazole sodium and hydrate, applied in the field of medicine, can solve the problems of high total amount of impurities, large number of impurities of esomeprazole sodium, low optical purity, etc.
Active Publication Date: 2013-07-03
TIANJIN HANRUI PHARMA
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[0009] In the research process, repeating the method of the above-mentioned patent documents, the obtained esomeprazole sodium has a large number of impurities, a high total amount of impurities, and low optical purity.
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Embodiment 1
[0057] Add 60 grams of esomeprazole sodium and 300 milliliters of water into a 500ml reaction bottle equipped with stirring, a thermometer and a condenser, add 0.5 grams of dimethylformamide (DMF) to the above aqueous solution, stir for 30 minutes, and filter , the filtrate was cooled to 12°C and set aside.
[0058] 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).
[0059] Elemental Analysis Results:
[0060] Measured value (calculated value), C:54.28(54.25),H:5.16(5.09),N:11.21(11.16),
[0061] S: 8.59 (8.52), Na: 6.19 (6.11).
[0062] The X-ray diffraction pattern of the crystal is shown in figure 1 . Instrument model...
[0066] Prescription: Esomeprazole Sodium Hemihydrate (20g as anhydrous substance), 100g mannitol, 140g lactose, 500ml water for injection, made into 1000 sticks.
[0067] Process: Take esomeprazole sodium hemihydrate, mannitol, lactose, and water for injection and stir to dissolve, then add 4g of activated carbon, stir at room temperature for 10 minutes, filter out the activated carbon, and use a microporous membrane to filter bacteria. Pack 1000 tubes, pre-freeze for 3 hours, freeze-dry under reduced pressure for 20 hours, then warm to room temperature, and seal.
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Abstract
The invention belongs to the technical field of medicine, and particularly relates to an esomeprazole sodium hemihydrate and a preparation method thereof; the esomeprazole sodium of the invention comprises a hemihydrate, and has the following advantages that: the chemical purity is 99.9%; the maximal impurity content is less than one thousandth; the optical purity is up to 99.96%ee; and the stability is good. The invention also relates to an application of a composition of the hydrate in the preparation of medicaments for treating stomach burning sensation caused by non-erosive gastroesophageal reflux, and erosive esophagitis.
Description
Technical field [0001] The invention is a pharmaceutical technology field, which involves the semi -hydrophilic compound and its preparation methods of Escepizole sodium. The present invention also involves the use of this hydrophobic composition to create a non -eroded gastroesophageal reflux of gastroesophageal reflux diseases.Applications in the stomach burning sensation and erosive esophagitis drugs. Background technique [0002] Medication of acid -related diseases, the first H2 receptor antagonist Simiidine, first launched in the 1970s, also found a proton pump inhibitor in the 1980s studies in the 1980s.Diseases such as gastrointestinal ulcers (including stress ulcers), gastroesophageal reflux disease (including reflux esophagitis), gastrine tumors, and some functional digestion, etc., so that the control rate of such diseases can be achievedIt has never been effective.Especially the proton pump inhibitors, because of its part, is the last step of the gastric mucosal wall ...
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