Mosapride citrate tablet and preparation method thereof
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A technology of mosapride citrate and tablet, applied in the field of medicine, can solve the problems of low mosapride citrate, cumbersome process, difficult to fully mix, etc., and achieves rapid drug dissolution and simple preparation process. Effect
Active Publication Date: 2017-07-04
SHANDONG NEWTIME PHARMA
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Problems solved by technology
But because mosapride citrate is an insoluble drug, it is almost insoluble in water, often encounters the problem that the dissolution rate is low or even unqualified in the actual production of mosapride citrate oral solid preparation; and because citric acid The content of mosapride in the preparation is low, and it is difficult to fully mix during preparation. When performing dissolution testing, there are often problems of high and low, and large differences in dissolution between tablets
When there is an urgent need for quick-acting and high-efficiency preparations in clinical practice, solving the problem of low bioavailability of insoluble drugs due to low solubility and slow dissolution has always been a major problem in the pharmaceutical industry
But the process is relatively cumbersome
Method used
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Embodiment 1
[0022]
[0023] Preparation Process:
[0024] Dissolve mosapride citrate in glacial acetic acid, add mesoporous silica, stir evenly, add sodium hydroxide aqueous solution to this solution under stirring condition, mosapride citrate and mesoporous silica The silicon oxide complex is precipitated, filtered, dried at 60°C, then mixed evenly with the mixed powder of microcrystalline cellulose and sodium carboxymethyl starch, added with magnesium stearate, mixed, and pressed into tablets.
Embodiment 2
[0026]
[0027]
[0028] Preparation Process:
[0029] Dissolve mosapride citrate in glacial acetic acid, add mesoporous silica, stir evenly, add sodium hydroxide aqueous solution to this solution under stirring condition, mosapride citrate and mesoporous silica The silicon oxide complex is precipitated, filtered, dried at 65°C, then mixed evenly with the mixed powder of microcrystalline cellulose and crospovidone, added with magnesium stearate, mixed, and pressed into tablets.
Embodiment 3
[0031]
[0032] Preparation Process:
[0033] Dissolve mosapride citrate in glacial acetic acid, add mesoporous silica, stir evenly, add sodium hydroxide aqueous solution to this solution under stirring condition, mosapride citrate and mesoporous silica The silicon oxide complex is precipitated, filtered, dried at 60°C, then mixed evenly with the mixed powder of microcrystalline cellulose and sodium carboxymethyl starch, added with magnesium stearate, mixed, and pressed into tablets.
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Abstract
The invention discloses a mosapride citrate tablet and a preparation method thereof. The preparation method comprises the following steps: dissolving mosapride citrate glacial acetic acid; adding mesoporous silica and carrying out uniform mixing under stirring; then adding an aqueous sodium hydroxide solution into a solution obtained in the previous step under stirring; allowing a compound of mosapride citrate and mesoporous silica to be precipitated and carrying out filtering and drying; then mixing the dried compound with a filler and a disintegrating agent and carrying out granulation and drying; and adding a lubricant into dry particles and then carrying out tabletting. Compared with the prior art, the mosapride citrate tablet prepared in the invention can be rapidly dissolved out in water, and the preparation method is simple in process and suitable for industrial production.
Description
technical field [0001] The invention belongs to the technical field of medicines, in particular to a mosapride citrate tablet and a preparation method thereof. Background technique [0002] Mosapride Citrate (Mosapride Citrate), the chemical name is 4-amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholinyl]methanol Base] benzamide citrate, white or off-white crystalline powder, odorless, slightly bitter. The melting point is 143-145°C. Soluble in dimethylformamide and pyridine, slightly soluble in methanol, insoluble in 95% ethanol, insoluble in water or ether. [0003] Mosapride citrate is a new third-generation gastric motility drug, mainly used for functional dyspepsia with heartburn, belching, nausea, vomiting, early satiety, upper abdominal distension and other gastrointestinal symptoms. The drug can enhance gastrointestinal motility, but does not affect gastric acid secretion, and has no side effects such as extrapyramidal reaction and diarrhea, and is well tol...
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