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A technology of axitinib tablets and nixitinib tablets, applied in the field of pharmaceutical preparations, can solve problems such as equipment corrosion, complicated technical processes, and increased production costs, and achieve the effect of stable quality and simple process
Active Publication Date: 2021-06-22
LUNAN PHARMA GROUP CORPORATION
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Patent application CN106913547A dissolves axitinib in glacial acetic acid, adds mesoporous silicon dioxide, and prepares a complex of axitinib and silicon dioxide in an alkaline solution of sodium hydroxide, and then mixes it with a filler , disintegrating agent, etc. mixing, granulation, tableting, etc. Although the drug dissolves quickly, the technology is complex and the equipment is severely corroded, prolonging the production line of the GMP workshop and increasing the production cost, so it is not suitable for industrial production
Patent CN105769785B discloses a...
Method used
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Embodiment 1
[0024] 1) prescription
[0025]
[0026] 2) Preparation Process
[0027] The administered busenib was added to 35 ml of 1 mol / L of the ethanol solution, and the mixture was mixed, and the mixed solution was mixed; mixed with mannitol, carboxymethyl starch sodium, mixed with a mixed solution containing Albinib, stir, Granulation, dried, then addition of sodium stearate, mixed, mixed, and tablet.
Embodiment 2
[0029] 1) prescription
[0030]
[0031] 2) Preparation Process
[0032] The administered busenib was added to 50 ml of 1.5 mol / L hydrochloride methanol solution, stirred evenly, mixed solution; mixed microcrystalline cellulose, carboxymethyl starch sodium, mix well, add mixed solution containing Albinib, Stir, granulated, dried, then magnesium stearate, mix, and tablets were added.
Embodiment 3
[0034] 1) prescription
[0035]
[0036]
[0037] 2) Preparation Process
[0038] The disposal amount of Albinib is added to 15 ml of 0.5 mol / L hydrochloride solution, stirred evenly, and mixed the solution; mixing lactose, crosslinked polyethylene, mixing mixed solution containing Albinib, stir, and Particles, dried, then magnesium stearate, mix, and tablets.
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Abstract
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to axitinib tablets. The preparation process of the axitinib tablet provided by the invention comprises the following steps: adding axitinib into a volatile hydrochloric acid alcohol solution, uniformly stirring, adding into a filling agent and a disintegrating agent, stirring, granulating, drying, adding a lubricating agent, mixing and tabletting to obtain the axitinib tablet. The prepared axitinib tablet is high in dissolution speed, high in stability, simple in preparation process and suitable for large-scale production.
Description
Technical field [0001] The present invention belongs to the technical field of medical preparations, and is specifically involved in aisotini tablet. Background technique [0002] AxitiniB is a multi-target tyrosine kinase inhibitor developed by PFizer, which can inhibit vascular endothelial growth factor receptor VEGFR1, VEGFR2, VEGFR3, platelet-derived growth factor receptor and C-Kit for use in Other systematic treatment inactive advanced kidney cancer, January 27, 2012, FDA approved. [0003] Albinib is a white powder, a melting point 218.4 ° C, slightly soluble in polyethylene glycol 400, slightly soluble in methanol or ethanol, is slightly soluble in acetonitrile, is almost insoluble in water, in a pH1.2 hydrochloric acid solution. The solubility of 0.8 mg / ml, the solubility in the pH 6.8 phosphate buffer solution is 0.2 μg / ml, which is a typical pH dependent agent. At the same time, the Albinib itself is easy to degrade the light in the case of heating or water, result...
Claims
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Application Information
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