Azacitidine freeze-drying powder needle for injection and method for preparing azacitidine freeze-drying powder needle
A technology of azacitidine and freeze-dried powder injection, which is applied in the field of medicine, and can solve the problems that the bioequivalence of the reconstituted suspension cannot reach bioequivalence, the crystal particle size is reduced, and the dissolution of the active agent of the drug is accelerated. , to achieve the effects of improving the stability of the liquid medicine, slowing down the production speed, and improving the quality of the preparation
Inactive Publication Date: 2018-07-20
KINDOS PHARM CO LTD +1
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Problems solved by technology
This patent uses ethanol, isopropanol, methanol or other alcohols containing hydroxy as solvents to accelerate the dissolution of pharmaceutical active agents, but research has found that when ethanol, isopropanol, methanol or other alcohols containing hydroxy are used as solvents, due to mannitol and There are several hydroxy...
Method used
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Embodiment 1
[0027] Azacitidine freeze-dried powder for injection, raw materials include azacitidine, mannitol and acetonitrile, the formula ratio of the parts by weight is: 2kg of azacitidine, 2kg of mannitol and 150kg of propionitrile.
Embodiment 2
[0029] Azacitidine freeze-dried powder for injection, raw materials include azacitidine, mannitol and acetonitrile, the formula ratio of the parts by weight is: 8kg azacitidine, 8kg mannitol and 400kg malononitrile.
Embodiment 3
[0031] Azacitidine freeze-dried powder for injection, raw materials include azacitidine, mannitol and acetonitrile, and the formula ratio of the parts by weight is: 3kg of azacitidine, 3kg of mannitol and 200kg of dimethylformamide.
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Abstract
The invention discloses an azacitidine freeze-drying powder needle for injection, the azacitidine freeze-drying powder needle comprises the raw materials, by weight, of 2-8 parts of azacitidine, 2-8 parts of mannitol and 150-400 parts of organic solvent. The invention further provides a method for preparing the azacitidine freeze-drying powder needle for injection. According to the azacitidine freeze-drying powder needle for injection and the method for preparing the azacitidine freeze-drying powder needle, by changing the technical key points of the product solvent formula, the solution preparation temperature, the charging sequence, the freeze-drying process and the like, the impurity level of the product can be effectively controlled, and the freeze-drying preparation with the stabilitysuperior to that of the foreign original research products can be produced.
Description
technical field [0001] The invention relates to the technical field of medicine, in particular to azacitidine freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Azacitidine is a cytidine analog that is mainly used in the treatment of myelodysplastic syndromes. U.S. FDA approved this medicine to go on the market in 2004, because the active ingredient azacitidine of this medicine is relatively poor in stability, hydrolyzes rapidly in water, so the preparation on the market is a powder injection preparation. At present, only original research products are on the market in my country. [0003] Publication No. CN101632643A, an invention patent titled "Azacitidine Freeze-Dried Powder Injection Preparation and Its Preparation Method", provides a freeze-dried powder injection preparation of azacitidine drug for the treatment of myelodysplastic syndrome and its preparation method , Azacitidine freeze-dried powder preparation prescripti...
Claims
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Patent Timeline
Login to view more IPC IPC(8): A61K9/19A61K47/16A61K47/26A61K47/18A61K47/20A61K31/706A61P7/00
CPCA61K9/0019A61K9/19A61K31/706A61K47/16A61K47/18A61K47/20A61K47/26
Inventor 谢谦史宣宇田欣欣
Owner KINDOS PHARM CO LTD
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