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Decitabine lyophilized preparation and preparation method thereof

A freeze-dried preparation and decitabine technology are applied in the field of decitabine freeze-dried preparations and their preparation, which can solve the problems of poor solubility and low purity of freeze-dried preparations, and achieve good stability, high safety, Good batch reproducibility

Active Publication Date: 2011-06-29
NANJING CAVENDISH BIO ENG TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Although the existing disclosed method is aware of the problem of decitabine degradation in water during the preparation process, generally speaking, the purity of the freeze-dried preparation product prepared by the process used in the invention is not high
At the same time, due to the poor solubility of decitabine in water, there are also high requirements for the solubility of lyophilized preparations.

Method used

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  • Decitabine lyophilized preparation and preparation method thereof
  • Decitabine lyophilized preparation and preparation method thereof
  • Decitabine lyophilized preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Prescription 1

[0072] Decitabine

50g

Potassium dihydrogen phosphate

68g

sodium hydroxide

11.6g

ethanol

5000ml

Add water for injection to

10000ml

production

1000 bottles

[0073] Configuration and lyophilization steps:

[0074] Weigh the prescribed amount of potassium dihydrogen phosphate and sodium hydroxide, add an appropriate amount of water for injection, and stir to dissolve. Add the prescribed amount of ethanol, add water for injection to the prescribed amount, and stir well. Add activated carbon for needles (about 0.2%) to the above mixed solution, stir at room temperature for 15-30 minutes, filter and decarbonize to obtain an excipient solution, put it in an ice-water bath for 15-60 minutes (about 5°C), and set aside. Weigh the prescribed amount of decitabine, add it to the excipient solution, and dissolve it quickly by ultrasonication and stirring under ice-water bath condition...

Embodiment 2

[0090] Prescription 2

[0091] Decitabine

50g

Potassium dihydrogen phosphate

68g

sodium hydroxide

11.6g

Methanol

5000ml

Add water for injection to

10000ml

production

1000 bottles

[0092] Weigh the prescribed amount of potassium dihydrogen phosphate and sodium hydroxide, add an appropriate amount of water for injection, and stir to dissolve. Add the prescribed amount of methanol, add water for injection to the prescribed amount, and stir evenly. Add activated carbon for needles (about 0.2%) to the above mixed solution, stir at room temperature for 15-30 minutes, filter and decarbonize to obtain an excipient solution, put it in an ice-water bath for 15-60 minutes (about 5°C), and set aside. Weigh the prescribed amount of decitabine, add it to the excipient solution, and dissolve it quickly by ultrasonication and stirring under ice-water bath conditions. Add activated carbon for needles (about 0.05...

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Abstract

The invention discloses a decitabine lyophilized preparation in a specific crystal form, which has the characteristics of good stability, high purity and good water solubility. The decitabine lyophilized preparation is prepared by mixing and lyophilizing the following components in weight ratio: 50g of decitabine, 68g of potassium dihydrogen phosphate, 11.6g of sodium hydroxide, 1000-8000ml of organic solvent and 10,000ml of water for injection.

Description

technical field [0001] The invention relates to a decitabine freeze-dried preparation and a preparation method thereof. The decitabine freeze-dried preparation prepared by the method has a specific crystal form, and the preparation has the characteristics of good stability, high purity and good water solubility . Background technique [0002] Decitabine, trade name Dacogen TM , is a DNA methylation specific inhibitor developed by Supergen. After decitabine is phosphorylated, it is directly incorporated into DNA methyltransferase to methylate DNA, leading to cell differentiation or apoptosis, thereby exerting an anti-tumor effect. It is clinically used for the treatment of myelodysplastic syndrome, including all types of myelodysplastic syndromes that conform to the French-American-English classification and the international prognosis scoring system is medium-1, medium-2 and high-risk groups. Patients with onset myelodysplastic syndrome. Its chemical name is 4-amino-1-(2...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/706A61K47/10A61P7/00A61P19/08
Inventor 严荣程浩陆洁许永翔
Owner NANJING CAVENDISH BIO ENG TECH
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