Decitabine freeze-dried powder injection

A technology of freeze-dried powder injection and decitabine, which is applied in the field of decitabine freeze-dried powder injection, can solve the problems of poor stability of decitabine, decreased drug efficacy, and no improvement of defects, etc., to achieve thorough water drying, Avoid the reduction of curative effect and the effect of uniform and stable quality

Active Publication Date: 2009-11-25
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the extremely poor stability of decitabine, it is easily degraded under high temperature and solution conditions, which reduces the efficacy of the drug and produces impurities that cause toxic and side effects
Existing known technology also does not improve the suggestion of above defective

Method used

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  • Decitabine freeze-dried powder injection
  • Decitabine freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] prescription

[0028] Decitabine 50g

[0029] Mannitol 200g

[0030] Potassium dihydrogen phosphate 68g

[0031] Sodium hydroxide 11.6g

[0032] tert-butanol 3000ml

[0033] Add water for injection to 10000ml

[0034]

[0035] A total of 1000 bottles were made

[0036] Measure tert-butanol into a container, add water for injection, potassium dihydrogen phosphate, sodium hydroxide and mannitol, stir and mix evenly, cool the mixed solvent to 6°C and keep it warm, then add decitabine, stir to make it Dissolve and mix evenly. After passing the intermediate inspection, send it to a sterile room with a peristaltic pump and filter it through a 0.22 μm microporous membrane until it becomes clear. Fill it into a vial, partially plug it with a butyl rubber stopper, and put it on a plate; Put the sample to be freeze-dried in the freeze-drying box, close the door, turn on the machine, open the circulating pump, compressor and plate cooling valve, u...

Embodiment 2

[0038] prescription

[0039] Decitabine 50g

[0040] Mannitol 100g

[0041] Potassium dihydrogen phosphate 68g

[0042] Sodium hydroxide 11.6g

[0043] tert-butanol 4000ml

[0044] Add water for injection to 20000ml

[0045]

[0046] A total of 1000 bottles were made

[0047] Measure tert-butanol into a container, add water for injection, potassium dihydrogen phosphate, sodium hydroxide and mannitol, stir and mix evenly, cool the mixed solvent to 8°C and keep it warm, then add decitabine, stir to make it Dissolve and mix evenly. After passing the intermediate inspection, send it to a sterile room with a peristaltic pump and filter it through a 0.22 μm microporous membrane until it becomes clear. Fill it into a vial, partially plug it with a butyl rubber stopper, and put it on a plate; Put the sample to be freeze-dried in the freeze-drying box, close the door, turn on the machine, open the circulating pump, compressor and plate cooling valve, u...

Embodiment 3

[0049] prescription

[0050] Decitabine 50g

[0051] Potassium dihydrogen phosphate 68g

[0052] Sodium hydroxide 11.6g

[0053] tert-butanol 5000ml

[0054] Add water for injection to 10000ml

[0055]

[0056] A total of 1000 bottles were made

[0057]Measure tert-butanol into a container, add water for injection, potassium dihydrogen phosphate and sodium hydroxide, stir and mix evenly, cool the mixed solvent to 6°C and keep it warm, then add decitabine, stir to dissolve and mix Uniformity, after passing the intermediate inspection, send it to the sterile room with a peristaltic pump and filter it through a 0.22 μm microporous membrane until it becomes clear, fill it in a vial, partially plug it with a butyl rubber stopper, and put it into a plate; put it into a plate Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, turn on the circulation pump, compressor and plate cooling valve, use heat tr...

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Abstract

The invention relates to a decitabine freeze-dried powder injection and a preparing method thereof. The prepared decitabine freeze-dried powder injection is used for treating myelodysplastic syndrome (MDS). The decitabine freeze-dried powder injection contains decitabine, utilizes the mixed solvent composed of the tert-butyl alcohol and the injection water in the preparation process, wherein the concentration of the decitabine in the mixed solvents is 2.5-5 mg / ml; and the volume ratio of the solvents is: 5-50% of tert-butyl alcohol and the balance of injection water. The potassium dihydrogen phosphate and the sodium hydroxide may be added for the pH regulator. The preparation process comprises the following steps: measuring tert-butyl alcohol, adding injection water, potassium dihydrogen phosphate and sodium hydroxide, stirring and mixing evenly, cooling to 2-15 DEG C, heat preserving, adding decitabine, stirring to dissolve, filtering, filling, plugging, disking, freeze-drying, pressing plug, out box, tying and packing after quality test qualification.

Description

technical field [0001] The invention relates to a decitabine freeze-dried powder injection and a preparation method thereof. The decitabine freeze-dried powder injection prepared by the method can be used for the treatment of myelodysplastic syndrome (MDS). Background technique [0002] Decitabine belongs to DNA methyltransferase inhibitors, after phosphorylation, it directly binds to DNA to inhibit DNA methyltransferase, causing DNA hypomethylation and cell differentiation and apoptosis. In vitro decitabine inhibits DNA methylation at concentrations that do not cause DNA synthesis inhibition. The hypomethylation induced by decitabine in tumor cells may restore normal function after strictly controlling cell differentiation and proliferation. In rapidly differentiating cells, the cytotoxicity of decitabine may be attributed to the covalent incorporation of decitabine into DNA by DNA methyltransferases. [0003] After intravenous injection, it is rapidly eliminated from the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/706A61P7/00
Inventor 叶东赵俊戴建国盛琼波
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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