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Decitabine freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and decitabine, which is applied in the field of medicine, can solve the problems of patients’ hidden dangers, reduce decitabine, optimize and screen the types and dosage of pH regulators, and achieve high safety and good stability Effect

Active Publication Date: 2014-01-29
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Patent CN101637458A discloses a preparation method of decitabine powder injection, which adopts low temperature filling to minimize the hydrolysis of decitabine, but does not optimize and screen the type and dosage of pH regulator, and the product is stable The stability is not the best. In addition, different types of pH regulators have different effects on drug stability, so it cannot be simply analogized.
[0010] The above-mentioned patents CN101361718A, CN101584670A, and CN101637458A did not fundamentally solve the problem of poor stability of decitabine in aqueous solution, and caused great hidden dangers to patients during use, so the stability of decitabine in aqueous solution was improved. sex is more important

Method used

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  • Decitabine freeze-dried powder injection and preparation method thereof
  • Decitabine freeze-dried powder injection and preparation method thereof
  • Decitabine freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The buffer salts mentioned in the examples are all prepared in accordance with the Chinese Pharmacopoeia Appendix XV E.

[0033]

[0034] Preparation Process:

[0035] 1. Dissolve decitabine and lecithin in absolute ethanol, evaporate under reduced pressure to remove the ethanol to obtain a decitabine phospholipid complex;

[0036] 2. Disperse the Decitabine Phospholipid Complex in a phosphate buffer, filter, fill, and freeze-dry it.

Embodiment 2

[0038]

[0039]

[0040] Preparation Process:

[0041] 1. Decitabine and distearoylphosphatidylcholine lipid are dissolved in methanol, evaporated under reduced pressure, and methanol is removed to obtain a decitabine phospholipid complex;

[0042] 2. Disperse the Decitabine Phospholipid Complex in a phosphate buffer, filter, fill, and freeze-dry it.

Embodiment 3

[0044]

[0045] Preparation Process:

[0046] 1. Decitabine and lecithin are dissolved in tert-butanol and evaporated under reduced pressure to remove tert-butanol to obtain decitabine phospholipid complex;

[0047] 2. Disperse the Decitabine Phospholipid Complex in a phosphate buffer, filter, fill, and freeze-dry it. Comparative Example 1:

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Abstract

The invention discloses a decitabine freeze-dried powder injection prepared by freezing and drying decitabine, phosphatide and a pH regulator, wherein the phosphatide is lecithin and / or distearoyl phosphatidylcholine. The decitabine freeze-dried powder injection related by the invention has good stability after redissolution, which indicates that the product has higher security in use.

Description

Technical field [0001] The invention relates to a stable decitabine freeze-dried powder injection and a preparation method thereof, and belongs to the technical field of medicine. Background technique [0002] Decitabine is a type of hypomethylation reagent with a unique mechanism of action. After phosphorylation, decitabine directly binds to DNA and inhibits DNA methyltransferase, thereby methylating DNA and leading to cell differentiation or apoptosis. It can not inhibit DNA synthesis in vitro, but can induce hypomethylation in tumor cells. It has the function of maintaining gene-related cell differentiation and proliferation control. Non-proliferating cells are relatively insensitive to the drug. . [0003] Decitabine is also known as 5-aza-2'-deoxycytidine, 5-aza-2'-deoxycytidine, and its chemical structure is as follows: [0004] [0005] The main impurity of Decitabine is α-type Decitabine, which is produced during the synthesis process, and because Decitabine is extremely un...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/706A61K47/24A61P35/00
Inventor 郝贵周任英
Owner SHANDONG NEWTIME PHARMA