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Preparation method of decitabine freeze-dried powder injection

A technology of freeze-dried powder injection and decitabine, which is applied in the field of medicine, can solve the problems of high toxicity, increased production cost, and no preparation method, and achieve the effects of low content of related substances, reduced production cost, and saved testing cost

Inactive Publication Date: 2010-09-29
连云港杰瑞药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Decitabine for injection is on the market in Europe and the United States, and foreign patents and literature are consulted. There is no report on the preparation method of decitabine freeze-dried powder injection for injection; Chinese patent CN10131718A discloses the preparation method of decitabine freeze-dried powder injection for injection , the process adopts the method of adding an organic solvent in the preparation process, although the stability of decitabine can be guaranteed, but there are many problems in industrial production: 1, poor safety, flammable and explosive properties; 2 , high toxicity, harmful to the environment and the health of operators; 3, the price of organic solvents is expensive, and it is not easy to recycle, resulting in an increase in production costs

Method used

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  • Preparation method of decitabine freeze-dried powder injection
  • Preparation method of decitabine freeze-dried powder injection
  • Preparation method of decitabine freeze-dried powder injection

Examples

Experimental program
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Embodiment 1

[0059] Add medicinal excipients into water, dissolve and adjust the pH to 6.0 to obtain an excipient solution, refrigerate to 0°C for use; add Decitabine to the excipient solution to dissolve, keep the drug solution at 0°C, adjust the pH to 6.0, add activated carbon , Filtration, filling, freeze-drying, ready to go.

Embodiment 2

[0061] Add medicinal excipients into water, dissolve and adjust the pH to 8.0 to obtain an excipient solution, refrigerate to 10°C, and use it for later use; add Decitabine to the excipient solution to dissolve, keep the drug solution at 10°C, adjust the pH to 8.0, add activated carbon , Filtration, filling, freeze-drying, ready to go.

Embodiment 3

[0063] Add medicinal excipients into water, dissolve, adjust the pH value to 6.5 to obtain an excipient solution, refrigerate to 5°C, and use it for later use; add Decitabine to the excipient solution to dissolve, keep the drug solution at 5°C, adjust the pH value to 6.5, add activated carbon , Filtration, filling, freeze-drying, ready to go.

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Abstract

The invention discloses a preparation method of a decitabine freeze-dried powder injection, which is characterized by comprising the following steps: adding a pharmaceutic adjuvant into water and dissolving; adjusting the pH value to be 6.0-8.0 to obtain adjuvant solution; refrigerating the adjuvant solution to 0-10DEG C for later use; adding decitabine into the adjuvant solution and dissolving; keeping the liquid medicine at 0-10DEG C; adjusting the pH value to be 6.0-8.0; and adding active carbon, filtering, filling and freeze-drying to obtain the decitabine freeze-dried powder injection. In the process method, an organic solvent is not added and is replaced by water; and by controlling the pH value and the temperature, the contents of relative substances of the obtained preparation are low.

Description

Technical field [0001] The invention relates to the technical field of medicine, in particular to a method for preparing a freeze-dried decitabine powder injection. Background technique [0002] Decitabine is a natural nucleoside 2'-deoxycytidine analog, its chemical name: 1-(β-D-2-deoxyribose)-4-amino-1,3,5-azine-2(1H) -Ketones; Decitabine is a type of hypomethylation reagent with a unique mechanism of action: After phosphorylation, Decitabine is directly incorporated into DNA methyltransferase to methylate DNA and cause cells Differentiation or apoptosis, so as to play an anti-tumor effect; it can not inhibit DNA synthesis in vitro, but can trigger hypomethylation in tumor cells, and has the function of maintaining gene-related cell differentiation and proliferation control. Non-proliferating cells are relatively insensitive to decitabine. Decitabine is a chemotherapeutic drug, and clinical reports show that it has broad-spectrum anti-tumor activity against hematological mali...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/706A61K47/02A61P35/00
Inventor 顾群金治刚孙学伟徐春霞王东孙德杰
Owner 连云港杰瑞药业有限公司
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