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Purification method of cytarabine

A technology of cytarabine and purification method, applied in the field of purification of cytarabine, can solve the problems of energy consumption, low yield, time-consuming and the like

Active Publication Date: 2021-08-24
SINOPHARM A THINK PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Resin purification is required for the post-treatment of crude cytarabine, resulting in a large amount of ammonia eluent, which requires rapid low-temperature concentration, neutralization, time-consuming, energy-consuming, and low yield

Method used

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  • Purification method of cytarabine
  • Purification method of cytarabine
  • Purification method of cytarabine

Examples

Experimental program
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Effect test

Embodiment 1

[0037] Add ammonia water (V 稀氨水 :m 阿糖胞苷粗品 =5:1, stir, add 15kg of crude cytarabine, control the system temperature at 30-40°C and stir for 15h, concentrate the above system under reduced pressure to dryness, and use ethyl acetate (V 乙酸乙酯 :m 阿糖胞苷 =2:1) ​​Stir to disperse, filter, and dry the solid at 65°C for 6 hours to obtain 13.5kg of purified cytarabine, with a yield of 90.0%. For the chromatographic results, see figure 1 .

Embodiment 2

[0039] Add ammonia water (V 稀氨水 :m 阿糖胞苷粗品 =5:1, stir, add 15kg of crude cytarabine, control the system temperature at 30-40°C, stir and react for 15h, concentrate the above system under reduced pressure to dryness, and use ethanol (V 乙醇 :m 阿糖胞苷 =2:1) ​​Stir and disperse, filter, and air-dry the solid at 55°C for 8 hours to obtain 13.6kg of purified cytarabine, with a yield of 90.7%. For the chromatographic results, see figure 2 .

Embodiment 3

[0041] Add 2mol / L potassium carbonate aqueous solution (V 碳酸钾水溶液 :m 阿糖胞苷粗品=5:1, stir, add 10kg of crude cytarabine, control the system temperature at 30-40°C and stir for 15h, concentrate the above system under reduced pressure to dryness, and use ethanol / water (V 乙醇 / 水 :m 阿糖胞苷 =2:1) ​​Stir and disperse, filter, and dry the solid at 60°C for 7 hours to obtain 8.1kg of purified cytarabine, with a yield of 81%. For the chromatographic results, see image 3 .

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Abstract

The invention relates to the technical field of medicines, in particular to a purification method of cytarabine. According to the method disclosed by the invention, an alkaline substance is adopted to purify the crude cytarabine product, the batch-to-batch consistency is good, the quality is controllable, and the purity can reach 99.9% or above. Compared with traditional resin column purification, the method has the characteristics of simplicity in operation, low energy consumption, short production period, low-toxicity, harmless, green and environment-friendly solvent and low purification cost, and is more suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for purifying cytarabine. Background technique [0002] The chemical name of cytarabine is 1-β-D-arabinofuranosyl-4-amino-2(1H)-pyrimidinone, and cytarabine was first synthesized by Richard Walwick, Walden Roberts and Charles Dekker of the University of California, Berkeley in 1959 . [0003] Cytarabine for injection was first launched in the United States by Upjohn (now Pfizer) in June 1969, and the listed product was named The listed specifications are 100mg, 500mg, 1g and 2g, which are the reference preparations recommended by the American Orange Book, but they have been withdrawn from the market (non-safety and effectiveness reasons). In 1990, the FDA approved HOSPIRA as a 20MG / ML injection, and it was recommended as RS. [0004] France: In 1985, Pfizer launched cytarabine for injection in France under the trade name The specification is 500mg, 1.0g and 2.0g w...

Claims

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Application Information

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IPC IPC(8): C07H1/06C07H19/09
CPCC07H1/06C07H19/09
Inventor 王淑娟徐昊李铁军李丹丹
Owner SINOPHARM A THINK PHARMA
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