Method for refining dexrazoxane

A technology for dextropropane imine and triethylamine, which is applied in the field of refining dextropropane imine, can solve the problems of high residual solvent, low purity, dark color and the like in the product, and achieves the effects of high purity, good color and luster, and high yield

Active Publication Date: 2008-03-12
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technology allows for better quality deoxyropiridium (DOP) products with improved whiteness levels compared to existing methods such as dichloroethylammonia salt solution. It also includes an analytical test that shows how well these DOPs were made from different sources.

Problems solved by technology

Technicians discuss various ways to improve the efficiency and safety of producing pharmaceuticals containing certain compounds called diketonuroside monomers. However, current techniques involve complicated steps like extraction with organosiliconanes followed by separation and analysis. These processes result in decreased yields due to contamination during manufacturing process and increased costs associated with each step. Therefore, new technical solutions aim at simplifying these procedures while maintaining their efficacy over existing ones.

Method used

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  • Method for refining dexrazoxane
  • Method for refining dexrazoxane

Examples

Experimental program
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Effect test

Embodiment 1

[0021] Take 50 g of the crude product of dextropropylimine (content 96.50%, pink), add 200 ml of methanol, add hydrogen chloride methanol solution under stirring, the solid gradually dissolves and clarifies and precipitates off-white crystals, adjust the pH value to 1, filter, discard the filtrate, and Mix the filter cake with 200ml of methanol, adjust the pH value to 8 with triethylamine under stirring, filter, rinse the filter cake with methanol, filter dry, and dry under vacuum at 40°C to obtain 44.5 g of white crystals of dextropropylimine, with a yield of 89.0%; The content detected by HPLC is: 99.92%.

[0022] Determine according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia edition in 2005)

[0023] HPLC chromatographic conditions: octadecylsilane bonded silica gel is used as filler; methanol-0.01mol / L potassium dihydrogen phosphate solution (15:85) is used as mobile phase, and the detection wavelength is 208nm. The number of theor...

Embodiment 2

[0025] Take 20 g of the crude product of dextropropylimine (content 96.50%, pink), add 200 ml of ethanol, add hydrogen chloride ethanol solution under stirring, adjust the pH value to 1, filter, discard the filtrate, mix the filter cake with 200 ml of ethanol, mix with three Adjust the pH value to 8 with ethylamine, filter, rinse the filter cake with ethanol, filter dry, and vacuum-dry at 40°C to obtain 15.5 g of white crystals of dextropropylimine, with a yield of 77.5%; the content detected by HPLC is: 99.63%. HPLC condition is the same as embodiment 1.

Embodiment 3

[0027] Take 10 g of the crude product of dextropropylimine (content 96.50%, pink), add 150 ml of isopropanol, add hydrogen chloride isopropanol solution under stirring, adjust the pH value to 2, filter, discard the filtrate, and mix the filter cake with 200 ml of isopropanol Mix, adjust the pH value to 9 with triethylamine under stirring, filter, rinse the filter cake with isopropanol, filter dry, and vacuum-dry at 40°C to obtain 8.4 g of white crystals of dextropropylimine, with a yield of 84.0%; HPLC detection content For: 99.68%.

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Abstract

The present invention relates to a method of refining preparation of the right razoxane. The method comprises the mixing and stirring of the right razoxane crude and the C1-3 alkyl alcohol of the weight of 2 to 20 times; the chloride hydrogen or the solution is added to adjust the pH value to be between 0.5 and 5; the solution is then filtered; the filter cake and the C1-3 alkyl alcohol of the weight of 2 to 20 times are then mixed and stirred; the triethylamine is used to adjust the pH value to be between 7 and 10; the solution is then filtered; the C1-3 alkyl alcohol is used to wash; the solution is filtered to be dry; the fine product of the right razoxane can be got after vacuum drying at the temperature between 30 and 60 DEG C. The refining method can effectively remove the color of the crude, and has the high product purity, the simple operation, the short production cycle, the high collection rate and the easiness for the industrial production.

Description

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Claims

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Application Information

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Owner JIANGSU AOSAIKANG PHARMA CO LTD
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