Method for refining oxaliplatin

A technology for oxaliplatin and refined products, which is applied in a refined field of oxaliplatin, can solve the problem of high oxalic acid content, and achieve the effect of increased yield and stable properties

Active Publication Date: 2008-03-05
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Further studies have shown that in the process of refining oxaliplatin with water, the oxalic acid content in the aqueous solution after thermal dissolution of oxaliplatin increases sharply with the prolongation of the storage time during the cooling process, and finally leads to the refined product of oxaliplatin. High oxalic acid content

Method used

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  • Method for refining oxaliplatin
  • Method for refining oxaliplatin
  • Method for refining oxaliplatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Dissolve 10 g of oxaliplatin containing 0.501% oxalic acid in 1000 g of 90°C hot water, add 1.6L of ethanol at one time while stirring, cool to 15°C, filter the precipitated solid, and dry at 60°C for 6 hours to obtain oxaliplatin Platinum refined product 8.6g, yield: 86%, melting point: 198-199.5°C, content: 99.9%.

[0019] The related substance oxalic acid detected by HPLC was 0.011%.

[0020] HPLC detection method: the chromatographic column uses octadecylsilane bonded silica gel as a filler (4.6mm × 150mm, 5.0 μm), and the mobile phase is phosphate buffer [1.36g potassium dihydrogen phosphate is added to 10ml tetrabutylammonium hydroxide solution ( 32%), add water to dilute to 1000ml, and adjust the pH value to 6.0]-acetonitrile (80:20) with phosphoric acid; the flow rate is 1.0ml / min, and the detection wavelength is 205nm.

Embodiment 2

[0022] Dissolve 5 g of oxaliplatin containing 0.998% oxalic acid in 400 g of hot water at 100°C, add 0.8L of ethanol at one time while stirring, cool to 15°C, filter the precipitated solid, and dry at 60°C for 6 hours to obtain oxaliplatin Platinum refined product 4.1g, yield: 82%, content: 99.9%. HPLC detection related substance oxalic acid is 0.055%,

[0023] HPLC condition is the same as embodiment 1.

Embodiment 3

[0025] Dissolve 5 g of oxaliplatin containing 0.501% oxalic acid in 400 g of hot water at 60°C, add 0.8L of ethanol at one time while stirring, cool to 15°C, filter the precipitated solid, and dry at 60°C for 6 hours to obtain oxaliplatin Platinum refined product 4.2g, yield: 84%, content: 99.9%. The related substance oxalic acid detected by HPLC was 0.009%.

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Abstract

The invention relates the method of refining osali platinum, comprising the following steps: dissolving the osali platinum into water at 40-100Deg.C, the rate of osali platinum and water being 5-100, adding C1-3 alkylol groups, cooling, extracting crystal, filtering, drying, and getting elaboration product, osali platinum The invention has the advantages of light osali platinum oxalic acid content and high productivity.

Description

technical field [0001] The invention relates to a method for refining oxaliplatin. Background technique [0002] Oxaliplatin, also known as oxaliplatin, is a new generation of platinum complexes after cisplatin and carboplatin. The chemical name of oxaliplatin is [(1R,2R)-(1,2-cyclohexanediamine-N,N')][oxalic acid (2-)-0,0']platinum, and its structural formula is : [0003] [0004] Oxaliplatin was first developed by Debiopharm in Switzerland and was approved for marketing in France in 1997. It is mainly used clinically for patients with colorectal and rectal cancer metastases after failure of fluorouracil therapy. It can be used alone or in combination with fluorouracil. Its combination of oxaliplatin + 5FU + FA is very mature in the treatment of metastatic colorectal cancer, and its clinical usage is growing rapidly. Oxaliplatin displaces the labile oxalate ligand through a non-enzymatic reaction in body fluids and converts it into biologically active monohydrated an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07F15/00A61K31/282A61P35/00
Inventor 宗在伟陈祥峰魏佳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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