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Process for synthesis of oxaliplatin as anticancer medicine

A technology of oxaliplatin and process, applied in the field of biopharmaceuticals, can solve the problems of long treatment process, introduction of silver impurities, increase of oxaliplatin production cost, etc., and achieve the effect of short synthesis route and simple recovery

Inactive Publication Date: 2008-07-02
KUNMING GUIYAN PHARMA
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Problems solved by technology

[0004] There are following shortcomings and deficiencies in the synthetic method of oxaliplatin that patent and literature adopt: the first, because silver compound is used in the synthesis, can introduce silver impurity in the final oxaliplatin product, influence the quality of product
Dispersion and loss of Pt due to long treatment process, expressed in K 2 PtCl 4 Calculated as the starting material, the loss of metal platinum reaches 5%, which greatly increases the production cost of oxaliplatin

Method used

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Examples

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Embodiment Construction

[0012] (1) Preparation of dichlorocyclohexanediamine platinum (II)

[0013] Take 10g (24mmol) K 2 PtCl 4 , dissolved in 100ml of water, added 2.8g (24.6mmol) of cyclohexanediamine (15ml of water plus 10ml of absolute ethanol) and reacted at 30-40°C for 2 hours, cooled, and precipitated pale yellow crystals, collected by filtration, water, After washing with ethanol, vacuum-dry at 65° C. for 4 hours to obtain 8.7 g of platinum dichlorocyclohexanediamine with a yield of 95%.

[0014] The characteristic structural parameters are: elemental analysis C 19.01%; H 3.61%; N 7.31%; Pt 51.27%, consistent with the theoretical value C 18.95%; H 3.68%; N 7.38%; Pt 51.3.

[0015] (2) Synthesis of Oxaliplatin

[0016] Take 4g (7.8mmol) of platinum dichlorocyclohexanediamine, put it in a 500ml beaker, add 320ml of water, then add 11.5g of potassium oxalate (62.4mmol), adjust the pH to 6-7 with 20% NaOH, and react at 60-70°C 8 hours, cooling, filtering, the filtrate was concentrated to a s...

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Abstract

The invention discloses an anti-cancer drug oushaliplatinum synthesis craft, which comprises the following steps: reacting with tetra-platinate M2PtCl4 and trans-1R, 2R-diamine cyclohexane; generating dichlor .trans-1R, 2R-diamine cyclohexane platinum (II) and then reacting with oxalate to get goal compound oushaliplatinum. The craft has short synthesis line, which has high recovery ratio.

Description

technical field [0001] The invention relates to a novel synthesis process of platinum anticancer drug oxaliplatin, which belongs to the field of biopharmaceuticals. Background technique [0002] The chemical name of oxaliplatin is (trans-1R, 2R-diaminocyclohexane) oxalatoplatinum (II), which is based on trans-1R, 2R-diaminocyclohexane (DACH for short) As a carrier, the platinum (II) complex with oxalate as a dissociative group was developed by Debiopharm in Switzerland and was first approved for marketing in France in October 1996. It is currently also available in other countries in Europe and South America. In 2003, global sales reached 800 million euros. my country approved the import of oxaliplatin injection in 1999, and conducted clinical trials with imported drugs in 15 domestic hospitals, with good results. In November 2000, the domestic oxaliplatin developed by Nanjing Pharmaceutical Factory obtained the new drug certificate and production approval issued by the S...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07F15/00A61P35/00
Inventor 何键刘伟平李永年侯树谦普绍平刘祝东
Owner KUNMING GUIYAN PHARMA
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