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Oxalibo purification

An oxaliplatin, trace technology, applied in the purification/separation of amino compounds, chemical instruments and methods, organic chemistry, etc., can solve the problems of difficult removal of trace silver and difficulty in meeting requirements

Inactive Publication Date: 2005-05-18
KUNMING INST OF PRECIOUS METALS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is difficult to meet the requirements according to the general conventional aqueous solution recrystallization refining method
The recrystallization method of aqueous solution mainly adopts hot filtration, and then the mother liquor is cooled and crystallized rapidly, but it is difficult to remove trace silver

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Dissolve 15 grams of oxaliplatin containing 50 ppm silver in 2 liters of hot water at 50°C, add 1 mg KI, stir for 10 minutes, cool and stand for 5 hours, filter through an ultrafine membrane, and concentrate to dryness under reduced pressure to obtain Oxa Platinum products. According to the flameless atomic absorption spectrometry analysis, the silver content is less than 5ppm; through the high performance liquid chromatography analysis, the oxaliplatin content is greater than 99%; the optical rotation analysis shows that the specific rotation is 74.5°.

Embodiment 2

[0027] Dissolve 10 grams of oxaliplatin containing 100 ppm silver in 2 liters of hot water at 60°C, add 5 mg KI, stir for 10 minutes, cool and stand for 6 hours, filter through an ultrafine membrane, and concentrate to dryness under reduced pressure to obtain Oxa Platinum products. According to the flameless atomic absorption spectrometry analysis, the silver content is less than 5ppm; through the high performance liquid chromatography analysis, the oxaliplatin content is greater than 99%; the optical rotation analysis shows that the specific rotation is 75.8°.

Embodiment 3

[0029] Dissolve 4 grams of oxaliplatin with a silver content of 300 ppm in 2 liters of 80°C hot water, add 9 mg KI, stir for 10 minutes, cool and stand for 5 hours, filter through an ultrafine membrane, and concentrate to dryness under reduced pressure to obtain Oxa Platinum products. According to the flameless atomic absorption spectrometry analysis, the silver content is less than 5ppm; through the high-performance liquid chromatography analysis, the oxaliplatin content is greater than 99%; the optical rotation analysis shows that the specific rotation is 76.0°.

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Abstract

The invention relates to a method for purifying the antineoplastic drug oxaliplatin, which comprises dissolving oxaliplatin in water at 40-90°C, adding potassium iodide to the oxaliplatin solution, cooling and standing, filtering, and concentrating under reduced pressure to obtain For the oxaliplatin product with extremely low silver content, the concentration of the oxaliplatin solution is 1-8 g / liter, and the silver content in the oxaliplatin: potassium iodide=0.75: (1-8). The silver content of the oxaliplatin treated by the method of the invention is less than 5ppm, the content of the oxaliplatin is greater than 99%, and the specific rotation is 73°-78°.

Description

technical field [0001] The invention relates to a purification method of a new antitumor drug oxaliplatin, which aims at reducing the silver content in the oxaliplatin. Background technique [0002] Oxaliplatin (Oxaliplatin, L-OHP oxaliplatin) is another platinum group metal anti-tumor drug after cisplatin and carboplatin, and it is also the first platinum complex of cyclohexanediamine (DACH) used in clinical practice. Its chemical structural formula is as follows: [0003] [0004] Oxaliplatin is mainly used in the treatment of advanced colorectal (rectal) cancer, ovarian cancer, prostate cancer, and cancers that are ineffective after the use of cisplatin, and its clinical use is increasing year by year. The content of heavy metal silver (Ag) is one of the main impurity control indicators for oxaliplatin raw materials, and strict control is required. At present, the following methods are mainly used for the preparation of oxaliplatin raw materials. [0005] method 1: ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61P35/00C07C209/84C07C211/36C07F15/00
Inventor 普绍平刘祝东高文桂余尧王玉天刘洋刘伟平何键谌喜珠
Owner KUNMING INST OF PRECIOUS METALS