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Method for purifying high-purity pemetrexed disodium

A technology of pemetrexed disodium and purification method, which is applied in the field of pharmaceutical manufacturing, can solve the problems of inability to effectively remove various impurities and degrade impurities, and achieve the effects of low cost, easy industrialization, and simple operation

Active Publication Date: 2013-03-20
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] The present invention aims at improving the salting-out method and mixed solvent crystallization method in the current purification method of pemetrexed disodium, which cannot effectively remove various impurities and the generation of degraded impurities caused by heating. The solvent / water mixed solvent crystallization operation can effectively remove the impurities in the pemetrexed disodium API, so that the purified product meets the general requirements of drug registration for the limit of impurities

Method used

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  • Method for purifying high-purity pemetrexed disodium
  • Method for purifying high-purity pemetrexed disodium
  • Method for purifying high-purity pemetrexed disodium

Examples

Experimental program
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Effect test

Embodiment 1

[0063] Weigh 20 g of pemetrexed disodium raw material 1 (content 98.86%) and add 8 times the amount of water to dissolve at room temperature, add 25% sodium chloride solution to make the concentration of sodium chloride reach 12%, stir, and place for crystallization for 2 hours. Filter, wash the filter cake with 12% sodium chloride solution, drain it, add 15 times the amount of water to dissolve the filter cake, add 95% ethanol to make the alcohol content reach 80%, and place it for 2 hours to crystallize after stirring. After filtering, the filter cake was washed with 80% ethanol, sucked dry, and dried under reduced pressure to obtain pemetrexed disodium.

Embodiment 2

[0065] Dissolve the wet product before drying under reduced pressure in Example 1 with 15 times the amount of water at room temperature, add 25% sodium chloride solution to make the concentration of sodium chloride reach 12%, stir, crystallize and place for 2 hours, filter, filter cake with 12 Wash the filter cake with 15% sodium chloride solution, drain it, add 15 times the amount of water to dissolve it, add 95% ethanol to make the alcohol content reach 80%, and place it for 2 hours to crystallize after stirring. After filtering, the filter cake was washed with 80% ethanol, sucked dry, and dried under reduced pressure to obtain pemetrexed disodium.

Embodiment 3

[0067] Weigh 20 g of pemetrexed disodium raw material 1 (content 98.86%) and add 8 times the amount of water to dissolve at room temperature, add 25% sodium chloride solution to make the concentration of sodium chloride reach 10%, stir, and place for crystallization for 2 hours, Filter, wash the filter cake with 10% sodium chloride solution, drain it, add 15 times the amount of water to dissolve the filter cake, add 95% ethanol to make the alcohol content reach 75%, and place it for 2 hours to crystallize. After filtering, the filter cake was washed with 75% ethanol, sucked dry, and dried under reduced pressure to obtain pemetrexed disodium.

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Abstract

The invention provides a method for purifying high-purity pemetrexed disodium. The method is realized by combining a salting-out method with an organic solvent / water mixed solvent crystallization method. The method provided by the invention is carried out at normal temperature; and by using the method, the quantities and contents of organic impurities and inorganic impurities in the purified products can be effectively controlled, the content of the organic impurities satisfies requirements on identification thresholds of the impurities of bulk drugs in China, and the quantity of the organic impurities is obviously reduced.

Description

technical field [0001] The invention relates to a purification method of pemetrexed disodium salt, which belongs to the technical field of medicine, and specifically belongs to the field of medicine manufacturing. Background technique [0002] Pemetrexed disodium (Pemetrexed disodium), the chemical name is N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidine) -5-Alkyl)ethyl]benzoyl]-L-glutamate disodium. [0003] Pemetrexed disodium is a multi-target folic acid antagonist developed by Eli Lilly and Company for the treatment of tumors. It can be used in combination with cisplatin to treat inoperable malignant pleural mesothelioma. At present, pemetrexed disodium is the world's It is the only drug for the treatment of malignant pleural mesothelioma (MPM), and it is also used for the second-line treatment of metastatic non-small cell lung cancer. Pemetrexed alone or combined with chemotherapy has obvious therapeutic effects on a variety of tumors, especially for pat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D487/04
Inventor 樊俊红刘翠艳容彦华刘媛媛郝卫华耿佳
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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