Method for purifying high-purity pemetrexed disodium

A technique of pemetrexed disodium and a purification method, which is applied in the field of pharmaceutical manufacturing, can solve problems such as the inability to effectively remove various impurities and degrade impurities, and achieve the effects of low cost, simple operation, and easy industrialization
CN102206218AActive Publication Date: 2011-10-05CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
Publication Date
2011-10-05

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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.
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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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