Method for preparing high-purity pomalidomide

A pomalidomide and high-purity technology is applied in the field of preparation of high-purity pomalidomide, which can solve the problems of unmentioned intermediate and product purity, inability to meet the requirements of the pharmaceutical industry, and high requirements for purity and impurity content, Achieve the effect of less waste, low price and high safety
CN103804350AActive Publication Date: 2014-05-21TIANJIN WEIJIE TECH
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
TIANJIN WEIJIE TECH
Publication Date
2014-05-21

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Abstract

The invention discloses a method for preparing high-purity pomalidomide. The method comprises the following steps: by taking 3-nitrophthalicanhydride and 3-aminopiperidine-2,6-diketone hydrochloride as raw materials, methylbenzene as a solvent, triethylamine as an acid attaching agent and N,N'-carbonyldimidazole as a condensing agent, carrying out a condensation reaction, thereby obtaining 3-nitro-N-(2,6-dioxo-3-piperidyl)-phthalimide; carrying out a hydrogenation reaction under catalysis of a palladium carbon catalyst, and recrystallizing to obtain the high-purity pomalidomide. The total yield is 62%, and the materials used in the reaction are low in price, simple and easily available; the second-step catalytic hydrogenation is performed under normal pressure, simple operations such as pulping, distilling and performing suction filtration are only used in the two-step reaction, and the operations are conventional production operations; intense heat release phenomena in the reaction process and after-treatment process are avoided, the operation is simple, and the safety is high; a mother solution obtained by after-treatment in the first-step reaction can be directly recycled, the amount of three wastes generated after after-treatment is small, and the operation is suitable for industrial production.
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Description

technical field

[0001] The invention belongs to the technical field of medicine, in particular to a preparation method of high-purity pomalidomide. Background technique

[0002] Pomalidomide is a derivative of Thalidomide. It has the same stability as Thalidomide. It is the most active immunomodulatory drug so far, which can regulate T cells and inhibit their proliferation. , by activating natural killer cells, promoting the apoptosis of tumor cells, and exerting an immunoregulatory effect, it is mainly used clinically for the treatment of multiple myeloma. Multiple myeloma, a type of blood cancer that starts in plasma cells in the bone marrow, mainly affects the elderly. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma each year and 10,710 die from the disease. The US Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) on February 8, 2013 for the treatment of multiple myeloma patients whose dise...

Claims

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