Method for purifying bendamustine hydrochloride

Abstract

The invention discloses a method for purifying bendamustine hydrochloride, which comprises the following steps of: dissolving a bendamustine hydrochloride crude product into hydrochloric acid solution for recrystallization, and performing filtration to obtain pure bendamustine hydrochloride. The method belongs to the fields of organic chemistry and medicinal chemistry, and has the advantages of simple process, short cycle, high yield, high quality of product, suitability for industrial production and the like.

Description

technical field

[0001] The invention relates to a method for purifying bendamustine hydrochloride, belonging to the fields of organic chemistry and medicinal chemistry. Background technique

[0002] Bendamustine (as shown in structural formula I) is a bifunctional alkylating agent used for the treatment of chronic lymphocytic leukemia and non-Hodgkin's lymphoma (NHL), which can significantly reduce the recurrence rate and mortality. In 1963, Ozegowski and Krebs synthesized bendamustine. Until 1990, it only applied to East Germany. East German studies found that bendamustine is suitable for the treatment of chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma and lung cancer. In March 2008, the US FDA approved Bendamustine Hydrochloride (Bendamustine Hydrochloride, trade name: Treanda) of Cephalon Company for the treatment of chronic lymphocytic leukemia (CLL). Bendamustine is the first drug approved in the United States for patients wi...

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