Method for preparing bendamustine hydrochloride

A technology of hydrochloric acid and concentrated hydrochloric acid, which is applied in the field of preparation of bendamustine hydrochloride, can solve the problems of accumulation, low refining yield, cumbersome operation, etc., and achieve the effects of short production cycle, high refining efficiency and high stability
CN110759867AActive Publication Date: 2020-02-07LIANYUNGANG RUNZHONG PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
LIANYUNGANG RUNZHONG PHARMA CO LTD
Publication Date
2020-02-07

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Abstract

The invention belongs to the field of drug synthesis and particularly relates to a method for preparing bendamustine hydrochloride. According to the preparation method, concentrated hydrochloric acidis adopted as a refining solvent, thus, the bendamustine hydrochloride can be rapidly dissolved in the concentrated hydrochloric acid at the temperature of 20 DEG C to 45 DEG C, and the production cycle is short; the method is applicable to enlarged-scale industrial production, the refining efficiency is high, the yield is high, the reproducibility is good, and the obtained bendamustine hydrochloride is high in stability; and proven by high-temperature, high-humidity, accelerated and long-term tests, related substances and content thereof are free of obvious changes, the content of each singleimpurity is lower than 0.1%, and particularly, an impurity, i.e., a bendamustine dimer is undetectable, so that the bendamustine hydrochloride meets the technical requirements of ICH European Union (EU) quality research technique governing principles on limit of impurities.
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Description

technical field

[0001] The application belongs to the field of drug synthesis and relates to a preparation method of bendamustine hydrochloride. Background technique

[0002] Bendamustine hydrochloride is a bifunctional alkylating agent, which can lead to the cross-linking of DNA single and double strands through alkylation, disrupting the function of DNA and the synthesis of DNA, so that DNA and protein, as well as protein Cross-linking with proteins, thus exerting anti-tumor effect and anti-metabolism effect, has shown good curative effect in various hematological tumors and solid tumors. On March 20, 2008, bendamustine hydrochloride developed by Cephalon was approved by the US FDA for the treatment of chronic lymphocytic leukemia (CLL), with the trade name Treanda; on October 31 of the same year, the drug was approved for inert Treatment of B-cell non-Hodgkin's lymphoma (NHL).

[0003] The chemical name of bendamustine hydrochloride: 4-[5-[bis(2-chloroethyl)amino]-1-met...

Claims

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