Bendamustine hydrochloride freeze-dried powder injection and preparation method thereof

Abstract

The invention discloses a bendamustine hydrochloride freeze-dried powder injection. The freeze-dried liquid medicine is prepared from the following raw materials: 1 to 2 parts of bendamustine hydrochloride, 2 to 3 parts of freeze-dried excipients, 14 to 50 parts of organic solvents and 45 to 83 parts of water. The use of organic solvent formulations, low-temperature liquids, filling and freeze-drying techniques can effectively control the level of impurities in products.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a bendamustine hydrochloride freeze-dried powder injection and a preparation method thereof. Background technique [0002] As early as the 1960s, bendamustine hydrochloride was developed by the former East Germany and was widely used. However, it was not until the end of the Cold War that the drug was used in Europe as a single drug or in combination with other drugs to treat various diseases. Clinical research on hematological malignancies or solid tumors, the curative effect is very impressive. [0003] Bendamustine hydrochloride monotherapy or combination therapy has been designated as the first-line or second-line treatment option for various hematologic malignancies by European and American clinical guidelines. In 2003, bendamustine hydrochloride was launched in Germany with the product name "Ribomustin". The trade name of bendamustine hydrochloride listed in the United S...

AI Technical Summary

Problems solved by technology

The stability of the liquid formulation without adding organic solvents will be relatively poor. The introduction of acetic acid solution increases its solubility but cannot increase its stability; and the high temperature of the preparation method is not conducive to impurity control

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