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Bendamustine hydrochloride compound

A technology of bendamustine hydrochloride and composition, which is applied in the field of bendamustine hydrochloride composition, and can solve the problems of poor stability of bendamustine hydrochloride, lack of improvement defects, and reduction of drug efficacy, so as to avoid curative effect Reduced, considerable economic and social benefits, the effect of thorough drying of water

Inactive Publication Date: 2011-09-28
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Due to the extremely poor stability of bendamustine hydrochloride, it is easily hydrolyzed and easily degraded under high temperature and light, which reduces the efficacy of the drug and produces impurities that cause toxic and side effects
Existing known technology also does not improve the suggestion of above defective

Method used

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  • Bendamustine hydrochloride compound
  • Bendamustine hydrochloride compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] prescription

[0031] Bendamustine Hydrochloride 100g

[0032] Hydroxypropyl beta-cyclodextrin 100g

[0033] Add water for injection to 10000ml

[0034] A total of 1000 bottles were made

[0035] Weigh hydroxypropyl β-cyclodextrin into a container, add water for injection, stir to dissolve and mix evenly, cool to 6°C and keep warm, then add bendamustine hydrochloride, stir to dissolve and mix evenly, After passing the inspection of the intermediate, it is sent to a sterile room by a peristaltic pump and filtered through a 0.22 μm microporous membrane until it is clear, filled in a brown vial, partially plugged with a butyl rubber stopper, and placed on a plate; Put the freeze-dried samples in the freeze-drying box, close the box door, turn on the machine, turn on the circulating pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and when the product temperature reaches -35°C, close the plate cooling valve and turn on the...

Embodiment 2

[0037] prescription

[0038] Bendamustine Hydrochloride 100g

[0039] Hydroxypropyl beta-cyclodextrin 300g

[0040] Add water for injection to 10000ml

[0041] A total of 1000 bottles were made

[0042] Weigh hydroxypropyl β-cyclodextrin into a container, add water for injection, stir to dissolve and mix evenly, cool to 2°C and keep warm, then add bendamustine hydrochloride, stir to dissolve and mix evenly, After passing the inspection of the intermediate, it is sent to a sterile room by a peristaltic pump and filtered through a 0.22 μm microporous membrane until it is clear, filled in a brown vial, partially plugged with a butyl rubber stopper, and placed on a plate; Put the freeze-dried samples in the freeze-drying box, close the box door, turn on the machine, turn on the circulating pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and when the product temperature reaches -35°C, close the plate cooling valve and turn on the...

Embodiment 3

[0044] prescription

[0045] Bendamustine Hydrochloride 100g

[0046] Hydroxypropyl beta-cyclodextrin 500g

[0047]Add water for injection to 10000ml

[0048] A total of 1000 bottles were made

[0049] Weigh hydroxypropyl β-cyclodextrin into a container, add water for injection, stir to dissolve and mix evenly, cool to 8°C and keep warm, then add bendamustine hydrochloride, stir to dissolve and mix evenly, After passing the inspection of the intermediate, it is sent to a sterile room by a peristaltic pump and filtered through a 0.22 μm microporous membrane until it is clear, filled in a brown vial, partially plugged with a butyl rubber stopper, and placed on a plate; Put the freeze-dried samples in the freeze-drying box, close the box door, turn on the machine, turn on the circulating pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and when the product temperature reaches -35°C, close the plate cooling valve and turn on the ...

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Abstract

The invention relates to a bendmustine hydrochloride compound and a method for preparing the same. The bendmustine hydrochloride compound prepared by the method can be used for treating chronic lymphocytic leukemia (CLL) and inertia B-cell non-Hodgkin's lymphoma (B-cell NHL). The bendmustine hydrochloride compound contains bendmustine hydrochloride and hydroxyproyl beta-cyclodextrin, wherein the mass ratio of bendmustine hydrochloride to hydroxyproyl beta-cyclodextrin is 1:1-20. During the preparation process, mixed solvent of tertiary butanol and water for injection can be used, wherein the concentration of bendmustine hydrochloride in the mixed solvent is 5-10mg / mL; the ratio in the solvent (100%) by volume is as follows: 5-50% of tertiary butanol and the balance of water. The preparation process comprises the following steps of: weighing the tertiary butanol, sequentially adding the solvent and the hydroxyproyl beta-cyclodextrin, dissolving, evenly mixing and cooling the mixture to2-15 DEG C, maintaining the temperature, then adding the bendmustine hydrochloride, stirring until bendmustine hydrochloride dissolves, filtering, filling, stoppering, dishing-up, freeze-drying, corking, out-box, covering and packaging, and finally, the bendmustine hydrochloride compound is obtained.

Description

technical field [0001] The present invention relates to a bendamustine hydrochloride composition and a preparation method thereof, the bendamustine hydrochloride composition prepared by the method can be used for chronic lymphocytic leukemia (CLL) and rituximab The treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease progresses during the course of treatment with anti-rituximab or rituximab-containing regimens, or within 6 months of treatment. Background technique [0002] Bendamustine Hydrochloride (Bendamustine Hydrochloride) is a nitrogen mustard derivative carrying a purine-like benzimidazole ring, and has a dual mechanism of action of an alkylating agent and a purine analogue (anti-metabolite). Can cause cell death through several different pathways and is effective on both quiescent and dividing cells. Its plasma protein binding rate is 94% to 96%, and the data show that the drug generally does not replace each other with other high pr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4184A61K47/40A61J3/02A61P35/02A61P35/00
Inventor 叶东戴建国赵小伟戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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