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Bendamustine hydrochloride freeze-dried powder injection

A technology of bendamustine hydrochloride and freeze-dried powder injection, which is applied in the field of bendamustine hydrochloride freeze-dried powder injection and its preparation, and can solve the problems of poor stability of bendamustine hydrochloride, lack of improvement, and drug efficacy Reduce and other problems to achieve the effect of avoiding the reduction of curative effect, considerable economic and social benefits, and thorough drying of water

Inactive Publication Date: 2009-11-25
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 freeze-dried powder injection
  • Bendamustine hydrochloride freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] prescription

[0026] Bendamustine Hydrochloride 100g

[0027] Mannitol 170g

[0028] tert-butanol 3000ml

[0029] Add water for injection to 10000ml

[0030]

[0031] A total of 1000 bottles were made

[0032] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 6°C and keep warm, then add bendamustine hydrochloride and mannitol, stir to dissolve and mix evenly, intermediate After passing the inspection, send it to a sterile room with a peristaltic pump and filter it through a 0.22 μm microporous membrane until it is clear, fill it in a brown vial, partially plug it with a butyl rubber stopper, and put it into a plate; put it into a plate and wait for freeze-drying Put the sample in the freeze-drying box, close the box door, turn on the machine, turn on the circulation pump, compressor and plate cooling valve, use heat transfer oil to lower the product tempe...

Embodiment 2

[0034] prescription

[0035] Bendamustine Hydrochloride 100g

[0036] Mannitol 300g

[0037] tert-butanol 7500ml

[0038] Add water for injection to 15000ml

[0039]

[0040] A total of 1000 bottles were made

[0041] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 8°C and keep warm, then add bendamustine hydrochloride and mannitol, stir to dissolve and mix evenly, intermediate After passing the inspection, send it to a sterile room with a peristaltic pump and filter it through a 0.22 μm microporous membrane until it is clear, fill it in a brown vial, partially plug it with a butyl rubber stopper, and put it into a plate; put it into a plate and wait for freeze-drying Put the sample in the freeze-drying box, close the box door, turn on the machine, turn on the circulation pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperatu...

Embodiment 3

[0043] prescription

[0044] Bendamustine Hydrochloride 100g

[0045] Lactose 200g

[0046] tert-butanol 1000ml

[0047] Add water for injection to 10000ml

[0048]

[0049]A total of 1000 bottles were made

[0050] Measure tert-butanol into a container, add water for injection, stir and mix well, cool the mixed solvent to 2°C and keep warm, then add bendamustine hydrochloride and lactose, stir to dissolve and mix well, intermediate inspection After passing the test, send it to a sterile room with a peristaltic pump and filter it through a 0.22 μm microporous membrane until it is clear, fill it in a brown vial, partially plug it with a butyl rubber stopper, and put it into a plate; put the sample in a plate to be freeze-dried Put it 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, when the...

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Abstract

The invention relates to a bendamustine hydrochloride freeze-dried powder injection and its preparing method. The prepared bendamustine hydrochloride freeze-dried powder injection is used for chronic lymphocytic leukemia (CLL) and in the treating process of rituximab / MabThera or containing the same, or for inert B cell non hodgkin lymphoma (B-NHL) patients whose illness state still deteriorates during the treatment period in six months. The bendamustine hydrochloride freeze-dried powder injection contains bendamustine hydrochloride and uses the mixed solvent composed of the tertiary butanol and the injection water in the preparation process. The concentration of the bendamustine hydrochloride in the mixed solvents is 5-10 mg / ml. The volume ratio of the solvents is: 5-50% of tertiary butanol and the balance of injection water. The preparation process is that: measuring the tertiary butanol, adding injection water, mixing evenly, cooling to 2-15 DEG C, heat preserving, then adding the bendamustine hydrochloride, stirring to dissolve, filtering, filling, plugging, disking, freeze-drying, pressing the plug, out box, tying and packing.

Description

technical field [0001] The present invention relates to a freeze-dried powder injection of bendamustine hydrochloride and a preparation method thereof, the freeze-dried powder injection of bendamustine hydrochloride prepared by the method can be used for chronic lymphocytic leukemia (CLL) and in The treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease progresses during the course of treatment with rituximab (rituximab, MabThera), 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...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4184A61P35/00A61P35/02
Inventor 叶东戴建国赵小伟戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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