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Preparation method of bendamustine hydrochloride composition for injection

A technology of bendamustine hydrochloride and composition, which is applied in the field of preparation of pharmaceutical compositions, and can solve the problems of safety and effectiveness, toxic and side effects, carcinogenicity, etc.

Inactive Publication Date: 2014-08-20
SICHUAN HUIYU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But so far, hydroxypropyl-β-cyclodextrin only has the approval number of oral and external use in China
And some data show that because hydroxypropyl-β-cyclodextrin can change the inherent pharmacokinetic characteristics and tissue distribution characteristics of the main drug to varying degrees, it may cause safety and effectiveness problems, mainly including nephrotoxicity and hemolysis. Sex and other safety issues, also carcinogenic, and there may be unknown more serious side effects

Method used

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  • Preparation method of bendamustine hydrochloride composition for injection
  • Preparation method of bendamustine hydrochloride composition for injection
  • Preparation method of bendamustine hydrochloride composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] (1) Dissolve 17g of mannitol in 250mL of water for injection, adjust the pH value with 30% hydrochloric acid to obtain a pH value of 1.0 for the mannitol solution, and store it at 5°C;

[0027] (2) Disperse 10 g of bendamustine hydrochloride in 200 mL of tert-butanol to obtain a bendamustine hydrochloride suspension;

[0028] (3) Mix the mannitol solution and the bendamustine hydrochloride suspension, stir to dissolve, add water for injection at 10°C to make the volume to 1000 mL, and obtain a bendamustine hydrochloride composition solution, Store at 5°C, send it to a sterile room with a peristaltic pump, filter it through a 0.22 μm microporous membrane until it is clear and transparent, that is, the sample to be freeze-dried, fill it in a vial, and partially plug it with a butyl rubber stopper. Packing: put the sample to be freeze-dried in the freeze-drying box, close the door, turn on the machine, open the circulation pump, compressor and plate cooling valve, use heat...

Embodiment 2

[0032] (1) Dissolve 17g of lactose in 250mL of water for injection, adjust the pH value with 35% hydrochloric acid to obtain a lactose solution with a pH value of 1.5, and store at 10°C;

[0033] (2) Disperse 10 g of bendamustine hydrochloride in 250 mL of tert-butanol to obtain a bendamustine hydrochloride suspension;

[0034] (3) Mix the lactose solution and the bendamustine hydrochloride suspension, stir to dissolve, add 5°C water for injection to make the volume to 1000mL, obtain the bendamustine hydrochloride composition solution, place in Store at 2°C, send it to a sterile room with a peristaltic pump, filter it through a 0.22 μm microporous membrane until it is clear and transparent, that is, the sample to be freeze-dried, fill it in a vial, partially plug it with a butyl rubber stopper, and put it on a plate Put the sample to be freeze-dried into the freeze-drying box, close the door, turn on the machine, open the circulation pump, compressor and plate cooling valve, a...

Embodiment 3

[0038] (1) Dissolve 17g of mannitol in 500mL of water for injection, adjust the pH value with 25% hydrochloric acid to obtain a pH value of 0.5 of the mannitol solution, and store it at 2°C;

[0039] (2) Disperse 10 g of bendamustine hydrochloride in 600 mL of tert-butanol to obtain a bendamustine hydrochloride suspension;

[0040](3) Mix the mannitol solution and the bendamustine hydrochloride suspension, stir to dissolve, add water for injection at 8°C to make the volume to 2000mL, obtain the bendamustine hydrochloride composition solution, place Store at 10°C, send it to a sterile room with a peristaltic pump and filter it through a 0.22 μm microporous membrane until it is clear and transparent, that is, the sample to be freeze-dried, fill it in a vial, and partially plug it with a butyl rubber stopper. plate; put the sample to be freeze-dried in the freeze-drying box, close the door, turn on the machine, open the circulation pump, compressor and plate cooling valve, use he...

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Abstract

The invention discloses a preparation method of a pharmaceutical composition, and in particular relates to a preparation method bendamustine hydrochloride composition for injection. The method comprises the following steps: (1) dissolving a filling agent into water of injection, adjusting pH with hydrochloric acid until the pH of the filling agent solution is 0.5 to 1.5, and then storing under 2 to 15 DEG C; (2) dispersing bendamustine hydrochloride into tert butyl alcohol to obtain bendamustine hydrochloride suspension; (3) mixing the filling agent solution and bendamustine hydrochloride suspension, agitating and dissolving, adding water of injection under 2 to 15 DEG C until the desired volume to obtain bendamustine hydrochloride composition solution, storing under 2 to 15 DEG C, filtering and sterilizing, and then freeze-drying to obtain the bendamustine hydrochloride composition for injection. The preparation method is simple and easy to operate, and the prepared bendamustine hydrochloride composition for injection is high in stability and low in impurity content.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical composition, in particular to a preparation method of a bendamustine hydrochloride composition for injection. Background technique [0002] Bendamustine hydrochloride was first developed in the early 1960s by Ozegowski and colleagues at the Institute for Microbiological Experiments in Jena, Germany. The purpose of the synthesis is to link an alkylated nitrogen mustard (a non-functional alkylating agent) to a purine and an amino acid. The major advantage of the newly synthesized compound over chlorambucil is its water solubility. Anger et al. published initial clinical results of the successful use of bendamustine in patients with plasmacytoma. Bendamustine was produced under the trade name Cytostasan by the pharmaceutical company Jena from 1971 to 1992. Since 1993, this cytostatic agent has been marketed under the trade name Ribomustine by ribosepharm GmbH. In 2008, the US FDA approv...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4184A61P35/00
Inventor 田刚丁兆孙朝国
Owner SICHUAN HUIYU PHARMA
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