Preparation method of bendamustine hydrochloride freeze-dried injection

A technology of bendamustine hydrochloride and bendamustine hydrochloride acetic acid, which is applied in the field of preparation of freeze-dried powder injection, can solve the problems of safety and effectiveness, carcinogenicity, toxic and side effects, and achieve reconstitution quick effect

Inactive Publication Date: 2014-12-03
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 freeze-dried injection
  • Preparation method of bendamustine hydrochloride freeze-dried injection
  • Preparation method of bendamustine hydrochloride freeze-dried injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] (1) Dissolve 17g of mannitol in 250ml of water for injection to obtain a mannitol solution

[0025] (2) 10g of bendamustine hydrochloride was dissolved in 600mL of 98% acetic acid solution by volume percentage to obtain bendamustine hydrochloride acetic acid solution;

[0026] (3) Mix the mannitol solution and the bendamustine hydrochloride acetic acid solution evenly, and at 25° C., add 98% acetic acid solution by volume and settle to 1000 mL to obtain bendamustine hydrochloride Sting composition solution, sent to a sterile room by a peristaltic pump and filtered through a 0.22 μm microporous membrane until clear and transparent, that is, the sample to be freeze-dried, filled in a vial, partially plugged with a butyl rubber stopper, and packed 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 heat transfer oil to lower the temperature of the sample t...

Embodiment 2

[0030] (1) Dissolve 17g of lactose in 100mL of water for injection to obtain a lactose solution

[0031] (2) 10 g of bendamustine hydrochloride was dissolved in 800 mL of 60% acetic acid solution by volume percentage to obtain bendamustine hydrochloride acetic acid solution;

[0032] (3) Mix the lactose solution and the bendamustine hydrochloride acetic acid solution evenly, and at 20° C., add 60% acetic acid solution by volume and settle to 1000 mL to obtain bendamustine hydrochloride The composition solution is sent to a sterile room with a peristaltic pump and filtered through a 0.22 μm microporous membrane until it is clear and transparent, that is, the sample to be freeze-dried, filled in a vial, partially plugged with a butyl rubber stopper, and placed in 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, and use heat transfer oil to lower the temperatur...

Embodiment 3

[0036] (1) Dissolve 20g of mannitol in 200ml of water for injection to obtain a mannitol solution

[0037] (2) 10 g of bendamustine hydrochloride was dissolved in 600 mL of 90% acetic acid solution by volume percentage to obtain bendamustine hydrochloride acetic acid solution;

[0038](3) Mix the mannitol solution and the bendamustine hydrochloride acetic acid solution evenly, and add water for injection to make the volume to 1000mL at 22°C to obtain the bendamustine hydrochloride composition solution. Use a peristaltic pump to send it to a sterile room and filter it through a 0.22 μm microporous membrane until it becomes clear and transparent, that is, the sample to be freeze-dried, filled in a vial, partially plugged with a butyl rubber stopper, and placed on a plate; Put the sample to be freeze-dried in the freeze-drying box, close the door, turn on the machine, turn on the circulation pump, compressor and plate cooling valve, use heat transfer oil to lower the temperature ...

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Abstract

The invention discloses a preparation method of a freeze-dried injection, and particularly relates to a preparation method of a bendamustine hydrochloride freeze-dried injection. The preparation method comprises the following steps: (1) dissolving filler into water for injection, so that a filler solution is obtained; (2) dissolving bendamustine hydrochloride into an acetic acid solution, so that a bendamustine hydrochloride-acetic acid solution is obtained; and (3) uniformly mixing the filler solution with the bendamustine hydrochloride-acetic acid solution, carrying out constant volume operation on the obtained mixture by using water for injection or an acetic acid solution at a temperature of 18-26 DEG C so as to obtain a bendamustine hydrochloride composition solution, and sequentially carrying out filtering, degerming and freeze drying on the bendamustine hydrochloride composition solution, so that the bendamustine hydrochloride freeze-dried injection is obtained. The preparation method disclosed by the invention is simple and easy to operate, and prepared products are good in stability and low in impurity content.

Description

technical field [0001] The invention relates to a preparation method of freeze-dried powder injection, in particular to a preparation method of bendamustine hydrochloride freeze-dried powder 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 app...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4184A61K47/26A61K47/10A61K47/18A61K47/14A61P35/00A61J3/02
Inventor 田刚丁兆孙朝国
Owner SICHUAN HUIYU PHARMA
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