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Bendamustine hydrochloride freeze-dried powder injection preparation method, product prepared through method, and use of product

A technology of bendamustine hydrochloride and freeze-dried powder injection, which is applied in the field of preparation of bendamustine hydrochloride preparations, can solve problems such as easy hydrolysis, and achieve the effects of loose and plump appearance, increased content and improved drying efficiency

Active Publication Date: 2014-06-18
HAIKOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since bendamustine hydrochloride is prone to hydrolysis in water, the stability of its freeze-dried powder injection still has a large room for improvement.

Method used

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  • Bendamustine hydrochloride freeze-dried powder injection preparation method, product prepared through method, and use of product
  • Bendamustine hydrochloride freeze-dried powder injection preparation method, product prepared through method, and use of product
  • Bendamustine hydrochloride freeze-dried powder injection preparation method, product prepared through method, and use of product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] This example is used to illustrate the preparation of bendamustine hydrochloride freeze-dried powder injection of the present invention.

[0041] Pre-cool the brown neutral borosilicate glass injection bottle in cold hydrazine. Pass the bendamustine hydrochloride raw material through a 150-mesh sieve for later use. Accurately weigh 25g of bendamustine hydrochloride and 30g of mannitol, add them into the liquid mixing tank, add 4500ml of water for injection cooled to 4~8°C, stir rapidly to dissolve, then add the remaining amount of water for injection to make up to 5000ml, Store in an ice bath (4-8°C).

[0042] Add 2.5 g of activated carbon to the resulting mixed solution, stir with an automatic stirrer for 15 minutes under ice bath (4-8 ° C), filter and decarburize, and use a 0.22 μm sterilizing microporous filter membrane to fine-filter the filtrate to obtain the drug liquid, and then measure the content of the liquid medicine, and pack it into 1000 injection bottles...

Embodiment 2

[0045] This example is used to illustrate the preparation of bendamustine hydrochloride freeze-dried powder injection of the present invention.

[0046] Pre-cool the brown neutral borosilicate glass injection bottle in cold hydrazine. Pass the bendamustine hydrochloride raw material through a 120-mesh sieve for later use. Accurately weigh 25g of bendamustine hydrochloride and 35g of mannitol, put them into the liquid mixing tank, add 4500ml of water for injection cooled to 4~8°C, stir quickly to dissolve, then add the remaining amount of water for injection to dilute to 5000ml, Store in an ice bath (0-4°C).

[0047] Add 2.5g of activated carbon to the resulting mixed solution, stir with an automatic stirrer for 15 minutes under ice bath (0-4°C), filter and decarburize, and use a 0.22 μm sterilizing microporous filter membrane to fine-filter the filtrate to obtain the drug liquid, and then measure the content of the liquid medicine, and pack it into 1000 injection bottles aft...

Embodiment 3

[0050] This example is used to illustrate the preparation of bendamustine hydrochloride freeze-dried powder injection of the present invention.

[0051] Pre-cool the brown neutral borosilicate glass injection bottle in cold hydrazine. Pass the bendamustine hydrochloride raw material through a 100-mesh sieve for later use. Accurately weigh 25g of bendamustine hydrochloride and 40g of mannitol, add them into the liquid mixing tank, add 2700ml of water for injection cooled to 4~8°C, stir rapidly to dissolve, then add the remaining amount of water for injection to dilute to 3000ml, Store in an ice bath (4-8°C).

[0052] Add 1.2g of activated carbon to the resulting mixed solution, stir with an automatic stirrer for 10 minutes under ice bath (4~8°C) to filter and decarburize, and use a 0.22μm sterile microporous filter membrane to fine filter the filtrate to obtain a medicinal solution , and then measure the content of the liquid medicine, and pack it into 1000 injection bottles ...

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Abstract

The invention provides a preparation method of a bendamustine hydrochloride freeze-dried powder injection. The preparation method is characterized in that the preparation method comprises the following steps: 1, dissolving: weighing bendamustine hydrochloride and an excipient, adding injection water, stirring for dissolving, and preserving the obtained solution in an ice bath; 2, depyrogenation: adding active carbon to the solution obtained in step 1, stirring in the ice bath, filtering for decarbonization, and carrying out fine filtration to obtain a soup; 3, pre-freezing: cooling the soup to -53 - -50DEG C to obtain a pre-frozen soup; 4, primary drying: evacuating the pre-frozen soup to 12- 20Pa, uniformly heating to 8-10DEG C, and uniformly heating to 18- 22DEG C to obtain a primary-dried soup; and 5, secondary drying: uniformly heating the primary-dried soup to 35DEG C, then uniformly heating to 45DEG C, and cooling the obtained powder to room temperature under vacuum conditions in order to obtain the bendamustine hydrochloride freeze-dried powder injection.

Description

technical field [0001] The invention relates to a preparation method of a bendamustine hydrochloride preparation, in particular to a preparation method of a bendamustine hydrochloride freeze-dried powder injection, and the bendamustine hydrochloride prepared according to the preparation method is freeze-dried A powder injection product, and the application of the product in the preparation of antitumor drugs. Background technique [0002] Bendamustine is an antineoplastic drug with a dual mechanism of action of nitrogen mustard and purine analogs. Nitrogen mustards and their derivatives are cleaved to generate electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic components. Bifunctional covalent linkage can lead to cell death through various pathways including induction of apoptosis and mitotic crisis. [0003] Bendamustine hydrochloride was originally developed in the 1860s by Ozegowski and Krebs (1963) at the Institute for Microbi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4184A61K47/26A61P35/00A61J3/02
Inventor 张志兰苏健强王俊红赵振锷
Owner HAIKOU PHARMA FACTORY
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