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Bendamustine hydrochloride freeze-dried powder injection for injection and preparation method thereof

A technology of bendamustine hydrochloride and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection of bendamustine hydrochloride for injection and its preparation, and can solve the problems of difficult redissolution, rough powder cake, and easily broken powder, etc. problem, to achieve the effect of no organic solvent residue, simple production process and good water solubility

Inactive Publication Date: 2011-02-09
上海丽思化工科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tests have shown that the freeze-dried powder prepared by using tert-butanol aqueous solution as the preparation solvent, after freeze-drying, the powder cake is relatively rough, and the powder is easily broken, and the appearance of the product is poor
When reconstituted with water for injection, it is difficult to reconstitute, and it takes a long time to shake, and sometimes there is turbidity after reconstitution
Therefore, the use of tert-butanol as a solvent in freeze-dried preparations not only puts forward special requirements for production, but also brings safety hazards to clinical medication.

Method used

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  • Bendamustine hydrochloride freeze-dried powder injection for injection and preparation method thereof
  • Bendamustine hydrochloride freeze-dried powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Bendamustine Hydrochloride Freeze-Dried Powder for Injection

[0025] Weigh 2.5 grams of mannitol, stir and dissolve in 80 ml of water for injection at 5°C; add 1.5 grams of bendamustine hydrochloride, stir and dissolve; dilute to 100 ml with water for injection; filter with a 0.22 μm microporous membrane, The filtrate is filtered through a 10,000-molecular-weight ultrafiltration membrane to remove pyrogens, then packaged, freeze-dried, and sealed to obtain bendamustine hydrochloride freeze-dried powder for injection.

[0026] Through measurement, after the freeze-dried powder injection is reconstituted with water for injection, the solution is clear; the marked content is 100.2%.

Embodiment 2

[0027] Example 2 Bendamustine Hydrochloride Freeze-dried Powder for Injection

[0028] Weigh 3 grams of mannitol, stir and dissolve in 80 ml of water for injection at 7°C; add 2 grams of bendamustine hydrochloride, stir and dissolve; dilute to 100 ml with water for injection; filter with a 0.45 μm microporous membrane, The filtrate is filtered through a 5000 molecular weight ultrafiltration membrane to remove pyrogens, then packaged, freeze-dried, and sealed to obtain bendamustine hydrochloride freeze-dried powder for injection.

[0029] Through measurement, after the freeze-dried powder injection is reconstituted with water for injection, the solution is clear; the marked content is 99.4%.

Embodiment 3

[0030] Example 3 Bendamustine Hydrochloride Freeze-Dried Powder for Injection

[0031] Weigh 4 grams of mannitol, stir and dissolve in 80 ml of water for injection at 3°C; add 1 g of bendamustine hydrochloride, stir and dissolve; dilute to 100 ml with water for injection; filter with a 0.45 μm microporous membrane, The filtrate is filtered through a 10,000-molecular-weight ultrafiltration membrane to remove pyrogens, then packaged, freeze-dried, and sealed to obtain bendamustine hydrochloride freeze-dried powder for injection.

[0032] Through measurement, after the freeze-dried powder injection is reconstituted with water for injection, the solution is clear; the marked content is 99.8%.

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Abstract

The invention relates to the technical field of medicinal preparations. Bendamustine hydrochloride is easy to degrade in the preparation process, so in order to prevent degradation products from generating, the aqueous solution of tertiary butanol with certain concentration is used as a solvent; therefore, medicaments and relevant auxiliary materials are dissolved, and the dissolved mixture is subjected to freeze-drying so as to obtain the bendamustine hydrochloride; however, the tertiary butanol is harmful to human bodies when inhaled or orally taken, the conventional literature indicates that the tertiary butanol can cause the oxidative injury of deoxyribonucleic acid (DNA), and experiments of rats and mice prove that the tertiary butanol has the carcinogenicity. The invention provides a bendamustine hydrochloride freeze-dried powder injection for injection and a preparation method thereof. In the preparation method, an organic solvent and particularly the tertiary butanol are not added in the processes of preparation and freeze-drying, so the safety of production and clinical medication is improved greatly. The bendamustine hydrochloride freeze-dried powder injection for the injection has the high stability and water solubility, has the characteristics of stability, controlled quality, safety and reliability, and particularly does not have organic solvent residues.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a bendamustine hydrochloride freeze-dried powder for injection that does not contain an organic solvent, in particular does not contain tert-butanol, and a preparation method thereof. Background technique [0002] Bendamustine Hydrochloride (Bendamustine Hydrochloride) was first developed by Ozegowski and his colleagues at the Microbial Experiment Association in Jena, Germany in the early 1860s. It is a bifunctional alkylating agent that can treat human ovarian cancer and breast cancer in vitro. Cytotoxic. The pharmacological action of bendamustine hydrochloride is to make DNA single-strand and double-strand cross-link through alkylation, interfere with DNA function and DNA synthesis, thereby exerting anti-tumor effect. Mainly used alone or in combination with other antineoplastic drugs to treat the following malignant tumors: Hodgkin's disease, non-Hodgkin's lymphoma, plasmac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4184A61P35/00A61P35/02
Inventor 侯丽红高保安束辰
Owner 上海丽思化工科技有限公司
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