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Stable bendamustine hydrochloride for injection and preparation method thereof

A technology for bendamustine hydrochloride and injection, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., and can solve the problems of low stability of bendamustine hydrochloride , to achieve the effect of reducing the difficulty of freeze-drying, avoiding decomposition, and reducing the content of related substances

Active Publication Date: 2020-05-19
SICHUAN HUIYU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The Chinese patent with publication number CN104173300A discloses a preparation method of bendamustine hydrochloride freeze-dried powder injection. In the bendamustine hydrochloride composition solution finally obtained in the method, the volume percentage of acetic acid is 50%- 75%, in this bendamustine hydrochloride composition solution, although the solubility of the bendamustine bulk drug has been increased, the stability of bendamustine hydrochloride is low, and the related substances of the product finally obtained increase

Method used

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  • Stable bendamustine hydrochloride for injection and preparation method thereof
  • Stable bendamustine hydrochloride for injection and preparation method thereof
  • Stable bendamustine hydrochloride for injection and preparation method thereof

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Embodiment 1

[0027] prescribing information

[0028]

[0029] The stable preparation method of bendamustine hydrochloride for injection of embodiment 1 comprises the following steps:

[0030] (1) Add the mannitol of the prescribed amount to the water for injection of the prescribed amount, stir to dissolve completely, then add the glacial acetic acid of the prescribed amount, stir to obtain solution A;

[0031] (2) Add the bendamustine hydrochloride of prescription amount to solution A, stir and make to dissolve completely, obtain solution B, solution B is filled with nitrogen and deoxygenated to the dissolved oxygen in solution B to be lower than 0.5mg / L, and keep until The filling is completed; and the temperature of solution B is lowered to below 15°C;

[0032] (3) Solution B is sterilized and filtered, filled and freeze-dried. details as follows:

[0033] Put clean nitrogen into the liquid preparation tank to pressurize, filter solution B through two 0.22μm PTFE filter elements, ...

Embodiment 2

[0036] The preparation method of bendamustine hydrochloride for injection of embodiment 2 differs from embodiment 1 in that:

[0037] The glacial acetic acid consumption of embodiment 2 is 45% (v / v). The prescription information of embodiment 2 is as follows:

[0038]

Embodiment 3

[0040] The difference between the preparation method of bendamustine hydrochloride for injection in Example 3 and Example 1 is that the dosage of glacial acetic acid in Example 3 is 35% (v / v). The prescription information of embodiment 3 is as follows:

[0041]

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Abstract

The invention discloses stable bendamustine hydrochloride for injection and a preparation method thereof. The method comprises the following steps: (1) adding mannitol into water for injection, performing stirring to completely dissolve the mannitol, then adding glacial acetic acid, and performing uniform stirring to obtain a solution A; (2) adding bendamustine hydrochloride into the solution A, performing stirring until the bendamustine hydrochloride is completely dissolved to obtain a solution B, introducing nitrogen into the solution B to remove oxygen, and performing cooling to below 15 DEG C; and (3) performing sterilizing, filtering, filling and freeze-drying on the solution B. In the invention, the acetic acid solution is used as a solvent to dissolve the bendamustine hydrochloride,so that the stability of the bendamustine hydrochloride is improved; meanwhile, the glacial acetic acid is diluted before the bendamustine hydrochloride is dissolved, so that the decomposition of thebendamustine hydrochloride caused by over-high concentration of the acetic acid can be avoided, the stability of the bendamustine hydrochloride in a liquid medicine is further improved, and the content of related substances in the liquid medicine and a finished product is reduced.

Description

technical field [0001] The invention relates to a stable bendamustine hydrochloride for injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Bendamustine hydrochloride is a bifunctional alkylating agent, which mainly causes DNA single-strand and double-strand cross-linking through alkylation, interferes with DNA function and synthesis, and exerts anti-tumor effects. It was developed in Germany in the 1970s It has been widely used in anticancer therapy. [0003] Bendamustine hydrochloride is unstable in water and is easily hydrolyzed and metabolized into HP1 (impurity D) and HP2 (impurity E). The content of impurity D and impurity E in currently marketed bendamox hydrochloride for injection is relatively high. [0004] [0005] The Chinese patent with publication number CN104173300A discloses a preparation method of bendamustine hydrochloride freeze-dried powder injection. In the bendam...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4184A61K47/12A61P35/00
CPCA61K9/19A61K9/0019A61K31/4184A61K47/12A61P35/00
Inventor 刘云龙
Owner SICHUAN HUIYU PHARMA
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