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 acet

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

Examples

Experimental program
Comparison scheme
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Example Embodiment

[0026] Example 1:

[0027] Prescription information

[0028]

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

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

[0031] (2) Add the prescription amount of bendamustine hydrochloride to solution A, stir to dissolve completely, and obtain solution B. Fill solution B with nitrogen and remove oxygen until the dissolved oxygen in solution B is less than 0.5mg / L, and keep it until Filling is finished; and the temperature of solution B is lowered to below 15℃;

[0032] (3) Sterilize solution B, filter, fill, and freeze-dry. details as follows:

[0033] Pour clean nitrogen into the dosing tank to pressurize, filter the solution B through two 0.22μm PTFE filter elements and then fill it into a med...

Example Embodiment

[0035] Example 2

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

[0037] The amount of glacial acetic acid used in Example 2 is 45% (v / v). The prescription information of Example 2 is as follows:

[0038]

Example Embodiment

[0039] Example 3

[0040] The preparation method of bendamustine hydrochloride for injection in Example 3 is different from Example 1 in that the amount of glacial acetic acid in Example 3 is 35% (v / v). The prescription information of Example 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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