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A kind of stable injection bendamustine hydrochloride and preparation method thereof

A technology for bendamustine hydrochloride and injection, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, and pharmaceutical formulations, and can solve the problems of low stability of bendamustine hydrochloride and the like , to reduce the difficulty of freeze-drying, improve the stability, and reduce the content of related substances

Active Publication Date: 2022-03-29
SICHUAN HUIYU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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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  • A kind of stable injection bendamustine hydrochloride and preparation method thereof
  • A kind of stable injection bendamustine hydrochloride and preparation method thereof
  • A kind of stable injection bendamustine hydrochloride and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Prescription information

[0028]

[0029] The stable hydrochloride hydrochloride prepared hydrochloride hydrochloride, including the following steps:

[0030] (1) Add the amount of mannitol in the injection of the injection, stir the complete dissolution, and then add the amount of glacial acetic acid, stir well, and mix well.

[0031] (2) Premimustine, beammustine, which is added to the solution A, stirred completely dissolve, obtain solution B, and dissolve the solution B-filled oxygen to the solution B below 0.5 mg / L, and hold to The filling is over; and the solution B is cooled to 15 ° C;

[0032] (3) Solution B was subjected to sterilization, filling, freeze drying. details as follows:

[0033] The liquid supply can be packed into the pressurization of clean nitrogen, and the solution B is filtered through 2 0.22 μmptfe filter filters to the medium boric silicon glass injection bottle, filling volume 5ml / bottle; holding the dissolved oxygen in solution B before ...

Embodiment 2

[0036] Example 2 had a preparation method for a phenamustine for an injective hydrochloride in Example 1 in:

[0037] The ice acetic acid of Example 2 was 45% (V / V). The prescription information of Example 2 is as follows:

[0038]

Embodiment 3

[0040] The hydrochloride of Example 3 was preparation method for the preparation of the preparation of Example 1 in that the amount of glacial acetic acid in Example 3 was 35% (V / V). The prescription information of Example 3 is as follows:

[0041]

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Abstract

The invention discloses a stable bendamustine hydrochloride for injection and a preparation method thereof, comprising: (1) adding mannitol to water for injection, stirring to completely dissolve, then adding glacial acetic acid, and stirring evenly to obtain solution A (2) Add bendamustine hydrochloride to solution A, stir to dissolve completely, and obtain solution B, fill solution B with nitrogen to remove oxygen and lower the temperature to below 15°C; (3) carry out sterilizing filtration on solution B, pour packed, freeze-dried. In the present invention, acetic acid solution is used as solvent to dissolve bendamustine hydrochloride, which helps to improve the stability of bendamustine; meanwhile, before dissolving bendamustine hydrochloride, glacial acetic acid is diluted to avoid The decomposition of bendamustine hydrochloride caused by the high concentration of acetic acid further improves the stability of bendamustine hydrochloride in the liquid medicine and reduces the content of related substances in the liquid medicine and finished products.

Description

Technical field [0001] The present invention relates to a stable hydrochloride-benimmustine, which is a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Benradamustine hydrochloride is a dual functional alkylation agent, which leads to DNA single-strand and double-chain crosslinks, and exerts anti-tumor effect in Germany by alkylation. It has been widely used in anti-cancer treatment. [0003] Benadamustine hydrochloride is unstable in water, and it is easy to hydrolyzing as HP1 (impurities D) and HP2 (impurity E). At present, the amount of hydrochloride dipoli impurity D and impurities E have a higher content of injection. [0004] [0005] The disclosure of which is a preparation method of a hydrochloride thretetine hydrochloride, which is a hydrochloride-benimmustin composition solution, and acetic acid volume in a hydrochloride polyacetic acid-based phenamustin composition solution. 75%, in this hydro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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