Cefmenoxime hydrochloride composition for injection and preparation thereof

A technology of cefmenoxime hydrochloride and a composition is applied in the field of cefmenoxime hydrochloride composition for injection, which can solve the problems of drug powder fluidity, poor stability, potential safety hazards, complicated process steps, etc., and achieves fast dissolution speed and increased collision. Opportunity, small amount of effect

Active Publication Date: 2012-06-20
桂林澳林制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent uses acetone as a solvent to recrystallize cefmenoxime hydrochloride, and generally there is a small amount of solvent residue in the recrystallization obtained, so the recrystallization crystal has certain hidden dangers. The method of crystallization and regrinding, the process steps are relatively complicated, and the fluidity and stability of the obtained drug powder are poor

Method used

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  • Cefmenoxime hydrochloride composition for injection and preparation thereof
  • Cefmenoxime hydrochloride composition for injection and preparation thereof
  • Cefmenoxime hydrochloride composition for injection and preparation thereof

Examples

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Effect test

Embodiment 1

[0043] The preparation method of embodiment 1 cefmenoxime hydrochloride composition

[0044] The composition comprises: 10 parts by weight of cefmenoxime hydrochloride crystals prepared by the invention, and 1.75 parts by weight of anhydrous sodium carbonate.

[0045] The preparation method is:

[0046] (1) take cefmenoxime hydrochloride crystal and anhydrous sodium carbonate in proportion, fully mix;

[0047] (2) sub-package into sterilized vials and stopper;

[0048] Wherein, the preparation method of cefmenoxime hydrochloride crystal is:

[0049] a. Take 0.5Kg of cefmenoxime hydrochloride solid and add 10L of water and stir to make a suspension, add 90g of anhydrous sodium carbonate at 15°C, stir and dissolve to obtain a clear liquid;

[0050] b. Adding the clarified liquid to 0.01% active carbon for decolorization by mass percentage, stirring the filtrate after 0.5 hours;

[0051] c. Add 2mol / L hydrochloric acid and an organic solvent to the filtrate obtained in step c...

Embodiment 2

[0053] The preparation method of embodiment 2 cefmenoxime hydrochloride composition

[0054] The composition comprises: 10 parts by weight of cefmenoxime hydrochloride crystals prepared by the invention, and 1.75 parts by weight of anhydrous sodium carbonate.

[0055] The preparation method is:

[0056] (1) take cefmenoxime hydrochloride crystal and anhydrous sodium carbonate in proportion, fully mix;

[0057] (2) sub-package into sterilized vials and stopper;

[0058] Wherein, the preparation method of cefmenoxime hydrochloride crystal is:

[0059] a. Take 0.5Kg of cefmenoxime hydrochloride solid and add 10L of water and stir to make a suspension, add 90g of anhydrous sodium carbonate at 15°C, stir and dissolve to obtain a clear liquid;

[0060] b. Adding the clarified liquid to 0.02% active carbon for decolorization by mass percent, and stirring the filtrate for 1 hour;

[0061] c. Add 4mol / L hydrochloric acid and an organic solvent to the filtrate obtained in step b at ...

Embodiment 3

[0063] The preparation method of embodiment 3 cefmenoxime hydrochloride composition

[0064] The composition comprises: 10 parts by weight of cefmenoxime hydrochloride crystals prepared by the invention, and 1.75 parts by weight of anhydrous sodium carbonate.

[0065] The preparation method is:

[0066] (1) take cefmenoxime hydrochloride crystal and anhydrous sodium carbonate in proportion, fully mix;

[0067] (2) sub-package into sterilized vials and stopper;

[0068] Wherein, the preparation method of cefmenoxime hydrochloride crystal is:

[0069] a. Take 0.5Kg of cefmenoxime hydrochloride solid and add 10L of water and stir to make a suspension, add 90g of sodium carbonate at 15°C, stir and dissolve to obtain a clear liquid;

[0070] b. Adding the clarified liquid to 0.05% activated carbon for decolorization by mass percent, stirring the filtrate after 1.5 hours;

[0071] c. Add 2mol / L hydrochloric acid and an organic solvent to the filtrate obtained in step b at 10°C u...

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Abstract

The invention relates to a cefmenoxime hydrochloride composition for injection which consists of 10 parts by weight of cefmenoxime hydrochloride and 1.5 to 2.5 parts by weight of anhydrous sodium carbonate, preferably 10 parts by weight of cefmenoxime hydrochloride and 1.75 to 1.8 parts by weight of anhydrous sodium carbonate. The cefmenoxime hydrochloride is crystal, having characteristic peaks at the diffraction angles 2 theta of 6.0 degrees, 7.4 degrees, 11.0 degrees, 12.2 degrees, 17.5 degrees, 19.8 degrees, 21.6 degrees, 24.8 degrees and 27.7 degrees in the X-ray powder diffraction measured using a Cu K-alpha ray. The main crystal size of cefmenoxime hydrochloride is 30 to 45 microns and the crystal size distribution width is 25 to 75 microns. The cefmenoxime hydrochloride composition of the invention is in the dosage form of injection which is dissolved quickly, suitable for clinic application, good in stability and reliable in safety.

Description

technical field [0001] The invention relates to a composition of cefmenoxime hydrochloride for injection, in particular to a composition of cefmenoxime hydrochloride with good water solubility and good stability and a preparation thereof prepared from a new crystal form of cefmenoxime hydrochloride. Background technique [0002] Cefmenoxime hydrochloride (cefmenoxime hydrochloride) is a semi-synthetic cephalosporin antibiotic. It achieves bactericidal effect by inhibiting the synthesis of bacterial cell walls. It has a broad-spectrum bactericidal effect on most Gram-positive and negative bacteria. The β-lactamase is stable and can be widely used in the treatment of various inflammations caused by bacterial infections. [0003] However, due to the poor water solubility of cefmenoxime hydrochloride, it is only slightly soluble in water, which brings many difficulties in practical application. At present, people have done a lot of research on the preparation of cefmenoxime hyd...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61P31/04
Inventor 黄文豪
Owner 桂林澳林制药有限责任公司
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