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Cefmenoxime hydrochloride compound used for injection

A technology of cefmenoxime hydrochloride and compound, which is applied in the field of cefmenoxime hydrochloride compound for injection, can solve the problems of complex process steps, potential safety hazards, poor fluidity and stability, etc., and achieves small dosage, uniform particle size, and dissolution rate. consistent effect

Active Publication Date: 2012-04-11
桂林澳林制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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 this recrystallization has certain hidden dangers. In addition, the first recrystallization method is adopted in this patent. The method of regrinding, the process steps are relatively complicated, and the fluidity and stability are poor

Method used

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  • Cefmenoxime hydrochloride compound used for injection
  • Cefmenoxime hydrochloride compound used for injection
  • Cefmenoxime hydrochloride compound used for injection

Examples

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Embodiment 1

[0043] The preparation of embodiment 1 cefmenoxime hydrochloride crystal

[0044] (1) 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;

[0045] (2) Adding the clarified liquid to the mass percentage is 0.01% active carbon decolorization, stirring the filtrate after 0.5 hours;

[0046] (3) The filtrate that step (2) obtains is under the condition of 10 DEG C, under the sound field that frequency is 30KHz, output power is 50W, while stirring, add 2mol / L hydrochloric acid and organic solvent simultaneously, adjust pH value to be 1.4, so The volume of the organic solvent that adds is 2.5L, and stirring speed is 60 revs / min; Organic solvent is the mixed solution of methanol and isobutanol that volume ratio is 1: 0.75; The speed that adds organic solvent is 25ml / min, hydrochloric acid and mixing After the solution was added, the stirring was st...

Embodiment 2

[0049] (1) 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 solution;

[0050] (2) Adding the clarified liquid to a mass percentage of 0.02% activated carbon for decolorization, stirring the filtrate after 1 hour;

[0051] (3) Add 4mol / L hydrochloric acid and an organic solvent to the filtrate obtained in step (2) at 10°C under a sound field with a frequency of 25KHz and an output power of 45W while stirring to adjust the pH value to 1.6. The volume of the organic solvent added is 5L, and the stirring speed is 45 rpm; the organic solvent is a mixed solution of methanol and isobutanol with a volume ratio of 1:1; the speed when adding the organic solvent is 20ml / min; After adding the hydrochloric acid and the mixed solution, the stirring was stopped, and the crystals were kept standing in the sound field for 2 hours, and the obtained crystals were f...

Embodiment 3

[0054] (1) 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;

[0055] (2) Adding the clarified liquid to a mass percentage of 0.05% activated carbon for decolorization, stirring the filtrate after 1.5 hours;

[0056] (3) under the condition of 10 DEG C, the filtrate obtained in step (2) is under the sound field whose frequency is 30KHz and output power is 40W, while stirring, add hydrochloric acid and organic solvent of 2mol / L simultaneously, adjust the pH value to 1.5, The volume of the added organic solvent is 10L, and stirring speed is 45 rev / mins, and organic solvent is the mixed solution of methanol and isobutanol that volume ratio is 1: 0.5; The speed that adds organic solvent is 25ml / min; Hydrochloric acid and mixing After the solution was added, the stirring was stopped, and the crystals were kept standing in the sound field for 1 hour to obt...

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Abstract

The invention relates to a cefmenoxime hydrochloride compound used for injection which is a crystal. X-ray powder obtained through Cu-K alpha ray measurement is diffracted at a 2 theta of 6.0 degree, 7.4 degree, 11.0 degree, 12.2 degree, 17.5 degree, 19.8 degree, 21.6 degree, 24.8 degree and 27.7 degree with characteristic peaks shown. The main granularity of the cefmenoxime hydrochloride crystal is 30-45 Mum and the distribution width of the cefmenoxime hydrochloride crystal is 25-75 Mum. Injections prepared through the cefmenoxime hydrochloride compound not only are rapid to dissolve and applicable to clinical application, but also have excellent stability, and are safe and reliable.

Description

technical field [0001] The invention relates to a cefmenoxime hydrochloride compound for injection, in particular to a new crystal form of cefmenoxime hydrochloride with good water solubility and good stability. Background technique [0002] Cefmenoxime hydrochloride (cefmenoxime hydrochloride) is a semi-synthetic cephalosporin antibiotic, which 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, and is stable to the β-lactamase produced by bacteria, 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 hydrochloride. A kind of synthetic method of cefmenoxime hy...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12
Inventor 黄文豪
Owner 桂林澳林制药有限责任公司
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