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Azlocillin sodium compound, its preparation method and pharmaceutical composition thereof

A technology of azlocillin sodium and a composition is applied in the field of azlocillin sodium compounds to achieve the effects of improving drug safety, good storage stability and good storage stability

Inactive Publication Date: 2015-09-09
四川省惠达药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Azlocillin sodium in the prior art has hygroscopicity, and when stored for a long time, the appearance of azlocillin sodium gradually changes from white loose powder to a light yellow lump, and related substances increase. In order to obtain a kind of azlocillin sodium with better performance Cillin sodium, specially proposed the present invention

Method used

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  • Azlocillin sodium compound, its preparation method and pharmaceutical composition thereof
  • Azlocillin sodium compound, its preparation method and pharmaceutical composition thereof
  • Azlocillin sodium compound, its preparation method and pharmaceutical composition thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0048] The preparation method of azlocillin sodium compound:

[0049] Prepare a mixed solvent of N,N-dimethylformamide and ethanol at a volume ratio of 5:1, take azlocillin sodium raw material, add the mixed solvent of N,N-dimethylformamide and ethanol, and heat to 50°C, stir until completely dissolved, adjust the pH of the solution to 6.0, keep warm, and carry out magnetic treatment on the solution. The magnetic treatment is: flow the solution through a 0.5T DC magnetic field at a speed of 7m / s, and the direction of the magnetic field is the same as The direction of solution flow is vertical. Add active carbon decolorization in the solution that has been processed, the amount of adding active carbon is 0.2%g / ml of the total volume of the medicinal solution, stir for 30min, filter to obtain a clear solution, add ethyl acetate to the clear solution under the condition of slow stirring, The volume ratio of ethyl acetate to the mixed solvent is 4:1, the stirring rate is 8rpm whe...

Embodiment 2

[0052] The preparation method of azlocillin sodium compound:

[0053] Prepare a mixed solvent of N,N-dimethylformamide and ethanol at a volume ratio of 3:1, take azlocillin sodium raw material, add the mixed solvent of N,N-dimethylformamide and ethanol, and heat to 65°C, stir until completely dissolved, adjust the pH of the solution to 7.0, keep warm, and perform magnetic treatment on the solution. The magnetic treatment is: flow the solution through a 0.5T DC magnetic field at a speed of 15m / s, and the direction of the magnetic field is the same as The direction of solution flow is vertical. Add active carbon decolorization in the solution that has been processed, the amount of adding active carbon is 0.3%g / ml of the total volume of the medicinal solution, stir for 30min, filter to obtain a clear solution, add ethyl acetate to the clear solution under the condition of slow stirring, The volume ratio of ethyl acetate to the mixed solvent is 6:1, the stirring rate is 15rpm whe...

Embodiment 3

[0056] Preparation of Azlocillin Sodium Sterile Powder Injection:

[0057] Weigh 99.5 g of azlocillin sodium and 0.5 g of sodium benzoate prepared in Example 1 under aseptic conditions, place them in a solid powder mixer and mix them evenly, and the raw materials obtained are transferred to the aseptic preparation workshop for precise metering and subpackaging, each bottle Containing 0.5g of azlocillin sodium, stoppered and capped, the finished product is packaged for storage and sent for inspection.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to an azlocillin sodium compound. The structural formula of the azlocillin sodium compound is defined in the specification, and the X-ray powder diffraction spectrogram of the azlocillin sodium compound, which is obtained by measurement by using Cu-K alpha ray, is shown in the figure 1. The invention further provides a preparation method of the azlocillin sodium compound, a medicine composition containing the azlocillin sodium compound, and a preparation method of the medicine composition. The dosage forms of the azlocillin sodium compound are sterile powder injection and freeze-dried powder injection. The azlocillin sodium compound provided by the invention almost does not absorb moisture, is easy to store and has good storage stability and low impurity content; and therefore, medication safety is greatly improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an azlocillin sodium compound, a preparation method thereof, a pharmaceutical composition containing the azlocillin sodium compound and a preparation method of the pharmaceutical composition. Background technique [0002] Azlocillin sodium, English name: Azlocillin Sodium, CAS: 37091-65-9, molecular formula: C 20 h 22 N 5 NaO 6 S, chemical name (2S,5R,6R)-3,3-dimethyl-6-[[[[(2-oxo-1-imidazolidinyl)carbonyl]amino]phenylacetyl]amino]- 7-Oxo-4-thia-1-azabicyclo[3,2,0]heptane-2-carboxylic acid sodium salt. [0003] Azlocillin sodium is a penicillin antibiotic, the third-generation broad-spectrum semi-synthetic penicillin, suitable for the treatment of various infections caused by sensitive Gram-negative bacteria and positive bacteria, as well as Pseudomonas aeruginosa infection, including sepsis, meningitis, heart disease, etc. Endometritis, suppurative pleurisy, pe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D499/68C07D499/18A61K31/431A61P31/04
Inventor 闫晓晔
Owner 四川省惠达药业有限公司
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