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Medicinal composition consisting of ceftriaxone sodium and sulbactam sodium and preparation method thereof

A technology of ceftriaxone sodium and sulbactam sodium, which is applied in medical formulations, active ingredients of heterocyclic compounds, medical preparations of non-active ingredients, etc., and can solve problems affecting the use of ceftriaxone sodium and sulbactam sodium , to achieve stable content, eliminate hidden dangers of medical accidents, and achieve remarkable clinical efficacy

Active Publication Date: 2012-05-23
XIANGBEI WELMAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The above problems have seriously affected the clinical use of the traditional compound preparation of ceftriaxone sodium and sulbactam sodium, and have not been fundamentally and effectively solved so far.

Method used

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  • Medicinal composition consisting of ceftriaxone sodium and sulbactam sodium and preparation method thereof
  • Medicinal composition consisting of ceftriaxone sodium and sulbactam sodium and preparation method thereof
  • Medicinal composition consisting of ceftriaxone sodium and sulbactam sodium and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0025]Under sterile and light-proof conditions, under sterile nitrogen (or other sterile inert gas) airflow, add 100g of ceftriaxone sodium (converted into anhydrous ceftriaxone sodium 100g), 50g of sulbactam sodium and 25g of Put mannitol into 90ml of 70% ethanol solution in a non-metallic container that has been cooled to below 10°C after pretreatment, stir to make it dissolve completely, drop in 0.1mol / L sodium bicarbonate aqueous solution pH value adjuster, adjust the pH value of the solution When the pH value reaches 6.5, filter aseptically, put it into a lyophilizer filled with inert gas for pre-freezing (-48~-20°C), decompress, sublimate, and dry to make a lyophilized eutectic powder raw material drug, and then Bacteria is packed into 91 bottles of powder injections to obtain 150 grams of eutectic bulk drug of the pharmaceutical composition of the present invention.

Embodiment 2

[0027] Under sterile and light-proof conditions, under sterile nitrogen flow, add 100g of ceftriaxone sodium (calculated as 100g of anhydrous ceftriaxone sodium), 45g of sulbactam sodium and 20g of mannitol into the pretreated It has been cooled to 80ml of 70% ethanol solution in a non-metallic container below 10°C, stir to dissolve completely, drop in 0.1mol / L sodium bicarbonate aqueous solution pH adjuster, adjust the pH of the solution to 6.3, and filter aseptically , put into a lyophilizer full of inert gas to pre-freeze (-48~-20 ℃), decompress, sublime, dry, and make lyophilized eutectic powder, which obtains the lyophilized powder of the pharmaceutical composition of the present invention. Preparation 94 bottles.

Embodiment 3

[0029] Under sterile and light-proof conditions, under sterile nitrogen flow, add 100g of ceftriaxone sodium (calculated as 100g of anhydrous ceftriaxone sodium), 50g of sulbactam sodium and 20g of lactose into the pretreated Cool to 90ml of 70% ethanol solution in a non-metallic container below 10°C, stir to make it dissolve completely, add dropwise 0.1mol / L sodium bicarbonate aqueous solution pH value regulator, adjust the pH value of the solution to 6.0, sterile filter, Put it into a lyophilizer filled with inert gas to pre-freeze (-48~-20°C), decompress, sublime, and dry to make lyophilized co-crystal powder, and then obtain the lyophilized preparation of the pharmaceutical composition of the present invention 93 bottles.

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PUM

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Abstract

The invention aims to provide a medicinal composition consisting of ceftriaxone sodium and sulbactam sodium, which does not have any sensitization effect, has high stability and is efficient, and a preparation method thereof. The weight ratio of the ceftriaxone sodium to the sulbactam sodium to a stable conditioning agent component in the medicinal composition is (1-100):(0.25-100):(0.0005-9). The medicinal composition provided by the invention is in a good crystal form, and has stable and controllable quality at the temperature between 20 DEG C below zero and 60 DEG C in production and transportation processes and a good curative effect; and an effective period can be up to 36 months. During clinical administration, the medicinal composition is dissolved and diluted through the conventional transfusion, the ceftriaxone sodium and the sulbactam sodium in the medicinal composition have stable content, high solubility and indecomposability, insoluble crystals and sensitized high polymers are not produced, the influences of temperature and illumination are small, high stability is achieved, and the effective period is 36 months, so that a better curative effect is achieved. A preparation method of the medicinal composition provided by the invention is scientific and reasonable, is convenient to operate, and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition with stable content of active ingredients. Specifically, it relates to a pharmaceutical composition with good crystal form, about 6-60°C, 5ml of water for injection, 2 grams of sterile ceftriaxone sodium / sulbactam sodium, which can be completely dissolved after shaking within 5 minutes, and It relates to a β-containing drug that can be diluted in any ratio with all clinical routine infusions, and the content of ceftriaxone sodium can be kept stable, and it can be dissolved quickly, without crystals and degradation products, and not affected by temperature. The pharmaceutical composition of lactamase inhibitors sulbactam sodium and ceftriaxone sodium has a validity period of 36 months. Background technique [0002] Ceftriaxone sodium is a semi-synthetic cephalosporin antibiotic with broad antibacterial spectrum and few side effects, and is widely used in clinic. In the treatment of infectious disea...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K31/43A61K47/02A61K47/18A61K47/12A61K9/19A61P31/04
Inventor 孙明杰王霆陈优生
Owner XIANGBEI WELMAN PHARMA CO LTD
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