Cefuroxime sodium crystal compound and composition powder injection thereof

A technology of cefuroxime sodium and cefuroxime acid, which is applied in the field of cefuroxime sodium new crystal compound and its composition powder injection, can solve the problem of complex production process of cefuroxime sodium, poor water solubility of cefuroxime sodium, and clinical application Inconvenient and other problems, to achieve the effect of fast dissolution, high solubility, and convenient clinical use

Inactive Publication Date: 2014-04-09
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commercially available cefuroxime sodium for injection has poor water solubility, low solubility in water, slow dissolution rate, and inconvenient clinical use
The production process of commercially available cefuroxime sodium for injection is relatively complicated and the production cost is high

Method used

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  • Cefuroxime sodium crystal compound and composition powder injection thereof
  • Cefuroxime sodium crystal compound and composition powder injection thereof
  • Cefuroxime sodium crystal compound and composition powder injection thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] 1. Prescription:

[0040] Cefuroxime Acid (95%) 1052g

[0041] Sodium bicarbonate for injection (98%) 202g

[0042] Water for injection 1578ml

[0043] 2. Production process:

[0044] According to aseptic operation requirements, 202g sodium bicarbonate was dissolved in 1000ml water, 1052g cefuroxime acid was dissolved in 578ml water to form sodium bicarbonate solution and cefuroxime acid solution, and sodium bicarbonate solution was slowly added in the cefuroxime acid solution (above Control the water temperature of the two solutions at 5-8°C), and keep stirring for 30 minutes. After the reaction is complete, add 0.1% activated carbon and stir to adjust the pH to 6.5-7.5. After filtering through 0.45 μm and 0.22 μm filter membranes, put them into a large freeze-drying plate (Liquid level height 3-4cm), immediately sent to a vacuum freeze-drying box to freeze-dry, first lower the temperature of the plate layer to below -40°C, and then send it into the product, within ...

Embodiment 2

[0051] 1. Prescription

[0052] Cefuroxime Acid (95%) 1052g

[0053] Sodium bicarbonate for injection (98%) 202g

[0054] Water for injection 1578ml

[0055] 2. Production process:

[0056] According to aseptic operation requirements, 202g sodium bicarbonate was dissolved in 1000ml water, 1052g cefuroxime acid was dissolved in 578ml water to form sodium bicarbonate solution and cefuroxime acid solution, and sodium bicarbonate solution was slowly added in the cefuroxime acid solution (above Control the water temperature of the two solutions at 5-8°C), and keep stirring for 30 minutes. After the reaction is complete, add 0.1% activated carbon and stir to adjust the pH to 6.5-7.5. After filtering through 0.45 μm and 0.22 μm filter membranes, put them into a large freeze-drying plate (Liquid level height 3-4cm), immediately sent to a vacuum freeze-drying box for freeze-drying, first lowered the temperature of the plate layer to below -45°C, and then sent it to the product, with...

Embodiment 3

[0059] Preparation of cefuroxime sodium composition powder injection: get 750g of cefuroxime sodium amorphous compound sterile powder prepared in Example 1, mannitol sterile powder 6g, mix well, according to specifications 2.5g / bottle (according to cefuroxime sodium Sodium meter), aseptically divided into antibiotic glass bottles, stoppered and capped, and the finished product is packaged and put into storage and sent for inspection.

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PUM

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Abstract

The invention provides a cefuroxime sodium crystal compound and a composition powder injection thereof, and relates to the fields of medicament and preparation method technology of medicament, and cefuroxime sodium crystal compound composition belongs to a new crystal type-amorphous. The crystal form of cefuroxime sodium is amorphous and the preparation method thereof is as follows: reacting cefuroxime acid with sodium bicarbonate to obtain a solution and adding active carbon to discolor it, and then quick-freezing for 2 hours at -40-50 DEG C after sterile filtration using a filter membrane with aperture of 0.45 mu m and 0.22 mu m, followed by vacuum drying (drying temperature below 15 DEG C, vacuum degree 10-20 Pa, time 30-35 hours). The components of the cefuroxime sodium composition powder injection are: 95-100 parts of cefuroxime sodium crystal compound and 5-10 parts of mannitol. The component is packaged into bottles of 0.25 g, 0.75 g, 1.5 g, 2.25 g or 2.5 g as power injection preparation for clinic injection. The cefuroxime sodium crystal compound has the advantages of a simple preparation method, good stability, high solubility and dissolving quickly in water, and is convenient for clinical use.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a new crystal compound of cefuroxime sodium and its composition powder injection. Background technique: [0002] The chemical name of cefuroxime sodium is: (6R,7R)-7-[2-furyl(methoxyimino)acetamido]-3-carbamoyloxymethyl-8-oxo-5-thia- 1-Azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Molecular formula: C 16 h 15 N 4 NaO 8 S, molecular weight: 446.37. Its chemical structural formula is: [0003] [0004] Cefuroxime sodium is a second-generation cephalosporin with broad antibacterial spectrum and strong antibacterial activity. It has good antibacterial activity against both Gram-positive and Gram-negative microorganisms. It is highly stable against β-lactamase and has no side effects. Small. The crystal form of cefuroxime sodium for injection currently available on the market belongs to the triclinic crystal system, and th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/04A61K31/546A61K9/14A61K9/19A61P31/04
CPCC07D501/34A61K9/19C07D501/04A61K9/1623A61K9/1682A61K31/546A61P31/04
Inventor 汪六一汪金灿李彪吴函峰刘海燕
Owner HAINAN WEI KANG PHARMA QIANSHAN
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