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Amoxicillin sodium and sulbactam sodium for injection and preparation of freeze-dried injection thereof

A technology of amoxicillin sodium sulbactam sodium and amoxicillin sodium, applied in the field of separation and purification of amoxicillin sodium and sulbactam sodium, can solve the problem of not providing amoxicillin sodium sulbactam sodium freeze-dried powder injection and other issues to achieve the effect of avoiding sample loss, improving stability and high purity

Inactive Publication Date: 2008-12-17
海南华旗药业销售有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no report on using high-speed countercurrent chromatography for the separation and purification of amoxicillin sodium and sulbactam sodium in the prior art, and there is no report on the application of high-speed countercurrent chromatography to prepare amoxicillin sodium-sulbactam sodium freeze-dried powder injection

Method used

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  • Amoxicillin sodium and sulbactam sodium for injection and preparation of freeze-dried injection thereof
  • Amoxicillin sodium and sulbactam sodium for injection and preparation of freeze-dried injection thereof
  • Amoxicillin sodium and sulbactam sodium for injection and preparation of freeze-dried injection thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A semi-preparative high-speed countercurrent chromatograph is used, equipped with a constant flow pump, a 15ml injection valve, a polytetrafluoroethylene column with a column volume of 200ml, and a UV ultraviolet detector. Mix chloroform, methanol, water, and ethyl acetate with a volume ratio of 2:1:1.5:1 in a separatory funnel, shake well, and let stand to separate layers. Take the upper layer solution (upper phase) as the stationary phase. The lower layer solution (lower phase) is the mobile phase. After ultrasonic degassing, first fill the entire column with the stationary phase, then turn on the high-speed countercurrent chromatograph, adjust the host speed to 1500rpm, and pump the mobile phase into the chamber at a flow rate of 1.5ml / min. After the dynamic equilibrium of the whole system is established, the amoxicillin sodium raw material is dissolved in the lower phase, and the sample is injected through the injection valve, and then according to the ultraviolet sp...

Embodiment 2

[0034] Purify amoxicillin sodium and sulbactam sodium raw materials according to the high-speed countercurrent chromatography operation steps of Example 1, the volume ratio of chloroform, methanol, water, and ethyl acetate is 1: 0.8: 1.2: 1, and analyzed by HPLC , the purity of amoxicillin sodium is 99.3%, the number of effective theoretical plates is 1870, the purity of sulbactam sodium is 99.2%, and the number of effective theoretical plates is 2230.

[0035] Pass the purified amoxicillin sodium and sulbactam sodium raw materials through 80-mesh sieve respectively, pulverize them, then mix them uniformly in a weight ratio of 2:1, and pack them under the condition of grade 100 in a sterile room to obtain amoxicillin sodium and sulbactam for injection Tan sodium powder injection, 3.0g per bottle.

Embodiment 3

[0037] Purify amoxicillin sodium and sulbactam sodium raw materials according to the high-speed countercurrent chromatography operation steps of Example 1, the volume ratio of chloroform, methanol, water, and ethyl acetate is 3: 2.5: 2: 1, and analyzed by HPLC , the amoxicillin sodium is 99.0%, the effective theoretical plate number is 2042, the purity of sulbactam sodium is 99.4%, and the effective theoretical plate number is 1955.

[0038]Pass the purified amoxicillin sodium and sulbactam sodium raw materials through a 100-mesh sieve and pulverize them, then mix them evenly at a weight ratio of 2:1, and pack them under the condition of grade 100 in a sterile room to obtain amoxicillin sodium and sulbactam for injection Tan sodium powder injection, 1.5g per bottle.

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Abstract

The invention discloses a preparation method of amoxicillin sodium and sulbactam sodium for injection and a freeze-dried powder injection thereof as well as a separating and purifying method of the amoxicillin sodium and sulbactam sodium for injection. By adopting high speed countercurrent chromatography, the invention prepares trichloromethane, ethyl acetate, methanol and water to form a solvent system with an immobile phase and a mobile phase and separates and purifies amoxicillin sodium and sulbactam sodium to obtain the amoxicillin sodium and sulbactam sodium for injection; the purity of the obtained product can reach more than 98% and the prepared injection has improved stability.

Description

technical field [0001] The invention provides a separation and purification method of amoxicillin sodium and sulbactam sodium for injection, and a preparation method of amoxicillin sodium sulbactam sodium powder injection. It belongs to the field of medicine. Background technique [0002] Amoxicillin is a bactericidal broad-spectrum antibiotic, and sulbactam sodium is an irreversible broad-spectrum β-lactamase inhibitor, which can effectively inhibit the β-lactamase produced by drug-resistant bacteria. Many gram-positive and gram-negative bacteria clinically produce β-lactamase, which can make amoxicillin lose its antibacterial activity. Due to the presence of sulbactam sodium, amoxicillin can be protected from the destruction of β-lactamase, so that the bacteria that have been resistant to amoxicillin and produce β-lactamase are still sensitive to amoxicillin. This product is a bactericidal antibiotic, which can kill a variety of Gram-positive and Gram-negative bacteria i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K9/08A61P31/04
Inventor 邱民
Owner 海南华旗药业销售有限公司
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