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Mezlocillin sodium and sulbactam sodium for injection and freeze-dried injection preparation thereof

A technology for mezlocillin sodium and sulbactam sodium and mezlocillin sodium is applied in the field of separation and purification of mezlocillin sodium and sulbactam sodium, which can solve the problems of large side effects and low purity of active ingredients, and achieves high recovery rate , avoid sample loss, improve the effect of solubility

Inactive Publication Date: 2010-06-23
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

[0003] The currently used mezlocillin sodium sulbactam sodium compound preparation has problems such as low purity of active ingredients and large side effects caused by it
[0004] High-Speed ​​Countercurrent Chromatography (High-Speed ​​Countercurrent Chromatography) is a continuous and high-efficiency liquid-liquid partition chromatography separation technology. Because it uses a liquid stationary phase and does not require a solid support, it avoids sample loss, inactivation and denaturation caused by irreversible adsorption. etc., have developed very rapidly in the past 20 to 30 years, but there is no report on the use of high-speed countercurrent chromatography for the separation and purification of mezlocillin sodium and sulbactam sodium

Method used

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  • Mezlocillin sodium and sulbactam sodium for injection and freeze-dried injection preparation thereof
  • Mezlocillin sodium and sulbactam sodium for injection and freeze-dried injection preparation thereof
  • Mezlocillin sodium and sulbactam sodium for injection and freeze-dried injection preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 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 with a volume ratio of 1.2:1.8:1: methanol: water in a separatory funnel, shake it up and let it stand to separate layers, take its upper layer solution (upper phase) as the stationary phase, and the lower layer solution (lower phase) ) as 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, pump the mobile phase into the column at a flow rate of 1.5ml / min, and wait for the entire system to After the dynamic equilibrium is established, the mezlocillin sodium raw material is dissolved in the lower phase, and the sample is injected through the injection valve, and then according to the ultraviolet spe...

Embodiment 2

[0033] 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 with a volume ratio of 0.8:2.5:1 in a separatory funnel, shake it up and let it stand for layering, take its upper layer solution (upper phase) as the stationary phase, and the lower layer solution (lower phase) ) as 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 speed of the main engine to 2000rpm, and pump the mobile phase into it at a flow rate of 1.2ml / min, and wait until the entire system is established After dynamic equilibrium, dissolve the raw material of mezlocillin sodium in the lower phase, inject the sample through the injection valve, and then collect the part above 9% according to the ul...

Embodiment 3

[0037] Embodiment 3 (comparison)

[0038]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 with a volume ratio of 0.7:2.6:1 in a separatory funnel, shake it up and let it stand for layering, take its upper layer solution (upper phase) as the stationary phase, and the lower layer solution (lower phase) ) as 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 1000rpm, pump the mobile phase into the column at a flow rate of 1.5ml / min, and wait until the entire system After the dynamic equilibrium is established, the mezlocillin sodium raw material is dissolved in the lower phase, and the sample is injected through the injection valve, and then accord...

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Abstract

The invention provides a preparation method of mezlocillin sodium-sulbactam sodium for injection and the freeze-dried powder injection thereof as well as a separating and purifying method of the mezlocillin sodium and sulbactam sodium for injection. By adopting high speed countercurrent chromatography, the invention prepares trichloromethane, methanol and water to form a solvent system with an immobile phase and a mobile phase and separates and purifies mezlocillin sodium and sulbactam sodium to obtain the mezlocillin sodium and sulbactam sodium for injection; the purity of the obtained product can reach more than 99% and the prepared injection has improved stability.

Description

technical field [0001] The invention provides a separation and purification method of mezlocillin sodium and sulbactam sodium for injection, and a preparation method of mezlocillin sodium sulbactam sodium powder injection. It belongs to the field of medicine. Background technique [0002] Mezlocillin is a penicillin-like broad-spectrum antibiotic, which mainly plays a bactericidal effect by interfering with the synthesis of bacterial cell walls; sulbactam has no antibacterial activity against other bacteria except for Neisseriaceae and Acinetobacter, but sulbactam has no antibacterial activity against bacteria caused by Most important β-lactamases produced by β-lactam antibiotic-resistant strains have irreversible inhibitory effects. Sulbactam can prevent drug-resistant bacteria from destroying penicillins and cephalosporins, and sulbactam has obvious synergistic effects with penicillins and cephalosporins. [0003] Currently used mezlocillin sodium sulbactam sodium compou...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/43A61K31/431A61P31/04
Inventor 邱民
Owner 海南华旗药业销售有限公司
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