Ertapenem separation and purification method

A purification method and purity technology, applied in the field of ertapenem purification, can solve the problems of unfavorable production scale-up, acid and alkali resistance, small particle size, etc., and achieve the effect of long service life, less time-consuming process and easy regeneration

Inactive Publication Date: 2010-09-22
NANJING UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are few literature reports on the purification of ertapenem, and column chromatography is the main method, that is, silica gel-bonded C8 is used as the separation carrier, and the system of buffer salt and acetonitrile is used as the eluent for separation and purification. The particle size of the silica gel C8 separation carrier used in this method is small, the cost is high, and it is not resistant to acid and alkali, which is not conducive to production scale-up

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Separation and purification conditions: pump: BT-100 constant flow pump, chromatography column: 200mm×10mm (I.D.), sample volume: 0.1g, eluent: 0.02mol / L phosphate buffer (pH7.0)- Acetonitrile (95:5), flow rate: 0.5ml / min. In terms of column volume, collect the effluent from the 4th to 6th column volume after loading the sample, and the effluent is post-processed to purify the product of ertapenem, with a yield of 62.9% and a purity of about 98.7% by HPLC .

Embodiment 2

[0036] Separation and purification conditions: pump, chromatographic column and sample loading are the same as in Example 1, eluent: A is phosphate buffer (pH7.0)-methanol (95:5) of 0.2mol / L, and B is 0.2mol / L of phosphate buffer (pH7.0)-methanol (60:40), where A was eluted for 3 column volumes and then B was used for elution of 4 column volumes, flow rate: 1.0ml / min. Calculated by column volume, the effluent from the 2nd to 4th column volumes of eluent B was collected, and the effluent was post-processed to purify the product of deltapenem, with a yield of 61.0%, and its purity was about 99.1% by HPLC %.

Embodiment 3

[0038] Separation and purification conditions: pump: BT-100 constant flow pump, chromatography column: 300mm×16mm (I.D.), sample volume: 1g, eluent: 0.1mol / L phosphate buffer (pH7.0)-acetonitrile (95:5), flow rate: 2.0ml / min. Calculated by column volume, collect the effluent of the 4th to 6th column volume after loading the sample, and the effluent is post-processed to purify the product of ertapenem, with a yield of 76.1%, and its purity is about 98.1% by HPLC .

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Abstract

The invention relates to an ertapenem purification method, which comprises the following steps: dissolving a crude product of ertapenem by water; using a chromatographic column adopting a porous polystyrene copolymer resin as a separation filler to carry out adsorption; carrying out eluting by using phosphate buffers with different organic phase ratios; and carrying out post treatment on the obtained eluent to obtain an ertapenem purified product. The method has simple operation and high product purity and yield and is suitable for industrial products.

Description

technical field [0001] The invention relates to a method for purifying ertapenem, in particular to a technique for purifying ertapenem by using a porous polystyrene copolymer resin. Background technique [0002] Ertapenem (ertapenem, MK-0826, L-749,345, trade name INVANZTM) is a new type of broad-spectrum carbapenem antibiotic recently developed by Merck & Co. of the United States. This product was launched in the United States and Europe in November 2001 and April 2002 respectively. It is the only I-β-methyl carbapenem antibiotic for parenteral administration. It has a wide range of antibacterial activities, including Gram-positive and Negative aerobic and anaerobic bacteria. [0003] Ertapenem is often mixed with various impurities during its production process, so the purification of ertapenem is very important in its production process. At present, there are few literature reports on the purification of ertapenem, and the method of column chromatography is mainly used,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D205/12B01D15/08A61P31/04
Inventor 刘晓宁魏荣卿方硕
Owner NANJING UNIV OF TECH
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