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A kind of refining method of ertapenem sodium

A technology for ertapenem sodium and a refining method, which is applied in the directions of organic chemistry and the like, can solve the problems that the color grade and heavy metal residue of ertapenem sodium products are difficult to reach qualified indicators, and achieve the effects of low cost and simple process

Active Publication Date: 2021-12-31
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The color grade and heavy metal residues of ertapenem sodium products prepared by existing methods are difficult to meet the qualified indicators, so it is of vital research significance to obtain pharmaceutical ertapenem sodium products with qualified color grades and heavy metal residues

Method used

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  • A kind of refining method of ertapenem sodium
  • A kind of refining method of ertapenem sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The refining of embodiment 1 ertapenem sodium

[0042] (1) Take 10.0 g of crude ertapenem sodium (color grade 7#, heavy metal 12.41 ppm), add it to a beaker filled with 300 mL of purified water pre-cooled to 0-5 °C, stir to dissolve evenly with a glass rod and set aside.

[0043] (2) Close the valve at the bottom of the alumina column, add the crude ertapenem sodium solution into the 1# alumina column in portions, and control the column temperature to 0-10°C. Open the valve at the bottom of the column, control the flow rate, and the material passing is completed in about 5±0.5h. The feed liquid of the first 2BV was tested to be free of Ertapenem sodium products, and the feed liquid was received from the third BV. Add 120mL of 4% sodium acetate solution (1000mL of purified water, add 40g of sodium acetate, and stir until the sodium acetate is completely dissolved. Carefully adjust the pH to 6.5-7.5 with glacial acetic acid. Cool to 0-10°C for later use) to elute. The e...

Embodiment 2

[0045] The refining of embodiment 2 ertapenem sodium

[0046] (1) Take 10.0g of crude ertapenem sodium (color grade 7#, heavy metal 12.41ppm), add it to a beaker filled with 200mL of purified water pre-cooled to 0-5°C, stir to dissolve evenly with a glass rod and set aside.

[0047] (2) Close the valve at the bottom of the alumina column, add the crude ertapenem sodium solution to the 1# alumina column in portions, and control the column temperature to 0-10°C. Open the valve at the bottom of the column, control the flow rate, and the material passing is completed in about 5±0.5h. The feed liquid of the first 2BV was tested to be free of Ertapenem sodium products, and the feed liquid was received from the third BV. Add 120mL of 4% sodium acetate solution to the alumina column for elution, and the elution rate is 1.5BV / h. After the elution was completed, the feed solutions were combined.

[0048] (3) The feed liquid uses n-butanol to adjust the water phase volume, and the vol...

Embodiment 3

[0049] The refining of embodiment 3 ertapenem sodium

[0050] (1) Take 10.0 g of crude ertapenem sodium (color grade 7#, heavy metal 12.41 ppm), add it to a beaker filled with 130 mL of purified water pre-cooled to 0-5 °C, stir to dissolve evenly with a glass rod and set aside.

[0051] (2) Close the valve at the bottom of the alumina column, add the crude ertapenem sodium solution to the 1# alumina column in portions, and control the column temperature to 0-10°C. Open the valve at the bottom of the column, control the flow rate, and the material passing is completed in about 5±0.5h. The feed liquid of the first 2BV was tested to be free of Ertapenem sodium products, and the feed liquid was received from the third BV. Add 120mL of 4% sodium acetate solution to the alumina column for elution, and the elution rate is 1.5BV / h. After the elution was completed, the feed solutions were combined.

[0052] (3) The feed liquid adjusts the water phase volume with n-butanol, and the v...

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Abstract

The invention discloses a refining method of ertapenem sodium and relates to the technical field of refining ertapenem sodium. The method comprises the following steps: (1) dissolving crude ertapenem sodium in water to prepare a crude ertapenem sodium solution; (2) adding the crude ertapenem sodium solution to an alumina column, and controlling the column temperature to 0 ‑10°C, receive the feed liquid, then add sodium acetate aqueous solution for desorption, after the desorption is completed, combine the feed liquid; (3) extract water from the feed liquid with n-butanol, adjust the volume of the feed liquid water phase, add organic solvent to the feed liquid water phase Crystallization to obtain the refined product of ertapenem sodium. The method has simple process and low cost, is mainly used for reducing the color level and heavy metal content of ertapenem sodium, and provides a refining method for unqualified ertapenem sodium.

Description

technical field [0001] The invention relates to the technical field of refining ertapenem sodium. Background technique [0002] Etapenem sodium (Etapenem sodium), the chemical name is (4R, 5S, 6S)-3-[[(3S, 5S)-5-[[(3-carboxyphenyl)carbamoyl]pyrrolidine-3 -yl]thio-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid sodium salt, structural formula: [0003] [0004] Ertapenem is a new type of broad-spectrum carbapenem antibiotic jointly developed by Merck and AstraZeneca. It was approved for clinical use in the United States and Europe in November 2001 and April 2002, respectively. In 2005, it was approved by Merck & Co. The company introduced into our country. Ertapenem has the characteristics of long-acting, strong antibacterial activity and low selectivity for bacterial resistance, and has obvious clinical advantages over other drugs. It is the first carbapenem drug approved by the FDA for community-acquired pneumonia. At the same time, i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D477/02C07D477/20
CPCC07D477/02C07D477/20
Inventor 黄学川魏青杰李世成徐永龙邱增会郝乐谢子龙
Owner 石药集团中诺药业(石家庄)有限公司