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Purification method of pravastiatin sodium

A technology of pravastatin sodium and purification method, which is applied in chemical instruments and methods, organic chemistry, preparation of organic compounds, etc., and can solve problems such as not being able to be removed well, endangering the health of production operators, and low concentration

Inactive Publication Date: 2004-08-04
SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] The existing method of purifying pravastatin sodium from fermented liquid all is to adopt organic solvent to directly extract fermented liquid, and the selected organic solvent is generally the ester of lower alcohols such as ethyl acetate, butyl acetate, this method is in Two problems are faced in industrialized production: first, because there are a large amount of impurities similar to pravastatin sodium in chemical structure in the pravastatin sodium fermented liquid, these impurities cannot be removed well by the extraction process of organic solvent, Thereby the purity of pravastatin sodium in the ester phase is relatively low; Secondly, because the concentration of pravastatin sodium in fermented liquid is generally very low, only 0.5-5g / L, when purifying pravastatin sodium with organic solvent extraction method A large amount of solvent (generally 1-2.5 times that of the fermentation broth) is required, which will cause serious environmental pollution and three wastes in the process of industrialized large-scale production, and endanger the health of production operators

Method used

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  • Purification method of pravastiatin sodium

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Experimental program
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Embodiment 1

[0019] Take 2.5 liters of the microbial transformation solution containing pravastatin sodium and detect by HPLC, the content of pravastatin sodium is 1.5 g / L (total 3.75 g), the HPLC purity is 65%, and the pH of the transformation solution is adjusted by sodium hydroxide 7.0, then add 20 grams of diatomaceous earth and stir for 15 minutes, then filter on a Buchner funnel lined with filter paper and collect the filtrate.

[0020] The filtrate obtained in the previous step was loaded onto a chromatography column containing 500 ml of XAD-16HP resin, and the sample flow rate was 0.5 bed volume per hour. After loading the sample, wash 2 volumes of resin with water at a flow rate of 1 column bed volume per hour. After washing, use 700 ml of methanol as the eluent, and the eluent flow rate is 1 column bed volume per hour. Collect the fraction containing pravastatin sodium and mix. The collected liquid was tested by HPLC, and the content of pravastatin sodium was 3.5 g (yield 93.3%) and ...

Embodiment 2

[0022] Take 15 liters of the microbial transformation solution containing pravastatin sodium and detect it by HPLC. The content of pravastatin sodium is 1.25 g / L (18.75 g in total), and the purity determined by HPLC is 72%. The transformation solution is adjusted by sodium hydroxide The pH is 7.2, then 80 grams of perlite is added and stirred for 15 minutes, and then filtered on a Buchner funnel with filter paper to collect the filtrate.

[0023] The filtrate obtained in the previous step was loaded onto a chromatography column containing 2.5 liters of HP-20 resin at a flow rate of 0.5 bed volume per hour. After loading the sample, wash 2 volumes of resin with water at a flow rate of 1 column bed volume per hour. After washing, use 4 liters of ethanol as the eluent, and the flow rate of the eluent is 1 column bed volume per hour. Collect the fractions containing pravastatin sodium and mix them. The collected solution was tested by HPLC, and the content of pravastatin sodium was 17...

Embodiment 3

[0025] Take 5 liters of the microbial transformation solution containing pravastatin sodium and detect it by HPLC. The content of pravastatin sodium is 1.25 g / L (total 6.25 g), and the purity determined by HPLC is 72%. The transformation solution is adjusted by sodium hydroxide The pH is 7.2, then 80 grams of perlite is added and stirred for 15 minutes, and then filtered on a Buchner funnel with filter paper to collect the filtrate.

[0026] Put about 5 liters of the filtrate obtained in the previous step in a 10 liter stainless steel bucket, add 1000ml XAD-16 resin, stir at room temperature for 120 minutes, then pour the filtrate containing the resin on a Buchner funnel covered with filter paper for filtration, and discard the obtained filtrate To remove, the resin is loaded into the chromatography column, washed with 1000 ml of water, and eluted with 1600 ml of ethanol after washing, to collect the fraction containing pravastatin sodium. The collected solution was tested by HPLC...

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Abstract

A process for purifying pravastiation sodium includes such steps as making the fermented liquid containing pravastatin sodium in contact with adsorptive resin, separating them from each other, washing the adsorptive resin with water, C1-4 alcohol, C1-4 ketone, or their mixture, making the eluted liquid in contact with the washed adsorptive resin, and collecting the eluted liquid containing the purified pravastation sodium. Its advantages are high purity of product and less environmental pollution.

Description

Technical field [0001] The invention relates to a method for purifying pravastatin sodium from fermentation broth. Background technique [0002] Cardiovascular disease is one of the main causes of human death, and its morbidity and mortality are the highest among all diseases. Studies have confirmed that the main pathological basis of cardiovascular disease is atherosclerosis. Hyperlipidemia is the primary factor leading to atherosclerosis. Therefore, the importance of lipid-lowering drugs in reducing the incidence of cardiovascular disease has attracted people's attention. [0003] Among the many types of lipid-lowering drugs, a class of hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, namely statins, was developed in the early 1980s. Due to their high cholesterol lowering efficiency, they inhibit The high selectivity and low toxicity of cholesterol synthesis have become the most active and rapidly developing field in the development of cardiovascular drugs. Such...

Claims

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Application Information

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IPC IPC(8): C07C67/56C07C69/22C07C69/732
Inventor 梅民权季晓铭高霄梁李严姚勇卓忠浩
Owner SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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