Method for directly preparing mycophenolate sodium from mycophenolic acid fermentation broth

A technology of sodium mycophenolate mofetil and fermentation liquid, which is applied in organic chemistry and other fields, can solve the problems of high production cost, serious environmental pollution, and large consumption of organic solvents, and achieve the effects of short operation time, low energy consumption and material consumption, and pollution reduction

Inactive Publication Date: 2012-07-04
福建和泉生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The above-mentioned method for preparing mycophenolic acid sodium by using mycophenolic acid has the following disadvantages: the raw material used in the above-mentioned process is mycophenolic acid powder, and the process of preparing mycophenolic acid powder from the mycophenolic acid fermentation liquid needs to consume a large amount of organic solvent; The preparation process from mycophenolic acid powder to sodium mycophenolate also needs to use a large amount of solvent, which leads to high production costs and serious environmental pollution

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Using 260L of fermentation filtrate with a mycophenolic acid concentration of 7.5g / L as the raw material, slowly add sodium hydroxide liquid while stirring to adjust the pH to 9.0, and continue stirring for 35 minutes, and then use a ceramic membrane with a pore size of 0.05um. The membrane flux is 35L / h·㎡, the operating pressure is 0.20Mpa, and the operating temperature is 30°C to remove large particles; The pressure is 5.0 bar, and the operating temperature is 25°C to remove impurities through the ultrafiltration membrane, and remove proteins, polysaccharides and color-forming substances. The ultrafiltration permeate is treated by nanofiltration with a composite membrane with a molecular weight cut-off of 300Da. Under the operating conditions of the nanofiltration membrane flux of 30 L / h·㎡, the operating pressure of 10.0 bar, and the operating temperature of 25 ° C, the nanofiltration Desalted, concentrated 3 times, and vacuum dried to obtain 1.98 kg of off-white myco...

Embodiment 2

[0040] Using 270L of fermentation broth containing mycophenolic acid with a concentration of 7.8g / L as the raw material, slowly add sodium hydroxide liquid while stirring to adjust the pH to 9.3, then continue stirring for 40 minutes, and then use a ceramic membrane with a pore size of 0.05um. The membrane flux is 35L / h·㎡, the operating pressure is 0.20Mpa, and the operating temperature is 35°C to remove large particles; The pressure is 5.0 bar, and the operating temperature is 30°C to remove impurities by ultrafiltration, remove proteins, polysaccharides and color-forming substances, etc. The ultrafiltration permeate is treated by nanofiltration with a composite membrane with a molecular weight cut-off of 300Da. Under the operating conditions of the nanofiltration membrane flux of 30 L / h·㎡, the operating pressure of 10.0 bar, and the operating temperature of 30 ° C, the nanofiltration Desalted, concentrated 4 times, and vacuum-dried at -0.08Mpa to obtain 2.12kg of off-white m...

Embodiment 3

[0042]Using 250L of fermentation broth containing mycophenolic acid with a concentration of 8.5g / L as raw material, slowly add sodium hydroxide liquid while stirring to adjust the pH to 8.5, and then continue stirring for 35 minutes, and then use a ceramic membrane with a pore size of 0.05um. The membrane flux is 40L / h·㎡, the operating pressure is 0.20Mpa, and the operating temperature is 30°C to remove large particles; The pressure is 5.0 bar, and the operating temperature is 35°C to remove impurities by ultrafiltration, and remove proteins, polysaccharides and color-forming substances. The ultrafiltration permeate is treated by nanofiltration with a composite membrane with a molecular weight cut-off of 500Da. Under the operating conditions of the nanofiltration membrane flux of 40 L / h·㎡, the operating pressure of 10.0 bar, and the operating temperature of 40 ° C, the nanofiltration Desalted, concentrated 3 times, and vacuum-dried at -0.09Mpa to obtain 2.12kg of off-white myc...

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Abstract

The invention provides a method for directly preparing mycophenolate sodium from mycophenolic acid fermentation broth. Soda is added into the mycophenolic acid fermentation broth, so that mycophenolate sodium liquor is produced, and after filtration and drying, mycophenolate sodium powder is prepared. The method directly prepares the mycophenolate sodium from the mycophenolic acid fermentation broth, the middle process in the preparation of the mycophenolate sodium powder is dispensed with, and organic solvent is not used, so that pollution is reduced and the production cost is saved, so the industrial production is facilitated.

Description

technical field [0001] The invention relates to a method for directly producing and preparing sodium mycophenolate from a mycophenolic acid fermentation liquid. Background technique [0002] In the late 1960s, Eli lilly disclosed the inhibitory effect of mycophenolic acid sodium salt (MPS) on the growth of malignant tumor cells in warm-blooded animals. Now Novartis has developed an enteric-coated formulation of mycophenolate sodium called Myfortic ? . [0003] Mycophenolate sodium (Mycophenolate sodium, MPS), the molecular formula is Cl7Hl9Na06, and the molecular weight is 342.32. The latest existing research shows that: mycophenolate mofetil works by inhibiting inosine monophosphate dehydrogenase, MPS has better tolerance, and has bioavailability and stability worthy of attention. The small MMF makes it more acceptable to patients and improves patient compliance. Gastrointestinal tolerance is an important issue for immunosuppressive therapy because it can affect the vi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D307/88
Inventor 杨斌陈灼湖
Owner 福建和泉生物科技有限公司
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