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Method for purifying and decolorizing mycophenolate mofetil

A mycophenolate morphinate and decolorization technology, applied in the direction of organic chemistry, can solve the problems of different detection conditions, product quality impact, sample yellowing, etc., and achieve the effect of high product purity, high yield and simple process

Active Publication Date: 2014-12-31
FUJIAN KERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a result, the detection conditions of vitamin C and mycophenolate mofetil are different, and if the mycophenolate mofetil containing residual vitamin C is left for a period of time, the sample will turn yellow, which will affect the quality of the final product. certain influence

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A method for purifying and decolorizing mycophenolate morphinate, comprising the following steps:

[0028] (1) Take by weighing the reaction product crude product that contains 1000g containing mycophenolate mofetil, dissolve with mixed solvent 6000ml; Described mixed solvent is normal hexane-ethyl acetate, and the volume ratio of described mixed solvent is normal hexane:ethyl acetate Esters = 10:90.

[0029] (2) The decolorization medium is installed in a decolorization device with a height to inner diameter ratio of 8:1, and a decolorization device with a degreased cotton filter layer at the bottom; The weight ratio of the crude reaction product is 1:3.

[0030] (3) After passing the mixed solvent obtained in (1) through the decolorization device obtained in (2), collect the colorless permeate, and then rinse the silica gel with 1 times the volume of the mixed solvent of the decolorization device, Collect the colorless permeate and combine the colorless permeate.

...

Embodiment 2

[0035] This part differs from Embodiment 1 in that:

[0036] (1) The mixed solvent is cyclohexane-ethyl acetate, and the volume ratio of the mixed solvent is cyclohexane:ethyl acetate=40:60;

[0037] (2) The decolorization medium is installed in a decolorization device with a height to inner diameter ratio of 3:1, and a decolorization device with a degreased cotton filter layer at the bottom; the decolorization medium is diatomaceous earth, and the decolorization medium and the reaction product The weight ratio of the crude product is 1:10.

[0038] (3) rinse the diatomite with the mixed solvent of 2 times the volume of the decolorizing device,

[0039] (6) Rinse 4 volumes of the decolorization device with acetone;

[0040] The HPLC detection purity was 99.5%, and the product yield was 90.2%.

Embodiment 3

[0042] This part differs from Embodiment 1 in that:

[0043] (1) The mixed solvent is petroleum ether-ethyl acetate, and the volume ratio of the mixed solvent is petroleum ether:ethyl acetate=30:70;

[0044] (2) The decolorization medium is installed in a decolorization device with a height to inner diameter ratio of 5:1, and a decolorization device with a degreased cotton filter layer at the bottom; the decolorization medium is alumina, and the decolorization medium and the crude product of the reaction product The weight ratio is 1:6.

[0045] (3) rinse the alumina with the mixed solvent of 1.5 times the volume of the decolorizing device;

[0046] The HPLC detection purity was 99.7%, and the product yield was 93.2%.

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PUM

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Abstract

The invention provides a method for purifying and decolorizing mycophenolate mofetil. The method for purifying and decolorizing mycophenolate mofetil comprises the following steps of dissolving mycophenolate mofetil reaction raw products by utilizing a mixed solvent; carrying out continuous decolorizing and purifying by enabling the solution to pass through a device containing a decolorizing medium; eluting collected liquid, removing residual mycophenolic acid, dewatering, concentrating and crystallizing to obtain purified and decolorized mycophenolate mofetil; and flushing 3-4 volumes of the device containing the decolorizing medium by utilizing acetone, and flushing two volumes by utilizing the mixed solvent. According to the method for purifying and decolorizing mycophenolate mofetil, disclosed by the invention, the process is simple, the industrial continuous production can be carried out, the yield is high, the product purity is high, and the prepared products are white samples so that problems of purity and appearance color of the products are solved.

Description

【Technical field】 [0001] The invention specifically relates to a method for purifying and decolorizing mycophenolate morphinate. 【Background technique】 [0002] In 1896, Gosio discovered mycophenolic acid (MPA) from the culture solution of Penicillium. The early research of MPA mainly focused on its antibacterial and antifungal aspects, and then found its antiviral, antitumor and immunosuppressive effects. With the development of medicine, Allison, Giblett et al speculated and proved that the proliferation of lymphocytes mainly depends on the classic synthesis pathway of purine, and thus found that MPA specifically inhibits the effect of T and B lymphocytes, and quickly entered the experimental anti-transplant rejection reaction Research. [0003] Mycophenolate Mofetil (Mycophenolate Mofetil, MMF, Mycophenolate Mofetil) is a more bioavailable MPA compound discovered in 1990. In May 1995, MMF was approved by the FDA to be used in the treatment of kidney transplantation. Ph...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D307/88
Inventor 乐占线王德森郑卫黄洪祥郑军荣连云阳薛光汉
Owner FUJIAN KERUI PHARMA