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Method for refining prednisone acetate based on resting cell transformation

A technology of resting cell transformation, prednisone acetate, applied in microorganism-based methods, biochemical equipment and methods, organic chemistry, etc., can solve problems such as unfavorable product quality, inability to optimize purification steps to remove, improve, etc. The effect of product quality

Active Publication Date: 2022-07-29
HUAZHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In the process, the substrate is usually directly fed into the fermented liquid of Arthrobacter and transformed, but the inventor finds in the production process that there is always a content in the refined product exceeding 0.1% impurity peak (located in prednisone acetate About twice the peak time), and cannot be removed by optimizing the purification steps, which is seriously unfavorable for the further improvement of product quality

Method used

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  • Method for refining prednisone acetate based on resting cell transformation
  • Method for refining prednisone acetate based on resting cell transformation
  • Method for refining prednisone acetate based on resting cell transformation

Examples

Experimental program
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Effect test

Embodiment 1

[0031] The preparation process of prednisone acetate is as follows:

[0032] (1) Cultivation of slant strains: take Arthrobacter preservation strains, inoculate the slant to expand the culture, the culture temperature is 33°C, and the culture period is 3 days.

[0033] (2) Expanded culture: transfer the above-mentioned slant strains into a sterilized liquid medium (glucose 1.0%, corn steep liquor 1.2%, yeast extract 0.5%, potassium dihydrogen phosphate 0.3%) in a shaker flask, and control the temperature for 30 ℃ ℃, 180rpm for bacterial expansion.

[0034] (3) Resting cell transformation: isolate the bacteria and add it to the same volume of sterile water as the fermentation broth (boil sterilization); first add 0.1 g / L trehalose, mix well and incubate for 30 minutes; then add 4% Ethanol and 30 g / L cortisone acetate were used for transformation, and the transformation conditions were: 33° C., 200 rpm, and the transformation period was 2 d.

[0035] (4) Extraction of predniso...

Embodiment 2

[0039] The difference from Example 1 is: in step (1), the culture temperature is 30° C., and the cycle is 3 days; in step (2), the temperature is 33° C. and 200 rpm; in step (3), the amount of trehalolipid added is 0.12 g / L, the addition amount of ethanol is 3%, and the addition amount of cortisone acetate is 25g / L.

[0040] HPLC test results are: prednisone 0.112, prednisone acetate 98.499, cortisone acetate 1.276, unknown maximum error 0.041.

Embodiment 3

[0042] The difference from Example 1 is: in step (3), the added amount of trehalolipid is 0.07 g / L, the added amount of ethanol is 4%, and the added amount of cortisone acetate is 35 g / L.

[0043] HPLC detection results are: prednisone 0.116, prednisone acetate 98.249, cortisone acetate 1.329, unknown maximum error 0.053.

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Abstract

The invention discloses a method for refining prednisone acetate based on resting cell transformation. The method comprises the following steps: preparing a resting cell system of arthrobacter; adding a surfactant into the resting cell system for incubation, and then adding cortisone acetate and a cosolvent for conversion; and extracting and purifying prednisone acetate. According to the method, impurities, especially unknown maximum single impurities, in the product can be effectively removed, the product quality is effectively improved, the operation steps are simple, the cost is low, and industrial production is facilitated.

Description

technical field [0001] The invention belongs to the technical field of preparation of prednisone acetate, and particularly relates to a method for refining prednisone acetate based on the transformation of resting cells. Background technique [0002] Prednisone acetate is a corticosteroid drug that acts on glucose metabolism and reduces the pathological response of body tissues to damaging stimuli. It is used for adrenal insufficiency, active rheumatism, rheumatoid arthritis, erythema Collagen diseases such as lupus, severe bronchial asthma, severe dermatitis and other allergic diseases and acute leukemia are also used for the comprehensive treatment of certain infections. [0003] At present, the main production process of prednisone acetate is to use cortisone acetate as a substrate, and to utilize Arthrobacter to carry out fermentation and dehydrogenation preparation, and its technical route is as follows: [0004] [0005] In this technological process, usually the s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12P33/02C07J5/00C12R1/06
CPCC12P33/02C07J5/0015
Inventor 徐明琴罗浩冯蕾王霜孙琼芳廖俊邹瑾霜
Owner HUAZHONG PHARMA
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