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Preparation method of prednisone acetate

A technology of prednisone acetate and seeds, applied in the field of medicine and chemical industry, can solve the problems such as insufficient conversion stability and insufficient stability of substrate dosage, and achieves suitable for large-scale industrial production, high production efficiency and high yield. Effect

Inactive Publication Date: 2021-04-06
HUAZHONG PHARMA
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Problems solved by technology

[0005] At present, Chinese patent CN108588163A of prednisone acetate has reported that Arthrobacter CPCC 140451 is used as the transformation strain to convert cortisone acetate into prednisone acetate. The substrate consumption is 5% to 8%, which is not too high; the HPLC conversion rate is 94%, the conversion time is 24-48 hours, and the stability is insufficient; after refining, the weight yield reaches 79-82%, and the yield is considerable
However, it has certain deficiencies in substrate dosage and transformation stability.

Method used

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  • Preparation method of prednisone acetate

Examples

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Effect test

example 1

[0025] The present invention proposes a kind of production fermentation technique of prednisone acetate, comprises the steps:

[0026] (1) Production of the slant of the strain: the composition of the slant medium is 2.0% agar, 1.5% glucose, 2.0% yeast extract powder, pH=6.9-7.6, and the balance is tap water. The culture medium is sterilized by high-pressure steam at 115-125°C for 15-25 minutes, cultured at a constant temperature at 28-33°C for 3-5 days, and stored at 2-8°C until use, and the preservation time does not exceed 45 days.

[0027] (2) Production of 10L of seed medium and 15L of fermentation medium: the components of the seed medium and fermentation medium are glucose 1.2%, corn steep liquor 0.8%, yeast extract powder 0.5%, potassium dihydrogen phosphate 0.2%, pH=6.5 ~7.2, the balance is tap water. The culture medium was sterilized by high-pressure steam at 115-125°C for 15-25 minutes.

[0028] (3) Seed liquid culture: Arthrobacter simplex on the slant of a 250ml...

example 2

[0032] Compared with Example 1, this example is mainly enlarged gradually in scale, and each operation process is the same as that of Example 1, and will not be repeated here. The difference is: by the method in example 1, the Arthrobacter simplex of 2 250ml eggplant bottle slopes is eluted and transferred to 20L seed culture medium (50L fermenter), cultivated for 12.3 hours; wherein 15L seed liquid is transferred to 75L In the fermentation medium (150L fermenter), cultivated for 6.2 hours; add methanol, 9.93kg substrate, soybean oil successively in the same proportion according to the operation of Example 1, adjust parameters, and transform for 32.6 hours; its HPLC conversion rate 96.32%, substrate residue 1.91%, the solid was collected by centrifugation, and 8.23kg of prednisone acetate finished product was obtained through downstream extraction, decolorization, refining, drying and other operations, with a weight yield of 82.88%. The product quality was tested in accordance ...

example 3

[0034] Compared with Example 1, this example is mainly enlarged gradually in scale, and each operation process is the same as that of Example 1, and will not be repeated here. The Arthrobacter simplex of 2 250ml eggplant bottle slopes is eluted by the method in example 1 and transfers in 20L seed medium (50L fermenter), cultivates 11.8 hours; Wherein 15L seed liquid is transferred into 75L fermentation medium (150L Fermentation tank), cultivated for 6.5 hours; add methanol, 10.68kg substrate, soybean oil successively in the same proportion according to the example 1 operation, adjust parameters, convert 34.8 hours, HPLC conversion rate 96.03%, substrate residue 2.05%, centrifuge to collect solid , 8.81 kg of prednisone acetate finished product was obtained through downstream extraction, decolorization, refining, drying and other operations, with a weight yield of 82.49%, and the product quality was tested in accordance with the "Chinese Pharmacopoeia" (2020 edition).

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Abstract

The invention discloses a preparation method of prednisone acetate, and the method comprises the following steps: adding a hydrophilic organic solvent into Arthrobacter simplex fermentation broth, and adding 8-12% of prednisone acetate micropowder; finally, adding a lipophilic organic solvent for fermentation reaction; and after the fermentation reaction is finished, filtering or centrifuging the product, performing separating, decolorizing and crystallizing to obtain prednisone acetate. The quality of the product prepared by the preparation method is equivalent to that of the product in the prior art, but the yield is slightly higher, the single-batch yield is higher, the production efficiency is higher, and the preparation method is more suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine and chemical industry, and in particular relates to a preparation method of prednisone acetate. Background technique [0002] Prednisone Acetate (PrednisoneAcetate 17a, 21-dihydroxypregna-1, 4-diene-3, 11, 20-triketone-21 acetate, CAS: 125-10-0) is white or almost white crystalline Powder, odorless, bitter taste; easily soluble in chloroform, slightly soluble in acetone, slightly soluble in ethanol or ethyl acetate, insoluble in water, specific rotation +183°~+190°. Its chemical structural formula is as follows: [0003] [0004] Prednisone acetate is an adrenal cortex hormone drug, which has the effects of affecting glucose metabolism, anti-inflammation, anti-allergy, anti-drug, and anti-malignant lymphoid tissue diseases. For adrenal insufficiency, severe bronchial asthma, dermatitis and other allergic diseases. [0005] At present, Chinese patent CN108588163A of prednisone acetate has re...

Claims

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Application Information

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IPC IPC(8): C12P33/00C12R1/06
CPCC12P33/00
Inventor 付林孙琼芳徐明琴廖俊曾建华冯蕾王霜
Owner HUAZHONG PHARMA
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