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A kind of production technology of prednisolone sodium phosphate

A technology for prednisolone sodium phosphate and prednisolone phosphate is applied in the field of chemical pharmacy and achieves the effects of simple process route, low cost and easy-to-obtain raw materials

Active Publication Date: 2016-08-31
HENAN LIHUA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Anti-toxic and anti-shock effects: Glucocorticoids can resist the stimulation of bacterial endotoxins on the body, reduce cell damage, and play a role in protecting the body. There are few reports about its preparation route and method

Method used

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  • A kind of production technology of prednisolone sodium phosphate

Examples

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Effect test

Embodiment 1

[0013] Weigh 100g of prednisolone phosphate, dissolve it in 500ml of methanol, add 550ml of purified water after dissolving, add dropwise sodium hydroxide aqueous solution to adjust the pH value to 9.5, control the temperature at 15-20°C, filter the feed liquid, and pour the feed liquid into Add 2200ml of ethanol to the dilution tank, stir to obtain a large amount of crystallization, then let it stand, overnight, filter, and dry after obtaining the material. The product quality meets the standards of EP6.0 and USP31.

Embodiment 2

[0015] Weigh 100g of prednisolone phosphate, dissolve in 450ml of methanol, and add 600ml of purified water after dissolving. Add sodium hydroxide aqueous solution dropwise to adjust the pH value to 9.4, control the temperature at 15-20°C, and filter the feed liquid. The feed solution is poured into a dilution tank with 2000ml of ethanol, stirred to obtain a large amount of crystallization, left standing, overnight, filtered, and dried after obtaining the feed. The product quality meets the standards of EP6.0 and USP31.

Embodiment 3

[0017] Weigh 100g of prednisolone phosphate, dissolve it in 450ml of methanol, add 550ml of purified water after dissolving, add dropwise sodium hydroxide aqueous solution to adjust the pH value to 9.6, control the temperature at 20-25°C, filter the feed liquid, and pour the feed liquid into Add 1800ml of ethanol to the dilution tank, stir to obtain a large amount of crystallization, then stand still, filter overnight, and dry after obtaining the material. The product quality meets the standards of EP6.0 and USP31.

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Abstract

The invention discloses a prednisolone sodium phosphate production technology, and belongs to the field of chemical pharmacy. The technology adopting prednisolone sodium phosphate as a raw material comprises the following steps: 1, dissolving prednisolone sodium phosphate by using methanol to clarification, adding purified water, adding a sodium hydroxide solution to a tank in a dropwise manner under a controlled speed at a temperature of 15-30DEG C in order to slowly adjust the pH value to 9.2-10, stirring, detecting the pH value again, and filtering if the pH value does not change; and 2, adding ethanol to a dilution tank, adjusting the temperature, adding the above obtained reacted filtrate, stirring to precipitate a large amount of crystals, standing for at least 8h, discharging, cleaning the obtained discharged material by using ethanol, and drying the cleaned material to obtain prednisolone sodium phosphate. The technology has the advantages of simple route and low cost, and allows prednisolone sodium phosphate meeting drug grade requirements to be obtained.

Description

technical field [0001] The invention relates to a production process of prednisone drugs, in particular to a production process of prednisolone sodium phosphate, which belongs to the field of chemical pharmacy. Background technique [0002] Prednisolone sodium phosphate, English name: Prednisolone Sodium Phosphate; Prednisoline21-Phosphonic Acid Disodium Salt, CAS number: 125-02-0, EINECS number: 204-722-9, [0003] Chemical name: Pregna-1,4-dione-3,20-diene, 11, 17-dihydroxy-21-(phosphoryl oxide)-, disodium, Molecular formula: C21H27Na2O8P [0004] [0005] Its clinical use is: as an adrenal cortex hormone drug, it has various pharmacological effects such as anti-inflammation, anti-allergy and immune suppression. Anti-inflammatory effect: Glucocorticoids reduce and prevent tissue responses to inflammation, thereby reducing the manifestations of inflammation. Immunosuppressive effects: prevent or inhibit cell-mediated immune responses, delay allergic reactions, and miti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07J51/00
CPCC07J51/00
Inventor 姬卫忠李合兴王泉泉王向丽李新安
Owner HENAN LIHUA PHARMA
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