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Process for preparing hydrocortisone acetate

A technology of hydrocortisone acetate and hydrocortisone, which is applied in the direction of organic chemistry and steroids, can solve the problems of unstable quality, yellow appearance, low yield, etc., to reduce production costs, reduce pollution, The effect of stable quality

Active Publication Date: 2005-04-06
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 1. Pyridine as a solvent is a toxic solvent with a special unpleasant smell, which is relatively harmful to the operator's body;
[0005] 2. Pyridine in the reaction mother liquor is not easy to recycle and reuse, resulting in a large amount of toxic waste water and causing serious pollution to the environment;
[0006] 3. The yield is low, generally 87.8%, and the appearance is yellow, and the quality is unstable during production;
[0007] 4. Pyridine has relatively high requirements for production equipment

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Put 10kg of hydrocortisone (abbreviated as Hydrocortisone), 3L of acetic acid, 15L of acetic anhydride, 300L of acetone, and 2kg of potassium acetate into the reaction tank, heat, raise the temperature to reflux, and keep it for 5 hours, then concentrate to 60°C under normal pressure, Concentrate under reduced pressure until viscous, then add a certain amount of water to dilute, stir, cool down, and stand still. The yield of hydrocortisone acetate is 95.1%, and the quality is single largest impurity 1.0%, total impurity 1.99%,

Embodiment 2

[0019] Put 10kg of hydrocortisone, 3L of acetic acid, 15L of acetic anhydride, 300L of methyl ethyl ketone, and 2kg of potassium acetate into the reaction tank, heat, raise the temperature to reflux, and keep it for 5 hours, then concentrate it to 60°C under normal pressure2, and then depressurize Concentrate until viscous, then add a certain amount of water to dilute, stir, cool down, and let it stand still. The yield of hydrocortisone acetate is 95.2%, and the quality is single largest impurity 1.0%, total impurity 2.00%,

Embodiment 3

[0021] Put 10kg of hydrocortisone, 3L of acetic acid, 15L of acetic anhydride, 300L of 2-pentanone, and 2kg of potassium acetate into the reaction tank, heat, raise the temperature to reflux, and keep it for 5 hours, then concentrate to 103°C under normal pressure, and then reduce Concentrate under pressure until viscous, then add a certain amount of water to dilute, stir, cool down, and let it stand still. The yield of hydrocortisone acetate is 95.1%, and the quality is a single maximum impurity 0.99%, total impurity 2.00%,

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PUM

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Abstract

This invention refers to a chemical synthesis preparation technique of acetic acid hydrocortisone. C3~C5 fat ketone is used as solvent and certain acetate is added. It is got by synthesizing hydrocortisone, acetic acid and acetic anhydride. Pyridine is replaced by low toxicity solvent, then pollution is reduced and yield is raised, the yield of acetic acid hydrocortisone can reach above 95%. The product quality is stabilized and cost is reduced, it is more acceptable for industrial production.

Description

technical field [0001] The invention relates to a preparation process of medicines, in particular to a chemical synthesis preparation process of hydrocortisone acid. Background technique [0002] The chemical synthesis preparation process of hydrocortisone acetate mostly adopts the pyridine method (seeing "Pharmaceutical Industry Compilation" in 1980) at present, that is, using pyridine as a solvent, acetic acid, acetic anhydride, and hydrocortisone are synthesized to prepare hydrocortisone acetate. [0003] The preparation of hydrocortisone acetate by pyridine method has the following problems: [0004] 1. Pyridine as a solvent is a toxic solvent with a special unpleasant smell, which is relatively harmful to the operator's body; [0005] 2. Pyridine in the reaction mother liquor is not easy to recycle and reuse, resulting in a large amount of toxic waste water and causing serious pollution to the environment; [0006] 3. The yield is low, generally 87.8%, and the appeara...

Claims

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Application Information

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IPC IPC(8): C07J7/00
Inventor 夏丙堃谭春艳
Owner SHANDONG XINHUA PHARMA CO LTD
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