Supercharge Your Innovation With Domain-Expert AI Agents!

Preparation method of hydrocortisone sodium succinate for injection

A technology of hydrocortisone sodium succinate and hydrocortisone succinate, which is applied in the field of chemical pharmacy, can solve the problems of severe solvation of products, unqualified clarity, difficult filtration and separation, etc., to reduce alkalinity and quality Stable and reliable, high reconstitution clarity effect

Active Publication Date: 2021-01-15
安徽海洋药业有限公司
View PDF4 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] ②Adopt neutralization reaction in acetone aqueous solution, and then directly distill to dry method, the impurity is relatively high, and the clarity after redissolving is unqualified
[0006] 3. Adopt the method of carrying out neutralization reaction in aqueous acetone, then add a large amount of acetone crystallization method, the obtained product is solvated seriously, is difficult to separate by filtration, is difficult to dry, and is not suitable for industrialization

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Preparation method of hydrocortisone sodium succinate for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A preparation method for hydrocortisone sodium succinate for injection, comprising the following steps:

[0038] ①Stir 200g of acetone and 100g of hydrocortisone succinate at 20-30°C until suspended to obtain a suspension;

[0039] ② In addition, mix 700g of water, 25g of sodium bicarbonate, and 10g of phosphate mixture at a temperature of 20-30°C, fully stir to dissolve and exhaust, and make a mixed salt solution;

[0040] ③Control the temperature at 20-30°C, slowly add the mixed salt solution obtained in step ② into the suspension in step ①, and carry out neutralization reaction. After dissolving in about 30 minutes, cool the reaction system to 18°C, and slowly Stir at a high speed for 3h, then filter;

[0041] ④Below 40°C, vacuum distill half the volume of acetone water from the filtrate, then add some water to adjust the solution concentration to 15%;

[0042] ⑤Reduce the temperature of the solution in step ④ to 15-20°C, add 3g of activated carbon, adjust the pH t...

Embodiment 2

[0047] A preparation method for hydrocortisone sodium succinate for injection, comprising the following steps:

[0048] ①Put 160g of acetone and 100g of hydrocortisone succinate into the neutralization kettle, stir and suspend at 20-30°C to obtain a suspension;

[0049] ② Separately mix 400g of water, 18g of sodium bicarbonate, and 6g of phosphate at a temperature of 20-30°C, fully stir to dissolve and exhaust, and make a mixed salt solution;

[0050] ③Control the temperature at 20-30°C, slowly add the mixed salt solution obtained in step ② into the suspension in step ①, and carry out the neutralization reaction. After 30 minutes of dissolution, cool the reaction system to 13°C, and then slowly Stir for 6h, then filter;

[0051] ④Below 40°C, vacuum distill half of the volume of acetone water from the filtrate, then add an appropriate amount of water to adjust the total concentration of hydrocortisone sodium succinate and phosphate to 20%;

[0052] ⑤Reduce the temperature of ...

Embodiment 3

[0057] A preparation method for hydrocortisone sodium succinate for injection, comprising the following steps:

[0058] ①Stir and suspend 220g of acetone and 100g of hydrocortisone succinate at 20-30°C to obtain a suspension;

[0059] ② Separately mix 800g of water, 20g of sodium bicarbonate, and 8g of phosphate mixture at a temperature of 20-30°C, fully stir to dissolve and exhaust, and make a mixed salt solution;

[0060] ③Control the temperature at 20-30°C, slowly add the mixed salt solution obtained in step ② into the suspension in step ①, and carry out the neutralization reaction. After 30 minutes of dissolution, cool the reaction system to 15°C, and then slowly Stir for 5h, then filter;

[0061]④Below 40°C, vacuum distill half the volume of acetone water from the filtrate, and then add an appropriate amount of water to adjust the solution concentration to 10%;

[0062] ⑤Reduce the temperature of the solution in step ④ to 15-20°C, add 2g of activated carbon, adjust the ...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses a preparation method of hydrocortisone sodium succinate for injection. The method comprises the following steps of firstly, proportionally mixing acetone and hydrocortisone succinate, then mixing purified water, sodium bicarbonate and phosphate at a certain temperature, then mixing two mixed solutions in a reactor, carrying out a neutralization reaction, filtering a reaction solution after the reaction is finished, concentrating a filtrate in vacuum, performing dilution, adding activated carbon for decoloration, and performing filtration sterilization, spray (or freeze)drying and packaging on the decolored filtrate. The method has the advantages of mild reaction conditions, high reaction speed, high product purity and high yield.

Description

technical field [0001] The invention relates to the field of chemical pharmacy, in particular to a preparation method of hydrocortisone sodium succinate for injection. Background technique [0002] Hydrocortisone sodium succinate for injection is usually a sterile powder injection prepared from hydrocortisone succinate under the action of a suitable base. Hydrocortisone succinate is almost insoluble in water, and it is difficult to be neutralized by sodium alkali in pure water. It needs to be heated to above 40°C for a period of time to be dissolved and neutralized, which will cause hydrolysis and turbidity. [0003] Hydrocortisone sodium succinate has strong hygroscopicity and is easily soluble in water. Unstable in solution state, more unstable when heated, prone to ester hydrolysis. The prior art uses the following processes: [0004] ① It is difficult to neutralize the reaction with sodium alkali (sodium hydroxide, sodium carbonate, sodium bicarbonate) in a pure aqueo...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/14A61K31/573A61K47/02
CPCA61K9/19A61K9/0019A61K9/143A61K31/573A61K47/02
Inventor 吴延柱谢延吴鹏吴楠杨怀玉
Owner 安徽海洋药业有限公司
Features
  • R&D
  • Intellectual Property
  • Life Sciences
  • Materials
  • Tech Scout
Why Patsnap Eureka
  • Unparalleled Data Quality
  • Higher Quality Content
  • 60% Fewer Hallucinations
Social media
Patsnap Eureka Blog
Learn More

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2025 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com