Omeprazole sodium freeze-dried powder injection preparation method

A technology of omeprazole sodium and freeze-dried powder injection, which is applied in the field of preparation of omeprazole sodium freeze-dried powder injection, can solve problems such as polymerization reaction, influence on product quality, discoloration, etc., to ensure quality and improve drug use Effects of safety, quality improvement and stability

Inactive Publication Date: 2017-10-20
HUNAN KELUN PHARMA
View PDF6 Cites 4 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the preparation process, the chemical structure of omeprazole sodium is prone to change, polymerizat

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
  • Omeprazole sodium freeze-dried powder injection preparation method
  • Omeprazole sodium freeze-dried powder injection preparation method
  • Omeprazole sodium freeze-dried powder injection preparation method

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0024] The invention provides a kind of preparation method of omeprazole sodium freeze-dried powder injection, comprises the following steps:

[0025] A) mixing the metal ion complexing agent with part of the water for injection, adjusting the pH value to 9.5-11 to obtain the first mixed solution;

[0026] B) mixing omeprazole sodium with the first mixed solution, adjusting the pH value to 9.9-11.1;

[0027] C) supplementing remaining water for injection to obtain omeprazole sodium solution;

[0028] D) Prefreeze the omeprazole sodium solution for 2 to 3 hours, and the prefreezing temperature is -35 to -40°C;

[0029] E) After pre-freezing, heat up to 0°C at a speed of 7-9°C / h, then rise from 0°C to 30°C at a speed of 3-5°C / h, and then increase the temperature from 0°C to 30°C at a speed of 1-3°C / h Raise the temperature from 30°C to 35°C-40°C to obtain omeprazole sodium powder;

[0030] F) keeping the omeprazole sodium powder at 35-40° C. for 3-5 hours to obtain omeprazole ...

Embodiment 1

[0054]

[0055] (1) During the entire preparation and filling process, the whole process should be protected from light.

[0056] Add 1200ml of water for injection into the concentrated irrigation, control the temperature at about 10°C, add 1.5g of EDTA, stir well to contact with the tank wall, and adjust the pH to 10.6 with 0.1M NaOH solution.

[0057] (2) Add 42.54g of omeprazole sodium (dried and pure) into the concentrated preparation tank, and stir to dissolve. Use 0.1M NaOH solution to adjust the pH to 10.8, add 1g of activated carbon, stir for 15 minutes, and decarbonize it with a titanium rod into a dilute tank.

[0058] (3) Add water for injection to 2000ml in the dilute preparation tank. After the semi-finished product passes the test, use a 0.45μm microporous filter element for coarse filtration, and finally pass a 0.22μm microporous filter element for fine filtration before filling and half stoppering.

[0059] Use the following process to freeze-dry:

[0060]...

Embodiment 2

[0065]

[0066]

[0067] (1) During the entire preparation and filling process, the whole process should be protected from light.

[0068] Add 1200ml of water for injection into the concentrated irrigation, control the temperature at about 10°C, add 1.5g of EDTA, stir well to contact with the tank wall, and adjust the pH to 10.7 with 0.1M NaOH solution.

[0069] (2) Add 42.54g of omeprazole sodium (dried and pure) into the concentrated preparation tank, and stir to dissolve. Use 0.1M NaOH solution to adjust the pH to 10.8, add 1g of activated carbon, stir for 15 minutes, and decarbonize it with a titanium rod into a dilute tank.

[0070] (3) Add water for injection to 2000ml in the dilute preparation tank. After the semi-finished product passes the test, use a 0.45μm microporous filter element for coarse filtration, and finally pass a 0.22μm microporous filter element for fine filtration before filling and half stoppering.

[0071] The freeze-drying process is:

[0072...

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 provides an omeprazole sodium freeze-dried powder injection preparation method. The method includes: A) mixing a metal ion complexing agent with part of water for injection, and adjusting a pH value to 9.5-11 to obtain first mixed solution; B) mixing omeprazole sodium with the first mixed solution, and adjusting a pH value to 9.9-11.1; C) adding the remaining water for injection to obtain omeprazole sodium solution; D) prefreezing the omeprazole sodium solution for 2-3h at a prefreezing temperature ranging from -35 DEG C to -40 DEG C; E) after prefreezing is finished, heating to 0 DEG C at a speed of 7-9DEG C/h, then heating from 0 DEG C to 30 DEG C at a speed of 3-5DEG C/h, and heating from 30 DEG C to 35-40 DEG C at a speed of 1-3DEG C/h to obtain omeprazole sodium powder; F) subjecting the omeprazole sodium powder to heat preservation at 35-40 DEG C for 3-5h. Quality and stability of a finished product are improved finally through regulation of parameters at steps of prefreezing, sublimation, heat-preservation drying and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of omeprazole sodium freeze-dried powder injection. Background technique [0002] Omeprazole sodium has the following structure: [0003] [0004] The indications for omeprazole sodium for injection include: 1. Peptic ulcer bleeding and anastomotic ulcer bleeding; 2. Acute gastric mucosal damage complicated by stress and acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs ;3. Prevention of stress state of severe diseases (such as cerebral hemorrhage, severe trauma, etc.) and upper gastrointestinal bleeding caused by gastric surgery; 4. As an alternative therapy for the following diseases when oral therapy is not applicable: duodenal ulcer , gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome (Zollinger-Ellison syndrome). [0005] Because omeprazole sodium has a sulfuryl benzimidazole chemical stru...

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
IPC IPC(8): A61K9/19A61K31/4439A61K47/18A61P1/04
CPCA61K47/18A61K47/183A61K9/0019A61K9/19A61K31/4439
Inventor 刘伟强吴中华刘思川廖孝曙逯佩荣刘志军余泽勇廖国栋黄松生
Owner HUNAN KELUN PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap