Preparing method of freeze-dried antibiotic formulation

A drying, said technology, applied in the field of preparation of antibiotic freeze-dried dosage forms, can solve problems such as heat sensitivity and instability

Inactive Publication Date: 2005-01-26
济南久创化学有限责任公司
View PDF0 Cites 7 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Since imipenem and cilastatin sodium contain sulfur, they are easily combined with

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
  • Preparing method of freeze-dried antibiotic formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Under the condition of nitrogen, 50g of sodium bicarbonate was added to 325g of water for injection, and 125g of imipenem was added, while stirring to obtain a clear solution with a pH value of 6.5-8.5. The solution was filtered with a 0.2 μm filter membrane, filled into a glass bottle, and placed in a freeze dryer (ChristAlpha1-2) to freeze-dry. -0.5 mbar) dry. After the main drying, the temperature was raised to 15° C., the vacuum degree was adjusted to 0.02 mbar, and the drying was continued for 2 hours to obtain an off-white freeze-dried product.

Embodiment 2

[0027] Under the condition of flowing nitrogen, 100 g of sodium bicarbonate was added to 500 g of water for injection, 250 g of cilastatin sodium was added, and stirred at the same time to obtain a clear solution with a pH value of 6.5-8.0. The solution was filtered with a 0.2 μm filter membrane, filled into a glass bottle, and placed in a freeze dryer (ChristAlpha1-2) to freeze-dry. The vial was cooled to -40°C, then raised to -20°C--5°C, vacuum (0.1 -0.5 mbar) dry. After the main drying, the temperature was raised to 20° C., the vacuum degree was adjusted to 0.02 mbar, and the drying was continued for 3 hours to obtain an off-white freeze-dried product.

Embodiment 3

[0029] Under nitrogen, 50g of sodium bicarbonate was added to 500g of water for injection, 125g of imipenem was added, and 125g of cilastatin sodium was added, while stirring to obtain a clear solution with a pH value of 6.5-8.5. The solution was filtered with a 0.2 μm filter membrane, filled into a glass bottle, and placed in a freeze dryer (Christ Alpha1-2) to freeze-dry. The vial was cooled to -45°C, then raised to -20°C--5°C, vacuum ( 0.1-0.5 mbar) dry. After the main drying, the temperature was raised to 15° C., the vacuum degree was adjusted to 0.02 mbar, and the drying was continued for 3 hours to obtain an off-white freeze-dried product.

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 dislcloses the process for preparing Imipenem/Cilastatin Sodiun cryodesiccation powder preparation, which is prepared from imipenem, Cilastatin Sodium or the mixture of imipenem and Cilastatin Sodium.

Description

(1) Technical field [0001] The invention belongs to a preparation method of imipenem / cilastatin sodium [Imipenem / Cilastatin Sodiun] freeze-dried powder dosage form. [0002] Imipenem (Imipenem) is a derivative of thiamycin with the molecular formula C 12 h 17 N 3 o 4 S·H 2 O, the molecular weight is 317.36. The molecular formula of cilastatin sodium is C 16 h 25 N 2 NaO 5 S, the molecular weight is 380.44. (2) Background technology [0003] Imipenem / Cilastatin Sodiun is a broad-spectrum carbapenem antibiotic. Imipenem is the first stable derivative of thiamycin and is characterized by a broader bactericidal spectrum than any other antibiotic studied. Cilastatin sodium is a specific enzyme inhibitor, which blocks the metabolism of imipenem in the kidney and makes it play a bactericidal effect. [0004] Imipenem / cilastatin sodium is currently available in powder form for intravenous infusion in China. It is mainly obtained by mixing imipenem sterile powder, cilast...

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): A61K9/19A61K31/195A61K31/407A61P31/04
Inventor 傅伟
Owner 济南久创化学有限责任公司
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