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Thiamphenicol freeze-dried powder for injection

A technology of thiamphenicol and freeze-dried powder injection, which is applied in the field of thiamphenicol freeze-dried powder injection, can solve the problems of low bioavailability, poor dissolution and the like, and achieves high clinical safety, less excipients, Effects of low levels of related substances

Active Publication Date: 2016-06-29
HAIMEN THE YELLOW SEA ENTREPRENEURSHIP PARK SERVICE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, thiamphenicol mainly has dosage forms such as tablets, capsules, and injections for clinical use. These dosage forms have poor dissolution rate in the gastrointestinal tract and low bioavailability

Method used

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  • Thiamphenicol freeze-dried powder for injection
  • Thiamphenicol freeze-dried powder for injection
  • Thiamphenicol freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029] Process:

[0030] 1. Take the prescribed amount of tartaric acid, lecithin and valine, add 50% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of thiamphenicol into the solution, stir and dissolve Stirring was continued for 15 minutes.

[0031] 2. Take the prescribed amount of sodium chloride and mannitol, add 40% water for injection, stir to dissolve.

[0032] 3. Combine solutions 1 and 2, add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, check intermediates, and filter to sterilize with a 0.22 μm filter membrane after passing the test.

[0033] 4. Pour the filtrate into a vial and freeze-dry to obtain a freeze-dried powder injection. After passing the inspection, pack it.

Embodiment 1

[0035]

[0036] The preparation method is the same as in Example 1.

Embodiment 2

[0038]

[0039] The preparation method is the same as in Example 1.

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Abstract

The invention relates to a thiamphenicol freeze-dried powder injection, wherein the thiamphenicol freeze-dried powder injection is made of the following raw materials: 5g thiamphenicol, 0.8g tartaric acid, 1g lecithin, 0.5g valine, 8g sodium chloride, 4g mannitol, 1000ml water for injection.

Description

technical field [0001] The invention relates to thiamphenicol freeze-dried powder for injection. Background technique [0002] Thiamphenicol English / Latin name: Thiamphenicol, alias thiamphenicol, thiamphenicol chloramphenicol. This product is white crystalline powder; odorless. [0003] Thiamphenicol is a synthetic broad-spectrum antibiotic and a substitute for chloramphenicol. Its antibacterial effect in vivo is stronger than that of chloramphenicol, but its toxicity is less than that of chloramphenicol. Thiamphenicol has poor water solubility, and its dosage form and clinical application are limited. [0004] Thiamphenicol acts by inhibiting bacterial protein synthesis, mainly reversibly binding to the 50s subunit of the bacterial 70s ribosome, inhibiting peptidyltransferase, thereby specifically preventing aminoacyl-tRNA from interacting with the ribosome Receptor binding inhibits the elongation of the peptide chain and prevents bacterial protein synthesis. The two h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/165A61K47/12A61K47/18A61P31/04
Inventor 李娜林月荣任书聿
Owner HAIMEN THE YELLOW SEA ENTREPRENEURSHIP PARK SERVICE CO LTD
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