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Pidotimod injection and preparation method thereof

A technology of pidotimod and injection, applied in the field of pharmaceutical preparations, to achieve the effect of reducing the generation of impurities, suitable for industrial production, and stable pH value

Inactive Publication Date: 2015-01-14
SUZHOU MACWELL BIOLOGICAL MEDICINE SCI & TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Domestic marketed dosage forms include oral liquid, granules, capsules, tablets, and dispersible tablets, etc., but no injections are yet on the market

Method used

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  • Pidotimod injection and preparation method thereof
  • Pidotimod injection and preparation method thereof
  • Pidotimod injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Take 1500ml of water for injection, inject nitrogen gas, add 200g of pidotimod, stir, add dropwise 4mol / L NaOH until dissolved, add sodium citrate to adjust the pH to 6.5--7.5, set the volume to 3000ml, add 0.05% activated carbon, Insulate and absorb at 45-50°C for 30 minutes, decarbonize and filter, 0.22μm fine filter, fill with nitrogen, potting, 3ml / cartridge. 121°C damp heat sterilization for 8 minutes, or 115°C damp heat sterilization for 30 minutes.

Embodiment 2

[0022] Take 1500ml of water for injection, inject nitrogen gas, add 200g of pidotimod, stir, add dropwise 4mol / L NaOH until dissolved, add anhydrous sodium carbonate to adjust the pH to 6.5--7.5, set the volume to 3000ml, add 0.05% activated carbon, Insulate and absorb at 45-50°C for 30 minutes, decarbonize and filter, 0.22μm fine filter, fill with nitrogen, potting, 3ml / cartridge. 121°C damp heat sterilization for 8 minutes, or 115°C damp heat sterilization for 30 minutes.

Embodiment 3

[0024] Take 1500ml of water for injection, inject nitrogen gas, add 200g of pidotimod, stir, add dropwise 4mol / L NaOH to dissolve, add disodium hydrogen phosphate to adjust the pH to 6.5--7.5, set the volume to 3000ml, add 0.05% activated carbon, Insulate and absorb at 45-50°C for 30 minutes, decarbonize and filter, 0.22μm fine filter, fill with nitrogen, potting, 3ml / cartridge. 121°C damp heat sterilization for 8 minutes, or 115°C damp heat sterilization for 30 minutes.

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Abstract

The invention provides a pidotimod injection and a preparation method thereof. The pidotimod injection is composed of pidotimod, a pH conditioning agent, and injection water, wherein the pH conditioning agent is sodium hydroxide and one or two of disodium phosphate, sodium dihydrogen phosphate, sodium carbonate and sodium citrate. It is surprisingly discovered that by using the appropriate and specific composite pH conditioning agent, the prepared pidotimod injection keeps stable pH value before and after a solution is sterilized and reduces generation of impurities, and also the injection does not need to use other stabilizers or auxiliary agents. The prepared pidotimod injection is stable and has good pharmaceutical effect, the preparation and the production technology are green and environment-friendly, and the preparation is suitable for industrialized production.

Description

technical field [0001] The invention provides a pidotimod injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Pidotimod [0003] Chemical name (R)-3-[(S)-(5-oxo-2-pyrrolidinyl)carbonyl]-tetrahydrothiazole-4-carboxylic acid. [0004] Structural formula: [0005] [0006] Molecular formula: C 9 h 12 N 2 o 4 S [0007] Molecular weight: 244.27 [0008] Pidotimod is a novel biological response modifier of a synthetic thymodipeptide structure with immunostimulatory activity in both animals and humans. Pidotimod is a safe and effective biological response modifier. The drug has no direct antimicrobial effect, and its drug effect is mainly realized by regulating the activity of immune factors or immune cells in the immune system. Works by stimulating and modulating cell-mediated immune responses. It mainly enhances specific immune function by stimulating helper T cells (CD4+, Th1), stimulatin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K47/04A61K47/12A61K9/08A61P37/04
Inventor 许强邱瑞宝刘洪海唐茂峰尹国民邓钢吴明辉
Owner SUZHOU MACWELL BIOLOGICAL MEDICINE SCI & TECH
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