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Preparation and application of pidotimod potassium salt

A technology of domody potassium salt and potassium salt is applied in the field of preparation of pidotimod potassium salt to achieve the effects of no toxic and side effects, improved solubility and good stability

Inactive Publication Date: 2011-06-22
QINGDAO VLAND BIOTECH INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The current report is affirmative to the safety of pidotimod. Toxicological animal model tests have proved that the drug is safe to use. The acute, subacute and chronic toxicity data are very good. It is observed that the maximum daily therapeutic dose 40 times to 50 times, no toxic reactions occurred, and pidotimod did not show any effect of causing genetic mutations

Method used

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  • Preparation and application of pidotimod potassium salt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Add 0.01mol pidotimod, 0.01mol potassium hydroxide and 20mL water into a 100mL beaker, stir for 5 minutes, the raw materials dissolve, the solution is clear and transparent, and the measured pH=7. Evaporate the solution under normal pressure or reduced pressure to remove the solvent, After drying the product, the resulting white solid was pidotimod potassium salt.

Embodiment 2

[0017] Add 0.01mol pidotimod, 0.01mol potassium hydroxide and 20mL ethanol into a 100mL beaker, stir for 5 minutes, the raw materials dissolve, the solution is clear and transparent, and the measured pH=7. Evaporate the solution under normal pressure or reduced pressure to remove the solvent, After drying the product, the resulting white solid was pidotimod potassium salt.

Embodiment 3

[0018] Embodiment 3: Pidotimod potassium salt for injection

[0019] Prescription: pidotimod potassium salt (mass in pidotimod) 20g

[0020] Mannitol 30g

[0021] Add water for injection to 400mL

[0022] Makes 100 bottles

[0023] Preparation method: Dissolve the prescribed amount of pidotimod potassium salt and mannitol in water for injection, add charcoal for injection, stir at 60°C for 15 minutes, filter to remove charcoal, add water for injection to dilute to 400 mL, and sterilize with a 0.2 μm filter membrane Filter, put into vials under aseptic conditions, 4mL each, half-tightened, pre-freeze at -40°C for 3 hours, heat up to 30°C at a rate of 3-5°C / hour, dehydrate after 1 hour of heat preservation, press Plug, remove the locking aluminum cap to obtain the powder injection of the present invention, which can be used by adding 5% glucose or 0.9% sodium chloride infusion before use.

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Abstract

The invention discloses preparation and application of a pidotimod potassium salt. The pidotimod potassium salt is used for treating recurrent respiratory tract infection, bronchitis, bronchial asthma, recurrent tonsillitis, urinary tract infection, chronic obstructive pulmonary diseases and acute worsening of chronic bronchitis caused by bacterial infection, and can be used with antibiotics for treatment. Pidotimod and equimolar potassium hydroxide react in water or any other solvent or a multi-solvent mixture to obtain the pidotimod potassium salt. The chemical name of the pidotimod potassium salt is potassium (R)-3-[(S)-(5-oxy-2-pyrrolidinyl)carbonyl]-thiazolidine-4-carboxylate. The pidotimod potassium salt can be made into various pharmaceutically acceptable preparation formulations, including but not limited to tablets, injections and the like.

Description

technical field [0001] The invention belongs to the field of new medicine technology and relates to a preparation method and application of pidotimod potassium salt. For the treatment of recurrent respiratory infection, bronchitis, bronchial asthma, recurrent tonsillitis, urinary tract infection, chronic obstructive pulmonary disease, acute exacerbation of chronic bronchitis caused by bacterial infection, and in combination with antibiotics. Specifically, it is a preparation method and application of pidotimod potassium salt. Background technique [0002] As a fully chemically synthesized dipeptide immune drug, pidotimod has no direct antibacterial and antiviral activities. By promoting the body's immune function, it can promote the phagocytic activity of macrophages and neutrophils, and improve their chemotaxis. Activation of natural killer cells; promotion of lymphocyte proliferation caused by mitogens, so that helper T cells (CD 4 + ) and suppressor T cells (CD 8 + )...

Claims

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Application Information

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IPC IPC(8): C07K5/078A61K38/05A61P11/00A61P11/06A61P13/02A61P31/04
Inventor 林扬郝智慧贾德强宋丽刘元元王春元张瑞丽
Owner QINGDAO VLAND BIOTECH INC