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Injection containing pidotimod potassium salt and preparation method thereof

A kind of technology of potassium salt and injection of domoda, applied in the new field of medicine

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

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- to 50-fold doses showed no toxic reactions, and pidotimod did not show any effects of causing genetic mutations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Embodiment 1: injection (specification 2mL: 0.1g)

[0013] Add 244.27g of pidotimod and 56.11g of potassium hydroxide into 3500mL of water for injection, dissolve completely while stirring, add 4g of charcoal for needles, continue to stir for 30min, filter out the charcoal, add water for injection to 4485.2mL, fine filter out Bacteria, aliquoted, 2mL / bottle, steam sterilized, made into injection.

Embodiment 2

[0014] Embodiment 2 powder for injection (specification 0.2g)

[0015] Add 244.27g of pidotimod and 56.11g of potassium hydroxide into 2000mL of water for injection, dissolve completely while stirring, add 4g of charcoal for needles, continue stirring for 30min, filter out the charcoal, and evaporate the solvent under normal pressure or reduced pressure. After drying, a solid powder is obtained, which is pidotimod potassium salt.

[0016] The pidotimod potassium salt is directly divided into vials under aseptic conditions, and the amount of each bottle is calculated as 0.2 g according to pidotimod.

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PUM

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Abstract

The invention discloses an injection containing a pidotimod potassium salt and a preparation method thereof. The preparation method comprises the following steps of: undergoing reaction between pidotimod and potassium hydroxide with equal mole in water or other solvent or a mixed solution of multiple solvents, preparing the pidotimod potassium salt and then preparing the injection. The injection containing the pidotimod potassium salt is characterized in that the effective component, the pidotimod, in the injection exists in the form of the pidotimod potassium salt, thus the solubility and the stability of the pidotimod in normal pH environment of a human body are improved. The injection containing the pidotimod potassium salt, disclosed by the invention, is used for treating the recurrent upper and lower respiratory tract infection (such as pharyngitis, tracheitis, bronchitis and tonsillitis), the recurrent infection (such as rhinitis, nasosinusitis and otitis), the urinary infection and gynecological infection, and can reduce the times of acute exacerbation, shorten the course of disease and relieve the degree of exacerbation; in addition, the injection can be also taken as the auxiliary treatment of antibiotics during the acute infection.

Description

technical field [0001] The invention belongs to the field of new medicine technology, and relates to an injection containing pidotimod potassium salt and a preparation method thereof. The injection is used for the treatment of recurrent upper and lower respiratory tract infections (pharyngitis, bronchitis, bronchitis, tonsillitis); recurrent infections (rhinitis, sinusitis, otitis); urinary tract infections and gynecological infections. It can reduce the number of acute attacks, shorten the course of the disease, reduce the degree of attacks, and can also be used as an adjuvant treatment of antibiotics in acute infections. It has good safety, can be used for children and pregnant women, is convenient to use, and has a quick effect, and is an immunoregulation accelerator with good prospects. Specifically, the invention relates to an injection containing pidotimod potassium salt and a preparation method thereof. Background technique [0002] Pidotimod is an immune enhancer, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/14A61K9/19A61K31/427A61P11/00A61P11/04A61P31/00A61P11/02A61P27/16A61P13/00A61P15/00A61P13/02
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
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