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A kind of pidotimod oral solution and preparation method thereof

A technology for oral solution and pidotimod, which is applied in the field of pharmaceutical compositions containing pidotimod and its preparation, can solve the problems of intensified molecular motion, difficulty in ensuring safety, poor stability and the like, and achieves product stability High, improve product quality and safety, improve the effect of solubility

Active Publication Date: 2021-03-26
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after the drug is made into a liquid preparation, the molecular motion is intensified, the stability becomes poor, and it is difficult to guarantee its safety. Therefore, it is imminent to research and develop a liquid preparation with good stability as a drug for children.

Method used

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  • A kind of pidotimod oral solution and preparation method thereof
  • A kind of pidotimod oral solution and preparation method thereof
  • A kind of pidotimod oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] formula:

[0040]

[0041]

[0042] Preparation Process:

[0043] 1) Preparation of drug-containing solution: at 40° C., the glucosamine of the recipe quantity is dissolved in 600ml of water, pidotimod, sorbitol and disodium edetate of the recipe quantity are added, and the grape seed proanthocyanidin extract is stirred to dissolve, Cool down to room temperature;

[0044] 2) preparation of sucralose, preservative solution: at room temperature, sucralose, sodium methylparaben, sodium propylparaben of recipe quantity are dissolved in 50ml water;

[0045] 3) Add 2) into 1), stir evenly, add cherry essence, and make up to 700ml with purified water, that is, it is obtained.

Embodiment 2

[0047] formula:

[0048]

[0049] Preparation Process:

[0050]1) Preparation of drug-containing solution: at 40° C., the glucosamine of the recipe quantity is dissolved in 600ml of water, pidotimod, sorbitol and disodium edetate of the recipe quantity are added, and the grape seed proanthocyanidin extract is stirred to dissolve, Cool down to room temperature;

[0051] 2) preparation of sucralose, preservative solution: at room temperature, sucralose, sodium methylparaben, sodium propylparaben of recipe quantity are dissolved in 50ml water;

[0052] 3) Add 2) into 1), stir evenly, add cherry essence, and make up to 700ml with purified water, that is, it is obtained.

Embodiment 3

[0054] formula:

[0055]

[0056]

[0057] Preparation Process:

[0058] 1) Preparation of drug-containing solution: at 40° C., the glucosamine of the recipe quantity is dissolved in 600ml of water, pidotimod, sorbitol and disodium edetate of the recipe quantity are added, and the grape seed proanthocyanidin extract is stirred to dissolve, Cool down to room temperature;

[0059] 2) preparation of sucralose, preservative solution: at room temperature, sucralose, sodium methylparaben, sodium propylparaben of recipe quantity are dissolved in 50ml water;

[0060] 3) Add 2) into 1), stir evenly, add cherry essence, and make up to 700ml with purified water, that is, it is obtained.

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing pidotimod and a preparation method thereof, and in particular relates to a pidotimod oral solution preparation with high stability and a preparation method thereof. According to the oral solution and the preparation method, provided by the invention, glucosamine is adopted as a pH adjusting agent and a grape seed proanthocyanidin extract is adopted as an antioxidant to prepare the pidotimod oral solution preparation with high stability. The preparation method provided by the invention is simple, the taste is good and the product stability is high; trometamol is not adopted, thereby reducing the toxic and side effects, the defect of poor stability of the existing pidotimod oral solution preparation is overcome, the product quality and safety are improved, and the needs of children's clinical medication is met.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing pidotimod and a preparation method thereof, in particular to a pidotimod oral solution preparation with high stability and a preparation method thereof. Background technique [0002] Pidotimod: (R)-3-[(S)-(5-oxo-2-pyrrolidinyl)carbonyl]-tetrahydrothiazole-4-carboxylic acid, the structural formula is as follows: [0003] [0004] This product is a brand-new chemically synthesized immune booster. Its structure is similar to dipeptide. It works by stimulating and regulating cell-mediated immune responses. It has good bioavailability by oral and intramuscular injection. It is currently the only oral drug in the world. Immunostimulatory modulators whose bioavailability can be determined after administration. The product was successfully researched and developed by the Italian company Puli Chemical, and was listed in Italy in 1993, Greece and Mexico in 1996, including the United States, Fra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K38/05A61K31/427A61K47/26A61K47/22A61P37/04A61K31/7008
CPCA61K9/0095A61K31/427A61K31/7008A61K38/05A61K47/22A61K47/26A61K2300/00
Inventor 杨杰李树英王英新王凤英
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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