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Pidotimod oral solution and preparation method thereof

An oral solution and technology of pidotimod, applied in the field of pharmaceutical composition containing pidotimod and its preparation, can solve the problems of poor stability, intensified molecular movement, difficulty in ensuring safety, etc., and achieve improved solubility , High product stability, the effect of improving product quality and safety

Active Publication Date: 2017-12-26
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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  • Pidotimod oral solution and preparation method thereof
  • Pidotimod oral solution and preparation method thereof
  • Pidotimod oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] formula:

[0041]

[0042]

[0043] Preparation Process:

[0044] 1) Preparation of the drug-containing solution: Dissolve the prescribed amount of glucosamine in 600ml of water at 40°C, add the prescribed amount of pidotimod, sorbitol, disodium edetate, and grape seed proanthocyanidin extract and stir to dissolve, Cool down to room temperature;

[0045] 2) Preparation of sucralose and preservative solution: dissolve the prescribed amount of sucralose, sodium methylparaben and sodium propylparaben in 50ml of water at room temperature;

[0046] 3) Add 2) into 1), stir evenly, add cherry essence, and dilute to 700ml with purified water to obtain the product.

Embodiment 2

[0048] formula:

[0049]

[0050] Preparation Process:

[0051] 1) Preparation of the drug-containing solution: Dissolve the prescribed amount of glucosamine in 600ml of water at 40°C, add the prescribed amount of pidotimod, sorbitol, disodium edetate, and grape seed proanthocyanidin extract and stir to dissolve, Cool down to room temperature;

[0052] 2) Preparation of sucralose and preservative solution: dissolve the prescribed amount of sucralose, sodium methylparaben and sodium propylparaben in 50ml of water at room temperature;

[0053] 3) Add 2) into 1), stir evenly, add cherry essence, and dilute to 700ml with purified water to obtain the product.

Embodiment 3

[0055] formula:

[0056]

[0057]

[0058] Preparation Process:

[0059] 1) Preparation of the drug-containing solution: Dissolve the prescribed amount of glucosamine in 600ml of water at 40°C, add the prescribed amount of pidotimod, sorbitol, disodium edetate, and grape seed proanthocyanidin extract and stir to dissolve, Cool down to room temperature;

[0060] 2) Preparation of sucralose and preservative solution: dissolve the prescribed amount of sucralose, sodium methylparaben and sodium propylparaben in 50ml of water at room temperature;

[0061] 3) Add 2) into 1), stir evenly, add cherry essence, and dilute to 700ml with purified water to obtain the product.

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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 highly stable pidotimod oral solution preparation 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 enhancer, its structure is similar to dipeptide, it works by stimulating and regulating the immune response mediated by cells, and it has good bioavailability by oral administration and intramuscular injection, and it is currently the only oral administration agent in the world. An immunostimulatory modulator whose bioavailability can be ascertained after administration. The product was successfully researched and developed by the Italian Puli Chemical Company, and was launched in Italy in 1993, and in Greece...

Claims

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Application Information

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Patent Type & Authority Applications(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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