Thymosin[alpha]1-containing lyophilized composition and preparation method thereof

A technology of thymosin and composition, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and freeze-dried delivery, can solve the problems of increased safety and low content of thymosin, and achieves Easy to operate, less variety and dosage, no powder scattering effect

Active Publication Date: 2020-12-22
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The inventor found in the test that due to the low thymusfasin content in the freeze-dried composition containing thymusfasin, it is necessary to add a large amount of auxiliary proppant (such as mannitol, sorbitol, glucose and sodium chloride, etc.) to make the frozen The dry composition has good formability, ensuring that the preparation does not appear powder scattering during the freeze-drying process; however, for pharmaceuticals, the introduction of too many excipients virtually increases the safety of clinical use, especially for injections

Method used

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  • Thymosin[alpha]1-containing lyophilized composition and preparation method thereof
  • Thymosin[alpha]1-containing lyophilized composition and preparation method thereof
  • Thymosin[alpha]1-containing lyophilized composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] prescription

[0028] Thymofasin 2.2g

[0029] 0.1mol / L meglumine solution to adjust the pH value to 7.6

[0030] Add water for injection to 1000ml

[0031] Preparation Process

[0032] Weigh the prescription amount of thymus method and add it to the water for injection, adjust the pH value with a pH value regulator, after the pH value adjustment is completed, use water for injection to make up the volume to the full amount, stir to dissolve and mix, filter, fill, freeze-dry, and Check the finished product.

[0033] Freeze-drying curve

[0034] 1. Pre-freezing stage

[0035] (1) Place the filled and half-stoppered semi-finished product on the partition in the freeze-drying cabinet to cool down to -2°C and keep it warm for 90 minutes;

[0036] (2) After the heat preservation is completed, the temperature is lowered to -45°C for the second time, the cooling time is 150 minutes, and the heat preservation time at -45°C is 90 minutes;

[0037] (3) After the heat prese...

Embodiment 2

[0043] prescription

[0044] Thymofasin 1.8g

[0045] 0.1mol / L meglumine solution to adjust the pH value to 7.6

[0046] Add water for injection to 1000ml

[0047] Preparation process: with embodiment 1

Embodiment 3

[0049] prescription

[0050] Thymofasin 2.2g

[0051] 0.1mol / L sodium phosphate solution to adjust the pH value to 7.6

[0052] Add water for injection to 1000ml

[0053] Preparation process: with embodiment 1

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Abstract

The invention discloses a thymosin[alpha]1-containing lyophilized composition and a preparation method thereof. The composition is prepared from an active ingredient of thymosin[alpha]1 and a pH regulator, and has the advantages that an auxiliary material is single; only one auxiliary material is used; a recipe is simple; the operation is convenient; a specific lyophilization procedure is used; the product appearance is good; a powder scattering phenomenon is avoided; the quality is stable; the redissolution time is short in use; and the performance of visible foreign matters and insoluble microparticles in a redissolved product is superior to that of an existing product in the market.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a freeze-dried composition containing thymus faxin and a preparation method thereof. Background technique [0002] Thymosin is a protein and polypeptide hormone produced by animal thymus, and it has been clinically used in my country for more than 20 years. Thymosin α1 (also known as thymosin α1, English name Thymosin α1) is a high-end product of thymosin, the main bioactive component of thymosin, and an important immune regulatory substance in the human body. The drug is composed of thymosin component 5 (TF5) A small molecule biologically active polypeptide isolated and purified, its content accounts for about 0.6% of TF5, its biological activity is 10-1000 times higher than that of TF5, it has high immune enhancement activity, and it can also stimulate the migration of vascular endothelial cells, promote Angiogenesis and wound healing have been used in...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K38/22A61K9/19A61K47/02A61K47/12A61K47/18A61P31/14A61P31/20A61P35/00A61P37/02F26B5/06
CPCA61K38/2292A61K9/19A61K47/02A61K47/12A61K47/18F26B5/06A61P35/00A61P37/02A61P31/20A61P31/14
Inventor董其松薛晓霞
OwnerCISEN PHARMA