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Drug composition of thymopentin composed of five kinds of amino acids and preparation method thereof

A technology of composition and thymus, which is applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of easy hydrolytic breakage of peptide bonds, easy breakage, and short storage time of thymopentin preparations And other problems, to achieve the effect of high stability, good quality and high stability

Active Publication Date: 2012-11-07
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, thymopentin is unstable, mainly because the peptide solution is easily oxidized and the peptide bond in the polypeptide is easily hydrolyzed and broken. The peptide bond formed by Asp is easier to break than other peptide bonds, especially the Asp-Pro and Asp-Gly peptide bonds. Resulting in short storage time of thymopentin preparations

Method used

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  • Drug composition of thymopentin composed of five kinds of amino acids and preparation method thereof
  • Drug composition of thymopentin composed of five kinds of amino acids and preparation method thereof
  • Drug composition of thymopentin composed of five kinds of amino acids and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Preparation of thymopentin injection with a specification of 1ml:1mg

[0043] Take 0.5g of citric acid and 1.5g of dipotassium hydrogen phosphate into 400g of water for injection, stir and dissolve, then add 0.5g of sodium tartrate and 50g of glucose, stir and dissolve; add water for injection to 900g, add 1g of thymopentin, stir and dissolve, Add the remaining 100g of water for injection, stir evenly, add 0.15% (g / ml) of activated carbon for needles, stir for 25 minutes, filter and decarbonize, check the intermediates, filter and sterilize the filtrate with a 0.22μm filter membrane after passing the test; press the filtrate to 1ml The specifications are poured into an ampoule bottle, filled with nitrogen, melted and sealed, and after passing the inspection, packaged to obtain the thymopentin pharmaceutical composition.

Embodiment 2

[0044] Example 2 Preparation of thymopentin injection with specifications of 1ml:10mg

[0045] Take 0.5g of citric acid and 1.5g of dipotassium hydrogen phosphate into 400g of water for injection, stir and dissolve, then add 0.5g of sodium tartrate and 50g of glucose, stir and dissolve; add water for injection to 900g, add 10g of thymopentin, stir and dissolve, Add the remaining 100g of water for injection, stir evenly, add 0.15% (g / ml) of activated carbon for needles, stir for 25 minutes, filter and decarbonize, check the intermediates, filter and sterilize the filtrate with a 0.22μm filter membrane after passing the test; press the filtrate to 1ml The specifications are poured into an ampoule bottle, filled with nitrogen, melted and sealed, and after passing the inspection, packaged to obtain the thymopentin pharmaceutical composition.

[0046]

Embodiment 3

[0047] Example 3 Preparation of thymopentin for injection with a specification of 1 mg

[0048]Take 0.5g of citric acid and 1.5g of dipotassium hydrogen phosphate into 400g of water for injection, stir and dissolve, then add 0.5g of sodium tartrate and 50g of glucose, stir and dissolve; add water for injection to 900g, add 1g of thymopentin, stir and dissolve, Add the remaining 100g of water for injection, stir evenly, add 0.15% (g / ml) of activated carbon for needles, stir for 25 minutes, filter and decarbonize, check the intermediates, filter and sterilize with a 0.22μm filter membrane after passing the test; freeze drying: ① Pre-freezing: Put about 1ml of sterilization solution into a freezer that has been pre-cooled to -20°C, keep it for 1 hour, cool down at a constant speed (≤1.5°C / min) to -40°C, and keep it warm for 2 hours; ②Sublimation: turn on the vacuum Device, control the vacuum degree to 12Pa, heat up at a constant rate (≤1.5℃ / min) to -18℃, keep at this temperature ...

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Abstract

The invention relates to a drug composition of thymopentin composed of five kinds of amino acids. The drug composition can improve immunity and cure diseases such as hepatitis, deficiency of T lymphocytes and autoimmune diseases, and contains, by weight, 1-10 parts of thymopentin composed of five kinds of amino acids, 0.4-0.6 part of citric acid, 1.4-1.6 parts of dipotassium phosphate and 48-52 parts of glucose. The preparation method includes adding the citric acid, the dipotassium phosphate and the glucose into water for injection to dissolve; adding thymopentin to dissolve with stirring and then stirring evenly, adding active carbon for injection and stirring, filtering for decarburization, and obtaining a filter solution through filter membrane filtration sterilization; and obtaining the drug composition of the thymopentin through filter solution subpackaging or freeze drying. Prepared thymopentin for injection and thymopentin injection have good quality and stability, and can maintain a high stability even at a room temperature and be stored for more than 36 months.

Description

technical field [0001] The invention relates to a thymopentin pharmaceutical composition for improving immunity and treating diseases such as hepatitis, T cell deficiency, autoimmune diseases and the like. Background technique [0002] A potent fraction of thymopoietin II in thymic secretions. Thymopoietin II is a single polypeptide compound isolated from thymus hormone, composed of 49 amino acids, and the peptide chain fragment composed of 5 amino acids has all the same physiological functions as thymopoietin II. This pentapeptide fragment is called thymopentin. Thymopentin is composed of five amino acids: arginine, lysine, aspartic acid, valine, and tyrosine. [0003] One of the roles of thymopentin is to induce T cell differentiation. It selectively induces the transformation of Thy-1- prethymocytes into Thy-1+ T cells. Its T cell differentiation is mediated by elevated intracellular cAMP levels. Another basic function of thymopentin is to bind to specific receptors...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/08A61K9/19A61K47/26A61K47/12A61K47/04A61P1/16A61P37/04
Inventor 曾艺胡成忠
Owner 湖北美林药业有限公司
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