Thymopentin dry powder formulation and preparation method thereof

A technology of dry powder preparation and thymus, which is applied in the field of thymopentin dry powder preparation and its preparation, can solve the problems of poor stability of peptide bonds of Asp residues, inability to remove, and inability to completely remove impurities, etc., to achieve good solubility, curative effect and safety sex-enhancing effect

Active Publication Date: 2009-04-22
上海华源药业(宁夏)沙赛制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In practical applications, when thymopentin is stored in solution, its stability is low, and the peptide bond of Asp residue in its molecular chain is poor in stability, and it is easy to break in aqueous solution, and it is easy to degrade thymopentin into dipeptide and tripeptide
In the preparation process of thymopentin, only activated carbon is used for decarbonization, but activated carbon can only play the role of decolorization and depyrogenation, and cannot completely re

Method used

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  • Thymopentin dry powder formulation and preparation method thereof
  • Thymopentin dry powder formulation and preparation method thereof
  • Thymopentin dry powder formulation and preparation method thereof

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Embodiment 1

[0051] Embodiment 1, specification is the preparation of the thymopentin dry powder preparation of 10mg

[0052] 1. Preparation:

[0053] 1. Measure 800ml of water for injection at 35°C, accurately weigh 30g of mannitol, dissolve the above-mentioned 30g of mannitol in the above-mentioned 800ml of water for injection, and mix well to obtain solution I; add activated carbon for needles (Shanghai Activated Carbon Factory) to solution I , activated carbon for needles accounted for 0.05% of the solution I mass, stirred at room temperature for 30 minutes, then decarbonized with a 0.45 μm microporous membrane filter, and collected the filtrate I;

[0054] Accurately weigh 10g of thymopentin, dissolve it in all the above-mentioned filtrates I, and mix well to obtain solution II; adjust the pH value of solution II to 7.0 with 0.1mol / L sodium dihydrogen phosphate solution, and make up solution II to 1000ml with water for injection ; Filter the solution II as follows in turn: filter thr...

Embodiment 2

[0095] Embodiment 2, the preparation of the Thymopentin dry powder preparation that specification is 1mg

[0096] 1. Preparation:

[0097] 1. Measure 400ml of water for injection at 37°C, accurately weigh 30g of mannitol, dissolve the above 30g of mannitol in the above 400ml of water for injection, and mix well to obtain solution I; add activated carbon for needles (Shanghai Activated Carbon Factory) to solution I , activated carbon for needles accounted for 0.05% of the solution I mass, stirred at room temperature for 30 minutes, then decarbonized with a 0.45 μm microporous membrane filter, and collected the filtrate I;

[0098] Accurately weigh 1g of thymopentin, dissolve it in all the above-mentioned filtrates I, and mix well to obtain solution II; adjust the pH value of solution II to 7.1 with 0.1mol / L sodium dihydrogen phosphate solution, and make up solution II to 500ml with water for injection ; Filter the solution II in sequence as follows: filter through a 0.22 μm mi...

Embodiment 3

[0133] Embodiment 3, specification is the preparation of the dry powder preparation of thymopentin of 10mg

[0134] 1. Preparation:

[0135] 1. Measure 800ml of water for injection at 40°C, accurately weigh 10g of lactose, dissolve the above 10g of lactose in the above 800ml of water for injection, and mix well to obtain solution I; add activated carbon for needles (Shanghai Activated Carbon Factory) to solution I, and inject Use activated carbon to account for 0.05% of the mass of solution I, stir at room temperature for 20 minutes, then filter and decarbonize with a 0.45 μm microporous membrane, and collect filtrate I;

[0136] Accurately weigh 10g of thymopentin, dissolve it in all the above filtrates I, and mix well to obtain solution II; adjust the pH value of solution II to 7.2 with 0.2mol / L sodium dihydrogen phosphate solution, and make up solution II to 1000ml with water for injection ; Filter the solution II as follows in turn: filter through a 0.22 μm microporous me...

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Abstract

The invention discloses a thymopeptide-5 powder preparation and a preparation method thereof. The method comprises the following steps: dissolving excipient in water to produce solution I, and filtering the solution I to collect filtrate I; adding the thymopeptide-5 to the filtrate I to obtain solution II, and filtering solution II to collect filtrate II; and freezing and drying the filtrate II to obtain the thymopeptide-5 powder preparation. The excipient can be any one of mannite, lactose and glycin. Experiments prove that, in the thymopeptide-5 powder preparation, thymopeptide-5 is not easy to be degraded, and has good solubility; low content of 'related substances' which is below 1.0 percent, so that healing efficacy and safety of the thymopeptide-5 powder preparation can be greatly improved.

Description

technical field [0001] The invention relates to a thymopentin dry powder preparation and a preparation method thereof. Background technique [0002] Thymopentin (TP-5) is an important functionally active part of TP. Its amino acid sequence and structure are the same as the 32-36 amino acids of thymopoietin II (thy-mopoletin II), and it can be synthesized artificially. The main physiological effect of thymopentin is to induce T cell differentiation, proliferation and maturation, and to increase the precursor pool of T cells. It can selectively induce Thy-1 prothymocytes to transform into Thy-1' T cells, and its mechanism of action is mediated by increasing intracellular cAMP levels. Thymopentin also has an effect on mature peripheral blood T cells. It can activate or regulate the number and function of different T cell subsets by stimulating the level of intracellular cAMP, so as to realize the two-way regulation of the entire body's immune system. [0003] Based on the abo...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/19A61K47/10A61K47/18A61K47/26A61P37/02
Inventor 刘伟强芦莉娜侯辉
Owner 上海华源药业(宁夏)沙赛制药有限公司
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