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Injection liquid of thymic peptide alpha 1 and preparation method thereof

A technology of injection and thymosin, which is applied in the field of medicine, can solve the problems of complex freeze-dried powder injection production process, high cost, and poor stability of thymosin α1

Active Publication Date: 2006-10-04
CHENGDU SHENGNUO BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the thymosin α1 preparation is clinically used as freeze-dried powder injection, each bottle contains 11.6 mg of thymosin α, and it is dissolved in 1ml of water for injection before use and injected subcutaneously immediately. The production process of freeze-dried powder injection is complicated, the cost is high, and the use inconvenient
[0005] Like most peptide drugs, thymosin α1 has poor stability in ordinary aqueous solution. The thymosin α1 injection provided by the present invention has good stability and is convenient for clinical use. There is no report at home and abroad.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment one: formula 1

[0025] Thymosin α1 0.16g

[0026] Mannitol 1.0g

[0027] Glycine 1.0g

[0028] m-cresol 0.1g

[0029] Sodium dihydrogen phosphate amount

[0030] Add water for injection to 100ml

[0031] Portions of 100 bottles

[0032] Take thymosin α1 and auxiliary materials, add 80ml of water for injection, adjust the pH to 6.5 with sodium dihydrogen phosphate buffer solution, dilute to 100ml, sterilize and filter, pack 1.0ml in each bottle, and stopper, stopper, cover and tie Cover and serve.

Embodiment 2

[0033] Embodiment two: formula 2

[0034] Thymosin α1 0.16g

[0035] Mannitol 1.0g

[0036] Glycine 1.0g

[0037] m-cresol 0.1g

[0038] Sodium dihydrogen phosphate amount

[0039] Add water for injection to 100ml

[0040] Portions of 100 bottles

[0041] Take thymosin α1 and auxiliary materials, add 80ml of water for injection, adjust the pH to 7.0 with sodium dihydrogen phosphate buffer solution, dilute to 100ml, sterilize and filter, pack 1.0ml in each bottle, and stopper, stopper, cover and tie Cover and serve.

Embodiment 3

[0042] Embodiment three: formula 3

[0043] Thymosin α1 0.16g

[0044] Mannitol 1.0g

[0045] Glycine 1.0g

[0046] m-cresol 0.1g

[0047] Sodium dihydrogen phosphate amount

[0048] Add water for injection to 100m1

[0049] Portions of 100 bottles

[0050] Take thymosin α1 and auxiliary materials, add 80ml of water for injection, adjust the pH to 7.5 with sodium dihydrogen phosphate buffer solution, dilute to 100ml, sterilize and filter, pack 1.0ml in each bottle, and stoppering, pressing, capping and tying Cover and serve.

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PUM

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Abstract

Disclosed is a novel preparation of Thymosin alpha-1, which comprises Thymosin alpha-1, medicinal adjuvant and water for injection. The prepared Thymosin alpha-1 injection can be used as an immunity enhancement medicament for the treatment of chronic hepatitis B (HBV), hepatitis C (HCV), hepatocytecancer, melanocarcinoma, infectious disease, self-immune disease and malignant tumor.

Description

Technical field: [0001] The invention relates to the technical field of medicine, is a novel preparation of thymosin α1, and is characterized in that it relates to thymosin α1 injection and a preparation method thereof. Background technique: [0002] Thymosin α1 (Thymosin α1) is the main bioactive component of thymosin and an important immunomodulatory substance in the human body. Studies have shown that thymosin α1 promotes the development and differentiation of bone marrow stem cells into pro-lymphocytes and pro-lymphocytes; induces the differentiation and maturation of T lymphocytes, and further differentiates mature T cells into several different subgroups, such as killer cells, memory cells, Effector cells, helper T lymphocytes, etc., and produce various soluble media; enhance the response of lymphocytes to mitogens, and increase the synthesis of proteins and nucleic acids in lymphoid tissues; increase r-IFN, a-IFN, IL-2, Production of IL-3 and lymphotoxin, enhancing a...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K38/22A61K9/08A61P1/16A61P31/20A61P35/00A61P37/02
Inventor 文永均谢期林王晓莉
Owner CHENGDU SHENGNUO BIOPHARM
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