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Thymosin alpha-1 aqua prepn and its prepn process and application

A technology of thymosin and aqueous solution, which is applied in the direction of medical preparations containing active ingredients, antiviral agents, and pharmaceutical formulas, and can solve the problems of increasing operation steps, stability of thymosin α1, and single dosage form

Active Publication Date: 2007-10-17
北京双鹭立生医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Due to the limitation of stability and other indicators, currently there is only freeze-dried powder injection of thymosin α1 on the market. This dosage form needs to be dissolved when used, which increases the chance of drug contamination while increasing the operation steps.
The present invention just aims at the single situation of thymosin α1 dosage form at present, creates the aqueous solution preparation of thymosin α1, solves the stability problem of thymosin α1 in aqueous solution, and this is the main purpose of the present invention

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The preparation of the pharmaceutical preparation described in embodiment 1, claim 7

[0056] Accurately weighed sodium chloride 7.0g, disodium hydrogen phosphate (containing 12 crystal water) 4.37g, sodium dihydrogen phosphate (containing 2 crystal water) 1.22g, edetate disodium 0.64g, thymosin α 11.6g , dissolved in water for injection, finally dissolved to 1000ml, and divided into 1000 vials with 2ml. The final specification is 1.6mg / support. According to this prescription, a total of 3 batches of samples were produced, numbered 01, 02, and 03 respectively. The operating procedures are carried out as described in the manual.

Embodiment 2

[0057] The preparation of the pharmaceutical preparation described in embodiment 2, claim 10

[0058] Accurately weighed sodium chloride 7.0g, disodium hydrogen phosphate (containing 12 crystal water) 4.37g, sodium dihydrogen phosphate (containing 2 crystal water) 1.22g, edetate disodium 0.64g, thymosin α 11.6g 1. Hydroxypropyl β-cyclodextrin 20g, dissolved in water for injection, finally dissolved to 1000ml, subpacked into 1000 sticks with 2ml vials. The final specification is 1.6mg / support. A total of 1 batch of samples, numbered 04, was produced according to the prescription. The operating procedures are carried out as described in the manual.

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Abstract

The present invention relates to one kind of thymosin alpha-1 aqua preparation and its preparation process and application in preparing medicine for treating chronic viral hepatitis and other immunological damage diseases. The preparation consists of thymic pentapeptide in 0.1-1000 mg each 0.1-500 ml, medicinal supplementary material, which may be mannitol, polyglycol, cyclodextrin, etc., and water. The preparation process includes compounding, sterilizing, packing, and other steps. The thymosin alpha-1 aqua preparation has high stability, easy preparation and other features, and has wide application foreground in preparing medicine for treating chronic viral hepatitis and other immunological damage diseases.

Description

technical field [0001] The invention relates to the field of medicines and preparations thereof. The core of the invention is to provide a new preparation of thymosin α1, its preparation method and its application in the preparation of medicines for treating chronic viral hepatitis and immune impairment. Background technique [0002] Thymosin α1 (Thymosin-α1, Tα1) is a polypeptide hormone with strong immune activity secreted by the thymus, the central immune organ of the human body. It was first discovered in 1966 and was successfully isolated in 1975. The amino acid sequence and nuclear nucleotide sequence. In the early 1990s, Tα1, which was produced by foreign chemical synthesis methods, entered Phase III human clinical trials and was launched in the United States in 1998. [0003] Tα1 molecule contains 28 amino acids, widely present in the body's thymus epithelial cells, peripheral blood, brain, pituitary, semen, follicular fluid and amniotic fluid. Tα1 can promote the...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61P1/16A61P31/14
Inventor 徐明波吴彦卓王勇波卢安京陈遥杨仲凡刘成东李振武邵兵王俊玲邓迪歌蔡祥胜
Owner 北京双鹭立生医药科技有限公司
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