Solution for preparing thymalfasin preparation and method for preparing thymalfasin preparation by virtue of solution

A thymus method new solution technology, applied in the preparation of thymus method new preparation solution, the field of preparation of thymus method new preparations, can solve the problems that may be brought into the final freeze-drying solution, shorten the freeze-drying cycle, stabilize Better performance and maintain porosity

Active Publication Date: 2015-05-06
SHANGHAI SOHO YIMING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Under normal circumstances, water is the only solvent, but sometimes the organic solvent remaining in the extraction and crystallization process of the drug may also be brought into the final freeze-drying solution, which will lead to some new changes

Method used

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  • Solution for preparing thymalfasin preparation and method for preparing thymalfasin preparation by virtue of solution
  • Solution for preparing thymalfasin preparation and method for preparing thymalfasin preparation by virtue of solution
  • Solution for preparing thymalfasin preparation and method for preparing thymalfasin preparation by virtue of solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1000ml is used to prepare the solution of thymusfasin preparation, which contains 1.7g thymusfasin (pure peptide), 45g glycine, 60ml tert-butanol, and the balance is the amount of lemon used to adjust the pH value of the solution to 4-5 Acid saturated aqueous solution and water for injection.

[0024] Use this solution to prepare the method for thymus method new preparation, comprise the following steps:

[0025] (1) Dissolve 45g of glycine in about 900ml of water, then add 60ml of tert-butanol, and stir slowly until the solution is clear;

[0026] (2) Add 1.7 g of thymofaxin to the solution obtained in step (1), and stir slowly until thymofaxin is completely dissolved;

[0027] (3) Adjust the pH value of the solution obtained in step (2) to 4.0-5.0 with a saturated aqueous solution of citric acid;

[0028] (4) Dilute the solution obtained in step (3) to 1000ml with water for injection;

[0029] (5) After the solution obtained above is aseptically filtered through a ...

Embodiment 2

[0033] 1000ml of solution for preparing thymusfaxin preparation, which contains 1.2g thymusfaxin (pure peptide), 40g alanine, 70ml n-butanol, and the rest is to adjust the pH value of the solution to 4-5. The weight content is 10% lactic acid aqueous solution and water for injection.

[0034] Use this solution to prepare the method for thymus method new preparation, comprise the following steps:

[0035] (1) Dissolve 40g of alanine in about 880ml of water, then add 70ml of n-butanol, and stir slowly until the solution is clear;

[0036] (2) Add 1.2 g of thymofasin to the solution obtained in step (1), and stir slowly until thymofasin is completely dissolved;

[0037] (3) adjusting the pH value of the solution obtained in step (2) to 4.0-5.0 with 10% lactic acid aqueous solution by weight;

[0038] (4) Dilute the solution obtained in step (3) to 1000ml with water for injection;

[0039] (5) After the solution obtained above is aseptically filtered through a 0.22μ microporous...

Embodiment 3

[0043] 1000ml is used to prepare the solution of thymusfasin preparation, which contains 2.5g thymusfasin (pure peptide), 50g serine, 50ml isobutanol, and the balance is the weight of the amount used to adjust the pH value of the solution to 4-5 15% maleic acid aqueous solution and water for injection.

[0044] Use this solution to prepare the method for thymus method new preparation, comprise the following steps:

[0045](1) Dissolve 50g of serine in 870ml of water for injection, then add 50ml of isobutanol, and stir slowly until the solution is clear;

[0046] (2) Add 2.5g thymofaxin to the solution obtained in step (1), and stir slowly until thymofaxin is completely dissolved;

[0047] (3) adjusting the pH value of the solution obtained in step (2) to 4.0 to 5.0 with a 15% maleic acid aqueous solution by weight;

[0048] (4) Dilute the solution obtained in step (3) to 1000ml with water for injection;

[0049] (5) After the solution obtained above is aseptically filtered ...

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Abstract

The invention provides a solution for preparing a thymalfasin preparation and a method for preparing the thymalfasin preparation by virtue of the solution. The pH value of the solution is 4-5, and each 1000ml of the solution contains 1-3g of a thymalfasin preparation, 35-55g of a stabilizer, 50-70ml of a cosolvent and the balance of a pH regulator and injection water. The thymalfasin preparation prepared by the solution disclosed by the invention is better in stability and shorter in freeze-drying cycle; and meanwhile, a freeze-dried product is porous.

Description

technical field [0001] The present invention relates to a solution, and more particularly, to a solution for preparing a thymus preparation and a method for preparing a thymus preparation using the solution. Background technique [0002] Thymus fasin, also known as Thymosin-α1 (Thymosin-α1), was first discovered in thymus tissue by Goldstein et al. Lung, spleen and other organs are also distributed. As an immunomodulator, thymofasin has been shown to have significant curative effects on hepatitis B and C, as well as certain curative effects on tumors and AIDS. In addition, thymofasin can be used as a vaccine adjuvant to enhance the response of immunocompromised patients to vaccines such as influenza and hepatitis B vaccines. According to statistics from the Ministry of Health, there are currently 120 million hepatitis B surface antigen-positive people in my country, and 30 million of them will be transformed into chronic hepatitis, cirrhosis or liver cancer. Therefore, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/22A61K47/18A61K9/08A61P37/02A61P1/16A61P31/20A61P31/14
Inventor 刘湘艳王文琪崔欣周逸明
Owner SHANGHAI SOHO YIMING PHARMA
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