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A kind of solution for preparing new preparation of thymus method and method of using the solution to prepare new preparation of thymus method

A technology of new thymus method and solution, which is applied in the field of preparation of new thymus method preparation solution and preparation of new thymus method preparation, which can solve the problems that may be brought into the final freeze-drying solution, so as to shorten the freeze-drying cycle and keep Better porosity and stability

Active Publication Date: 2017-06-23
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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  • A kind of solution for preparing new preparation of thymus method and method of using the solution to prepare new preparation of thymus method
  • A kind of solution for preparing new preparation of thymus method and method of using the solution to prepare new preparation of thymus method
  • A kind of solution for preparing new preparation of thymus method and method of using the solution to prepare new preparation of thymus method

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 new preparation of thymus and a method for preparing a new preparation of thymus using the solution. The pH value of the solution is 4-5, and every 1000ml of the solution contains 1-3g of thymus Faxin, 35-55g stabilizer, 50-70ml co-solvent, the balance is pH regulator and water for injection. The new thymus method preparation prepared by the solution of the present invention has better stability, shorter freeze-drying period and the obtained freeze-dried product still maintains porosity.

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 Patents(China)
IPC IPC(8): A61K38/22A61K47/18A61K9/08A61P37/02A61P1/16A61P31/20A61P31/14
Inventor 刘湘艳王文琪崔颀周逸明
Owner SHANGHAI SOHO YIMING PHARMA
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