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Thymalfasin-containing freeze-dried preparation

A new technology of freeze-dried preparation and thymus method, which is applied in the field of medicine, can solve the problems of increased impurity content and poor stability, and achieves the effect of improving the bacteriostatic effect, shortening the freeze-drying period, and having a significant curative effect.

Active Publication Date: 2013-03-06
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stability of this patent is not very good, and the impurity content increases significantly after a long period of storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription:

[0030]

[0031] Preparation:

[0032] 1. Take 50% of the prescribed amount of water for injection, add tert-butanol, mannitol, and sodium acetate in sequence and stir to dissolve.

[0033] 2. Take the prescribed amount of Thymus Faxin and add it to the above-mentioned solution, stir to dissolve completely.

[0034] 3. Adjust the pH value of the solution to 5.5-6.5 with 0.5M acetic acid or sodium acetate.

[0035] 4. Dilute the above solution to 1000ml with water for injection.

[0036] 5. Use a tangential flow ultrafiltration system with a molecular weight cut-off of 5,000 Daltons to filter the above-mentioned medicinal solution to remove heat sources and possible microorganisms, and detect the content of thymosin in it.

[0037] 6. Divide the liquid medicine obtained above into 1ml colorless medium borosilicate glass vials, and half stoppered.

[0038] 7. Put the control bottle containing the above-mentioned liquid medicine into the cold trap of ...

Embodiment 2

[0041] prescription:

[0042]

[0043] Preparation:

[0044] 1. Take 50% of the prescribed amount of water for injection, add tert-butanol, mannitol, and sodium acetate in sequence and stir to dissolve.

[0045] 2. Take the prescribed amount of Thymus Faxin and add it to the above-mentioned solution, stir to dissolve completely.

[0046] 3. Adjust the pH value of the solution to 5.5-6.5 with 0.5M acetic acid or sodium acetate.

[0047] 4. Dilute the above solution to 1000ml with water for injection.

[0048] 5. Use a tangential flow ultrafiltration system with a molecular weight cut-off of 5,000 Daltons to filter the above-mentioned medicinal solution to remove heat sources and possible microorganisms, and detect the content of thymosin in it.

[0049] 6. Divide the liquid medicine obtained above into 1ml colorless medium borosilicate glass vials, and half stoppered.

[0050] 7. Put the control bottle containing the above-mentioned liquid medicine into the cold trap of ...

Embodiment 3

[0053] prescription:

[0054]

[0055] Preparation:

[0056] 1. Take 50% of the prescribed amount of water for injection, add tert-butanol, mannitol, and sodium acetate in sequence and stir to dissolve.

[0057] 2. Take the prescribed amount of Thymus Faxin and add it to the above-mentioned solution, stir to dissolve completely.

[0058] 3. Adjust the pH value of the solution to 5.5-6.5 with 0.5M acetic acid or sodium acetate.

[0059] 4. Dilute the above solution to 1000ml with water for injection.

[0060] 5. Use a tangential flow ultrafiltration system with a molecular weight cut-off of 5,000 Daltons to filter the above-mentioned medicinal solution to remove heat sources and possible microorganisms, and detect the content of thymosin in it.

[0061] 6. Divide the liquid medicine obtained above into 1ml colorless medium borosilicate glass vials, and half stoppered.

[0062] 7. Put the control bottle containing the above-mentioned liquid medicine into the cold trap of th...

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PUM

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Abstract

The invention relates to a thymalfasin-containing freeze-dried preparation. The freeze-dried preparation is prepared from thymalfasin serving as an active ingredient and pharmaceutically-acceptable auxiliary materials. Tert-butyl alcohol is added into a prescription, and the pH value of a solution is adjusted by adopting an acetate buffer solution before freeze drying, so that the freeze drying period is shortened, degradation of main medicaments in a preparation process is suppressed, the stability of main medicaments is enhanced, and the quality of a product is ensured.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a new freeze-dried preparation of the thymus method and a preparation method thereof. Background technique [0002] Thymalfasin (Thymalfasin), also known as thymosin a1, thymosin a1, its amino acid sequence is: N-Acetyl-Ser-Asp-Ala-Ala-Val-Asp-Thr-Ser-Ser-Glu-Ile-Thr -Thr-Lys-Asp-Leu-Lys-Glu-Lys-Lys-Glu-Val-Val-Glu-Glu.-Ala-Glu-Asn-OH, the molecular formula is: C 129 h 215 N 33 o 35 , Molecular weight: 3108.280. [0003] [0004] Thymus fasin for injection is a drug developed by SciClone Pharmaceuticals International to treat hepatitis B and improve immunity. [0005] SciClone Pharmaceuticals International announced in its new instructions for Thymus for Injection listed in Italy that the composition of the preparation is mannitol, sodium dihydrogen phosphate monohydrate, and disodium hydrogen phosphate heptahydrate. In addition, the package also contains a b...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/22A61K47/12A61P1/16A61P31/20A61P37/04
Inventor 李宝齐董凯孙长海姚小青
Owner TIANJIN CHASE SUN PHARM CO LTD
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