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Thymalfasin-containing drug composition and preparation thereof

A technology of thymus method and composition, which is applied in the field of medicine, can solve problems such as platelet aggregation chain reaction and vascular endothelial cell damage, and achieve the effects of easy industrial production, convenient storage and transportation, and low production cost

Active Publication Date: 2014-05-21
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Chinese patent application 201110220652 discloses a medicinal composition containing thymofasin and a preparation method thereof. The pharmaceutical composition contains the following ingredients: thymofasin, mannitol, sorbitol 0.01M acetic acid-sodium acetate buffer solution to adjust the pH 3.8~4.2, but the pH value of normal human blood is 7.35~7.45, the solution outside this range will cause damage to vascular endothelial cells, and induce platelet aggregation and a chain reaction of thrombophlebitis

Method used

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  • Thymalfasin-containing drug composition and preparation thereof
  • Thymalfasin-containing drug composition and preparation thereof
  • Thymalfasin-containing drug composition and preparation thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0063] Under clean conditions, put 40g of mannitol into the liquid preparation device, add 700ml of water for injection and stir to dissolve, cool to room temperature, add 1.8g of disodium hydrogen phosphate, 0.2g of sodium dihydrogen phosphate, stir well, add 0.1% ( g / ml) with activated carbon for needles, stirred and adsorbed, and filtered to remove carbon; after the above preparation solution dropped to room temperature, add 1.5g thymus fasin, measure the pH value, and adjust the pH to 6.53 with sodium phosphate buffer (pH=7.2). , and then adjust the pH to 6.65 with tris-hydrochloric acid buffer solution (pH 7.7), add water for injection to the full amount, and filter through a 0.22 μm microporous membrane to obtain the Thymusfaxin filtrate. Dispense 3ml into ampoules, freeze-dry for 72 hours to make sterile freeze-dried powder injection.

Embodiment 2

[0065] Under clean conditions, put 45g of mannitol into the liquid preparation device, add 700ml of water for injection and stir to dissolve, cool to room temperature, add 1.9g of disodium hydrogen phosphate, 0.3g of sodium dihydrogen phosphate, stir well, add 0.1% ( g / ml) with activated carbon for needles, stirred and adsorbed, and filtered to remove carbon; after the above preparation solution dropped to room temperature, add 1.6g thymus fasin, measure the pH value, and adjust the pH to 6.55 with sodium phosphate buffer (pH=7.2). , and then adjust the pH to 6.7 with tris-hydrochloric acid buffer solution (pH 7.7), add water for injection to the full amount, and filter through a 0.22 μm microporous membrane to obtain the thymus method new filtrate. Dispense 3ml into ampoules, freeze-dry for 72 hours to make sterile freeze-dried powder injection.

Embodiment 3

[0067] Under clean conditions, put 50g of mannitol into the liquid dispensing device, add 700ml of water for injection and stir to dissolve, cool to room temperature, add 2.0g of disodium hydrogen phosphate, 0.4g of sodium dihydrogen phosphate, stir well, add 0.1% ( g / ml) with activated carbon for needles, stirred and adsorbed, and filtered to remove carbon; after the above preparation solution dropped to room temperature, add 1.7g thymusfasin, measure the pH value, and adjust the pH to 6.6 with sodium phosphate buffer (pH=7.2). , and then adjust the pH to 7.0 with tris-hydrochloric acid buffer solution (pH 7.7), add water for injection to the full amount, and filter through a 0.22 μm microporous membrane to obtain the thymus method new filtrate. Dispense 3ml into ampoules, freeze-dry for 72 hours to make sterile freeze-dried powder injection.

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PUM

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Abstract

The invention belongs to the technical field of medicine, and provides a thymalfasin-containing drug composition and a preparation thereof. According to the present invention, the lyophilized powder provided for injection and prepared from the composition has characteristics of good solubility, good stability, good reconstituting property, easy use and easy storage and transportation; and the preparation method has characteristics of simpleness, easy industrialization production, and low production cost.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a thymus-containing pharmaceutical composition and preparation thereof. . Background technique [0002] Thymusfasin (also known as thymosin α1), the molecular formula is C 129 h 215 N 33 o 55 , is a polypeptide composed of 28 amino acids, the relative molecular mass is 3108.28, it is white or off-white powder, and its amino acid composition sequence is [0003] 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. [0004] In the early 1980s, laboratories such as Merrifield in the United States artificially synthesized thymus method new products. At present, the new thymus method products of Sciclone in the United States and Sclavo SPA in Italy have been listed in Italy and other countries. The trade name is Zadxin (Ridaxian). It has entered the Chinese market at the end of the last centu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/22A61K47/18A61K47/02
Inventor 姜波董伟王梅袁春玲
Owner 长春海悦药业股份有限公司
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