Thymalfasin-containing medicinal composition and preparation method thereof

A technology of thymus method and composition, which is applied in the direction of medical preparations containing active ingredients, medical preparations of non-active ingredients, drug combinations, etc., and can solve problems such as schemes and test data that do not specify mannitol stabilizers

Active Publication Date: 2011-11-23
HAINAN ZHONGHE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The literature does not indicate the protocol and test data of mannitol in combination with other polyols as a stabilizer
At the same time, literature data show that, in the 30-day stability study using the protocol described in the literature, the content of thymofasin (thymosin α1) decreased greatly (related substances increased), and the validity period of thymofaxin preparations is generally 2 years. It is foreseeable that within the period of validity, the scheme of this document may not meet the indicators under the relevant substances and contents newly stipulated in the 2010 version of the Thymus Law

Method used

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  • Thymalfasin-containing medicinal composition and preparation method thereof
  • Thymalfasin-containing medicinal composition and preparation method thereof
  • Thymalfasin-containing medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]

[0041] Take 500ml of the above-mentioned liquid composition, sub-package, freeze-dry, add bromobutyl rubber stoppers, and roll aluminum-plastic combined caps to make 500 freeze-dried powder injections containing thymus fasin.

[0042] In addition, 500 ml of the liquid composition was taken, divided into packages, added with bromobutyl rubber stoppers, and rolled aluminum-plastic composite caps to make 500 sticks of Thymus Faxin Injection.

Embodiment 2

[0044]

[0045] Take 500ml of the above-mentioned liquid composition, sub-package, freeze-dry, add bromobutyl rubber stoppers, and roll aluminum-plastic combined caps to make 500 freeze-dried powder injections containing thymus fasin.

[0046] In addition, 500 ml of the liquid composition was taken, divided into packages, added with bromobutyl rubber stoppers, and rolled aluminum-plastic composite caps to make 500 sticks of Thymus Faxin Injection.

Embodiment 3

[0048]

[0049] Take 500ml of the above-mentioned liquid composition, sub-package, freeze-dry, add bromobutyl rubber stoppers, and roll aluminum-plastic combined caps to make 500 freeze-dried powder injections containing thymus fasin.

[0050] In addition, 500 ml of the liquid composition was taken, divided into packages, added with bromobutyl rubber stoppers, and rolled aluminum-plastic composite caps to make 500 sticks of Thymus Faxin Injection.

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PUM

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Abstract

The invention belongs to the field of medicaments, and particularly relates to a medicinal composition, in particular to a thymalfasin-containing medicinal composition and a preparation method thereof. The medicinal composition comprises the following components: thymalfasin, mannitol and sorbitol, wherein the weight ratio of the thymalfasin to the mannitol to the sorbitol is 16:(25-75):(25-75); and the thymalfasin, the mannitol and the sorbitol are processed and prepared into injection or freeze-dried powder injection. The medicinal composition has high medicinal stability.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition, in particular to a thymofasin medicinal composition, which can be prepared into injection liquid or freeze-dried to make thymofasin for injection, and has good drug stability. Background technique: [0002] Thymalfasin, also known as thymosin α1, thymosin α1, its polypeptide sequence is: N-Acceyl-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: 3108.28. [0003] Thymus fasin for injection is a drug developed by SciClone Pharmaceuticals International for treating hepatitis B and improving immunity. The trade name is ZADAXIN, which is domestically produced and Japanese. Wait for the thymus method for injection to be newly listed. Thymus fasin for injection is stored at 2-8°C. The import standard JX19990203 and the 2010 edition of the Chinese Pharmacopoeia st...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K38/22A61K47/10A61P1/16A61P31/20A61P37/04
Inventor 崔学云杨平
Owner HAINAN ZHONGHE PHARM CO LTD
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