Thymopentin injecta liquid formulation

A technology for injection and thymus, which can be used in pharmaceutical formulations, drug delivery, allergic diseases, etc., and can solve problems such as adverse reactions, adverse effects of thymopentin drug stability, etc.

Inactive Publication Date: 2007-08-29
HAINAN ZHONGHE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the prescription of Thymopentin injection contains preservatives, it has brought certain adverse reactions. Therefore, it is beneficial for patients to develop a Thymopentin injection preparation that is easy to use while avoiding side effects.
[0003] It is generally believed that non-use of preservatives will have adverse effects on the stability of thymopentin drugs. At present, there is no report that the stability of thymopentin injections can be solved without using preservatives.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The whole process is completed under the condition of 100-level laminar flow.

[0051] Weigh 9000mg of sodium chloride and 400mg of sodium acetate, put them in a dry and sterilized container, add 800ml of water for injection to stir and dissolve, continue to add 1000mg of thymopentin to the solution, stir to dissolve, adjust the pH value with acetic acid to 6.0-7.0, add water for injection to make up to 1000ml. Sterilize and filter with a 0.22 μm microporous membrane. Each pre-filled syringe is filled with 1.0ml, and a total of 1,000 are obtained, which are plugged with push rods, sealed in aluminum and plastic, labeled, and packaged.

Embodiment 2

[0053] The whole process is completed under the condition of 100-level laminar flow.

[0054] Weigh 9000mg of sodium chloride and 100mg of sodium acetate, put them in a dry and sterilized container, add 800ml of water for injection, stir and dissolve, then continue to add 10000mg of thymopentin to the solution, stir to dissolve, adjust the pH with acetic acid to 6.0-7.0, add water for injection to make up to 1000ml. Sterilize and filter with a 0.22 μm microporous membrane. Each pre-filled syringe is filled with 1.0ml, and a total of 1,000 are obtained, which are plugged with push rods, sealed in aluminum and plastic, labeled, and packaged.

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PUM

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Abstract

The present invention relates to a prescription of thymus pentapetide injection. Said prescription includes 1-100 mg of thymus pentapeptide, 0-100 mg of anhydrous sodium acetate, 0-50 mg of citric acid, 300-1000 mg of sodium chloride and 0.2-5 ml of injection water. Said thymus pentapeptide injection can be made into ampule package form.

Description

technical field [0001] The invention relates to a new pharmaceutical preparation, in particular to an injection preparation of the immunoregulatory drug thymopentin, its prescription, application and preparation method. Background technique [0002] Thymopentin, as an immunomodulatory drug, has been used clinically for many years. At present, thymopentin is mainly in the form of powder injection, and its formula does not contain preservatives. Although thymopentin also has injection preparations, because thymopentin is unstable, it needs to be stabilized by adding preservatives. For pharmaceutical preparations, liquid injection injections are superior to powder injections in terms of ease of use. However, because the prescription of Thymopentin injection contains preservatives, it has brought certain adverse reactions. Therefore, it is beneficial for patients to develop a Thymopentin injection preparation that is easy to use and avoid side effects. [0003] It is generally...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K9/08A61P37/02
Inventor 杨顶建凌振宏
Owner HAINAN ZHONGHE PHARM CO LTD
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