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Thymopentin injection and preparation method thereof

A preparation method and injection technology, applied in the field of medicine, can solve the problems of short storage time, short storage time, unstable thymopentin and the like

Active Publication Date: 2015-11-04
BEIJING SHIQIAO BIOPHAM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, thymopentin is unstable and has a short storage time, especially for injection preparations.

Method used

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  • Thymopentin injection and preparation method thereof
  • Thymopentin injection and preparation method thereof
  • Thymopentin injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Such as figure 1 A kind of preparation method of Thymopentin injection shown is characterized in that, comprises the steps:

[0028] Step 1) Preparation of auxiliary materials:

[0029] Add water for injection into the auxiliary material preparation tank, weigh sodium citrate, sodium chloride and glucose into the auxiliary material preparation tank, stir and dissolve for 10 minutes; add 7.3 grams of sodium citrate and 4.5 grams of chloride to 1L of water for injection Sodium, 4.5 grams of glucose;

[0030] Step 2) Filter:

[0031] Use nitrogen to pressurize the auxiliary material preparation tank, so that the liquid in the auxiliary material preparation tank enters the medicinal liquid preparation tank through the sterilizing filter element; the pressure of nitrogen is 0.10-0.15Mpa;

[0032] Step 3) liquid medicine configuration:

[0033] Thymopentin is added to the liquid medicine preparation tank, stirred for 15-30in, preferably 20min, while stirring, adjust the p...

Embodiment 2

[0040] Thymopentin injection was made according to the preparation steps of Example 1, and pure Thymopentin injection was used as a contrast, wherein nitrogen protection was not added in the production process of control group 1, and all the other conditions were completely consistent with the experimental group; The production conditions are exactly the same. Stability tests at elevated temperatures were performed. Wherein the concentration determination method of thymopentin adopts the high performance liquid chromatography in Chinese Pharmacopoeia to measure.

[0041] Chromatographic conditions and system adaptability test: use octadecylsilane bonded silica gel as filler, 0.05mol / L phosphate buffer (pH7.0)-methanol (90:10) as mobile phase; detection wavelength is 275nm, The number of theoretical plates should not be less than 3000 based on the thymopentin peak.

[0042] Thymopentin content=(average peak area of ​​test solution / average peak area of ​​comparison solution)*1...

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Abstract

The invention discloses a thymopentin injection and a preparation method thereof. The thymopentin injection comprises, by weight, 1-10 parts of thymopentin, 6-8 parts of sodium citrate, 4-5 parts of sodium chloride, 4-5 parts of glucose and 1000 parts of water for injections, and PH of the thymopentin injection ranges from 7.7 to 7.9. According to the thymopentin injection and the preparation method thereof, by means of addition of a certain amount of the sodium citrate solution, the sodium chloride solution and the glucose solution and the certain preparation technology, the storage time of the thymopentin injection is greatly prolonged, and the effective storage time of the thymopentin injection reaches more than 24 months.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a thymopentin injection and a preparation method thereof. Background technique [0002] Thymopentin is a polypeptide composed of five amino acids, arginine, lysine, aspartic acid, valine, and tyrosine, corresponding to the amino acid sequence at positions 32 to 36 of thymopoietin, and has natural thymus The full biological activity of Genogenin. One of the functions of thymopentin is to induce the differentiation of T cells. Under normal body conditions, thymopentin exhibits immunostimulatory effects, and can enhance the initial or second response of the immune response. Thymopentin can also enhance the phagocytosis of macrophages, increase the content of circulating antibodies, and enhance the immune function of red blood cells. [0003] Thymopentin can be used for the treatment of hepatitis B, various primary or secondary T cell deficiency diseases, rheumatoid arthritis, systemic lup...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/08A61K47/12A61K47/26A61K47/02A61P35/00A61P31/20A61P37/00A61P29/00A61P19/02A61P37/04
Inventor 冯桂深云穗生林韶辉魏荣宝段洪艳魏存乐申京建刘亚利曲毅
Owner BEIJING SHIQIAO BIOPHAM
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