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Medicinal composition containing thymopentin compound

A composition and thymus technology, applied in the directions of drug combination, medical preparations containing active ingredients, pharmaceutical formulations, etc., can solve the problems of easy fluctuation of pH value, insufficient content, instability, etc., and achieve convenient use, rapid dissolution, good stability

Active Publication Date: 2013-03-27
姚云
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Thymopentin injections that have been on the market are freeze-dried powder injections, containing mannitol, and using sodium bicarbonate to adjust the pH value to achieve a suitable stable balance, so as to play a stabilizing effect, but low temperature storage is still required to avoid drug discoloration during use
In addition, during the production process, activated carbon is added for decolorization and then filtered, which may easily lead to insufficient content. The pH value of the product is prone to fluctuations during storage, which is unstable. At the same time, the dissolution rate is not ideal, and the validity period is only 12 months.

Method used

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  • Medicinal composition containing thymopentin compound
  • Medicinal composition containing thymopentin compound
  • Medicinal composition containing thymopentin compound

Examples

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Effect test

Embodiment 1

[0048] Thymopentin 1g;

[0049] Mannitol 150g;

[0050] EDTA calcium 2g;

[0051] Vitamin C 1.5g,

[0052] 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4,

[0053]

[0054] Preparation: First prepare 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above amount of thymopentin, mannitol, calcium EDTA, vitamin C and citric acid buffer solution to dissolve, then dilute to 2000ml with water for injection , It is filtered through a filter membrane with a pore size cutoff of 20,000 molecular weight, and after the clarity is qualified, it is filled, semi-plugged, freeze-dried in the box, and packaged. Among them, the preparation method of disodium hydrogen citrate and trisodium citrate buffer solution is as follows: weigh 13 g of disodium hydrogen citrate, and dissolve 60 g of trisodium citrate in 1000 ml of water for injection to obtain a buffer solution with a pH of 7.0.

Embodiment 2

[0056] Thymopentin 2g;

[0057] Mannitol 200g;

[0058] EDTA calcium 3g;

[0059] Vitamin C 2g,

[0060] 1000ml buffer solution of disodium hydrogen citrate and trisodium citrate with a molar ratio of 1:4

[0061]

[0062] Preparation: Preparation: First prepare 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above amount of thymopentin, mannitol, calcium EDTA, vitamin C and citrate buffer solution to dissolve, and then dilute with water for injection When the volume reaches 2000ml, it is filtered through a filter membrane with a pore size of 20,000 molecular weight cut-off. After the clarity is qualified, it is filled, half-press stopper, freeze-dried in the box, and packaged. Among them, the preparation method of disodium hydrogen citrate and trisodium citrate buffer solution is as follows: weigh 13 g of disodium hydrogen citrate, and dissolve 60 g of trisodium citrate in 1000 ml of water for injection to obtain a buffer solution with a pH of...

Embodiment 3

[0064] Thymopentin 0.5g;

[0065] 100g of mannitol;

[0066] EDTA calcium 1g;

[0067] Vitamin C 1g,

[0068] 1000ml buffer solution of disodium hydrogen citrate and trisodium citrate with a molar ratio of 1:4

[0069]

[0070] Preparation: Preparation: First prepare 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution, then take the above amount of thymopentin, mannitol, calcium EDTA, vitamin C and citric acid buffer to dissolve, and then dilute with water for injection When the volume reaches 2000ml, it is filtered through a filter membrane with a pore size of 20,000 molecular weight cut-off. After the clarity is qualified, it is filled, half-press stopper, freeze-dried in the box, and packaged. Among them, the preparation method of disodium hydrogen citrate and trisodium citrate buffer solution is as follows: weigh 13 g of disodium hydrogen citrate, and dissolve 60 g of trisodium citrate in 1000 ml of water for injection to obtain a buffer solution with a pH of...

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Abstract

The invention relates to a medicinal composition containing a thymopentin compound, and in particular relates to an injection as well as a formula, application and a preparation method thereof. Each 1,000 injections are prepared from the following components: 0.5 to 2g of thymopentin, 50 to 200g of mannitol, 1 to 3g of ethylene diamine tetraacetic acid (EDTA) calcium, 1 to 2g of vitamin C, 1,000ml of buffer solution of disodium hydrogen citrate and trisodium citrate at a mole ratio of 1: 4, and the balance of injection water to the volume of 2,000ml.

Description

Technical field: [0001] The invention relates to a new pharmaceutical preparation, in particular to an injection preparation of an immunomodulatory drug thymopentin, its prescription, application and preparation method. Background technique: [0002] Thymopentin (TP-5) is a synthetic pentapeptide (Arg-Lys-Asp-Val-Tyr), which corresponds to the amino acid sequence at positions 32 to 36 of thymopoietin, and has all the biological activities of natural thymopoietin. As an immunomodulatory drug, it has been used clinically for many years. At present, thymopentin is mainly in the form of powder injection. However, due to the influence of many factors, the dissolution speed of existing products is not satisfactory. It must be used immediately after dissolution. Although there are injection preparations of thymopentin, because thymopentin is unstable, it is necessary to add preservatives to stabilize it. For pharmaceutical preparations, water injection for injection is better than pow...

Claims

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Application Information

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IPC IPC(8): A61K38/08A61K9/19A61P37/02
Inventor 姚云
Owner 姚云
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