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Thymalfasin containing pharmaceutical composition

A technology of thymus method and composition, which is applied in the direction of drug combination, medical preparations containing active ingredients, pharmaceutical formulas, etc. It can solve problems such as poor patient compliance, affect the stability of finished products, and unstable quality, and achieve good stability. , the effect of great application value

Active Publication Date: 2018-09-04
YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Thymusfasin that has been on the market is all freeze-dried powder injections, such as imported Zidaxian, domestically produced Jitai, Maipuxin, Heri, etc. Thymusfasin is prepared into freeze-dried powder injections by adding stabilizers. Its stability has been improved to a certain extent, but it still needs to be stored at 2-8°C, and freeze-drying is a very complicated physical and chemical change process accompanied by heat and mass conversion. Various factors may affect the stability of the finished product: such as During the solution preparation process, there may be unstable quality and degradation reactions; high salt concentration caused by freeze-concentration during the freeze-drying process, pH value changes and surface effects caused by drying loss; moisture content of preparations, crystallization of excipients, etc.
And the administration mode of freeze-dried powder injection that has been listed is single, and the interval is short, and the duration is long, as its recommended dose in the treatment of chronic hepatitis B is every needle 1.6mg subcutaneous injection, twice a week, continuous administration for 6 months (total 52 needles), the period cannot be interrupted, and the patient's compliance with this way of administration is very poor

Method used

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  • Thymalfasin containing pharmaceutical composition
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  • Thymalfasin containing pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

1.0

[0015] Preparation:

[0016] 1) Preparation of mixed solution: Accurately weigh each material, add 50mL water / trifluoroacetic acid / dichloromethane mixed solvent (volume ratio 3:3:4) to dissolve completely;

[0017] 2) Liquefied CO 2 It is continuously introduced into the high-pressure crystallization kettle of the supercritical fluid crystallization equipment system through a high-pressure pump, and the flow rate is controlled at 30mL / min;

[0018] 3) Control temperature and pressure: control the pressure in the high-pressure crystallization kettle to 140bar, and control the temperature in the kettle to 40°C through the preheater and thermostat, so that the CO in the kettle 2 reaching a supercritical state;

[0019] 4) Solution injection: spray the solution prepared in step 1 into the crystallization kettle through the middle channel of the kettle head through a 150 μm nozzle. Before passing into the solution, first pass into the mixed solvent of water / trifluoro...

Embodiment 2

3.0

[0024] Preparation:

[0025] 1) Preparation of mixed solution: Accurately weigh each material, add 150mL water / trifluoroacetic acid / dichloromethane mixed solvent (volume ratio 4:3:3) to dissolve completely;

[0026] 2) Liquefied CO 2 It is continuously introduced into the high-pressure crystallization kettle of the supercritical fluid crystallization equipment system through a high-pressure pump, and the flow rate is controlled at 40mL / min;

[0027] 3) Regulate temperature and pressure: control the pressure in the high-pressure crystallization kettle to 150bar, and control the temperature in the kettle to 35°C through the preheater and thermostat, so that the CO in the kettle 2 reaching a supercritical state;

[0028] 4) Solution injection: spray the solution prepared in step 1 into the crystallization kettle through the middle channel of the kettle head through an 80 μm nozzle. Before passing into the solution, first pass into the mixed solvent of water / trifluo...

Embodiment 3

[0032] prescription:

[0033] Material composition

Prescription ratio (g)

Thymofasin

1.0

Pluronic F-127

1.5

hypromellose

2.0

[0034] Preparation:

[0035] 1) Preparation of mixed solution: Accurately weigh each material, add 140mL water / trifluoroacetic acid / dichloromethane mixed solvent (volume ratio 4:2:4) to completely dissolve;

[0036] 2) Liquefied CO 2 It is continuously introduced into the high-pressure crystallization kettle of the supercritical fluid crystallization equipment system through a high-pressure pump, and the flow rate is controlled at 60mL / min;

[0037] 3) Control temperature and pressure: control the pressure in the high-pressure crystallization kettle to 160bar, and control the temperature in the kettle to 30°C through the preheater and thermostat, so that the CO in the kettle 2 reaching a supercritical state;

[0038] 4) Solution injection: spray the solution prepared in step 1 into the crystallization...

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PUM

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Abstract

The invention discloses thymalfasin containing pharmaceutical composition. The pharmaceutical composition is prepared from thymalfasin and a pharmaceutically-acceptable high polymer material, whereinthe weight ratio of the thymalfasin to the pharmaceutically-acceptable high polymer material is 1 to (1 to 3). The pharmaceutical composition is prepared by the steps: dissolving the ingredients intoa water / trifluoroacetic acid / dichloromethane mixed solvent and separating out through supercritical fluid crystallization. The thymalfasin containing pharmaceutical composition disclosed by the invention has good stability and can be stored for a long time under room temperature; furthermore, the thymalfasin containing pharmaceutical composition with a specific release speed and the specific particle size can be obtained by choosing appropriate ingredients, the solvent and supercritical fluid crystallization conditions; thus, different drug use requirements can be met, and larger application value is achieved.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing thymus fasin. Background technique [0002] Thymofasin, also known as Thymosin-α1 (Thymosin-α1), is an important immunomodulatory substance in the human body, which can be used to treat chronic hepatitis B and enhance the immune system. It can also stimulate the migration of vascular endothelial cells, promote angiogenesis and wound Healing and other effects have been used in the clinical treatment and research of hepatitis B, hepatitis C, malignant tumors and immunodeficiency diseases. As an immunomodulator, Thymofasin has a clear mechanism of action and has been recognized and accepted by doctors and patients. [0003] Thymusfasin that has been on the market is all freeze-dried powder injections, such as imported Zidaxian, domestically produced Jitai, Maipuxin, Heri, etc. Thymusfasin is prepared into freeze-dried powder injections by adding stabilizers. Its stability has been improved...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61K47/10A61K47/12A61K47/06A61P37/04
CPCA61K38/22A61K47/06A61K47/10A61K47/12A61P37/04
Inventor 夏春森施猛钟艳红刘志强袁海成
Owner YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD