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Lyophilized composition for injection containing thymalfasin and preparation method thereof

A thymosin and composition technology, which is applied in the field of medicine, can solve the problems that the stability cannot meet the requirements of the stability of injections, potential safety hazards, and shorten the storage period of injections, and achieves high-quality reliability, less energy consumption, and residual moisture. less effect

Inactive Publication Date: 2013-06-12
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] At present, most studies on the stability of thymusfaxin freeze-dried powder preparations are aimed at the selection of excipients or pH regulators. Although some achievements have been made, their stability still cannot meet the stability of injections after long-term storage. Therefore, the storage period of injections is shortened, and there are potential safety hazards in clinical medication.

Method used

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  • Lyophilized composition for injection containing thymalfasin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Weigh 50g of mannitol, disodium hydrogen phosphate (as Na 2 HPO 4 Calculated) 0.71g, sodium dihydrogen phosphate (as NaH 2 PO 4 Add 0.6g into the auxiliary material tank, add 1200mL water for injection, and stir to dissolve. Add the wetted activated carbon, stir and absorb for 20 minutes, then turn off the stirring, use clean compressed air as the power, pass the solution through a titanium rod, decarbonize, and put it into the liquid mixing tank, and rinse the auxiliary materials with water for injection to obtain the first filtrate. Add water for injection to 1800mL in the batching tank, control the water temperature at 25 o Below C, stir, and after detecting that the pH of the solution is 6.4~7.2, slowly add 1.6g of thymofasin into the batching tank, and stir to dissolve. After detecting that the pH of the solution is 6.4~7.2, continue to add water for injection to 2000mL, and after stirring for 5~15 minutes, filter the medicinal solution through a 0.22μm micropo...

Embodiment 2

[0051] Weigh 50g of mannitol, disodium hydrogen phosphate (as Na 2 HPO 4 Calculated) 0.71g, sodium dihydrogen phosphate (as NaH 2 PO 4 Add 0.6g into the auxiliary material tank, add 1000mL water for injection, and stir to dissolve. Add the wetted activated carbon, stir and absorb for 20 minutes, then turn off the stirring, use clean compressed air as the power, pass the solution through a titanium rod, decarbonize, put it into the liquid mixing tank, and rinse the auxiliary materials with water for injection to obtain the first filtrate. Add water for injection to 1300mL in the batching tank, control the water temperature at 25 o Below C, stir, slowly add 1.6g of thymus fasin into the batching tank, stir to dissolve. Continue to add water for injection to 1500mL, continue to stir for 5-15 minutes, then filter the medicinal solution through a 0.22μm microporous membrane to obtain the second filtrate, and divide the filtrate into vials, each 1.5mL.

[0052] Freeze-drying pr...

Embodiment 3

[0054] Weigh 50g of mannitol, disodium hydrogen phosphate (as Na 2 HPO 4 Calculated) 0.71g, sodium dihydrogen phosphate (as NaH 2 PO 4 Add 0.6g into the auxiliary material tank, add 2200mL water for injection, and stir to dissolve. Add the wetted activated carbon, stir and absorb for 20 minutes, then turn off the stirring, use clean compressed air as the power, pass the solution through a titanium rod, decarbonize, put it into the liquid mixing tank, and rinse the auxiliary materials with water for injection to obtain the first filtrate. Control the water temperature at 25 o Below C, stir, slowly add 1.6g thymofasin into the batching tank, stir to dissolve. Continue to add water for injection to 2500mL, continue to stir for 5-15 minutes, then filter the medicinal solution through a 0.22μm microporous membrane, and divide the filtrate into 2.5mL vials.

[0055] Freeze-drying process: same as Example 1.

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a lyophilized composition for injection containing thymalfasin and a preparation method thereof. By changing the preparation process of the lyophilized composition for injection containing thymalfasin, the lyophilized composition for injection containing thymalfasin higher in stability and quality can be obtained. Meanwhile, the condition that concentration of a pH adjustor is locally overhigh with a short time in the process of dissolving the liquid of auxiliary materials and thymalfasin is avoided. The lyophilized composition for injection containing thymalfasin provided by the invention has the advantages of high reliability in quality, easiness in industrialized production, energy saving and the like.

Description

[0001] technical field [0002] The invention belongs to the technical field of medicines, and in particular relates to a new freeze-dried composition for injection of thymus method and a preparation method thereof. [0003] Background technique [0004] In 1965, Goldstein et al. first isolated a biologically active polypeptide from animal thymus and named it thymosin. Since then, people have deepened their understanding of thymosin and used it as a new treatment method for human diseases, especially immunodeficiency, tumors and infectious diseases. The treatment of diseases is especially concerned by people. At present, there are many polypeptides isolated from the thymus and called thymus hormones, and one of the most clearly recognized is thymosin component 5 (TF5). Animal experiments and human experiments have shown that TF5 can correct many immune deficiencies caused by thymus function, and is also used to treat viral and infectious diseases. Adding TF5 to tumor treat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/22A61K39/00A61K39/39A61P31/20A61P31/14A61P1/16A61P31/18A61P35/00A61P37/04
Inventor 陈庆财蔡继兰赵砚荣杨奇珍
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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