Immunomodulator polypeptide slow-release microsphere preparation and preparation method thereof

A slow-release technology for immunomodulators and polypeptides, which can be used in pharmaceutical formulations, peptide/protein components, medical preparations of non-active ingredients, etc. Dosing frequency, effect of improving adaptability

Inactive Publication Date: 2014-08-06
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These dosage forms all require multiple administrations, and the administration is troublesome. Therefore, developing a new type of preparation has become an important issue at present.

Method used

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  • Immunomodulator polypeptide slow-release microsphere preparation and preparation method thereof
  • Immunomodulator polypeptide slow-release microsphere preparation and preparation method thereof
  • Immunomodulator polypeptide slow-release microsphere preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Weigh 10g thymopentin, 5g gelatin, 5g glycerin and dissolve in purified water to obtain the inner water phase; weigh 160g polylactide and dissolve it in dichloromethane to obtain the oil phase; put the oil phase and the inner water phase in a stirrer In the room, put it on the emulsification disperser at room temperature at high speed (30000rpm) for 30 seconds to form a W / O emulsion; prepare 50ml of polyvinyl alcohol solution with a concentration of 5%, and then transfer the obtained W / O emulsion to 50ml5% Put it in the polyvinyl alcohol solution, place it on an emulsifying disperser at a speed of 5000rpm, and homogenize it for 1 minute to obtain a W / O / W type double emulsion; add the W / O / W double emulsion into purified water, and stir magnetically for 2 hours at room temperature, Remove the organic solvent, ultracentrifuge, collect the obtained microspheres, wash with distilled water for several times, then collect by centrifugation, add 5 g of sorbitol, and freeze-dry t...

Embodiment 2

[0027]Weigh 10g thymopentin, 2g gelatin, 2g glycerin and dissolve in purified water to obtain the inner water phase; weigh 45g polyglycolide and dissolve it in dichloromethane to obtain the oil phase; put the oil phase and the inner water phase under stirring In the container, put it on the emulsification disperser at room temperature at high speed (30000rpm) for 30 seconds to form a W / O emulsion; prepare 50ml of polyvinyl alcohol solution with a concentration of 5%, and then transfer the obtained W / O emulsion to 50ml5 % polyvinyl alcohol solution, placed on an emulsifying disperser at a speed of 5000rpm, and homogenized for 1 minute to obtain a W / O / W type double emulsion; add W / O / W double emulsion to purified water, and magnetically stir at room temperature for 2 hours , remove the organic solvent, ultracentrifuge, collect the obtained microspheres, wash with distilled water for several times, then collect by centrifugation, add 5g of mannitol, and freeze-dry to obtain a prepa...

Embodiment 3

[0038] Weigh 10g thymopentin, 2g gelatin, 2g glycerin and dissolve in purified water to obtain the inner water phase; weigh 25g polylactide-glycolide and dissolve it in dichloromethane to obtain the oil phase; mix the oil phase and the inner water phase Put it in a stirrer, and put it on an emulsifying disperser at room temperature at high speed (30000rpm) for 30 seconds to form a W / O emulsion; prepare 50ml of polyvinyl alcohol solution with a concentration of 5%, and then mix the obtained W / O emulsion Transfer to 50ml of 5% polyvinyl alcohol solution, put it on an emulsification disperser at a speed of 5000rpm, and mix it evenly for 1 minute to obtain a W / O / W double emulsion; add the W / O / W double emulsion to purified water, and magnetically Stir for 2 hours, remove the organic solvent, collect the obtained microspheres by ultracentrifugation, wash with distilled water for several times, then collect by centrifugation, add 2g of lactose, and freeze-dry to obtain an immunomodula...

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Abstract

The invention belongs to the field of medical preparations, and relates to an immunomodulator polypeptide slow-release microsphere preparation and a preparation method thereof. Particularly, the immunomodulator polypeptide comprises thymopentin, thymalfasin and thymosin beta4. The slow-release microsphere comprises 0.1-30% (w/w) of immunomodulator polypeptide, 60-80% of biodegradable high polymer material with biocompatibility, of which the molecular weight is 5,000-200,000 Dalton, and 0.1-20% of other pharmaceutical acceptable auxiliary materials on the basis of the total weight of the microsphere. According to the slow-release microsphere disclosed by the invention, the mean grain size is 5-60mu m; the encapsulation efficiency is greater than 90%; the slow release period of the slow-release microsphere can be up to a few days and months, the medication times is obviously reduced, the bioavailability is improved, the toxic and side effects of the medicine are reduced, and clinical treatment is facilitated. The product is good in production process repeatability and good in feasibility.

Description

technical field [0001] The invention relates to the technical field of slow-release microsphere preparations, in particular to a slow-release microsphere preparation of an immunomodulator polypeptide and a preparation method thereof. Background technique [0002] Immunomodulators are drugs that do not affect normal immune function, but can enhance already weakened immune function and regulate immune response. In cases of low immune response, it can enhance skin delayed allergic reaction to various antigens; and enhance the production of lymphocyte mediators. When phagocytes and T cells are down, immune modulators can restore them to normal. It can be used clinically to treat recurrent and chronic infections, tumors, rheumatoid diseases, and low-response diseases after viral infection. Common immunomodulators include immunostimulators, immunosuppressants, and two-way immune modulators. Thymus preparation is a non-specific immunomodulatory preparation. [0003] Thymosin is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K38/22A61K38/08A61K47/34A61P37/02
Inventor 邱焕杰廖梦春曹演威李云开舒遂智
Owner SHENZHEN JYMED TECH
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