Oral nanoparticle polypeptide composition tablets and preparation method thereof

A polypeptide composition and nanoparticle technology, which is applied in the direction of drug combination, cyclic peptide composition, pill delivery, etc., can solve the problems of low bioavailability, difficult route of administration, and little clinical value

Active Publication Date: 2014-08-13
深圳市健翔生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the instability of protein and polypeptide drugs, if they are directly administered orally without chemical or preparation modification, their bioavailability is often only 0.1%-2% or lower, and the clinical use value is not great, so it has become the most difficult drug to administer. drug pathway

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Weigh 20 g of thymopentin and 10 g of sodium glycocholate in water to obtain the internal water phase; weigh 160 g of polylactic acid and dissolve in dichloromethane to obtain the oil phase. First move the internal water phase solution into the oil phase solution, and place it on an emulsifying disperser at room temperature at high speed (30000rpm) for 30 seconds to obtain a W / O emulsion; then transfer the W / O emulsion to 50ml of 5% polymer Place the vinyl alcohol solution in an emulsifying disperser at 5000 rpm and homogenize the milk for 1 minute to obtain W / O / W double emulsion. Stir magnetically at room temperature and rotate at 500 rpm for 2 hours. Remove the organic phase, centrifuge and collect The obtained nanoparticles precipitate, washed with distilled water several times, and then collected by centrifugation, add 10g sorbitol, freeze-dry to obtain nanoparticles, then add 10g corn starch, 10g cross-linked polyvinylpyrrolidone, 10g starch, 10g magnesium stearate, ...

Embodiment 2

[0023] Weigh 30 g of thymopentin and 15 g of camostat mesylate dissolved in water to obtain the internal water phase; weigh 200 g of polyglycolic acid and dissolve in dichloromethane to obtain the oil phase. First move the internal water phase solution into the oil phase solution, and place it on an emulsifying disperser at room temperature at high speed (30000rpm) for 30 seconds to obtain a W / O emulsion; then transfer the W / O emulsion to 50ml of 5% polymer In the vinyl alcohol solution, place it on an emulsifying disperser at 5000 rpm and homogenize for 1 minute to obtain a W / O / W double emulsion. Stir magnetically at room temperature and stir at 500 rpm for 2 hours at low speed. Remove organic solvents and centrifuge. Collect the obtained nanoparticle precipitate, wash it with distilled water several times, and then collect it by centrifugation, add 15g mannitol, freeze-dry, freeze-dry to obtain nanoparticles, then add 15g dextrin, 15g croscarmellose sodium, 15g carboxypropyl ...

Embodiment 3

[0026] Weigh 40 g of thymopentin and 15 g of bacitracin to dissolve in water to obtain an internal aqueous phase; weigh out 180 g of polylactic acid-glycolic acid copolymer and dissolve in dichloromethane to obtain an oil phase. First move the internal water phase solution into the oil phase solution, and place it on an emulsifying disperser at room temperature at high speed (30000rpm) for 30 seconds to obtain a W / O emulsion; then transfer the W / O emulsion to 50ml of 5% polymer Place the vinyl alcohol solution in an emulsifying disperser at 5000 rpm and homogenize the emulsion for 1 minute to obtain W / O / W double emulsion, magnetically stir at room temperature, stir at 500 rpm at low speed for 2 hours, centrifuge, and collect the resulting nanoparticle precipitate , Washed with distilled water for several times, then collected by centrifugation, added 10g of sucrose, freeze-dried to obtain nanoparticles, then added 10g of microcrystalline cellulose, 10g of cross-linked polyvinylp...

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PUM

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Abstract

The invention relates to a medicinal preparation and a preparation method thereof, and in particular relates to a series of polypeptide thymopentin, thymalfasin and thymosin beta4 combined enzyme inhibitors capable of improving the immunity. An oral preparation is prepared by adopting a nanoparticle technology. A pharmaceutically-acceptable biodegradable high polymer material is coated with a polypeptide medicament for improving the immunity to prepare nanoparticles, and tablets are made by tableting. The medicament-loading nanoparticles prepared by using the preparation method have high bioavailability.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an oral nanoparticle polypeptide composition tablet for improving immunity and a preparation method thereof. Background technique [0002] With the development of biomedical technology, more and more peptide and protein drugs have been researched and developed and applied to the clinic, which also brings new challenges to pharmaceutical preparations. Due to the unstable and perishable nature of peptide and protein drugs, it is a complicated and arduous task to make them into stable, safe and efficient pharmaceutical preparations. At present, a large number of studies have been conducted on the drug delivery system of polypeptide and protein drugs, and a variety of new drug delivery systems for different routes of administration have been reported. [0003] Thymopentin is also an important immune-regulating polypeptide. The anti-infective and therapeutic effects of thymopentin a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61K38/22A61K38/08A61K38/12A61K38/55A61K9/20A61P37/04
Inventor 李新宇姚志勇邱焕杰廖梦春李云开杨帆曹演威
Owner 深圳市健翔生物制药有限公司
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