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Oral thymosin alpha1 solid lipid nanoparticle absorption preparation and preparing method thereof

A solid lipid nanometer and solid lipid technology, which can be used in peptide/protein components, antiviral agents, pharmaceutical formulations, etc., and can solve problems such as no reports of thymosin

Inactive Publication Date: 2013-11-27
TIANJIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, polypeptide drugs such as calcitonin, cyclosporine, and somatostatin have been prepared into solid lipid nanoparticles, but there is no report on the oral absorption preparation of thymosin α1 solid lipid nanoparticles

Method used

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  • Oral thymosin alpha1 solid lipid nanoparticle absorption preparation and preparing method thereof
  • Oral thymosin alpha1 solid lipid nanoparticle absorption preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A preparation method for oral absorption preparation of thymosin α1 solid lipid nanoparticles, comprising the steps of:

[0026] (1) Preparation of the inner water phase: Precisely weigh 0.1 g of thymosin α1 and dissolve it in 5 ml of phosphate buffer with pH=6.8 to obtain the inner water phase;

[0027] (2) Preparation of organic phase: Accurately weigh 0.7g of glyceryl behenate, 0.8g of glyceryl palmitostearate and 0.2g of lecithin, dissolve in 10mL of dichloromethane, and form the organic phase;

[0028] (3) Preparation of the external water phase: Precisely weigh 0.1 g of polyethylene glycol 1000 vitamin E succinate and dissolve it in 100 ml of ultrapure water to form the external water phase;

[0029] (4) Add the inner water phase dropwise to the stirring organic phase, and after the addition of the inner water phase is completed, ultrasonicate for 15 seconds at 40W to obtain colostrum; add the colostrum dropwise to the stirring outer water In the phase, the colos...

Embodiment 2

[0031] A preparation method for oral absorption preparation of thymosin α1 solid lipid nanoparticles, comprising the steps of:

[0032] (1) Preparation of the inner water phase: Precisely weigh 0.01 g of thymosin α1 and dissolve it in 5 ml of phosphate buffer solution with pH=7.4 to obtain the inner water phase;

[0033] (2) Preparation of the organic phase: Accurately weigh 0.65g of stearic acid, 0.8g of palmitic acid and 0.15g of phosphatidylcholine, and dissolve them in 24ml of anhydrous ethanol and acetone mixed solution (5:1) to obtain the organic phase ;

[0034] (3) Preparation of the external water phase: Precisely weigh 0.25g of Tween-80, dissolve it in 90ml of ultrapure water, and make it the external water phase;

[0035] (4) Add the inner water phase dropwise to the stirring organic phase. After the addition of the inner water phase is completed, shear at a speed of 8000rpm for 6 minutes to obtain colostrum; add the colostrum dropwise to the stirring organic phase...

Embodiment 3

[0037] A preparation method for oral absorption preparation of thymosin α1 solid lipid nanoparticles, comprising the steps of:

[0038] (1) Preparation of the inner water phase: Precisely weigh 0.15 g of thymosin α1 and dissolve it in 5 ml of phosphate buffer with pH=7.0 to obtain the inner water phase;

[0039](2) Preparation of the organic phase: Accurately weigh 0.5g of tripalmitin, 0.75g of cetyl alcohol and 0.2g of Span-80, dissolve in 20ml of acetone and chloroform mixed solution (4:1) to obtain the organic phase ;

[0040] (3) Preparation of the external water phase: Precisely weigh 0.2 g of sodium cocoamphoacetate and dissolve it in 100 ml of ultrapure water to form the external water phase;

[0041] (4) Add the inner water phase dropwise to the stirring organic phase. After the addition of the inner water phase is completed, cut for 5 minutes at a speed of 10,000 rpm to obtain colostrum; add the colostrum dropwise to the stirring In the external water phase of the c...

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Abstract

The invention discloses an oral thymosin alpha1 solid lipid nanoparticle absorption preparation and a preparing method thereof. The preparing method comprises the following steps of: (1) preparing an internal water phase; (2) preparing an organic phase; (3) preparing an external water phase; (4) dropwise adding the internal water phase into the stirring organic phase, performing ultrasonic or shearing to obtain beestings, dropwise adding the beestings into the stirring external water phase, performing ultrasonic or dispersion to obtain multiple emulsion, performing reduced-pressure rotation and evaporation so as to remove an organic solvent to obtain a thymosin alpha1 solid lipid nanoparticle dispersion liquid, adding a freeze-drying protecting agent into the dispersion liquid, evenly stirring, freeze-drying to obtain powder, and subpackaging into enteric-dissolved capsules. Proven by experiments, the encapsulation rate of nanoparticles in the oral thymosin alpha1 solid lipid nanoparticle absorption preparation is 65.4%-85.3%, the zeta potential ranges from minus 25.5mV to minus 38.2mV, and the oral bioavailability of mice is greater than 50%.

Description

technical field [0001] The invention relates to the field of medicine and health product preparations, in particular to a thymosin α1 solid lipid nanoparticle oral absorption preparation and a preparation method. Background technique [0002] Thymosin α1 (Thymosin α1, T-α1) is a small molecular biologically active polypeptide isolated and purified from the fifth component of thymosin in the late 1970s. The T-α1 molecule contains 28 amino acids and plays a very important role in the body's immune response. T-α1 can increase the secretion of various lymphokines such as interferon, interleukin 2 and interleukin 3 produced by T cells after antigen or mitogen activation, and increase the level of lymphokine receptors on the surface of T cells. T-α1 acts on the differentiation and maturation of thymocytes, stimulates T cells to produce CD3+, CD4+ and natural killer (NK) cells, and enhances the killing effect of NK cells. T-α1 can significantly increase the levels of various lymp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/22A61K9/51A61P37/04A61P35/00A61P31/20
Inventor 葛志强黄箫喃杜新莹
Owner TIANJIN UNIV