Hirudin albumin nanoparticles and preparation method thereof

A technology of albumin nanoparticles and hirudin, which is applied in the fields of peptide/protein components, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve problems such as not being easy, and achieve low cost, good biocompatibility, The effect of easy control of process parameters

Active Publication Date: 2019-06-07
THE AFFILIATED HOSPITAL OF QINGDAO UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although it is a conventional technical means to make drugs into nanoparticles, it is not easy to develop a formula and preparation method that has the advantages of good curative effect, controllable drug release, good biocompatibility, and stability. Creative labor, a large number of experiments and condition screening

Method used

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  • Hirudin albumin nanoparticles and preparation method thereof
  • Hirudin albumin nanoparticles and preparation method thereof
  • Hirudin albumin nanoparticles and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1 Preparation of Hirudin Albumin Nanoparticles

[0044]The steps are as follows: (1) Take 80 mg of albumin and 20 mg of hirudin respectively in a conical flask, add 10 ml of water for injection, and ultrasonically dissolve them; Add 30ml of dehydrated ethanol dropwise to the Erlenmeyer flask, and milky white opalescence is found; (3) after the ethanol has been added dropwise, add 20 μl of 2.5% glutaraldehyde; After solidification for 12 hours, ethanol was removed by concentration under reduced pressure to obtain hirudin albumin nanoparticles.

Embodiment 2

[0045] Example 2 Preparation of Hirudin Albumin Nanoparticles

[0046] The steps are as follows: (1) Take 70 mg of albumin and 30 mg of hirudin respectively in a conical flask, add 10 ml of water for injection, and ultrasonically dissolve; Add 30ml of dehydrated ethanol dropwise to the Erlenmeyer flask, and milky white opalescence is found; (3) after adding ethanol dropwise, add 30 μl of 2.5% glutaraldehyde; (4) reduce the stirring speed, at 600r / min After solidification for 12 hours, ethanol was removed by concentration under reduced pressure to obtain hirudin albumin nanoparticles.

[0047] After diluting with water, observe its morphology with a H-7000 transmission electron microscope, as shown in figure 1 shown. Depend on figure 1 It can be seen that the obtained hirudin albumin nanoparticles are uniform in size and round in shape.

Embodiment 3

[0048] Example 3 Preparation of Hirudin Albumin Nanoparticles

[0049] The steps are as follows: (1) Take 75 mg of albumin and 25 mg of hirudin respectively in a conical flask, add 10 ml of water for injection, and dissolve them by ultrasonic; Add 30ml of dehydrated ethanol dropwise to the Erlenmeyer flask, and find that milky white opalescence occurs; (3) after adding ethanol dropwise, add 2.5% glutaraldehyde 40μl; (4) reduce the stirring speed, at 600r / min Solidified for 12 hours, concentrated under reduced pressure to remove ethanol to obtain hirudin albumin nanoparticles, and freeze-dried.

[0050] Wherein, the freeze-drying process is: take 10wt% mannitol and dextran (mass ratio is 1: 1), dissolve in hirudin albumin nanoparticles, then subpackage in vials, and place in an ultra-low temperature refrigerator at -80°C Pre-freeze for 24 hours, take it out, quickly transfer it to a freeze dryer, freeze-dry at -40°C and 0.10mbar for 48 hours, and seal it with a stopper.

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Abstract

The invention belongs to the field of pharmaceutical preparations and relates to a preparation method of hirudin albumin nanoparticles. The hirudin albumin nanoparticles mainly comprise hirudin, albumin, a dehydrating agent and a cross-linking agent. The preparation method is an improved desolvation-cross-linking method. The hirudin albumin nanoparticles prepared by the preparation method disclosed by the invention have an in-vivo sustained release function and can prolong the in-vivo circulation time of a medicament, the particle size is about 160nm, the in-vivo half-life of hirudin can be prolonged, the curative effect is improved, the bioavailability of the hirudin is improved, and the hirudin albumin nanoparticles have the advantages of good biocompatibility, easiness in degradation, high entrapment rate, high drug loading capacity and the like.

Description

technical field [0001] The invention relates to a hirudin albumin nanoparticle and a preparation method thereof. Background technique [0002] Hirudin is the main effective anticoagulant component in leeches. The leeches are all of the annelidae Hirudoaipponica Whitman, the leech (Whitmaniapigra uhitman) or the willow leaf leech (Whitmaniaacranulaata Whitman). Hirudin is an amino acid polypeptide consisting of 65 amino acid residues with anticoagulant activity. Its N-terminal contains 3 disulfide bonds, which is the core region, is hydrophobic, and is the active site of thrombin. The C-terminus of the tail contains more acidic amino acids, which prevent the recognition site of thrombin and fibrinogen and produce anticoagulant effect. The middle part is the catalytic site where hirudin binds to thrombin. The sulfation of tyrosine at position 63 improves the binding ability of hirudin to thrombin and enhances the specificity of its anticoagulant effect. Through a systemat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K38/58A61K47/42A61P7/02
Inventor 荆凡波隋忠国徐文刘东华
Owner THE AFFILIATED HOSPITAL OF QINGDAO UNIV
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