CN114053487A - Mechanical bionic absorption filler and manufacturing method thereof - Google Patents

Abstract

The invention discloses a method for manufacturing a mechanical bionic absorption filler, which comprises the following steps: the absorbable polyester microspheres are PLA, and/or PCL, and/or PGA, and PDO, and can absorb homopolymers and/or copolymers of a synthetic polyester material, the sodium hyaluronate is non-crosslinked high molecular weight sodium hyaluronate, the dispersion is buffer solution, and/or normal saline, and/or water for injection, and the osmotic pressure similar to cellular fluid and the pH value similar to interstitial fluid are provided for a product.

Description

Mechanical bionic absorption filler and manufacturing method thereof

Technical Field

The invention relates to the technical field of bionic absorption filling, in particular to a mechanical bionic absorption filling material and a manufacturing method thereof.

Background

The products currently on the market for facial filling have the following drawbacks: (1) because of the problems of materials or formula, the materials or the formula are incompatible in mechanics, too soft, easy to deform after being implanted, incapable of achieving the expected effect, and too hard, easy to form adverse reactions such as caking, nodules and the like; (2) the volume or physical property of the absorbable material can be changed along with degradation, so that the implanted material is deformed or displaced in the degradation process; (3) the most commonly used filling materials are those obtained by cross-linking sodium hyaluronate to improve the mechanical properties of the material, which has certain beneficial effects, but the cross-linking process increases the safety risk and cannot circumvent the above disadvantages.

Therefore, it is necessary for engineers skilled in the relevant art to develop a novel filling material, which can have the following properties:

(1) the viscoelasticity of the filling material approximates that of facial tissue;

(2) the viscoelasticity of the filling material does not change greatly within a certain degradation period;

(3) the material does not pose a new potential safety risk.

Disclosure of Invention

The invention aims to solve the technical problem of providing a mechanical bionic absorption filler with the properties of easy injection, degradability and no obvious change of viscoelasticity in the degradation process.

In order to solve the technical problems, the technical scheme of the invention is as follows:

a mechanical biomimetic absorbent padding comprising:

absorbable polyester microspheres, which are homopolymers, and/or copolymers of PLA, and/or PCL, and/or PGA, and PDO absorbable synthetic polyester materials;

sodium hyaluronate which is uncrosslinked high molecular weight sodium hyaluronate;

and the dispersion liquid is buffer solution, and/or normal saline and/or water for injection, provides the product with the osmotic pressure similar to cell fluid and the pH value similar to tissue fluid, and is further preferably PBS buffer solution.

Preferably, the absorbable polyester microspheres are 5-45, the sodium hyaluronate is 0.1-3, and the dispersion liquid is 52-94.9.

Preferably, the sodium hyaluronate is uncrosslinked high molecular weight sodium hyaluronate, and the molecular weight of the sodium hyaluronate is not less than 120 ten thousand, more preferably 180-260 ten thousand, and most preferably 220-240 ten thousand.

Preferably, the absorbable polyester microspheres range from 100nm to 100 μm, more preferably from 5 μm to 75 μm, and most preferably from 25 μm to 50 μm.

A manufacturing method of a mechanical bionic absorption filler is characterized by comprising the following steps:

s1, preparing the polyester material into microspheres with a certain particle size range by an emulsification volatilization method, an electrostatic spray method and/or a microfluidic method;

s2, stirring and dissolving the sodium hyaluronate in a PBS buffer solution, and homogenizing by using a high-speed homogenizer to form emulsion;

s3, adding the polyester microspheres into the emulsion, mixing, dispersing and removing bubbles in vacuum;

s4, vacuum filling the mixed liquid after vacuum defoaming into a pre-filling and sealing syringe

The invention has the beneficial effects that:

the invention has the advantages of easy injection, degradability and no obvious change of viscoelasticity in the degradation process, compared with the existing product, the filling material can provide more similar viscoelasticity for facial tissues, the viscoelasticity of the filling material does not change obviously in a certain degradation period, and the material does not cause new potential safety risk.

Drawings

FIG. 1 is a flow chart of a mechanical bionic absorbent filler and a manufacturing method thereof according to an embodiment of the present invention;

FIG. 2 is a viscoelastic curve diagram of an experiment of a mechanical bionic absorption filler and a manufacturing method according to an embodiment of the invention;

fig. 3 is a dynamic viscosity curve diagram of an experiment of the mechanical bionic absorption filler and the manufacturing method of the invention.

Detailed Description

The following further describes embodiments of the present invention with reference to the drawings. It should be noted that the description of the embodiments is provided to help understanding of the present invention, but the present invention is not limited thereto. In addition, the technical features involved in the embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

As shown in fig. 1-3, a mechanical biomimetic absorbent padding, comprising:

absorbable polyester microspheres, wherein the absorbable polyester microspheres are homopolymers and/or copolymers of PLA, and/or PCL, and/or PGA, and PDO absorbable synthetic polyester materials;

sodium hyaluronate, which is uncrosslinked high molecular weight sodium hyaluronate;

the dispersion is buffer solution, and/or normal saline, and/or water for injection, and provides the product with osmotic pressure similar to that of cell fluid and pH value similar to that of tissue fluid.

In a preferred embodiment of the present invention, the absorbable polyester microspheres are 5 to 45, the sodium hyaluronate is 0.1 to 3, and the dispersion is 52 to 94.9.

In the preferred embodiment of the invention, the sodium hyaluronate is uncrosslinked high molecular weight sodium hyaluronate, and the molecular weight of the sodium hyaluronate is more than or equal to 120 ten thousand.

In the preferred embodiment of the present invention, the absorbable polyester microspheres range from 100nm to 100 μm.

A manufacturing method of a mechanical bionic absorption filler comprises the following steps:

s1, preparing the polyester material into microspheres with a certain particle size range by an emulsification volatilization method, an electrostatic spray method and/or a microfluidic method;

s2, stirring and dissolving sodium hyaluronate in a PBS buffer solution, and homogenizing by using a high-speed homogenizer to form emulsion;

s3, adding the polyester microspheres into the emulsion, mixing, dispersing and removing bubbles in vacuum;

s4, vacuum filling the mixed liquid after vacuum defoaming into a pre-filling and sealing syringe

Specifically, other examples are as follows:

the first embodiment is as follows:

s1, adding 2.2 parts by weight of sodium hyaluronate powder with a molecular weight of 158 ten thousand into 62.8 parts by weight of PBS buffer, and stirring for 2 hours at a stirring speed of 150rpm to completely dissolve the sodium hyaluronate in the PBS buffer;

s2, pouring the dissolved solution into a mixing instrument, adding 35 parts by mass of PCL microspheres with the particle size range of 40-50 micrometers, and stirring while homogenizing and shearing for 30min at the stirring speed of 100rpm and the homogenizing and shearing speed of 10000 rpm;

closing homogenizing and shearing, starting a vacuum pump, pumping the vacuum degree in the container to be below-0.08 MPa, keeping for 2 hours, and eliminating bubbles to be uniformly mixed;

example two:

s1, adding 2 parts by weight of sodium hyaluronate powder with the molecular weight of 200 ten thousand into 88 parts by weight of physiological saline, and stirring for 2 hours at a stirring speed of 150rpm to completely dissolve the sodium hyaluronate in the physiological saline;

s2, pouring the dissolved solution into a mixing instrument, adding 10 parts by mass of PLGA microspheres with the particle size range of 10-45 microns, and carrying out homogenizing and shearing for 30min while stirring at the stirring speed of 100rpm and the homogenizing and shearing speed of 10000 rpm;

closing homogenizing and shearing, starting a vacuum pump, pumping the vacuum degree in the container to be below-0.08 MPa, keeping for 2 hours, and eliminating bubbles to be uniformly mixed;

example three:

s1, adding 1.2 parts by weight of sodium hyaluronate powder with the molecular weight of 300 ten thousand into 73.8 parts by weight of PBS buffer solution, and stirring for 2 hours at the stirring speed of 150rpm to completely dissolve the sodium hyaluronate in the PBS buffer solution;

s2, pouring the dissolved solution into a mixing instrument, adding 25 parts by mass of PGCL microspheres with the particle size range of 20-75 micrometers, and carrying out homogenizing and shearing for 30min while stirring at the stirring speed of 100rpm and the homogenizing and shearing speed of 10000 rpm;

closing homogenizing and shearing, starting a vacuum pump, pumping the vacuum degree in the container to be below-0.08 MPa, keeping for 2 hours, and eliminating bubbles to be uniformly mixed;

the cross point of the viscoelastic modulus, the viscoelastic curve and the dynamic viscosity curve of the embodiment of the product are detected, and the performance of the embodiment of the product shows the performance which is very similar to that of animal soft tissues, and the performance is not obviously changed before and after degradation.

The embodiments of the present invention have been described in detail with reference to the accompanying drawings, but the present invention is not limited to the described embodiments. It will be apparent to those skilled in the art that various changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, and the scope of protection is still within the scope of the invention.

Claims (5)

1. A mechanical biomimetic absorbent padding, comprising:

absorbable polyester microspheres, which are homopolymers, and/or copolymers of PLA, and/or PCL, and/or PGA, and PDO absorbable synthetic polyester materials;

sodium hyaluronate which is uncrosslinked high molecular weight sodium hyaluronate;

and the dispersion is buffer solution, and/or normal saline and/or water for injection, and provides the product with osmotic pressure similar to that of cell fluid and pH value similar to that of tissue fluid.

2. The mechanical bionic absorption filler as claimed in claim 1, wherein the number of the absorbable polyester microspheres is 5-45, the number of the sodium hyaluronate is 0.1-3, and the number of the dispersion liquid is 52-94.9.

3. The mechanical bionic absorption filler as claimed in claim 1, wherein the sodium hyaluronate is non-crosslinked high molecular weight sodium hyaluronate, and the molecular weight of the sodium hyaluronate is not less than 120 ten thousand.

4. The mechanical bionic absorption filler as claimed in claim 1, wherein the range of the absorbable polyester microspheres is 100 nm-100 μm.

5. The method for manufacturing the mechanical bionic absorption filler according to the claims 1 to 4, characterized by comprising the following steps:

s1, preparing the polyester material into microspheres with a certain particle size range by an emulsification volatilization method, an electrostatic spray method and/or a microfluidic method;

s2, stirring and dissolving the sodium hyaluronate in a PBS buffer solution, and homogenizing by using a high-speed homogenizer to form emulsion;

s3, adding the polyester microspheres into the emulsion, mixing, dispersing and removing bubbles in vacuum;

and S4, vacuum filling the mixed liquid after vacuum defoaming into the pre-filling and sealing syringe.

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