Composite material skin filler and preparation process thereof

Abstract

The invention belongs to the technical field of biomedical materials, and particularly relates to a composite material skin filler and a preparation process thereof, and the composite material skin filler comprises the following raw materials: medical-grade poly-L-lactic acid (PLLA) microspheres, a human hair keratin suspension and hyaluronic acid. Keratin is used as a main structural protein of skin and hair, and has good biocompatibility; hyaluronic acid is widely applied to skin care due to excellent moisturizing and repairing characteristics; the PLLA microspheres are synthesized by stimulating collagen of the skin, and have good long-acting filling and anti-aging effects; the filling agent is unique in proportion in materials in the field of subcutaneous filling, the problems of short-term wrinkle improvement and long-term maintenance are solved on the premise that safety is guaranteed, compared with existing products in the market, hyaluronic acid is added, the problem of short-term moisturizing is solved, hair keratin is added, and the problem of long-term effect maintenance is solved; keratin has the advantages that the keratin cannot be swallowed by immune cells easily, and immune response cannot occur.

Description

Technical Field

[0001] The invention relates to the technical field of biomedical materials, in particular to a composite material skin filler and a preparation process thereof. Background Art

[0002] Biomedical materials are materials used to diagnose, treat, repair or replace damaged tissues and organs or enhance their functions. They are the basis for studying artificial organs and medical devices and have become an important branch of contemporary materials science. Especially with the vigorous development and major breakthroughs in biotechnology, biomedical materials have become a hot spot for scientists from all over the world to compete for research and development.

[0003] With the development of society and people's pursuit of beauty, the problem of skin aging has received increasing attention.

[0004] The existing technology has the following defects or problems: Existing skin fillers mainly include ingredients such as hyaluronic acid and polylactic acid, which can effectively fill facial wrinkles and restore skin elasticity and fullness. However, these materials have certain limitations, such as short duration of effect or insufficient skin repair function, so improved and innovative fillers are needed.

[0005] It should be noted that the above contents belong to the technical knowledge of the inventor and do not necessarily constitute prior art. Summary of the invention

[0006] In view of the deficiencies of the prior art, the present invention provides a composite material skin filler to solve the existing problems.

[0007] To achieve the above object, the present invention provides the following technical solution: a composite material skin filler, comprising the following raw materials:

[0008] Medical grade poly (L-lactic acid) PLLA microspheres, human hair keratin suspension and hyaluronic acid.

[0009] As a preferred technical solution of the present invention, the diameter of the medical-grade poly(L-lactic acid) PLLA microspheres is 20-40 microns, the drug loading mass ratio is controlled between 0.1-0.5%, and the weight average molecular weight of the medical-grade poly(L-lactic acid) PLLA microspheres is 2.67W.

[0010] As a preferred technical solution of the present invention, the human hair keratin suspension is formed by mixing human hair keratin powder and a hydration solution to form a uniform suspension, and the concentration mass ratio thereof is 1-10%.

[0011] As a preferred technical solution of the present invention, the hyaluronic acid is macromolecular hyaluronic acid, the molecular weight of which is controlled between 5-200W, and the concentration-to-mass ratio is 0.1-5%.

[0012] Another technical problem to be solved by the present invention is to provide a method for preparing a high fatigue resistance material for a buffer block, comprising the following steps:

[0013] Step 1: After the preparation of L-polylactic acid microspheres is completed, 150 mg of L-polylactic acid microspheres are weighed on an electronic balance for later use;

[0014] Step 2: After the preparation of human hair keratin suspension is completed, use a syringe to complete the extraction and take 1.5 ml;

[0015] Step 3: Use 100 ml of normal saline to dilute the hyaluronic acid, taking 1 g of hyaluronic acid to prepare a hyaluronic acid solution;

[0016] Step 4: Add the weighed 150 mg of L-polylactic acid microspheres and 1.5 ml of human hair keratin suspension into a 50 ml centrifuge tube, then add 2 ml of hyaluronic acid suspension and normal saline to make the volume to 5 ml, and stir evenly by stirring the mixture through a stirring mechanism;

[0017] Step 5: sterilize the above mixture to ensure its sterility;

[0018] Step 6: Draw out through a disposable syringe and inject into the application site.

[0019] In some of the embodiments, the preparation process of the L-polylactic acid microspheres is as follows:

[0020] 1) adding a certain amount of L-polylactic acid into dichloromethane, stirring with a magnetic stirrer at room temperature, and dissolving to obtain a uniform solution;

[0021] 2) Prepare an aqueous phase solution, usually an aqueous solution containing an emulsifier, the concentration of which needs to be controlled at 0.5-2%;

[0022] 3) slowly dripping the L-polylactic acid into the aqueous solution and using a high-speed stirrer for emulsification;

[0023] 4) The stirring operation is carried out at room temperature to promote the evaporation of dichloromethane in the emulsion. After the dichloromethane evaporates, the L-polylactic acid will condense into microspheres;

[0024] 5) Drying the collected L-polylactic acid microspheres to maintain the shape and particle size of the microspheres and avoid denaturation of the L-polylactic acid due to heat treatment;

[0025] 6) Use dynamic light scattering to measure the particle size distribution of the microspheres to ensure that their diameter remains between 20 and 40 microns.

[0026] In some embodiments, the preparation process of the human hair keratin suspension is as follows:

[0027] 1) Take human hair as raw material and remove the dirt and oil from the hair;

[0028] 2) Use sodium chloride to deconstruct the structure of the hair, thereby releasing the keratin;

[0029] 3) separating keratin from the solution by centrifugation and washing to remove other impurities;

[0030] 4) adding the extracted keratin powder into deionized water at a specified concentration;

[0031] 5) stirring with a magnetic stirrer until the keratin is completely dissolved;

[0032] 6) If necessary, a proper amount of stabilizer can be added to the keratin solution to prevent the keratin from precipitating during storage. The stabilizer can be selected from one of glycerol and polysorbate;

[0033] 7) The prepared mixture is filtered using a 0.22 micron microporous filter membrane to remove possible impurities and sterilized by high temperature

[0034] Compared with the prior art, the present invention provides a composite material skin filler and a preparation process thereof, which has the following beneficial effects:

[0035] The composite material skin filler and its preparation process are composed of poly (L-lactic acid) PLLA microspheres, human hair keratin suspension and hyaluronic acid to form the skin filler. Human hair keratin, as the main structural protein of skin and hair, has good biocompatibility and potential for promoting skin repair. Hyaluronic acid is widely used in skin care due to its excellent moisturizing and repairing properties. The poly (L-lactic acid) PLLA microspheres have good long-term filling and anti-aging effects by stimulating collagen synthesis in the skin.

[0036] In combination with the above content, this filler has a unique ratio in the field of subcutaneous filling materials. It solves the problems of short-term wrinkle improvement and long-term maintenance while ensuring safety. Compared with existing products on the market, the addition of hyaluronic acid solves the problem of short-term hydration, and the addition of hair keratin solves the problem of long-term effect maintenance. Keratin has the advantages of not being easily phagocytosed by immune cells and will not cause immune response. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 The figure is a schematic diagram of the preparation process of the composite material skin filler of the present invention. DETAILED DESCRIPTION

[0038] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0039] It should be understood that the step numbers used in this article are only for the convenience of description and are not intended to limit the order in which the steps are executed.

[0040] It should be understood that the terms used in the present specification are only for the purpose of describing specific embodiments and are not intended to limit the present invention. As used in the present specification and the appended claims, unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" are intended to include plural forms.

[0041] The terms “include” and “comprising” indicate the presence of described features, integers, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or combinations thereof.

[0042] The term "and / or" means and includes any and all possible combinations of one or more of the associated listed items.

[0043] See also Figure 1 In this embodiment: a composite material skin filler comprises the following raw materials:

[0044] Medical grade poly (L-lactic acid) PLLA microspheres, human hair keratin suspension and hyaluronic acid;

[0045] The diameter of the medical-grade poly(L-lactic acid) PLLA microspheres is 20-40 microns, the drug loading mass ratio is controlled between 0.1% and 0.5%, and the weight average molecular weight of the medical-grade poly(L-lactic acid) PLLA microspheres is 2.67W;

[0046] The human hair keratin suspension is prepared by mixing human hair keratin powder and a hydration solution to form a uniform suspension, and the concentration mass ratio thereof is 1-10%;

[0047] The hyaluronic acid material adopts macromolecular hyaluronic acid, the molecular weight of which is controlled between 5-200W, and the concentration mass ratio of which is 0.1-5%.

[0048] Based on the above composite material skin filler, a preparation process of the composite material skin filler is proposed, comprising the following steps:

[0049] Step 1: After the preparation of L-polylactic acid microspheres is completed, 150 mg of L-polylactic acid microspheres are weighed on an electronic balance for later use;

[0050] The preparation process of the L-polylactic acid microspheres is as follows:

[0051] 1) adding a certain amount of L-polylactic acid into dichloromethane, stirring with a magnetic stirrer at room temperature, and dissolving to obtain a uniform solution;

[0052] 2) Prepare an aqueous phase solution, usually an aqueous solution containing an emulsifier, the concentration of which needs to be controlled at 0.5-2%;

[0053] 3) slowly dripping the L-polylactic acid into the aqueous solution and using a high-speed stirrer for emulsification;

[0054] 4) The stirring operation is carried out at room temperature to promote the evaporation of dichloromethane in the emulsion. After the dichloromethane evaporates, the L-polylactic acid will condense into microspheres;

[0055] 5) Drying the collected L-polylactic acid microspheres to maintain the shape and particle size of the microspheres and avoid denaturation of the L-polylactic acid due to heat treatment;

[0056] 6) Use dynamic light scattering to measure the particle size distribution of the microspheres to ensure that their diameter remains between 20 and 40 microns;

[0057] Step 2: After the preparation of human hair keratin suspension is completed, use a syringe to complete the extraction and take 1.5 ml;

[0058] The preparation process of the human hair keratin suspension is as follows:

[0059] 1) Take human hair as raw material and remove the dirt and oil from the hair;

[0060] 2) Use sodium chloride to deconstruct the structure of the hair, thereby releasing the keratin;

[0061] 3) separating keratin from the solution by centrifugation and washing to remove other impurities;

[0062] 4) adding the extracted keratin powder into deionized water at a specified concentration;

[0063] 5) stirring with a magnetic stirrer until the keratin is completely dissolved;

[0064] 6) If necessary, a proper amount of stabilizer can be added to the keratin solution to prevent the keratin from precipitating during storage. The stabilizer can be selected from one of glycerol and polysorbate;

[0065] 7) The prepared mixture is filtered using a 0.22 micron microporous filter membrane to remove possible impurities, and sterilized by high temperature;

[0066] Step 3: Use 100 ml of normal saline to dilute the hyaluronic acid, taking 1 g of hyaluronic acid to prepare a hyaluronic acid solution;

[0067] Step 4: Add the weighed 150 mg of L-polylactic acid microspheres and 1.5 ml of human hair keratin suspension into a 50 ml centrifuge tube, then add 2 ml of hyaluronic acid suspension and normal saline to make the volume to 5 ml, and stir evenly by stirring the mixture through a stirring mechanism;

[0068] Step 5: sterilize the above mixture to ensure its sterility;

[0069] Step 6: Draw out through a disposable syringe and inject into the application site.

[0070] Each embodiment in this specification is described in a progressive manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the system embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0071] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A composite material skin filler, characterized in that: Including the following raw materials: Medical grade poly (L-lactic acid) PLLA microspheres, human hair keratin suspension and hyaluronic acid.

2. The composite material skin filler according to claim 1, characterized in that: The diameter of the medical-grade poly(L-lactic acid) PLLA microspheres is 20-40 microns, the drug loading mass ratio is controlled between 0.1% and 0.5%, and the weight average molecular weight of the medical-grade poly(L-lactic acid) PLLA microspheres is 2.67W.

3. The composite material skin filler according to claim 1, characterized in that: The human hair keratin suspension is prepared by mixing human hair keratin powder and a hydration solution to form a uniform suspension, and the concentration mass ratio thereof is 1-10%.

4. The composite material skin filler according to claim 1, characterized in that: The hyaluronic acid is macromolecular hyaluronic acid, the molecular weight of which is controlled between 5-200W, and the concentration-mass ratio is 0.1-5%.

5. A process for preparing a composite material skin filler, characterized in that: The steps include: Step 1: After the preparation of L-polylactic acid microspheres is completed, 150 mg of L-polylactic acid microspheres are weighed on an electronic balance for later use; Step 2: After the preparation of human hair keratin suspension is completed, use a syringe to complete the extraction and take 1.5 ml; Step 3: Use 100 ml of normal saline to dilute the hyaluronic acid, taking 1 g of hyaluronic acid to prepare a hyaluronic acid solution; Step 4: Add the weighed 150 mg of L-polylactic acid microspheres and 1.5 ml of human hair keratin suspension into a 50 ml centrifuge tube, then add 2 ml of hyaluronic acid suspension and normal saline to make the volume to 5 ml, and stir evenly by stirring the mixture through a stirring mechanism; Step 5: sterilize the above mixture to ensure its sterility; Step 6: Draw out through a disposable syringe and inject into the application site.

6. The preparation process of a composite material skin filler according to claim 5, characterized in that: The specific process for preparing the L-polylactic acid microspheres described in step 1 is as follows: 1) adding a certain amount of L-polylactic acid into dichloromethane, stirring with a magnetic stirrer at room temperature, and dissolving to obtain a uniform solution; 2) Prepare an aqueous phase solution, usually an aqueous solution containing an emulsifier, the concentration of which needs to be controlled at 0.5-2%; 3) slowly dripping the L-polylactic acid into the aqueous solution and using a high-speed stirrer for emulsification; 4) The stirring operation is carried out at room temperature to promote the evaporation of dichloromethane in the emulsion. After the dichloromethane evaporates, the L-polylactic acid will condense into microspheres; 5) Drying the collected L-polylactic acid microspheres to maintain the shape and particle size of the microspheres and avoid denaturation of the L-polylactic acid due to heat treatment; 6) Use dynamic light scattering to measure the particle size distribution of the microspheres to ensure that their diameter remains between 20 and 40 microns.

7. The process for preparing a composite material skin filler according to claim 5, characterized in that: The preparation process of the human hair keratin suspension in step 2 is as follows: 1) Take human hair as raw material and remove the dirt and oil from the hair; 2) Use sodium chloride to deconstruct the structure of the hair, thereby releasing the keratin; 3) separating keratin from the solution by centrifugation and washing to remove other impurities; 4) adding the extracted keratin powder into deionized water at a specified concentration; 5) stirring with a magnetic stirrer until the keratin is completely dissolved; 6) If necessary, a proper amount of stabilizer can be added to the keratin solution to prevent the keratin from precipitating during storage. The stabilizer can be selected from one of glycerol and polysorbate; 7) The prepared mixture is filtered using a 0.22 micron microporous filter membrane to remove possible impurities, and sterilized by high temperature.

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