Compound used as biomedical material and preparation method thereof

Abstract

A compound for a biomedical material comprises biodegradable fibers and a water-soluble polymer carrier, the biodegradable fibers comprise biodegradable fiber segments composed of a high-molecular polymer, the diameter of the biodegradable fiber segments is 50 nm to 10 [mu] m, the length is 1 [mu] m to 300 [mu] m, and the water-soluble polymer carrier is a water-soluble polymer carrier. The mass ratio of the polyester fibers in all biodegradable fibers is at least 50%.

Description

Technical Field

[0001] The present invention relates to the field of biomedical materials, and in particular to a composite comprising a degradable polymer fiber segment and a water-soluble polymer carrier, which is suitable for soft tissue filling, stimulating collagen regeneration and scar repair in medical cosmetology. Background Art

[0002] Aging leads to the continuous degradation of the skin's extracellular matrix (ECM), accompanied by a decrease in the number and activity of fibroblasts. This clinically manifests as progressive wrinkle formation, fat loss, and deterioration in skin quality. Dermal fillers are specifically designed to repair soft tissue volume loss and deeper, static wrinkles or folds, offering advantages such as ease of use, minimal trauma, a quick recovery time, and significant repair effects.

[0003] Compared to traditional subcutaneous fillers such as cross-linked sodium hyaluronate gel, which only has a physical filling effect, the new generation of sheet-like and microsphere-type regenerative fillers such as poly(lactic acid), polycaprolactone, hydroxyapatite, polymethyl methacrylate, and polyvinyl alcohol can induce a foreign body reaction, stimulate fibroblast proliferation and collagen formation, and thus repair wrinkles and depressions. However, they still have the following shortcomings:

[0004] (1) Although they have been proven to have good biocompatibility, the incidence of complications such as nodules and granulomas caused by such sheet-like and microsphere-like fillers is still high.

[0005] (2) The immediate filling effect of this type of filler depends on the physical support of the material. With the rapid absorption of the matrix material, the subsequent production of new collagen is slow, and there will be a window period with no filling effect, which affects the appearance.

[0006] (3) The microstructure of the active ingredients of this type of filler is mostly flake-like or microspherical, which does not have the high specific surface area required for an ideal tissue regeneration scaffold material, and the cell adhesion and proliferation effect still needs to be improved.

[0007] Fiber materials have a high specific surface area and can well simulate the morphology of the extracellular matrix, promote cell adhesion, and achieve the embedded growth of surrounding autologous tissue into the filler, ensuring the long-term stable fixation of the filler in the preset position to promote collagen regeneration. The larger surface area also helps the fibers to be evenly dispersed in the solution, making it less likely to aggregate to form nodules and cysts, and thus providing greater safety. However, the fiber membranes prepared by methods such as electrospinning, melt spinning, solution spinning, and 3D printing are continuous in length and difficult to process into free short fibers, which in turn affects their injectability and their actual use effect.

[0008] There is a need in the art to provide biomedical materials with high specific surface area and that can overcome the deficiencies of the above-mentioned materials. Summary of the Invention

[0009] Provided is a composite for use in the field of medical aesthetics, such as as a subcutaneous filler, which has a high specific surface area, is easy to disperse, and has good needle permeability.

[0010] In one aspect of the present invention, the present invention provides a composite for biomedical materials, comprising biodegradable fibers and a water-soluble polymer carrier, wherein the biodegradable fibers include biodegradable fiber segments composed of high molecular weight polymers, the biodegradable fiber segments having a diameter of 50 nm to 10 μm and a length of 1 μm to 300 μm, and accounting for at least 50% by mass of all biodegradable fibers.

[0011] According to the composite, the high molecular polymer of the biodegradable fiber segment is selected from one or more of polylactic acid, polycaprolactone, polydioxanone, and polylactic acid-glycolic acid.

[0012] According to the composite, the high molecular polymer of the biodegradable fiber segment is polylactic acid.

[0013] According to the composite, the weight average molecular weight of the high molecular weight polymer of the biodegradable fiber segment is 10,000 g / mol to 500,000 g / mol.

[0014] According to the composite, the weight average molecular weight of the high molecular weight polymer of the biodegradable fiber segment is 50,000 g / mol to 400,000 g / mol.

[0015] According to the composite, the diameter of the biodegradable fiber segment is 300 nm to 3 μm, and the length is 5 μm to 100 μm.

[0016] According to the complex, the water-soluble polymer carrier is selected from one or more of sodium hyaluronate, collagen, polyribonucleotides, polydeoxyribonucleotides, carboxymethyl cellulose, hydroxypropyl methylcellulose, chitosan, agarose, and dextran.

[0017] According to the complex, the water-soluble polymer carrier is one or more of sodium hyaluronate, collagen or polyribonucleotide.

[0018] According to the complex, the collagen can be animal-derived collagen or recombinant collagen.

[0019] According to the composite, the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 5% to 99%.

[0020] According to the composite, the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 10% to 95%.

[0021] According to the composite, the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 20% to 90%.

[0022] According to the composite, the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 40% to 88%.

[0023] According to the composite, the mass proportion of the biodegradable fiber segments in the total biodegradable fibers is at least 90%.

[0024] According to the composite, the mass proportion of the biodegradable fiber segments in the total biodegradable fibers is at least 95%.

[0025] According to the composite, the mass proportion of the biodegradable fiber segments in the total biodegradable fibers is at least 99%.

[0026] In another aspect of the present invention, the present invention provides a composite for biomedical materials, which is mainly composed of biodegradable fibers and a water-soluble polymer carrier, wherein the biodegradable fibers are biodegradable fiber segments composed of high molecular polymers, and the biodegradable fiber segments have a diameter of 50 nm to 10 μm and a length of 1 μm to 300 μm, and account for at least 50% by mass of all biodegradable fibers.

[0027] In another aspect of the present invention, the present invention provides a composite for biomedical materials, which is substantially composed of the biodegradable fiber, a water-soluble polymer carrier and water.

[0028] In another aspect of the present invention, the present invention also provides a method for preparing the composite of the present invention, comprising the following steps:

[0029] The biodegradable raw materials are dissolved in an organic solvent and a fiber membrane is prepared by electrospinning;

[0030] The fiber membrane is sheared and crushed at high speed under liquid nitrogen protection to obtain fiber fragments, and

[0031] The fiber fragments are homogenized under high pressure to form the biodegradable fiber segments of the present invention.

[0032] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0034] Figure 1 This is the fiber membrane provided in Comparative Example 1.

[0035] Figure 2 This is a scanning electron microscope image of the fiber membrane provided in Comparative Example 1.

[0036] Figure 3 This is a microscope magnified photo (×40 times) of the fiber membrane provided in Comparative Example 1 after high-speed shearing and crushing.

[0037] Figure 4 This is a scanning electron microscope photograph of product B obtained in Example 1.

[0038] Figure 5a This is an optical microscope photograph (×100 times) of the suspension of Product B obtained in Example 1.

[0039] Figure 5b for Figure 5a A partial enlarged photo.

[0040] Figure 6 This is a freeze-dried cake of Product B obtained from Example 1 and sodium hyaluronate.

[0041] Figure 7 for Figure 6 Scanning electron micrograph of the freeze-dried cake.

[0042] Figure 8 This is a photo of the commercially available polylactic acid microsphere product 30 minutes after reconstitution.

[0043] Figure 9 This is a photo taken 30 minutes after reconstitution of the freeze-dried cake of Product B obtained in Example 1 and sodium hyaluronate.

[0044] Figure 10 The filling effects of the three combinations in the first week after injection.

[0045] Figure 11 The filling effects of the three combinations at four weeks after injection.

[0046] Figure 12 The results of pathological HE staining of fiber segments and carrier complexes.

[0047] Figure 13 The results of Masson staining of the fiber segment and carrier complex pathology.

[0048] Figure 14 The results of pathological HE staining of the microsphere and carrier complex.

[0049] Figure 15 The results of Masson staining of the microsphere and carrier complex were shown.

[0050] Figure 16 This is a photo of the sample gel numbered #1.

[0051] Figure 17 This is a photo of the sample gel numbered #2.

[0052] Figure 18 This is a photo of the sample gel numbered #3. DETAILED DESCRIPTION

[0053] According to one aspect of the present invention, a composite is provided, comprising biodegradable fibers and a water-soluble polymer carrier, wherein the biodegradable fibers comprise biodegradable fiber segments composed of high molecular weight polymers.

[0054] The raw material of the biodegradable fiber segment is one or more selected from the group consisting of polylactic acid, polycaprolactone, polydioxanone, and polylactic-co-glycolic acid. Preferably, the raw material of the biodegradable fiber segment is polylactic acid.

[0055] The weight-average molecular weight of the polymer comprising the biodegradable fiber segment may be, but is not limited to, 10,000 g / mol to 500,000 g / mol. Specifically, the weight-average molecular weight of the biodegradable fiber segment may be 20,000 g / mol, 40,000 g / mol, 60,000 g / mol, 80,000 g / mol, 100,000 g / mol, 120,000 g / mol, 140,000 g / mol, 160,000 g / mol, 200,000 g / mol, 240,000 g / mol, 260,000 g / mol, 280,000 g / mol, 300,000 g / mol, 350,000 g / mol, 400,000 g / mol, or 450,000 g / mol. Since the weight-average molecular weight of the biodegradable fiber segment is within the above range, it can be easily processed into a composite, and the stability of the composite can be improved.

[0056] The biodegradable fiber segments described in the present invention may have a diameter of 50 nm to 10 μm and a length of 1 μm to 300 μm, but are not limited thereto. Specifically, the diameter of the biodegradable fiber segments may be 100 nm to 7 μm, 200 nm to 5 μm, or 300 nm to 3 μm; and the length may be 2 μm to 250 μm, 3 μm to 200 μm, 4 μm to 150 μm, or 5 μm to 100 μm. Biodegradable fiber segments with diameters and lengths within these ranges help maintain a stable suspension in the solution for extended periods, facilitate injection through a thinner needle, and reduce pain during injection.

[0057] The present invention has found that traditional methods, such as mechanical shearing, to process fibers, such as processing fiber membranes obtained by electrospinning, actually mainly obtain fiber particles or fragments. Under magnification, the fiber particles are basically in the form of sheets. The particles / fragments are still composed of fibers entangled and intertwined. In particular, if fibers with a diameter of less than 10 μm are used, the free fibers that can be obtained are generally less than 5%, which is not conducive to dispersion in the solution and passing through finer needles. Such degradable fiber products have poor dispersibility, poor product uniformity, and unstable quality. When used as fillers, they are prone to causing nodules, granulomas, etc. Fibers with a diameter greater than 50 μm, although it is possible to obtain a slightly higher proportion of free fibers through traditional shearing, crushing or grinding, such fibers have a small specific surface area and are obviously not conducive to use in biomedicine, especially in the field of medical beauty. In the composite of the present invention, the biodegradable fiber segments generally have a diameter of less than 10 μm and are essentially composed of separate, approximately rod-shaped fiber segments. The fiber segments of the present invention are essentially individually dispersed in the solution, with little or no entanglement or interweaving between them. Such products have high uniformity, large specific surface area, good dispersibility in solution, strong syringe passability, and also achieve good results when used on animal body tissues. According to the present invention, the biodegradable fiber segments can be obtained by a variety of methods, such as mechanical processing and high-pressure homogenization. In the composite of the present invention, the majority of the degradable fiber components are such fiber segments, rather than fiber particles or fragments. In one embodiment of the present invention, the fiber segments account for at least 99% of the total degradable fiber component, in another embodiment, the fiber segments account for at least 95%, in another embodiment, the fiber segments account for at least 90%, in another embodiment, the fiber segments account for at least 85%, in another embodiment, the fiber segments account for at least 80%, in another embodiment, the fiber segments account for at least 75%, in another embodiment, the fiber segments account for at least 70%, in another embodiment, the fiber segments account for at least 60%, and in another embodiment, the fiber segments account for at least 50%.

[0058] According to the present invention, the water-soluble polymer carrier in the composite has the ability to disperse and fix the biodegradable fiber segments. Specifically, the water-soluble polymer carrier is one or more selected from sodium hyaluronate, collagen, polyribonucleotides, polydeoxyribonucleotides, carboxymethyl cellulose, hydroxypropyl methylcellulose, chitosan, agarose, and dextran, preferably sodium hyaluronate or collagen.

[0059] The mass ratio of the biodegradable fiber to the water-soluble polymer carrier can be 5:95 to 99:1, but is not limited thereto. Specifically, the mass ratio of the biodegradable fiber to the water-soluble polymer contained in the composite can be 10:90, 20:80, 35:65, 45:55, 55:45, 65:35, 75:25, 80:20, 85:15, 90:10. Since the mass ratio of the biodegradable fiber to the water-soluble polymer carrier is within this range, the composite can be processed and dissolved more easily, and the system is more stable after dissolution. In the dispersion containing biodegradable fibers of the present invention, the fiber segments account for the majority of the degradable fibers. The dispersion of the present invention is not easy to settle, has good permeability, and reduces the difficulty of injection.

[0060] According to another aspect of the present invention, there is provided a method for preparing a biodegradable fiber segment, comprising the following steps:

[0061] (1) Dissolving biodegradable raw materials in an organic solvent and preparing a fiber membrane by electrospinning;

[0062] (2) crushing the fiber membrane by high-speed shearing under the protection of liquid nitrogen;

[0063] (3) The product obtained in (2) is dispersed in a solution, further crushed by high-pressure homogenization, filtered, washed, and freeze-dried to obtain biodegradable fiber segments.

[0064] According to another aspect of the present invention, there is provided a method for preparing a composite based on the fiber segment of the present invention, comprising the following steps:

[0065] (4) The fiber segments obtained in step (3) are mixed with a water-soluble polymer carrier, and a composite is obtained after freeze-drying.

[0066] Comparative Example 1

[0067] The fiber membrane was broken by high-speed shearing method, and its complex with sodium hyaluronate was prepared.

[0068] (1) Electrospinning

[0069] 15g of commercially available polylactic acid with a weight average molecular weight of 189000g / mol was dissolved in a mixed solvent of hexafluoroisopropanol and dichloromethane with a mass ratio of 6:4 at a concentration of 9wt% to prepare a polylactic acid spinning solution. The spinning solution was added to a syringe, the rate of the microinjection pump was adjusted to 10mL / h, the positive voltage of the high-voltage generator was adjusted to 15kV, the negative voltage was adjusted to -5kV, and the fiber membrane was collected using commercially available release paper ( Figure 1 and Figure 2 ).

[0070] (2) Fiber membrane breakage

[0071] The fiber membrane is broken by the existing shearing method. The dried fiber membrane is cut into 5cm×5cm size and broken using a commercially available high-speed shearing machine under liquid nitrogen protection to obtain a large number of fiber membrane fragment particles and a small amount of separated, independent free fibers. The proportion of these free fibers is generally less than 1% by mass, such as Figure 3 As shown, the field of view is basically fiber fragments, with the fibers intertwined and interwoven. Only a small number of independent free fibers exist around the fragments, but the lengths of the free fibers vary greatly. The fragmented product is dried and recorded as Product A.

[0072] Weigh a certain mass of product A, designated M1. Disperse it evenly in an aqueous solution, then run a sieve through it to separate the membrane fragments from the free fibers. The membrane fragments trapped on the sieve are collected, dried, and weighed, designated M2. The difference between the two masses represents the free fiber content, calculated as (M1 - M2) / M1 * 100%. Using the high-speed shearing method, the yield of free fibers is 4.7%.

[0073] (3) Preparation of fiber membrane fragments and sodium hyaluronate complex

[0074] Weigh 170 mg of the above-mentioned product A and 30 mg of sodium hyaluronate, disperse and dissolve them in 5 g of aqueous solution, and freeze-dry to obtain a lyophilized cake. 3 mL of sterile injection solution was added to the lyophilized cake, and the reconstituted suspension was transferred to a syringe. The suspension could not be injected smoothly through a 27G needle.

[0075] Comparative Example 2

[0076] Preparation of microsphere+fiber+carrier complex

[0077] Microspheres: Purchase commercially available polylactic acid microspheres with a diameter of 25-60 μm.

[0078] Fiber: Polylactic acid electrospinning was performed using the method in Comparative Example 1, and the fiber diameter was controlled at 50-150 μm. The fiber membrane was then broken using a high-speed shearing method, and a screen was used to separate free fibers from fiber membrane fragments. The length of the free fibers screened was 300-700 μm.

[0079] The microspheres, free fibers and sodium hyaluronate were mixed evenly at a mass ratio of 10:1:500 and freeze-dried for storage.

[0080] Example 1

[0081] High-speed shearing combined with high-pressure homogenization to break up the fiber membrane

[0082] Product A obtained in Comparative Example 1 was dispersed in a solution and processed using a commercially available high-pressure homogenizer under mechanical forces such as high-speed shearing, cavitation, and convective impact to produce uniform fiber segments with an average length of 32 μm. The suspension after treatment with the high-pressure homogenizer completely passed through a sieve, yielding a 100% fiber segment recovery rate. The fiber segments were freeze-dried and stored as Product B.

[0083] The fiber segments were observed using a Hitachi scanning electron microscope SU8600. Figure 4 As shown, the obtained degradable fiber segments are basically rod-shaped, and the diameters and lengths of the fiber segments are not much different. Most of the diameters are below 5 μm, and the lengths are between 10 and 50 μm.

[0084] The fiber segment suspension was observed using a commercially available optical microscope. Figure 5a and 5b As shown, the biodegradable fibers are basically separated from each other, and there are almost no entangled or interwoven fiber fragments in the field of view.

[0085] Example 2

[0086] Preparation of fiber segment and sodium hyaluronate complex

[0087] Weigh 170 mg of the product B in Example 1 and 30 mg of sodium hyaluronate, disperse and dissolve them in 5 g of aqueous solution, and freeze-dry to obtain the following: Figure 6 The freeze-dried cake was obtained as Figure 7 Scanning electron microscopy images show that the fiber segments are uniformly dispersed in the carrier. Add 3 mL of sterile injection solution to the lyophilized cake and transfer the reconstituted suspension into a syringe. The suspension can be injected smoothly through a 27G needle.

[0088] Example 3

[0089] Comparison of suspension stability between the composite of Example 1 and commercially available polylactic acid microspheres

[0090] After fully dissolving the complex described in Example 1 and the commercially available polylactic acid microsphere product in 3 mL of sterile water for injection, the mixture was allowed to stand for 30 minutes. Figure 8 As shown in Figure 2, the commercially available polylactic acid microsphere product began to settle and stratify after 30 minutes of redissolution. Figure 9 As shown, the fiber segment and hyaluronic acid complex of the present invention has better stability after re-dissolution, does not settle for a long time, and does not delaminate, which can ensure that the fiber segment is evenly dispersed in the solution and avoid nodules caused by material agglomeration after injection.

[0091] Example 4

[0092] Animal experiments

[0093] Select 6 New Zealand rabbits weighing about 2.5kg. After quarantine is completed, the veterinarian assesses that there is no abnormal state and subsequent experiments can be carried out. Anesthesia is selected for 0.3% sodium pentobarbital by 1mL / kg ear vein injection. After the anesthesia takes effect, the animal is fixed on the rabbit platform and maintained by a respiratory anesthesia machine. The animal's back is depilated and the skin is prepared. The sample of Example 1 (fiber segment + carrier), commercially available polylactic acid microsphere product (microsphere + carrier) and comparative example 2 sample (microsphere + free fiber + carrier) after 0.2mL redissolution are injected respectively. The animals are killed and anatomically observed at the 1st and 4th weeks, and the injection site is sampled and HE, Masson staining and pathological analysis are performed.

[0094] Skin histopathological changes were observed using HE staining, and the number of inflammatory cells, angiogenesis, fibrosis, and fatty infiltration in the filled area were counted. Inflammation scores were as follows: 0-2.9 for no irritation; 3.0-8.9 for mild irritation; 9.0-15 for moderate irritation; and >15 for severe irritation.

[0095] Masson staining was used to detect collagen fiber formation in the skin. Collagen fiber area: Observed under a microscope, and a comprehensive pathological description and raw data analysis were performed. Collagen fiber area ratio = collagen fiber area / total area * 100%.

[0096] Table 1 Analysis of pathological results of different prescription combinations

[0097]

[0098] like Figure 10 and Figure 11 As shown, the circles in the figure represent, from left to right, the fiber segments + carrier of Example 1 of the present invention, the commercially available microspheres + carrier (Aesthefill), and the microspheres + fiber segments + carrier of Comparative Example 2. Immediately after injection, the filling effects of all groups were more obvious. As time went on, the matrix material was absorbed by the tissue. In the fourth week, both the commercially available polylactic acid microsphere product containing microspheres and the sample of Comparative Example 2 showed a significant decline, among which the commercially available polylactic acid microsphere product group had the largest decline, and the sample of Comparative Example 2 containing a small amount of fiber maintained a small amount of filling volume. The fiber segment group of Example 1 can maintain the filling volume very well, solving the problem that traditional microspheres are slow to take effect and have a decline period.

[0099] As shown in Table 1, the inflammatory responses of the three combinations at different time points were similar (the sample of the present invention scored slightly higher), but the composite containing fiber segments of the present invention can stimulate the production of more collagen fibers and achieve better filling effects. Combined with the pathological sections, the combination of Example 1 (fiber segments + carrier) showed similar results in HE staining ( Figure 12 ) showed uniform infiltration of inflammatory cells and neovascularization; Masson staining ( Figure 13 ) It can be seen that the fiber segments are interwoven to form a three-dimensional scaffold structure, and there are a large number of newly formed collagen fibers around the material. Figure 14 and Figure 15 As shown in the figure, although the combination of microspheres + carriers can also stimulate collagen fiber production, the microspheres have a small specific surface area, which is not conducive to cell infiltration, has a longer degradation cycle, and a higher risk of nodules. The scaffold structure formed by the fiber segment-containing composite of the present invention is more conducive to cell growth, is not easy to form nodules, has more uniform inflammatory infiltration, produces more new blood vessels, and does not rely on the volume of the material for filling and occupying space. The support effect is more natural than that of microspheres. The effect of comparative example 2 (microspheres + fiber segments + carriers) in stimulating collagen regeneration is between that of fiber segments + carriers and microspheres + carriers.

[0100] Example 5

[0101] Preparation of fiber segment and collagen complex

[0102] The formula is shown in Table 2. Sample #1 is used as an example for the following description. 100 mg of collagen was weighed and dissolved in 9 mL of dilute hydrochloric acid solution. 25 mg of the fiber segments from Example 3 were weighed and dispersed in 1 mL of 10× PBS buffer. The two were then mixed evenly, the pH was adjusted to 7.2, and the mixture was stored at low temperature. The sample was placed in a 37°C water bath and incubated for 30 minutes to allow the sample to transform from solution to gel. Figure 14 、 Figure 15 、 Figure 16 As shown, the mass ratios of the fiber segments to collagen corresponding to sample numbers #1, #2 and #3 are 20:80, 50:50 and 80:20 respectively. The complexes can complete the thermosensitive transition from solution to gel at 37°C and can play a supporting and filling role when injected into the face.

[0103] Table 2

[0104] Sample No. Fiber segment (mg / mL) Collagen (mg / mL) 1 2.5 10 2 10 10 3 40 10

[0105] Those skilled in the art will understand that various components / parts of the products, formulations, devices, methods, systems and embodiments described herein may be modified (added and / or removed) without departing from the overall scope and spirit of the invention, which encompasses such modifications.

Claims

1. A composite material for biomedical use, comprising biodegradable fibers and a water-soluble polymer carrier, wherein the biodegradable fibers include biodegradable fiber segments composed of a high molecular weight polymer, the biodegradable fiber segments having a diameter of 50 nm to 10 μm and a length of 1 μm to 300 μm, and accounting for at least 50% by mass of the total biodegradable fibers.

2. The composite according to claim 1, wherein the high molecular polymer of the biodegradable fiber segment is selected from one or more of polylactic acid, polycaprolactone, polydioxanone, and polylactic acid-glycolic acid. The composite material of claim 1 , wherein the high molecular weight polymer of the biodegradable fiber segment is polylactic acid. The composite of claim 1 , wherein the weight average molecular weight of the high molecular weight polymer of the biodegradable fiber segment is 10,000 g / mol to 500,000 g / mol. The composite of claim 1 , wherein the weight average molecular weight of the high molecular weight polymer of the biodegradable fiber segment is 50,000 g / mol to 400,000 g / mol. 6 . The composite of claim 1 , wherein the biodegradable fiber segments have a diameter of 300 nm to 3 μm and a length of 5 μm to 100 μm.

7. The complex according to claim 1, wherein the water-soluble polymer carrier is one or more selected from the group consisting of sodium hyaluronate, collagen, polyribonucleotides, polydeoxyribonucleotides, carboxymethyl cellulose, hydroxypropyl methylcellulose, chitosan, agarose, and dextran.

8. The complex according to claim 1, wherein the water-soluble polymer carrier is one or more of sodium hyaluronate, collagen or polyribonucleotide.

9. The complex of claim 7, wherein the collagen is animal-derived collagen or recombinant collagen.

10. The composite according to claim 1, wherein the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 5% to 99%.

11. The composite according to claim 1, wherein the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 10% to 95%.

12. The composite according to claim 1, wherein the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 20% to 90%.

13. The composite according to claim 1, wherein the mass content of the biodegradable fiber in the mixture of the biodegradable fiber and the water-soluble polymer carrier is 40% to 88%.

14. The composite of claim 1, wherein the biodegradable fiber segments account for at least 90% by weight of all biodegradable fibers.

15. A method for preparing the composite according to any one of claims 1 to 14, comprising the steps of: The biodegradable raw materials are dissolved in an organic solvent and a fiber membrane is prepared by electrospinning; crushing the fiber membrane by high-speed shearing under the protection of liquid nitrogen to obtain fiber fragments; and The fiber fragments are homogenized under high pressure to form the biodegradable fiber segments.

Images