Absorbable bone hemostatic repair stent and preparation method and application thereof

Abstract

The present application relates to a kind of absorbable bone hemostasis repair bracket, the absorbable bone hemostasis repair bracket includes the following weight parts of raw materials: excipient 15~60 parts, softening agent 15~60 parts and promote bone repair component 5~70 parts;The excipient includes polyoxyethylene-polyoxypropylene copolymer;The softening agent includes semi-solid mobile phase polymer;The promote bone repair component includes coating and core, the coating includes polylactic acid-glycolic acid copolymer, zinc stearate and potassium bromide, the core includes calcium phosphate salt particle, and the coating is wrapped in the surface of core.The preparation method includes the following steps: the preparation of promote bone repair component;The preparation of absorbable bone hemostasis repair bracket.The present application absorbable bone hemostasis repair bracket hemostasis anti-ability of scattering is strong, and has good inflammation regulation and promote bone repair effect.The present application absorbable bone hemostasis repair bracket can be used for any bone injury wound surface bone hemostasis and promote bone repair.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of bone hemostatic repair materials, in particular to an absorbable bone hemostatic repair stent and a preparation method and application thereof. BACKGROUND

[0002] Clinically, two problems will be faced in the treatment of orthopedic trauma: bone bleeding and bone repair after trauma. Therefore, orthopedic hemostatic and bone healing products will be used in the clinical treatment of orthopedic trauma. At present, there are separate bone hemostatic and bone repair medical products in the clinic, but there is no product scheme that simultaneously has good bone hemostasis and bone repair. After bone injury, it will go through: bone bleeding → inflammation period → proliferation remodeling period.

[0003] Bone bleeding after injury is mainly cancellous bone. There is no obvious artery / vein trunk in cancellous bone, but a network structure composed of sinusoidal capillaries (blood sinuses) with a diameter of 20-100 μm. The walls of these blood sinuses are thin (only 1-2 layers of endothelial cells without smooth muscle layer) and have poor elasticity. After injury, they cannot achieve self-closure through "vessel contraction", and usually only physical plugging with bone wax can achieve hemostasis.

[0004] The inflammation period of bone injury is the first core stage of the bone repair process, usually lasting 0-7 days after injury (the specific duration varies depending on the severity of the injury and individual immune state fluctuations). The inflammation period of bone injury is not a single "inflammatory state", but a progressive process that presents "pro-inflammatory → anti-inflammatory → repair initiation" over time, laying the foundation for the subsequent proliferation repair period and bone remodeling period. If the inflammation stage of bone injury is abnormal, it will seriously affect the subsequent bone repair process. Therefore, a good bone hemostatic and repair material should be able to regulate inflammation, achieve "inhibition of excessive inflammation, promotion of inflammation to repair, adaptation to bone healing timing", and avoid repair disorders (such as nonunion, bone infection) after hemostasis due to inflammation disorders.

[0005] The bone proliferation remodeling period is a key functional implementation stage of bone injury repair, which follows the inflammation period and runs through the "proliferation repair period (2-8 weeks after injury)" and "bone remodeling period (8 weeks to 2 years after injury)". The bone proliferation remodeling period is the longest and most complex stage in bone injury repair, with difficulties concentrated in the three dimensions of "osteogenesis-osteoclast balance regulation", "repair and functional adaptation", and "microenvironment interference factors". These difficulties directly affect the efficiency and quality of bone repair, and may lead to delayed union, nonunion or poor mechanical function recovery. Therefore, materials used for bone hemostasis and bone repair after bone injury are extremely important.

[0006] The prior art has disclosed materials with bone hemostasis and bone repair functions, such as bone wax with bone repair function and its preparation method and application, which comprises polyoxypropylene-polyoxyethylene copolymer, strontium-doped carbon nanometer hydroxyapatite and other components, and has bone hemostasis and bone repair functions. However, the method has poor anti-disintegration ability, and lacks zinc ions, and has no obvious inflammation regulation function. There is also disclosed a plastic bone graft composition, which comprises about 10-50 wt% of biphasic calcium phosphate particles comprising hydroxyapatite and tricalcium phosphate; and about 1-40 wt% of at least one bioactive glass. However, the method mainly uses water-soluble polymers, and the material has strong plasticity but poor anti-disintegration ability, and has no obvious inflammation regulation function. There is also disclosed a bone hemostasis and repair material and its preparation method, and the preparation raw materials of the bone hemostasis and repair material comprise 4-80 parts by weight of bioactive glass and 1-50 parts by weight of excipient. However, the method has no obvious inflammation regulation effect. SUMMARY

[0007] In view of the deficiencies of the prior art, the present application provides an absorbable bone hemostasis and repair scaffold, which is characterized by comprising the following raw materials in parts by weight: 15-60 parts of excipient, 15-60 parts of softening agent and 5-70 parts of bone repair promoting component; the excipient comprises polyoxyethylene-polyoxypropylene copolymer (PEG-ran-PPG); the softening agent comprises semi-solid mobile phase polymer;

[0008] The bone repair promoting component comprises a coating and a core, the coating comprises polylactic acid-glycolic acid copolymer, zinc stearate and potassium bromide, and the core comprises calcium phosphate salt particles, and the coating is wrapped on the surface of the core.

[0009] In one embodiment, the excipient comprises at least one of poloxamer P188, poloxamer 407, poloxamer P338 and poloxamer F108.

[0010] In one embodiment, the softening agent comprises at least one of vitamin E acetate and polyoxyethylene-polyoxypropylene random copolymer.

[0011] The calcium phosphate salt particles comprise α-tricalcium phosphate, β-tricalcium phosphate or hydroxyapatite.

[0012] In one embodiment, the particle size of the potassium bromide is ≤100 nm, and the size of the calcium phosphate salt particles is 1-200 μm.

[0013] The second aspect of the present application further provides a preparation method of the above-mentioned absorbable bone hemostasis and repair scaffold, which comprises the following steps:

[0014] Preparation of the bone repair promoting component: poly-lactic-co-glycolic acid, zinc stearate, potassium bromide and calcium phosphate salt particles are mixed, stirred and mixed uniformly in an environment of 135℃ to 175℃, transferred to a room temperature environment, continuously stirred and cooled to obtain the bone repair promoting component;

[0015] Preparation of the absorbable bone hemostasis repair bracket: excipient, softening agent and bone repair promoting component are mixed, heated, stirred and mixed uniformly, shaped and cooled to obtain the absorbable bone hemostasis repair bracket.

[0016] In one of the embodiments, in the preparation of the bone repair promoting component, the mass ratio of the poly-lactic-co-glycolic acid, the zinc stearate, the potassium bromide and the calcium phosphate salt particles is (0.3-0.6):(0.1-0.3):(0.03-0.06):1.

[0017] In the poly-lactic-co-glycolic acid (PLGA), the molar ratio of lactic acid (LA) monomers to glycolic acid (GA) monomers is 75:25.

[0018] In one of the embodiments, in the preparation of the bone repair promoting component, the stirring speed for stirring and mixing uniformly is 30-60 r / min, and the stirring time is greater than or equal to 30 min; the stirring speed for continuous stirring is 30-50 r / min.

[0019] In one of the embodiments, in the preparation of the absorbable bone hemostasis repair bracket, the heating temperature for keeping heating is 60-90℃, the heating time is greater than or equal to 1 h, the stirring speed for stirring and mixing uniformly is 30-60 r / min, and the stirring time is greater than or equal to 30 min.

[0020] The third aspect of the application further provides the use of the absorbable bone hemostasis repair bracket or the absorbable bone hemostasis repair bracket prepared by the preparation method in the preparation of a bone hemostasis repair product.

[0021] In addition, the application further provides a bone hemostasis repair product comprising the absorbable bone hemostasis repair bracket or the absorbable bone hemostasis repair bracket prepared by the preparation method.

[0022] Compared with the prior art, the application has the following beneficial effects:

[0023] The bone hemostasis repair bracket has strong hemostasis and anti-erosion ability, good bone hemostasis effect, good inflammation regulation and bone repair promoting effect. In the early inflammatory stage of bone repair, the Zn 2+ (zinc ions) and Br -The bromide ion can regulate the inflammatory response and activate the repair cell function through synergistic effect, so as to lay a key foundation for subsequent bone tissue regeneration. In combination with the phosphate core, the process of bone repair can be effectively accelerated, and the quality of bone repair can be ensured. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 Electron micrograph of calcium phosphate salt particles coated with PLGA / zinc stearate / potassium bromide coating;

[0025] Figure 2 Result graph of slow release of zinc ions and bromide ions of calcium phosphate salt particles coated with PLGA / zinc stearate / potassium bromide coating;

[0026] Figure 3 Plasticity of the bone hemostasis repair scaffold;

[0027] Figure 4 Bone hemostasis repair scaffold skull repair capacity graph (Micro CT 3D, scale 1mm). DETAILED DESCRIPTION

[0028] The calcium phosphate salt particles (1-200 mu m) coated with PLGA / zinc stearate / potassium bromide coating are prepared by hot melt coating method, then the calcium phosphate salt particles coated with PLGA / zinc stearate / potassium bromide coating are hot-melt blended with excipients (polyoxyethylene-polyoxypropylene copolymer) and softening agents, and then cooled and shaped to obtain the absorbable and arbitrarily shaped bone hemostasis repair scaffold. Thanks to the softening ability and semi-hydrophobic nature of the softening agent, the bone hemostasis repair scaffold has good hemostatic effect and anti-disintegration property. In the process of bone repair, the excipients and softening agents are gradually degraded and absorbed, and the PLGA / zinc stearate / potassium bromide coating calcium phosphate salt particles are exposed to the bone wound environment. The zinc stearate is usually difficult to release Zn 2+ , but the acidic substances (lactic acid, glycolic acid) produced by the degradation of PLGA can promote the degradation of zinc stearate into stearic acid and Zn 2+ , and the degradation of PLGA and zinc stearate will lead to the release of Br - in the coating. Therefore, the synergistic degradation of PLGA and zinc stearate in the coating plays a key role in the slow release of Zn 2+ and Br - . And in the early inflammatory stage of bone repair, the outer PLGA / zinc stearate / potassium bromide coating releases Zn 2+ (zinc ion) and Br -The bromide ion can regulate the inflammatory response and activate the repair cell function through synergistic effect, and lay a key foundation for subsequent bone tissue regeneration. The bone repair process can be effectively accelerated, and the quality of bone repair can be ensured. When the outer PLGA / zinc stearate / potassium bromide coating degrades, the inner core calcium phosphate salt particles are exposed and contacted with the bone wound surface, the function is changed from "auxiliary inflammation regulation" to "promoting bone regeneration and structure reconstruction" - by providing an "inorganic scaffold" for bone regeneration, releasing phosphate / calcium ions to regulate the microenvironment, and guiding the ordered remodeling of bone tissue.

[0029] The bone hemostasis repair scaffold of the application is a bone hemostasis repair scaffold which can be widely applied to bone defect filling and can be arbitrarily shaped, has strong anti-disintegration ability, can immediately stop bleeding, can regulate inflammation, and can promote bone repair.

[0030] In order to facilitate the understanding of the present application, the present application will be described more fully below with reference to the accompanying drawings. The preferred embodiments of the present application are shown in the drawings. However, the present application can be realized in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the present application more thorough and comprehensive.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present application belongs. The terms used in the specification of the present application herein are only for the purpose of describing specific embodiments and are not intended to limit the present application. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0032] The reagents, materials and equipment used in the present embodiment are commercially available unless otherwise specified. The test methods are conventional test methods in the art unless otherwise specified.

[0033] Embodiment

[0034] The present application provides a preparation method of an absorbable bone hemostasis repair scaffold, wherein the molar ratio of LA:GA of PLGA used is 75:25 (75% lactic acid-25% glycolic acid copolymer), the melting point is 110-130 DEG C, the thermal decomposition temperature is 180-190 DEG C, the zinc stearate used has a melting point of 118-125 DEG C, and the thermal decomposition temperature is 200-230 DEG C, the particle size of potassium bromide used is not more than 180,000 (not more than 100 nm), the size of the calcium phosphate salt particles used is 1-200 mu m, and the preparation method specifically comprises the following steps:

[0035] (1) Preparation of PLGA (poly lactic acid-glycolic acid copolymer) / zinc stearate / potassium bromide coating wrapped calcium phosphate salt particles

[0036] The PLGA: zinc stearate: potassium bromide: calcium phosphate salt particles are mixed according to a mass ratio of 0.5:0.2:0.05:1, and then placed in a high-temperature environment of 135-175 DEG C. After the PLGA and zinc stearate are completely melted, the PLGA, zinc stearate, potassium bromide, and calcium phosphate salt particles are fully stirred and mixed uniformly at a stirring speed of 30-60 r / min, and the stirring time is not less than 30 min. Then, the mixture is transferred to a room-temperature environment, and continuously stirred at a speed of 40 r / min + / - 10 r / min. Too high a stirring speed will cause the coating to be damaged, and too low a stirring speed will cause the particles to be adhered and formed into blocks. After the material temperature is reduced to room temperature, the surface of the calcium phosphate salt particles is covered with a layer of PLGA / zinc stearate / potassium bromide coating, and the PLGA / zinc stearate / potassium bromide coated calcium phosphate salt particles can be obtained.

[0037] (2) Preparation of absorbable bone hemostasis repair scaffold

[0038] The absorbable bone hemostasis repair scaffold is composed of 15-60 parts of excipient, 15-60 parts of softening agent, and 5-70 parts of bone repair promoting component. The excipient includes any one or a combination of two of poloxamer P188, poloxamer 407, poloxamer P338, and poloxamer F108. The softening agent is a semi-solid flow phase polymer, and includes any one or a combination of two of vitamin E acetate and polyoxyethylene-polyoxypropylene random copolymer (PEG-ran-PPG). The bone repair promoting component is the PLGA / zinc stearate / potassium bromide coated calcium phosphate salt particles prepared in step (1).

[0039] The excipient, softening agent, and bone repair promoting component are mixed according to the ratio and placed in the same clean container. The container is heated at 60-90 DEG C for not less than 1 h to sufficiently soften the excipient and softening agent, and then stirred at a speed of 30-60 r / min for not less than 30 min to mix the excipient, softening agent, and bone repair promoting component uniformly. Then, the mixture is injected into a stainless steel mold and cooled at room temperature to form a product.

[0040] The specific formulations of the examples and comparative examples of the present application are shown in Table 1. The absorbable bone hemostasis repair scaffold can be obtained by heating, softening, mixing, and cooling according to the above preparation method.

[0041] Table 1

[0042]

[0043] Evaluation of implementation effect

[0044] I. Take the samples of Examples 1-6 and Comparative Examples 1-8, evaluate the plasticity (softening property), anti-collapse property, in vitro hemostatic effect (in vitro plugging ability), in vitro osteogenesis promoting ability, and anti-inflammatory ability.

[0045] Among them, Examples 1-6 verify the feasibility of the formula. Comparative Examples 1 and 2 verify the ratio range of the bone repair promoting component, Comparative Examples 3 and 4 verify the ratio range of the softening agent and the excipient, and Comparative Examples 5-8 and Example 1 verify the slow release of Zn 2+ and Br - in the preparation of PLGA / zinc stearate / potassium bromide coated calcium phosphate salt particles.

[0046] Specific evaluation methods and standards are as follows:

[0047] 1. Plasticity: knead the bone hemostatic repair scaffold by hand, which should have good plasticity, and the material should not be too hard or too soft.

[0048] 2. Anti-collapse property: simulate the in vivo body fluid environment, observe the structural changes of the material under constant temperature and static immersion, and analyze its morphological stability. Take each group of materials, make uniform size samples (cylinders with a diameter of 1 cm and a thickness of 5 mm), immerse them in PBS with pH=7.4, and place them at 37°C. The material should not collapse for more than 8 hours to minimize the risk of secondary bleeding on the bone surface.

[0049] 3. In vitro hemostatic effect (in vitro plugging ability): prepare a hollow plastic tube with a diameter of 5 mm and a length of 1.91 m (equivalent to 140 mm of mercury column pressure, equivalent to the maximum arterial pressure bleeding pressure in the human body), and use the softened and shaped material to plug one end. Add purified water from the other end to simulate the maximum pressure plugging effect of the human medullary cavity bleeding. The material should be plugged for at least 60 minutes, i.e., the plugging site should not leak water within 60 minutes.

[0050] 4. Osteogenesis promoting ability: the viability of osteoblasts is an important indicator for evaluating bone healing ability. Take osteoblasts and materials and co-culture them in culture medium for 72 hours. Compared with the blank control (ordinary culture medium), the viability of osteoblasts in the experimental group should be not less than 1.2 times.

[0051] 5. Anti-inflammatory ability: one of the important indicators of anti-inflammatory is the promotion of macrophages from pro-inflammatory phenotype M1 to anti-inflammatory phenotype M2. Select mouse macrophage RAW264.7 as the research object, co-culture the cells with equal amounts of materials for 48 hours, and then use flow cytometry to detect CD86 + cells (M1 phenotype) and CD206 + cells (M2 phenotype), calculate the M2 / M1 ratio, and M2 / M1 should be >1.5.

[0052] II. Verification of experimental results.

[0053] 1. Morphology observation of PLGA / zinc stearate / potassium bromide coated calcium phosphate particles

[0054] The prepared PLGA / zinc stearate / potassium bromide coated calcium phosphate particles were observed by scanning electron microscope to observe their structure.

[0055] The results are shown in Figure 1 , the PLGA / zinc stearate / potassium bromide coated calcium phosphate particles still showed independent particle structure.

[0056] 2. Results of PLGA / zinc stearate / potassium bromide coated calcium phosphate particles releasing zinc ions and bromide ions

[0057] The prepared PLGA / zinc stearate / potassium bromide coated calcium phosphate particles were dispersed in PBS solution with pH=7.4, and the release rates of Zn 2+ and Br - were detected at 1 day, 2 days, 4 days, 6 days, 8 days, 10 days, 12 days and 14 days, respectively.

[0058] The results of the release rates of Zn 2+ and Br - are shown in Figure 2 , the release rate reached about 50% at 6 days, and the release rate was more than 70% at 10 days, indicating that the degradation process of the PLGA / zinc stearate / potassium bromide coating can basically match the process of bone wound inflammation, anti-inflammation and repair, and has a positive promoting effect on bone repair.

[0059] Zinc stearate is generally difficult to release Zn 2+ , but the acidic substances (lactic acid, hydroxyacetic acid) produced by the degradation of PLGA can promote the degradation of zinc stearate into stearic acid and Zn 2+ , and the degradation of PLGA and zinc stearate will lead to the release of Br - in the coating. Therefore, the synergistic degradation of PLGA and zinc stearate in the coating plays a key role in the release of Zn 2+ and Br - .

[0060] 3. Plasticity of bone hemostasis and repair scaffold

[0061] The prepared bone hemostasis and repair scaffold has good plasticity and can be plasticized into various shapes, as shown in Figure 3 , the plastic type of example 1 is spherical and cylindrical, and can be plasticized to meet various gap shapes of bone defect filling and hemostasis and repair in clinic.

[0062] 4. Skull repair ability of bone hemostasis and repair scaffold

[0063] Bama miniature pig was selected as experimental animal, the skull anatomical structure was similar to human, and had obvious bony lamella structure close to human adult skull. A model was made on the skull of pig using high-speed skull drill: critical bone defect with diameter of 25 mm and depth of 10 mm, and then the bone hemostasis repair scaffold of Example 1 and Comparative Example 5 was used to stop bleeding at the defect site. At the 8th week, the skull defect site of the animal was reconstructed by Micro CT 3D, and the results are shown in Figure 4 .

[0064] The bone repair effect of the test group (Example 1) was much better than that of the control group (Comparative Example 5). It was proved that the prepared PLGA / zinc stearate / potassium bromide coating wrapped calcium phosphate salt particles could release Zn 2+ and Br - to synergistically promote bone repair.

[0065] The effect comparison results of Example and Comparative Example are shown in Table 2.

[0066] Table 2 Effect comparison results of Example and Comparative Example

[0067]

[0068] Comparison results:

[0069] 1. According to Comparative Example 1 and Comparative Example 2, the bone repair promoting component will affect the effectiveness and plasticity, anti-dispersion, and plugging effect of the bone hemostasis repair scaffold. If the proportion of the bone repair promoting component is too low, the in-vitro bone promoting ability is unqualified; if the proportion of the bone repair promoting component is too high, the material texture is soft due to the powder of the bone repair promoting component, and the anti-dispersion does not meet the requirements, which further leads to the material being washed away by water during in-vitro hemostasis, resulting in plugging failure.

[0070] 2. According to Comparative Example 3 and Comparative Example 4, the excipient and softening agent will affect the plasticity (material texture) of the material and the in-vitro hemostasis effect. If the proportion of the softening agent is too low and the proportion of the excipient is too high, the material texture will be hard and not easy to shape; if the proportion of the softening agent is too high and the proportion of the excipient is too low, the material texture will be soft and easy to be washed away by water pressure during in-vitro hemostasis, resulting in plugging failure.

[0071] 3. According to Example 1 and Comparative Example 5, and the experimental results Figure 4 , it was proved that the prepared PLGA / zinc stearate / potassium bromide coating wrapped calcium phosphate salt particles could release Zn 2+ and Br -The bone repair is positively promoted. The formulation of Example 1 and Comparative Example 5 is basically the same, the only difference is that the bone repair promoting component of Example 1 is the PLGA / zinc stearate / potassium bromide coated calcium phosphate salt particles, while the Comparative Example 5 is the calcium phosphate salt particles without zinc and bromide ion coating.

[0072] 4. The comparison of Examples 1-8 and Comparative Examples 5-8 can prove that the prepared PLGA / zinc stearate / potassium bromide coated calcium phosphate salt particles release Zn 2+ and Br - have synergistic anti-inflammatory and repair promoting ability, both of which are indispensable. Replacing bromide ions in the coating with magnesium ions greatly reduces the synergistic effect.

[0073] The technical features of the above-described examples can be combined in any manner. In order to make the description concise, all possible combinations of the technical features in the above-described examples are not described, however, as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope of the present disclosure.

[0074] The above-described examples only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be noted that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application. Therefore, the scope of protection of the present application should be subject to the appended claims.

Claims

1. An absorbable bone hemostatic repair stent, characterized in that, The absorbable bone hemostatic repair scaffold comprises the following raw materials in parts by weight: 15-60 parts excipient, 15-60 parts softener, and 5-70 parts bone-repairing components; the excipient comprises a polyoxyethylene-polyoxypropylene copolymer; the softener comprises a semi-solid mobile phase polymer; The bone-repairing component includes a coating and a core. The coating includes polylactic acid-glycolic acid copolymer, zinc stearate, and potassium bromide. The core includes calcium phosphate salt particles. The coating coats the surface of the core. In the bone-repairing component, the mass ratio of the polylactic acid-glycolic acid copolymer: zinc stearate: potassium bromide: calcium phosphate particles is (0.3~0.6):(0.1~0.3):(0.03~0.06):1; In the polylactic acid-glycolic acid copolymer, the molar ratio of lactic acid monomer to glycolic acid monomer is 75:

25.

2. The absorbable bone hemostatic repair scaffold according to claim 1, characterized in that, The excipients include at least one of poloxamer P188, poloxamer 407, poloxamer P338, and poloxamer F108.

3. The absorbable bone hemostatic repair scaffold according to claim 1, characterized in that, The softener includes at least one of vitamin E acetate and polyoxyethylene-polyoxypropylene random copolymer; The calcium phosphate particles include α-tricalcium phosphate, β-tricalcium phosphate, or hydroxyapatite.

4. The absorbable bone hemostatic repair scaffold according to claim 1, characterized in that, The potassium bromide has a particle size ≤100nm, and the calcium phosphate has a particle size of 1~200μm.

5. The method for preparing the absorbable bone hemostatic repair scaffold as described in any one of claims 1-4, characterized in that, Includes the following steps: Preparation of bone-repairing components: Mix polylactic acid-glycolic acid copolymer, zinc stearate, potassium bromide and calcium phosphate salt particles, place in an environment of 135℃~175℃, stir and mix evenly, transfer to room temperature, continue stirring, and cool down to obtain the final product; Preparation of absorbable bone hemostatic repair scaffold: Mix excipients, softeners and bone-repairing components, keep heating, stir and mix evenly, shape, and cool to obtain the scaffold.

6. The preparation method according to claim 5, characterized in that, In the preparation of the bone-repairing component, the stirring speed for uniform mixing is 30~60 r / min, and the stirring time is ≥30 min; the stirring speed for continued mixing is 30~50 r / min.

7. The preparation method according to claim 5, characterized in that, In the preparation of the absorbable bone hemostatic repair scaffold, the heating temperature is maintained at 60~90℃, the heating time is ≥1h, the stirring speed for uniform mixing is 30~60r / min, and the stirring time is ≥30min.

8. The use of the absorbable bone hemostatic repair stent as described in any one of claims 1-4, or the absorbable bone hemostatic repair stent obtained by the preparation method described in any one of claims 5-7, in the preparation of bone hemostatic repair products.

9. A bone hemostasis and repair product, characterized in that, The bone hemostasis and repair product includes the absorbable bone hemostasis and repair stent according to any one of claims 1-4, or the absorbable bone hemostasis and repair stent obtained by the preparation method according to any one of claims 5-7.

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