CN112138204A

CN112138204A - Bone hemostatic material

Info

Publication number: CN112138204A
Application number: CN201910558726.XA
Authority: CN
Inventors: 徐宝艳
Original assignee: Guangdong Bo Yu Regenerative Medicine Co ltd
Current assignee: Shaanxi Bio Regenerative Medicine Co ltd
Priority date: 2019-06-26
Filing date: 2019-06-26
Publication date: 2020-12-29

Abstract

The invention provides a bone hemostatic material comprising calcium phosphate, an aqueous sodium silicate solution, poloxamer and triglycerides; wherein the poloxamer is selected from at least two of poloxamer 338, poloxamer 105, poloxamer 124, poloxamer 184, poloxamer 237, poloxamer 335, poloxamer 403 and poloxamer 401. The bone hemostatic material provided by the invention has good adhesion performance and strong hemostatic performance, can obviously promote bone wound repair, can be degraded and absorbed in vivo, and has no immunogenicity and high safety.

Description

Bone hemostatic material

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to a bone hemostatic material.

Background

The bleeding is treated in a certain way, so that the outward flowing of blood is quickly stopped, namely the hemostasis process, and the hemostasis process mainly comprises three processes of vasoconstriction, platelet thrombosis and blood coagulation. Hemostasis is an important step of medical treatment, the tissue and organ injury and operation of a patient need to be fully stopped, and rapid hemostasis is needed when sudden trauma occurs in daily life, so that the rapid and effective hemostasis is particularly important to realize in severe war environments and wound emergency treatment in complex emergencies; the hemostasis effect varies from person to person, and is fast, slow and related to blood platelets, under normal conditions, bleeding caused by small blood vessel injury can stop within a few minutes, the phenomenon is called physiological hemostasis, which is one of important protection mechanisms of the organism and is the result of interaction of various factors and mechanisms. The hemostatic function of normal human body can only act on slow and small amount of bleeding, but the action effect is not obvious to various large-scale accidents and hidden bleeding phenomena of rupture of artery bleeding, viscera and the like in surgical operation, and an effective hemostatic material is urgently needed.

Generally, in the case where the blood of a human body is normally coagulated by itself, general tissue wounds can be self-repaired, and epidermal bleeding or venous bleeding can be self-coagulated. However, arterial bleeding, major venous bleeding, severe tissue trauma, or most surgical procedures do not allow the blood to self-coagulate and achieve self-protection in time, and if measures are not taken in time, serious bleeding can occur, and excessive blood loss can be life-threatening. Especially, under various conditions such as battlefields, field sudden accidents, earthquake natural disasters, surgical operations and the like, the use of the quick and effective hemostatic material is particularly important.

Intraoperative wound bleeding is a common surgical problem and can cause blood transfusion and related complications, the operation time is prolonged due to excessive intraoperative bleeding, serious complications such as hemorrhagic shock occur, and even death of a patient is caused. Intraoperative hemorrhage not only causes difficulty for doctors, but also brings undesirable loss to patients. Therefore, the development of hemostatic materials is always one of the major concerns in the fields of clinical medicine, biomaterials, and medical devices.

The bleeding of the cancellous wound surface in the orthopedic operation is not only stopped or the complete hemostasis is difficult, which is a troublesome problem often encountered by craniocerebral surgery, orthopedics and orthopedic surgeons. Cancellous bone is loose in structure and rich in blood circulation, and the wound surface is mostly caused by sharp instrument cutting and violent striking, the bleeding is mostly oozing blood, different from bleeding of other tissues, the self hemostasis by vasoconstriction is difficult, and the complete hemostasis is also difficult to be realized by conventional methods such as electric coagulation, clamping, hemostatic gauze and collagen sponge filling in the operation.

At present, the cancellous bone wound surface hemostasis is carried out on the bone wax which is commonly used clinically, the main components of the cancellous bone wound surface hemostasis are beeswax, sesame oil and the like, the biocompatibility is poor, the cancellous bone wound surface hemostasis is difficult to degrade and absorb by organisms, residues are locally and greatly hindered to bone healing, and the formation of original callus is not facilitated, so that bone non-healing is caused.

Patent CN109675094A discloses an absorbable bone wax with hemostatic function, whose raw material is composed of solid matter and water, the solid matter includes cross-linked hyaluronic acid, calcium phosphate and soluble starch, the weight of the water is 20% -100% of the weight of the solid matter; the weight ratio of the solid is as follows: cross-linked hyaluronic acid: calcium phosphate: the soluble starch is (20-70): (20-50): (0-10). Aiming at the defects of poor biocompatibility, nondegradable property and influence on bone healing of the traditional bone wax, the bone wax can be naturally degraded in vivo without causing related complications of residues in a later period while keeping the good hemostatic effect of the traditional bone wax. However, the system has general adhesiveness on the bone wound surface, and the preparation process is relatively complex, so that the system is inconvenient for clinical use.

Therefore, in the field of medical technology, in order to satisfy clinical convenience, improvement of the performance of the existing bone hemostatic material is still required.

Disclosure of Invention

In view of the above, the present invention aims to provide a bone hemostatic material which has good adhesion and strong hemostatic property and can promote bone wound repair and be degradable and absorbable, and a preparation method thereof.

Therefore, the invention provides the following technical scheme.

In a first aspect, the present invention provides a bone hemostatic material comprising a calcium phosphate, an aqueous sodium silicate solution, a poloxamer and a triglyceride; wherein the content of the first and second substances,

the poloxamer is selected from at least two of poloxamer 338, poloxamer 105, poloxamer 124, poloxamer 184, poloxamer 237, poloxamer 335, poloxamer 403, and poloxamer 401.

In a preferred embodiment, the poloxamer is selected from two of poloxamer 237 and poloxamer 335.

In a preferred embodiment, the calcium phosphate is present in an amount of 10 to 40 parts by weight.

In a more preferred embodiment, the weight fraction of the calcium phosphate may be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40.

In a preferred embodiment, the sodium silicate aqueous solution is 20 to 60 parts by weight.

In a more preferred embodiment, the sodium silicate aqueous solution may be 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 parts by weight.

In a preferred embodiment, the mass fraction of sodium silicate in the sodium silicate aqueous solution is 0.1-5%.

In a preferred embodiment, the poloxamer is present in an amount of 10 to 40 parts by weight.

In a more preferred embodiment, the poloxamer may be present in 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 parts by weight.

In a preferred embodiment, the weight fraction of triglycerides is 10-50.

In a more preferred embodiment, the weight fraction of triglycerides may be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50.

In a second aspect, the invention provides a bone hemostatic material, which comprises, by weight, 10-40 parts of calcium phosphate, 20-60 parts of an aqueous sodium silicate solution, 10-40 parts of poloxamer and 10-50 parts of triglyceride; wherein the content of the first and second substances,

the mass fraction of sodium silicate in the sodium silicate aqueous solution is 0.1-5%;

In a preferred embodiment, the sodium silicate aqueous solution has a sodium silicate mass fraction of 2%.

In a third aspect, the present invention provides a bone hemostatic material, comprising, in parts by weight, 20 parts of calcium phosphate, 30 parts of an aqueous sodium silicate solution, 30 parts of poloxamer and 40 parts of triglyceride; wherein the content of the first and second substances,

In a fourth aspect, the present invention provides a method for preparing a bone hemostatic material, comprising the steps of:

1) mixing 10-40 parts of calcium phosphate, 20-60 parts of sodium silicate aqueous solution, 10-40 parts of poloxamer and 10-50 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

2) will prepareMolding the obtained daub-shaped bone hemostatic material in a mold to obtain a block-shaped bone hemostatic material, and packaging⁶⁰Sterilizing with Co rays to obtain bone hemostatic material, and sealing and storing at normal temperature; wherein the content of the first and second substances,

In a fifth aspect, there is provided a bone hemostatic product comprising a bone hemostatic material according to the present invention.

In a sixth aspect, a pharmaceutical composition is provided comprising a safe and effective amount of a bone hemostatic material according to the present invention.

In addition, the invention also provides the application of the bone hemostatic material in preparing bone hemostatic products or pharmaceutical compositions.

In the present invention, better adhesion performance can be achieved by controlling the mass fraction of sodium silicate in the sodium silicate aqueous solution within the range of 0.1-5%; the adhesion is reduced after the sodium silicate in the sodium silicate aqueous solution with too low mass fraction is blended with the calcium phosphate, the poloxamer and the triglyceride; the mass fraction of the sodium silicate in the sodium silicate aqueous solution is too high, so that the adhesion is too large and difficult to control, and the clinical use is inconvenient.

In the present invention, a safe and effective amount refers to an amount of a combination of agents sufficient to significantly induce a positive benefit, preferably a positive hemostatic benefit, including the benefits disclosed herein, either individually or in combination, but low enough to avoid serious side effects, i.e., to provide a reasonable benefit to risk ratio, within the scope of sound judgment of the skilled artisan.

Compared with the prior art, the invention has the beneficial effects that:

the calcium phosphate bioactive ceramic material added in the invention has the similarity of chemical components and crystal structures with inorganic minerals of natural bone tissues, has good biocompatibility and high bioactivity, is easily accepted by organisms, and can be combined with host bone tissues in a bone nature to form a new bone organism, thereby promoting the repair of bone injury parts; according to the invention, the repair of the damaged part of the bone can be effectively promoted by controlling the weight part of the calcium phosphate within the range of 10-40, the bone repair promoting effect is gentle when the content of the calcium phosphate is too high, and the bone repair effect is not obvious any more; too low a calcium phosphate content is relatively ineffective in bone repair.

The sodium silicate aqueous solution used in the invention can not only improve the strength of the bone hemostatic material, but also enhance the ductility and the adhesiveness of the product after being blended with poloxamer, calcium phosphate and triglyceride, thereby being convenient for clinical use.

Poloxamers used in the present invention act as a mechanical barrier by retarding vascular bleeding. The poloxamer can also form a wax-like or paste-like material in the sodium silicate aqueous solution together with the calcium phosphate, and the wax-like or paste-like material with different viscosities can be obtained by controlling the dosage of the poloxamer, so that the shaping and clinical use are facilitated. In addition, due to the combination of multiple poloxamers, the water-soluble bone hemostatic materials with different hydrophilicities are prepared, so that the degradation period of the bone hemostatic materials in vivo is improved, and the bone hemostatic materials are convenient to be used for hemostasis and repair of different bone injury wounds.

The bone hemostatic material can be degraded and absorbed in vivo, has no immunogenicity and high safety, can be selected according to the repair time of a bone injury part in clinical use, and improves the use convenience of doctors.

On the other hand, the bone hemostatic material of the invention has simple components and low cost.

On the other hand, the bone hemostatic material of the invention has simple preparation process and is convenient for large-scale production.

Drawings

FIG. 1 is a diagram illustrating the effect of drawing materials after 112 weeks in an experimental bone wound repair;

FIG. 2 is a diagram showing the effect of the comparative example 112 weeks after drawing materials in the bone wound repair experiment;

FIG. 3 is a graph showing the effect of a white control group in a bone wound repair experiment after taking materials for 12 weeks;

FIG. 4 is a graph of the effect of Mirco-CT at 112 weeks in a bone wound repair experiment;

FIG. 5 is a graph of the effect of Mirco-CT at comparative example 112 weeks in a bone wound repair experiment;

FIG. 6 is a graph of the effect of Mirco-CT on the white control group at 12 weeks in the bone wound repair experiment.

Detailed Description

The present invention will be described in detail below with reference to specific embodiments and examples, and the advantages and various effects of the present invention will be more clearly apparent therefrom. It will be understood by those skilled in the art that these specific embodiments and examples are for the purpose of illustrating the invention and are not to be construed as limiting the invention.

Throughout the specification, unless otherwise specifically noted, terms used herein should be understood as having meanings as commonly used in the art. Thus, unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. If there is a conflict, the present specification will control.

The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

Example 1

This example provides a bone hemostatic material comprising, in parts by weight, 10 parts calcium phosphate, 20 parts 0.1% aqueous sodium silicate solution, 5 parts poloxamer 338, 5 parts poloxamer 105, and 10 parts triglyceride.

The bone hemostatic material of this example was prepared as follows:

1) mixing 10 parts of calcium phosphate, 20 parts of 0.1% sodium silicate aqueous solution, 5 parts of poloxamer 338, 5 parts of poloxamer 105 and 10 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

2) the prepared daubMolding the bone-shaped hemostatic material in a mold to obtain a block-shaped bone hemostatic material, and packaging⁶⁰Sterilizing with Co rays to obtain bone hemostatic material, and sealing and storing at room temperature.

Example 2

This example provides a bone hemostatic material comprising, in parts by weight, 40 parts calcium phosphate, 60 parts 5% aqueous sodium silicate solution, 20 parts poloxamer 338, 20 parts poloxamer 105, and 50 parts triglyceride.

The bone hemostatic material of this example was prepared as follows:

1) mixing 40 parts of calcium phosphate, 60 parts of 5% sodium silicate aqueous solution, 20 parts of poloxamer 338, 20 parts of poloxamer 105 and 50 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

2) molding the prepared daub-shaped bone hemostatic material in a mold to obtain a block-shaped bone hemostatic material, and packaging⁶⁰Sterilizing with Co rays to obtain bone hemostatic material, and sealing and storing at room temperature.

Example 3

This example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium phosphate, 30 parts 2% aqueous sodium silicate solution, 15 parts poloxamer 237, 15 parts poloxamer 335, and 40 parts triglyceride.

The bone hemostatic material of this example was prepared as follows:

1) mixing 20 parts of calcium phosphate, 30 parts of 2% sodium silicate aqueous solution, 15 parts of poloxamer 237, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

Comparative example 1

To further illustrate the beneficial effects of the present invention, comparative example 1 is provided, which is different from example 3 in that: calcium phosphate was replaced by calcium hydrogen phosphate.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium hydrogen phosphate, 30 parts 2% aqueous sodium silicate solution, 15 parts poloxamer 237, 15 parts poloxamer 335, and 40 parts triglyceride.

The preparation method of the bone hemostatic material of the comparative example is as follows:

1) mixing 20 parts of calcium hydrophosphate, 30 parts of 2% sodium silicate aqueous solution, 15 parts of poloxamer 237, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a daub-shaped bone hemostatic material;

Comparative example 2

To further illustrate the beneficial effects of the present invention, comparative example 2 is provided, which comparative example 2 differs from example 3 in that: poloxamer 237 was replaced with tween-80.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium phosphate, 30 parts 2% aqueous sodium silicate solution, 15 parts tween-80, 15 parts poloxamer 335, and 40 parts triglyceride.

1) mixing 20 parts of calcium phosphate, 30 parts of 2% sodium silicate aqueous solution, 15 parts of tween-80, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

Comparative example 3

To further illustrate the beneficial effects of the present invention, comparative example 3 is provided, which comparative example 3 differs from example 3 in that: poloxamer 237 was replaced with poloxamer 188.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium phosphate, 30 parts 2% aqueous sodium silicate solution, 15 parts poloxamer 188, 15 parts poloxamer 335, and 40 parts triglyceride.

1) mixing 20 parts of calcium phosphate, 30 parts of 2% sodium silicate aqueous solution, 15 parts of poloxamer 188, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

Comparative example 4

To further illustrate the beneficial effects of the present invention, comparative example 1 is provided, which is different from example 3 in that: poloxamer 237 was replaced with poloxamer 407.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium phosphate, 30 parts 2% aqueous sodium silicate solution, 15 parts poloxamer 407, 15 parts poloxamer 335, and 40 parts triglyceride.

1) mixing 20 parts of calcium phosphate, 30 parts of 2% sodium silicate aqueous solution, 15 parts of poloxamer 407, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

Comparative example 5

To further illustrate the beneficial effects of the present invention, comparative example 5 is provided, which comparative example 5 differs from example 3 in that: the triglyceride was replaced with triethyl citrate.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium phosphate, 30 parts 2% aqueous sodium silicate solution, 15 parts poloxamer 237, 15 parts poloxamer 335, and 40 parts triethyl citrate.

1) mixing 20 parts of calcium phosphate, 30 parts of 2% sodium silicate aqueous solution, 15 parts of poloxamer 237, 15 parts of poloxamer 335 and 40 parts of triethyl citrate, and mechanically stirring uniformly to form a daub-shaped bone hemostatic material;

Comparative example 6

To further illustrate the beneficial effects of the present invention, comparative example 6 is provided, which comparative example 6 differs from example 3 in that: the mass fraction of sodium silicate in the sodium silicate aqueous solution is adjusted to 0.05%.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium phosphate, 30 parts 0.05% aqueous sodium silicate solution, 15 parts poloxamer 237, 15 parts poloxamer 335, and 40 parts triglyceride.

1) mixing 20 parts of calcium phosphate, 30 parts of 0.05% sodium silicate aqueous solution, 15 parts of poloxamer 237, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

Comparative example 7

To further illustrate the beneficial effects of the present invention, comparative example 7 is provided, which comparative example 7 differs from example 3 in that: the weight part of the calcium phosphate is adjusted to 9 parts.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 9 parts calcium phosphate, 30 parts 2% aqueous sodium silicate solution, 15 parts poloxamer 237, 15 parts poloxamer 335, and 40 parts triglyceride.

1) mixing 9 parts of calcium phosphate, 30 parts of 2% sodium silicate aqueous solution, 15 parts of poloxamer 237, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

Comparative example 8

To further illustrate the beneficial effects of the present invention, comparative example 1 is provided, which is different from example 3 in that: the weight part of the sodium silicate aqueous solution was adjusted to 19 parts.

This comparative example provides a bone hemostatic material comprising, in parts by weight, 20 parts calcium phosphate, 19 parts 2% aqueous sodium silicate solution, 15 parts poloxamer 237, 15 parts poloxamer 335, and 40 parts triglyceride.

1) mixing 20 parts of calcium phosphate, 19 parts of 2% sodium silicate aqueous solution, 15 parts of poloxamer 237, 15 parts of poloxamer 335 and 40 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material;

Comparative example 9

To further illustrate the beneficial effects of the present invention, an absorbable bone wax with hemostatic function is provided, which is prepared by the method of patent CN 109675094A.

Effect verification:

adhesion test:

twenty-four cortical bone rings having a width of 10mm were prepared from bovine femoral bone, the samples prepared in examples 1 to 3 and comparative examples 1 to 9 were uniformly applied to one cortical bone ring surface (area S), and the other cortical bone ring was brought into contact with the above-treated cortical bone ring surface, respectively, and pressure was applied to 78N at a rate of 1mm/min for 1 min. Then connecting the two sides of the cortical bone ring with a stretching clamp of a multifunctional mechanical testing machine, pulling the two cortical bone rings apart at the speed of 1mm/min until the bonded part is broken, recording the maximum tensile force F when the bonded part is broken, and calculating the bonding strength (MPa) as F/S. The results of the experiment are shown in table 1.

Hemostasis test:

the experimental animals are 48 New Zealand rabbits, which are divided into 12 groups on average, skin, soft tissues and periosteum are cut in turn along the midline of the skull of the New Zealand rabbits by a dermatome, and bone defects with the diameter of 5mm and the depth of about 3mm are drilled at positions 1cm away from the orbit and 1cm away from the ear on the sagittal line respectively. The samples prepared in examples 1 to 3 and comparative examples 1 to 9 were implanted into skull defects of new zealand rabbits, respectively, without using the sample as a blank, the injury site was covered with periosteum covering material by using a piece of sterile gauze of known weight M1, the bleeding at the defect site was observed after 10min, the gauze was removed and weighed as M2, and the bleeding weight (M3) was calculated, wherein M3 is M2-M1. The results of the experiment are shown in table 1.

Bone wound repair experiment:

the experimental animals are 48 New Zealand rabbits, which are divided into 12 groups on average, skin, soft tissues and periosteum are cut in turn along the midline of the skull of the New Zealand rabbits by a dermatome, and bone defects with the diameter of 5mm and the depth of about 3mm are drilled at positions 1cm away from the orbit and 1cm away from the ear on the sagittal line respectively. Samples prepared in examples 1 to 3 and comparative examples 1 to 9 were implanted into skull defects of New Zealand rabbits, respectively, without using the sample for a blank control, taking the sample for 12 weeks, and observing the BV/TV (bone volume fraction) results. The results of the experiment are shown in table 1.

TABLE 1

Likewise, to further illustrate the beneficial effects of the present invention, the following comparative examples are provided:

comparative example 6.1 is provided, which is distinguished from example 3 by the following: adjusting the mass fraction of sodium silicate in the sodium silicate aqueous solution to 6%;

the osteogenic hemostatic material prepared by the preparation method is tested according to the test methods of an adhesion experiment, a hemostasis experiment and a bone wound repair experiment. Experimental verification results of the bone hemostatic material prepared in comparative example 6.1 were observed. The results were similar to those in comparative example 6 described above.

comparative example 7.1 is provided, which is distinguished from example 3 by the following: adjusting the weight part of the calcium phosphate to 41 parts;

the osteogenic hemostatic material prepared by the preparation method is tested according to the test methods of an adhesion experiment, a hemostasis experiment and a bone wound repair experiment. Experimental verification results of the bone hemostatic material prepared in comparative example 7.1 were observed. The results were similar to those in comparative example 7 described above.

comparative example 8.1 is provided, which comparative example 8.1 differs from example 3 in that: the weight part of the sodium silicate aqueous solution was adjusted to 61 parts.

The osteogenic hemostatic material prepared by the preparation method is tested according to the test methods of an adhesion experiment, a hemostasis experiment and a bone wound repair experiment. Experimental verification results of the bone hemostatic material prepared in comparative example 8.1 were observed. The results were similar to those in comparative example 8 described above.

From the above results, it can be seen that:

the bonding strength of the bone hemostatic material is about 0.16MPa, and the bonding strength of the bone hemostatic material can be improved to about 0.20MPa by further screening the reagent components and the dosage of each reagent component in the bone hemostatic material. Compared with the comparative example, the bone hemostatic material has higher bonding strength and better adhesion performance, and can more effectively prevent the bone material from falling off.

The weight of the exudation blood of the bone hemostatic material is about 0.05g, and the weight of the exudation blood of the bone hemostatic material can be reduced to about 0.01g by further screening the reagent components and the dosage of each reagent component in the bone hemostatic material. Compared with a comparative example, the bone hemostatic material has less exudation blood volume and better hemostatic performance, and can more effectively realize short-term hemostatic effect.

The bone volume fraction of the bone hemostatic material is about 35%, and the bone volume fraction of the bone hemostatic material can be increased to about 45% by further screening the reagent components and the dosage of each reagent component in the bone hemostatic material. Compared with a comparative example, the bone hemostatic material has a larger bone body integral number and a better bone wound repair effect, and can remarkably promote the bone wound repair.

Fig. 1 and 4 are an effect diagram and a Mirco-CT effect diagram after drawing materials for 112 weeks in an example of a bone wound repair experiment, respectively, fig. 2 and 5 are an effect diagram and a Mirco-CT effect diagram after drawing materials for 112 weeks in a comparative example of the bone wound repair experiment, respectively, and fig. 3 and 6 are an effect diagram and a Mirco-CT effect diagram after drawing materials for 12 weeks in a white control group in the bone wound repair experiment, respectively. As can be seen from FIGS. 1-6, after 112 weeks of the example, the bone hemostatic material has been partially degraded, the boundary between the normal bone tissue and the bone hemostatic material is clear, and fibrous tissue grows into the bone defect; after 112 weeks of the comparative example, an annular light-transmitting band exists between the normal bone tissue and the bone hemostatic material, and bone defects are visible; after 12 weeks in the blank control group, the bone defect part was obvious and the bone defect was not completely healed.

It is to be understood that the invention disclosed is not limited to the particular methodology, protocols, and materials described, as these may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims.

Those skilled in the art will also recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

Claims

1. A bone hemostatic material comprising a calcium phosphate, an aqueous sodium silicate solution, a poloxamer and a triglyceride; wherein the poloxamer is selected from at least two of poloxamer 338, poloxamer 105, poloxamer 124, poloxamer 184, poloxamer 237, poloxamer 335, poloxamer 403 and poloxamer 401.

2. The bone hemostatic material according to claim 1, wherein the calcium phosphate is 10-40 parts by weight.

3. The bone hemostatic material according to claim 1, wherein the sodium silicate aqueous solution is 20 to 60 parts by weight.

4. The bone hemostatic material according to claim 1, wherein the sodium silicate aqueous solution comprises 0.1-5% by weight of sodium silicate.

5. The bone hemostatic material of claim 1, wherein the poloxamer is present in an amount of 10-40 parts by weight.

6. The bone hemostatic material of claim 1, wherein the triglyceride is present in an amount of 10-50 parts by weight.

7. A bone hemostatic material comprises, by weight, 10-40 parts of calcium phosphate, 20-60 parts of a sodium silicate aqueous solution, 10-40 parts of poloxamer and 10-50 parts of triglyceride; wherein the mass fraction of sodium silicate in the sodium silicate aqueous solution is 0.1-5%; the poloxamer is selected from at least two of poloxamer 338, poloxamer 105, poloxamer 124, poloxamer 184, poloxamer 237, poloxamer 335, poloxamer 403, and poloxamer 401.

8. A method of preparing a bone hemostatic material, the method comprising the steps of:

mixing 10-40 parts of calcium phosphate, 20-60 parts of sodium silicate aqueous solution, 10-40 parts of poloxamer and 10-50 parts of triglyceride, and mechanically stirring uniformly to form a cement-shaped bone hemostatic material; molding the prepared daub-shaped bone hemostatic material in a mold to obtain a block-shaped bone hemostatic material, and packaging⁶⁰Sterilizing with Co rays to obtain bone hemostatic material, and sealing and storing at normal temperature; wherein the mass fraction of sodium silicate in the sodium silicate aqueous solution is 0.1-5%; the poloxamer is selected from at least two of poloxamer 338, poloxamer 105, poloxamer 124, poloxamer 184, poloxamer 237, poloxamer 335, poloxamer 403, and poloxamer 401.

9. A bone hemostatic product, wherein the bone hemostatic product comprises the bone hemostatic material of any one of claims 1-7.

10. Use of the bone hemostatic material of any one of claims 1-7 in the preparation of a bone hemostatic product or pharmaceutical composition.