CN114732940A

CN114732940A - High-elasticity starch cavity hemostatic material and application and preparation method thereof

Info

Publication number: CN114732940A
Application number: CN202210434297.7A
Authority: CN
Inventors: 姚小祥; 黄晓峰; 刘国平
Original assignee: Jiangsu Hanren Biotechnology Co ltd
Current assignee: Jiangsu Hanren Biotechnology Co ltd
Priority date: 2022-04-24
Filing date: 2022-04-24
Publication date: 2022-07-12
Anticipated expiration: 2042-04-24
Also published as: CN114732940B

Abstract

The invention discloses a high-elasticity starch cavity hemostatic material and a use and preparation method thereof, wherein the product is flexible and rich in elasticity, and the shape and the size of the product are designed differently according to different use parts. The preparation method comprises the following steps: dissolving starch and derivatives thereof and/or other high molecular substances; then pouring the mixture into a corresponding container, and freezing and freeze-drying the product by using a gradient cooling method; carrying out high-temperature acid crosslinking on the freeze-dried product in an acid vapor reactor; and then packaging and sterilizing the product to obtain the final product. The high-elasticity starch cavity hemostatic material has the advantages of stable structure, smooth and fine sample surface, strong liquid absorption capacity, relatively simple and convenient manufacturing process, high repeatability and high product safety, and can be widely applied to the field of medical instruments. The product is degraded after being placed in the cavity 2-4 and flows out of the cavity, so that the secondary wound of a patient caused by taking out the product after an operation is avoided.

Description

High-elasticity starch cavity hemostatic material and application and preparation method thereof

Technical Field

The invention belongs to the field of biomedical materials, and particularly relates to a high-elasticity starch cavity hemostatic material and a preparation method thereof.

Background

The human body has many cavities, such as cavities, auditory canals, vaginas and the like, and has many sinuses caused by diseases or operations. The cavity generally causes massive bleeding during the operation treatment, and the bleeding of the cavity is difficult to perform hemostasis operation due to the deeper bleeding point, thereby causing great trouble to clinicians. Therefore, aiming at the particularity of the cavity, a hemostatic material with high elasticity is developed. Polyvinyl alcohol sponges are often used in the clinical market, and have limited hemostatic effects and are not degradable, thereby causing secondary injury and bleeding of patients when the patients are taken out. The degradable material can be automatically degraded within 2-5 days without being taken out. Therefore, the degradable cavity hemostatic material is a hot spot in the field of material application at present. Among them, patent "CN 110496240A" mentions a sponge preparation technology, which uses acid-crosslinked sodium carboxymethylcellulose to prepare sponge, and the technology has the influence on product safety due to acid residue, and the crosslinking efficiency of acid solution is poor, and requires a long reaction time. The patent "US 9061087B 2" refers to a sponge technology, and refers to a sponge made of cellulose, starch and other materials through processes of freeze drying, humidifying and the like. The method does not perform cross-linking of the sponge, has poor water absorption and high degradation speed, and cannot support the hemostatic effect.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a high-elasticity starch cavity hemostatic material and a using and preparation method thereof aiming at the defects of the background art, and the high-elasticity starch cavity hemostatic material has a simple structure and is convenient to prepare; when in use, the water-absorbing polyurethane foam has the characteristics of uniform pores, fine and smooth surface, high elasticity, high water absorption, timely degradation and high safety.

The invention adopts the following technical scheme for solving the technical problems:

a high-elasticity starch hemostatic material for cavity and tract is in the form of sponge structure and is prepared from one or more of starch or starch derivatives and one or more of other high-molecular materials through mixing.

Further, the starch or starch derivative is potato starch, sodium carboxymethyl starch, pregelatinized starch, hydroxypropyl starch or dextrin; the high molecular material is sodium carboxymethylcellulose, croscarmellose sodium, polylactic acid, hyaluronic acid, carboxymethyl chitosan, sodium alginate, hyaluronic acid, gelatin or collagen.

A preparation method of a high-elasticity starch cavity hemostatic material comprises the following steps:

step 1, dissolving a feed liquid; adding starch or one or more of its derivatives into a beaker, swelling for 1-12 hr, heating to 40-90 deg.C, and slowly adding other high molecular materials under stirring;

step 2, freeze-drying; after the material liquid in the step 1 is dissolved, pouring the material liquid into a freeze-drying container, putting the freeze-drying container into a freezer or a freeze dryer at the temperature of 5-55 ℃, standing for 12-48 hours, and adjusting the temperature to quickly freeze the material liquid; freeze-drying after the solution is completely frozen to obtain a product;

step 3, after the step 2 is finished, putting the freeze-dried product and the freeze-drying container into an acid vapor reactor together, and setting the temperature to be 50-200 ℃ for high-temperature acid vapor crosslinking;

step 4, after the step 3 is finished, putting the product into a crusher, starting the crusher to crush the product, and sieving the crushed product through a screen to obtain sponge powder;

step 5, after the step 4 is finished, adding 1-10 parts of sodium carboxymethylcellulose into 100 parts of purified water, dissolving for 3-8 hours, adding the sponge powder obtained in the step 4 into the solution after the sodium carboxymethylcellulose is completely dissolved, and continuously stirring for 1-12 hours to uniformly mix the solution;

step 6, after the step 5 is finished, repeating the freeze-drying process of the step 2;

and 7, after the step 6 is finished, putting the reaction product into a bubble cap and an aluminum-plastic bag, and performing sterilization treatment to obtain a finished product.

Further, in step 2, the lyophilization process is as follows:

a. the temperature of the freezer or the freeze dryer is 1 ℃, and the time is 1-12 h;

b. the temperature of the freezer or the freeze dryer is-3 ℃ and the time is 1-15 h;

c. the temperature of the freezer or the freeze dryer is-7 ℃ and the time is 1-9 h;

d. the temperature of the freezer or the freeze dryer is-10 ℃ and the time is 0.5-20 h;

e. the temperature of the freezer or the freeze dryer is-55 ℃ and the time is 3-15 h;

f. the temperature of the partition board is-15 ℃, and the time is 3-10 h;

g. the temperature of the clapboard is 0 ℃, and the time is 5-24 hours;

h. the temperature of the partition board is 25 ℃, and the time is 3-15 h; .

Further, the acid used in step 3 is glacial acetic acid, hydrochloric acid, hydrofluoric acid, lactic acid, nitric acid, the inner surface of the acid vapor reactor is made of polytetrafluoroethylene, a heating device is arranged in the acid vapor reactor, and a tail gas recovery device is arranged at the tail end of the acid vapor reactor.

Further, the operation steps of step 3 are:

placing the product on a partition plate of an acid steam reactor and placing the product uniformly, pouring acid into a lower acid heating plate of the acid steam reactor, heating the acid heating plate to 50-150 ℃, starting an internal circulation fan of the acid steam reactor after the acid is completely volatilized, raising the temperature to 100-200 ℃, reacting for 1-5 hours, opening a vacuum pump of the acid steam reactor after the reaction is finished, extracting vacuum, and keeping the vacuum state for 5-12 hours to ensure that the residual acid steam is completely removed.

Further, the pulverizer in the step 4 selects a household food processor or a professional pulverizer, the rotating speed is 2000-10000 r/min, and the pulverizing time is 1-20 min; the screen mesh is a 40-400 mesh screen mesh; the particle size range is 40-400 microns.

Further, the sponge powder in the step 5 is added in an amount of 2-20 parts per 100 parts of the solution.

Further, the sterilization mode mentioned in step 7 is cobalt-60 irradiation sterilization, electron beam irradiation sterilization or ethylene oxide sterilization.

A method for using a high-elasticity starch cavity hemostatic material comprises the following steps:

the high-elasticity starch cavity hemostatic material is placed in the cavity of a patient after being wholly or cut into a size suitable for the cavity of the patient; after the blood is placed in the cavity, whether the physiological saline is injected or not is determined according to the bleeding condition of the patient; after hemostasis is finished, the product can be degraded into gel or powdery substance, flows out from the cavity, and can be cleaned by a doctor by using a proper tool if a small amount of residue exists.

Compared with the prior art, the invention adopting the technical scheme has the following technical effects:

the invention adopts a gradient cooling freeze-drying technology to prepare the sponge, and simultaneously uses a high-temperature acid steam crosslinking mode to perform product crosslinking. The gradient cooling freeze-drying technology enables the freeze-dried sponge tissue to have the characteristics of uniform gaps and fine and smooth surface. The high-temperature acid steam crosslinking enables the sponge to have the characteristics of high elasticity, high water absorption and timely degradation. Meanwhile, the high-temperature acid steam crosslinking mode is more efficient than the traditional solution crosslinking mode, and the acid is more conveniently removed after the reaction. Compared with water absorption tests and animal tests, the performance of the final product is superior to that of similar products on the market.

Drawings

FIG. 1 is a schematic diagram of a structure of a high-elasticity starch cavity hemostatic material and an electron microscope photograph;

FIG. 2 is a block diagram of an acid vapor reactor;

FIG. 3 is a diagram showing the arrangement of the hemostatic material in the acid vapor reactor;

in the figure, 1, a reactor body; 2. a vacuum pump; 3. a gas recovery device; 4. a controller; 5. heating the acid plate; 6. a storage partition plate.

Detailed Description

The technical scheme of the invention is further explained in detail by combining the attached drawings:

as shown in figures 1-3, the invention provides a high-elasticity starch cavity hemostatic material which is in a sponge structure and is prepared by mixing one or more degradable starch or starch derivatives with one or more other degradable high polymer materials.

In the high-elasticity starch cavity hemostasis material, the starch and/or the derivative can be at least one of potato starch, sodium carboxymethyl starch, pregelatinized starch, hydroxypropyl starch and dextrin, and the other macromolecules can be at least one of sodium carboxymethyl cellulose, cross-linked sodium carboxymethyl cellulose, polylactic acid, hyaluronic acid, carboxymethyl chitosan, sodium alginate, hyaluronic acid, gelatin and collagen.

The invention also provides a using method of the high-elasticity starch cavity hemostatic material, which comprises the following steps: the high-elasticity starch cavity hemostasis material is placed in a cavity of a patient after being wholly or cutting into a size suitable for the cavity of the patient, whether normal saline is injected or not can be determined according to the bleeding condition of the patient after the high-elasticity starch cavity hemostasis material is placed in the cavity, after hemostasis is finished, the product can be degraded into gel or powdery substances, the gel or the powdery substances flow out from the cavity, and if a small amount of residues exist, a doctor can clean the cavity by using a proper tool.

The invention further provides a preparation method of the high-elasticity starch cavity hemostatic material, which comprises the following steps:

dissolving the feed liquid, and filling by using a proper container; and (2) freeze-drying the product by using a gradient cooling mode, putting the sponge obtained by freeze-drying into a special container for high-temperature acid steam crosslinking, crushing and sieving the crosslinked sponge, then putting the sponge powder into a carboxymethyl cellulose solution, and freeze-drying the product by using the gradient cooling mode. And packaging and sterilizing the freeze-dried product to obtain the high-elasticity starch cavity hemostatic material.

In the preparation method, the specific steps are as follows:

step 1, dissolving feed liquid; adding one or more of the starch or the derivatives thereof into a beaker, swelling for 1-12 hours, heating to 40-90 ℃, and slowly adding other high molecular materials under stirring.

Step 2, freeze-drying; after the solution in the step 1 is dissolved, pouring the solution into a freeze-drying container according to different specifications, putting the mold into a freezer or a freeze dryer at the temperature of 5-55 ℃, standing for 12-48 hours, and adjusting the temperature to quickly freeze the solution; freeze-drying after the solution is completely frozen; the process can ensure that the sponge structure has uniform pores and fine and smooth surface.

Wherein the freezing and freeze-drying processes are specifically shown as the following a-f:

f. the temperature of the partition board is-15 ℃, and the time is 3-10 h;

g. the temperature of the clapboard is 0 ℃, and the time is 5-24 hours;

h. the temperature of the partition board is 25 ℃, and the time is 3-15 h;

through the freeze-drying process, the product can be completely freeze-dried.

And 3, after the step 2 is finished, putting the product and the freeze-drying container into an acid vapor reactor, and setting the temperature to be 50-200 ℃ for high-temperature acid vapor crosslinking.

The acid used in the step is glacial acetic acid, hydrochloric acid, hydrofluoric acid, lactic acid or nitric acid, the acid vapor reactor is an acid fumigation device which is self-developed and designed, the inner surface of the acid vapor reactor is made of polytetrafluoroethylene, a heating device is arranged in the acid vapor reactor, and a tail gas recovery device is arranged at the tail end of the acid vapor reactor. The acid vapor reactor may be heated to 250 ℃. The acid steam reactor comprises 6 parts, namely a reactor body 1, a vacuum pump 2, a gas recovery device 3, a controller 4, an acid heating plate 5 and a partition plate 6.

Specifically, the reaction step comprises the steps of placing the product on a partition plate 6 of an acid reactor and placing the product uniformly, pouring acid into an acid heating plate 5 on the lower layer of the instrument, closing a box door, heating to 50-150 ℃, starting an internal circulation fan after the acid is completely volatilized, raising the temperature to 100-200 ℃, reacting for 1-5 hours, opening a vacuum pump after the reaction is finished, extracting vacuum, and keeping the vacuum state for 5-12 hours to ensure that all residual acid steam is removed.

And 4, after the step 3 is finished, putting the product into a grinder, starting the grinder to grind the product, and sieving the ground product through a screen to obtain powder with a certain particle size.

The pulverizer can be a household food processor or a professional pulverizer, the rotating speed is 2000 plus 10000 r/min, and the pulverizing time is 1-20 min.

In step 4, the screen is a 40-400 mesh screen. The particle size range is 40-400 microns.

And 5, after the step 4 is finished, adding 1-10 parts of sodium carboxymethylcellulose into 100 parts of purified water, dissolving for 3-8 hours, adding the sponge powder obtained in the step 4 into the solution after the sodium carboxymethylcellulose is completely dissolved, and continuously stirring for 1-12 hours to uniformly mix the solution. The amount of the powder added is 2-20 parts per 100 parts of the solution.

And 6, after the step 5 is finished, repeating the freeze-drying process in the step 2.

And 7, after the step 6 is finished, putting the reaction product into a bubble cap and an aluminum-plastic bag, and performing sterilization treatment to obtain a finished product. The sterilization mode can be one of cobalt-60 irradiation sterilization, electron beam irradiation sterilization, ethylene oxide sterilization and the like.

The invention further provides the following specific examples:

example 1

The embodiment provides a preparation method of a high-elasticity starch cavity hemostatic material, which comprises the following steps:

1. adding 100ml of purified water into a beaker, adding 2g of carboxymethyl starch sodium, swelling for 2 hours, heating to 80 ℃, slowly adding 3g of carboxymethyl chitosan under stirring, and continuing stirring for 4 hours to fully dissolve the solution.

2. After the solution in the step 1 is dissolved, pouring the solution into a freeze-drying container according to different specifications, putting a mold into a freezer, and keeping the temperature of the freezer at 1 ℃ for 8 hours according to a; b. the temperature of the freezer is-3 ℃ and the time is 15 h; c. the temperature of the freezer is-7 ℃ and the time is 8 h; d. the temperature of the freezer is-10 ℃ and the time is 20 h; e. the temperature of the freeze dryer is-55 ℃ and the time is 3 h; f. the temperature of a clapboard of the freeze dryer is-15 ℃ and the time is 10 hours; g. the temperature of a clapboard of the freeze dryer is 0 ℃, and the time is 24 hours; h. the temperature of a clapboard of the freeze dryer is 25 ℃, and the time is 5 hours; through the freeze-drying process, the product can be completely freeze-dried.

3. After the step 2 is finished, placing the product on a partition plate of an acid reactor and uniformly placing the product as shown in figure 3, pouring 100ml of glacial acetic acid into an acid heating plate at the lower layer of the instrument, closing a box door, heating to 150 ℃, starting an internal circulation fan after the acid is completely volatilized, raising the temperature to 190 ℃, reacting for 1 hour, opening a vacuum pump after the reaction is finished, extracting vacuum, and keeping the vacuum state for 12 hours to ensure that all residual acid steam is removed.

4. And (3) after the step 3 is finished, putting the product into a food processor, starting a grinder to grind the product, wherein the rotating speed of the grinder is 2000 r/min, the grinding time is 5min, screening the ground product, and collecting screened sponge powder for later use, wherein the screen mesh can be 40 meshes.

5. And (4) after the step (4) is finished, adding 2 parts of sodium carboxymethylcellulose into 100 parts of purified water, dissolving for 3 hours, adding 3 parts of sponge powder obtained in the step (4) into the solution after the sponge powder is completely dissolved, and continuously stirring for 3 hours to uniformly mix the solution.

6. After step 5 is completed, the lyophilization process of step 2 is repeated.

7. And (5) after the step 6 is finished, putting the reaction product into a bubble cap and an aluminum plastic bag, and performing cobalt-60 irradiation sterilization treatment with the irradiation dose of 15k to obtain a finished product.

Example 2

1. adding 100ml of purified water into a beaker, adding 3g of dextrin, swelling for 2 hours, heating to 50 ℃, slowly adding 4g of sodium carboxymethylcellulose while stirring, and continuously stirring for 5 hours to fully dissolve the solution.

2. After the solution in the step 1 is dissolved, pouring the solution into a freeze-drying container according to different specifications, putting a mold into a freezer, and keeping the temperature of the freezer at 1 ℃ for 3 hours according to a; b. the temperature of the freezer is-3 ℃ and the time is 6 h; c. the temperature of the freezer is-7 ℃ and the time is 9 h; d. the temperature of the freezer is-10 ℃ and the time is 20 h; e. the temperature of the freeze dryer is-55 ℃ and the time is 3 h; f. the temperature of a clapboard of the freeze dryer is-15 ℃ and the time is 10 hours; g. the temperature of a clapboard of the freeze dryer is 0 ℃, and the time is 24 hours; h. the temperature of a clapboard of the freeze dryer is 25 ℃, and the time is 5 hours; through the freeze-drying process, the product can be completely freeze-dried.

3. After the step 2 is finished, placing the product on a partition plate of an acid reactor and uniformly placing the product as shown in fig. 3, pouring 70ml of lactic acid into an acid heating plate at the lower layer of the instrument, closing a box door, heating to 140 ℃, starting an internal circulation fan after the acid is completely volatilized, raising the temperature to 180 ℃, reacting for 2 hours, opening a vacuum pump after the reaction is finished, extracting vacuum, and keeping the vacuum state for 5 hours to ensure that the residual acid steam is completely removed.

4. And (4) after the step (3) is finished, putting the product into a food processor, starting a grinder to grind, wherein the rotating speed of the grinder is 3000 r/min, the grinding time is 12min, the ground product is sieved, the mesh can be 100 meshes, and the sieved sponge powder is collected for later use.

5. And (5) after the step (4) is finished, adding 3 parts of sodium carboxymethylcellulose into 100 parts of purified water, dissolving for 4 hours, adding 5 parts of sponge powder obtained in the step (4) into the solution after the sodium carboxymethylcellulose is completely dissolved, and continuously stirring for 2 hours to uniformly mix the solution.

6. After step 5 is completed, the lyophilization process of step 2 is repeated.

7. And (6) after the step 6 is finished, putting the reaction product into a bubble cap and an aluminum-plastic bag, and performing electron beam irradiation sterilization treatment with the irradiation dose of 12k to obtain a finished product.

Example 3

1. adding 100ml of purified water into a beaker, adding 2.5g of hydroxypropyl starch, swelling for 1 hour, heating to 55 ℃, slowly adding 2g of hyaluronic acid under stirring, and continuously stirring for 2 hours to fully dissolve the solution.

2. After the solution in the step 1 is dissolved, pouring the solution into a freeze-drying container according to different specifications, putting a mould into a freeze-drying machine, and keeping the temperature of a partition plate of the freeze-drying machine at 3 ℃ for 1.5 hours according to a; b. the temperature of a clapboard of the freeze dryer is-1 ℃ and the time is 3 h; c. the temperature of a clapboard of the freeze dryer is-5 ℃ and the time is 7 hours; d. the temperature of the freezer or the freeze dryer is-10 ℃ and the time is 17 hours; e. the temperature of the freeze dryer is-55 ℃ and the time is 2 h; f. the temperature of a clapboard of the freeze dryer is-15 ℃ and the time is 12 hours; g. the temperature of a clapboard of the freeze dryer is 0 ℃ and the time is 21 h; h. the temperature of a clapboard of the freeze dryer is 25 ℃, and the time is 2 hours; through the freeze-drying process, the product can be completely freeze-dried.

3. After the step 2 is finished, placing the product on a partition plate of an acid reactor and uniformly placing the product as shown in figure 3, pouring 100ml of nitric acid into an acid heating plate on the lower layer of the instrument, closing a box door, heating to 100 ℃, starting an internal circulation fan after the acid is completely volatilized, raising the temperature to 160 ℃, reacting for 2 hours, opening a vacuum pump after the reaction is finished, extracting vacuum, and keeping the vacuum state for 5 hours to ensure that all residual acid steam is removed.

4. And (3) after the step 3 is finished, putting the product into a food processor, starting a grinder to grind, wherein the rotating speed of the grinder is 4000 revolutions per minute, the grinding time is 7 minutes, and screening the ground product, wherein the screen can be 60 meshes, and collecting the screened sponge powder for later use.

5. And (5) after the step (4) is finished, adding 3 parts of sodium carboxymethylcellulose into 100 parts of purified water, dissolving for 2 hours, adding 3 parts of the sponge powder obtained in the step (4) into the solution after the sodium carboxymethylcellulose is completely dissolved, and continuously stirring for 3 hours to uniformly mix the solution.

6. After step 5 is completed, the lyophilization process of step 2 is repeated.

7. And (5) after the step 6 is finished, putting the reaction product into a bubble cap and an aluminum plastic bag, and performing cobalt-60 irradiation sterilization treatment with the irradiation dose of 25k to obtain a finished product.

Example 4

1. adding 4 parts of potato starch into 100 parts of purified water beaker, swelling for 4 hours, heating to 78 ℃, slowly adding 4 parts of sodium alginate while stirring, and continuously stirring for 6 hours.

2. And (3) after the solution in the step (1) is dissolved, pouring the solution into a freeze-drying container according to different specifications, and putting the mold into a freeze dryer. The freezing and freeze-drying processes are as follows:

a. the temperature of a clapboard of the freeze dryer is 7 ℃, and the time is 1 h; b. the temperature of a clapboard of the freeze dryer is-3 ℃ and the time is 1 h; c. the temperature of a clapboard of the freeze dryer is-7 ℃, and the time is 1 h; d. the temperature of a clapboard of the freeze dryer is-10 ℃ and the time is 15 hours; e. the temperature of a clapboard of the freeze dryer is-55 ℃ and the time is 4 hours; f. the temperature of the clapboard is-15 ℃ and the time is 3 h; g. the temperature of the clapboard is 0 ℃ and the time is 22 h; h. the temperature of the clapboard is 25 ℃, and the time is 12 hours; through the freeze-drying process, the product can be completely freeze-dried.

3. And (3) after the step (2) is finished, placing the product on a partition plate of an acid reactor and uniformly placing the product as shown in the figure 3, pouring acid into a lower-layer acid heating plate of the instrument, closing a box door, heating to 50 ℃, starting an internal circulation fan after the acid is completely volatilized, raising the temperature to 150 ℃, reacting for 2 hours, opening a vacuum pump after the reaction is finished, extracting vacuum, and keeping the vacuum state for 9 hours to ensure that all residual acid steam is removed.

4. And (3) after the step 3 is finished, putting the product into a special crusher, starting the crusher to crush the product, wherein the rotating speed of the crusher is 5000 revolutions per minute, and the crushing time is 20 minutes. Sieving the pulverized product with 80 mesh sieve.

5. And (4) after the step 4 is finished, adding 10 parts of sodium carboxymethylcellulose into 100 parts of purified water, dissolving for 8 hours, adding 6 parts of sponge powder obtained in the step 4 into the solution after the sodium carboxymethylcellulose is completely dissolved, and continuously stirring for 12 hours to uniformly mix the solution.

6. After step 5 is completed, the lyophilization process of step 2 is repeated.

7. And (6) after the step 6 is finished, putting the reaction product into a bubble cap and an aluminum-plastic bag, and performing ethylene oxide sterilization treatment to obtain a finished product.

The product performance of the invention was tested as follows:

the samples of examples 1-4 were selected for comparison with two common hemostatic materials, and the comparative sample was "absorbable hemostatic sponge Stypro" from Corusson corporation, "degradable otorhinoplasty (sponge absorbing sponge)" from Schekk power. The liquid absorption capacity, the degradation capacity, the elastic performance and the like of the product are respectively tested and compared.

1. Liquid absorption Performance test

The samples of examples 1-4 were taken with two controls and the initial weight M was weighed₀Then the sample is put into different liquids and the mass M is weighed after the complete imbibition_hImbibition capacity of M_h/M₀The calculated value of (a). During imbibition and recording the imbibition time T at which the absorption is saturated. The absorbed liquid is 0.9% normal saline, PBS buffer solution and anticoagulated rabbit blood. The results of the liquid absorption performance test of each sample are summarized in table 1.

TABLE 1 Effect of liquid absorption Properties test of respective samples

The best imbibition performance of example 2 was analyzed from table 1.

2. Test for degradation Properties

The samples of examples 1 to 4 were taken with two controls, by mass: adding the three liquids in a volume ratio of 1:60 respectively, placing the three liquids in a constant temperature incubator at 37 +/-1 ℃ for 7 days, and observing the degradation effect. The degradation effect is shown in Table 2.

TABLE 2 degradation effect of the examples

It can be seen from table 2 that formulations 2 and 3 are better degraded.

3. Test for elastic Properties

The samples of examples 1 to 4 and two kinds of control samples were subjected to a compression elasticity test using a universal tensile machine, and the volume change ratio before and after compression of the samples and the pressure generated during the compression were measured, respectively. The notes are given in table 3 below.

TABLE 3

Sample name	Elastic Properties (kPa)	Rebound ratio (%)
			Example 1	5.6	67
Example 2	7.8	95
			Example 3	4.5	78
Example 4	5.9	90
			Stypro	2.3	89
Nano absorbent cotton	3.9	98

As can be seen from Table 3, formulation 2 exhibited the best elastic and resilient properties.

It will be understood by those skilled in the art that, unless otherwise defined, all terms (including 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. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The above embodiments are only for illustrating the technical idea of the present invention, and the technical idea of the present invention is not limited thereto, and any modifications made on the basis of the technical solution according to the technical idea of the present invention fall within the protective scope of the present invention. While the embodiments of the present invention have been described in detail, the present invention is not limited to the above embodiments, and various changes can be made without departing from the spirit of the present invention within the knowledge of those skilled in the art.

Claims

1. A high-elasticity starch cavity hemostatic material is characterized in that: is in a sponge structure and is prepared by mixing one or more of starch or starch derivatives with one or more of other high polymer materials.

2. The high-elasticity starch tract hemostatic material as claimed in claim 1, wherein: the starch or starch derivative is potato starch, sodium carboxymethyl starch, pregelatinized starch, hydroxypropyl starch or dextrin; the high molecular material is sodium carboxymethylcellulose, croscarmellose sodium, polylactic acid, hyaluronic acid, carboxymethyl chitosan, sodium alginate, hyaluronic acid, gelatin or collagen.

3. A preparation method of a high-elasticity starch cavity hemostatic material is characterized by comprising the following steps: the method comprises the following steps:

step 1, dissolving feed liquid; adding starch or one or more of its derivatives into a beaker, swelling for 1-12 hr, heating to 40-90 deg.C, and slowly adding other high molecular materials under stirring;

step 2, freeze-drying; after the feed liquid in the step 1 is dissolved, pouring the material liquid into a freeze-drying container, putting the freeze-drying container into a freezer or a freeze dryer with the temperature of 5 to-55 ℃, standing for 12 to 48 hours, and adjusting the temperature to quickly freeze the feed liquid; freeze-drying after the solution is completely frozen to obtain a product;

step 6, after the step 5 is finished, repeating the freeze-drying process in the step 2;

4. The method for preparing the high-elasticity starch cavity hemostatic material according to claim 3, wherein the method comprises the following steps: in step 2, the lyophilization process is as follows:

f. the temperature of a clapboard of the freezer or the freeze dryer is-15 ℃, and the time is 3-10 h;

g. the temperature of a clapboard of the freezer or the freeze dryer is 0 ℃, and the time is 5-24 hours;

h. the temperature of a clapboard of the freezer or the freeze dryer is 25 ℃, and the time is 3-15 h; .

5. The preparation method of the high-elasticity starch cavity hemostatic material according to claim 3, wherein the preparation method comprises the following steps: the acid used in the step 3 is glacial acetic acid, hydrochloric acid, hydrofluoric acid, lactic acid or nitric acid, the inner surface of the acid vapor reactor is made of polytetrafluoroethylene, a heating device is arranged in the acid vapor reactor, and a tail gas recovery device is arranged at the tail end of the acid vapor reactor.

6. The preparation method of the high-elasticity starch cavity hemostatic material according to claim 3, wherein the preparation method comprises the following steps: the operation steps of the step 3 are as follows:

7. The preparation method of the high-elasticity starch cavity hemostatic material according to claim 3, wherein the preparation method comprises the following steps: the crushing machine in the step 4 selects a household food processor or a professional crushing machine, the rotating speed is 2000-10000 r/min, and the crushing time is 1-20 min; the screen mesh is a 40-400 mesh screen mesh; the particle size range is 40-400 microns.

8. The method for preparing the high-elasticity starch cavity hemostatic material according to claim 3, wherein the method comprises the following steps: the addition amount of the sponge powder in the step 5 is 2-20 parts per 100 parts of the solution.

9. The preparation method of the high-elasticity starch cavity hemostatic material according to claim 3, wherein the preparation method comprises the following steps: the sterilization mode mentioned in step 7 is cobalt-60 irradiation sterilization, electron beam irradiation sterilization or ethylene oxide sterilization.

10. A use method of a high-elasticity starch cavity hemostatic material is characterized by comprising the following steps: the method comprises the following steps:

the high-elasticity starch cavity hemostatic material is placed in a cavity of a patient after being wholly or cutting into a size suitable for the cavity of the patient; after the blood is placed in the cavity, whether the physiological saline is injected or not is determined according to the bleeding condition of the patient; after hemostasis is finished, the product can be degraded into gel or powdery substance, flows out from the cavity, and can be cleaned by a doctor by using a proper tool if a small amount of residue exists.