Hemostatic powder with fast water absorption and hemostatic capacities

Abstract

Provided is a hemostatic powder with fast water absorption capacity, comprising an inorganic component such as lithium magnesium silicate, amino-modified polyethylene glycol, and amido-modified polyethylene glycol. For serious bleeding from skin wounds, organ wounds, or vascular wounds, the hemostatic powder can achieve gelation within 1 minute and produce a hemostatic effect. The further addition of components having dual functions of color development and bacteriostasis to the hemostatic powder may provide improved visibility in hemostasis during endoscopic surgery.

Description

A hemostatic powder capable of quickly absorbing water and stopping bleeding TECHNICAL FIELD

[0001] The present application relates to a hemostatic composition, in particular to a hemostatic powder capable of quickly absorbing water and stopping bleeding, and a preparation method and application thereof. BACKGROUND

[0002] Digestive endoscopic surgery such as mucosal resection and separation, polyp and tumor tissue resection, etc. can cause bleeding. The current market hemostatic clips, burning and other technologies cannot meet the clinical needs such as large area bleeding, and at the same time bring many complications such as gastrointestinal perforation.

[0003] In view of this clinical demand and problem, COOK Medical launched a hemostatic powder which can quickly absorb water and stop bleeding, but the hemostatic powder does not have the adhesion effect on the tissue of the bleeding site, and will fall off the bleeding site under the conditions of normal saline, patient's own mucus and gastrointestinal peristalsis, etc., resulting in high risk of rebleeding. In view of this problem, Next Biomedical launched a hemostatic powder which can form a hydrogel after absorbing water, which can not only quickly absorb water and stop bleeding, but also form a gel and have adhesion effect on the tissue of the bleeding site, thereby reducing the risk of rebleeding. However, the components of this product have natural materials (dextran), and it is difficult to avoid the toxins and antigens of the source materials in the production and purification process, which causes certain risk to the patients. In addition, the production process of this product is very complex, and chemical modification, purification, separation, etc. are required for each main component such as dextran, polylysine, etc., which results in long production time and high production cost. SUMMARY

[0004] The present application provides a hemostatic powder capable of quickly absorbing water and stopping bleeding, which comprises the following components:

[0005] (1) magnesium lithium silicate, montmorillonite, kaolin, zeolite, bentonite or a combination thereof;

[0006] (2) amino-modified polyethylene glycol or thiol-modified polyethylene glycol;

[0007] (3) amide-modified polyethylene glycol;

[0008] (4) optionally methylene blue, gentian violet or a combination thereof.

[0009] The first component of the hemostatic powder, magnesium lithium silicate, montmorillonite, kaolin, zeolite, bentonite and other inorganic components can quickly absorb water and stop bleeding. The second component of the amino-modified polyethylene glycol or the thiol-modified polyethylene glycol can be chemically cross-linked with the third component of the amide-modified polyethylene glycol after water absorption, thereby forming a hydrogel. The combination of the first to third components not only can complete gelation within 1 minute to play a hemostatic effect, but also can improve the adhesion of the gelatinized film to the biological tissue and reduce the risk of shedding and rebleeding. On the basis of the three components, the fourth component of methylene blue, gentian violet or a combination thereof is further added, which increases the visibility under an endoscope and provides a bacteriostatic effect, and is suitable for severe bleeding of organ wounds or blood vessel wounds in endoscopic surgery.

[0010] In one aspect, the present application provides a rapid water-absorbing hemostatic powder comprising or consisting of the following components by weight:

[0011] 60-80% w / w of magnesium lithium silicate, montmorillonite, kaolin, zeolite, bentonite or a combination thereof;

[0012] 10-20% w / w of amino-modified polyethylene glycol or thiol-modified polyethylene glycol;

[0013] 10-20% w / w of amide-modified polyethylene glycol;

[0014] The total amount of each component is 100%.

[0015] In some embodiments, the rapid water-absorbing hemostatic powder comprises or consists of the following components by weight:

[0016] 60-75% w / w of magnesium lithium silicate;

[0017] 12.5-20% w / w of amino-modified polyethylene glycol,

[0018] 12.5-20% w / w of amide-modified polyethylene glycol,

[0019] The total amount of each component is 100%.

[0020] In some embodiments, the rapid water-absorbing hemostatic powder comprises or consists of the following components by weight:

[0021] 65-70% w / w of magnesium lithium silicate;

[0022] 15-17.5% w / w of amino-modified polyethylene glycol,

[0023] 15-17.5% w / w of amide-modified polyethylene glycol,

[0024] The total amount of each component is 100%.

[0025] In some embodiments, the amount of lithium magnesium silicate, montmorillonite, kaolin, zeolite, bentonite or a combination thereof is selected from the group consisting of: 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80% w / w.

[0026] In some embodiments, the amount of each of the amino- or mercapto-modified polyethylene glycol or the amido-modified polyethylene glycol is independently selected from the group consisting of 10-20% w / w, preferably 15-17.5% w / w, and specifically selected from the group consisting of: 10%, 11%, 12%, 12.5%, 13%, 14%, 15%, 16%, 16.5%, 16.6%, 16.7%, 16.8%, 17%, 18%, 19%, 20% by weight.

[0027] In some embodiments, the rapid water-absorbing hemostatic powder further comprises 0.1-1% w / w of methylene blue or gentian violet or a combination thereof; preferably 0.1-0.5% w / w of methylene blue, 0-0.5% w / w of gentian violet or a combination thereof, on the basis of the aforementioned rapid water-absorbing hemostatic powder. The amount of each of the methylene blue or gentian violet is independently selected from the group consisting of 0.01, 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5% w / w.

[0028] In some embodiments, the rapid water-absorbing hemostatic powder comprises or consists of the following components by weight:

[0029] 66.7 parts by weight of lithium magnesium silicate;

[0030] 16.6 parts by weight of amino- or mercapto-modified polyethylene glycol,

[0031] 16.6 parts by weight of amido-modified polyethylene glycol,

[0032] 0.1-0.5 parts by weight of methylene blue,

[0033] 0-0.5 parts by weight of gentian violet.

[0034] In some embodiments, the rapid water-absorbing hemostatic powder comprises or consists of the following components by weight:

[0035] 66.7 parts by weight of lithium magnesium silicate;

[0036] 16.6 parts by weight of amino- or mercapto-modified polyethylene glycol,

[0037] 16.6 parts by weight of amido-modified polyethylene glycol,

[0038] 0.1-0.5 parts by weight of methylene blue,

[0039] 0-0.5 parts by weight of gentian violet.

[0040] In some embodiments, the lithium magnesium silicate is used in an amount of 60-80 parts by weight, in particular selected from the group consisting of: 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80 parts by weight.

[0041] In some embodiments, the amino- or thiol-modified polyethylene glycol or amido-modified polyethylene glycol is used in an amount independently selected from the group consisting of: 10-20 parts by weight, preferably 15-17.5 parts by weight, in particular selected from the group consisting of: 10, 11, 12, 12.5, 13, 14, 15, 16, 16.5, 16.6, 16.7, 16.8, 17, 18, 19, 20 parts by weight.

[0042] In some embodiments, the methylene blue or gentian violet is used in an amount independently selected from the group consisting of: 0.01, 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5 parts by weight.

[0043] In some embodiments, the amino-modified polyethylene glycol is selected from the group consisting of: four-arm-polyethylene glycol amine (4arm-PEG-Amine, 4arm-PEG-NH2, 4arm-Polyethylene Glycol-Amine), eight-arm-polyethylene glycol amine (8arm-PEG-Amine, 8arm-PEG-NH2, 8arm-Polyethylene Glycol-Amine) or a combination thereof.

[0044] In some embodiments, the thiol-modified polyethylene glycol is selected from the group consisting of: four-arm-polyethylene glycol thiol (4arm-PEG-Thiol, 4arm-PEG-SH, 4arm-Polyethylene Glycol-Thiol), eight-arm-polyethylene glycol thiol (8arm-PEG-Thiol, 8arm-PEG-SH, 8arm-Polyethylene Glycol-Thiol) or a combination thereof.

[0045] In some embodiments, the amido-modified polyethylene glycol is selected from the group consisting of: two-arm-polyethylene glycol amine (2arm-PEG-Amine, 2arm-PEG-NH2), two-arm-polyethylene glycol succinimidyl glutaramide (2arm-PEG-SGA, 2arm-PEG-Succinimidyl Glutaramide), four-arm-polyethylene glycol amine (4arm-PEG-Amine, 4arm-PEG-NH2), four-arm-polyethylene glycol succinimidyl glutaramide (4arm-PEG-SGA, 4arm-PEG-Succinimidyl Glutaramide), six-arm-polyethylene glycol amine (6arm-PEG-Amine, 6arm-PEG-NH2), six-arm-polyethylene glycol succinimidyl glutaramide (6arm-PEG-SGA, 6arm-PEG-Succinimidyl Glutaramide), or a combination thereof.

[0046] In some embodiments, the amido-modified polyethylene glycol is selected from the group consisting of: two-arm-polyethylene glycol amine (2arm-PEG-Amine, 2arm-PEG-NH2), two-arm-polyethylene glycol succinimidyl glutaramide (2arm-PEG-SGA, 2arm-PEG-Succinimidyl Glutaramide), four-arm-polyethylene glycol amine (4arm-PEG-Amine, 4arm-PEG-NH2), four-arm-polyethylene glycol succinimidyl glutaramide (4arm-PEG-SGA, 4arm-PEG-Succinimidyl Glutaramide), six-arm-polyethylene glycol amine (6arm-PEG-Amine, 6arm-PEG-NH2), six-arm-polyethylene glycol succinimidyl glutaramide (6arm-PEG-SGA, 6arm-PEG-Succinimidyl Glutaramide), or a combination thereof.

[0047] In some embodiments, the amido-modified polyethylene glycol is selected from the group consisting of: two-arm-polyethylene glycol amine (2arm-PEG-Amine, 2arm-PEG-NH2), two-arm-polyethylene glycol succinimidyl glutaramide (2arm-PEG-SGA, 2arm-PEG-Succinimidyl Glutaramide), four-arm-polyethylene glycol amine (4arm-PEG-Amine, 4arm-PEG-NH2), four-arm-polyethylene glycol succinimidyl glutaramide (4arm-PEG-SGA, 4arm-PEG-Succinimidyl Glutaramide), six-arm-polyethylene glycol amine (6arm-PEG-Amine, 6arm-PEG-NH2), six-arm-polyethylene glycol succinimidyl glutaramide (6arm-PEG-SGA, 6arm-PEG-Succinimidyl Glutaramide), or a combination thereof.

[0048] In some embodiments, the amido-modified polyethylene glycol is selected from the group consisting of: two-arm-polyethylene glycol amine (2arm-PEG-Amine, 2arm-PEG-NH2), two-arm-polyethylene glycol succinimidyl glutaramide (2arm-PEG-SGA, 2arm-PEG-Succinimidyl Glutaramide), four-arm-polyethylene glycol amine (4arm-PEG-Amine, 4arm-PEG-NH2), four-arm-polyethylene glycol succinimidyl glutaramide (4arm-PEG-SGA, 4arm-PEG-Succinimidyl Glutaramide), six-arm-polyethylene glycol amine (6arm-PEG-Amine, 6arm-PEG-NH2), six-arm-polyethylene glycol succinimidyl glutaramide (6arm-PEG-SGA, 6arm-PEG-Succinimidyl Glutaramide), or a combination thereof.

[0049] In some embodiments, the amino-modified polyethylene glycol is eight-arm-polyethylene glycol amine (8arm-PEG-Amine, 8arm-PEG-NH2), the amido-modified polyethylene glycol is eight-arm-polyethylene glycol-succinimidyl glutaramide (8arm-PEG-SGA, 8arm-PEG-Succinimidyl Glutaramide), and the weight ratio or molar ratio is 1:2-2:1, and the specific value can be selected from 1:2, 1:1.5, 1:1.25, 1:1.1, 1:1, 1.1:1, 1.25:1, 1.5:1, 2:1, preferably 1:1.

[0050] In some embodiments, the molecular weight of the amino-modified polyethylene glycol, the thiol-modified polyethylene glycol, or the amido-modified polyethylene glycol is 1000-20000 Dalton. The specific molecular weight can be selected from 1000, 3400, 7000, 8000, 9000, 10000, 11000, 12000, 13000, 14000, 15000, 16000, 17000, 20000 Dalton.

[0051] In some embodiments, the particle size of the hemostatic powder is no more than 1000 microns. The specific value can be selected from 1, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, 200, 300, 400, 500, 600, 700, 800, 900, 1000 microns.

[0052] In some embodiments, the hemostatic powder is gelled within 1 minute after being in contact with the bleeding wound, preferably within 50 seconds, 45 seconds, 40 seconds, 35 seconds, or 30 seconds.

[0053] In another aspect, the present application provides a method for preparing the instant water-absorbing hemostatic powder, comprising the following steps:

[0054] Step 1, accurately weighing each component according to the formula ratio,

[0055] Step 2, low-speed grinding and mixing each component,

[0056] Step 3, passing the ground and mixed fine powder through an 80-325 mesh sieve, and discarding the components that do not pass through the mesh sieve; the specific mesh can be selected from 80, 100, 120, 150, 200, 325 mesh.

[0057] Step 4, vacuum drying the sieved powder at room temperature for 12-48 hours, specifically selected from 12, 24, 36, 48 hours.

[0058] Step 5, sterilizing the dried powder, and the sterilization is gamma ray irradiation sterilization, ethylene oxide sterilization, or electron beam sterilization.

[0059] Step 6, sealing the package after loading the packaging material.

[0060] In another aspect, the present application provides use of the aforementioned rapid water-absorbing hemostatic powder in the preparation of a hemostatic drug or a hemostatic device. The hemostatic device comprises the hemostatic powder of the present application and a device part for applying the hemostatic.

[0061] In some embodiments, the wound is a Grade 4 severe bleeding in the 6-point bleeding scale system. For a brief introduction of the 6-point bleeding scale system, see Dennis C. Morse et al., DOI 10.1007 / s11239-016-1388-6), and for the specific grading criteria, see Table 2.

[0062] In some embodiments, the wound is an epidermal wound, an organ wound or a blood vessel wound.

[0063] In some embodiments, the wound is an endoscope-visualized wound.

[0064] Definitions

[0065] As used herein, the term "comprise" means "comprise, but not limited to" and can be used interchangeably therewith. As used herein, the term "include" means "include, but not limited to" and can be used interchangeably therewith. The technical solutions using "comprise" or "include" in the present patent can be further defined as "consist of" or "consist in".

[0066] As used herein, "%" means the percentage of the total weight as the basis for calculating the weight percentage of individual components. Unless otherwise specified, "%" is weight %, and when solid and liquid are mixed, it is weight / volume percentage.

[0067] As used herein, the term "or" means "and / or" and can be used interchangeably therewith, unless otherwise specified.

[0068] As used herein, numerical values include, in addition to the numerical values themselves, the range of measurement or operation errors acceptable in the art. Unless specifically defined, the error range of the present application can be ±10% of the specific numerical value. Unless otherwise specified, the numerical range in the present application covers any integer within the numerical range.

[0069] The terms "two-arm", "four-arm", "six-arm", "eight-arm" have the following schematic basic structures, respectively. R or R1 in the structures represents a modified group on the polyethylene glycol, and n or p represents the repeated PEG units. A linker can be optionally added between the modified group and the PEG unit.

[0070] The term "amino modification" refers to modification with a -NH2 group at the end.

[0071] The term "thiol modification" refers to modification with a -SH group at the end.

[0072] The term "amide modification" refers to modification with a group at the end.

[0073] The term "four-arm-polyethylene glycol-glutaramide", "4arm-PEG-SGA", "4a-PEG-SGA", "4arm-PEG-Succinimidyl Glutaramide" refers to a compound with the following structure:

[0074] The term "four-arm-polyethylene glycol amine", "4arm-PEG-Amine", "4arm-PEG-NH2" refers to a compound with the following structure:

[0075] Beneficial technical effects

[0076] 1. The first component of the hemostatic powder, lithium magnesium silicate, montmorillonite, kaolin, zeolite, bentonite, can quickly absorb water to stop bleeding. The second component of the amino-modified polyethylene glycol or the thiol-modified polyethylene glycol and the third component of the amide-modified polyethylene glycol can undergo a chemical cross-linking reaction after water absorption, thereby forming a hydrogel, and completing gelation within 1 minute to exert a hemostatic effect. Compared with the use of the first component alone or the combination of the second and third components alone, the use of inorganic components such as lithium magnesium silicate accelerates the penetration and spread of blood moisture from the contact site to the interior of the hemostatic powder, overcoming the defect that the second component and the third component prevent water diffusion after gelation. The hemostatic time of the combination of the above three components is significantly shortened, and the gelation can be completed within 1 minute to exert a hemostatic effect.

[0077] 2. The gelatinized coating formed after the combination of the above three components has good adhesion to biological tissues, reducing the risk of rebleeding caused by shedding.

[0078] 3. The introduction of the inorganic component lithium magnesium silicate reduces the amount of the second component of the amino-modified polyethylene glycol or the thiol-modified polyethylene glycol and the third component of the amide-modified polyethylene glycol, while accelerating the hemostatic time and reducing the production cost.

[0079] 4. On the basis of the combination of the three components, further adding the fourth component of methylene blue and gentian violet increases the visibility under an endoscope and provides improved bacteriostatic effect. After compounding, the hemostatic powder is suitable for severe bleeding of organ wounds or blood vessel wounds in endoscopic surgery. It is convenient for doctors to adjust the application position and amount of the hemostatic powder in time through an endoscope. BRIEF DESCRIPTION OF DRAWINGS

[0080] Figure 1 shows a schematic diagram of the 6-point visual bleeding score system described in the present application

[0081] Figure 2 shows the results of the hemostatic powder test of Example 3 described in the present application

[0082] Figures 3-4 show the test results of the biological tissue adhesion of the present application DETAILED DESCRIPTION

[0083] In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions of the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are one module embodiment of the present application, rather than all embodiments. The elements and features described in one embodiment of the present application can be combined with the elements and features shown in one or more other embodiments. It should be noted that, for the purpose of clarity, the representations and descriptions of components and processes unrelated to the present application and known to those of ordinary skill in the art are omitted in the description. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0084] Animal model and test method

[0085] SD rats (about 160 g) were used as model animals, and the SD rats were subjected to midline laparotomy surgery, the liver was exposed and separated, and the liver bleeding model was prepared by punching with a 4mm pathological punch and directly scratching with a scalpel. Once the pathological wound is formed, the wound site needs 1-4 seconds to fill with blood (initial bleeding score is 3 or 4). Referring to the 6-point visual bleeding score system of Dennis C. Morse et al (reference: DOI 10.1007 / s11239-016-1388-6), the hemostatic effect of the hemostatic powder of the embodiment was evaluated. In the test, 1g of hemostatic powder was applied to each experimental group. The lower the score in the test, the better the hemostatic effect. The evaluation was carried out by researchers who were unaware of the composition information in each test item to maintain the objectivity of the research results. The test results are summarized in Table 3.

[0086] Table 1

[0087] Bacteriostatic effect test

[0088] The bacteriostatic effect of the hemostatic powder of the embodiment on Escherichia coli and Staphylococcus aureus was studied by the bacteriostatic circle method, and the diameter of the bacteriostatic circle was recorded. The test results are summarized in Table 3.

[0089] Biological tissue adhesion experiment

[0090] The adhesion of the biological tissue of the examples was studied using pigskin as a substrate. Several pieces of pigskin, each about 6.5 g, 55 mm x 30 mm in size, were prepared. A 10 x 10 mm square frame was marked on the pigskin at 1 cm below the surface using a marker pen. An equal amount of the example was carefully laid on the square frame with a small amount of water. After the example absorbed the water, another piece of pigskin was quickly laid on top of the first one, with the square frame aligned. After 1 minute, the two pieces of pigskin adhered together were mounted on a tensile testing machine for tensile testing until the two pieces of pigskin were separated. The test pictures are shown in Figures 3-4, and the test results are summarized in Table 3.

[0091] Hemostatic powder formulation and preparation method

[0092] Comparative Example 1

[0093] Formulation: Magnesium lithium silicate 100 g

[0094] Preparation method:

[0095] Step 1, dry the magnesium lithium silicate powder at room temperature under vacuum for 24 hours,

[0096] Step 2, sterilize the dried powder by gamma irradiation;

[0097] Step 3, seal the package after filling the packaging material.

[0098] Comparative Example 2

[0099] Formulation:

[0100] 4-arm PEG amine 15 g

[0101] 4-arm PEG succinamide 15 g.

[0102] Preparation method:

[0103] Step 1, accurately weigh each component according to the formulation,

[0104] Step 2, mix the components at low speed,

[0105] Step 3, pass the finely ground mixture through a 200-mesh sieve, and discard the components that do not pass through the mesh;

[0106] Step 4, dry the sieved powder at room temperature under vacuum for 24 hours,

[0107] Step 5, sterilize the dried powder by gamma irradiation;

[0108] Step 6, seal the package after filling the packaging material.

[0109] Comparative Example 3

[0110] Formulation:

[0111] Lithium magnesium silicate 90 g

[0112] 4-armed PEG amino 5 g

[0113] 4-armed PEG succinyl glutaramide 5 g.

[0114] Preparation method:

[0115] Step 1, accurately weigh each component according to the formulation,

[0116] Step 2, low-speed grinding mixing of each component,

[0117] Step 3, the fine powder of grinding mixing is passed through a 200 mesh sieve, and the components not passing through the mesh sieve are discarded;

[0118] Step 4, the screened powder is vacuum dried at room temperature for 24 hours,

[0119] Step 5, the dried powder is sterilized by γ-ray irradiation;

[0120] Step 6, after being filled into packaging materials, it is sealed and packaged.

[0121] Example 1

[0122] Formulation:

[0123] Lithium magnesium silicate 66.7 g

[0124] 4-armed PEG amino 16.7 g

[0125] 4-armed PEG succinyl glutaramide 16.7 g.

[0126] Preparation method:

[0127] Step 1, accurately weigh each component according to the formulation,

[0128] Step 2, low-speed grinding mixing of each component,

[0129] Step 3, the fine powder of grinding mixing is passed through a 200 mesh sieve, and the components not passing through the mesh sieve are discarded;

[0130] Step 4, the screened powder is vacuum dried at room temperature for 24 hours,

[0131] Step 5, the dried powder is sterilized by γ-ray irradiation;

[0132] Step 6, after being filled into packaging materials, it is sealed and packaged.

[0133] Example 2

[0134] Formulation:

[0135] Lithium magnesium silicate 15 g

[0136] 4-arm PEG amino 15 g

[0137] 4-arm PEG glutaroyl glutaramide 70 g

[0138] Methylene blue 0.8 g

[0139] Preparation method:

[0140] The rapid water-absorbing hemostatic powder described in Example 2 was prepared by a dry mixing method similar to that of Example 1.

[0141] Example 3

[0142] Lithium magnesium silicate 70 g

[0143] 4-arm PEG amino 15 g

[0144] 4-arm PEG glutaroyl glutaramide 15 g

[0145] Methylene blue 0.5 g

[0146] Carmusine 0.5 g

[0147] Preparation method:

[0148] The rapid water-absorbing hemostatic powder described in Example 3 was prepared by a dry mixing method similar to that of Example 1.

[0149] Examples 4-8

[0150] The rapid water-absorbing hemostatic powders described in Examples 4-8 were prepared by a dry mixing method similar to that of Example 1. The hemostatic powders of Examples 4-8 were prepared according to the following Table 2 (unit: g).

[0151] Table 2

[0152] Test results

[0153] The blood powders of Comparative Example 1 and Examples 1-4 were used to test their 6-level visual bleeding scores, hemostatic time, and antibacterial effect, and the test results are summarized in Table 3.

[0154] Table 3

Claims

1. Quick water-absorbing hemostatic powder, characterized in that, comprising the following components in parts by weight: 60-80% w / w of magnesium lithium metasilicate, montmorillonite, kaolin, zeolite, bentonite or a combination thereof; 10-20% w / w of amino-modified polyethylene glycol or thiol-modified polyethylene glycol or a combination thereof; 10-20% w / w of amido-modified polyethylene glycol; The total amount of each component is 100%.

2. The rapid water-absorbing hemostatic powder according to claim 1, characterized in that, comprising the following components in parts by weight: 60-75% w / w of magnesium lithium metasilicate; 12.5-20% w / w of amino-modified polyethylene glycol, 12.5-20% w / w of amido-modified polyethylene glycol, The total amount of each component is 100%.

3. The instant water-absorbing hemostatic powder according to claim 1, wherein, The amount of each component is: 65-70% w / w of magnesium lithium metasilicate; 15-17.5% w / w of amino-modified polyethylene glycol, 15-17.5% w / w of amido-modified polyethylene glycol, The total amount of each component is 100%.

4. The instant water-absorbing hemostatic powder according to any one of claims 1 to 3, characterized in that, Further added is 0.1-1% w / w of methylene blue, gentian violet or a combination thereof; preferably 0.1-0.5% w / w of methylene blue, 0-0.5% w / w of gentian violet or a combination thereof.

5. The instant water-absorbing hemostatic powder according to claim 1, wherein The amount of each component is: 66.7 parts by weight of magnesium lithium metasilicate; 16.6 parts by weight of amino or thiol-modified polyethylene glycol, 16.6 parts by weight of amido-modified polyethylene glycol.

6. The instant water-absorbing hemostatic powder according to claim 1, wherein, The amount of each component is: 66.7 parts by weight of magnesium lithium metasilicate; 16.6 parts by weight of amino or thiol-modified polyethylene glycol, 16.6 parts by weight of amido-modified polyethylene glycol, 0.1-0.5 parts by weight of methylene blue, 0-0.5 parts by weight of gentian violet.

7. The rapid water-absorbing hemostatic powder of any one of claims 1-6, wherein the amino-modified polyethylene glycol is selected from the group consisting of two-armed-polyethylene glycol amine, four-armed-polyethylene glycol amine, six-armed-polyethylene glycol amine, eight-armed-polyethylene glycol amine or a combination thereof; the thiol-modified polyethylene glycol is selected from the group consisting of two-armed-polyethylene glycol thiol, four-armed-polyethylene glycol thiol, six-armed-polyethylene glycol thiol, eight-armed-polyethylene glycol thiol or a combination thereof; the amido-modified polyethylene glycol is selected from the group consisting of two-armed-polyethylene glycol-glutaramide, four-armed-polyethylene glycol-glutaramide, six-armed-polyethylene glycol-glutaramide, eight-armed-polyethylene glycol-glutaramide or a combination thereof.

8. The rapid water-absorbing hemostatic powder of any one of claims 1-6, wherein the amino-modified polyethylene glycol is two-armed-polyethylene glycol amine and the amido-modified polyethylene glycol is two-armed-polyethylene glycol-glutaramide, and the ratio of the two is about 1:1; or the amino-modified polyethylene glycol is four-armed-polyethylene glycol amine and the amido-modified polyethylene glycol is four-armed-polyethylene glycol-glutaramide, and the ratio of the two is about 1:1; or the amino-modified polyethylene glycol is six-armed-polyethylene glycol amine and the amido-modified polyethylene glycol is six-armed-polyethylene glycol-glutaramide, and the ratio of the two is about 1:1; or the amino-modified polyethylene glycol is eight-armed-polyethylene glycol amine and the amido-modified polyethylene glycol is eight-armed-polyethylene glycol-glutaramide, and the ratio of the two is about 1:

1.

9. The fast water-absorbing hemostatic powder according to any one of claims 1-8, wherein the molecular weight of the amino-modified polyethylene glycol, the thiol-modified polyethylene glycol, and the amido-modified polyethylene glycol is independently selected from the group consisting of 1000-20000 Dalton.

10. The instant water-absorbing hemostatic powder according to any one of claims 1 to 9, characterized in that, The particle size of the hemostatic powder is no more than 1000 microns.

11. The instant water-absorbing hemostatic powder according to any one of claims 1 to 10, characterized in that, The hemostatic powder is gelled within 1 minute, preferably within 45 seconds or 30 seconds after being contacted with a bleeding wound.

12. A process for the preparation of the rapid water-absorbing hemostatic powder according to any one of claims 1-11, characterized in that, The method comprises the following steps: Step 1, accurately weighing each component according to the formulation ratio, Step 2, low-speed grinding and mixing each component, Step 3, passing the ground and mixed fine powder through an 80-325 mesh sieve, and discarding the components that do not pass through the mesh sieve; Step 4, vacuum drying the sieved powder at room temperature for 12-48 hours, Step 5, sterilizing the dried powder, wherein the sterilization is gamma ray irradiation sterilization, ethylene oxide sterilization, or electron beam sterilization; Step 6, sealing the package after being filled with packaging materials.

13. Use of the fast water-absorbing hemostatic powder according to any one of claims 1-11 in the preparation of a wound hemostatic drug or hemostatic device.

14. The use according to claim 13, wherein the wound is a Grade 4 severe bleeding according to the 6-point bleeding classification system.

15. The use according to claim 14, wherein the wound is an epidermal wound, an organ wound, or a blood vessel wound, and further preferably the wound is an endoscope- visible wound.

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