CN109432491B

CN109432491B - Slow-release hemostatic gauze

Info

Publication number: CN109432491B
Application number: CN201811337796.4A
Authority: CN
Inventors: 车七石; 刘少辉; 李新霞
Original assignee: Guangzhou Rainhome Pharm and Tech Co Ltd
Current assignee: Guangzhou Rainhome Pharm and Tech Co Ltd
Priority date: 2018-11-12
Filing date: 2018-11-12
Publication date: 2021-06-25
Anticipated expiration: 2038-11-12
Also published as: CN109432491A

Abstract

The application relates to a slow-release hemostatic gauze, which comprises a hollow fiber structure body; the hollow fiber structure body is soluble gauze and comprises sodium carboxymethyl cellulose; the hollow fiber structure body is internally provided with a plurality of cavities, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. On one hand, the slow-release hemostatic gauze adopts the design of an absorbable hollow fiber structure body, is favorable for blood coagulation and hemostasis, and can be retained in the body and degraded and absorbed; on the other hand, the slow-release anti-inflammation body design of the anti-inflammation particles with the wrapping layers is adopted, so that the slow-release time of the slow-release hemostatic gauze can be controlled according to the ingenious design of the wrapping layers in the process of being degraded and absorbed, a long slow-release anti-inflammation effect is achieved, the slow-release anti-inflammation particles can be controlled to be released as required in the whole absorption process or part of the absorption process of the slow-release hemostatic gauze, and the slow-release anti-inflammation gauze has an anti-inflammation effect which is incomparable to the traditional technology.

Description

Slow-release hemostatic gauze

Technical Field

The application relates to the field of medical materials, in particular to slow-release hemostatic gauze.

Background

The soluble hemostatic gauze is a hemostatic gauze suitable for in vivo and in vitro, can absorb moisture in blood, swell to form gel, attach to a wound surface of a bleeding opening, block and seal small blood vessels and capillary vessel ends, and achieve the purpose of auxiliary hemostasis. With the technical research, a plurality of soluble hemostatic gauzes appear to be sold on the market, and the current market applied to the body is the fast-growing yarn hemostatic gauze of the hadamard corporation; there are also a number of patent documents relating to soluble slow-release hemostatic gauze, which are described below.

For example, chinese patent publication No. CN101199866B discloses a soluble cotton fiber, and more particularly, to a soluble cotton fiber with various biological activities and a method for preparing the same. The preparation method is that the soluble cotton fiber and glycopeptide antibiotic pingyangmycin with alkaline group are combined dynamically and quantitatively in a non-aqueous solvent system by a chemical method under specific conditions to generate the novel medical soluble cotton fiber. The cotton fiber has the functions of stopping bleeding and debridement of soluble cotton fiber, and has various external medical functions of pingyangmycin medicaments, including antibiosis, antiphlogosis, body surface and cavity tumor resistance and wart caused by human papilloma virus, especially condyloma acuminatum and flat wart, and has good curative effect, no pain and no stimulation. The pingyangmycin medicament is combined with the soluble cotton fiber and is a dry product under a normal state, so that the storage stability of the medicament is greatly improved, and the sustained-release effect can be achieved in clinical application.

For another example, chinese patent publication No. CN104524624A discloses a chitosan hemostatic gauze, which is characterized by being prepared from the following raw materials in parts by weight: 3-5 parts of geranium, 3-5 parts of angelica dahurica, 1-2 parts of pseudo-ginseng, 1-2 parts of cape jasmine, 4-6 parts of chitosan, 8-12 parts of gelatin, 0.1-0.2 part of squalane, 800.1-0.2 part of polysorbate, 2-4 parts of sodium alginate, 2-4 parts of sodium carboxymethylcellulose, 1-2 parts of hydroxyethyl starch, 1-2 parts of auxiliary materials and 250 parts of water 200. The soluble hemostatic gauze prepared by the synergy of chitosan and other natural polymer materials has good hemostatic function, good antibacterial effect, easy absorption by human body, good biocompatibility and no toxic or side effect; by extracting and compounding natural plant effective components, the composition can diminish inflammation, relieve pain, astringe and remove scars, has a slow release effect, effectively prolongs the action time and achieves a better use effect.

For another example, chinese patent publication No. CN108324724A discloses a local sustained release method of kreb, which comprises the steps of a preparation method of a kreb soluble film preparation, and is characterized in that: s1, selecting an ionic active agent containing (-CH2-) and having a chain length of 3-15 as a raw material of the dispersant, and selecting an alcohol substance as a stabilizer of the corresponding dispersant; s2, performing gas dispersion on a kreb crystal original drug in the ultrasonic intensity range of 60W/m2-80W/m2, adding a dispersing agent raw material, processing for 20-40 minutes in the environment of keeping the room temperature, adding the stabilizing agent, and performing ultrasonic treatment for 20-30 minutes at the same intensity to form a widely distributed original solution; s3, continuously filtering the stock solution for 2-3 times by using filter paper with the filter hole specification of 0.22 mu m, and collecting the filtrate to obtain the 0.10-0.15 mu m monodispersed Clibolo soluble membrane preparation. By applying the technical scheme of the invention, the finished medicine with uniform particle size dispersion and stable and controllable release curve can be obtained by selecting the ionic active agent with proper length and controlling the ultrasonic intensity, and the practicability is improved.

However, the soluble hemostatic gauze in the traditional technology usually realizes the slow release effect through proportioning design, so the design defect exists.

Disclosure of Invention

Based on this, there is a need for a slow-release hemostatic gauze.

A slow release hemostatic gauze comprises a hollow fiber structure body; the hollow fiber structure body is soluble gauze and comprises sodium carboxymethyl cellulose; a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer.

As a preferred embodiment of the present modified release hemostatic gauze, in one embodiment, the coating comprises chitosan and/or alginate fibers.

As a preferable implementation mode of the improved slow release of the slow release hemostatic gauze, in one embodiment, the wrapping layer comprises chitosan and alginate fibers in a mass ratio of 1: 1-1: 4.

As a preferred embodiment of the present modified release hemostatic gauze, in one embodiment, the coating comprises modified starch.

As a preferred embodiment of the present application for improved anti-inflammation of the slow release hemostatic gauze, in one embodiment, the anti-inflammatory microparticles comprise a sulfonamide.

As a preferred embodiment of the modified anti-inflammatory of the slow release hemostatic gauze of the present application, in one embodiment, the anti-inflammatory particles comprise one or more of quinolone drugs, povidone-iodine, phosphatidylserine, and degradative enzymes.

As a preferred embodiment of the slow release hemostatic gauze of the present application for improving inflammation diminishing, in one embodiment, the hollow fiber structure body further comprises one or more of chitin fiber, alginate fiber, oxidized regenerated cellulose sodium salt, hydrophobic amino acid, sodium hyaluronate, and sodium alginate.

As a preferred embodiment of the present application for improved absorption of the slow release hemostatic gauze, in one embodiment, the hydrophobic amino acid comprises one or more of tyrosine, valine, tryptophan, phenylalanine, leucine, and isoleucine.

As a preferred embodiment of the improved absorption of the slow release hemostatic gauze of the present application, in one embodiment, the hydrophobic amino acids include tyrosine, valine, tryptophan, phenylalanine and leucine in a mass ratio of 1:1:1: 2.

As a preferred embodiment of the improved sustained release of the sustained release hemostatic gauze of the present application, in one embodiment, each sustained release antiphlogistic body is divided into at least two sustained release antiphlogistic body groups, and the thicknesses of the wrapping layers of the sustained release antiphlogistic body groups are set differently.

On one hand, the slow-release hemostatic gauze adopts the design of an absorbable hollow fiber structure body, is favorable for blood coagulation and hemostasis, and can be retained in the body and degraded and absorbed; on the other hand, the slow-release anti-inflammation body design of the anti-inflammation particles with the wrapping layers is adopted, so that the slow-release time of the slow-release hemostatic gauze can be controlled according to the ingenious design of the wrapping layers in the process of being degraded and absorbed, a long slow-release anti-inflammation effect is achieved, the slow-release anti-inflammation particles can be controlled to be released as required in the whole absorption process or part of the absorption process of the slow-release hemostatic gauze, and the slow-release anti-inflammation gauze has an anti-inflammation effect which is incomparable to the traditional technology.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present application more comprehensible, specific embodiments thereof are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. This application is capable of embodiments in many different forms than those described herein and that modifications may be made by one skilled in the art without departing from the spirit and scope of the application and it is therefore not intended to be limited to the specific embodiments disclosed below.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

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 application belongs. The terminology used herein in the description of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In one embodiment of the present application, a slow release hemostatic gauze comprises a hollow fiber structure body; the hollow fiber structure body is soluble gauze and comprises sodium carboxymethyl cellulose; a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. On one hand, the slow-release hemostatic gauze adopts the design of an absorbable hollow fiber structure body, is favorable for blood coagulation and hemostasis, and can be retained in the body and degraded and absorbed; on the other hand, the slow-release anti-inflammation body design of the anti-inflammation particles with the wrapping layers is adopted, so that the slow-release time of the slow-release hemostatic gauze can be controlled according to the ingenious design of the wrapping layers in the process of being degraded and absorbed, a long slow-release anti-inflammation effect is achieved, the slow-release anti-inflammation particles can be controlled to be released as required in the whole absorption process or part of the absorption process of the slow-release hemostatic gauze, and the slow-release anti-inflammation gauze has an anti-inflammation effect which is incomparable to the traditional technology.

Further, in one embodiment, each sustained-release antiphlogistic body is uniformly distributed. Furthermore, part or all of the cavities have different thickness positions in the hollow fiber structure body, that is, the distance between at least two cavities and the contact surface of the hollow fiber structure body to the position to be stopped blood is different, that is, the distance between the midpoint of the cavities or the position of the contact surface closest to the position to be stopped blood and the contact surface is different. Further, each cavity has a different thickness position inside the hollow fiber structure body, so that the distance between each cavity and the contact surface of the position to be stopped blood is different. The design is beneficial to forming difference of release time of the slow-release anti-inflammatory bodies in the cavities, so that in the process of degrading and absorbing the slow-release hemostatic gauze, the slow-release starting time of the slow-release anti-inflammatory bodies in each cavity is formed to be different, and a longer slow-release anti-inflammatory effect is achieved. Further, in one embodiment, each of the cavities has a different thickness position inside the hollow fiber structure body, and the thickness positions of the cavities form an increasing number sequence, which may also be referred to as a first increasing number sequence; in one embodiment, the thickness position of each cavity forms an arithmetic progression row, which may also be referred to as a first arithmetic progression row.

In one embodiment, each sustained-release antiphlogistic body is divided into at least two sustained-release antiphlogistic body groups, and the thicknesses of the wrapping layers of the sustained-release antiphlogistic body groups are different. Further, in one embodiment, the sustained-release antiphlogistics in each sustained-release antiphlogistic group are uniformly arranged, and in one embodiment, at least one sustained-release antiphlogistics in another sustained-release antiphlogistic group is arranged between any two sustained-release antiphlogistics in each sustained-release antiphlogistic group. In one embodiment, the sustained-release antiphlogistics in each sustained-release antiphlogistic body group are arranged into a matrix, the matrix formed by arranging the sustained-release antiphlogistic body groups is at least partially overlapped, and the overlapped shape is overlapped and the matrix elements are not overlapped. Further, in one embodiment, each of the sustained-release anti-inflammatory bodies is divided into N sustained-release anti-inflammatory body groups, and the thicknesses of the wrapping layers of the N sustained-release anti-inflammatory body groups are different and form an increasing series, which may also be referred to as a second increasing series; n is a natural number greater than 1; further, in one embodiment, the difference between the thicknesses of the two adjacent sustained-release antiphlogistic groups in the increasing array is 1/N of the complete degradation time of the hollow fiber structure body; further, in one embodiment, the thicknesses of the wrapping layers of the N sustained-release anti-inflammatory body groups are different and form an arithmetic progression sequence, which may also be referred to as a second arithmetic progression sequence. Due to the design, the release process of the anti-inflammatory particles in the sustained-release anti-inflammatory body is long-term appeared in the degradation and absorption process of the sustained-release hemostatic gauze, and the degradation and absorption process of the sustained-release hemostatic gauze is finally reached, so that a long sustained-release anti-inflammatory effect is achieved. And, cooperate in the cavity position design that has different thickness position inside the hollow fiber structure body, be favorable to forming the release time of difference on the one hand, on the other hand is favorable to controlling the time of beginning to release of diminishing inflammation particle, make above-mentioned slow-release hemostatic gauze can be controlled the slow-release time according to the ingenious design of parcel layer in the in-process that is degraded and absorbed, thereby played longer slow-release anti-inflammation effect, and then can control in the absorbed overall process or partial stage of slow-release hemostatic gauze slowly-release diminishing inflammation particle as required, have the comparable anti-inflammatory effect of traditional technique.

In one embodiment, the wrapping layer comprises chitosan or alginate fibers. In one embodiment, the wrapping layer comprises chitosan and alginate fibers. Chitosan (chitosan), also known as chitosan, is obtained by deacetylation of chitin (chitin) widely existing in nature, and is chemically named polyglucosamine (1-4) -2-amino-B-D glucose. Further, in one embodiment, the chitosan is chitosan with N-acetyl groups removed by more than 80%, i.e. the degree of N-deacetylation is more than 80%. Further, in one embodiment, the chitosan is chitosan with N-acetyl groups removed by more than 85%, i.e. the degree of N-deacetylation is more than 85%. The alginate fiber is one of artificial fiber, and is prepared from alginic acid extracted from brown algae in sea; the alginate fiber is prepared by spinning the substances extracted from natural seaweed, and has good biocompatibility, degradability, absorbability and the like because the raw materials are from the natural seaweed. For example, fine ground seaweed powder is added to the spinning solution to be spun to obtain a seaweed fiber. The algae powder is mainly from brown algae, red algae, green algae and blue algae. The alginate fibers are also absorbent, and can absorb 20 times of the liquid in volume, so that the alginate fibers can reduce microbial breeding and possible peculiar smell generated by the microbial breeding on wounds, and are particularly suitable for hemostasis and used as in-vivo absorption materials. In one embodiment, the wrapping layer comprises chitosan and alginate fibers in a mass ratio of 1: 1-1: 4. Further, in one embodiment, the wrapping layer comprises chitosan and alginate fibers in a mass ratio of 1:1, 1:2, 1:3 or 1: 4. Therefore, the chitosan is used as part or all of the coating layer, and the characteristics of inhibiting the bacterial activity of the chitosan can be utilized, so that part of the antibacterial and anti-inflammatory effects are also achieved. In one embodiment, the coating comprises destructured starch. The wrapping layer is an important invention of the application, the soluble slow-release hemostatic gauze is gradually degraded and absorbed in a body to a certain degree, the wrapping layer is exposed, then the wrapping layer is also degraded and absorbed to a certain degree, the anti-inflammatory particles in the wrapping layer are exposed, and the anti-inflammatory effect is exerted, so that a longer slow-release anti-inflammatory effect is achieved.

In one embodiment, the anti-inflammatory microparticles comprise an anti-inflammatory drug, in one embodiment, the anti-inflammatory microparticles comprise a sulfonamide, i.e., the anti-inflammatory drug comprises a sulfonamide, and so on in other embodiments; sulfonamides are broad-spectrum antibacterial agents, mainly comprise derivatives of para-aminobenzenesulfonamide, have good antibacterial activity on gram-positive bacteria and gram-negative bacteria, and can selectively inhibit streptococcus pyogenes, streptococcus pneumoniae, haemophilus influenzae, escherichia coli, proteus mirabilis, chlamydia trachomatis, venereal lymphogranulomatous chlamydia and the like, as well as actinomycetes, pneumocystis, nocardia and the like. Sulfonamides can widely permeate into tissues of the whole body and various extracellular fluids such as pleural fluid, peritoneal fluid, synovial fluid, aqueous humor, saliva, sweat, urine, bile and the like, can permeate through a blood brain barrier to enter cerebrospinal fluid, and can also enter milk and pass through a placenta barrier. In one embodiment, the sulfa drug is or includes sulfadiazine, sulfamethoxazole, phthalylsulfathiazole, sulfacetamide, sulfadiazine silver salt. And/or, in one embodiment, the anti-inflammatory microparticles comprise one or more of a quinolone drug, povidone-iodine, phosphatidylserine, and a degrading enzyme. In one embodiment, the anti-inflammatory microparticles comprise a quinolone drug, i.e., the anti-inflammatory drug comprises a quinolone drug; quinolone drugs are also known as pyridonic acids or pyridonic acids, and are artificially synthesized antibacterial drugs containing 4-quinolone basic structures. Quinolones target the deoxyribonucleic acid (DNA) of bacteria, hinder DNA gyrase, further cause irreversible damage to the DNA of the bacteria, and achieve an antibacterial effect; the product has antibacterial effect on multiple gram-negative bacteria, and can be widely used for treating genitourinary system diseases, gastrointestinal diseases, and gram-negative bacterial infection of respiratory tract and skin tissue. In one embodiment, the quinolone drug is or includes norfloxacin, ofloxacin, ciprofloxacin, fleroxacin. In one embodiment, the quinolone drug is enrofloxacin, which has the characteristics of wide antibacterial spectrum, strong bactericidal power, quick action, wide in-vivo distribution, no cross resistance with other antibiotics and the like, and/or in one embodiment, the anti-inflammatory particles comprise povidone iodine, namely the anti-inflammatory drug comprises povidone iodine; povidone iodine (Povidone iodine) is a loose compound formed by combining elemental iodine and a polymer carrier, and Povidone plays a role in the carrier and helps to dissolve. It is a broad-spectrum strong disinfectant, and has strong action for killing virus, bacteria, fungi and mould spore. The product has low irritation to skin, low toxicity, and long-lasting effect. Safe and simple use. Has no irritation to tissue, and can be used for disinfecting skin and mucosa, such as cleaning before operation, and disinfecting operation part and wound. And/or, in one embodiment, the anti-inflammatory microparticles comprise phosphatidylserine, i.e. the anti-inflammatory drug comprises phosphatidylserine; phosphatidylserine is also called compound nervonic acid, which is called Phosphatidylserine (PS for short) and is usually extracted from natural soybean oil residues. Are active substances of cell membranes, in particular in brain cells. The medicine has the functions of improving nerve cell function, regulating nerve pulse transmission and promoting brain memory, and has very strong lipophilicity, so that the medicine can enter brain quickly through blood brain barrier after being absorbed, and has the functions of relieving blood vessel smooth muscle cells and increasing blood supply of brain. In each embodiment, the anti-inflammatory particles, namely the particles prepared from the medicine with the anti-inflammatory effect, have a lasting anti-inflammatory effect under the slow release effect, and the particles exist in the wrapping layer in a solid form, so that the shelf life of the product, namely the shelf life of the slow release hemostatic gauze, is longer, and the service life is guaranteed. Further, in one embodiment, the anti-inflammatory particles are in a powder form, which is more efficiently absorbed by interstitial fluid. In each embodiment, the amount and proportion of the anti-inflammatory particles are set according to the product design. Further, in one embodiment, the mass ratio of the wrapping layer to the anti-inflammatory particles in the wrapping layer is 10: 1-120: 1. Further, in one embodiment, the anti-inflammatory particles comprise sulfonamide drugs and phosphatidylserine in a mass ratio of 9: 1-16: 1. Further, in one embodiment, the anti-inflammatory particles comprise 9:1 to 16:1 mass ratio of quinolone drugs to phosphatidylserine. Further, in one embodiment, the anti-inflammatory microparticles comprise a sulfonamide, povidone-iodine and phosphatidylserine in a mass ratio of 10:2: 1. Further, in one embodiment, the anti-inflammatory particles comprise a sulfonamide drug and a quinolone drug in a mass ratio of 1: 1. Further, in one embodiment, the anti-inflammatory particles comprise sulfonamides, quinolones, povidone-iodine and phosphatidylserines in a mass ratio of 12:10:2: 1. It is understood that the anti-inflammatory microparticles may also include other anti-inflammatory drugs, and the application is not limited thereto.

Further, in one embodiment, the anti-inflammatory microparticles include or further include a degrading enzyme such as cellulase, and in one embodiment, the anti-inflammatory microparticles include an anti-inflammatory drug and a degrading enzyme. In one embodiment, the anti-inflammatory particles comprise anti-inflammatory drugs and degrading enzymes in a mass ratio of 10: 1-20: 1. The design that the degrading enzyme is wrapped is beneficial to accelerating the degradation and absorption of the hollow fiber structure body in the middle and later period of the degradation and absorption of the hollow fiber structure body, so that the overall time for the degradation and absorption of the hollow fiber structure body is reduced.

In one embodiment, the hollow fiber structure body further comprises one or more of chitin fibers, alginate fibers, oxidized regenerated cellulose sodium salt, hydrophobic amino acid, sodium hyaluronate, and sodium alginate. In one embodiment, the hollow fiber structural body further comprises chitin fibers. In one embodiment, the hollow fiber structure body comprises 180-300 parts by mass of sodium carboxymethyl cellulose and 18-25 parts by mass of chitin fiber. In one embodiment, the hollow fiber structure body comprises 210 parts of sodium carboxymethyl cellulose and 21 parts of chitin fiber by mass. In one embodiment, the mass ratio of the sodium carboxymethyl cellulose to the chitin fibers is 10: 1. And/or, in one of the embodiments, the hollow fiber structural body further comprises alginate fibers. In one embodiment, the hollow fiber structure body comprises 180-300 parts by mass of sodium carboxymethyl cellulose and 35-55 parts by mass of alginate fibers. In one embodiment, the hollow fiber structure body comprises 230 parts by mass of sodium carboxymethyl cellulose and 46 parts by mass of alginate fibers. In one embodiment, the mass ratio of the sodium carboxymethyl cellulose to the alginate fibers is 5: 1. Further, in one embodiment, the hollow fiber structure body comprises, in parts by mass: 180 to 300 portions of sodium carboxymethylcellulose, 35 to 55 portions of alginate fiber and 18 to 25 portions of chitin fiber; namely, the hollow fiber structure body comprises the following components in parts by mass: 180 to 300 portions of sodium carboxymethyl cellulose, 35 to 55 portions of alginate fiber and 18 to 25 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 to 280 portions of sodium carboxymethylcellulose, 38 to 52 portions of alginate fiber and 19 to 24 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 220 to 260 portions of sodium carboxymethylcellulose, 40 to 50 portions of alginate fiber and 20 to 23 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 180 parts of sodium carboxymethylcellulose, 35 parts of alginate fibers and 18 parts of chitin fibers. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 300 parts of sodium carboxymethylcellulose, 55 parts of alginate fibers and 25 parts of chitin fibers. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 parts of sodium carboxymethylcellulose, 52 parts of alginate fibers and 24 parts of chitin fibers. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 280 parts of sodium carboxymethylcellulose, 38 parts of alginate fibers and 19 parts of chitin fibers. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 220 parts of sodium carboxymethylcellulose, 40 parts of alginate fibers and 23 parts of chitin fibers. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 260 parts of sodium carboxymethylcellulose, 50 parts of alginate fibers and 20 parts of chitin fibers. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 240 parts of sodium carboxymethylcellulose, 45 parts of alginate fibers and 22 parts of chitin fibers. The rest of the examples are analogized. The parts, i.e., parts by mass, are understood to mean grams, milligrams, kilograms, pounds, tons, and the like. In grams as an example, 1 part is a certain mass of 0.0001 to 10000 grams; for example, 1 part may be 0.0001g, 0.001g, 0.005g, 0.01g, 0.02g, 0.05g, 0.1g, 0.2g, 0.5g, 1g, 2g, 3g, 4g, 5g, 10g, 15g, 20g, 30g, 50g, 80g, 100g, 500g, 1000g, 5000g, 10000g, 50000g, etc., and the like, and the parts are not limited thereto, and may be selected according to actual production, and the like in each example. In each embodiment, Sodium carboxymethyl Cellulose (CMC-Na) is a Cellulose derivative with the glucose polymerization degree of 100-2000, is the Cellulose type with the widest application range and the largest dosage in the world at present, is matched with oxidized regenerated Cellulose, alginate fiber and chitin fiber, is beneficial to preventing wound infection, has no obvious difference from the traditional gauze dressing, is obviously superior to the gauze dressing in controlling the exudation of wound tissue fluid and the quick healing of the wound, has the functions of relieving postoperative edema and wound irritation and is also beneficial to relieving the postoperative peritoneal adhesion degree. Among the natural organic compounds present on earth, the largest amount is cellulose, and the second is chitin, the former is mainly produced by plants, and the latter is mainly produced by animals. Chitin and its derivative chitosan have certain flow ductility and filamentation, are all good fiber-forming materials, select the appropriate spinning condition, can make chitin fibre with higher intensity and elongation through the conventional wet spinning process, it has better spinnability but is difficult to pure spinning. The chitosan macromolecule structure contains a large amount of amino groups, so that the solubility and the biological activity of the chitosan macromolecule structure are high. In the chitin fiber, the macromolecular structure of chitin is the same as the composition of glucosamine in human body, and has a structure similar to human ossein tissue, and the double structure endows the chitin fiber with excellent biomedical characteristics: the antibacterial anti-infective hemostatic gauze is nontoxic and non-irritant to a human body, can be decomposed and absorbed by lysozyme in the human body, has good biocompatibility with human tissues, has the functions of resisting bacteria, diminishing inflammation, stopping bleeding, relieving pain, promoting wound healing and the like, is very suitable for being applied to the sustained-release hemostatic gauze, and has the advantages of resisting bacteria, resisting infection, having no rejection and being easy to absorb. The applicant finds in research that the alginate fiber and the chitin fiber are particularly suitable for being applied to slow-release hemostatic gauze except for some technical difficulties in the aspect of spinning, so that the alginate fiber and the chitin fiber are matched with a large amount of sodium carboxymethylcellulose for use together, the problem of spinning is solved, and the hemostatic property and the solubility are good.

In one embodiment, the hollow fiber structure body further comprises 4 to 8 parts by weight of hydrophobic amino acid; namely, the hollow fiber structure body comprises the following components in parts by mass: 180 to 300 portions of sodium carboxymethylcellulose, 4 to 8 portions of hydrophobic amino acid, 35 to 55 portions of alginate fiber and 18 to 25 portions of chitin fiber; that is, the hollow fiber structure body further comprises the following components in parts by mass: 4-8 parts of hydrophobic amino acid; the rest of the examples are analogized. The design of hydrophobic amino acid is favorable for reducing the water content in the excessive blood absorbed by the hollow fiber structure body in the using process, and reducing the blood loss while blood coagulation and hemostasis. In one embodiment, the hollow fiber structure body further comprises 5 to 7 parts by weight of hydrophobic amino acid; in one embodiment, the hollow fiber structural body further comprises 5 parts, 5.5 parts, 6 parts or 6.5 parts of hydrophobic amino acid by mass; in one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 to 280 portions of sodium carboxymethylcellulose, 5 to 7 portions of hydrophobic amino acid, 38 to 52 portions of alginate fiber and 19 to 24 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 180 parts of sodium carboxymethylcellulose, 6 parts of hydrophobic amino acid, 35 parts of alginate fiber and 18 parts of chitin fiber; the rest of the examples are analogized. In one embodiment, the hydrophobic amino acid comprises at least one of valine, tryptophan, phenylalanine, leucine, isoleucine, and methionine. In one embodiment, the hydrophobic amino acid is valine, tryptophan, phenylalanine, leucine, isoleucine, or methionine; in one embodiment, the hydrophobic amino acids comprise valine to tryptophan in a mass ratio of 1: 1; in one embodiment, the hollow fiber structural body further comprises 6 parts by mass of hydrophobic amino acid, and the hydrophobic amino acid comprises valine and tryptophan in a mass ratio of 1:1, that is, the hollow fiber structural body further comprises 3 parts by mass of valine and 3 parts by mass of tryptophan, and the rest of the embodiments are similar; in one embodiment, the hydrophobic amino acids comprise valine and leucine or isoleucine in a mass ratio of 1: 2; leucine or isoleucine may be preferred for use with valine. In one embodiment, the hydrophobic amino acids comprise valine, tryptophan and phenylalanine in a mass ratio of 1:1: 1. In one embodiment, the hydrophobic amino acid further comprises tyrosine, and the mass ratio of tyrosine to phenylalanine is 1:1, i.e., the hydrophobic amino acid comprises tyrosine, valine, tryptophan, and phenylalanine in a mass ratio of 1:1:1: 1. In one embodiment, the hydrophobic amino acids comprise tyrosine, valine, tryptophan, phenylalanine, and leucine in a mass ratio of 1:1:1:1: 2; or the hydrophobic amino acid comprises tyrosine, valine, tryptophan, phenylalanine and isoleucine in a mass ratio of 1:1:1:1: 2. Valine is matched with leucine or isoleucine to help promote growth recovery, and tyrosine helps to synergistically promote metabolism and growth development; and tyrosine, valine, tryptophan, phenylalanine, leucine or isoleucine are matched with sodium carboxymethylcellulose, alginate fibers and chitin fibers, so that the recovery is promoted after blood coagulation and hemostasis, and the nervous system is prevented from being stimulated, so that the discomfort of a patient is reduced, the patient can be absorbed, and rejection reaction is avoided.

Further, in one embodiment, the hollow fiber structure body further comprises 100 to 200 parts by mass of oxidized regenerated cellulose; oxidized Regenerated Cellulose (ORC) can cause platelet rupture due to rough surface, generate a large amount of platelet coagulation factors, change fibrinogen into fibrin, and form thrombus to stop bleeding. Another possible mechanism is that the local hemostatic effect is caused by the hydroxyl groups in cellulose and Ca in plasma²⁺Form cross-linking bonds to form a gel-like blood clot to stop bleeding. In addition, the oxidized regenerated cellulose has broad-spectrum bactericidal action on gram-positive bacteria and gram-negative bacteria. In the aspect of in vivo absorption, the oxidized regenerated cellulose can be kept in vivo, and can be gradually absorbed by tissues within 2-7 days, and can be completely absorbed in about 6 weeks. And the oxidized regenerated cellulose is absorbed from the body without cell reaction or fibrosis; is particularly suitable for moderate bleeding which can not be sutured or ligated in the operation. In one embodiment, the hollow fiber structure body further comprises 120-180 parts by weight of oxidized regenerated cellulosePreparing; in one embodiment, the hollow fiber structural body further comprises 130 parts, 145 parts, 150 parts, 160 parts or 170 parts of oxidized regenerated cellulose and the like by mass parts; in one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 to 280 portions of sodium carboxymethylcellulose, 120 to 180 portions of oxidized regenerated cellulose, 38 to 52 portions of alginate fiber and 19 to 24 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 220 to 260 portions of sodium carboxymethylcellulose, 120 to 180 portions of oxidized regenerated cellulose, 4 to 8 portions of hydrophobic amino acid, 40 to 50 portions of alginate fiber and 20 to 23 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 300 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 5 parts of hydrophobic amino acid, 55 parts of alginate fiber and 25 parts of chitin fiber. It is understood that any of the above examples of hydrophobic amino acids may be used in each of the above examples relating to hydrophobic amino acids, and in one of the examples, the hydrophobic amino acids include valine to tryptophan in a mass ratio of 1: 1; the rest of the examples are analogized.

Further, in one embodiment, the hollow fiber structure body further comprises 40-60 parts by mass of oxidized regenerated cellulose sodium salt; oxidized regenerated cellulose sodium salt (ORC-Na) is generally obtained by carrying out controllable neutralization reaction on oxidized regenerated cellulose and sodium hydroxide, the neutralization reaction is basically difficult and does not need to reach the reaction degree of 100%, and a mixture of the oxidized regenerated cellulose sodium salt and the oxidized regenerated cellulose can be adopted, and only the mass part or the mass ratio of the mixture meets the limitations of related examples. In one embodiment, the hollow fiber structure body further comprises 45-55 parts by mass of oxidized regenerated cellulose sodium salt. In one embodiment, the hollow fiber structural body further comprises 48, 49, 50 or 53 parts of oxidized regenerated cellulose sodium salt and the like by mass parts. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 to 280 portions of sodium carboxymethylcellulose, 45 to 55 portions of oxidized regenerated cellulose sodium salt, 38 to 52 portions of alginate fiber and 19 to 24 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 parts of sodium carboxymethylcellulose, 55 parts of oxidized regenerated cellulose sodium salt, 52 parts of alginate fiber and 24 parts of chitin fiber. Further, in various embodiments, the hollow fiber structural body has both oxidized regenerated cellulose and oxidized regenerated cellulose sodium salt. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 180 to 300 portions of sodium carboxymethylcellulose, 100 to 200 portions of oxidized regenerated cellulose, 40 to 60 portions of oxidized regenerated sodium cellulose salt, 35 to 55 portions of alginate fiber and 18 to 25 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 220 to 260 portions of sodium carboxymethylcellulose, 120 to 180 portions of oxidized regenerated cellulose, 45 to 55 portions of oxidized regenerated sodium cellulose salt, 40 to 50 portions of alginate fiber and 20 to 23 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 280 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 50 parts of oxidized regenerated cellulose sodium salt, 4 parts of hydrophobic amino acid, 38 parts of alginate fiber and 19 parts of chitin fiber. In each embodiment that the hollow fiber structure body simultaneously comprises oxidized regenerated cellulose and oxidized regenerated cellulose sodium salt, the mass ratio of the oxidized regenerated cellulose to the oxidized regenerated cellulose sodium salt is (2-3): 1; in one embodiment, the mass ratio of oxidized regenerated cellulose to oxidized regenerated cellulose sodium salt is 3:1 or 2.5: 1. When the oxidized regenerated cellulose sodium salt and the oxidized regenerated cellulose of the hollow fiber structure body have a reasonable mass ratio, and the carboxyl is continuously increased along with the oxidation time during the degradation of the hollow fiber structure body, the etching degree of the fiber surface of the oxidized regenerated cellulose is increased and the fiber surface is fractured, at the moment, holes and cracks appear under the microscopic state, namely, the bonding force and the elongation of the oxidized regenerated cellulose fiber and the sodium salt fiber thereof are in a descending trend; and once the fiber fracture degree and the fracture elongation rate are reduced sharply at the beginning of oxidation, when the mass fraction of carboxyl reaches a certain degree, the reduction of the fracture degree and the fracture elongation rate is relatively smooth, but the fracture degree and the fracture elongation rate of the oxidized regenerated cellulose fiber are higher than those of the corresponding oxidized regenerated cellulose sodium salt fiber, the oxidized regenerated cellulose mixed with the oxidized regenerated cellulose sodium salt has higher hemostasis speed, and the absorption and degradation are completed in 7-14 days in vivo; in addition, the adoption of the oxidized regenerated cellulose sodium salt is beneficial to improving the pH value of the slow-release hemostatic gauze in the degradation and absorption process, and avoids the excessive stimulation of acidic oxidized regenerated cellulose to the nervous system of a human body in the absorption process.

Further, in one embodiment, the hollow fiber structure body further comprises 5-20 parts of sodium alginate by mass. Sodium alginate is a natural polysaccharide, has the stability, solubility, viscosity and safety required by pharmaceutical preparation accessories, the molecule of the sodium alginate is formed by connecting beta-D-mannuronic acid (M) and alpha-L-guluronic acid (alpha-L-guluronic acid, G) according to a bond of 1 → 4, and the sodium alginate has better hemostatic effect by matching oxidized regenerated cellulose, alginate fiber and chitin fiber, and has the advantage of stable performance. In one embodiment, the hollow fiber structure body further comprises 10-15 parts of sodium alginate by mass. In one embodiment, the hollow fiber structure body further comprises 12 parts, 13 parts or 14 parts of sodium alginate and the like by mass. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 180 to 300 portions of sodium carboxymethylcellulose, 5 to 20 portions of sodium alginate, 35 to 55 portions of alginate fiber and 18 to 25 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 to 280 portions of sodium carboxymethylcellulose, 120 to 180 portions of oxidized regenerated cellulose, 40 to 60 portions of oxidized regenerated sodium cellulose, 10 to 15 portions of sodium alginate, 38 to 52 portions of alginate fiber and 19 to 24 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 220 parts of sodium carboxymethylcellulose, 130 parts of oxidized regenerated cellulose, 52 parts of oxidized regenerated cellulose sodium salt, 5 parts of hydrophobic amino acid, 12 parts of sodium alginate, 40 parts of alginate fiber and 23 parts of chitin fiber. The rest of the examples are analogized.

Further, in one embodiment, the hollow fiber structure body further includes 1 to 10 parts by mass of sodium hyaluronate. The sodium hyaluronate is a sodium salt of disaccharide unit hyaluronic acid consisting of D-glucuronic acid and N-acetylglucosamine, the basic structure of the hyaluronic acid is a large polysaccharide consisting of two disaccharide units of D-glucuronic acid and N-acetylglucosamine, the sodium hyaluronate is one of the structures of human skins, is an acidic mucose which is the most widely distributed in human bodies, exists in a matrix of connective tissues, has a good moisturizing effect, and can promote cell repair when being applied to the slow-release hemostatic gauze, and has a good adhesion preventing effect when being matched with oxidized regenerated cellulose and sodium carboxymethylcellulose. In one embodiment, the hollow fiber structure body further comprises 3-8 parts by mass of sodium hyaluronate. In one embodiment, the hollow fiber structure body further comprises 4 parts, 5 parts, 6 parts or 7 parts of sodium hyaluronate by mass. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 180 to 300 portions of sodium carboxymethylcellulose, 1 to 10 portions of sodium hyaluronate, 35 to 55 portions of alginate fiber and 18 to 25 portions of chitin fiber; in one embodiment, the hollow fiber structure body comprises, in parts by mass: 200 to 280 portions of sodium carboxymethylcellulose, 40 to 60 portions of oxidized regenerated sodium cellulose, 4 to 8 portions of hydrophobic amino acid, 3 to 8 portions of sodium hyaluronate, 38 to 52 portions of alginate fiber and 19 to 24 portions of chitin fiber. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 260 parts of sodium carboxymethylcellulose, 140 parts of oxidized regenerated cellulose, 45 parts of oxidized regenerated cellulose sodium salt, 8 parts of hydrophobic amino acid, 5 parts of sodium hyaluronate, 50 parts of alginate fiber and 20 parts of chitin fiber. The rest of the examples are analogized.

Further, in one embodiment, the hollow fiber structure body comprises, in parts by mass: 240 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 50 parts of oxidized regenerated cellulose sodium salt, 6 parts of hydrophobic amino acid, 5 parts of sodium hyaluronate, 13 parts of sodium alginate, 45 parts of alginate fiber and 22 parts of chitin fiber; wherein the hydrophobic amino acid comprises tyrosine, valine, tryptophan, phenylalanine and leucine in a mass ratio of 1:1:1:1: 2. In one embodiment, the hollow fiber structure body comprises, in parts by mass: 240 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 50 parts of oxidized regenerated cellulose sodium salt, 6 parts of hydrophobic amino acid, 5 parts of sodium hyaluronate, 13 parts of sodium alginate, 45 parts of alginate fiber and 22 parts of chitin fiber; wherein the hydrophobic amino acid comprises tyrosine, valine, tryptophan, phenylalanine and isoleucine in a mass ratio of 1:1:1:1: 2.

In one embodiment, the hollow fiber has a fiber structure with a thin tubular cavity in the fiber axial direction, and the thin tubular cavity is arranged along the direction penetrating through the fiber axial direction, so that the weight of the hollow fiber can be reduced by 20-30% compared with that of a solid fiber, and a large number of hollow tube bodies, namely the thin tubular cavities, are arranged; further, in one embodiment, the hollow fiber structural body is made by: the components of each embodiment are dissolved in a spinning solution to obtain a solution or suspended to obtain a suspension, then the suspension is spun and woven according to requirements, and the spinning solution is cut after being dried. The process can be realized by adopting the traditional spinning technology of cellulose, alginate fiber or chitin fiber, is not the invention point of the application, and the application only utilizes the existing spinning technology. In one embodiment, the components of each embodiment are dissolved in a spinning solution to obtain a solution or suspension to obtain a suspension, and then the solution is spun into hollow fibers, namely the hollow fiber structural body, by spinning through an annular hollow spinneret plate, a C-shaped spinneret plate or an eccentric hollow spinneret plate; in one embodiment, the components of each embodiment are dissolved in a spinning solution to obtain a solution or suspended solution to obtain a suspension, and then a hollow spinneret is adopted to spin hollow fibers by a dry-wet spinning or melt spinning mode; in one embodiment, the central portion of the hollow fibers is also aerated during spinning.

Further, in one embodiment, a side of the hollow fiber structure body facing the protective layer is provided with a nano hydrophobic material region. The hydrophobic molecules are biased to be nonpolar and can be dissolved in neutral and nonpolar solutions, the hydrophobic molecules are generally converged into a cluster in water, the water can form a large contact angle to form a drop shape when being on the surface of the hydrophobic solution, and the design of the nano hydrophobic material area is favorable for preventing a large amount of blood from simultaneously flowing into the slow-release hemostatic gauze, so that buffer time is provided for the coagulation of the hollow fiber structure body, and excessive blood loss of a patient in the hemostasis process can be avoided. Further, in one embodiment thereof, the nano hydrophobic material region has a plurality of through holes; in one embodiment, the total area of each through hole is 20-45% of the area of the nano hydrophobic material region; in one embodiment, the total area of each of the through holes is 25%, 30%, 35%, 40% or 45% of the area of the nano hydrophobic material region; thus, part of blood can be blocked by the nano hydrophobic material area, and part of blood enters the hollow fiber structure body through the through hole and realizes the blood coagulation and hemostasis effect. Further, in one embodiment, the nano hydrophobic material region is a nano hydrophobic material layer with a plurality of through holes, that is, a side of the hollow fiber structure body facing the protective layer is provided with a nano hydrophobic material layer with a plurality of through holes. In one embodiment, the number of the nano hydrophobic material regions is multiple, and a gap exists between each nano hydrophobic material region. Like this, adopt the regional design of nanometer hydrophobic material, the combination of "enclosing" and "stifled" has been utilized ingeniously, enclose earlier, it becomes little to break up the whole into parts grow for subsequent blood coagulation hemostasis is more effective, be favorable to avoiding absorbing the moisture in too much blood in the use on the one hand and even absorbing too much blood, on the other hand is favorable to exerting pressure through the regional portion of treating the hemostasis in order to stop the blood outflow of nanometer hydrophobic material, on the other hand hollow fiber structure body still produces blood coagulation hemostasis to blood on the one hand again, thereby the volume of bleeding has been reduced better under the prerequisite of effective hemostasis. In one embodiment, the nano hydrophobic material area is rectangular or rounded rectangular; in one embodiment, the nano hydrophobic material area is in an oval shape or a track shape, and a plurality of through holes are arranged in the nano hydrophobic material area in a vacant or a plurality of through holes. In one embodiment, the nano hydrophobic material region is a gold nano hydrophobic material, which is found in a white rat test, if a nano hydrophilic material is adopted, the nano hydrophobic material can be accumulated in the small intestine and the lung more after passing through blood, while the nano hydrophobic material is adopted in each embodiment of the application, and the nano hydrophobic material can be accumulated in each organ less after passing through blood; and the nano hydrophobic material is gradually discharged out of the body with the passage of time, so that no potential safety hazard is found in animals. Besides the gold nano hydrophobic material, the nano hydrophobic material area can also adopt other existing nano hydrophobic materials to form a contact surface between the hollow fiber structure body and a position to be stopped bleeding; furthermore, bubbles exist in the nano hydrophobic material, so that a saccular hydrophobic layer can be formed, and on one hand, the nano hydrophobic material is favorable for degradation and on the other hand, the nano hydrophobic material is favorable for improving hydrophobic capacity. Further, the nano hydrophobic material area is formed by using a nano hydrophobic material with a contact angle exceeding 120 degrees; further, the nano hydrophobic material area is formed by adopting a nano hydrophobic material with a contact angle of more than 150 degrees; further, the nano hydrophobic material area is formed by using a nano hydrophobic material with a contact angle of more than 150 degrees and a sliding angle of less than 20 degrees; therefore, the hydrophobic membrane has a good hydrophobic effect, and the potential safety hazard is low because the dosage is very small and the hydrophobic membrane can be effectively discharged out of a body. Compared with the traditional slow-release hemostatic gauze sold in the market, the embodiment of the hollow fiber structure body provided with the nano hydrophobic material region on one side facing the protective layer can reduce the blood loss by about 30-80% according to different test conditions and operations by adopting animals such as white mice and rats.

Further, in one embodiment, the hollow fiber structure body of the embodiments of the present application has a plurality of protrusions on a side facing a site to be hemostated; the design of the protruding part enables the slow-release hemostatic gauze to be suitable for various non-planar hemostatic parts, the contact surface is larger, the contact hemostatic effect is better, and the slow-release hemostatic gauze is favorably absorbed. Further, in one embodiment, each of the protrusions is located at a gap between each of the nano hydrophobic material regions. Further, in one embodiment, each of the protrusions occupies 10% to 20% of the total area of one side of the hollow fiber structure body, that is, the area occupied by each of the protrusions is 12% to 18% of the total area of the side thereof. In one embodiment, each of the protrusions occupies 14% to 16% of the total area of one side of the hollow-fiber structural body. In one embodiment, each of the protrusions occupies 14%, 15%, or 16% of the total area of a side of the hollow fiber structural body. Further, in one embodiment, the protruding height of the protruding portion is 2.5% to 10% of the thickness of the hollow fiber structure body. In one embodiment, the protruding height of the protruding portion is 3% to 8% of the thickness of the hollow fiber structure body. In one embodiment, the protrusion height of the protrusion is 3%, 4%, 5%, 6%, 7% or 8% of the thickness of the hollow fiber structure body. The protruding height of the protruding part is not too high, so that the protruding part is beneficial to increasing the contact area and improving the blood coagulation and hemostasis effects on one hand, and is beneficial to increasing the pressure contact force to a certain extent and also beneficial to improving the blood coagulation and hemostasis effects on the other hand, and if the protruding height is too high, the design significance is lost; however, the protruding height of the protruding part is not too low, and the design purpose is difficult to achieve if the protruding height of the protruding part is too low, and in tests, the blood coagulation and hemostasis effect is good when the protruding height of the protruding part is 3% -8% of the thickness of the hollow fiber structure body. Further, in one of the embodiments, the density of the protrusions is less than the density of the hollow fibrous structure body. Therefore, the deformation of the protruding part is larger when pressure is applied, so that the contact area is increased to further improve the blood coagulation and hemostasis effects; theoretical deduction and animal experiments respectively determine that the slow-release hemostatic gauze can be suitable for the operation or the operation of the abdomen, the urinary tract, the breast, the thyroid, the oral cavity, the gynecology and the like, and has better hemostatic effect no matter the operation is normal operation or minimally invasive operation.

In one embodiment, the plurality of protrusions are regularly arranged in a plurality of groups of preset shapes. In one embodiment, the plurality of sets of predetermined shapes have at least one protrusion in common. In one embodiment, the preset shape comprises a straight line shape, a broken line shape, an arc shape, a five-end shape, a six-end shape or a combination thereof; it will be appreciated that the straight line, i.e. the plurality of projections, are arranged in a straight line, and the rest of the shapes are so forth. Further, in one embodiment, a plurality of six-point shapes are adjacently arranged, and two adjacent six-point shapes share two protrusions. Or in one embodiment, a plurality of six-point shapes are arranged adjacently, and two adjacent six-point shapes share two protrusions. The five-end point shapes are adjacently arranged, and two adjacent five-end point shapes share two protruding parts. Further, in one embodiment, the predetermined shape includes a non-complete ring shape formed by multiple arc-shaped intervals, i.e. a ring shape having multiple interruptions. Further, in one embodiment, the predetermined shape includes a combination of a multi-segment arc shape and a multi-segment dogleg shape. Such design is favorable to adapting to internal complex environment on the one hand, is applicable to various non-planar hemostasis positions, makes hollow fiber structure body and internal tissue contact surface are bigger to it is better to produce the hemostatic effect of contact, helps realizing the body fluid infiltration on this basis, and then is favorable to being absorbed of above-mentioned slow release hemostatic gauze, has promoted the internal degradation efficiency of slow release hemostatic gauze promptly.

Further, in one embodiment, the hollow fiber structure body is provided with a sandwich structure of surface layer-flocculent layer-surface layer, that is, the hollow fiber structure body is provided with two surface layers and one flocculent layer, and the flocculent layer is located between the two surface layers; the flocculent layer has the same composition as the surface layer, but has a greater difference in density, i.e. the degree of distribution of the active ingredients, e.g. fibers, of the hollow-fiber structure body in the same volume, which is generally understood as the degree of distribution or density, can be simplified. In one embodiment, the density of the flocculent layer is 20-50% of the density of the surface layer; that is, the mass of the batt layer is 20% to 50% of the mass of the surface layer within the same volume, for example, a hollow fiber structure body volume of 0.125 cubic centimeters. In one embodiment, the density of the batt layer is 20%, 30% or 40% of the density of the top layer. In one embodiment, the thickness of the flocculent layer is 60% -100% of the thickness of the surface layer, or the thickness of the flocculent layer is slightly thinner than the thickness of the surface layer; in one embodiment, the thickness of the batt layer is 70%, 80% or 90% of the thickness of the skin layer. The advantage that sets up the flocculus layer promotes the deformability and the blood-sucking hemostasis ability of hollow fiber structure body, and because the cohesion on flocculus layer and top layer is far less than the connection power of the inside line in slow-release hemostasis gauze especially top layer, consequently can also get rid of the one deck top layer of outside when realizing stanching to greatly reduced remaining surplus in vivo, promoted the in vivo degradation efficiency of slow-release hemostasis gauze. Further, in one of the embodiments, the density of the protrusions is less than the density of the surface layer; in one embodiment, the density of the protruding part is smaller than that of the surface layer and is larger than that of the flocculent layer; alternatively, in one embodiment, the density of the protruding portion is equal to or greater than the density of the flocculent layer. Thus, the strength of the protruding part is smaller than that of the surface layer, so that deformation is easy to occur, and the strength of the protruding part is equal to or greater than that of the flocculent layer, so that the effect of contacting the part to be hemostatic to a certain degree can be ensured. In addition, the design is beneficial to ensuring the flexibility of the protruding part, so that the protruding part is deformed when contacting various non-planar hemostasis parts, thereby having a larger contact surface and further generating better contact hemostasis effect.

Further, in one embodiment, the hollow fiber structure body is sequentially provided with a first surface layer, a flocculent layer and a second surface layer, wherein the first surface layer is used for contacting with an affected part or a position needing hemostasis. In one embodiment, the thickness ratio of the first surface layer, the flocculent layer and the second surface layer is (5-6): 6-10): 4-5. In one embodiment, the thickness ratio of the first skin layer, the batt layer and the second skin layer is 6:8: 4. Typically, the first skin layer has a thickness greater than the thickness of the second skin layer. Thus, the second surface layer can be optionally reserved or removed when necessary, for example, the second surface layer is reserved when hemostasis is needed, and the second surface layer can be removed when the hemostasis is met, even a part of the flocculent layer or even all of the flocculent layer is removed, so that the residual in vivo is greatly reduced, and the in vivo degradation efficiency of the slow-release hemostatic gauze is improved.

Further, in one embodiment, the surface layer of the hollow fiber structure body contacting the affected part or the position needing hemostasis or the first surface layer has a hollow fiber structure, that is, a tubular hollow fiber structure, and the inside of the hollow fiber structure is filled with the coagulation factor. In one embodiment, the hollow fiber structure body further comprises 1-12 parts of a blood coagulation factor by mass. In one embodiment, the hollow fiber structure body further comprises 2-10 parts of a blood coagulation factor by mass. In one embodiment, the hollow fiber structural body further comprises 3, 4, 5, 6, 7, 8 or 9 parts of blood coagulation factors by mass. Coagulation factors are various protein components involved in the blood coagulation process, and their physiological roles are: are activated when the blood vessel bleeds, adhere to the platelets and fill the leak in the blood vessel. This process is called coagulation. The whole coagulation process can be roughly divided into two stages, activation of prothrombin and formation of gelatinous fibrin. Experiments show that the surface layer of the hollow fiber structure body filled with the blood coagulation factors, which is contacted with an affected part or a position needing hemostasis, or the first surface layer is favorable for accelerating the blood coagulation and hemostasis effect. In one embodiment, the blood coagulation factor comprises fibrinogen and prothrombin in a mass ratio of (1-2): 1; in one embodiment, the blood coagulation factors comprise fibrinogen, prothrombin and calcium factors in a mass ratio of (1-2) to 1 (1-2). The blood coagulation factor with the ratio is beneficial to the joint matching of fibrinogen and prothrombin, on one hand, the promotion of the prothrombin is accelerated, on the other hand, the formation rate of gelatinous fibrin is also improved, particularly, the activation of the prothrombin and the formation of the gelatinous fibrin can be well played by matching with a calcium factor, and the blood coagulation and hemostasis effects are favorably accelerated.

Further, in one embodiment, the surface layer of the hollow fiber structure body contacting the affected part or the position needing hemostasis or the first surface layer has a hollow fiber tube structure, that is, a tubular hollow fiber structure, and the inside of the hollow fiber tube structure is filled with a hemostatic auxiliary material micro-body. In one embodiment, the hollow fiber structure body further comprises 1-12 parts of a hemostatic auxiliary material micro-body according to the mass parts. In one embodiment, the hollow fiber structure body further comprises 2-10 parts of a hemostatic auxiliary material micro-body according to the mass parts. In one embodiment, the hollow fiber structure body further comprises 3, 4, 5, 6, 7, 8 or 9 parts of a hemostatic auxiliary material micro-body according to the mass parts. In one embodiment, the hemostatic excipient body comprises a blood coagulation factor; in one embodiment, the hemostatic excipient microsome further comprises fibrin glue microparticles; in one embodiment, the hemostatic excipient micro-body further comprises microporous polysaccharide hemostatic powder; in one embodiment, the hemostatic excipient body further comprises thrombin microparticles. In one embodiment, the hemostatic auxiliary material micro-body comprises fibrin glue particles and blood coagulation factors in a mass ratio of (1-2): 1. In one embodiment, the hemostatic auxiliary material micro-body comprises fibrin glue particles, blood coagulation factors and microporous polysaccharide hemostatic powder in a mass ratio of (1-2) to (1-2). In one embodiment, the hemostatic adjuvant micro-body comprises fibrin glue particles, thrombin particles, blood coagulation factors and microporous polysaccharide hemostatic powder in a mass ratio of (1-2) to (1: 1) (1-2). In the above embodiments, the blood coagulation factor is a powdery particle, and the specific mesh data is set as required. By adopting the design, on one hand, the hemostatic accessory micro-body is ingeniously filled into the hollow fiber tube structure and contacts with a blood source at the first time to generate a blood coagulation and hemostasis effect, on the other hand, the hemostatic accessory micro-body can be protected to a certain extent, the quality guarantee period of a product is prolonged, and the failure is avoided; on the other hand, the hemostatic auxiliary material micro-body is favorable for triggering the rapid activation of an endogenous coagulation system and promoting the generation of thrombin, then under the action of the thrombin, the fibrinogen is accelerated to be hydrolyzed and is reinforced by the fibrin stabilizing factor to form an insoluble fibrin polymer, thereby realizing the effects of hemostasis and tissue adhesion prevention, and being favorable for promoting the healing of a wound surface on the basis.

Further, in one embodiment, the slow release hemostatic gauze further comprises a liquid storage layer, the liquid storage layer is disposed between the hollow fiber structure body and the release layer, that is, the liquid storage layer is connected to the other side surface of the hollow fiber structure body, and the release layer is connected to one side surface of the liquid storage layer away from the hollow fiber structure body; in one embodiment, the reservoir layer is disposed on a surface layer or the second surface layer of the hollow fiber structure body facing away from the affected area or the location requiring hemostasis. In one embodiment, the reservoir layer comprises a supporting structure and a plurality of microcapsules arranged in the supporting structure, the microcapsules storing the wetting fluid therein, the microcapsules being adapted to rupture to release the wetting fluid therein when subjected to a certain pressure. Or in one embodiment, the liquid storage layer comprises a bearing structure and a liquid storage region arranged in the bearing structure, the wall of the liquid storage region facing the protrusions, i.e. facing the hollow fiber structure body, i.e. facing the side surface of the hollow fiber structure body with the protrusions, is provided with a plurality of unidirectional micropores, and the unidirectional micropores are used for being opened unidirectionally when a certain pressure is applied to release the wetting liquid in the liquid storage region. Thus, when the slow release hemostatic gauze is used, one side surface of the hollow fiber structure body with the plurality of protrusions is contacted with an affected part or a position needing hemostasis, a certain pressure is generated on the liquid storage layer at the moment, the liquid storage layer is caused to release a wetting liquid to the hollow fiber structure body, so that the hollow fiber structure body is wetted or partially wetted, and the liquid storage layer is torn off after use, so that the hollow fiber structure body is favorably controlled to be contacted with the affected part more properly, the contact hemostasis effect is favorably improved, the hollow fiber structure body, particularly sodium carboxymethyl cellulose, alginate fibers and chitin fibers in the hollow fiber structure body rapidly absorb blood in a wetted or slightly wetted state to realize swelling and dissolution, a cover can be formed with blood clots, and the wound surface is protected, and the liquid storage layer is thrown away after being used up, does not remain in the body, thereby avoiding degradation problems; on the other hand, the slow-release hemostatic gauze adopts a dry-wet separation design, so that the shelf life of the slow-release hemostatic gauze is greatly prolonged. Further, in one embodiment, the carrying structure of the reservoir layer is of the same composition as the hollow fiber structure body. Therefore, the production process of the liquid storage layer is simplified, the production efficiency is improved, and the production and manufacturing cost is reduced.

Further, in one embodiment, the wetting fluid comprises an ethanol solution with a volume concentration of 75-90% and an additive. It is generally preferred that the ethanol solution is not too high, in excess of 92% or even 95%, which may affect the body of the hollow fiber structure having oxidized regenerated cellulose and/or oxidized regenerated cellulose sodium salt. The ethanol solution has a bactericidal effect on the one hand and a moistening effect on the other hand. In one embodiment, the mass ratio of the ethanol solution to the additive is (20-30): 1-2. In one embodiment, the additive comprises at least one of disodium hydrogen phosphate, sodium hyaluronate, polyethylene glycol, amino acid, nano silver particles and dimethicone; in one embodiment, the additive is disodium hydrogen phosphate, sodium hyaluronate, polyethylene glycol, amino acid, nano silver particles or dimethicone; in one embodiment, the additive comprises sodium hyaluronate and amino acid in a mass ratio of 1: 1. In one embodiment, the additive comprises amino acid and nano silver particles in a mass ratio of (35-80): (1-3); the nano silver particles have good anti-inflammatory effect, and the amino acid is beneficial to supplement and repair and improves the healing speed. In one embodiment, the additive comprises amino acid and nano silver particles in a mass ratio of 40: 1; in one embodiment, the additive comprises disodium hydrogen phosphate, sodium hyaluronate, polyethylene glycol, amino acid, nano silver particles and dimethyl silicone oil in a mass ratio of (50-100): 20-60): 150-400: (35-80): 1-3): 50-150. In one embodiment, the additive comprises disodium hydrogen phosphate, sodium hyaluronate, polyethylene glycol, amino acid, nano silver particles and dimethicone at a mass ratio of 60:20:200:40:1: 100. In one embodiment, the amino acid comprises at least one of threonine, valine, and tryptophan; in one embodiment, the amino acid is threonine, valine, or tryptophan; in one embodiment, the amino acids include threonine, valine, and tryptophan in a mass ratio of 2:1: 1. The amino acid compositions and proportions of the above embodiments are derived from three selected essential amino acids for human body, and are particularly suitable for matching with the rest components of the additive to realize moistening and repairing effects.

Some examples are given below and experimental comparisons are made; it can be understood that due to capital and resource limitations, it is difficult to perform experimental comparison on all the examples of the present application one by one; in order to save the life resources of the test animals, it is also difficult to perform animal experiments in every direction for verification, so the following only uses some examples to perform experimental comparison to verify the related technical effects of the present application.

Example 1, a slow release hemostatic gauze comprising a hollow fiber structure body; the hollow fiber structure body is soluble gauze and comprises sodium carboxymethyl cellulose; a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. Wherein, the coating layer comprises chitosan, and the anti-inflammatory particles comprise sulfonamides.

Embodiment 2, a slow release hemostatic gauze comprising a hollow fiber structure body; the hollow fiber structure body is soluble gauze and comprises 210 parts of sodium carboxymethylcellulose and 21 parts of chitin fibers by mass; the hollow fiber structure body is internally provided with a plurality of cavities, each cavity is provided with different thickness positions in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. The coating layer comprises modified starch, and the anti-inflammatory particles comprise quinolone drugs and cellulase in a mass ratio of 10: 1-20: 1.

Example 3, a slow release hemostatic gauze comprising a hollow fiber structure body; the hollow fiber structure body is soluble gauze, just the hollow fiber structure body includes according to the part by mass: 200 parts of sodium carboxymethylcellulose, 52 parts of alginate fibers and 24 parts of chitin fibers; the hollow fiber structure body is internally provided with a plurality of cavities, each cavity is filled with a slow-release anti-inflammatory body, each slow-release anti-inflammatory body is divided into two slow-release anti-inflammatory body groups, and the thicknesses of wrapping layers of the two slow-release anti-inflammatory body groups are different; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. Wherein the wrapping layer comprises alginate fibers, and the anti-inflammatory particles are phosphatidylserine.

Example 4, a slow release hemostatic gauze comprising a hollow fiber structure body; the hollow fiber structure body is soluble gauze, just the hollow fiber structure body includes according to the part by mass: 240 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 50 parts of oxidized regenerated cellulose sodium salt, 6 parts of hydrophobic amino acid, 5 parts of sodium hyaluronate, 13 parts of sodium alginate, 45 parts of alginate fiber and 22 parts of chitin fiber; wherein the hydrophobic amino acid comprises tyrosine, valine, tryptophan, phenylalanine and isoleucine in a mass ratio of 1:1:1:1: 2; a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. The coating layer comprises chitosan and alginate fibers in a mass ratio of 1:1, the chitosan is chitin with more than 80% of N-acetyl removed, and the anti-inflammatory particles comprise quinolone medicines and phosphatidylserine in a mass ratio of 12: 1.

Example 5, a slow release hemostatic gauze comprising a hollow fiber structure body; the hollow fiber structure body is soluble gauze, just the hollow fiber structure body includes according to the part by mass: 300 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 5 parts of hydrophobic amino acid, 55 parts of alginate fiber and 25 parts of chitin fiber, wherein the hydrophobic amino acid comprises valine and tryptophan in a mass ratio of 1: 1; a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. The anti-inflammatory particles comprise sulfonamides, povidone iodine and phosphatidylserine in a mass ratio of 10:2: 1.

Example 6, a slow release hemostatic gauze comprising a hollow fiber structure body; the hollow fiber structure body is soluble gauze and comprises 230 parts of sodium carboxymethylcellulose and 46 parts of alginate fibers in parts by mass; the surface layer of the hollow fiber structure body, which is in contact with an affected part or a position needing hemostasis, is provided with a hollow fiber tube structure, a coagulation factor is filled in the hollow fiber tube structure, the hollow fiber structure body further comprises 1-12 parts of the coagulation factor according to parts by mass, and the coagulation factor comprises fibrinogen and prothrombin with the mass ratio of (1-2): 1; a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. The anti-inflammatory particles comprise sulfonamides, quinolones, povidone iodine and phosphatidylserine in a mass ratio of 12:10:2: 1.

Comparative example 1: some absorbable and soluble hemostatic gauze is commercially available.

Comparative example 2: a slow release hemostatic gauze comprises a hollow fiber structure body; the hollow fiber structure body is soluble gauze, just the hollow fiber structure body includes according to the part by mass: 300 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 5 parts of hydrophobic amino acid, 55 parts of alginate fiber and 25 parts of chitin fiber, wherein the hydrophobic amino acid comprises valine and tryptophan in a mass ratio of 1: 1; a plurality of cavities are arranged in the hollow fiber structure body, and an anti-inflammatory body is filled in each cavity; the anti-inflammatory body is an anti-inflammatory particle which comprises sulfonamide, povidone iodine and phosphatidylserine in a mass ratio of 10:2: 1. This comparative example is similar to example 5 except that the wrapping layer was removed.

Comparative example 3: a slow release hemostatic gauze comprises a hollow fiber structure body; the hollow fiber structure body is soluble gauze, just the hollow fiber structure body includes according to the part by mass: 300 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 5 parts of hydrophobic amino acid, 55 parts of alginate fiber and 25 parts of chitin fiber, wherein the hydrophobic amino acid comprises valine and tryptophan in a mass ratio of 1: 1; a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is attached to the outside of each cavity; the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a coating layer. The anti-inflammatory particles comprise sulfonamides, povidone iodine and phosphatidylserine in a mass ratio of 10:2: 1. This comparative example is similar to example 5 except that the wrapping is placed outside the cavity.

Comparative example 4: a slow release hemostatic gauze comprises a hollow fiber structure body; the hollow fiber structure body is soluble gauze, just the hollow fiber structure body includes according to the part by mass: 300 parts of sodium carboxymethylcellulose, 150 parts of oxidized regenerated cellulose, 5 parts of hydrophobic amino acid, 55 parts of alginate fiber and 25 parts of chitin fiber, wherein the hydrophobic amino acid comprises valine and tryptophan in a mass ratio of 1: 1; a plurality of cavities are arranged in the hollow fiber structure body, and an anti-inflammatory body is attached to the outside of each cavity; the anti-inflammatory body is an anti-inflammatory microparticle. This comparative example is similar to example 5 except that the anti-inflammatory body is not provided with a coating and is disposed outside the cavity.

The cytotoxicity test was carried out by using examples 1 to 6 and comparative examples 1 to 4, and the specific procedures were as follows:

preparing a slow-release hemostatic gauze leaching solution: after the slow release hemostatic gauze in examples 1 to 6 and the hemostatic gauze in comparative examples 1 to 4 are respectively saturated in DMEM medium which absorbs 10% fetal bovine serum, leaching at 0.1g/mL for 24 hours at 37 ℃, and respectively taking the obtained leaching liquor as a test sample; wherein the DMEM medium is a culture medium containing various amino acids and glucose, can be self-made or purchased externally, and can be a high-sugar type or a low-sugar type.

Preparing cells: the frozen mouse fibroblast (L929) is recovered and transferred to 2 generations, and then 1X 10 cells are prepared⁴The cell suspension/mL was added to a 96-well plate at 200. mu.L per well, and the plate was incubated at 37 ℃ in a 5% carbon dioxide incubator for 24 hours.

Sample adding and culturing: the cultured mouse fibroblasts were discarded from the original culture solution, and the dead cells were washed away with PBS (phosphate buffered saline), and 200. mu.L of the test article was added to each well, and at least 6 wells of the test articles of the control example and each example were added to each well, and the resulting mixture was placed in a 5% carbon dioxide incubator at 37 ℃ and cultured for 24 hours.

And (3) detection: and (3) detecting cytotoxicity of each test sample by adopting an MTT colorimetric method. MTT colorimetry is a method of detecting cell survival and growth. The detection principle is that succinate dehydrogenase in mitochondria of living cells can reduce exogenous MTT into water-insoluble blue-purple crystalline Formazan (Formazan) and deposit the blue-purple crystalline Formazan in the cells, and dead cells do not have the function. Dimethyl sulfoxide (DMSO) can dissolve formazan in cells, and its light absorption value is measured at 490nm wavelength by enzyme linked immunosorbent detector, which can indirectly reflect living cell number. Within a certain range of cell number, MTT crystals are formed in an amount proportional to the cell number. The relative cell proliferation rate RGR was calculated as (test OD value/control OD value) × 100% by measuring the Optical Density (OD) value by MTT colorimetry. The results of the measurements are shown in Table 1 below.

TABLE 1

As can be seen from table 1 above, the slow-release hemostatic gauze of examples 1 to 6 and the hemostatic gauze of comparative examples 1 to 4 are non-toxic and have a certain cell proliferation promoting effect, and the cell proliferation promoting effect of the slow-release hemostatic gauze of example 2 is better than that of the other examples and comparative examples 1 to 4.

The dissolution test is carried out by adopting examples 1 to 6 and comparative examples 1 to 4, and the specific operation steps are as follows: the slow release hemostatic gauze of examples 1 to 6 and the hemostatic gauze of the control example were placed in a rotating basket, the rotating speed was adjusted to 100r/min, the gauze was placed in 900mL of degassed hydrochloric acid solution which was kept at a constant temperature of (37. + -. 0.5) DEG C, 10mL of the degassed hydrochloric acid solution was sampled at 0.25, 0.5, 1, 2, 3, 4, and 7d, and 10mL of blank medium was added immediately after sampling. The samples were filtered and 5mL of filtrate was measured accurately, diluted to 100mL with hydrochloric acid, the a value was measured at 293nm, the drug concentration was calculated using the regression equation and the average cumulative percent dissolution over time was calculated as shown in table 2 below.

TABLE 2

As can be seen from table 2 above, the slow release hemostatic gauze of examples 1 to 6 and the hemostatic gauze of comparative examples 2 and 3 both require a certain time to dissolve out, and have a slow release effect. And the dissolution rate of the hemostatic gauze of examples 1 to 6 was significantly lower than that of the hemostatic gauze of comparative examples 1 to 4. The hollow fiber structure body of the slow release hemostatic gauze of embodiments 5 and 6 is provided with a plurality of cavities to help reduce the dissolution rate, and meanwhile, the hemostatic gauze is provided with the anti-inflammatory particles of the wrapping layer to help reduce the dissolution rate.

The hemostasis time detection is carried out by adopting the embodiments 1 to 6 and the comparison example 1, and the specific operation steps are as follows: the slow release hemostatic gauze of examples 1 to 6 and the hemostatic gauze of control example 1 were respectively selected to have a size of 2cm × 2cm, the experimental subjects were healthy male New Zealand pure white rabbits 21 were divided into 7 groups, the weight range was 2.5 ± 0.25kg, 3% sodium pentobarbital solution was slowly injected for auricular vein disinfection, and the experiment was performed after complete anesthesia; the hemostasis part is the central aorta of the ear, and is disinfected by iodophor, and then a surgical knife is used as a wound surface of 1cm multiplied by 1cm, so as to form a bleeding ulcer wound surface with 1cm multiplied by 1cm full-thickness skin defect (1 per side of each new zealand pure white rabbit); the hemostatic gauze of examples 1 to 6 and comparative example 1, each having a size of 2cm × 2cm, was rapidly applied to a bleeding wound surface and the bleeding from the wound surface was intermittently cleaned with a common sterile gauze, and examples 1 to 6 and comparative example 1 were each assigned to 7 groups of 3 rabbits each. The hemostatic effect was then observed and the hemostatic time was recorded, averaged for each group and the hemostatic time test results are shown in table 3 below.

Test group

Example 1

Example 2

Example 3

Example 4

Example 5

Example 6

Comparative example 1

Mean hemostasis time per second

210±7

196±11

184±10

189±9

182±8

168±6

256±8

TABLE 3

As can be seen from table 3 above, the slow-release hemostatic gauze of examples 1 to 6 and the hemostatic gauze of comparative example 1 both have better hemostatic effects, and the slow-release hemostatic gauze of examples 1 to 6 is better than the hemostatic gauze of comparative example 1, and the slow-release hemostatic gauze of example 6 has the shortest mean hemostatic time due to the effect of blood coagulation factors, which is helpful for reducing bleeding amount and blood absorption amount of the slow-release hemostatic gauze.

The degradation time detection is carried out by adopting the embodiments 1 to 6 and the comparative example 1, and the specific operation steps are as follows: the slow release hemostatic gauze of examples 1 to 6 and the hemostatic gauze of control example 1 were respectively measured to have a size of 1cm × 2cm, the experimental subjects were healthy male New Zealand pure white rabbits 21 were divided into 7 groups, the weight range was 2.5 ± 0.25kg, 3% sodium pentobarbital solution was slowly injected for auricular vein disinfection, and the experiment was performed after complete anesthesia; disinfecting the position of the patient close to the femoral vein by adopting iodophor, and then making a 1cm wound by using a scalpel; the hemostatic gauze of examples 1 to 6 and comparative example 1, which were 1cm × 2cm, respectively, were quickly inserted into the wound and the wound was cleansed of exuded blood using a general sterilized gauze and then sutured, and examples 1 to 6 and comparative example 1 were assigned to 7 groups of 3 rabbits each. Then, the wound was observed and the anti-inflammatory effect was tested by blood test at 120 hours after the operation, the stitches were removed at 168 hours after the operation, the remaining amount of each of the slow-release hemostatic gauze of examples 1 to 6 was measured and recorded and averaged, and the remaining amount of the hemostatic gauze of comparative example 1 was measured and recorded and averaged, and the test results of the degradation time were as shown in table 4 below.

TABLE 4

As can be seen from table 4 above, the degradation rate and the degradation time reflected by the slow-release hemostatic gauze described in examples 1 to 6 are significantly better than those of the hemostatic gauze of the comparative example 1, and the degradation rate of the slow-release hemostatic gauze described in example 2 is significantly fastest, i.e., the degradation time after the degrading enzyme is effective is significantly better than that of the comparative example 1 and other examples. The slow release hemostatic gauze described in example 6 also degraded relatively quickly. In addition, in examples 1 to 6 and comparative example 1, no adverse reactions such as rejection or xenogenesis were observed. Furthermore, blood was drawn in the middle stage of degradation to test the presence of an anti-inflammatory component in blood, and it was found that examples 1 to 6 all have an anti-inflammatory component, and thus it was confirmed that they have a sustained-release anti-inflammatory effect.

Further, the degradation time of examples 1 to 6 and comparative example 1 was measured by using a simulated body fluid system, which uses SBF simulated body fluid or co-formulated simulated body fluid of jiekang biotechnology limited, and the measurement results are shown in table 5 below.

Test group

Example 1

Example 2

Example 3

Example 4

Example 5

Example 6

Comparative example 1

Degradation time/day

8.6±0.2

6.6±0.4

8.0±0.5

7.9±0.2

7.8±0.3

7.1±0.3

9.7±0.5

TABLE 5

As can be seen from table 5 above, the degradation time of the slow release hemostatic gauze in examples 1 to 6 is significantly better than that of the hemostatic gauze in comparative example 1, the degradation speed of the slow release hemostatic gauze in example 2 is significantly fastest, and the degradation speed of the slow release hemostatic gauze in example 6 is relatively fast.

Other embodiments of the present application further include a slow release hemostatic gauze formed by combining the technical features of the above embodiments.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A slow-release hemostatic gauze is characterized by comprising a hollow fiber structure body;

the hollow fiber structure body is soluble gauze and comprises sodium carboxymethyl cellulose;

a plurality of cavities are arranged in the hollow fiber structure body, and a slow-release anti-inflammatory body is filled in each cavity;

the slow-release anti-inflammatory body is an anti-inflammatory microparticle with a wrapping layer;

the hollow fiber structure body is provided with two surface layers and a flocculent layer, and the flocculent layer is positioned between the two surface layers; the components of the flocculent layer are the same as those of the surface layer, and the density of the flocculent layer is 20% -50% of that of the surface layer;

each sustained-release anti-inflammatory body is divided into N sustained-release anti-inflammatory body groups, the thicknesses of wrapping layers of the N sustained-release anti-inflammatory body groups are different and form an increasing series, N is a natural number greater than 1, and the sustained-release time of the Nth sustained-release anti-inflammatory body group in the increasing series is the complete degradation time of the hollow fiber structure body.

2. The slow release hemostatic gauze of claim 1, wherein the coating comprises chitosan or alginate fibers.

3. The slow release hemostatic gauze of claim 1, wherein the coating comprises chitosan and alginate fibers.

4. The slow-release hemostatic gauze according to claim 3, wherein the coating layer comprises chitosan and alginate fibers in a mass ratio of 1: 1-1: 4.

5. The slow release hemostatic gauze of claim 1, wherein the coating comprises modified starch.

6. The slow release hemostatic gauze of claim 1, wherein the anti-inflammatory particles comprise a sulfonamide.

7. The slow release hemostatic gauze of claim 1, wherein the anti-inflammatory particles are selected from one or more of quinolone drugs, povidone iodine, phosphatidylserine, and degradative enzymes.

8. The slow release hemostatic gauze of claim 1, wherein the hollow fiber structure body further comprises one or more of chitin fibers, alginate fibers, oxidized regenerated cellulose sodium salt, hydrophobic amino acids, sodium hyaluronate, and sodium alginate.

9. The slow release hemostatic gauze of claim 8, wherein the hydrophobic amino acid comprises one or more of tyrosine, valine, tryptophan, phenylalanine, leucine, and isoleucine.

10. The slow release hemostatic gauze of claim 9, wherein the hydrophobic amino acids comprise tyrosine, valine, tryptophan, phenylalanine, and leucine in a mass ratio of 1:1:1:1: 2.