CN113975452A - Kaolin hemostatic composition, hemostatic dressing containing kaolin hemostatic composition and preparation method of kaolin hemostatic dressing - Google Patents
Kaolin hemostatic composition, hemostatic dressing containing kaolin hemostatic composition and preparation method of kaolin hemostatic dressing Download PDFInfo
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/0005—Ingredients of undetermined constitution or reaction products thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/40—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/44—Medicaments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/0047—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L24/0052—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with an inorganic matrix
- A61L24/0068—Inorganic materials not covered by groups A61L24/0057 or A61L24/0063
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/30—Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
Abstract
The invention relates to a kaolin hemostatic material composition, which comprises kaolin and one or two selected from calcium oxide and puffball powder; the invention also relates to a kaolin hemostatic dressing using the composition and a preparation method of the hemostatic dressing. The components of the hemostatic material composition provided by the invention have synergistic hemostatic effect, so that the hemostatic time is obviously shortened; the prepared kaolin hemostatic dressing can be combined with more hemostatic materials by the provided preparation method, and is not easy to fall off, so that adverse effects caused by falling of the hemostatic materials in the use process are avoided.
Description
Technical Field
The invention belongs to the technical field of biomedical materials, and particularly relates to a kaolin hemostatic composition, a hemostatic dressing containing the kaolin hemostatic composition and a preparation method of the hemostatic dressing.
Background
In battlefield, uncontrolled hemorrhage of large blood vessels and extensive bleeding of wounded tissues are one of the important causes of death of wounded. From statistics of time to death, the death accounted for about 55% within 30 minutes after bleeding from injury. Therefore, the bleeding after injury is within 1h, which is a gold rescue period, and if the bleeding can be effectively controlled in the period, the method has very important significance for reducing the casualties in battlefields and saving the lives of the wounded.
In life, people can also suffer from natural disasters such as earthquake, flood, hurricane, torrential rain and the like to cause casualties. In addition, the accident bleeding caused by accidents of people in traffic, exploration, outdoor activities and the like also exists. Timely and effective hemostasis can strive for precious rescue time for the patient to save life.
A rapid hemostatic material, Combat Gauze (Kaolin battle wound Gauze), was developed by Z-medical corporation in 2006 and used for bleeding victims who are not suitable for tourniquets or who are expected to have an evacuation time exceeding 2 hours.
The kaolin plays a role in hemostasis mainly by activating an intrinsic blood coagulation path, the hemostasis function depends on the amount of a human body blood coagulation factor and the blood coagulation function of the human body, when the blood loss of the human body is excessive, the body temperature can be reduced, potential complications such as blood coagulation dysfunction can be caused, and at the moment, the kaolin is applied to hemostasis, so that the hemostasis function of the kaolin is greatly reduced.
The proper temperature increase can improve the activity of enzyme, promote enzymatic reaction and accelerate blood coagulation. The zeolite material has an exothermic effect and is approved for emergency treatment of severe bleeding wounds due to its fast hemostatic speed and non-biotoxicity. However, the exothermic effect of the zeolite material is severe and studies have reported that the local temperature can rise to 90 ℃.
Puffball is a common Chinese herbal medicine which is commonly used as a traumatic hemostatic in rural areas, especially in mountain areas. The puffball stores a great amount of microporous fibers, can quickly absorb moisture in blood, can mechanically block vascular lacerations and capillary blood seepage, and simultaneously, the physical barrier can isolate wounds to play a role in stopping bleeding immediately.
201310349837.2 discloses a topical hemostatic dressing containing Lasiosphaera Seu Calvatia, which is prepared by beating Lasiosphaera Seu Calvatia powder on a substrate or soaking Lasiosphaera Seu Calvatia slurry in the substrate by wet method to make medical sponge or nonwoven fabric have micropores or filled with pulverized Lasiosphaera Seu Calvatia between layers. However, the hemostatic dressing obtained by the method has single hemostatic component, and puffball powder is very weak in attachment and very easy to fall off, so that the hemostatic effect is reduced.
In order to solve the technical problems, the invention provides a kaolin hemostatic material composition with rapid hemostasis, which takes kaolin as a main active ingredient and calcium oxide and/or puffball powder as auxiliary ingredients, and the components have synergistic action, so that the hemostatic composition has rapid hemostasis.
Disclosure of Invention
The technical scheme provided by the invention is as follows:
a kaolin hemostatic material composition comprising kaolin and one or both of calcium oxide (CaO) and puffball powder.
The weight ratio of the kaolin to the calcium oxide is 10: 0.5-2.
The weight ratio of the kaolin to the puffball powder is 10: 1-3.
The weight ratio of the kaolin to the calcium oxide to the puffball powder is 10: 0.5-2: 1-3, preferably 10: 0.8-1.8: 1.5-2.5, and most preferably 10: 1: 2.
The kaolin is washed kaolin, and the specific surface area of the kaolin is 200m2/g～500m2/g。
The calcium oxide is powder or granular, and the particle size is smaller than 100 meshes.
In the hemostatic material composition, calcium oxide is an exothermic material, and when the calcium oxide is in contact with blood, the calcium oxide releases heat and plays a role in regulating temperature.
The puffball powder is peeled puffball powder, and the particle size of the puffball powder is 1-10 mu m.
The invention further relates to a kaolin hemostatic dressing comprising a non-woven substrate and a hemostatic material composition according to the invention.
The nonwoven fabric substrate of the present invention may be selected from any suitable material, such as a nonwoven fabric made from fibers of cotton, viscose, silk, wool, rayon, chitosan fibers, chitin fibers, lyocell, polypropylene, polyester, polyethylene, and the like, or mixtures thereof.
When the base material comprises chitosan fibers, the content of chitosan is 50% -100%, and the deacetylation degree is 60% -90%.
The weight ratio of kaolin on the hemostatic dressing is 5-30%, the weight ratio of calcium oxide is 0-6%, and the weight ratio of puffball powder is 0-9%, and the hemostatic dressing is based on a non-woven fabric base material.
The hemostatic dressing of the invention has an average hemostatic time within 77s in hemostatic applications.
The kaolin hemostatic dressing according to the invention can be prepared by the following hot rolling method:
1) laying down the fibres used to make the non-woven fabric, scattering the haemostatic material composition and optionally the binder;
2) repeating the operation of step 1) one or more times as required;
3) and (4) performing hot rolling to form the composite kaolin hemostatic dressing.
Wherein the components of the hemostatic material composition may be applied simultaneously or in steps in any order, and then repeated as desired; the components of the hemostatic material composition applied in each layer may be the same as in the previous step or may be different, for example: one layer of kaolin, one layer of calcium oxide and/or puffball, another layer of kaolin, and then another layer of calcium oxide and/or puffball.
The fibers may be any suitable fibers for making nonwoven fabrics, such as polypropylene, polyester, polyethylene, cotton, viscose, silk, wool, rayon, lyocell, and the like, or mixtures thereof.
Wherein the polypropylene, polyester and polyethylene fibers are hot melt fibers.
Wherein, in the case that the fiber for preparing the non-woven fabric contains the hot-melt fiber, the adhesive is optionally added, and the hemostatic material is fixed by the hot-melt fiber during the hot rolling. In the case where the fibers used to make the nonwoven fabric do not contain hot melt fibers, then an adhesive is added to fixedly bond the hemostatic material.
The adhesive is hot melt adhesive, such as ethylene-vinyl acetate copolymer, ethylene-ethyl acrylate copolymer, polycaprolactone, polyamide, polyurethane, polyester, polyethylene or any combination of the above components, the dosage is 10-30%, and the adhesive is based on non-woven fabric substrate fibers.
In the obtained hemostatic dressing, based on the weight of the non-woven fabric base material fiber, the weight ratio of the kaolin is 5-30%, the weight ratio of the calcium oxide is 0-6%, and the weight ratio of the puffball powder is 0-9%.
The kaolin hemostatic dressing prepared by the hot rolling method can be combined with more hemostatic materials, so that the product has a good hemostatic effect in terms of the dosage of the hemostatic materials, and the hemostatic composition has strong binding force with the base material non-woven fabric, is not easy to fall off in the process of contacting with a wound, and avoids embolism caused by the hemostatic material particles entering blood vessels.
The kaolin hemostatic dressing according to the invention can also be prepared by the following method:
the hemostatic material composition and the adhesive are prepared into a suspension by absolute ethyl alcohol, and then the suspension is coated on a non-woven fabric substrate, wherein the weight-volume ratio of the hemostatic material composition to the absolute ethyl alcohol is 1: 25-45.
Wherein the non-woven fabric may be a non-woven fabric made of a material selected from the group consisting of polypropylene, polyester, polyethylene, cotton, viscose, silk, wool, rayon, lyocell, chitin, chitosan, or a mixture thereof.
The adhesive can be selected from polyvinyl alcohol, glycerol, polyethylene glycol, sodium carboxymethylcellulose, sodium alginate, calcium alginate, polyvinylpyrrolidone or any combination of the above components, the dosage is 10-30%, and the adhesive is based on a non-woven fabric base material.
In the obtained hemostatic dressing, based on the weight of the non-woven fabric base material fiber, the weight ratio of the kaolin is 5-30%, the weight ratio of the calcium oxide is 0-6%, and the weight ratio of the puffball powder is 0-9%.
The hemostatic dressing composition of the present invention contains CaO, which generates calcium hydroxide (Ca (OH) in water (blood)2) The heat is released, when the hemostasis is carried out on the wound surface, especially under the conditions of body temperature reduction caused by more blood loss and the reduction of the blood coagulation function of a human body, the temperature of the bleeding part can be properly increased, and the rapid hemostasis is facilitated. In addition, the generated calcium ion is one of the thirteen coagulation factors, is an activator of a plurality of prothrombin, can convert the prothrombin into thrombin and promote blood coagulation.
Kaolin and puffball powder have different hemostasis mechanisms, the Kaolin plays a role in hemostasis mainly by activating an intrinsic blood coagulation path, and the puffball powder plays a role in hemostasis mainly by rapidly absorbing water in blood, mechanically blocking blood vessel lacerations, capillary blood seepage and the like. The kaolin and the puffball powder are combined according to a certain proportion, so that the hemostatic effect of the product is obviously improved. In addition, puffball powder has strong bacteriostasis and can inhibit bacterial infection to a certain extent.
The invention has the following beneficial effects:
(1) the components of the hemostatic material composition have synergistic hemostatic effect, can realize hemostasis within 45s at the fastest speed, obviously shortens the hemostatic time, and has excellent hemostatic effect.
(2) The hemostatic material composition can activate an endogenous coagulation path, can independently play a hemostatic role without depending on a self coagulation path, and can inhibit bacterial infection of wounds to a certain extent while remarkably improving the hemostatic effect.
(3) The heat-release material CaO contained in the hemostatic material composition can properly increase the temperature of a bleeding part, improve the hemostatic effect of the hemostatic material and accelerate hemostasis when the body temperature is reduced due to excessive blood loss; in addition, the introduction of calcium ions is beneficial to promoting blood coagulation and improving the hemostatic effect.
(4) The hemostatic dressing is a multilayer composite kaolin bandage prepared by hot rolling the non-woven fabric and the hemostatic material composition, the hemostatic material has strong adhesion, and adverse effects caused by falling of the hemostatic material in the use process are avoided.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in detail and fully below by examples.
The kaolin used in the hemostatic material composition of the embodiment of the invention has a specific surface area of 350m2The particle size of calcium oxide is 400 meshes, and the puffball powder is peeled puffball powder with the particle size of 7 mu m.
Examples 1 to 14:
the fibers used to prepare the nonwoven fabric consisted of cotton fibers, to which a hemostatic material composition of different composition according to the invention and 10g/m were added after the fiber was laid2The adhesive polycaprolactone is reinforced by a hot rolling process, then cut into pieces with the size of 7.5cm multiplied by 1m, folded in a Z shape, packaged and sterilized to obtain a finished product. The amounts of the components added are shown in Table 1.
Examples 15 to 17:
the fiber for preparing the non-woven fabric consists of cotton fiber and polyethylene fiber (the weight ratio is 75: 25), the hemostatic material composition is added after the fiber is lapped, the fiber is reinforced by a hot rolling process, and then the fiber is cut into pieces with the size of 7.5cm multiplied by 1m, folded in a Z shape, packaged and sterilized to obtain the finished product. The amounts of the components added are shown in Table 1.
Examples 18 to 20:
weighing 1g of polyvinylpyrrolidone, adding 30ml of absolute ethyl alcohol, stirring to dissolve, adding the hemostatic material composition to prepare uniform suspension. Taking the gram weight as 60g/m2Uniformly coating the hemostatic material suspension on a 7.5cm × 1m cotton fiber non-woven fabric, drying by blowing at 70 deg.C, folding in zigzag, packaging, and sterilizing to obtain the final product. The amounts of the components added are shown in Table 1.
TABLE 1
Comparative examples 1 to 7
In comparative examples 1, 4 and 5, only the addition was made after the nonwoven fiber was laidKaolin and 10g/m2The binder polycaprolactone of (1), in comparative examples 2 and 3, kaolin and calcium oxide were added, but the amount of calcium oxide used was outside the scope of the present invention, and in comparative examples 6 and 7 only puffball powder and 10g/m were added2The adhesive polycaprolactone is reinforced by a hot rolling process without adding calcium oxide, is cut into pieces with the size of 7.5cm multiplied by 1m, is folded in a Z shape, is packaged and is sterilized, and the hemostatic dressing is prepared. The amounts of the components added are shown in Table 2.
TABLE 2
Examples of Effect test
Study on femoral artery hemostatic effect of rabbits
(1) Test products: the kaolin hemostatic dressing prepared in examples 1-20;
comparison products: hemostatic dressings prepared according to comparative examples 1-7.
(2) Animals and materials: 162 rabbits for experiment, 81 rabbits for male and female respectively, and 2.0-3.0 kg of body weight; the groups were randomized into 27 groups of 6 individuals.
(3) The method comprises the following steps: the tests were divided into 27 groups, with groups 1 to 20 for the kaolin hemostatic dressings prepared in examples 1 to 20 and groups 21 to 27 for the hemostatic dressings prepared in comparative examples 1 to 7.
Constructing a test model by using an experimental rabbit, wherein the normal body temperature of the rabbit is 38.8-39.2 ℃, 3% sodium pentobarbital is subjected to intravenous injection anesthesia (1.5 mL/kg), the left femoral artery is separated on a supine dissection table, a 10mL injector is used for puncturing the arterial blood vessel, after jet bleeding occurs, a hemostatic dressing is immediately used at the wound, the index finger and the middle finger are closed together to press and stop bleeding, a stopwatch is used for timing, the hemostatic condition is observed by slightly loosening the hand after 45s, if no active bleeding exists, hemostasis is defined, and the time is recorded; if bleeding still occurs, continuing to press, observing once every 10s, and judging as hemostasis failure if hemostasis does not occur for more than 300 s; the hemostasis time was recorded for each of the 6 animals in each group, and the mean hemostasis time was calculated and the maximum temperature during hemostasis was recorded, and the results are shown in table 3.
TABLE 3
As can be seen from table 3, the calcium oxide is added to the hemostatic dressings prepared in examples 1 to 5, and the average hemostatic time for femoral artery hemorrhage of the rabbits is within 75s, while the hemostatic dressing prepared in comparative example 1 only contains kaolin, and the addition amount of the kaolin is the same as that of the hemostatic dressings prepared in examples 3 to 5, but the hemostatic time is greatly different, namely 174s, which indicates that the hemostatic effect of the product is improved by the addition of the calcium oxide.
In comparative examples 2 and 3, the addition amount of calcium oxide is adjusted, and the experimental result shows that when the addition amount of calcium oxide is less, the heat release is not obvious, and the hemostasis time is longer; when the calcium oxide is added too much, the temperature of the bleeding part is raised too high, the hemostasis time is relatively long, and the analysis reason is probably that the blood circulation is accelerated due to the overhigh temperature, and the thrombin activity in the blood is obviously reduced, so that the hemostasis is not facilitated.
The mean hemostatic time of the hemostatic dressings prepared in comparative examples 4 and 5 containing only kaolin was 145s and 127s, respectively, the mean hemostatic dressings prepared in comparative examples 6 and 7 containing only puffball powder were 240s and 215s, respectively, and the change of the hemostatic time was insignificant when the content of kaolin or puffball powder was increased, whereas the mean hemostatic dressings prepared in examples 6 to 9 containing a combination of kaolin and puffball powder had a mean hemostatic time within 77s, which significantly improved the hemostatic rate.
The hemostatic dressing prepared in the embodiment 10-13 obviously shortens the hemostatic time of femoral artery hemorrhage of the rabbit, and can complete hemostasis within 45s, which shows that the hemostatic effect is obviously improved by the combination of kaolin, puffball powder and calcium oxide.
In addition, the experimental results show that when the kaolin hemostatic dressing is prepared by a hot rolling method, the hemostatic effect of the product is not affected no matter the adhesive or the hot-melt fiber is adopted to fix the hemostatic material.
The kaolin hemostatic dressing prepared by the hot rolling method has a slightly better hemostatic effect than the kaolin hemostatic dressing prepared by the coating method, but the difference is small, so that the interaction relationship of the components in the hemostatic material composition is the key for influencing the hemostatic effect of the product. For subtle differences in effect, it is speculated that it should be correlated with the adhesion strength of the hemostatic dressing.
The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (10)
1. A kaolin hemostatic material composition comprises kaolin and one or two selected from calcium oxide and Lasiosphaera Seu Calvatia powder.
2. The kaolin hemostatic material composition of claim 1, wherein: the kaolin is washed kaolin, and the specific surface area of the kaolin is 200m2/g～500m2/g。
3. The kaolin hemostatic material composition of claim 1, wherein: the calcium oxide is powder or granular, and the particle size is smaller than 100 meshes.
4. The kaolin hemostatic material composition of claim 1, wherein: the puffball powder is peeled puffball powder, and the particle size of the puffball powder is 1-10 mu m.
5. The kaolin hemostatic material composition of claim 1, wherein: the weight ratio of the kaolin to the calcium oxide to the puffball powder is 10: 0.5-2: 1-3, preferably 10: 0.8-1.8: 1.5-2.5, and most preferably 10: 1: 2.
6. A kaolin hemostatic dressing comprising a non-woven substrate and the hemostatic material composition of any one of the preceding claims.
7. The kaolin hemostatic dressing according to claim 6, wherein: the non-woven fabric substrate is selected from non-woven fabrics made of fibers of cotton, viscose, silk, wool, rayon, chitosan fibers, chitin fibers, lyocell, polypropylene, polyester, polyethylene, and the like or mixtures thereof.
8. The kaolin hemostatic dressing according to claim 6, wherein: the weight ratio of kaolin on the hemostatic dressing is 5-30%, the weight ratio of calcium oxide is 0-6%, and the weight ratio of puffball powder is 0-9%, and the hemostatic dressing is based on a non-woven fabric base material.
9. The method of making a kaolin haemostatic dressing as claimed in any preceding claim, comprising the steps of:
1) laying down the fibres used to make the non-woven fabric, scattering the haemostatic material composition and optionally the binder;
2) repeating the operation of step 1) one or more times as required;
3) and (4) performing hot rolling to form the composite kaolin hemostatic dressing.
10. The method of claim 9, wherein the components of the hemostatic material composition are applied simultaneously or in steps in any order, and then repeated as desired; the components of the hemostatic material composition applied in each layer may be the same as in the previous step or may be different.
Priority Applications (1)
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