CN107412842B - Preparation method of alginate wound dressing with thrombin - Google Patents
Preparation method of alginate wound dressing with thrombin Download PDFInfo
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- A—HUMAN NECESSITIES
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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
- 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
- A61L15/38—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing enzymes
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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
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
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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
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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
- A61L15/50—Lubricants; Anti-adhesive 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
- A61L2300/412—Tissue-regenerating or healing or proliferative 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
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Abstract
The invention relates to the field of medical care, in particular to a preparation method of an alginate wound dressing with thrombin, which comprises the following steps: preparing ethanol aqueous solution of thrombin, then placing alginate long-bundle fibers into a reaction tank containing the ethanol aqueous solution of thrombin for soaking at constant temperature, drying and cutting the soaked alginate short fibers to prepare alginate short fibers, curling the short fibers, preparing non-woven fabrics by non-woven processes such as opening, carding, lapping, needling and the like, cutting the non-woven fabrics into dressing cores with required sizes, compounding the dressing cores with a silicone gel film with holes, a polyurethane film adhesive tape and an anti-sticking layer by a dressing machine, and finally packaging and sterilizing to prepare the alginate wound dressing finished product with thrombin. The composite plaster prepared by the invention can keep the activity of thrombin to the maximum extent, has excellent hemostasis and imbibition performances, can prevent the adhesion of the plaster and a wound, provides a moist healing environment for the wound surface and promotes the wound healing.
Description
Technical Field
The invention relates to the field of medical care, in particular to a preparation method of an alginate wound dressing with thrombin.
Background
The skin is the largest organ of the human body and also is the first line of defense arranged between the human body and the external environment, and plays an important role in protecting the stability of the internal environment of the organism and resisting the stimulation of the external environment and the invasion of pathogenic bacteria.
In the medical care field, researchers pay more and more attention to how to better care skin, and the practicability and convenience of products are particularly important. The wound dressing has good protection effect on the wound, is free from external secondary pollution, reduces the risk of infection of patients and brings convenience to people.
However, the dressing core of most of the application products is single, and the composite material only has the function of absorbing wound exudate when being used for wounds and cannot have the effects of moisturizing and stopping bleeding of the wounds.
With the development of functional dressings, wound application is continuously improved, the single function of the product cannot meet the requirements of clinical doctors and patients, and the product is still not a more effective product for effectively stopping bleeding, effectively promoting the healing of wounds and promoting the growth of granulation of the wounds aiming at hemorrhagic wounds.
Therefore, it is a necessary and significant matter how to overcome the above disadvantages and provide a wound dressing which can effectively stop bleeding, has a remarkable healing effect and relieves the pain of patients.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides a preparation method of a thrombin-carrying alginate wound dressing. In order to achieve the purpose, the technical scheme provided by the invention is as follows:
a preparation method of a thrombin-carrying alginate wound dressing specifically comprises the following steps:
s1, preparing an ethanol water solution of thrombin, wherein the volume ratio of ethanol to water is (2-3): 1, and the thrombin content is 50-100 units/ml;
s2, placing the alginate long-strand fibers into a reaction tank containing thrombin and ethanol water solution, soaking for 0.5-1 h at constant temperature, wherein the temperature is 30-35 ℃, and the reaction tank is provided with an S-shaped channel;
s3, after soaking, pulling the long fiber bundle out of the reaction tank, and drying the long fiber bundle in an oven at the drying temperature of 35-37 ℃ for 1-2 h;
s4, drying, cutting to obtain alginate short fibers with thrombin and the length of 38-65 mm, and curling the short fibers, wherein the number of curls is not less than 3/cm;
s5, weaving the short fibers into non-woven fabrics by non-woven processes such as opening, carding, lapping, needling and the like;
s6, cutting the non-woven fabric into required application cores by a cutting machine;
s7, compounding the dressing core with the silicone gel film with the holes, the polyurethane film adhesive tape and the anti-sticking layer through a dressing machine;
s8, packaging and sterilizing to obtain the alginate wound dressing finished product with thrombin.
Further, the thrombin is human thrombin, bovine thrombin or recombinant thrombin.
Furthermore, the needling frequency of the alginate non-woven fabric with thrombin is 250-500 needles/min.
Furthermore, the gram weight of the alginate non-woven fabric with thrombin is 120-150 g/m2。
Furthermore, the aperture of the silicone gel film with the holes is 0.5-1 mm, and the peeling strength is 1-3N/cm.
Furthermore, the upper surface of the medical polyurethane film adhesive tape is coated with pressure-sensitive adhesive.
Further, the pressure-sensitive adhesive is any one of acrylic pressure-sensitive adhesive, polyurethane pressure-sensitive adhesive and medical polyisobutylene pressure-sensitive adhesive.
Furthermore, the area of the silicone gel film with the holes is equal to that of the medical polyurethane film adhesive tape, and the silicone gel film with the holes covers the compress core layer and is adhered to the medical polyurethane film adhesive tape to form a bag to wrap the compress core.
Furthermore, the anti-sticking layer is glassine silicone oil paper, and has the advantage of easy peeling; the anti-sticking layer is two pages, extends from two ends of the application to the middle respectively until covering each other, and is stuck and fixed with the outer edge of the application.
Furthermore, the sterilization mode is cobalt-60 irradiation sterilization, the irradiation dose is 25 kGy-50 kGy, and the irradiation time is 2 h-3 h.
Compared with the prior art, the invention has the following beneficial effects:
(1) the invention loads thrombin on alginate fibers by an S-shaped channel soaking method, and the S-shaped channel increases the contact area of the fibers and the thrombin, ensures constant reaction temperature, can furthest ensure the uniformity of the thrombin attached to the fibers, and solves the problem that protein is difficult to fix on a dressing base material.
(2) After the alginate contacts wound exudate, calcium ions are released, and the double effects of the alginate and thrombin are achieved, so that the hemostatic effect on the wound is enhanced.
(3) The silicone gel film with the holes is compounded with the dressing core, so that alginate fiber scraps can be prevented from being left on a wound, an anti-adhesion effect is achieved, secondary damage to the wound can be avoided when the dressing is uncovered, and the silicone gel film is an inert hydrophobic material, so that the sensitization rate to skin can be reduced.
(4) The polyurethane film is waterproof and breathable, is transparent, facilitates observation of wound conditions, provides a moist closed environment for wound surfaces, and promotes wound healing.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
The present invention will be described in further detail with reference to specific examples.
Example 1:
a preparation method of a thrombin-carrying alginate wound dressing comprises the following steps:
(1) preparing an ethanol water solution of thrombin, wherein the volume ratio of ethanol to water is 2:1, and the content of thrombin is 50 units/ml;
(2) soaking the alginate long-strand fibers in a reaction tank containing thrombin and ethanol water solution at constant temperature, wherein the reaction tank is provided with an S-shaped channel, the soaking time is 0.5h, and the temperature is 30 ℃;
(3) after soaking, pulling the long fiber bundle out of the reaction tank, and drying the long fiber bundle in an oven at the drying temperature of 35 ℃ for 1 h;
(4) drying, cutting to obtain alginate short fiber with thrombin, and crimping the short fiber to obtain cut short fiber with length of 38mm and crimp number of 3/cm;
(5) the short fibers are woven into non-woven fabric by non-woven processes of opening, carding, lapping, needling, and the like, the needling frequency is 250 needles/min, and the gram weight of the non-woven fabric is 120g/m2；
(6) Cutting the non-woven fabric into required dressing cores by a cutting machine;
(7) compounding the dressing core with a silicone gel film with holes, a polyurethane film adhesive tape and an anti-sticking layer by a dressing machine, wherein the hole diameter of the silicone gel film with holes is 0.5mm, and the peeling strength is 1N/cm;
(8) packaging and sterilizing to obtain the alginate wound dressing finished product with thrombin, wherein the irradiation dose is 28kGy, and the irradiation time is 2 h.
Example 2:
a preparation method of a thrombin-carrying alginate wound dressing comprises the following steps:
(1) preparing an ethanol water solution of thrombin, wherein the volume ratio of ethanol to water is 3:1, and the thrombin content is 100 units/ml;
(2) soaking the alginate long-strand fibers in a reaction tank containing thrombin and ethanol water solution at constant temperature, wherein the reaction tank is provided with an S-shaped channel, the soaking time is 1h, and the temperature is 35 ℃;
(3) after soaking, pulling the long fiber bundle out of the reaction tank, and drying the long fiber bundle in an oven at 37 ℃ for 2 hours;
(4) drying, cutting to obtain alginate short fiber with thrombin, and crimping the short fiber to obtain cut short fiber with length of 60mm and crimp number of 4/cm;
(5) the short fibers are woven into non-woven fabric by non-woven processes of opening, carding, lapping, needling, and the like, the needling frequency is 300 needles/min, and the gram weight of the non-woven fabric is 140g/m2；
(6) Cutting the non-woven fabric into required dressing cores by a cutting machine;
(7) compounding the dressing core with a silicone gel film with holes, a polyurethane film adhesive tape and an anti-sticking layer by a dressing machine, wherein the hole diameter of the silicone gel film with holes is 0.8mm, and the peeling strength is 2N/cm;
(8) packaging and sterilizing to obtain the alginate wound dressing finished product with thrombin, wherein the irradiation dose is 38kGy and the irradiation time is 3 h.
Example 3: hemostasis Performance test
Test groups: selecting the product prepared in the example 2 as a test group;
control group: gauze hemostatic products were used as a control group in the market.
The test procedure was as follows:
(1) according to the proportion of 1ml/kg, 3% sodium pentobarbital is slowly injected into the ear vein of the rabbit for anesthesia, then a wound towel is paved on the left abdominal side of the rabbit, and the surgical site is disinfected by iodine tincture and 75% alcohol.
(2) A5.0 cm longitudinal incision was made along the left inner edge, approximately 1cm to the left of the midline of the abdomen, the abdominal muscles were incised to the peritoneal layer, and the peritoneum was dissected.
(3) The spleen of the rabbit was found with 2 fingers or forceps and kept moist with physiological saline.
(4) Blank control group: on the visceral surface of the spleen, two symmetrical wounds with the length of 1cm and the depth of 1mm are cut along the long axis of the spleen by using an operation blade, and the wound surface is actively bled. And observing the bleeding condition of the wound surface, and recording the automatic hemostasis time of the rabbit.
(5) Control group: on the visceral surface of the spleen, a wound with a length of 1cm and a depth of 1mm is cut along the long axis of the spleen by using a surgical blade, and bleeding on the wound surface is active. After 10 seconds, ordinary gauze is applied to stop bleeding, and fingers are lightly pressed for 1 minute until the bleeding is stopped. And after 1 minute, observing the bleeding condition of the wound surface, if the bleeding does not occur within 2 minutes, considering that the hemostasis is successful, otherwise, removing blood clots and gauze of the wound surface, reapplying the medicine, slightly pressing the fingers for 1 minute, and repeating the steps until the hemostasis is successful. The time of hemostasis was recorded and the adhesion of the hemostatic formulation to the wound surface was observed.
(6) Test groups: on the visceral surface of the spleen, a wound with a length of 1cm and a depth of 1mm is cut along the long axis of the spleen by using a surgical blade, and bleeding on the wound surface is active. And (3) stopping bleeding by applying an alginate wound dressing with thrombin after 10 seconds, slightly pressing the finger for 1 minute, observing bleeding of the wound surface after 1 minute with inactive bleeding, if bleeding does not occur within 2 minutes, judging that the bleeding is successful, otherwise removing blood clots of the wound surface and the alginate wound dressing with thrombin, reapplying the dressing, slightly pressing the finger for 1 minute, and repeating the steps until the bleeding is successfully stopped. The time of hemostasis was recorded and the adhesion of the hemostatic formulation to the wound surface was observed.
The test results are shown in table 1:
table 1: hemostatic performance test results
| Grouping | Sex | Hemostatic time (min) of material-free or gauze | Hemostasis time (min) of material | Gauze hemostasis time (min) |
| Blank group | Female part | 30 | — | — |
| Male part | 33 | — | — | |
| Control group | Female part | — | — | 17 |
| Male part | — | — | 16 | |
| Test group | Female part | — | 9 | — |
| Male part | — | 10 | — |
As can be seen from the test results, the product of the invention has excellent rapid hemostatic performance compared with the hemostatic gauze on the existing market.
It should be noted that the foregoing description of the specific embodiments is merely exemplary for clearly illustrating the present invention and is not intended to limit the embodiments of the present invention. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.
Claims (10)
1. A preparation method of a thrombin-carrying alginate wound dressing is characterized by comprising the following specific steps:
s1, preparing an ethanol water solution of thrombin, wherein the volume ratio of ethanol to water is (2-3): 1, and the thrombin content is 50-100 units/ml;
s2, placing the alginate long-strand fibers into a reaction tank containing thrombin and ethanol water solution, soaking for 0.5-1 h at constant temperature, wherein the temperature is 30-35 ℃, and the reaction tank is provided with an S-shaped channel;
s3, after soaking, pulling the long fiber bundle out of the reaction tank, and drying the long fiber bundle in an oven at the drying temperature of 35-37 ℃ for 1-2 h;
s4, drying, cutting to obtain alginate short fibers with thrombin and the length of 38-65 mm, and curling the short fibers, wherein the number of curls is not less than 3/cm;
s5, weaving the short fibers into non-woven fabrics by opening, carding, lapping and needling non-woven processes;
s6, cutting the non-woven fabric into required application cores by a cutting machine;
s7, compounding the dressing core with the silicone gel film with the holes, the polyurethane film adhesive tape and the anti-sticking layer through a dressing machine; s8, packaging and sterilizing to obtain the alginate wound dressing finished product with thrombin.
2. The method for preparing a thrombin-carrying alginate wound dressing according to claim 1, wherein said thrombin is human thrombin, bovine thrombin or recombinant thrombin.
3. The method for preparing the alginate wound dressing with thrombin according to claim 1, wherein the needling frequency of the alginate nonwoven fabric with thrombin is 250-500 needles/min.
4. The method for preparing the alginate wound dressing with thrombin according to claim 1, wherein the gram weight of the alginate non-woven fabric with thrombin is 120-150 g/m2。
5. The method for preparing the alginate wound dressing with thrombin according to claim 1, wherein the pore diameter of the silicone gel film with the pores is 0.5-1 mm, and the peel strength is 1-3N/cm.
6. The method for preparing a alginate wound dressing with thrombin according to claim 1, wherein the upper surface of the polyurethane film adhesive tape is coated with a pressure sensitive adhesive.
7. The method for preparing the alginate wound dressing with thrombin according to claim 6, wherein the pressure sensitive adhesive is any one of acrylic pressure sensitive adhesive, polyurethane pressure sensitive adhesive and medical polyisobutylene pressure sensitive adhesive.
8. The method for preparing the alginate wound dressing with thrombin according to claim 1, wherein the area of the silicone gel film with holes is equal to that of the medical polyurethane film adhesive tape, the silicone gel film with holes covers the dressing layer and is adhered to the medical polyurethane film adhesive tape to form a bag, and the dressing core is wrapped in the bag.
9. The method for preparing a alginate wound dressing with thrombin according to claim 1, wherein the anti-adhesion layer is glassine, and the anti-adhesion layer is two pages which respectively extend from two ends of the dressing to the middle until the two pages cover each other and are bonded and fixed with the outer edge of the dressing.
10. The method for preparing the alginate wound dressing with the thrombin according to claim 1, wherein the sterilization mode is cobalt-60 irradiation sterilization, the irradiation dose is 25 kGy-50 kGy, and the irradiation time is 2 h-3 h.
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| CN108210976A (en) * | 2018-02-05 | 2018-06-29 | 广东泰宝医疗器械技术研究院有限公司 | A kind of preparation method of antibacterial silicone composite foam application |
| CN108379644A (en) * | 2018-03-03 | 2018-08-10 | 青岛大学 | A kind of preparation method for the efficient hemostatic material being suitable for open drowned wound |
| CN115161873B (en) * | 2022-07-26 | 2024-07-23 | 深圳市鑫鸿佳科技有限公司 | Degradable enteromorpha non-woven fabric |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103131037A (en) * | 2013-01-28 | 2013-06-05 | 北京化工大学常州先进材料研究院 | Preparation of natural polymer base hemostasis dressing |
| CN203885716U (en) * | 2014-05-27 | 2014-10-22 | 江西3L医用制品集团股份有限公司 | Self-adhesive alginate applying patch |
| CN104338173A (en) * | 2013-08-06 | 2015-02-11 | 许春晖 | Preparation method and application of quick absorption saturation gelation seaweed hemostatic dressing |
| CN104721878A (en) * | 2015-04-07 | 2015-06-24 | 广州市电纺生物科技有限公司 | Preparation method of hemostatic material |
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| AU2004206150B2 (en) * | 2003-01-20 | 2009-10-29 | Km Biologics Co., Ltd. | Hemostatic materials |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103131037A (en) * | 2013-01-28 | 2013-06-05 | 北京化工大学常州先进材料研究院 | Preparation of natural polymer base hemostasis dressing |
| CN104338173A (en) * | 2013-08-06 | 2015-02-11 | 许春晖 | Preparation method and application of quick absorption saturation gelation seaweed hemostatic dressing |
| CN203885716U (en) * | 2014-05-27 | 2014-10-22 | 江西3L医用制品集团股份有限公司 | Self-adhesive alginate applying patch |
| CN104721878A (en) * | 2015-04-07 | 2015-06-24 | 广州市电纺生物科技有限公司 | Preparation method of hemostatic material |
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