CN111467560A - Medical hemostatic dressing, preparation method and application thereof - Google Patents
Medical hemostatic dressing, preparation method and application thereof Download PDFInfo
- Publication number
- CN111467560A CN111467560A CN202010462977.0A CN202010462977A CN111467560A CN 111467560 A CN111467560 A CN 111467560A CN 202010462977 A CN202010462977 A CN 202010462977A CN 111467560 A CN111467560 A CN 111467560A
- Authority
- CN
- China
- Prior art keywords
- parts
- water
- hemostatic dressing
- medical hemostatic
- solution
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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Abstract
The invention discloses a medical hemostatic dressing, a preparation method and application thereof. The medical hemostatic dressing provided by the invention comprises the following raw materials in parts by weight: 0.5-2 parts of recombinant collagen, 1-5 parts of water-soluble high molecular polymer and 0.2-1 part of water retention agent. The medical hemostatic dressing provided by the invention has super-strong water absorption and blood absorption, the moisture absorption rate is 50-300 times of the self weight, the wound surface liquid can be effectively removed, and the hemostatic dressing has an obvious hemostatic effect on bleeding wound surfaces. Because the water retention agent and the water-soluble high molecular polymer are added, the surface of the dressing is soft and smooth, no adhesion exists, and secondary injury of the wound in the processes of hemostasis and wound cleaning is avoided. In addition, the raw material used is recombinant collagen, so that the medicine carrying capacity is higher, the wound healing effect is obvious, and the medical hemostatic dressing has wide application, can be used for surgical hemostasis with large bleeding amount and clearing and treating common wound surfaces in life, and is suitable for various periods of wounds.
Description
Technical Field
The invention relates to the technical field of biomedical materials, in particular to a medical hemostatic dressing, a preparation method and application thereof.
Background
At present, trauma is one of the leading causes of death worldwide. Since most of the trauma patients are young people, a huge burden is imposed on the society. The hemostatic dressings commonly used at present mainly comprise gelatin sponge, oxidized cellulose, fibrin glue, collagen sponge and the like, but have certain defects. For example, gelatin sponges and collagen sponges achieve hemostasis by aggregating large quantities of platelets and clotting factors, and their poor water absorption capacity greatly limits their range of use. Fibrin glue is mainly prepared from blood plasma, and has a high probability of infecting viruses in the using process. The traditional medical hemostatic gauze is not thorough in wound cleaning when used for treating wounds, and has almost no auxiliary effect on wound healing. In addition, when wound treatment is carried out, the cleaning of the wound surface is very important, and many hemostatic dressings in the market at present have poor hygroscopicity, cannot clean residual blood, foreign matters and the like of the wound surface completely, need to be used for multiple times, can cause secondary injury to the wound, and increase the pain feeling and economic burden of a patient. With the continuous and deep research on wound dressings, people begin to add medicines, antibiotics and the like which are beneficial to wound healing into the dressings, but due to the limited technology, many dressings show low medicine carrying capacity, poor medicine locking capacity, large medicine loss and low utilization rate, and the expected effect of promoting wound healing cannot be achieved.
In the face of many problems, the invention provides a wound surface anti-adhesion hemostatic dressing which has the advantages of good moisture absorption effect, obvious hemostatic effect, antibacterial property, edema resistance, adhesion resistance, good tissue compatibility with organisms, in-vivo degradation and good drug-loading capacity, can reduce the economic burden of patients, improve the wound treatment effect, prevent other diseases caused by wounds and has a great application prospect.
CN101002957A discloses a biodegradable rapid hemostatic dressing and a preparation method thereof, wherein the hemostatic dressing mainly comprises 85-90% of human-like collagen, 10-15% of hyaluronic acid, 0.2-0.3% of plasticizer and 0.2-0.4% of thrombin by mass percent.
CN108498844A discloses a rapid hemostatic dressing for obstetrics and gynecology department and a preparation method thereof, wherein the hemostatic dressing is composed of the following raw materials: human-like collagen, hyaluronic acid, a plasticizer, thrombin, chitosan, heparin sodium, aloin, hydroxymethyl chitin, alginate, an antibacterial agent, an anti-inflammatory agent, starch, sodium carboxymethylcellulose, polyvinyl alcohol, pseudo-ginseng, dextrin and gelatin, wherein the raw materials comprise the following components in parts by weight: 50-60 parts of human-like collagen, 10-15 parts of hyaluronic acid, 1-2 parts of plasticizer, 1-2 parts of thrombin, 10-15 parts of chitosan, 2-3 parts of heparin sodium, 2-3 parts of aloin, 4-8 parts of hydroxymethyl chitin, 6-8 parts of alginate, 1-4 parts of antibacterial agent, 1-4 parts of anti-inflammatory agent, 8-10 parts of starch, 6-8 parts of sodium carboxymethyl cellulose, 4-6 parts of polyvinyl alcohol, 6-8 parts of pseudo-ginseng, 2-5 parts of dextrin and 3-6 parts of gelatin.
Disclosure of Invention
In order to solve the problems, the invention provides a medical hemostatic dressing, a preparation method and application thereof. The specific technical scheme of the invention is as follows:
the invention provides a medical hemostatic dressing, which comprises the following raw materials in parts by weight: 0.5-2 parts of recombinant collagen, 1-5 parts of water-soluble high molecular polymer and 0.2-1 part of water retention agent.
Preferably, in the medical hemostatic dressing, the recombinant collagen is 1 to 2 parts, the water-soluble high molecular polymer is 1 to 2 parts, and the water retention agent is 0.2 to 0.5 part by weight.
Preferably, in the medical hemostatic dressing, the water-soluble high molecular polymer is one or more selected from the group consisting of polyvinyl alcohol, polylactic acid, sodium hyaluronate and chitosan.
Preferably, in the medical hemostatic dressing, the water retaining agent is one or more selected from the group consisting of sodium carboxymethylcellulose, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, and calcium dihydrogen phosphate.
Preferably, as for the medical hemostatic dressing, the medical hemostatic dressing further comprises the following raw materials in parts by weight: 0.05-2 parts of stabilizer, preferably 0.05-1 part of stabilizer.
Preferably, in the medical hemostatic dressing, the stabilizer is one or more selected from polysorbate 80, propylene glycol, epoxidized soybean oil, and hydroxyethyl cellulose.
Preferably, as for the medical hemostatic dressing, the medical hemostatic dressing further comprises the following raw materials in parts by weight: 0.5 to 10 parts of plasticizer, preferably 0.5 to 5 parts of plasticizer.
Preferably, in the medical hemostatic dressing, the plasticizer is selected from glycerol, tri-n-hexyl butyryl citrate and diethyl phthalate.
The invention provides a preparation method of a medical hemostatic dressing, which comprises the following steps:
dissolving the recombinant collagen to obtain solution A;
dissolving a water-soluble high molecular polymer and a water retention agent to obtain a solution B;
mixing the solution A, the solution B, an optional stabilizer and an optional plasticizer to obtain a first mixed solution;
freezing the first mixed solution, then soaking, cleaning and carrying out centrifugal sterilization to obtain the collagen protein water-soluble polymer water-soluble collagen protein water-soluble polymer water-soluble collagen protein water.
Preferably, in the above production method, wherein, in the step of obtaining the first mixed solution, the mixing is performed in a water bath at 60 to 80 ℃.
Preferably, in the above preparation method, the freezing step comprises:
freezing the first mixed solution for 20-24h, thawing to obtain a second mixed solution, and preferably, repeating the freezing and thawing steps 3-5 times.
Preferably, for the above preparation method, the soaking time is 2-4h, and preferably, washing is performed 3-5 times.
Preferably, in the above production method, the recombinant collagen is 1 to 2 parts by weight, the water-soluble high molecular polymer is 1 to 2 parts by weight, and the water retaining agent is 0.2 to 0.5 part by weight.
Preferably, in the above production method, the water-soluble polymer is one or more selected from the group consisting of polyvinyl alcohol, polylactic acid, hyaluronic acid and chitosan.
Preferably, in the above production method, the water retaining agent is one or more selected from the group consisting of sodium carboxymethylcellulose, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate and calcium dihydrogen phosphate.
Preferably, in the above preparation method, the stabilizer is one or more selected from polysorbate 80, propylene glycol, epoxidized soybean oil, and hydroxyethyl cellulose.
Preferably, in the above production method, the plasticizer is selected from the group consisting of glycerol, tri-n-hexyl butyryl citrate, and diethyl phthalate.
The invention provides the application of the hemostatic dressing or the hemostatic dressing prepared by the preparation method in a wound hemostatic material or a surgical hemostatic material, preferably in a wound hemostatic material.
ADVANTAGEOUS EFFECTS OF INVENTION
The medical hemostatic dressing provided by the invention has super-strong water absorption and blood absorption, the moisture absorption rate is 50-300 times of the self weight, the wound surface liquid can be effectively removed, and the hemostatic dressing has an obvious hemostatic effect on bleeding wound surfaces. Because the water retention agent and the water-soluble high molecular polymer are added, the surface of the dressing is soft and smooth, no adhesion exists, and secondary injury of the wound in the processes of hemostasis and wound cleaning is avoided. In addition, the raw material used is recombinant collagen, so that the medicine carrying capacity is stronger, and the wound healing effect is obvious.
The medical hemostatic dressing provided by the invention is wide in application, can be used for surgical hemostasis with large bleeding amount and clearing and treating common wound surfaces in life, and is suitable for various periods of wounds.
The medical hemostatic dressing provided by the invention provides convenience for treating common wounds of families, reduces the labor intensity of medical workers due to a small amount of use in an operation, greatly reduces the probability of wound infection of patients due to the special composition of the dressing, can be quickly degraded in vivo, and has good biological tissue compatibility.
Detailed Description
The present invention will be described in detail below. While specific embodiments of the invention have been shown, it should be understood that the invention may be embodied in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
It should be noted that certain terms are used throughout the description and claims to refer to particular components. As one skilled in the art will appreciate, various names may be used to refer to a component. This specification and claims do not intend to distinguish between components that differ in name but not function. In the following description and in the claims, the terms "include" and "comprise" are used in an open-ended fashion, and thus should be interpreted to mean "include, but not limited to. The description which follows is a preferred embodiment of the invention, however, the description is given for the purpose of illustrating the general principles of the invention and not for the purpose of limiting the scope of the invention. The scope of the present invention is defined by the appended claims.
The invention provides a medical hemostatic dressing, which comprises the following raw materials in parts by weight: 0.5-2 parts of recombinant collagen, 1-5 parts of water-soluble high molecular polymer and 0.2-1 part of water retention agent.
The recombinant Collagen is named as Van's recombinant Collagen or Van's Human Collagen (FH L C), which is the recombinant Collagen of claim 1 of Chinese patent application publication CN1371919A, has a triple-chain and triple-helix structure, and can be prepared by using a genetic engineering expression method disclosed in the Chinese patent application publication CN 1371919A.
The water-soluble high molecular polymer is a high molecular material with strong hydrophilicity, can be dissolved or swelled in water to form an aqueous solution or a dispersion system, is one of the most important materials at present due to good biocompatibility and environmental friendliness, and contains a large amount of hydrophilic groups.
The moisture retention agent is a substance which is widely applied to the food processing process, can improve the stability of products, maintain the internal moisture retention of foods and improve the shape, flavor, color and the like of the foods after being added, and has the functions of isolating air and preventing moisture from evaporating in the dressing.
The recombinant collagen may be 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts or any range therebetween in parts by weight.
The water-soluble high molecular polymer may be 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts or any range therebetween.
The water retaining agent may be 0.2 parts, 0.3 parts, 0.4 parts, 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 part, or any range therebetween.
In a preferred embodiment of the present invention, wherein, the recombinant collagen is 1-2 parts, preferably 1-1.5 parts by weight; 1-2 parts of water-soluble high molecular polymer, preferably 1.2-2 parts; and the water retention agent is 0.2 to 0.5 part, preferably 0.3 to 0.5 part.
In a preferred embodiment of the present invention, the water-soluble high molecular polymer is one or more selected from polyvinyl alcohol, polylactic acid, sodium hyaluronate and chitosan, and is preferably polyvinyl alcohol and/or hyaluronic acid.
The polylactic acid is a polymer obtained by polymerizing lactic acid serving as a main raw material, and is a novel biodegradable material.
Sodium hyaluronate, whose basic structure is a large polysaccharide sodium salt composed of two disaccharide units, D-glucuronic acid and N-acetylglucosamine, is a major component constituting connective tissues such as human intercellular substance, ocular vitreous body, synovial fluid of joints, etc., and plays important physiological functions of retaining water, maintaining extracellular space, regulating osmotic pressure, lubricating and promoting cell repair in vivo.
Chitosan is a chitin N-deacetylated product, has many unique properties such as biodegradability, cell affinity and biological effect, and particularly contains free amino groups, and is the only basic polysaccharide in natural polysaccharides.
In a preferred embodiment of the present invention, the water-retaining agent is one or more selected from the group consisting of sodium carboxymethylcellulose, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate and calcium dihydrogen phosphate, and preferably sodium carboxymethylcellulose.
In a preferred embodiment of the present invention, the medical hemostatic dressing further comprises the following raw materials in parts by weight: 0.05-2 parts of stabilizer, preferably 0.05-1 part of stabilizer.
The stabilizing agent is capable of increasing the stability of the high polymer in the dressing. It can slow down reaction, maintain chemical balance, reduce surface tension, prevent light, heat decomposition or oxidation decomposition, etc. and prolong the service life of the dressing.
In a more preferred embodiment of the present invention, the stabilizer is one or more selected from polysorbate 80, propylene glycol, epoxidized soybean oil and hydroxyethyl cellulose, and preferably polysorbate 80 or epoxidized soybean oil.
In a preferred embodiment of the present invention, the medical hemostatic dressing further comprises the following raw materials in parts by weight: 0.5 to 10 parts of plasticizer, preferably 0.5 to 5 parts of plasticizer.
The plasticizer is a high-boiling point, low-volatility substance. Plasticizer molecules can be inserted between polymer molecular chains, so that the acting force between the molecules is weakened, and the distance and the activity space between the polymer molecular chains are increased. It can improve the elongation, flexibility and pliability of the dressing.
In a more preferred embodiment of the present invention, the plasticizer is selected from glycerol, tri-n-hexyl butyryl citrate, diethyl phthalate, and preferably glycerol or tri-n-hexyl butyryl citrate.
The invention provides a preparation method of a medical hemostatic dressing, which comprises the following steps:
dissolving the recombinant collagen to obtain solution A;
dissolving a water-soluble high molecular polymer and a water retention agent in the solution to obtain a solution B;
mixing the solution A, the solution B, an optional stabilizer and an optional plasticizer to obtain a first mixed solution;
freezing the first mixed solution, then soaking, cleaning and centrifugally sterilizing to obtain the medical hemostatic dressing, wherein the medical hemostatic dressing comprises 0.5-2 parts by weight of recombinant collagen, 1-5 parts by weight of water-soluble high polymer and 0.2-1 part by weight of water retention agent.
Wherein "optionally" means that the raw material may or may not be added.
In a more preferred embodiment of the present invention, the method comprises the following steps:
dissolving the recombinant collagen to form a solution A;
dissolving a water-soluble high molecular polymer and a water retention agent to form a solution B;
and mixing the solution A, the solution B, an optional stabilizer and an optional plasticizer to obtain a first mixed solution.
Freezing the first mixed solution for 20-24h, thawing to obtain a second mixed solution, and preferably repeating the freezing-thawing step 3-5 times.
Soaking the second mixed solution for 2-4h, and cleaning for 3-5 times, each time for 10-20min to obtain the cleaned object.
And centrifuging the cleaned substance, and then sterilizing to obtain the medical hemostatic dressing.
In a more preferred embodiment of the present invention, the preparation method comprises the following steps:
dissolving the recombinant collagen in water to form a solution A;
dissolving a water-soluble high molecular polymer and a water retention agent in water to form a solution B;
mixing the solution A, the solution B, an optional stabilizer and an optional plasticizer in a water bath at the temperature of 60-80 ℃ to obtain a first mixed solution.
Freezing the first mixed solution for 20-24h, thawing, and repeating the freezing-thawing step for 3-5 times to obtain a second mixed solution.
And (3) soaking the second mixed solution in purified water for 2-4h, and then cleaning in an ultrasonic cleaning machine for 3-5 times, wherein each time lasts for 10-20min, so as to obtain a cleaned object.
Centrifuging the cleaned substance at 50-200rpm for 5-20min, taking out, standing at 20-25 deg.C for 2-12h, and adding Co60And irradiating for 48-72h for sterilization to obtain the medical hemostatic dressing.
The medical hemostatic dressing obtained by the invention has stronger drug loading capacity and drug utilization rate, and has more obvious advantage of promoting wound healing.
The hemostatic dressing provided by the invention or prepared by the preparation method is applied to a wound hemostatic material or a surgical hemostatic material, preferably to a wound hemostatic material.
The medical hemostatic dressing obtained by the invention can be used for different wound types such as burn, abrasion, cut, puncture, bite and the like in different periods, and preferably in the initial period of the wound.
The invention is described generally and/or specifically for the materials used in the tests and the test methods, in the following examples,% means wt%, i.e. percent by weight, unless otherwise specified. The reagents or instruments used are not indicated by the manufacturer, and are all conventional reagent products or conventional laboratory instruments which are commercially available.
Experimental materials used in Table 1
EXAMPLE 1 preparation of medical hemostatic dressing
(1) Dissolving 1g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 2g of polyvinyl alcohol and 0.5g of sodium carboxymethyl cellulose in 28.5m L of distilled water in a water bath kettle at the temperature of 80 ℃ to form a solution B;
(3) 20m of L A solution, 28.5m of L B solution, 1.26g of glycerol and 0.53g of polysorbate 80 were thoroughly mixed in a water bath at 60 ℃, taken out of the water bath and immediately poured into an aluminum mold to obtain a first mixed solution.
(4) Freezing the first mixed solution in a refrigerator at-20 ℃ for 24h, taking out the first mixed solution, standing the first mixed solution at room temperature for 3h to fully thaw the first mixed solution, and repeating the freezing-thawing process for 3 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 2h, and then cleaning in an ultrasonic cleaning machine for 3 times, wherein 10min is carried out each time to obtain a cleaned object;
(6) centrifuging the cleaned substance in a centrifuge at 100rpm for 5min, taking out, standing at 20 deg.C for 4h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 48 hours to obtain the medical hemostatic dressing.
EXAMPLE 2 preparation of medical hemostatic dressing
(1) Dissolving 2g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 1g of sodium hyaluronate and 0.5g of sodium carboxymethylcellulose in 29m of L distilled water in a water bath kettle at the temperature of 80 ℃ to form a solution B;
(3) fully mixing a solution of 20m L A, a solution of 29m L B, 0.8g tri-n-hexyl butyryl citrate and 0.9g epoxidized soybean oil in a water bath at 60 ℃, taking out from the water bath, and immediately pouring into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 24h, taking out the first mixed solution, standing the first mixed solution at room temperature for 3h to fully thaw, and repeating the freezing-thawing process for 3 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 3h, and then cleaning in an ultrasonic cleaning machine for 4 times, wherein 15min is carried out each time to obtain a cleaned object;
(6) placing the cleaned substance in a centrifuge at 50rpm for 20min, taking out, standing at 25 deg.C for 10h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 48 hours to obtain the medical hemostatic dressing.
EXAMPLE 3 preparation of medical hemostatic dressing
(1) Dissolving 1.5g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 1.2g of polyvinyl alcohol and 0.4g of sodium carboxymethyl cellulose in 27.5m of L distilled water in a water bath kettle at the temperature of 80 ℃ to form a solution B;
(3) fully mixing a solution 20m of L A, a solution 27.5m of L B, 0.26g of polysorbate 80 and 2.5g of glycerol in a water bath at 60 ℃, taking out from the water bath, and immediately pouring into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 20h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 5 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 4h, and then cleaning in an ultrasonic cleaning machine for 5 times, wherein 15min is carried out each time to obtain a cleaned object;
(6) placing the cleaned substance in a centrifuge at 100rpm for 5min, taking out, standing at 20 deg.C for 6h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 72h to obtain the medical hemostatic dressing.
EXAMPLE 4 preparation of medical hemostatic dressing
(1) Dissolving 1.5g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 1.5g of polyvinyl alcohol and 0.3g of sodium carboxymethyl cellulose in 26m L of distilled water in a water bath kettle at the temperature of 70 ℃ to form a solution B;
(3) fully mixing 20m of L A solution, 26m of L B solution, 0.53g of polysorbate 80 and 1.26g of glycerol in a water bath at 70 ℃, taking out from the water bath, and immediately pouring into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 22h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 4 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 3h, and then cleaning in an ultrasonic cleaning machine for 5 times, wherein 15min is carried out each time to obtain a cleaned object;
(6) placing the cleaned substance in a centrifuge at 100rpm for 10min, taking out, standing at 20 deg.C for 6h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 60h to obtain the medical hemostatic dressing.
EXAMPLE 5 preparation of medical hemostatic dressing
(1) Dissolving 1.8g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 2g of polyvinyl alcohol and 0.2g of sodium carboxymethyl cellulose in 29m of L distilled water in a water bath kettle at the temperature of 80 ℃ to form a solution B;
(3) fully mixing 20m of L A solution, 29m of L B solution, 0.05g of polysorbate 80 and 3g of glycerol in a water bath at 60 ℃, taking out from the water bath, and immediately pouring into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 20h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 5 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 3h, and then cleaning in an ultrasonic cleaning machine for 4 times, wherein each time is 10min to obtain a cleaned object;
(6) placing the cleaned substance in a centrifuge at 50rpm for 20min, taking out, standing at 25 deg.C for 2h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 48 hours to obtain the medical hemostatic dressing.
EXAMPLE 6 preparation of medical hemostatic dressing
(1) Dissolving 1g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 1g of polyvinyl alcohol and 0.5g of sodium carboxymethyl cellulose in 27.5m L of distilled water in a water bath kettle at the temperature of 80 ℃ to form a solution B;
(3) fully mixing a solution 20m L A, a solution 27.5m L B, 0.1g polysorbate 80 and 5g glycerol in a water bath at 70 ℃, taking out from the water bath, and immediately pouring into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 24h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 3 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 2h, and then cleaning in an ultrasonic cleaning machine for 3 times, wherein each time is 20min to obtain a cleaned object;
(6) centrifuging the cleaned substance in a centrifuge at 200rpm for 5min, taking out, standing at 25 deg.C for 8h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 48 hours to obtain the medical hemostatic dressing.
EXAMPLE 7 preparation of medical hemostatic dressing
(1) Dissolving 0.5g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 5g hyaluronic acid and 0.8g sodium dihydrogen phosphate in 32m L distilled water in 80 deg.C water bath to obtain solution B;
(3) fully mixing 20m of L A solution, 32m of L B solution, 1.5g of epoxidized soybean oil and 7g of butyryl tri-n-hexyl citrate in a water bath at 70 ℃, taking out the mixture from the water bath pot, and immediately pouring the mixture into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 20h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 3 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 2h, and then cleaning in an ultrasonic cleaning machine for 3 times, wherein each time is 20min to obtain a cleaned object;
(6) placing the cleaned substance in a centrifuge at 50rpm for 20min, taking out, standing at 25 deg.C for 2h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 48 hours to obtain the medical hemostatic dressing.
EXAMPLE 8 preparation of medical hemostatic dressing
(1) Dissolving 2g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 1g of chitosan and 1g of disodium hydrogen phosphate in 30m of L distilled water in a water bath kettle at the temperature of 80 ℃ to form a solution B;
(3) fully mixing 20m of L A solution, 30m of L B solution, 2g of polysorbate 80 and 10g of diethyl phthalate in a water bath at 60 ℃, taking out from the water bath, and immediately pouring into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 24h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 5 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 4h, and then cleaning in an ultrasonic cleaning machine for 5 times, wherein 15min is carried out each time to obtain a cleaned object;
(6) centrifuging the cleaned substance in a centrifuge at 200rpm for 5min, taking out, standing at 20 deg.C for 6h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 72h to obtain the medical hemostatic dressing.
Comparative example 1 preparation of ordinary medical hemostatic dressing
(1) Dissolving 0.3g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 5g hyaluronic acid and 0.8g sodium dihydrogen phosphate in 32m L distilled water in 80 deg.C water bath to obtain solution B;
(3) fully mixing 20m of L A solution, 32m of L B solution, 1.5g of epoxidized soybean oil and 7g of butyryl tri-n-hexyl citrate in a water bath at 70 ℃, taking out the mixture from the water bath pot, and immediately pouring the mixture into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 20h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 3 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 2h, and then cleaning in an ultrasonic cleaning machine for 3 times, wherein each time is 20min to obtain a cleaned object;
(6) placing the cleaned substance in a centrifuge at 50rpm for 20min, taking out, standing at 25 deg.C for 2h, sealing and packaging with aluminum foil paper, and Co60And performing irradiation sterilization for 48 hours to obtain the medical hemostatic dressing.
Comparative example 2 preparation of ordinary medical hemostatic dressing
(1) Dissolving 2.2g of recombinant collagen in 20m L of distilled water at room temperature to form solution A;
(2) dissolving 1g of chitosan and 1g of disodium hydrogen phosphate in 30m of L distilled water in a water bath kettle at the temperature of 80 ℃ to form a solution B;
(3) fully mixing 20m of L A solution, 30m of L B solution, 2g of polysorbate 80 and 10g of diethyl phthalate in a water bath at 60 ℃, taking out from the water bath, and immediately pouring into an aluminum mold to obtain a first mixed solution;
(4) freezing the first mixed solution in a refrigerator at-20 ℃ for 24h, taking out the first mixed solution, standing the first mixed solution at room temperature for 4h to fully thaw, and repeating the freezing-thawing process for 5 times to obtain a second mixed solution;
(5) soaking the second mixed solution in purified water for 4h, and then cleaning in an ultrasonic cleaning machine for 5 times, wherein 15min is carried out each time to obtain a cleaned object;
(6) and (3) placing the cleaned object in a centrifuge for 5min at 200rpm, taking out the cleaned object, placing the cleaned object at 20 ℃ for 6h, sealing and packaging the cleaned object by using aluminum foil paper, and performing Co60 irradiation sterilization for 72h to obtain the medical hemostatic dressing.
TABLE 2 Components and quality tables for the examples and comparative examples
Experimental example 1 blood volume adsorption experiment
15m L blood was placed in a beaker, 3 commercially available medical hemostatic dressings (5cm × 15cm Henan Istek Biotech Co., Ltd.) as a control group and 3 medical hemostatic dressings obtained in comparative examples 1-2 were cut into 2cm (length) × 2cm (width) × 0.4.4 cm (height) rectangular blocks, and different samples were placed in the beaker at room temperature for 30 seconds, respectively, and blood adsorption test was performed, the test results are shown in Table 3, where the moisture absorption ratio refers to the weight/initial weight of the product after moisture absorption and the maximum adsorption time refers to the time required for the product to reach the maximum moisture absorption, and the specific operation was that the product was placed in physiological saline for the initial timing and the time required for the constant moisture absorption weight was the maximum adsorption time.
TABLE 3 blood volume adsorption test results
As can be seen from Table 3, the medical hemostatic dressings obtained in examples 1-8 have higher moisture absorption rates, more than 180 seconds, and lower maximum adsorption time, less than 20 seconds, which indicates that the medical hemostatic dressings obtained in the invention have better adsorption effect, and the adsorption effect is better than that of comparative examples 1-2 and the control groups 1-3 of the commercially available hemostatic dressings.
Comparing comparative example 1 with example 7, which are different only in the amount of the recombinant collagen used, the amount of the recombinant collagen used in comparative example 1 is 0.3g, and the amount of the recombinant collagen used in example 7 is 0.5g, i.e., the amount of the recombinant collagen in comparative example 1 is outside the range of the present invention, it can be seen from table 3 that the moisture absorption rate of example 7 is 176, the maximum adsorption time is 19s, the moisture absorption rate of comparative example 1 is 143, and the maximum adsorption time is 21s, which illustrates that the adsorption effect of the obtained medical hemostatic dressing is better when the amount of the recombinant collagen is within the range of the present invention.
Comparing comparative example 2 with example 8, the difference is that the amount of the recombinant collagen of comparative example 2 is outside the range of the present invention, and as can be seen from table 3, the moisture absorption rate of comparative example 2 is 152 and the maximum adsorption time is 21s, while the moisture absorption rate of example 8 is 183 and the maximum adsorption time is 19s, which shows that when the amount of the recombinant collagen is within the range of the present invention, the adsorption effect of the obtained medical hemostatic dressing is better.
Experimental example 2 Rapid hemostasis test
39 new zealand rabbits weighing 2.2-2.5kg (fourth university of military medicine laboratory animals center) were selected, randomly divided into 13 groups of 3 rabbits each, labeled test group 1-8, control group 1-3 and control group 1-2, and the ear hair of each new zealand rabbit was shaved off, the left ear vein, right ear vein and two thirds of the left hind limb femoral artery were cut after iodine sterilization, and the groups of examples 1-3 and a commercially available medical hemostatic dressing (hitachi biosciences, henna) were pressed on the wound after 5s of free bleeding. The results of the experiment are shown in table 4.
TABLE 4 quick hemostasis test results
As can be seen from Table 4, the hemostatic effect of the medical hemostatic dressings in examples 1-8 is better than that of the medical hemostatic dressings in the control groups 1-3 and comparative examples 1-2 in the market, especially when the hemostatic time of the left hind leg femoral artery with a large amount of bleeding is measured, the hemostatic effect of the invention is better, the hemostatic purpose can be achieved in a short time, and the hemostatic speed is far shorter than that of the medical hemostatic dressings in the market and comparative examples 1-2.
Example 3 drug Loading Performance test
The dressing prepared by the invention is loaded with tetracycline hydrochloride by a dry state soaking method to detect the drug loading capacity. The dressings obtained in examples 1 to 8 were used as a test group, 3 commercially available hemostatic dressings (Istek Biotech Co., Ltd., Henan) for medical use as a control group, and the hemostatic dressings obtained in comparative examples 1 to 2 were used as a comparative example. The sample is processed by a freeze-drying method to obtain a dry dressing. Then the dry dressing is immersed in a tetracycline hydrochloride aqueous solution with a certain content, kept stand for 4 hours at 25 ℃ to reach a swelling equilibrium state, is frozen and dried to constant weight, weighed by an electronic balance, and sealed for storage. The total drug uptake of the hydrogel was calculated by measuring the tetracycline hydrochloride content of the remaining solution. The results of the experiment are shown in Table 5.
TABLE 5 test results of drug loading Performance
As can be seen from Table 5, the drug loading capacity of the wound anti-adhesion hemostatic dressings in examples 1 to 8 is superior to that of the medical hemostatic dressings in the market and the medical hemostatic dressings in comparative examples 1 to 2, the drug loading capacity of the dressings is increased along with the increase of the initial concentration of the drug, but when the initial concentration of tetracycline hydrochloride is 400 mug/ml, the drug loading capacity of the wound anti-adhesion hemostatic dressings in examples 1 to 8 is larger, and the dressing anti-infection and the wound rapid healing promotion effects are obvious.
In conclusion, the medical hemostatic dressing has blood adsorption capacity obviously superior to that of commercially available medical hemostatic dressings with the same function and medical hemostatic dressings obtained in comparative examples 1-2, and the strong moisture absorption performance of the medical hemostatic dressing reduces the usage amount of the dressing in the process during wound cleaning, so that the labor amount of medical staff and the economic burden of patients are reduced. Meanwhile, the hemostatic effect and the drug loading capacity of the hemostatic dressing are superior to those of the medical hemostatic dressing sold in the market and the medical hemostatic dressings obtained in comparative examples 1-2, and the hemostatic dressing has the advantages of adhesion resistance, antibacterial property and good tissue compatibility, so that the infection risk and anaphylactic reaction in the wound treatment process are greatly reduced.
The foregoing is directed to preferred embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow. However, any simple modification, equivalent change and modification of the above embodiments according to the technical essence of the present invention are within the protection scope of the technical solution of the present invention.
Claims (10)
1. The medical hemostatic dressing is characterized by comprising the following raw materials in parts by weight: 0.5-2 parts of recombinant collagen, 1-5 parts of water-soluble high molecular polymer and 0.2-1 part of water retention agent.
2. The medical hemostatic dressing according to claim 1, wherein the amount of the recombinant collagen is 1 to 2 parts, the amount of the water-soluble high molecular polymer is 1 to 2 parts, and the amount of the water-retaining agent is 0.2 to 0.5 part by weight.
3. The medical hemostatic dressing according to claim 1 or 2, wherein the water-soluble high molecular polymer is one or more selected from polyvinyl alcohol, polylactic acid, sodium hyaluronate and chitosan.
4. The medical hemostatic dressing according to any one of claims 1 to 3, wherein the moisture retention agent is selected from one or more of sodium carboxymethylcellulose, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, and calcium dihydrogen phosphate.
5. The medical hemostatic dressing according to any one of claims 1 to 4, further comprising the following raw materials in parts by weight: 0.05-2 parts of stabilizer, preferably 0.05-1 part of stabilizer.
6. The medical hemostatic dressing according to claim 5, wherein the stabilizer is one or more selected from polysorbate 80, propylene glycol, epoxidized soybean oil, and hydroxyethyl cellulose.
7. The medical hemostatic dressing according to any one of claims 1 to 6, further comprising the following raw materials in parts by weight: 0.5 to 10 parts of plasticizer, preferably 0.5 to 5 parts of plasticizer.
8. The medical hemostatic dressing according to claim 7, wherein the plasticizer is selected from glycerol, tri-n-hexyl butyryl citrate and diethyl phthalate.
9. A preparation method of a medical hemostatic dressing comprises the following steps:
dissolving the recombinant collagen to obtain solution A;
dissolving a water-soluble high molecular polymer and a water retention agent to obtain a solution B;
mixing the solution A, the solution B, an optional stabilizer and an optional plasticizer to obtain a first mixed solution;
freezing the first mixed solution, then soaking, cleaning and carrying out centrifugal sterilization to obtain the collagen protein water-soluble polymer water-soluble collagen protein water-soluble polymer water-soluble collagen protein water.
10. Use of the hemostatic dressing according to any one of claims 1 to 8 or the hemostatic dressing prepared by the preparation method according to claim 9 in a wound or surgical hemostatic material, preferably in a wound hemostatic material.
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