CN114470301B - Preparation method of soybean polypeptide absorbable medical suture line - Google Patents
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- CN114470301B CN114470301B CN202111584447.4A CN202111584447A CN114470301B CN 114470301 B CN114470301 B CN 114470301B CN 202111584447 A CN202111584447 A CN 202111584447A CN 114470301 B CN114470301 B CN 114470301B
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- 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
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/06—At least partially resorbable materials
- A61L17/10—At least partially resorbable materials containing macromolecular 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
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/06—At least partially resorbable materials
- A61L17/10—At least partially resorbable materials containing macromolecular materials
- A61L17/12—Homopolymers or copolymers of glycolic acid or lactic acid
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Abstract
The invention provides an absorbable medical suture line and a preparation method thereof, belonging to the technical field of medical materials. In order to reduce the cost and improve the production efficiency, the absorbable medical suture line takes soybean polypeptide as a main raw material; the soybean polypeptide is obtained by two-step enzymolysis of soybean proteolytic enzyme, the soybean polypeptide has good biocompatibility, and the prepared suture line can be gradually degraded in vivo, so that the prepared suture line does not need to be dismantled after operation, and the pain of a patient can be relieved; meanwhile, the soybean polypeptide has the function of promoting wound healing, and can shorten the wound healing period.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to a soybean polypeptide absorbable medical suture line and a preparation method thereof.
Background
In recent years, the effects of suturing and promoting wound healing are not satisfied, and research and development of high-efficiency, good-effect and small-hazard sutures are started. Novel coatings, slow release anti-inflammatory, antimicrobial drug-loading, electronics, shape memory, and the like have attracted attention as smart sutures that promote wound treatment and have additional capabilities, but no suture has yet been available to meet all types of surgical and medical requirements.
There are many types of medical sutures on the market at present, but none of the sutures is ideal in terms of wire diameter, mechanical properties, knot-tying firmness, stability, degradability, biocompatibility, and a compromise still needs to be made in use.
The non-absorbable suture line often causes secondary injury after operation, greatly improves the inflammation infection rate of wounds, causes great pain to patients during disassembly, has the outstanding characteristics of easy degradation, promotion of wound healing, anti-inflammation, high compatibility with human bodies and the like, is derived from soybean protein, has higher extraction rate, meets the requirement of ideal suture line, and has important practical significance in developing the soybean polypeptide suture line.
The invention aims to provide novel soybean polypeptide medical suture.
Disclosure of Invention
The invention provides an absorbable medical suture line and a preparation method thereof. The specific technical scheme is as follows:
an absorbable medical suture line is prepared from soybean polypeptide as main raw material.
Further, the soy polypeptide suture component further comprises chitosan.
Further, the soybean polypeptide ethanol extract: the chitosan is about (5:4) - (8:7) by weight.
The soybean polypeptide absorbable biological suture consists of the following components in parts by weight:
the soybean polypeptide ethanol extract is prepared by soaking soybean polypeptide ethanol extract in 35-55% ethanol solution for 12-24 hr, and filtering to obtain filtrate.
The chitosan is 84% -87% deacetylated chitosan.
The ratio of the soybean polypeptide to the ethanol solution is 7-8 g/200 mL.
The soybean polypeptide is extracted by the following method: cleaning soybean, crushing, extruding and puffing, mixing the extruded and puffed product with water, taking the mixture for enzymolysis to obtain an enzymolysis liquid, performing series treatment on the enzymolysis liquid, controlling the temperature to 55-60 ℃ and the pH value to 8.5, and adding alkaline protease with the enzyme content of 2-3% for enzymolysis for 60-90 min. The enzymolysis temperature is kept at 55-60 ℃, the pH is adjusted to 9.0, and alkaline protease with the enzyme content of 3-4% is added for enzymolysis for 45-60 min. Centrifugally separating the enzymatic hydrolysis mixed solution to obtain oily liquid, water phase and solid residue; regulating pH of the water phase to 4.5, precipitating, centrifuging, and lyophilizing to obtain soybean polypeptide.
A preparation method of soybean polypeptide absorbable biological suture comprises the following steps:
(1) Weighing the components according to the formula amount, and continuously stirring chitosan, polycaprolactone, citric acid and glycerol for 75min under the condition of 600r/min to obtain a product A;
(2) Adding the product A obtained in the step (1) into a double-screw extruder for melt mixing, preparing master batches after water cooling, drying and granulating an extruded sample, drawing the master batches after melt defoaming, and stretching and shaping the prepared primary fibers in nitrogen at 25-30 ℃ to obtain finished fibers;
(3) Immersing the finished fiber prepared in the step (2) into 40-50 parts of soybean polypeptide ethanol extract, immersing for 45-60min at 25-30 ℃, taking out and drying, immersing for 60min again at 25-30 ℃, taking out and drying again, repeating the steps four times, sterilizing and packaging to obtain the product, namely the soybean polypeptide absorbable biological suture line.
The drying condition is that the drying is carried out for 45min at 65-70 ℃;
the temperature of the melt mixing is 120-135 ℃;
the temperature of the wire drawing is 155-165 ℃;
the sterilization is carried out under the ultraviolet light of 240-280nm for 20-30 minutes.
The technical scheme of the invention has the following advantages:
(1) The medical device is degradable, does not need to be dismantled, and reduces the pain caused by secondary injury of patients;
(2) Can obviously promote wound healing, and is not easy to cause inflammation and infection;
(3) High extraction rate of raw materials and low cost.
Detailed Description
Example 1
The soybean polypeptide absorbable biological suture consists of the following components in parts by weight:
the soybean polypeptide ethanol extract is obtained by soaking the soybean polypeptide ethanol extract in 55% ethanol solution for 12 hours, and then filtering to obtain filtrate.
The chitosan is 84% -87% deacetylated chitosan.
The ratio of the soybean polypeptide to the ethanol solution is 8g to 200mL.
The soybean polypeptide is extracted by the following method: cleaning and crushing soybeans, extruding and puffing, mixing the extruded and puffed products with water, taking the mixture for enzymolysis to obtain an enzymolysis liquid, performing series treatment on the enzymolysis liquid, controlling the temperature to 60 ℃, controlling the pH to 8.5, and adding alkaline protease with the enzyme content of 3% for enzymolysis for 60 min. The enzymolysis temperature is kept unchanged at 60 ℃, the pH is adjusted to 9.0, and alkaline protease with the enzyme amount of 4% is added for 45min enzymolysis. Centrifugally separating the enzymatic hydrolysis mixed solution to obtain oily liquid, water phase and solid residue; regulating pH of the water phase to 4.5, precipitating, centrifuging, and lyophilizing to obtain soybean polypeptide.
A preparation method of soybean polypeptide absorbable biological suture comprises the following steps:
(1) Weighing the components according to the formula amount, and continuously stirring chitosan, polycaprolactone, citric acid and glycerol for 75min under the condition of 600r/min to obtain a product A;
(2) Adding the product A obtained in the step (1) into a double-screw extruder for melt mixing, preparing master batches after water cooling, drying and granulating an extruded sample, drawing the master batches after melt defoaming, and stretching and shaping the prepared primary fibers in nitrogen at 25 ℃ to obtain finished fibers;
(3) Immersing the finished fiber obtained in the step (2) into 40 parts of soybean polypeptide ethanol extract, immersing for 45min at 30 ℃, taking out and drying, immersing for 45min at 30 ℃ again, taking out and drying, repeating the steps four times, sterilizing and packaging to obtain the product, namely the soybean polypeptide absorbable biological suture line.
The drying condition is that the drying is carried out for 60min at 65 ℃;
the temperature of the melt mixing is 135 ℃;
the temperature of the wire drawing is 165 ℃;
the sterilization is carried out under the ultraviolet light of 240-275nm for 20min.
Example 2
The soybean polypeptide absorbable biological suture consists of the following components in parts by weight:
the soybean polypeptide ethanol extract is obtained by soaking the soybean polypeptide ethanol extract in 35% ethanol solution for 24 hours, and then filtering to obtain filtrate.
The chitosan is 84% -87% deacetylated chitosan.
The ratio of the soybean polypeptide to the ethanol solution is 7g to 200mL.
The soybean polypeptide is extracted by the following method: cleaning and crushing soybeans, extruding and puffing, mixing the extruded and puffed products with water, taking the mixture for enzymolysis to obtain an enzymolysis liquid, performing series treatment on the enzymolysis liquid, controlling the temperature to 55 ℃, controlling the pH to 8.5, and adding alkaline protease with the enzyme content of 3% for enzymolysis for 90 min. The enzymolysis temperature is kept unchanged at 55 ℃, the pH is adjusted to 9.0, and alkaline protease with the enzyme content of 3% is added for enzymolysis for 60 min. Centrifugally separating the enzymatic hydrolysis mixed solution to obtain oily liquid, water phase and solid residue; regulating pH of the water phase to 4.5, precipitating, centrifuging, and lyophilizing to obtain soybean polypeptide.
A preparation method of soybean polypeptide absorbable biological suture comprises the following steps:
(1) Weighing the components according to the formula amount, and continuously stirring chitosan, polycaprolactone, citric acid and glycerol for 75min under the condition of 600r/min to obtain a product A;
(2) Adding the product A obtained in the step (1) into a double-screw extruder for melt mixing, preparing master batches after water cooling, drying and granulating an extruded sample, drawing the master batches after melt defoaming, and stretching and shaping the prepared primary fibers in nitrogen at 25 ℃ to obtain finished fibers;
(3) Immersing the finished fiber prepared in the step (2) into 50 parts of soybean polypeptide ethanol extract, immersing for 60min at 25 ℃, taking out and drying, immersing for 60min at 25 ℃ again, taking out and drying, repeating the steps four times, sterilizing and packaging to obtain the product, namely the soybean polypeptide absorbable biological suture line.
The drying condition is that the drying is carried out for 45min at 70 ℃;
the temperature of the melt mixing is 120 ℃;
the temperature of the wire drawing is 155 ℃;
the sterilization is carried out under the ultraviolet light of 260-280nm for 30min.
EXAMPLE 3 Experimental Soy polypeptide absorbable biological suture for wound inflammation infection after mouse treatment
45 experimental mice are selected for the first time, and the weight is 230-260g. Mice were randomized into A, B, C groups of 15 mice each. Group A does not use suture; group B adopts soybean polypeptide absorbable biological suture, group C adopts common non-degradable suture, and three mice in group A, B, C are observed on the first day, third day, fifth day, seventh day and ninth day respectively.
Intraperitoneal injection anesthesia was performed with 3.5% chloral hydrate at 0.1ml/10g rat weight, with a needle insertion angle of 45 degrees to the body and a depth of about 1cm at the lower right abdominal cavity. The back of the mouse is dehaired by sodium sulfide, so that the mouse cannot lick a wound, a round area with the diameter of 1.0cm is punched on the skin by a puncher, and the wound is immediately wrapped by a soybean polypeptide suture line after reaching fascia. The number of mice inflamed on the wound every two days was recorded from 24 hours after the experimental treatment, as shown in table 1-1.
TABLE 1-1 Effect of biological sutures on wound experiments
45 experimental mice are selected for the second time, and the weight is 230-260g. Mice were randomized into A, B, C groups of 15 mice each. A is not a suture line; group B adopts soybean polypeptide absorbable biological suture, group C adopts common non-degradable suture, and three mice in group A, B, C are observed on the first day, third day, fifth day, seventh day and ninth day respectively.
Intraperitoneal injection anesthesia was performed with 3.5% chloral hydrate at 0.1ml/10g rat weight, with a needle insertion angle of 45 degrees to the body and a depth of about 1cm at the lower right abdominal cavity. The back of the mouse is dehaired by sodium sulfide, so that the mouse cannot lick a wound, a round area with the diameter of 1.0cm is punched on the skin by a puncher, and the wound is immediately wrapped by a soybean polypeptide suture line after reaching fascia. The number of mice inflamed on the wound every two days was recorded from 24 hours after the experimental treatment, as shown in tables 1-2.
TABLE 1-2 Effect of biological sutures on wound experiments
45 experimental mice are selected for the third time, and the weight is 230-260g. Mice were randomized into A, B, C groups of 15 mice each. Group A does not use suture; group B adopts soybean polypeptide absorbable biological suture, group C adopts common non-degradable suture, and three mice in group A, B, C are observed on the first day, third day, fifth day, seventh day and ninth day respectively.
Intraperitoneal injection anesthesia was performed with 3.5% chloral hydrate at 0.1ml/10g rat weight, with a needle insertion angle of 45 degrees to the body and a depth of about 1cm at the lower right abdominal cavity. The back of the mouse is dehaired by sodium sulfide, so that the mouse cannot lick a wound, a round area with the diameter of 1.0cm is punched on the skin by a puncher, and the wound is immediately wrapped by a soybean polypeptide suture line after reaching fascia. The number of mice inflamed on the wound every two days was recorded from 24 hours after the experimental treatment, as shown in tables 1 to 3.
TABLE 1-3 Effect of biological sutures on wound experiments
The experimental results show that: compared with the control group, the soybean polypeptide experimental group mice and the common suture line group have certain effect of preventing wound inflammation, and the soybean polypeptide experimental group mice are superior to the common suture line group. From the experimental results, it can also be seen that there was no significant difference between the experimental group and the control group on the ninth day.
EXAMPLE 4 Soybean polypeptide absorbable biological suture experiments on changes in the Main physical Properties of the suture after wound treatment in mice
45 experimental mice, with a weight of 230-260g. Mice were randomly grouped into 3 groups of 15 mice each. The experiment was repeated three times, and three mice were observed for each experiment.
The control group was not changed, and anesthesia was performed by intraperitoneal injection with 3.5% chloral hydrate at a weight of 0.1ml/10g in rats, with the needle insertion point being the lower right abdominal cavity, the needle insertion angle being 45 degrees to the body, and the depth being about 1cm. The back of the mouse is dehaired by sodium sulfide, so that the mouse cannot lick a wound, a round area with the diameter of 1.0cm is punched on the skin by a puncher, and the wound is immediately wrapped by a soybean polypeptide suture line after reaching fascia. From the fifth day after the experimental treatment, sutures were removed from the mice every five days and the main physical properties were recorded, as shown in table 2 below.
TABLE 2 variation in wound suture strength, flexibility and diameter for groups of mice
The experimental results show that: compared with the unused suture, the main physical properties of the suture are not changed obviously within fifteen days before wound healing, and the strength, flexibility and diameter are reduced slightly after twenty days, but still meet the suture requirement.
Claims (4)
1. A soy polypeptide absorbable biosphere, characterized by comprising the following components: 40-50 parts of soybean polypeptide alcohol solution, 35-40 parts of chitosan, 7-9 parts of glycerol, 6-8 parts of polycaprolactone and 4-7 parts of citric acid;
the preparation method of the soybean polypeptide comprises the following steps:
cleaning soybean, crushing, extruding and puffing, mixing the extruded and puffed product with water, taking the mixture for enzymolysis to obtain an enzymolysis liquid, performing serial treatment on the enzymolysis liquid, controlling the temperature to be 55-60 ℃ and the pH to be 8.5, adding alkaline protease with the enzyme content of 2-3% for enzymolysis for 60-90min, keeping the enzymolysis temperature to be 55-60 ℃, adjusting the pH to be 9.0, adding alkaline protease with the enzyme content of 3-4% for enzymolysis for 45-60min, and performing centrifugal separation on the enzymolysis mixed liquid to obtain oily liquid, water phase and solid residues; regulating pH of the water phase to 4.5, precipitating, centrifuging, and lyophilizing to obtain soybean polypeptide;
the preparation method of the soybean polypeptide absorbable suture comprises the following steps: weighing the components according to the formula amount, and continuously stirring chitosan, polycaprolactone, citric acid and glycerol for 75min under the condition of 600r/min to obtain a product A; then adding the product A into a double-screw extruder for melt mixing, preparing the extruded sample into master batches after water cooling, drying and granulating, drawing the master batches after melt defoaming, and stretching and shaping the prepared primary fibers in nitrogen at 25-30 ℃ to obtain finished fibers; soaking the obtained fiber into 40-50 parts of soybean polypeptide ethanol extract, soaking at 25-30deg.C for 45-60min, taking out, drying, soaking again at 25-30deg.C for 60min, taking out, drying, repeating the steps four times, sterilizing, and packaging to obtain the final product, namely soybean polypeptide absorbable biological suture.
2. The soybean polypeptide absorbable biosphere of claim 1, wherein the soybean polypeptide is present at a level of 43.5-43.7%.
3. The soy polypeptide absorbable biosphere of claim 1, wherein the drying conditions are drying at 65-70 ℃ for 45min, the melt mixing temperature is 120-135 ℃, the melt drawing temperature is 155-165 ℃, and the sterilization is under 240-280nm uv light for 20-30 min.
4. The absorbable biological suture of soybean polypeptide of claim 1, wherein the soybean polypeptide ethanol extract is prepared by soaking in 35-55% ethanol solution for 12-24 hr, and filtering to obtain filtrate; the chitosan is 84% -87% deacetylated chitosan; the ratio of the soybean polypeptide to the ethanol solution is 7-8g to 200mL.
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| US5382431A (en) * | 1992-09-29 | 1995-01-17 | Skin Biology, Inc. | Tissue protective and regenerative compositions |
| US8349349B2 (en) * | 2006-02-28 | 2013-01-08 | Covidien Lp | Tissue adhesives and sealants and method for their use |
| KR20080061611A (en) * | 2006-12-28 | 2008-07-03 | 주식회사농심 | Natural soy peptide mixture as heme oxygenase-1 inducer |
| US11077169B2 (en) * | 2015-07-22 | 2021-08-03 | Temple University-Of The Commonwealth System Of Higher Education | Soy-derived bioactive peptides for use in compositions and methods for wound healing, tissue engineering, and regenerative medicine |
| WO2019094526A1 (en) * | 2017-11-08 | 2019-05-16 | President And Fellows Of Harvard College | Biomimetic pro-regenerative scaffolds and methods of use thereof |
| CN108187026A (en) * | 2018-03-16 | 2018-06-22 | 南京财经大学 | A kind of product that can promote wound healing |
| CN110302417A (en) * | 2019-06-18 | 2019-10-08 | 珠海稻田医疗科技有限公司 | A kind of antibacterial, biodegradable suture |
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