CN115400254A - A kind of Ruyi Jinhuang San Band-Aid and its research process - Google Patents

Abstract

The invention discloses a Ruyi Golden Powder Band-Aid and a research process, and relates to the technical field of Band-Aids, in particular to a Ruyi Golden Powder Band-Aid, comprising a base material, the surface of the base material is fixedly connected with a water-absorbing pad, and the surface of the base material is coated with Covered with acrylic glue, the surface of the absorbent pad is connected with a wound protection film, the surface of the wound protection film and the surface of the substrate are all adhered with protective tear strips, the material of the absorbent pad is fish skin collagen sponge, and Ruyi golden powder is built into the absorbent pad. The Ruyi Jinhuang San Band-Aid and its research process use fish skin collagen sponge as the hemostatic material of the water-absorbing pad, compounded with anti-inflammatory and antibacterial traditional Chinese medicine—Ruyi Jinhuang San to form a water-absorbing pad, so that the water-absorbing pad has good wound healing ability, hydrophilicity, and water absorption , water retention, etc., and fish skin collagen has good cytocompatibility and hemostatic performance. It is a new source of biomedical hemostatic materials.

Description

A kind of Ruyi Jinhuang San Band-Aid and its research process

technical field

The invention relates to the technical field of band-aids, in particular to a Ruyi golden powder band-aid and a research process.

Background technique

Band-aid is the most commonly used surgical drug carrier in daily life. It has the functions of hemostasis and wound protection, and is often used for acute small wound bleeding.

The existing band-aids in the market do not contain compound anti-inflammatory drugs and use absorbent cotton as the main material of the absorbent pad. The principle of hemostasis is mainly compression and hemostasis. However, such as Yunnan Baiyao Band-Aids, there are few band-aids with compound anti-inflammatory drugs of traditional Chinese medicine;

Through investigation, it can be found that new types of band-aids such as liquid band-aids have appeared on the market at present. Liquid band-aids are easy to apply, quickly form a film, and closely adhere to the skin, but are more expensive and inconvenient to carry. For this, we propose a Ruyi golden powder Band-aids and research processes.

Contents of the invention

Aiming at the deficiencies in the prior art, the present invention provides a kind of Ruyi Jinhuang San Band-Aid and its research process, which solves the problem that new types of Band-Aids such as liquid Band-Aids have appeared on the market in the above-mentioned background technology. The Liquid Band-Aids are easy to apply and quickly form a film. It fits closely with the skin but is expensive and inconvenient to carry.

In order to achieve the above object, the present invention is achieved through the following technical solutions: a kind of Ruyi Jinhuang San Band-Aid, comprising a base material, the surface of the base material is fixedly connected with a water-absorbing pad, the surface of the base material is coated with acrylic glue, the The surface of the water-absorbing pad is connected with a wound protection film, and the surface of the wound protection film and the surface of the base material are all adhered with protective tear strips. The material of the water-absorbing pad is fish skin collagen sponge, and the water-absorbing pad is built with Ruyi golden powder.

Preferably, the material of the base material is a PU type base material, and the end is in the shape of a round head.

Preferably, the wound protection film adopts a porous polyethylene perforated film.

A research process of Ruyi Jinhuang San Band-Aid, comprising the following steps:

S1: Research on fish skin glue; use collagen extracted from tilapia fish skin as the main raw material, and judge its feasibility as a biological dressing for wound healing mainly from the aspects of physical properties, biological safety, and animal in vivo activity ,

By measuring the microstructure, tensile strength, porosity, and water absorption of the fish skin collagen sponge, it is shown that the fish skin collagen sponge is regularly arranged in fibers, and the pore size is between 100-200 μm, which can effectively resist the invasion of foreign matter from the outside; it has good pores High rate and water absorption performance, can absorb wound blood and tissue exudate, and provide enough contact surface and growth space for cell proliferation; and the tensile strength is small, the tensile force is lower than that of composite materials, which can reduce the impact on the skin The secondary injury of tearing,

Studies have shown that the hemolysis rate of fish skin collagen sponge is far lower than the standard stipulated for medical device samples, and it can be considered that it does not cause hemolysis reaction; mice have no adverse clinical reactions, and their weight changes are normal, with a slight increase in body weight, indicating that fish Skin collagen has no potential toxicity in a short period of time; compared with the negative group, the fish skin collagen test group has no negative impact on the spleen and thymus of mice, and does not cause erythema edema in mice, which proves that the material has no obvious toxic effect on immune organs. Under the experimental conditions, there is no sensitization, and the local reaction test after implantation also confirmed that the fish skin collagen sponge has good biocompatibility, and its degradation in rats is better, the inflammatory response is small, and the number of fibroblasts increases , conducive to wound healing;

S2: Research on Ruyi Jinhuang Powder; the study conducted an irritation test on rabbits with Zengxiao Ruyi Jinhuang Ointment. Antibacterial, anti-inflammatory, and wound-healing effects,

The bacteriostasis experiment of Ruyi Jinhuang powder shows that the drug has antibacterial effect at a certain concentration, and its sensitivity is from large to small: hemolytic streptococcus, staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli, week established a model of granulation sac inflammation, and then applied Jinhuang Sanshui externally for 8 days. The results showed that the drug can protect vascular endothelial cells and reduce vascular permeability, thereby achieving the effects of detumescence and anti-inflammation.

The mechanism of the heat-clearing and detoxifying effect of Ruyi Jinhuang Powder may be related to the expression of interferon INF-γ. The anti-inflammatory effect of Ruyi Jinhuang Powder may be related to the regulation of the expression and release of inflammatory mediators such as tumor necrosis factor TNF-α. Staphylococcus aureus After infecting the wounds of rats, one group applied Jinhuang ointment externally, plus intramuscular injection of penicillin, and the other group used penicillin alone. After the solution was diluted 100 times, it was injected into the peritoneal cavity of mice, and compared with Refnur and normal saline, the survival rate of macrophages and the phagocytosis of foreign bodies were finally measured, revealing the anti-infection and detumescence effects of this drug. Regulating the body and enhancing the body's resistance to disease. Wang's experiment shows that macrophages are activated after using Jinhuang powder, which can increase the volume of phagocytic cells, increase pseudopodia, increase vesicles, and move directionally, so as to achieve phagocytosis and killing. kill bacteria,

Studies have found that Jinhuang Powder can promote the secretion of lysozyme, increase its content in animal purulent secretions, and promote lymphocyte transformation, thereby eliminating microorganisms and improving the body's anti-inflammatory ability. According to research, Ruyi Golden Powder is clinically made into Papua Dosage forms such as medicament, black ointment, and film can better exert its anti-inflammatory and analgesic effects, and have remarkable effects in the treatment of internal, external, gynecological, and pediatric diseases;

S3: Extraction of active ingredients of Ruyi Jinhuang Powder;

S3.1. Extract the volatile oil of Ruyi Jinhuang Powder by steam distillation for later use.

S3.2, take the distilled medicine dregs, etc., add ethanol, heat and reflux twice, recover ethanol under reduced pressure,

S3.3. Add water to decoct the remaining medicinal residues, decoct twice, combine the filtrate, heat and concentrate the extract to a density of 1.25 to obtain the active ingredient of Ruyi Jinhuang Powder;

S4: Preparation of fish skin collagen sponge; all steps were performed at 4 °C to minimize collagen denaturation,

S4.1, soak the tilapia fish skin piece with 0.1mol/L NaOH for 24 hours, and stir continuously, to remove non-collagen protein substances,

S4.2. Wash the fish skin repeatedly with cooled deionized water to ensure that the NaOH is washed out.

S4.3, add 0.5mol/L acetic acid at a ratio of 1:50, extract for two days,

S4.4. After two days, centrifuge it at 10,000 rpm for 30 minutes at 4°C,

S4.5, collecting the supernatant, adding NaCl to the collected supernatant until reaching a concentration of 0.9mol/L to salt out the collagen,

S4.6. Centrifuge at 10,000 rpm for 30 minutes at 4°C to separate the precipitated collagen and dissolve it again in 0.5 mol/L acetic acid.

S4.7. Using a dialysis membrane with a molecular weight cut-off of 50kDa, dialyze the collagen solution in 0.1mol/L acetic acid for 24 hours, then dialyze it in ultrapure water for 48 hours, and change the water every eight hours.

S4.8, freeze-dry the obtained collagen for three days, and seal it in a polyethylene bag,

Extraction rate ASC yield (%)=weight (grams) of dry collagen × 100/weight (grams) of dry skin;

S5: Preparation of fish skin collagen sponge compounded with Ruyi Jinhuang Powder; after the fish skin collagen is extracted, add 0.6% glycerin with a mass fraction of 1% fish skin collagen, and stir evenly at a magnetic stirring speed of 100r/min , poured into a petri dish with a thickness of 5mm, placed in a freeze dryer, pre-frozen at -80°C for 24h, set the temperature curve to -80°C, vacuumed after 2h, increased to 35°C at a rate of 5°C/h, and kept at a constant temperature 15h, get the collagen sponge,

Dissolving the obtained extract in acetic acid to obtain Ruyi Jinhuangsan extract, immersing the prepared collagen sponge until it is fully absorbed, and air-drying naturally to obtain a fish skin collagen sponge compounded with Ruyi Jinhuangsan;

S6: Experimental research,

S6.1: Mouse auricle swelling experiment, take 15 healthy mice, weighing 18-22g, and randomly divide them into blank control group, single-layer Ruyi Jinhuang ointment external application group, and external application of fish skin collagen sponge combined with Ruyi Jinhuang ointment There are 3 groups in total, 5 in each group,

Each group was smeared locally on the right auricle, and the drug was administered as Ruyi Jinhuang Ointment 12-24g. The blank control group was given 70% ethanol, and the positive control group was externally applied for 3 days. After 0.5h of the last administration, 25μl xylene was applied. In the right auricle of the mouse, no drug was given to the left ear, which was kept as a control.

After 0.5 h, the mice were sacrificed by cervical dislocation, and the ears were cut off along the pinna line, and the ear pieces were punched at the same part of both ears with a puncher with a diameter of 8 mm, and weighed separately. As the ear swelling degree value, calculate the swelling degree inhibition rate, swelling degree=right ear piece weight-left ear piece weight, swelling degree inhibition rate (%)=(average swelling degree of model group-average swelling degree of drug administration group)/model group The average swelling degree × 100%, to explore the anti-inflammatory effect of Ruyi Jinhuang powder external application in different states,

S6.2: Construction of mouse skin excision trauma model

Each mouse was anesthetized by intraperitoneally injecting 0.01ml/g of 10% chloral hydrate solution,

After the mouse is anesthetized, use sterile surgical scissors to cut off the hair on the back of the mouse, use an appropriate amount of depilatory cream for depilatory treatment, wash the back hair and residual depilatory cream with warm water, and dry the residual liquid on the back with dry and clean cotton.

Put the treated mice into a dry and clean environment to continue culturing for 24 hours,

The above-mentioned depilated mice were randomly divided into groups A, B, C, and D. The mice treated with ordinary band-aids without drugs were group A, and the mice treated with ordinary fish skin collagen sponge band-aids were group B. The mice treated with ordinary band-aids compounded with Ruyi Jinhuang Powder were group C, and the mice treated with this product, that is, fish skin collagen sponge compounded with Ruyi Golden Powder band-aids, were group D. Two mice were fluorescently labeled as 1, 2, and 3 respectively. , No. 4, after povidone iodine disinfection, use a puncher to make a total skin excision wound with a diameter of 8 mm on both sides of the back of the mouse,

In group A, the wound on the left side was treated without any treatment, and the wound on the right side was treated with ordinary band-aid; in group B, the wound on the left side was treated without any treatment, and the wound on the right side was treated with ordinary fish skin collagen sponge band-aid; group C In group D, the wound on the left side was left without any treatment, and the wound on the right side was treated with ordinary band-aid compounded with Ruyi Jinhuang San; in group D, the wound on the left side was treated without any treatment, and the wound on the right side was treated with this product.

After the operation, the mice were normally kept in cages and given a normal diet.

After trauma treatment, observe the hemostasis and scar conditions of the total skin resection wounds in the two groups of mice, and record the hemostasis time and scar size of each wound.

On the 0th, 4th, 6th, 10th and 14th day after treatment, observe and record the healing and scar conditions of the mouse skin wounds treated with four groups of different band-aids, take pictures and record the size of each wound And calculate the condensation percentage of the wound (healing area/wound area×100%), and analyze the results.

The present invention provides a Ruyi Jinhuang San Band-Aid and a research process, which have the following beneficial effects:

1. The Ruyi Golden Powder Band-Aid and the research process, through the combined use of protective tear strips, wound protection film, absorbent pads, substrates, and Ruyi Golden Powder, the use of protective tear strips can protect the glue viscosity of the substrate; protect the wound The protective film and absorbent pad are not polluted by dust, etc., and the wound protective film is made of porous polyethylene permeable film to prevent the wound surface from sticking to the absorbent pad surface and cause pain when unwrapping; to make the drug seep out smoothly; blood and wound exudate It can be absorbed by the absorbent pad smoothly. The fish skin collagen sponge is used as the hemostatic material of the absorbent pad, and the anti-inflammatory and antibacterial traditional Chinese medicine-Ruyi Jinhuang powder is combined to form an absorbent pad, so that the absorbent pad has good wound healing ability, hydrophilicity, water absorption, Water retention, etc., and fish skin collagen has good cytocompatibility and hemostatic performance. It is a source of new biomedical hemostatic materials. This layer can store anti-inflammatory traditional Chinese medicine; absorb blood and exudate; oppress hemostasis, which is conducive to wound healing. Reduce scar formation, and Ruyi Jinhuang San can better stop bleeding and promote wound healing. By using PU-type base material close to skin color as the base material, its main function is to make the hemostatic part of the Band-Aid stick firmly to the wound and improve the hemostatic effect, and PU The type base material has good comprehensive performance, comfortable and beautiful. The glue is selected from acrylic glue suitable for PU type base material. It has low allergies, good initial adhesion, moderate peeling degree and no sticking hair when tearing the band-aid, thus providing a kind of A new type of Ruyi Jinhuangsan Band-Aid that stops bleeding, promotes wound healing, and reduces scar formation.

2. The Ruyi Jinhuang San Band-Aid and its research process, by establishing a model of swelling of the outer ear of mice with inflammation, to explore the anti-inflammatory effect of Ruyi Jinhuang San external application in different states, and at the same time, to compare the effects of Ruyi Jinhuang San Band-Aid on mice The hemostatic and healing effects of skin excision wounds, and then determine the role of this Ruyi Jinhuang San Band-Aid.

Description of drawings

Fig. 1 is the structural representation of Ruyi golden powder band-aid of the present invention;

Fig. 2 is a schematic structural view of the back of the Ruyi Golden Powder Band-Aid of the present invention;

Fig. 3 is the structural representation of research flow process of the present invention;

Fig. 4 is a schematic diagram of mouse skin excision modeling of the present invention.

In the figure: 1. Protective tear strip; 2. Wound protective film; 3. Absorbent pad; 4. Base material.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention.

Please refer to Fig. 1 to Fig. 2, the present invention provides a kind of technical scheme: a kind of Ruyi golden loose band-aid, comprises base material 4, and the surface of base material 4 is fixedly connected with water-absorbing pad 3, and the surface of base material 4 is coated with acrylic glue,

Selection of mucilage: The solvent-based zinc oxide mucilage commonly used in elastic cloth band-aids has a high allergy rate. The choice of glue should be related to the substrate, and the following aspects should be considered at the same time: ①Initial adhesion; Generally speaking, the initial adhesion of acrylic adhesive is good, and the degree of peeling is moderate, but when using acrylic adhesive, it is necessary to balance the relationship between initial adhesion and stickiness.

The surface of the water-absorbing pad 3 is connected with a wound protection film 2, and the surface of the wound protection film 2 and the surface of the base material 4 are adhered with a protective tear strip 1. The material of the water-absorbing pad 3 is fish skin collagen sponge, and the water-absorbing pad 3 has a built-in wish golden scattered,

Among them, the material of the base material 4 is a PU base material, and the end is in the shape of a round head. As a band-aid base material, the elastic cloth is not ideal in terms of waterproofness, softness, texture, and air permeability. It will surely replace elastic cloth, especially PU, with obvious comprehensive advantages.

Wherein, the wound protection film 2 adopts a porous polyethylene perforated film.

The glue viscosity of the base material 4 can be protected by the protection tear strip 1, and the wound protection film 2 and the absorbent pad 3 are not polluted by dust, etc., and the wound protection film 2 is made of a porous polyethylene perforated film. Prevent the wound surface from sticking to the absorbent pad surface and cause pain when uncovering; make the medicine seep out smoothly; blood and wound exudate can be smoothly absorbed by the absorbent pad, use fish skin collagen sponge as the hemostatic material of the absorbent pad, and compound anti-inflammatory and antibacterial traditional Chinese medicine ——Ruyi Jinhuang powder forms a water-absorbing pad 3, so that the water-absorbing pad 3 has good wound healing ability, hydrophilicity, water absorption, water retention, etc.

Moreover, fish skin collagen has good cell compatibility and hemostatic performance, and is a source of new biomedical hemostatic materials. This layer can store anti-inflammatory traditional Chinese medicine; absorb blood and exudate; oppress hemostasis, which is beneficial to wound healing and reduces scar formation. Moreover, Ruyi Jinhuang Powder can better stop bleeding and promote wound healing. By using PU-type base material close to skin color as the base material 4, its main function is to make the hemostatic part of the Band-Aid stick to the wound firmly and improve the hemostatic effect, and the PU-type base material Good overall performance, comfortable and beautiful. The glue is made of acrylic glue suitable for PU-type substrates. It has low allergies, good initial adhesion, moderate peeling degree and no hair sticking when the band-aid is torn, thus providing a hemostasis and promoting A new type of Ruyi Jinhuangsan Band-Aid for wound healing and reduction of scar formation.

Please refer to Figure 3 to Figure 4, a research process of Ruyi Jinhuang San Band-Aid, including the following steps:

S1: Research on fish skin glue; use collagen extracted from tilapia fish skin as the main raw material, and judge its feasibility as a biological dressing for wound healing from the aspects of physical properties, biological safety, and animal in vivo activity. ,

By measuring the microstructure, tensile strength, porosity, and water absorption of the fish skin collagen sponge, it is shown that the fish skin collagen sponge is regularly arranged in fibers, and the pore size is between 100-200 μm, which can effectively resist the invasion of foreign matter from the outside; it has good pores High rate and water absorption performance, can absorb wound blood and tissue exudate, and provide enough contact surface and growth space for cell proliferation; and the tensile strength is small, the tensile force is lower than that of composite materials, which can reduce the impact on the skin The secondary injury of tearing,

Studies have shown that the hemolysis rate of fish skin collagen sponge is far lower than the standard stipulated for medical device samples, and it can be considered that it does not cause hemolysis reaction; mice have no adverse clinical reactions, and their weight changes are normal, with a slight increase in body weight, indicating that fish Skin collagen has no potential toxicity in a short period of time; compared with the negative group, the fish skin collagen test group has no negative impact on the spleen and thymus of mice, and does not cause erythema edema in mice, which proves that the material has no obvious toxic effect on immune organs. Under the experimental conditions, there is no sensitization, and the local reaction test after implantation also confirmed that the fish skin collagen sponge has good biocompatibility, and its degradation in rats is better, the inflammatory response is small, and the number of fibroblasts increases , conducive to wound healing;

S2: Research on Ruyi Jinhuang Powder; the study conducted an irritation test on rabbits with Zengxiao Ruyi Jinhuang Ointment. Antibacterial, anti-inflammatory, and wound-healing effects,

The bacteriostasis experiment of Ruyi Jinhuang powder shows that the drug has antibacterial effect at a certain concentration, and its sensitivity is from large to small: hemolytic streptococcus, staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli, week established a model of granulation sac inflammation, and then applied Jinhuang Sanshui externally for 8 days. The results showed that the drug can protect vascular endothelial cells and reduce vascular permeability, thereby achieving the effects of detumescence and anti-inflammation.

The mechanism of the heat-clearing and detoxifying effect of Ruyi Jinhuang Powder may be related to the expression of interferon INF-γ. The anti-inflammatory effect of Ruyi Jinhuang Powder may be related to the regulation of the expression and release of inflammatory mediators such as tumor necrosis factor TNF-α. Staphylococcus aureus After infecting the wounds of rats, one group applied Jinhuang ointment externally, plus intramuscular injection of penicillin, and the other group used penicillin alone. After the solution was diluted 100 times, it was injected into the peritoneal cavity of mice, and compared with Refnur and normal saline, the survival rate of macrophages and the phagocytosis of foreign bodies were finally measured, revealing the anti-infection and detumescence effects of this drug. Regulating the body and enhancing the body's resistance to disease. Wang's experiment shows that macrophages are activated after using Jinhuang powder, which can increase the volume of phagocytic cells, increase pseudopodia, increase vesicles, and move directionally, so as to achieve phagocytosis and killing. kill bacteria,

Studies have found that Jinhuang Powder can promote the secretion of lysozyme, increase its content in animal purulent secretions, and promote lymphocyte transformation, thereby eliminating microorganisms and improving the body's anti-inflammatory ability. According to research, Ruyi Golden Powder is clinically made into Papua Dosage forms such as medicament, black ointment, and film can better exert its anti-inflammatory and analgesic effects, and have remarkable effects in the treatment of internal, external, gynecological, and pediatric diseases;

S3: Extraction of active ingredients of Ruyi Jinhuang Powder;

S3.1. Extract the volatile oil of Ruyi Jinhuang Powder by steam distillation for later use.

S3.2, take the distilled medicine dregs, etc., add ethanol, heat and reflux twice, recover ethanol under reduced pressure,

S3.3. Add water to decoct the remaining medicinal residues, decoct twice, combine the filtrate, heat and concentrate the extract to a density of 1.25 to obtain the active ingredient of Ruyi Jinhuang Powder;

S4: Preparation of fish skin collagen sponge; all steps were performed at 4 °C to minimize collagen denaturation,

S4.1, soak the tilapia fish skin piece with 0.1mol/L NaOH for 24 hours, and stir continuously, to remove non-collagen protein substances,

S4.2. Wash the fish skin repeatedly with cooled deionized water to ensure that the NaOH is washed out.

S4.3, add 0.5mol/L acetic acid at a ratio of 1:50, extract for two days,

S4.4. After two days, centrifuge it at 10,000 rpm for 30 minutes at 4°C,

S4.5, collecting the supernatant, adding NaCl to the collected supernatant until reaching a concentration of 0.9mol/L to salt out the collagen,

S4.6. Centrifuge at 10,000 rpm for 30 minutes at 4°C to separate the precipitated collagen and dissolve it again in 0.5 mol/L acetic acid.

S4.7. Using a dialysis membrane with a molecular weight cut-off of 50kDa, dialyze the collagen solution in 0.1mol/L acetic acid for 24 hours, then dialyze it in ultrapure water for 48 hours, and change the water every eight hours.

S4.8, freeze-dry the obtained collagen for three days, and seal it in a polyethylene bag,

Extraction rate ASC yield % = weight gram of dry collagen × 100/weight gram of dry skin;

S5: Preparation of fish skin collagen sponge compounded with Ruyi Jinhuang Powder; after the fish skin collagen is extracted, add 0.6% glycerin with a mass fraction of 1% fish skin collagen, and stir evenly at a magnetic stirring speed of 100r/min , poured into a petri dish with a thickness of 5mm, placed in a freeze dryer, pre-frozen at -80°C for 24h, set the temperature curve to -80°C, vacuumed after 2h, increased to 35°C at a rate of 5°C/h, and kept at a constant temperature 15h, get the collagen sponge,

Dissolving the obtained extract in acetic acid to obtain Ruyi Jinhuangsan extract, immersing the prepared collagen sponge until it is fully absorbed, and air-drying naturally to obtain a fish skin collagen sponge compounded with Ruyi Jinhuangsan;

S6: Experimental research,

S6.1: Mouse auricle swelling experiment, take 15 healthy mice, weighing 18-22g, and randomly divide them into blank control group, single-layer Ruyi Jinhuang ointment external application group, and external application of fish skin collagen sponge combined with Ruyi Jinhuang ointment There are 3 groups in total, 5 in each group,

Each group was smeared locally on the right auricle, and the drug was administered as Ruyi Jinhuang Ointment 12-24g. The blank control group was given 70% ethanol, and the positive control group was externally applied for 3 days. After 0.5h of the last administration, 25μl xylene was applied. In the right auricle of the mouse, no drug was given to the left ear, which was kept as a control.

After 0.5 h, the mice were sacrificed by cervical dislocation, and the ears were cut off along the pinna line, and the ear pieces were punched at the same part of both ears with a puncher with a diameter of 8 mm, and weighed separately. As the ear swelling degree value, calculate the swelling degree inhibition rate, swelling degree=right ear piece weight-left ear piece weight, swelling degree inhibition rate (%)=(average swelling degree of model group-average swelling degree of drug administration group)/model group The average swelling degree × 100%, to explore the anti-inflammatory effect of Ruyi Jinhuang powder external application in different states,

S6.2: Construction of mouse skin excision trauma model, please refer to Figure 4,

Experimental animals: 8 healthy male mice of the same or similar age and size were injected intraperitoneally with 10% chloral hydrate solution 0.01ml/g for anesthesia.

After the mouse is anesthetized, use sterile surgical scissors to cut off the hair on the back of the mouse, use an appropriate amount of depilatory cream for depilatory treatment, wash the back hair and residual depilatory cream with warm water, and dry the residual liquid on the back with dry and clean cotton.

Put the treated mice into a dry and clean environment to continue culturing for 24 hours,

The above-mentioned depilated mice were randomly divided into groups A, B, C, and D. The mice treated with ordinary band-aids without drugs were group A, and the mice treated with ordinary fish skin collagen sponge band-aids were group B. The mice treated with ordinary band-aids compounded with Ruyi Jinhuang Powder were group C, and the mice treated with this product, that is, fish skin collagen sponge compounded with Ruyi Golden Powder band-aids, were group D. Two mice were fluorescently labeled as 1, 2, and 3 respectively. , No. 4, after povidone iodine disinfection, use a puncher to make a total skin excision wound with a diameter of 8 mm on both sides of the back of the mouse,

In group A, the wound on the left side was treated without any treatment, and the wound on the right side was treated with ordinary band-aid; in group B, the wound on the left side was treated without any treatment, and the wound on the right side was treated with ordinary fish skin collagen sponge band-aid; group C In group D, the wound on the left side was left without any treatment, and the wound on the right side was treated with ordinary band-aid compounded with Ruyi Jinhuang San; in group D, the wound on the left side was treated without any treatment, and the wound on the right side was treated with this product.

After the operation, the mice were normally kept in cages and given a normal diet.

After trauma treatment, observe the hemostasis and scar conditions of the total skin resection wounds in the two groups of mice, and record the hemostasis time and scar size of each wound.

On the 0th, 4th, 6th, 10th and 14th day after treatment, observe and record the healing and scar conditions of the mouse skin wounds treated with four groups of different band-aids, take pictures and record the size of each wound And calculate the percentage of wound condensation healing area/wound area × 100%, and analyze the results.

Ruyi Jinhuang San Band-Aid adopts the method of "coating-cutting-composite-packaging-sterilization" to make a round head-shaped Band-Aid based on PU, which uses fish skin collagen sponge as an absorbent pad and compound Ruyi Jinhuang San anti-inflammatory drugs. Version.

Economic benefits: Band-Aids on the market basically use absorbent cotton as the main material of the absorbent pad without compound anti-inflammatory drugs, and its hemostatic principle is mainly to stop bleeding by compression, and there are problems such as poor anti-inflammatory function, high price or inconvenient to carry. The new type of biological skin band-aid produced by our team will use fish skin collagen instead of absorbent cotton as a water-absorbing pad, compounded with Chinese medicine Ruyi Jinhuang Powder, which not only has better water absorption, hemostasis, wound protection, and improved wound healing. Effect, anti-inflammatory, antibacterial, Antispasmodic and analgesic effect.

At the same time, we will use low-cost tilapia fish skin as the main raw material for fish skin collagen extraction. The raw material is cheap and not too expensive, which is conducive to the acceptance of ordinary consumers and will provide a wound treatment with more reliable curative effect and convenient application for the majority of patients. new selection.

Social benefits: Aquatic animal source collagen dressing is one of the most widely used biomedical dressings, including collagen sponge, collagen patch, etc. Domestic scholar Li Jie et al. used tilapia fish skin as raw material to prepare medical collagen sponge. Through research, it has been confirmed that its microstructure is stable, and its high porosity and interconnected structure have obvious effects on the absorption of wound exudate, oxygen supply and cell proliferation. It is an excellent wound dressing in the field of biomedical materials.

Collagen patch can be used as a dermis substitute in vitro and a therapeutic dressing for burns and scalds. A new type of collagen burn healing film was prepared by compounding Ruyi Jinhuang powder with collagen, which not only has excellent biocompatibility, but also has antibacterial, anti-inflammatory and anti-allergic effects. In addition, the film can absorb wound secretions and slowly release drugs in the film, and can also promote the growth of epithelial cells and reduce the degree of contraction of wounds. It is an ideal treatment material for burn wounds.

Antioxidant ability is one of the most significant pharmacological effects of collagen. Relevant studies have shown that fish skin collagen peptides have good performance in terms of DPPH scavenging ability, hydroxyl radical scavenging ability, superoxide anion free radical scavenging ability, reducing ability, anti-lipid peroxidation ability and metal ion binding ability. Antioxidant activity.

To sum up, the Ruyi Jinhuang San Band-Aid and the research process, when used, extract the volatile oil of Ruyi Jinhuang Powder by steam distillation for later use, take the distilled medicine dregs, etc., add ethanol to heat and reflux twice, recover the ethanol under reduced pressure, and add water to the remaining medicine dregs Decoct, decoct twice, combine the filtrate, heat and concentrate the extract to a density of 1.25 to obtain the active ingredient of Ruyi Jinhuang Powder;

Preparation of fish skin collagen sponge; all steps were performed at 4 °C to minimize collagen denaturation, and tilapia fish skin pieces were soaked in 0.1 mol/L NaOH for 24 h with continuous stirring to remove non- Collagen substance, wash the fish skin repeatedly with cooled deionized water to ensure that the NaOH is washed out, add 0.5mol/L acetic acid at a ratio of 1:50, extract for two days, and after two days, put it at 10000rpm at 4°C Centrifuge for 30 minutes, collect the supernatant, add NaCl to the collected supernatant until reaching a concentration of 0.9mol/L to salt out the collagen, and then centrifuge at 10,000rpm at 4°C for 30 minutes to separate the precipitated collagen , and redissolve it in 0.5mol/L acetic acid, use a dialysis membrane with a molecular weight cut-off of 50kDa, dialyze the collagen solution in 0.1mol/L acetic acid for 24 hours, and then dialyze it in ultrapure water for 48 hours, The water was changed every eight hours, and the obtained collagen was freeze-dried for three days and sealed in polyethylene bags,

After the fish skin collagen is extracted, add 0.6% glycerin to the fish skin collagen with a mass fraction of 1%, stir evenly at a magnetic stirring speed of 100r/min, pour it into a petri dish with a thickness of 5mm, and place it in the freezer In the dryer, pre-freeze at -80°C for 24h, set the temperature curve to -80°C, vacuum after 2h, increase to 35°C at a rate of 5°C/h, and keep the temperature for 15h to obtain collagen sponge.

Dissolving the obtained extract in acetic acid to obtain Ruyi Jinhuangsan extract, immersing the prepared collagen sponge until it is fully absorbed, and air-drying naturally to obtain a fish skin collagen sponge compounded with Ruyi Jinhuangsan;

Production process, the production process of Band-Aid is generally: coating - cutting - compounding - packaging - sterilization. The first step is compounding, which is to compound the slit base material master roll with the absorbent pad cover paper; the second step is punching, which is to punch the compounded base material into a Band-Aid patch; the third step is packaging, which is to make the Band-aid patch Placed in double-layer cold-sealed paper, pressed, cut, and packaged.

The above is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Anyone familiar with the technical field within the technical scope disclosed in the present invention, according to the technical solutions of the present invention and its Any equivalent replacement or change of the inventive concept shall fall within the protection scope of the present invention.

Claims (4)

1. A Ruyi golden powder band-aid, comprising a base material (4), is characterized in that: the surface of the base material (4) is fixedly connected with a water-absorbing pad (3), and the surface of the base material (4) is coated with acrylic acid glue, the surface of the absorbent pad (3) is connected with a wound protection film (2), and the surface of the wound protection film (2) and the surface of the base material (4) are all adhered with protective tear strips (1), so The material of the water-absorbing pad (3) is fish skin collagen sponge, and the water-absorbing pad (3) has built-in Ruyi golden powder. 2. A kind of Ruyi Golden San Band-Aid according to claim 1, characterized in that: the material of the base material (4) is a PU base material, and the end is in the shape of a round head. 3. A kind of Ruyi Jinhuang San Band-Aid and research process according to claim 1, characterized in that: the wound protection film (2) adopts porous polyethylene perforated film. 4. The research flow of a kind of Ruyi Jinhuang San Band-Aid according to claim 1, characterized in that: comprising the following steps: S1: Research on fish skin glue; use collagen extracted from tilapia fish skin as the main raw material, and judge its feasibility as a biological dressing for wound healing from the aspects of physical properties, biological safety, and animal in vivo activity. , By measuring the microstructure, tensile strength, porosity, and water absorption of the fish skin collagen sponge, it is shown that the fish skin collagen sponge is regularly arranged in fibers, and the pore size is between 100-200 μm, which can effectively resist the invasion of foreign matter from the outside; it has good pores High rate and water absorption performance, can absorb wound blood and tissue exudate, and provide enough contact surface and growth space for cell proliferation; and the tensile strength is small, the tensile force is lower than that of composite materials, which can reduce the impact on the skin The secondary injury of tearing, Studies have shown that the hemolysis rate of fish skin collagen sponge is far lower than the standard stipulated for medical device samples, and it can be considered that it does not cause hemolysis reaction; mice have no adverse clinical reactions, and their weight changes are normal, with a slight increase in body weight, indicating that fish Skin collagen has no potential toxicity in a short period of time; compared with the negative group, the fish skin collagen test group has no negative impact on the spleen and thymus of mice, and does not cause erythema edema in mice, which proves that the material has no obvious toxic effect on immune organs. Under the experimental conditions, there is no sensitization, and the local reaction test after implantation also confirmed that the fish skin collagen sponge has good biocompatibility, and its degradation in rats is better, the inflammatory response is small, and the number of fibroblasts increases , conducive to wound healing; S2: Research on Ruyi Jinhuang Powder; the study conducted an irritation test on rabbits with Zengxiao Ruyi Jinhuang Ointment. Antibacterial, anti-inflammatory, and wound-healing effects, The bacteriostasis experiment of Ruyi Jinhuang powder shows that the drug has antibacterial effect at a certain concentration, and its sensitivity is from large to small: hemolytic streptococcus, staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli, week established a model of granulation sac inflammation, and then applied Jinhuang Sanshui externally for 8 days. The results showed that the drug can protect vascular endothelial cells and reduce vascular permeability, thereby achieving the effects of detumescence and anti-inflammation. The mechanism of the heat-clearing and detoxifying effect of Ruyi Jinhuang Powder may be related to the expression of interferon INF-γ. The anti-inflammatory effect of Ruyi Jinhuang Powder may be related to the regulation of the expression and release of inflammatory mediators such as tumor necrosis factor TNF-α. Staphylococcus aureus After infecting the wounds of rats, one group applied Jinhuang ointment externally, plus intramuscular injection of penicillin, and the other group used penicillin alone. After the solution was diluted 100 times, it was injected into the peritoneal cavity of mice, and compared with Refnur and normal saline, the survival rate of macrophages and the phagocytosis of foreign bodies were finally measured, revealing the anti-infection and detumescence effects of this drug. Regulating the body and enhancing the body's resistance to disease. Wang's experiment shows that macrophages are activated after using Jinhuang powder, which can increase the volume of phagocytic cells, increase pseudopodia, increase vesicles, and move directionally, so as to achieve phagocytosis and killing. kill bacteria, Studies have found that Jinhuang Powder can promote the secretion of lysozyme, increase its content in animal purulent secretions, and promote lymphocyte transformation, thereby eliminating microorganisms and improving the body's anti-inflammatory ability. According to research, Ruyi Golden Powder is clinically made into Papua Dosage forms such as medicament, black ointment, and film can better exert its anti-inflammatory and analgesic effects, and have remarkable effects in the treatment of internal, external, gynecological, and pediatric diseases; S3: Extraction of active ingredients of Ruyi Jinhuang Powder; S3.1. Extract the volatile oil of Ruyi Jinhuang Powder by steam distillation for later use. S3.2, take the distilled medicine dregs, etc., add ethanol, heat and reflux twice, recover ethanol under reduced pressure, S3.3. Add water to decoct the remaining medicinal residues, decoct twice, combine the filtrate, heat and concentrate the extract to a density of 1.25 to obtain the active ingredient of Ruyi Jinhuang Powder; S4: Preparation of fish skin collagen sponge; all steps were performed at 4 °C to minimize collagen denaturation, S4.1, soak the tilapia fish skin piece with 0.1mol/L NaOH for 24 hours, and stir continuously, to remove non-collagen protein substances, S4.2. Wash the fish skin repeatedly with cooled deionized water to ensure that the NaOH is washed out. S4.3, add 0.5mol/L acetic acid at a ratio of 1:50, extract for two days, S4.4. After two days, centrifuge it at 10,000 rpm for 30 minutes at 4°C, S4.5, collecting the supernatant, adding NaCl to the collected supernatant until reaching a concentration of 0.9mol/L to salt out the collagen, S4.6. Centrifuge at 10,000 rpm for 30 minutes at 4°C to separate the precipitated collagen and dissolve it again in 0.5 mol/L acetic acid. S4.7. Using a dialysis membrane with a molecular weight cut-off of 50kDa, dialyze the collagen solution in 0.1mol/L acetic acid for 24 hours, then dialyze it in ultrapure water for 48 hours, and change the water every eight hours. S4.8, freeze-dry the obtained collagen for three days, and seal it in a polyethylene bag, Extraction rate ASC yield (%)=weight (grams) of dry collagen × 100/weight (grams) of dry skin; S5: Preparation of fish skin collagen sponge compounded with Ruyi Jinhuang Powder; after the fish skin collagen is extracted, add 0.6% glycerin with a mass fraction of 1% fish skin collagen, and stir evenly at a magnetic stirring speed of 100r/min , poured into a petri dish with a thickness of 5mm, placed in a freeze dryer, pre-frozen at -80°C for 24h, set the temperature curve to -80°C, vacuumed after 2h, increased to 35°C at a rate of 5°C/h, and kept at a constant temperature 15h, get the collagen sponge, Dissolving the obtained extract in acetic acid to obtain Ruyi Jinhuangsan extract, immersing the prepared collagen sponge until it is fully absorbed, and air-drying naturally to obtain a fish skin collagen sponge compounded with Ruyi Jinhuangsan; S6: Experimental research; S6.1: Mouse auricle swelling experiment, take 15 healthy mice, weighing 18-22g, and randomly divide them into blank control group, single-layer Ruyi Jinhuang ointment external application group, and external application of fish skin collagen sponge combined with Ruyi Jinhuang ointment There are 3 groups in total, 5 in each group, Each group was smeared locally on the right auricle, and the drug was administered as Ruyi Jinhuang Ointment 12-24g. The blank control group was given 70% ethanol, and the positive control group was externally applied for 3 days. After 0.5h of the last administration, 25μl xylene was applied. In the right auricle of the mouse, no drug was given to the left ear, which was kept as a control. After 0.5 h, the mice were sacrificed by cervical dislocation, and the ears were cut off along the pinna line, and the ear pieces were punched at the same part of both ears with a puncher with a diameter of 8 mm, and weighed separately. As the ear swelling degree value, calculate the swelling degree inhibition rate, swelling degree=right ear piece weight-left ear piece weight, swelling degree inhibition rate (%)=(average swelling degree of model group-average swelling degree of drug administration group)/model group The average swelling degree × 100%, to explore the anti-inflammatory effect of Ruyi Jinhuang powder external application in different states, S6.2: Construction of mouse skin excision trauma model: Each mouse was anesthetized by intraperitoneally injecting 0.01ml/g of 10% chloral hydrate solution, After the mouse is anesthetized, use sterile surgical scissors to cut off the hair on the back of the mouse, use an appropriate amount of depilatory cream for depilatory treatment, wash the back hair and residual depilatory cream with warm water, and dry the residual liquid on the back with dry and clean cotton. Put the treated mice into a dry and clean environment to continue culturing for 24 hours, The above-mentioned depilated mice were randomly divided into groups A, B, C, and D. The mice treated with ordinary band-aids without drugs were group A, and the mice treated with ordinary fish skin collagen sponge band-aids were group B. The mice treated with ordinary band-aids compounded with Ruyi Jinhuang Powder were group C, and the mice treated with this product, that is, fish skin collagen sponge compounded with Ruyi Golden Powder band-aids, were group D. Two mice were fluorescently labeled as 1, 2, and 3 respectively. , No. 4, after povidone iodine disinfection, use a puncher to create a total skin excision wound with a diameter of 8 mm on both sides of the back of the mouse, In group A, the wound on the left side was treated without any treatment, and the wound on the right side was treated with ordinary band-aid; in group B, the wound on the left side was treated without any treatment, and the wound on the right side was treated with ordinary fish skin collagen sponge band-aid; group C In group D, the wound on the left side was left without any treatment, and the wound on the right side was treated with ordinary band-aid compounded with Ruyi Jinhuang San; in group D, the wound on the left side was treated without any treatment, and the wound on the right side was treated with this product. After the operation, the mice were normally kept in cages and given a normal diet. After trauma treatment, observe the hemostasis and scar conditions of the total skin resection wounds in the two groups of mice, and record the hemostasis time and scar size of each wound. On the 0th, 4th, 6th, 10th and 14th day after treatment, observe and record the healing and scar conditions of the mouse skin wounds treated with four groups of different band-aids, take pictures and record the size of each wound And calculate the condensation percentage of the wound (healing area/wound area×100%), and analyze the results.

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