Convenient hemostatic PICC patch and preparation method thereof

Abstract

The invention belongs to the technical field of medical supplies, and particularly relates to a convenient hemostatic PICC patch and a preparation method thereof. The convenient hemostatic PICC patch sequentially comprises a self-adhesion layer, an antibacterial hemostatic layer and a protective layer from top to bottom, the antibacterial hemostatic layer is arranged in the middle of the self-adhesion layer, the protective layer covers the surface of the antibacterial hemostatic layer, and the edge of the protective layer is fixed to the self-adhesion layer. The PICC patch has the advantages of being good in water absorption, high in antibacterial property and short in hemostasis time, attaching is firm, the situations of blood oozing and liquid oozing are avoided, using is more convenient and sanitary, and good application prospects are achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical supplies, and particularly relates to a convenient hemostatic PICC dressing and a preparation method thereof. Background Art

[0002] PICC (peripherally inserted central catheter) refers to the placement of a central venous catheter through a peripheral vein. The placement of a central venous catheter through a peripheral vein is to puncture a peripheral arm vein with a catheter, and the catheter reaches a large vein close to the heart, avoiding direct contact between chemotherapy drugs and arm veins. Coupled with the very fast blood flow rate in the large vein, the chemotherapy drugs can be quickly diluted, preventing drug irritation to blood vessels, better protecting blood vessels, effectively reducing the pain of patients, providing convenience for clinical rescue, and also improving the work efficiency of clinical nurses. It is a common intervention method for patients who need long-term intravenous infusion clinically. Therefore, it can effectively protect the upper limb veins, reduce the occurrence of phlebitis, relieve the pain of patients, and improve the quality of life of patients.

[0003] At present, self-adhesive film dressings are commonly used clinically after PICC catheterization. Most patients report that self-adhesive film dressings are prone to curling, often requiring medical staff to clean them. During the cleaning process, it is easy to touch the catheter, causing pain to the patient, and it is also prone to bacterial infection. In addition, they do not adhere firmly and are prone to bleeding and exudation.

[0004] Patent application numbers: CN201510209105.2A, CN202411202795.4A, CN202420921933.3U, CN202220595083.3U, etc. have all disclosed a PICC dressing, but none of them can solve the problems existing in the existing PICC dressings. Summary of the Invention

[0005] Based on the above technical background, the main purpose of the present invention is to provide a convenient hemostatic PICC dressing and a preparation method thereof to overcome the deficiencies in the prior art.

[0006] To achieve the foregoing invention purpose, the technical solutions adopted by the present invention include: In the first aspect of the present invention, there is provided a convenient hemostatic PICC dressing, which sequentially includes a self-adhesive layer, an antibacterial hemostatic layer, and a protective layer from top to bottom. The antibacterial hemostatic layer is disposed at the middle position of the self-adhesive layer, the protective layer covers the surface of the antibacterial hemostatic layer, and the edge of the protective layer is fixed to the self-adhesive layer.

[0007] The protective layer can protect the antibacterial hemostatic layer from external contamination. The self-adhesive layer can adhere to the skin surface at the PICC puncture site. The antibacterial hemostatic layer has the function of antibacterial hemostasis for the PICC puncture site.

[0008] The antibacterial hemostatic layer includes a hemostatic layer, an absorption layer, and an antibacterial layer. The hemostatic layer and the antibacterial layer are both disposed on the surface of the absorption layer, and the antibacterial layer is disposed around the hemostatic layer.

[0009] The hemostatic layer is in a convex shape and can compress the PICC puncture site from a physical perspective for compression hemostasis. The antibacterial layer disposed around the hemostatic layer can, on the one hand, prevent the PICC puncture site from being contaminated, and on the other hand, prevent the absorbed liquid from oozing out, avoiding causing contamination and improving the patient's usage experience.

[0010] The hemostatic layer is prepared from gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, bletilla striata polysaccharide solution, surfactant, and photoinitiator.

[0011] The mass ratio of the gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, bletilla striata polysaccharide solution, surfactant, and photoinitiator is (10 - 20):(3 - 6):(8 - 12):(9 - 13):(2 - 4):0.2.

[0012] Preferably, the mass ratio of the gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, bletilla striata polysaccharide solution, surfactant, and photoinitiator is 15:5:10:10:3:0.2.

[0013] The mass concentration of the bletilla striata polysaccharide solution is 7 - 11%, preferably 10%.

[0014] The photoinitiator is selected from one or more of ultraviolet photoinitiators. Preferably, the photoinitiator is ethyl 2,4,6-trimethylbenzoylphosphinate or 2,4,6-(trimethylbenzoyl) diphenylphosphine oxide (TPO).

[0015] The carboxymethyl chitosan added in the hemostatic layer of the present invention has the following functions: ① Hemostatic property. Chitosan is a cationic basic polysaccharide. The positive charges it carries are easily attracted to the negative charges on the surface of red blood cells, causing them to aggregate. It also promotes platelet adhesion and aggregation, which can promote wound healing and thus achieve the hemostatic effect. In addition, it also has analgesic and antibacterial effects; ② Antibacterial property. Chitosan has a certain inhibitory and killing effect on both Gram-positive and Gram-negative bacteria, which can prevent wound infection and deterioration; ③ Moisturizing property. Due to its high hydrophilicity, chitosan has extremely strong moisturizing ability, which can produce a comfortable moist feeling and a soft touch at the affected area; ④ Biocompatibility and promotion. Chitosan has good biocompatibility and can accelerate the healing of growth factors for skin cells; ⑤ Molding property. Chitosan is easy to mold and can be blended with many high-molecular compounds to form various forms, such as fibers, membranes, hydrogels, sponges, etc., which can be used for various purposes. However, due to the poor water solubility of chitosan, it can only be dissolved in weak acidic solutions, which limits the application of chitosan to a certain extent. But the new derivative of chitosan - carboxymethyl chitosan, in addition to having the above properties of chitosan, its water solubility and biodegradability are more prominent, and it also has broad-spectrum antibacterial, antioxidant, anti-ulcer and other effects.

[0016] The combined action of the carboxymethyl chitosan, sodium carboxymethyl cellulose and gelatin can not only form a gel-like substance, so as to keep the hemostatic layer in a certain shape, but also enable the blood to coagulate within a short time, further achieving the hemostatic effect.

[0017] The surfactant is preferably monoglyceryl laurate.

[0018] Monoglyceryl laurate is a lipophilic non-ionic surfactant. It can not only evenly disperse carboxymethyl chitosan, sodium carboxymethyl cellulose and gelatin. Moreover, monoglyceryl laurate has hydrophobicity, can promote the aggregation of red blood cells, further improve the hemostatic effect, and can also generate a stable pore structure inside the hemostatic layer, with a large blood absorption capacity, which is suitable for hemostasis of deeper or larger wounds with more bleeding. Moreover, the rapid hemostatic dressing of the present invention has a simple structure and is convenient to use.

[0019] The Bletilla striata polysaccharide contains rich Bletilla striata gum, which is a glucomannan polymerized by glucose and mannose (1:3) through β-glycosidic bonds, and has the effects of arresting bleeding, clearing away heat and dampness, and promoting granulation and wound healing; In addition, as a natural high-molecular material, Bletilla striata polysaccharide has functions of slow release, local retention, self-degradability, no irritation, no toxic side effects, and excellent film-forming property.

[0020] The antibacterial layer is prepared from a biological sponge and an antibacterial composition. The mass ratio of the biological sponge to the antibacterial composition is (1-3):1.

[0021] Preferably, the mass ratio of the biological sponge to the antibacterial composition is 2:1.

[0022] The biological sponge is prepared from gelatin and carboxymethyl chitosan in a mass ratio of (1-3):1.

[0023] Preferably, the biological sponge is prepared from gelatin and carboxymethyl chitosan in a mass ratio of 1:1.

[0024] The antibacterial composition is prepared from the following raw materials in parts by weight: 5-7 parts of Rheum tanguticum, 2-4 parts of Embelia laeta, 6-9 parts of Oxytropis falcata, 4-6 parts of vitamin C, 1-3 parts of angelica polysaccharide, and 1-3 parts of ligustrum lucidum polysaccharide.

[0025] Preferably, the antibacterial composition is prepared from the following raw materials in parts by weight: 6 parts of Rheum tanguticum, 3 parts of Embelia laeta, 7 parts of Oxytropis falcata, 5 parts of vitamin C, 2 parts of angelica polysaccharide, and 2 parts of ligustrum lucidum polysaccharide.

[0026] Rheum tanguticum has a wide range of antibacterial, antifungal, antiviral, and antiprotozoal effects. The antibacterial active ingredient is the free aglycone, among which rhein, emodin, and aloe-emodin have the strongest antibacterial effects. Emodin shows significant antibacterial activity against Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus. Emodin can also inhibit the growth of Helicobacter pylori and significantly reduce the recurrence rate. Rheum tanguticum in vitro has inhibitory effects on influenza virus, herpes simplex virus, hepatitis B virus, and coxsackievirus to varying degrees. It has inhibitory effects on hepatitis B virus, cytomegalovirus, Epstein-Barr virus, coronavirus, and poliovirus.

[0027] The total flavonoids and volatile oil composition of Oxytropis falcata have good anti-inflammatory and analgesic activities when administered transdermally. Among them, the flavonoid aglycone has strong antibacterial effects against 9 kinds of pathogenic bacteria. 2',4'-dihydroxy chalcone in Oxytropis falcata has the effects of shortening the bleeding time of mice, accelerating blood coagulation, and shortening the prothrombin time.

[0028] Embelia laeta has pharmacological effects such as anti-tumor and antibacterial.

[0029] Vitamin C is a water-soluble antioxidant that can directly scavenge ROS and inhibit the release of inflammatory factors. Supplementing vitamin C can reduce the levels of inflammatory markers C-reactive protein (CRP) and IL-6 and improve various chronic inflammation-related diseases. Vitamin C (ascorbic acid) has a certain role in immune regulation and antibacterial.

[0030] Angelica polysaccharide is an active ingredient extracted from traditional Chinese medicine Angelica sinensis, with a wide range of functions. Angelica polysaccharide shows certain inhibitory effects on various tumor cells in vitro, and its mechanism may be related to inducing apoptosis and inhibiting tumor cell proliferation. Angelica polysaccharide has antioxidant, immunomodulatory, promoting the proliferation and differentiation of hematopoietic stem cells, and enhancing the hematopoietic function of bone marrow.

[0031] The chemical components of Ligustrum lucidum polysaccharide include polysaccharides, phenolic acid compounds, triterpenoid compounds, etc. Ligustrum lucidum polysaccharide has significant anti-aging effects, can inhibit the degeneration of immune organs, enhance the immune function of the body, and scavenge free radicals. Ligustrum lucidum polysaccharide has inhibitory effects on certain tumor cells, and its mechanism may involve enhancing immune function and inhibiting tumor cell proliferation.

[0032] The components in the antibacterial composition described in the present invention have a synergistic effect, can significantly reduce the concentrations of peripheral blood inflammatory factors (such as TNF-α, IL-6), promote bactericidal, bacteriostatic, and antibacterial effects in peripheral blood, and can provide a more comprehensive bactericidal and anti-inflammatory effect. In addition, this composition also reduces the risk of potential adverse reactions and side effects, making the applicable population wider.

[0033] The absorption layer is prepared from gelatin and carboxymethyl chitosan according to a mass ratio of (1-3):1.

[0034] Preferably, the absorption layer is prepared from gelatin and carboxymethyl chitosan according to a mass ratio of 1:1.

[0035] The main composition of gelatin is a mixture of polypeptide molecules with the same amino acid composition but a very wide molecular weight distribution, and the molecular weight is generally from tens of thousands to more than one hundred thousand. Gelatin is insoluble in organic solvents and cold water, swells 5-10 times its own volume in cold water, is easily soluble in warm water, and can form a gel when cooled.

[0036] The product prepared by jointly using gelatin and carboxymethyl chitosan in the present invention has the excellent properties of both carboxymethyl chitosan and gelatin. It not only has excellent hemostatic, antibacterial, and promoting wound healing effects, but can also be shaped into various shapes, and it contains a large number of pores inside, similar to a "sponge shape". It can not only stop bleeding at the PICC puncture site, but also absorb exuded liquid to prevent contamination of the surrounding skin. The present invention makes full use of its characteristics as the absorption layer and antibacterial layer of the PICC dressing.

[0037] The protective layer is release paper.

[0038] The self-adhesive layer is a common self-adhesive layer for dressings, with adhesive on one side and no adhesive on the other side.

[0039] In the second aspect of the present invention, it is to provide a preparation method of the above-mentioned convenient hemostatic PICC dressing, and the preparation method includes the following steps: Bond the hemostatic layer to the middle of the upper surface of the absorbent layer, bond the antibacterial layer around the hemostatic layer to obtain an antibacterial hemostatic layer, bond the antibacterial hemostatic layer to the middle of the surface of the self-adhesive layer, cover the antibacterial hemostatic layer with a protective layer, and fix the edge of the protective layer to the self-adhesive layer.

[0040] According to a preferred embodiment of the present invention, the preparation method of the hemostatic layer comprises the following steps: Add carboxymethyl chitosan, surfactant, sodium carboxymethyl cellulose and gelatin to water in sequence, stir evenly after heating in a water bath, then add the polysaccharide solution of Bletilla striata and a photoinitiator, stir evenly, inject the evenly stirred mixture into a mold, and carry out photocuring molding under ultraviolet light irradiation to obtain the hemostatic layer.

[0041] Preferably, heat in a water bath to 45-60°C, stir evenly at 200-300 rpm, then add the polysaccharide solution of Bletilla striata and a photoinitiator, and stir evenly again at 200-300 rpm.

[0042] More preferably, heat in a water bath to 55°C, stir evenly at 250 rpm, then add the polysaccharide solution of Bletilla striata and a photoinitiator, and stir evenly again at 250 rpm.

[0043] Preferably, the conditions for photocuring molding are: the light intensity is 3-10 W / cm 2 , the photocuring time is 15-25 min, and the wavelength is 365 nm.

[0044] More preferably, the conditions for photocuring molding are: the light intensity is 5 mW / cm 2 , the wavelength is 365 nm, and the photocuring time is 20 min.

[0045] According to a preferred embodiment of the present invention, the preparation method of the antibacterial layer comprises the following steps: Immerse the biological sponge in the antibacterial composition, soak at room temperature for 20-30 h to allow the antibacterial composition to completely immerse in the biological sponge, and then carry out vacuum drying at -25 to -15°C and a vacuum degree of 0.5-2 Pa for 1-2 h to obtain the antibacterial layer.

[0046] Soaking at room temperature for 20-30 h is beneficial for the antibacterial composition to fully immerse in the biological sponge. Freeze-drying under vacuum conditions can prevent the biological composition from oozing out of the biological sponge and reduce the use effect of the antibacterial layer.

[0047] Preferably, immerse the biological sponge in the antibacterial composition, soak at room temperature for 24 h to allow the antibacterial composition to completely immerse in the biological sponge, and then carry out vacuum drying at -20°C and a vacuum degree of 1 Pa for 2 h to obtain the antibacterial layer.

[0048] According to a further preferred embodiment of the present invention, the preparation method of the biological sponge comprises the following steps: Step a: Add carboxymethyl chitosan into water, stir evenly, and then add glacial acetic acid and stir evenly to obtain a carboxymethyl chitosan solution; Step b: Add gelatin into the carboxymethyl chitosan solution, mix evenly, filter to obtain a filtrate, add the filtrate into a mold, carry out vacuum drying, then add it into absolute ethanol, and finally wash and dry to obtain the biological sponge.

[0049] In step a, preferably, the dosage of water is not particularly limited as long as it can completely dissolve carboxymethyl chitosan.

[0050] Add carboxymethyl chitosan into water and stir at a stirring speed of 100 - 300 rpm for 20 - 45 min.

[0051] Preferably, add carboxymethyl chitosan into water and stir at a stirring speed of 200 rpm for 30 min.

[0052] Add glacial acetic acid and continue to stir at a stirring speed of 100 - 300 rpm for 30 - 60 min.

[0053] Preferably, add glacial acetic acid and continue to stir at a stirring speed of 200 rpm for 45 min.

[0054] The concentration of glacial acetic acid in the carboxymethyl chitosan solution is 2 - 5%, preferably, the concentration of glacial acetic acid in the carboxymethyl chitosan solution is 3%.

[0055] In step b, add gelatin into the carboxymethyl chitosan solution and mix evenly at a temperature of 35 - 45°C and a stirring speed of 400 - 600 rpm. At this temperature and stirring speed, it can be fully dissolved and mixed.

[0056] Preferably, add gelatin into the carboxymethyl chitosan solution and mix evenly at a temperature of 40°C and a stirring speed of 500 rpm.

[0057] The conditions for the vacuum drying are: under the conditions of - 35 - - 20°C and a vacuum degree of 2 - 5 Pa, vacuum dry for 1 - 3 h.

[0058] Preferably, the conditions for the vacuum drying are: under the conditions of - 25°C and a vacuum degree of 3 Pa, vacuum dry for 2 h.

[0059] After vacuum drying, soak it in absolute ethanol for 2 - 5 h, preferably soak for 3 h, to remove the residual acid.

[0060] Finally, wash it with water 3 - 6 times, and then under the conditions of - 25 - - 20°C and a vacuum degree of 1 - 3 Pa, vacuum dry for 1 - 2 h.

[0061] Preferably, wash it 5 times with water, and then vacuum dry it for 1.5 h at -20°C and a vacuum degree of 2 Pa.

[0062] According to a further preferred embodiment of the present invention, the preparation method of the antibacterial composition comprises the following steps: Step 1: Crush Rheum tanguticum, Embelia laeta and Oxytropis falcata, sieve them, add them to ethanol for soaking, then heat up for reflux extraction, filter, add the obtained filter residue to ethanol for soaking again, then heat up for reflux extraction and filter again, and combine and concentrate the filtrates obtained each time to obtain a concentrated solution; Step 2: Add vitamin C, Angelica polysaccharide and Ligustrum lucidum polysaccharide to the concentrated solution, heat and stir evenly to obtain an antibacterial composition.

[0063] In Step 1, crush Rheum tanguticum, Embelia laeta and Oxytropis falcata, and sieve them through a 80-120 mesh sieve, preferably through a 100 mesh sieve.

[0064] After sieving, soak them in ethanol for 15-25 h, the addition amount of ethanol is 15-25 times the total weight of Rheum tanguticum, Embelia laeta and Oxytropis falcata, and the concentration of ethanol is 50-70%.

[0065] Preferably, soak them in ethanol for 20 h, the addition amount of ethanol is 20 times the total weight of Rheum tanguticum, Embelia laeta and Oxytropis falcata, and the concentration of ethanol is 60%.

[0066] The conditions for the reflux extraction are: heat up to 50-65°C and reflux extract for 0.5-2 h.

[0067] Preferably, the conditions for the reflux extraction are: heat up to 60°C and reflux extract for 1 h.

[0068] Repeat the steps of soaking, heating up for reflux extraction and filtering 2-5 times, preferably repeat 3 times.

[0069] Performing multiple reflux extractions can increase the content of active ingredients in the concentrated solution, thereby improving the antibacterial, bacteriostatic and hemostatic effects of the prepared antibacterial layer.

[0070] In Step 2, heat to 40-50°C and stir evenly at a stirring speed of 200-500 rpm.

[0071] Preferably, heat to 45°C and stir evenly at a stirring speed of 300 rpm.

[0072] Performing heating and stirring can increase the dissolution rate of vitamin C, Angelica polysaccharide and Ligustrum lucidum polysaccharide, and improve the preparation efficiency.

[0073] The beneficial effects of the present invention: (1) The PICC dressing described in the present invention sequentially includes a self - adhesive layer, an antibacterial hemostatic layer, and a protective layer from top to bottom. The antibacterial hemostatic layer includes a hemostatic layer, an absorption layer, and an antibacterial layer. The hemostatic layer is prepared from gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, and Bletilla striata polysaccharide solution as main raw materials. Through the synergistic effect of gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, and Bletilla striata polysaccharide solution, not only can the hemostatic layer maintain a certain shape to form a convex shape, and physically compress the PICC puncture point for hemostasis, but also through the combined action of the above - mentioned substances, it can promote the adhesion and aggregation of red blood cells and platelets, thereby achieving an excellent hemostatic effect on the PICC puncture point.

[0074] (2) The antibacterial layer is prepared from a biological sponge and an antibacterial composition. In the present invention, Rheum tanguticum, Embelia laeta, Oxytropis falcata, vitamin C, Angelica sinensis polysaccharide, and Ligustrum lucidum polysaccharide are rationally formulated in a specific ratio. By utilizing the different antibacterial and anti - inflammatory mechanisms of the above - mentioned substances acting on each other, each antibacterial component complements and synergistically enhances each other, forming a composite antibacterial effect, effectively improving the antibacterial effect and stability of the antibacterial composition described in the present invention.

[0075] (3) The absorption layer is prepared from a biological sponge, and this biological sponge is prepared from carboxymethyl chitosan and gelatin, combining the excellent properties of carboxymethyl chitosan and gelatin. It can not only stop bleeding at the PICC puncture point but also absorb the exuded liquid, prevent contamination of the surrounding skin, and avoid the occurrence of blood leakage and fluid leakage, making it more convenient and hygienic to use.

[0076] (4) When using the PICC dressing, just tear off the protective layer, cover the antibacterial hemostatic layer on the affected area, and fix it with the stickiness of the self - adhesive layer, which is convenient to use.

[0077] The preparation of the PICC dressing described in the present invention is carried out at low temperature, which is safe and environmentally friendly. Detailed implementation method

[0078] The present invention will be described in detail below, and its features and advantages will become clearer and more definite with these descriptions.

[0079] Example:

[0080] The following further elaborates the present invention through specific examples. These examples are only for illustrating the present invention and are not used to limit the scope of the present invention. The raw materials used in the examples of the present invention are all commercially available.

[0081] In the example, the mass concentration of the Bletilla striata polysaccharide solution is 10%. The protective layer in the example is release paper, and the self - adhesive layer is a common self - adhesive layer for dressings, with adhesive on one side and no adhesive on the other side.

[0082] Example 1. A preparation method of the above-mentioned convenient hemostatic PICC dressing, the preparation method comprising the following steps: 1) Weigh each raw material according to the mass ratio of gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, polysaccharide solution of bletilla striata, monoglyceride laurate and ethyl 2,4,6-trimethylbenzoylphosphinate of 15:5:10:10:3:0.2. Add carboxymethyl chitosan, monoglyceride laurate, sodium carboxymethyl cellulose and gelatin to deionized water in sequence, heat in a water bath to 55 °C, stir evenly at 250 rpm, then add the polysaccharide solution of bletilla striata and ethyl 2,4,6-trimethylbenzoylphosphinate, and stir evenly again at 250 rpm. Inject the uniformly stirred mixture into a mold, and under the light intensity of 5 W / cm at a wavelength of 365 nm 2 photocure for 20 min, demold to obtain a hemostatic layer.

[0083] 2) Add carboxymethyl chitosan to water and stir at a stirring speed of 200 rpm for 30 min. Then add glacial acetic acid and continue to stir at a stirring speed of 200 rpm for 45 min to obtain a carboxymethyl chitosan solution. The concentration of glacial acetic acid in the carboxymethyl chitosan solution is 3%.

[0084] 3) Add gelatin to the carboxymethyl chitosan solution, and the mass ratio of gelatin to carboxymethyl chitosan is 1:1. Mix evenly at a stirring speed of 500 rpm at 40 °C, filter to obtain a filtrate, add the filtrate to a mold, and under the conditions of -25 °C and a vacuum degree of 3 Pa, vacuum dry for 2 h, demold, soak in absolute ethanol for 3 h, finally wash 5 times with water, and then under the conditions of -20 °C and a vacuum degree of 2 Pa, vacuum dry for 1.5 h to obtain a biological sponge.

[0085] 4) Weigh each raw material according to the following weight parts: 6 parts of rheum tanguticum, 3 parts of embelia laeta, 7 parts of oxytropis falcata, 5 parts of vitamin C, 2 parts of angelica polysaccharide, 2 parts of ligustrum lucidum polysaccharide. Crush rheum tanguticum, embelia laeta and oxytropis falcata, pass through a 100-mesh sieve, and then soak in ethanol for 20 h. The addition amount of ethanol is 20 times the total weight of rheum tanguticum, embelia laeta and oxytropis falcata, and the concentration of ethanol is 60%. Subsequently, heat to 60 °C and reflux for 1 h, and repeat the steps of soaking, heating and refluxing, and filtering 3 times; Combine and concentrate the filtrate obtained each time to obtain a concentrated solution.

[0086] 5) Add vitamin C, angelica polysaccharide and ligustrum lucidum polysaccharide to the concentrated solution, heat to 45 °C, and stir evenly at a stirring speed of 300 rpm to obtain an antibacterial composition.

[0087] 6) Immerse the biological sponge in the antibacterial composition, with the mass ratio of the biological sponge to the antibacterial composition being 2:1. Soak it at room temperature for 24 h to completely immerse the antibacterial composition into the biological sponge. Then, under the conditions of -20 °C and a vacuum degree of 1 Pa, conduct vacuum drying for 2 h to obtain the antibacterial layer.

[0088] 7) Cut the biological sponge into a square or a circle as the absorption layer. Bond the hemostatic layer in the middle of the upper surface of the absorption layer. The hemostatic layer is convex. Bond the antibacterial layer around the hemostatic layer. The antibacterial layer is annular to obtain the antibacterial hemostatic layer. Bond the antibacterial hemostatic layer in the middle position of the sticky surface of the self-adhesive layer. Cover the surface of the antibacterial hemostatic layer with the protective layer and fix the edge of the protective layer to the self-adhesive layer to obtain the product.

[0089] Example 2: 1) Weigh each raw material according to the mass ratio of gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, polysaccharide solution of bletilla striata, monoglyceride laurate, and ethyl 2,4,6-trimethylbenzoylphosphinate being 10:3:8:9:2:0.2. Add carboxymethyl chitosan, monoglyceride laurate, sodium carboxymethyl cellulose, and gelatin to deionized water in sequence, heat it in a water bath to 45 °C, stir evenly at 300 rpm, then add the polysaccharide solution of bletilla striata and ethyl 2,4,6-trimethylbenzoylphosphinate, and stir evenly again at 300 rpm. Inject the uniformly stirred mixture into a mold and conduct photocuring for 25 min under the light intensity of 3 W / cm at a wavelength of 365 nm, then demold to obtain the hemostatic layer. 2 8) Add carboxymethyl chitosan to water and stir at a stirring speed of 100 rpm for 45 min. Then add glacial acetic acid and continue to stir at a stirring speed of 100 rpm for 60 min to obtain the carboxymethyl chitosan solution. The concentration of glacial acetic acid in the carboxymethyl chitosan solution is 2%.

[0090] 2) Add carboxymethyl chitosan to water and stir at a stirring speed of 100 rpm for 45 min. Then add glacial acetic acid and continue to stir at a stirring speed of 100 rpm for 60 min to obtain the carboxymethyl chitosan solution. The concentration of glacial acetic acid in the carboxymethyl chitosan solution is 2%.

[0091] 3) Add gelatin to the carboxymethyl chitosan solution, with the mass ratio of gelatin to carboxymethyl chitosan being 2:1. Mix evenly at 45 °C and a stirring speed of 400 rpm, filter to obtain the filtrate. Add the filtrate to a mold, conduct vacuum drying for 1 h under the conditions of -20 °C and a vacuum degree of 2 Pa, then demold, soak it in absolute ethanol for 5 h, finally wash it with water three times, and then conduct vacuum drying for 2 h under the conditions of -25 °C and a vacuum degree of 1 Pa to obtain the biological sponge.

[0092] 4) Weigh each raw material according to the following parts by weight: 7 parts of Rheum tanguticum, 4 parts of Embelia laeta, 9 parts of Oxytropis falcata, 6 parts of vitamin C, 3 parts of Angelica polysaccharide, and 3 parts of Ligustrum lucidum polysaccharide. Crush Rheum tanguticum, Embelia laeta, and Oxytropis falcata, pass through an 80-mesh sieve, and then add them to ethanol for soaking for 15 h. The addition amount of ethanol is 25 times the total weight of Rheum tanguticum, Embelia laeta, and Oxytropis falcata, and the concentration of ethanol is 50%. Subsequently, heat to 65 °C and reflux for 0.5 h, and repeat the steps of soaking, heating and refluxing, and filtering 5 times; Combine and concentrate the filtrate obtained each time to obtain a concentrated solution.

[0093] 5) Add vitamin C, Angelica polysaccharide, and Ligustrum lucidum polysaccharide to the concentrated solution, heat to 40 °C, and stir evenly at a stirring speed of 500 rpm to obtain an antibacterial composition.

[0094] 6) Immerse the biological sponge in the antibacterial composition. The mass ratio of the biological sponge to the antibacterial composition is 3:1, and soak at room temperature for 20 h to completely immerse the antibacterial composition in the biological sponge. Then, under the conditions of -15 °C and a vacuum degree of 2 Pa, vacuum dry for 1 h to obtain an antibacterial layer.

[0095] 7) Bond the hemostatic layer to the middle of the upper surface of the absorbent layer. The hemostatic layer is convex, bond the antibacterial layer around the hemostatic layer. The antibacterial layer is annular to obtain an antibacterial hemostatic layer. Bond the antibacterial hemostatic layer to the middle position of the adhesive surface of the self-adhesive layer, cover the antibacterial hemostatic layer with the protective layer, and fix the edge of the protective layer to the self-adhesive layer to obtain the product.

[0096] Example 3, 1) Weigh each raw material according to the mass ratio of gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, Bletilla striata polysaccharide solution, monoglycerin laurate, and ethyl 2,4,6-trimethylbenzoylphosphinate of 20:6:12:13:4:0.2. Add carboxymethyl chitosan, monoglycerin laurate, sodium carboxymethyl cellulose, and gelatin to deionized water in sequence, heat in a water bath to 60 °C, stir evenly at 200 rpm, then add Bletilla striata polysaccharide solution and ethyl 2,4,6-trimethylbenzoylphosphinate, and stir evenly again at 200 rpm. Inject the evenly stirred mixture into a mold, and photocure for 15 min under the light intensity of 10 W / cm at a wavelength of 365 nm, and demold to obtain a hemostatic layer. 2 of the light intensity, and demold to obtain a hemostatic layer.

[0097] 2) Add carboxymethyl chitosan to water and stir at a stirring speed of 300 rpm for 20 min. Then add glacial acetic acid and continue to stir at a stirring speed of 300 rpm for 30 min to obtain a carboxymethyl chitosan solution. The concentration of glacial acetic acid in the carboxymethyl chitosan solution is 5%.

[0098] 3) Add gelatin to the carboxymethyl chitosan solution. The mass ratio of gelatin to carboxymethyl chitosan is 3:1. Mix evenly at a stirring speed of 600 rpm at 35°C, filter to obtain a filtrate. Add the filtrate to a mold, and under the conditions of -35°C and a vacuum degree of 5 Pa, vacuum dry for 3 h, demold, soak in absolute ethanol for 2 h, finally wash with water 6 times, and then under the conditions of -20°C and a vacuum degree of 3 Pa, vacuum dry for 1 h to obtain a biological sponge.

[0099] 4) Weigh each raw material according to the following parts by weight: 5 parts of Rheum tanguticum, 2 parts of Embelia laeta, 6 parts of Oxytropis falcata, 4 parts of vitamin C, 1 part of Angelica polysaccharide, and 1 part of Ligustrum lucidum polysaccharide. Crush Rheum tanguticum, Embelia laeta, and Oxytropis falcata, pass through a 120-mesh sieve, and then add to ethanol and soak for 25 h. The addition amount of ethanol is 15 times the total weight of Rheum tanguticum, Embelia laeta, and Oxytropis falcata, and the concentration of ethanol is 70%. Subsequently, heat to 50°C and reflux extract for 2 h, and repeat the steps of soaking, heating and reflux extraction, and filtering 2 times; Combine and concentrate the filtrate obtained each time to obtain a concentrated solution.

[0100] 5) Add vitamin C, Angelica polysaccharide, and Ligustrum lucidum polysaccharide to the concentrated solution, heat to 50°C, and stir evenly at a stirring speed of 200 rpm to obtain an antibacterial composition.

[0101] 6) Immerse the biological sponge in the antibacterial composition. The mass ratio of the biological sponge to the antibacterial composition is 1:1. Immerse at room temperature for 30 h to make the antibacterial composition completely immerse in the biological sponge, and then under the conditions of -25°C and a vacuum degree of 0.5 Pa, vacuum dry for 2 h to obtain an antibacterial layer.

[0102] 7) Bond the hemostatic layer to the middle of the upper surface of the absorbent layer. The hemostatic layer is convex, bond the antibacterial layer around the hemostatic layer. The antibacterial layer is annular to obtain an antibacterial hemostatic layer. Bond the antibacterial hemostatic layer to the middle position of the sticky surface of the self-adhesive layer, cover the antibacterial hemostatic layer with the protective layer, and fix the edge of the protective layer to the self-adhesive layer to obtain the product.

[0103] Example 4. The preparation of the convenient hemostatic PICC dressing is carried out in a similar manner to Example 1, except that: Weigh each raw material according to the mass ratio of gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, Bletilla striata polysaccharide solution, monoglyceride laurate, and ethyl 2,4,6-trimethylbenzoylphosphinate of 20:6:8:9:2:0.2.

[0104] Example 5. The preparation of the convenient hemostatic PICC dressing is carried out in a similar manner to Example 1, except that: Weigh each raw material according to the following parts by weight: 7 parts of Rheum tanguticum, 2 parts of Embelia laeta, 6 parts of Oxytropis falcata, 6 parts of vitamin C, 1 part of Angelica polysaccharide, and 1 part of Ligustrum lucidum polysaccharide.

[0105] Comparative Example:

[0106] Comparative Example 1: The preparation of the convenient hemostatic PICC dressing was carried out in a similar manner to Example 1, except that: the polysaccharide solution of Bletilla striata was not added to the hemostatic layer.

[0107] Comparative Example 2: The preparation of the convenient hemostatic PICC dressing was carried out in a similar manner to Example 1, except that: carboxymethyl chitosan was not added to the hemostatic layer.

[0108] Comparative Example 3: The preparation of the convenient hemostatic PICC dressing was carried out in a similar manner to Example 1, except that: Rheum tanguticum was not added to the antibacterial composition.

[0109] Comparative Example 4: The preparation of the convenient hemostatic PICC dressing was carried out in a similar manner to Example 1, except that: vitamin C was not added to the antibacterial composition.

[0110] Experimental Example:

[0111] Experimental Example 1 Performance Test: The water absorbency, antibacterial property and hemostatic property of the antibacterial and hemostatic layers of the PICC dressings prepared in Examples 1 - 5 and Comparative Examples 1 - 4 were tested respectively. The test results are shown in Table 1.

[0112] (1) Water absorbency test procedure: Cut the prepared antibacterial and hemostatic layer into square pieces: with dimensions of 60mm×60mm×1mm, put the sample into a drying oven to dry (50 °C / 24 hours), wait until it cools to room temperature, and measure the weight M1 of the sample. Immerse the sample in distilled water at a temperature of 23 °C, after soaking for 24 hours, take it out and remove the surface moisture with filter paper, and weigh the weight M2 of the sample within 1 minute after taking it out. Calculate the water absorption rate according to the following formula: Water absorption rate = (M1 - M2) / M1 × 100%.

[0113] (2) Antibacterial property test: The PICC dressings prepared in Examples 1 - 5 and Comparative Examples 1 - 4 were respectively subjected to a plate coating antibacterial property test to test their antibacterial property against Staphylococcus aureus.

[0114] (3) Hemostatic property test: The PICC dressing was used to test the hemostatic property on a rat tail amputation model. Put a pre - weighed filter paper under the rat tail, and cut 1.5 cm from the bottom of the tail. Immediately stick the PICC dressing on the bleeding site until the tail stops bleeding. Carefully record the coagulation time after hemostasis.

[0115] Table 1

[0116] As can be seen from Table 1, the water absorption rates of the PICC dressings prepared in Examples 1-5 of the present invention are relatively high, all higher than 2280%. The antibacterial properties of the PICC dressings prepared in Examples 1-5 against Staphylococcus aureus are all higher than 95%, and their hemostasis times are all shorter than 224 s, with the shortest reaching 202 s. This indicates that the PICC dressing described in the present invention has the advantages of good water absorption and antibacterial properties and a short hemostasis time.

[0117] Comparing Comparative Example 1 with Example 1, Bletilla striata polysaccharide was not added in Comparative Example 1. From the test results, the water absorption rate and antibacterial property of the PICC dressing prepared in Comparative Example 1 decreased slightly, but the hemostasis time of Comparative Example 1 was longer, indicating that adding Bletilla striata polysaccharide is beneficial to blood coagulation and shortens the hemostasis time.

[0118] Comparing Comparative Example 2 with Example 1, carboxymethyl chitosan was not added in Comparative Example 2. The antibacterial property of the PICC dressing prepared in Comparative Example 2 decreased, and the hemostasis time became significantly longer, indicating that adding carboxymethyl chitosan is beneficial to improving antibacterial property and shortening the blood coagulation time.

[0119] Comparing Comparative Example 3 with Example 1, Rheum tanguticum Maxim. ex Balf. was not added in Comparative Example 3. The antibacterial property of Comparative Example 3 decreased significantly, indicating that adding Rheum tanguticum Maxim. ex Balf. is beneficial to improving antibacterial property.

[0120] Comparing Comparative Example 4 with Example 1, vitamin C was not added in Comparative Example 4. The antibacterial property of Comparative Example 4 was lower than that of Example 1, indicating that adding vitamin C is beneficial to improving the antibacterial property of the PICC dressing.

[0121] The above results indicate that the PICC dressing described in the present invention has the advantages of good water absorption, high antibacterial property, and short hemostasis time. At the same time, it shows that the added raw materials and their dosage ratios of the PICC dressing of the present invention have an important impact on its performance. The various raw materials used in the present invention complement each other and synergistically enhance the effect, and none of them can be missing.

[0122] The present invention has been described in detail above in combination with specific embodiments and exemplary examples, but these descriptions should not be construed as limiting the present invention. Those skilled in the art understand that without departing from the spirit and scope of the present invention, various equivalent substitutions, modifications, or improvements can be made to the technical solutions and their implementation manners of the present invention, and all of these fall within the scope of the present invention. The protection scope of the present invention is subject to the appended claims.

Claims

1. A convenient hemostatic PICC dressing, characterized in that, The convenient hemostatic PICC dressing sequentially includes a self - adhesive layer, an antibacterial hemostatic layer, and a protective layer from top to bottom. The antibacterial hemostatic layer is disposed at the middle position of the self - adhesive layer, the protective layer covers the surface of the antibacterial hemostatic layer, and the edge of the protective layer is fixed to the self - adhesive layer. The antibacterial hemostatic layer includes a hemostatic layer, an absorption layer, and an antibacterial layer. Both the hemostatic layer and the antibacterial layer are disposed on the surface of the absorption layer, and the antibacterial layer is disposed around the hemostatic layer.

2. The convenient hemostatic PICC dressing according to claim 1, wherein the hemostatic layer is prepared from gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, bletilla striata polysaccharide solution, surfactant, and photoinitiator; the mass ratio of gelatin, carboxymethyl chitosan, sodium carboxymethyl cellulose, bletilla striata polysaccharide solution, surfactant, and photoinitiator is (10 - 20):(3 - 6):(8 - 12):(9 - 13):(2 - 4):0.

2.

3. The convenient hemostatic PICC dressing according to claim 2, wherein the photoinitiator is selected from one or more of ultraviolet photoinitiators; and / or the surfactant is monoglyceride laurate.

4. The convenient hemostatic PICC dressing according to claim 1, wherein the antibacterial layer is prepared from a biological sponge and an antibacterial composition. The mass ratio of the biological sponge to the antibacterial composition is (1 - 3):1; the absorption layer is prepared from a biological sponge.

5. The convenient hemostatic PICC dressing according to claim 4, wherein the biological sponge is prepared from gelatin and carboxymethyl chitosan in a mass ratio of (1 - 3):1; and / or the antibacterial composition is prepared from the following raw materials in parts by weight: 5 - 7 parts of rheum tanguticum, 2 - 4 parts of embelia laeta, 6 - 9 parts of oxytropis falcata, 4 - 6 parts of vitamin C, 1 - 3 parts of angelica polysaccharide, 1 - 3 parts of ligustrum lucidum polysaccharide.

6. A preparation method of the convenient hemostatic PICC dressing according to any one of claims 1 to 5, characterized in that, The preparation method comprises the following steps: Bond the hemostatic layer to the middle of the upper surface of the absorption layer, bond the antibacterial layer around the hemostatic layer to obtain the antibacterial hemostatic layer, bond the antibacterial hemostatic layer to the middle of the surface of the self - adhesive layer, cover the protective layer on the surface of the antibacterial hemostatic layer, and fix the edge of the protective layer to the self - adhesive layer.

7. The preparation method according to claim 6, characterized in that, The preparation method of the hemostatic layer comprises the following steps: Sequentially add carboxymethyl chitosan, surfactant, sodium carboxymethyl cellulose, and gelatin into water, stir evenly after water - bath heating, then add bletilla striata polysaccharide solution and photoinitiator, stir evenly, inject the uniformly - stirred mixture into a mold, and cure it by ultraviolet light irradiation to obtain the hemostatic layer.

8. The preparation method according to claim 6, characterized in that, The preparation method of the antibacterial layer comprises the following steps: Immerse the biological sponge in the antibacterial composition, soak it at room temperature for 20 - 30 h to make the antibacterial composition completely immerse in the biological sponge, and then vacuum - dry it at - 25 - - 15°C and a vacuum degree of 0.5 - 2 Pa for 1 - 2 h to obtain the antibacterial layer.

9. The method according to claim 8, wherein The preparation method of the biological sponge comprises the following steps: Step a: Add carboxymethyl chitosan into water, stir evenly, and then add glacial acetic acid, stir evenly to obtain a carboxymethyl chitosan solution; Step b: Add gelatin to the carboxymethyl chitosan solution, mix evenly, filter to obtain a filtrate, add the filtrate to a mold, perform vacuum drying, then add it to anhydrous ethanol, and finally wash and dry to obtain a biological sponge.

10. The method according to claim 8, wherein According to a further preferred embodiment of the present invention, the preparation method of the antibacterial composition comprises the following steps: Step 1: Crush Rheum tanguticum, Embelia laeta and Oxytropis falcata, sieve them, add them to ethanol for soaking, then heat up for reflux extraction, filter, add the obtained filter residue to ethanol for soaking again, then heat up for reflux extraction and filter again, combine and concentrate the filtrates obtained each time to obtain a concentrated solution; Step 2: Add vitamin C, Angelica polysaccharide and Ligustrum lucidum polysaccharide to the concentrated solution, heat and stir evenly to obtain an antibacterial composition.

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