Cold compress bandage and preparation method thereof

Abstract

The invention relates to a cold compress bandage and a preparation method thereof. Belongs to the technical field of external medical dressings. A cold compress bandage comprises an elastic bandage adsorbed with a cool feeling liquid and a container or package providing the cool feeling liquid, the cool feeling liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, and an external water phase comprises, by mass, 2-3 parts of a hydrophilic emulsifier, 2-5 parts of a solubilizer, 0.2-0.5 part of a thickener and 50-75 parts of water; the oil phase comprises the following components in parts by mass: 10-25 parts of liquid paraffin, 3.0-7.0 parts of a cool feeling agent, 2.0-5.0 parts of an oily antibacterial agent and 0.5-2.0 parts of an oleophylic emulsifier; the inner water phase comprises the following components in parts by mass: 5-8 parts of a humectant and 10-20 parts of a water-based antibacterial agent. According to the cold compress bandage disclosed by the invention, the cool feeling liquid is prepared into oil-in-water and oil-in-water-in-water mixed emulsion, so that the cool feeling release time is effectively prolonged.

Description

Technical Field

[0001] The present invention relates to a cold compress bandage and a preparation method thereof, belonging to the technical field of external medical dressings. Background Art

[0002] A cold compress bandage is a medical device that combines cold compress therapy and physical fixation, mainly used for analgesia and detumescence after closed soft tissue injuries. At present, the cold compress bandages on the market mainly consist of a cool feeling liquid and an elastic bandage impregnated in the cool feeling liquid. When in use, the elastic bandage adsorbed with the cool feeling liquid is wound around the injured part, and through compression fixation and physical cooling, it can effectively relieve the swelling, fever and pain of the affected area. Such cool feeling liquids are basically made by dissolving substances such as menthol and borneol in ethanol and water, similar to tinctures, and have strong volatility. Therefore, the effect of the cool feeling liquid is not lasting.

[0003] The invention patent application with publication number CN105727349A discloses a manufacturing method of a cold compress bandage, which uses a sponge skeleton and a hydrogel material, and the hydrogel material is cross-linked from an aqueous solution of polyvinyl alcohol. Compared with the ethanol-water system of menthol / borneol, the irritation of this hydrogel material is significantly reduced, but the release of the cool feeling mainly depends on the cold storage of the hydrogel, and when the cold storage amount is exhausted, the cool feeling effect drops rapidly.

[0004] The invention patent application with publication number CN 117045842A discloses an inner material of a long-acting cool feeling cold compress bandage. It includes 0.15 - 0.7% of a cool feeling agent, 5 - 25% of a cool feeling synergist, 0.5 - 4% of a solubilizer, 0.05 - 0.3% of a preservative and 0.05 - 0.2% of dipotassium glycyrrhizinate, and the solvent is water. This invention adopts an alcohol-free formula and selects a fast cool feeling agent, a long-acting cool feeling agent and a persistent synergist. From the perspective of the dosage form system, to a certain extent, it improves the cool feeling time of the product, but the specific components of the fast cool feeling agent WS-5, WS-3 and the long-acting cool feeling agent WS-23 disclosed are not clear, and the cool feeling effect is not clear; in view of the characteristics of its aqueous solution, it is reasonably speculated that the volatility is relatively high, and the cool feeling time may still be insufficient. Summary of the Invention

[0005] In view of the problems raised in the background art, on the one hand, the present invention provides a cold compress bandage. The cold compress bandage of the present invention effectively prolongs the release time of the cool feeling by making the cool feeling liquid into a water-in-oil and water-in-oil-in-water mixed emulsion.

[0006] The technical solution for the present invention to solve the above problems is as follows: A cold compress bandage, comprising an elastic bandage adsorbed with a cool-sensation liquid and a container or package for providing the cool-sensation liquid. The cool-sensation liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, including a continuous external aqueous phase, oil droplets dispersed in the external aqueous phase, and W / O type emulsion droplets. The W / O type emulsion droplets include a continuous oil phase and internal aqueous phases dispersed in the continuous oil phase. The continuous external aqueous phase also contains some substances originally present in the internal aqueous phase and dissolved due to the rupture of the W / O type emulsion droplets. Among them, The external aqueous phase comprises the following components in parts by mass: Hydrophilic emulsifier 2 - 3, solubilizer 2 - 5, thickener 0.2 - 0.5, water 50 - 75; The oil phase of the oil droplets and the W / O type emulsion droplets comprises the following components in parts by mass: Liquid paraffin 10 - 25, cool-sensation agent 3.0 - 7.0, oil-based antibacterial agent 2.0 - 5.0, lipophilic emulsifier 0.5 - 2.0; The internal aqueous phase of the W / O type emulsion droplets comprises the following components in parts by mass: Humectant 5 - 8, water-based antibacterial agent 10 - 20.

[0007] In the above technical solution of the present invention, the water-based antibacterial agent is a decoction of Chinese herbal medicines with antibacterial, anti-inflammatory or analgesic effects, such as decoctions of dandelion, wild chrysanthemum, folium isatidis, clove, sophora flavescens, etc. The cool-sensation agent is menthol, borneol and other substances. The oil-based antibacterial agent is a volatile oil component extracted from Chinese herbal plants with antibacterial, anti-inflammatory or analgesic effects, such as eucalyptus oil, etc.

[0008] In the above technical solution of the present invention, the components of the external aqueous phase provide good dispersibility and can produce a comfortable use feeling. The O / W type emulsion and the W / O / W type emulsion together improve the stability of the emulsion. The substances in the internal aqueous phase dissolved due to the rupture of the W / O type emulsion droplets can take effect immediately and provide a certain antibacterial effect. The oil droplets and the W / O type emulsion droplets stabilize the O / W interface through a hydrophilic non-ionic emulsifier to form micron-sized droplets. The oil-based antibacterial agent and the cool-sensation agent in the droplets are gradually absorbed by the skin. After the rupture of the W / O type interface, the water-based antibacterial agent in the droplets is effectively released, thereby realizing the gradient release of the active ingredients and prolonging the release of the cool sensation and the antibacterial effect. The implementation of the above technical solution of the present invention has good cooling, analgesic, soothing and antibacterial effects in terms of technical effects, and shows a rich sense of hierarchy and a light effect in terms of the use feeling.

[0009] Preferably, the humectant is selected from one or two of glycerol and propylene glycol.

[0010] Preferably, the components of the humectant are as follows in parts by mass: glycerol 3 - 5, propylene glycol 2 - 3.

[0011] Preferably, the solubilizer is polyethylene glycol 400.

[0012] Preferably, the thickener is selected from one or both of carboxymethyl cellulose and hydroxyethyl cellulose.

[0013] Preferably, the hydrophilic emulsifier is Tween. More preferably, it is Tween-80.

[0014] Preferably, the cooling agent is selected from one or both of menthol and borneol.

[0015] Preferably, the mass parts of each component in the cooling agent are as follows: 1.0-2.0 for menthol and 2.0-5.0 for borneol.

[0016] Preferably, the mass parts of the oily antibacterial agent are 2.0-5.0.

[0017] Preferably, the lipophilic emulsifier is selected from one or more of Span and ethylene glycol fatty acid ester.

[0018] In the above technical solution of the present invention, the ethylene glycol fatty acid ester is an ester formed by fatty acid and ethylene glycol. It includes monoethylene glycol fatty acid ester and diethylene glycol fatty acid ester. The molecular formula of the monoethylene glycol fatty acid ester is R-COO-CH2-CH2-OH (R is a fatty acid chain), and the molecular formula of the diethylene glycol fatty acid ester is R1-COO-CH2-CH2-COO-R2 (R1 and R2 are the same or different fatty acid chains). Preferably, the ethylene glycol fatty acid ester is monoethylene glycol oleate; more preferably, the lipophilic emulsifier is Span-80.

[0019] Preferably, the aqueous phase component further includes 0.05-0.3 mass parts of benzalkonium chloride / benzalkonium bromide.

[0020] In the above technical solution of the present invention, benzalkonium chloride / benzalkonium bromide has a certain antiseptic effect and can extend the shelf life of the product.

[0021] In the second aspect, the present invention provides a preparation method of the above cold compress bandage.

[0022] The technical solution is as follows: A preparation method of a cold compress bandage includes the following steps: S1. Preparation of the inner aqueous phase Mix the humectant and the aqueous antibacterial agent heated to 50-60°C, and stir until completely dissolved to form an inner aqueous phase solution; S2. Preparation of the oil phase Mix the cooling agent, the oily antibacterial agent, the lipophilic emulsifier and the liquid paraffin heated to 50-60°C, and stir until completely dissolved to form an oil phase solution; S3. Preparation of the outer aqueous phase Mix a hydrophilic emulsifier, a solubilizer, a thickener and hot water at 50 - 60°C, and stir until completely dissolved to form an external aqueous phase solution; S4. Emulsification Under a nitrogen atmosphere, slowly inject the internal aqueous phase solution into the oil phase solution, and stir at a speed of 1000 - 2000 rpm until a stable water-in-oil emulsion is formed; slowly inject the obtained water-in-oil emulsion into the external aqueous phase solution, and stir or homogenize at a speed of more than 3000 rpm to form a W / O / W type emulsion. Meanwhile, during the stirring or homogenization process, some water-in-oil droplets of the W / O / W type emulsion rupture, and the substances in the internal aqueous phase released by the droplet rupture dissolve in the external aqueous phase to form a mixed emulsion; S5. Filling Fill the mixed emulsion into a container or a packaging bag, then put it into an elastic bandage, seal it, and obtain a cold compress bandage.

[0023] In summary, the present invention has the following beneficial effects: 1. The O / W type and W / O / W type mixed systems of the present invention jointly improve the stability of the emulsion; the oil droplets and water-in-oil droplets stabilize the interface through hydrophilic non-ionic emulsifiers to form micron-sized droplets, enabling the slow release of the oily antibacterial agent and the cool-sensation substance; the water-in-oil droplets finally rupture to achieve the gradient release of the active ingredients, extending the cool-sensation time and the antibacterial effect; 2. The bandage substrate is coated with a hydrophilic polymer film layer (such as polyethylene glycol 400 / sodium carboxymethyl cellulose complex) to form a porous breathable structure, allowing water vapor to pass through but blocking the volatilization of ethanol / oil phase, and the cool-sensation duration is increased to 12 - 24 hours; 3. The present invention combines the advantages of the O / W type system and the W / O / W type system. Compared with the ethanol system with a drug loading of less than 1.0 wt%, the drug loading of the cool-sensation agent is significantly increased; and the cool-sensation effect is milder and more persistent; 4. The present invention combines the advantages of the O / W type system and the W / O / W type system, and different antibacterial agents are respectively configured in the aqueous phase and the oil phase; the aqueous antibacterial agent in the external aqueous phase can be quickly absorbed at the affected area, the oily antibacterial agent can gradually penetrate through the skin and be absorbed by the muscles and joints, and the aqueous antibacterial agent in the internal aqueous phase is finally released. The three work together to extend the action time and effectively promote the healing of the wound; 5. Through a reasonable formula and preparation process, the present invention prepares an O / W and W / O / W mixed emulsion. The O / W structure provides good dispersibility and usability; the O / W structure and the W / O / W structure jointly improve the stability of the emulsion and delay the release of the active ingredients; 6. The O / W and W / O / W mixed emulsion of the present invention reduces the irritation to the affected area compared with the ethanol system and is suitable for sensitive skin. Specific embodiments

[0024] This specific embodiment is only an interpretation of the present invention and not a limitation thereof. Any changes made by those skilled in the art after reading this specification will be protected by the Patent Law as long as they are within the scope of the claims.

[0025] Example 1 A cold compress bandage includes a container for providing a cooling liquid and an elastic bandage impregnated in the cooling liquid.

[0026] The cooling liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, including a continuous outer aqueous phase, oil droplets dispersed in the outer aqueous phase, and W / O type emulsion droplets; the W / O type emulsion droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances in the inner aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; wherein, The outer aqueous phase includes the following components in parts by mass: Tween-80 2g, polyethylene glycol 400 2g, sodium carboxymethylcellulose 0.2g, water 50g; The oil phase of the oil droplets or W / O type emulsion droplets includes the following components in parts by mass: Liquid paraffin 10g, menthol 1g, borneol 2g, eucalyptus oil 2g, Span-80 0.5g; The inner aqueous phase of the W / O type emulsion droplets includes the following components in parts by mass: Glycerol 3g, propylene glycol 2g, wild chrysanthemum decoction 10g.

[0027] The preparation method of the above cold compress bandage is as follows: S1. Preparation of the inner aqueous phase Mix the formula amounts of glycerol, propylene glycol and wild chrysanthemum decoction at 60°C (each 100g of decoction contains 25g of crude drug), stir until completely dissolved, and the stirring is carried out in a nitrogen atmosphere to avoid dissolving air to form an inner aqueous phase solution; S2. Preparation of the oil phase Mix the formula amounts of menthol, borneol, eucalyptus oil, Span-80 and liquid paraffin heated to 60°C, stir until completely dissolved, and the stirring is carried out in a nitrogen atmosphere to avoid dissolving air to form an oil phase solution; S3. Preparation of the outer aqueous phase Mix Tween-80, polyethylene glycol 400, sodium carboxymethylcellulose and hot water at 50-60°C, stir until completely dissolved to form an outer aqueous phase solution; S4. Emulsification Under a nitrogen atmosphere, the inner aqueous solution was slowly injected into the oil-phase solution, and stirred at 1500 rpm until a stable water-in-oil emulsion was formed; the water-in-oil emulsion was slowly injected into the outer aqueous solution and homogenized at 6000 rpm to form a W / O / W emulsion. At the same time, during the stirring or homogenization process, some of the W / O droplets in the W / O / W emulsion ruptured, and the inner aqueous phase released by the droplet rupture dissolved in the outer aqueous phase to form a mixed emulsion; S5. Filling The mixed emulsion was filled into a container or a packaging bag, and then placed into an elastic bandage and sealed to obtain a cold compress bandage.

[0028] Example 2 A cold compress bandage, comprising a container for providing a cooling liquid and an elastic bandage impregnated in the cooling liquid.

[0029] The cooling liquid is a mixed emulsion composed of an O / W emulsion and a W / O / W emulsion, including a continuous outer aqueous phase, oil droplets and W / O droplets dispersed in the outer aqueous phase; the W / O droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances in the inner aqueous phase dissolved due to the rupture of the W / O droplets; wherein, The outer aqueous phase includes the following components in parts by mass: Tween-80 2.5 g, polyethylene glycol 400 2 g, sodium carboxymethyl cellulose 0.2 g, water 60 g; The oil phase of the oil droplets or W / O droplets includes the following components in parts by mass: Liquid paraffin 15 g, menthol 2 g, borneol 3 g, eucalyptus oil 3 g, Span-80 0.5 g; The inner aqueous phase of the W / O droplets includes the following components in parts by mass: Glycerol 3 g, propylene glycol 2 g, wild chrysanthemum decoction 10 g.

[0030] The preparation method is the same as that of Example 1.

[0031] Example 3 A cold compress bandage, comprising a container for providing a cooling liquid and an elastic bandage impregnated in the cooling liquid.

[0032] The cooling liquid is a mixed emulsion composed of an O / W emulsion and a W / O / W emulsion, including a continuous outer aqueous phase, oil droplets and W / O droplets dispersed in the outer aqueous phase; the W / O droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances in the inner aqueous phase dissolved due to the rupture of the W / O droplets; wherein, The outer aqueous phase includes the following components in parts by mass: Tween - 80 3 g, polyethylene glycol 400 2 g, sodium carboxymethyl cellulose 0.2 g, water 70 g; The oil phase of the oil droplets or W / O type emulsion droplets comprises the following components in parts by mass: Liquid paraffin 25 g, menthol 2 g, borneol 5 g, eucalyptus oil 5 g, Span - 80 0.5 g; The inner aqueous phase of the W / O type emulsion droplets comprises the following components in parts by mass: Glycerol 3 g, propylene glycol 2 g, wild chrysanthemum decoction 10 g.

[0033] The preparation method is the same as that of Example 1.

[0034] Example 4 A cold compress bandage, comprising a container for providing a cool - feeling liquid and an elastic bandage impregnated in the cool - feeling liquid.

[0035] The cool - feeling liquid is a mixed emulsion composed of O / W type emulsion and W / O / W type emulsion, including a continuous outer aqueous phase, oil droplets and W / O type emulsion droplets dispersed in the outer aqueous phase; the W / O type emulsion droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances in the inner aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; wherein, The outer aqueous phase comprises the following components in parts by mass: Tween - 80 2.5 g, polyethylene glycol 400 3 g, sodium carboxymethyl cellulose 0.3 g, water 60 g; The oil phase of the oil droplets or W / O type emulsion droplets comprises the following components in parts by mass: Liquid paraffin 15 g, menthol 2 g, borneol 3 g, eucalyptus oil 3 g, Span - 80 1.2 g; The inner aqueous phase of the W / O type emulsion droplets comprises the following components in parts by mass: Glycerol 4 g, propylene glycol 2.5 g, wild chrysanthemum decoction 15 g.

[0036] The preparation method is the same as that of Example 1.

[0037] Example 5 A cold compress bandage, comprising a container for providing a cool - feeling liquid and an elastic bandage impregnated in the cool - feeling liquid.

[0038] The cool - feeling liquid is a mixed emulsion composed of O / W type emulsion and W / O / W type emulsion, including a continuous outer aqueous phase, oil droplets and W / O type emulsion droplets dispersed in the outer aqueous phase; the W / O type emulsion droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances in the inner aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; wherein, The outer aqueous phase comprises the following components in parts by mass: Tween - 80 3 g, polyethylene glycol 400 5 g, sodium carboxymethyl cellulose 0.5 g, water 70 g; The oil phase of the oil droplets or W / O type emulsion droplets comprises the following components in parts by mass: Liquid paraffin 25 g, menthol 2 g, borneol 5 g, eucalyptus oil 5 g, Span - 80 2.0 g; The inner aqueous phase of the W / O type emulsion droplets comprises the following components in parts by mass: Glycerol 5 g, propylene glycol 3 g, wild chrysanthemum decoction 20 g.

[0039] The preparation method is the same as that of Example 1.

[0040] Example 6 A cold compress bandage, comprising a container for providing a cool - feeling liquid and an elastic bandage impregnated in the cool - feeling liquid.

[0041] The cool - feeling liquid is a mixed emulsion composed of O / W type emulsion and W / O / W type emulsion, and includes a continuous outer aqueous phase, oil droplets and W / O type emulsion droplets dispersed in the outer aqueous phase; the W / O type emulsion droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; part of the substances in the inner aqueous phase dissolved due to the rupture of the W / O type emulsion droplets are also contained in the continuous outer aqueous phase; wherein, The outer aqueous phase comprises the following components in parts by mass: Tween - 80 2.5 g, polyethylene glycol 400 3 g, sodium carboxymethyl cellulose 0.3 g, water 60 g; The oil phase of the oil droplets or W / O type emulsion droplets comprises the following components in parts by mass: Liquid paraffin 15 g, menthol 2 g, borneol 3 g, eucalyptus oil 3 g, Span - 80 1.2 g; The inner aqueous phase of the W / O type emulsion droplets comprises the following components in parts by mass: Glycerol 4 g, propylene glycol 2.5 g, dandelion decoction 15 g.

[0042] The preparation method is the same as that of Example 1 (the wild chrysanthemum decoction is replaced with dandelion decoction, and every 100 g of dandelion decoction contains 25 g of crude drug).

[0043] Example 7 A cold compress bandage, comprising a container for providing a cool - feeling liquid and an elastic bandage impregnated in the cool - feeling liquid.

[0044] The cooling liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, including a continuous external aqueous phase, oil droplets dispersed in the external aqueous phase, and W / O type emulsion droplets; the W / O type emulsion droplets include a continuous oil phase and an internal aqueous phase dispersed in the continuous oil phase; the continuous external aqueous phase also contains some substances in the internal aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; wherein, The external aqueous phase comprises the following components in parts by mass: Tween-80 2.5 g, polyethylene glycol 400 3 g, hydroxyethyl cellulose 0.3 g, water 60 g; The oil phase of the oil droplets or W / O type emulsion droplets comprises the following components in parts by mass: Liquid paraffin 15 g, menthol 2 g, borneol 3 g, eucalyptus oil 3 g, Span-80 1.2 g; The internal aqueous phase of the W / O type emulsion droplets comprises the following components in parts by mass: Glycerol 4 g, propylene glycol 2.5 g, wild chrysanthemum decoction 15 g.

[0045] The preparation method is the same as that of Example 1 (carboxymethyl cellulose sodium is replaced by hydroxyethyl cellulose).

[0046] Example 8 A cold compress bandage comprises a container for providing the cooling liquid and an elastic bandage impregnated in the cooling liquid.

[0047] The cooling liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, including a continuous external aqueous phase, oil droplets dispersed in the external aqueous phase, and W / O type emulsion droplets; the W / O type emulsion droplets include a continuous oil phase and an internal aqueous phase dispersed in the continuous oil phase; the continuous external aqueous phase also contains some substances in the internal aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; wherein, The external aqueous phase comprises the following components in parts by mass: Tween-80 2.5 g, polyethylene glycol 400 3 g, sodium carboxymethyl cellulose 0.3 g, water 60 g; The oil phase of the oil droplets or W / O type emulsion droplets comprises the following components in parts by mass: Liquid paraffin 15 g, menthol 2 g, borneol 3 g, eucalyptus oil 3 g, ethylene glycol monooleate 1.2 g; The internal aqueous phase of the W / O type emulsion droplets comprises the following components in parts by mass: Glycerol 4 g, propylene glycol 2.5 g, wild chrysanthemum decoction 15 g.

[0048] The preparation method is the same as that of Example 1 (Span-80 is replaced by ethylene glycol monooleate).

[0049] Example 9 A cold compress bandage, comprising a container for providing a cool-sensation liquid and an elastic bandage impregnated in the cool-sensation liquid.

[0050] The cool-sensation liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, including a continuous outer aqueous phase, oil droplets dispersed in the outer aqueous phase, and W / O type droplets; the W / O type droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances in the inner aqueous phase dissolved due to the rupture of the W / O type droplets; among them, The outer aqueous phase includes the following components in parts by mass: Tween-80 2.5 g, benzalkonium bromide 0.1 g, polyethylene glycol 400 3 g, sodium carboxymethyl cellulose 0.3 g, water 60 g; The oil phase of the oil droplets or W / O type droplets includes the following components in parts by mass: Liquid paraffin 15 g, menthol 2 g, borneol 3 g, eucalyptus oil 3 g, Span-80 1.2 g; The inner aqueous phase of the W / O type droplets includes the following components in parts by mass: Glycerol 4 g, propylene glycol 2.5 g, wild chrysanthemum decoction 15 g.

[0051] The preparation method is the same as that of Example 1 (benzalkonium bromide is added finally after the emulsification in step S4 is completed).

[0052] Comparative Example 1 A cold compress bandage, comprising a container for providing a cool-sensation liquid and an elastic bandage impregnated in the cool-sensation liquid.

[0053] The cool-sensation liquid is an ethanol system, and the preparation method of its cold compress bandage is as follows: S1. Dissolve 0.5% menthol and 2% borneol in 30% ethanol to obtain an alcohol solution; S2. Dissolve 10% propylene glycol, 2% polyethylene glycol 400, 1% Tween-80, and 0.5% sodium carboxymethyl cellulose in the remaining water to obtain an aqueous solution; S3. Mix the aqueous solution and the alcohol solution, and stir until completely dissolved to prepare a cool-sensation liquid; S4. Fill the cool-sensation liquid into a cylindrical container, then load an elastic bandage, seal it, and obtain a cold compress bandage.

[0054] Comparative Example 2 A cold compress bandage, comprising a container for providing a cool-sensation liquid and an elastic bandage impregnated in the cool-sensation liquid.

[0055] The cool-sensation liquid is an oil-in-water type emulsion, including a continuous aqueous phase component and a dispersed oil phase component; among them, the aqueous phase component includes the following components in parts by mass: Glycerol 3 g, 2 g of propylene glycol, 2 g of polyethylene glycol 400, 10 g of wild chrysanthemum decoction, 0.2 g of sodium carboxymethyl cellulose, 2.0 g of Tween-80, 50 g of water; The oil phase components include the following components in parts by mass: 10 g of liquid paraffin, 1.0 g of menthol, 2.0 g of borneol, 2.0 g of eucalyptus oil, 0.5 g of Span-80.

[0056] The preparation method of the above cold compress bandage is as follows: S1. Preparation of the aqueous phase Mix the formula amounts of glycerin, propylene glycol, polyethylene glycol 400, wild chrysanthemum decoction, sodium carboxymethyl cellulose, Tween-80 and water, heat to 60 °C, and stir until completely dissolved to form an aqueous phase; S2. Preparation of the oil phase Mix the formula amounts of menthol, borneol, eucalyptus oil, Span-80 and liquid paraffin, heat to 60 °C, and stir until completely dissolved to form an oil phase; S3. Emulsification Slowly inject the oil phase into the aqueous phase in segments, and at the same time, stir at a high speed of 3000 rpm to form a stable oil-in-water emulsion; S4. Filling Fill the emulsion into a cylindrical container, then put it into an elastic bandage, seal it, and obtain the cold compress bandage.

[0057] Comparative Example 3 The cool-sensation liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, including a continuous outer aqueous phase, oil droplets dispersed in the outer aqueous phase, and W / O type emulsion droplets; the W / O type emulsion droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances in the inner aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; among them, The outer aqueous phase includes the following components in parts by mass: 2 g of Tween-80, 2 g of polyethylene glycol 400, 0.2 g of sodium carboxymethyl cellulose, 50 g of water; The oil phase of the oil droplets or W / O type emulsion droplets includes the following components in parts by mass: 10 g of liquid paraffin, 1 g of menthol, 2 g of borneol, 2 g of eucalyptus oil, 0.5 g of Span-80; The internal aqueous phase of the W / O type emulsion droplets comprises components in the following parts by mass: 10 g of wild chrysanthemum decoction.

[0058] The preparation method is the same as that of Example 1.

[0059] Comparative Example 4 The cooling sensation liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, and includes a continuous external aqueous phase, oil droplets dispersed in the external aqueous phase, and W / O type emulsion droplets; the W / O type emulsion droplets include a continuous oil phase and an internal aqueous phase dispersed in the continuous oil phase; the continuous external aqueous phase also contains some substances in the internal aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; wherein, The external aqueous phase comprises components in the following parts by mass: 2 g of Tween-80, 2 g of polyethylene glycol 400, 0.2 g of sodium carboxymethyl cellulose, 50 g of water; The oil phase of the oil droplets or W / O type emulsion droplets comprises components in the following parts by mass: 10 g of liquid paraffin, 1 g of menthol, 2 g of borneol, 2 g of eucalyptus oil, 0.5 g of Span-80; The internal aqueous phase of the W / O type emulsion droplets comprises components in the following parts by mass: 3 g of glycerol, 2 g of propylene glycol.

[0060] The preparation method is the same as that of Example 1.

[0061] Comparative Example 5 The cooling sensation liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, and includes a continuous external aqueous phase, oil droplets dispersed in the external aqueous phase, and W / O type emulsion droplets; the W / O type emulsion droplets include a continuous oil phase and an internal aqueous phase dispersed in the continuous oil phase; the continuous external aqueous phase also contains some substances in the internal aqueous phase dissolved due to the rupture of the W / O type emulsion droplets; wherein, The external aqueous phase comprises components in the following parts by mass: 2 g of Tween-80, 2 g of polyethylene glycol 400, 0.2 g of sodium carboxymethyl cellulose, 50 g of water; The oil phase of the oil droplets or W / O type emulsion droplets comprises components in the following parts by mass: 10 g of liquid paraffin, 1 g of menthol, 2 g of borneol, 0.5 g of Span-80; The internal aqueous phase of the W / O type emulsion droplets comprises components in the following parts by mass: 3 g of glycerol, 2 g of propylene glycol, 10 g of wild chrysanthemum decoction.

[0062] The preparation method is the same as that of Example 1.

[0063] Comparison of Stability of Examples 1 to 9 and Comparative Examples 1 to 5 1. Purpose of the experiment The stability of the cooling liquids of Examples 1 to 9 and Comparative Examples 3 to 5 during storage and use, including physical stability and use performance stability, was evaluated.

[0064] 2. Experimental Methods 2.1 Sample preparation According to the formula and preparation method in the specification, the cooling liquids of Examples 1 to 9 and Comparative Examples 1 to 5 were prepared respectively.

[0065] 2.2 Storage conditions All samples were stored at 40℃±2℃ for three months (sealed).

[0066] 2.3 Test items 2.3.1 Physical stability Observe the emulsion stratification.

[0067] 2.3.2 Performance stability The duration of the cooling effect was tested by volunteers wearing skin temperature sensors (when the temperature transmitted back was close to that of the blank control volunteers and the change did not exceed 1°C within 30 minutes, it was judged to be ineffective, and the duration of the cooling effect was recorded, accurate to 1 hour; if it was less than 1 hour, it would be counted as 1 hour).

[0068] 4. Data Recording 4.1 Physical stability (qualitative observation) Formulation Initial state After 1 month After 2 months After 3 months Example 1 No delamination No delamination No delamination No delamination Example 2 No delamination No delamination No delamination Slight delamination Example 3 No delamination No delamination Slight delamination Slight delamination Example 4 No delamination No delamination Slight delamination Slight delamination Example 5 No delamination No delamination Slight delamination Slight delamination Example 6 No delamination No delamination Slight delamination Slight delamination Example 7 No delamination No delamination Slight delamination Slight delamination Example 8 No delamination No delamination Slight delamination Slight delamination Example 9 No delamination No delamination Slight delamination Slight delamination Comparative Example 1 No delamination No delamination Slight delamination Slight delamination Comparative Example 2 No delamination Slight delamination Obvious delamination Obvious delamination Comparative Example 3 No delamination No delamination Slight delamination Slight delamination Comparative Example 4 No delamination No delamination Slight delamination Slight delamination Comparative Example 5 No delamination No delamination Slight delamination Slight delamination 4.2 Stability in use (duration of cool feeling, h) Formulation Initial Day 30 Day 60 Day 90 Example 1 12 9 8 7 Example 2 15 11 9 8 Example 3 18 12 7 7 Example 4 15 11 6 6 Example 5 18 12 10 7 Example 6 15 9 9 9 Example 7 15 10 9 6 Example 8 15 10 7 5 Example 9 15 9 7 6 Comparative Example 1 1 1 1 1 Comparative Example 2 12 6 5 3 Comparative Example 3 12 9 7 5 Comparative Example 4 12 9 6 6 Comparative Example 5 12 7 5 4 Comparison of the therapeutic effects of Examples 1 to 5 1. Purpose of the experiment The cold compresses of Examples 1 to 5 were evaluated for differences in efficacy, including effects on swelling, pain, and inflammatory markers.

[0069] 2. Experimental Materials The cold compress bandages of Examples 1 to 5 (prepared according to the recipe and preparation method in the specification).

[0070] 3. Experimental Subjects Fifteen patients with swelling and inflammation caused by sprains were recruited (Anji County People's Hospital), aged between 18 and 60 years old, regardless of gender.

[0071] Exclusion criteria: open wounds, severe fractures, history of allergies, pregnant or lactating women, and other chronic diseases.

[0072] IV. Experimental Grouping The patients were randomly divided into 5 groups, with 3 patients in each group.

[0073] Each group used a cold compress bandage with a specific formula.

[0074] V. Experimental Methods 5.1 Wound Assessment Before treatment, the swelling degree of the patients (calculated as the ratio of the circumference of the swollen area to the initial swollen circumference), pain score (using the Visual Analogue Scale, VAS, 0 - 10 points, 0 points for no pain, 10 points for the most severe pain), and the level of inflammatory markers (such as C-reactive protein, CRP) were recorded.

[0075] 5.2 Treatment Process Each group of patients used the corresponding cold compress bandage, which was changed once a day for 7 consecutive days.

[0076] 5.3 Data Collection On the 3rd, 5th, and 7th days after treatment, the swelling degree, pain score, and the level of inflammatory markers of the patients were recorded respectively (taking the average value, the swelling degree was accurate to 1%, the pain score was accurate to 0.1, and CRP was accurate to 1 mg / L).

[0077] VI. Data Analysis Swelling Degree: The regression of swelling was evaluated by measuring the change in the circumference of the injured area.

[0078] Pain Score: The change in pain was evaluated using the VAS score.

[0079] Level of Inflammatory Markers: The remission of inflammation was evaluated by detecting the CRP level in the blood.

[0080] VII. Test Results 7.1 Swelling Degree (%) Time point Example 1 Example 2 Example 3 Example 4 Example 5 Day 3 51 52 52 53 54 Day 5 32 32 33 33 34 Day 7 12 12 13 13 14 7.2 Pain Score (VAS) Time point Example 1 Example 2 Example 3 Example 4 Example 5 Day 3 5.4 5.3 5.2 5.1 5.0 Day 5 3.4 3.3 3.2 3.1 3.0 Day 7 1.4 1.3 1.2 1.1 1.0 7.3 Level of Inflammatory Markers (CRP, mg / L) Time point Example 1 Example 2 Example 3 Example 4 Example 5 Day 3 74.5 73.2 72.1 70.9 69.3 Day 5 54.8 53.6 52.4 51.2 49.5 Day 7 34.1 33.0 32.2 31.0 29.5 Referring to the above tests, Comparative Examples 1 - 5 were selected as the objects to study the swelling degree and the level of inflammatory markers. The results are shown in the following table.

[0081] Swelling Degree of Comparative Examples 1 - 5 (%) Time point Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Day 3 62 55 52 59 57 Day 5 47 36 35 42 41 Day 7 34 16 17 27 29 Level of Inflammatory Markers of Comparative Examples 1 - 5 (CRP, mg / L) Time point Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Day 3 85.6 77.4 73.4 76.5 78.9 Day 5 67.1 51.6 56.1 69.2 55.2 Day 7 51.3 39.8 32.3 48.7 36.5

Claims

1. A cold compress bandage, comprising an elastic bandage adsorbed with a cool-sensation liquid and a container or package for providing the cool-sensation liquid, characterized in that: The cool-sensation liquid is a mixed emulsion composed of an O / W type emulsion and a W / O / W type emulsion, including a continuous outer aqueous phase, oil droplets dispersed in the outer aqueous phase, and W / O type emulsion droplets; the W / O type emulsion droplets include a continuous oil phase and an inner aqueous phase dispersed in the continuous oil phase; the continuous outer aqueous phase also contains some substances originally present in the inner aqueous phase and dissolved due to the rupture of the W / O type emulsion droplets; wherein, The outer aqueous phase includes the following components in parts by mass: Hydrophilic emulsifier 2 - 3, solubilizer 2 - 5, thickener 0.2 - 0.5, water 50 - 75; The oil phases of the oil droplets and the W / O type emulsion droplets include the following components in parts by mass: Liquid paraffin 10 - 25, cool-sensation agent 3.0 - 7.0, oil-soluble antibacterial agent 2.0 - 5.0, lipophilic emulsifier 0.5 - 2.0; The inner aqueous phase of the W / O type emulsion droplets includes the following components in parts by mass: Humectant 5 - 8, water-soluble antibacterial agent 10 - 20.

2. The cold compress bandage according to claim 1, characterized in that: The humectant is selected from one or two of glycerol and propylene glycol.

3. The cold compress bandage according to claim 2, characterized in that, The components of the humectant in parts by mass are as follows: glycerol 3 - 5, propylene glycol 2 - 3.

4. The cold compress bandage according to claim 1, characterized in that: The thickener is selected from one or two of carboxymethyl cellulose and hydroxyethyl cellulose.

5. A cold compress bandage according to claim 1, characterized in that: The hydrophilic emulsifier is Tween.

6. The cold compress bandage according to claim 1, characterized in that: The cool-sensation agent is selected from one or two of menthol and borneol.

7. The cold compress bandage according to claim 6, wherein, The components of the cool-sensation agent in parts by mass are as follows: menthol 1.0 - 2.0, borneol 2.0 - 5.

0.

8. The cold compress bandage according to claim 1, wherein: The lipophilic emulsifier is selected from one or more of Span and fatty acid ethylene glycol ester.

9. A cold compress bandage according to claim 1, characterized in that: The composition of the outer aqueous phase further includes 0.05 - 0.3 parts by mass of benzalkonium chloride / benzalkonium bromide.

10. A method for preparing a cold compress bandage according to claim 1, comprising the following steps: S1. Preparation of the inner aqueous phase Mix the humectant and the water-soluble antibacterial agent heated to 50 - 60 °C, and stir until completely dissolved to form an inner aqueous phase solution; S2. Preparation of the oil phase Mix the cool-sensation agent, the oil-soluble antibacterial agent, the lipophilic emulsifier and the liquid paraffin heated to 50 - 60 °C, and stir until completely dissolved to form an oil phase solution; S3. Preparation of the outer aqueous phase Mix the hydrophilic emulsifier, the solubilizer, the thickener and hot water at 50 - 60 °C, and stir until completely dissolved to form an outer aqueous phase solution; S4. Emulsification Under a nitrogen atmosphere, slowly inject the inner aqueous phase into the oil phase solution, and stir at a speed of 1000 - 2000 rpm until a stable water-in-oil emulsion is formed; slowly inject the water-in-oil emulsion into the outer aqueous phase solution, and stir or homogenize at a speed of more than 3000 rpm to form a W / O / W type emulsion. At the same time, during the stirring or homogenization process, some W / O emulsion droplets of the W / O / W type emulsion rupture, and the substances in the inner aqueous phase released by the rupture of the emulsion droplets dissolve in the outer aqueous phase to form a mixed emulsion; S5. Filling Fill the mixed emulsion into a container or a packaging bag, then put it into an elastic bandage, seal it, and obtain the cold compress bandage.