Temperature control type dragon's blood cataplasm as well as preparation method and application thereof

Abstract

The invention discloses temperature control type dragon's blood cataplasm as well as a preparation method and application thereof, and belongs to the technical field of medical instruments and traditional Chinese medicine external preparations. The cataplasm is of a layered composite structure and comprises a backing layer, a temperature control heating layer, a heat insulation temperature control layer, a cataplasm matrix layer containing a dragon's blood extract and an anti-sticking layer. Through cooperation of the heating layer material and the breathable temperature control material, the application temperature can be accurately controlled to be 40-50 DEG C and lasts for 2-4 hours, controllable low-temperature thermal therapy and the pharmacological action of the dragon's blood are organically combined, and synergistic interaction of thermal therapy and medical therapy is achieved. The product can remarkably promote hematoma absorption and relieve swelling and pain, is safe and convenient to use, is particularly suitable for treatment of subacute stages such as post-trauma subcutaneous hematoma, post-arterial paracentesis subcutaneous hematoma and soft tissue injury, and has a wide clinical application prospect.

Description

Technical Field

[0001] This invention belongs to the field of medical device and traditional Chinese medicine external preparation technology, and in particular relates to a temperature-controlled dragon's blood plaster, its preparation method and application. Background Technology

[0002] Subcutaneous hematoma and soft tissue contusion following trauma are common clinical conditions. After the acute phase (usually 48-72 hours after injury), the condition progresses to the subacute phase, characterized by blood stasis, swelling, pain, and tissue repair. The core of treatment at this stage is to promote hematoma absorption, eliminate inflammation, relieve pain, and accelerate tissue repair.

[0003] Currently, commonly used clinical treatments have many limitations. Physical therapies, such as infrared irradiation and hot compresses, can dilate local blood vessels and promote blood circulation, but they lack direct drug intervention, have limited efficacy, are highly dependent on equipment, and are inconvenient for patients. Traditional Chinese medicine external application, such as applying powdered blood-activating and stasis-removing herbs like dragon's blood mixed with vinegar or wine, has some efficacy, but problems include easy drying and detachment of the medicine, uneven release of active ingredients, limited permeability, uncontrollable temperature, easy staining of clothing, and inconvenience for patients to operate themselves. Modern external plasters, such as ordinary poultices or rubber plasters, are convenient to use, but usually do not have heating functions and cannot enhance transdermal drug absorption and local blood flow through heat effects; while ordinary self-heating patches on the market (such as heat packs) only provide heat therapy, do not contain therapeutic drugs, and have limited functions.

[0004] Dragon's blood possesses clear pharmacological effects such as anti-inflammatory, analgesic, microcirculation-improving, and tissue-repair-promoting properties. Its efficacy in treating pressure injuries, diabetic foot, and phlebitis through external application has been extensively studied. These core effects address the pathological needs of subacute hematoma treatment, including blood stasis removal, anti-inflammation, and repair promotion. As a modern transdermal drug delivery carrier, poultices offer advantages such as high drug loading capacity, good breathability, and reusability. Theoretically, combining controlled thermotherapy with traditional Chinese medicine poultices, through the thermal effect promoting local blood circulation and drug penetration, holds promise for achieving synergistic therapeutic effects.

[0005] However, there are currently no reports of mature products that combine Dragon's Blood Plaster with safe, stable, and controllable low-temperature self-heating technology and are specifically used for the treatment of subacute hematomas.

[0006] Therefore, developing a compound product that can organically combine the pharmacological effects of dragon's blood with continuous and safe physical thermotherapy, and that is convenient to use and has a definite curative effect, has important clinical significance and market value. Summary of the Invention

[0007] The purpose of this invention is to provide a temperature-controlled dragon's blood ointment, its preparation method, and its application, which can completely solve the shortcomings of the prior art.

[0008] The objective of this invention is achieved through the following technical solution:

[0009] A temperature-controlled dragon's blood poultice has a layered composite structure, comprising, from the side furthest from the skin to the side applied to the skin, the following components:

[0010] Backing layer;

[0011] The temperature-controlled heating layer comprises a heating material and a breathable temperature-controlled material. The breathable temperature-controlled material is used to control the oxygen entry rate so that the temperature of the skin contact surface is stably maintained between 40°C and 50°C during application and can continuously generate heat for 2 to 4 hours.

[0012] The heat insulation and temperature control layer, located between the temperature control and heating layer and the medicated poultice matrix layer, is made of microporous material or low thermal conductivity material and is used to homogenize heat flow.

[0013] The medicated poultice base layer is a poultice paste containing dragon's blood extract;

[0014] Anti-stick layer.

[0015] The thermal conductivity of the heat-insulating and temperature-controlling layer is 0.03-0.3 W / (m·K), preferably 0.05-0.15 W / (m·K), and its thermal resistance is 0.01-0.1 m²·K / W. When microporous materials are used, their average pore size is 10-200 μm, and their porosity is 40%-80%. The above parameter range ensures that the layer can effectively buffer potential local hot spots in the temperature-controlled heating layer, converting point heat sources into uniform planar thermal radiation, while also ensuring sufficient heat transfer to the drug-containing poultice matrix layer, achieving simultaneous synergistic effects of thermotherapy and drug therapy.

[0016] The backing layer is made of a breathable flexible material, such as breathable nonwoven fabric, perforated plastic film or microporous breathable membrane, with an air permeability of not less than 500 cm³ / (m²·s) (under a pressure difference of 100Pa), to ensure that the temperature-controlled heating layer can obtain enough oxygen from the outside to carry out the oxidation heating reaction.

[0017] Preferably, the dragon's blood extract accounts for 1% to 20% of the mass percentage of the drug-containing poultice matrix layer.

[0018] Preferably, the medicated poultice matrix layer comprises the following components by weight: 2-8 parts sodium polyacrylate, 0.2-1.0 parts aluminum hydroxyacetate, 30-50 parts glycerin, 0.5-2.0 parts sodium carboxymethyl cellulose, 3-15 parts dragon's blood extract, 0.1-0.5 parts tartaric acid, and 40-60 parts purified water.

[0019] Preferably, the medicated poultice matrix layer comprises the following components by weight: 4-6 parts sodium polyacrylate, 0.4-0.6 parts aluminum hydroxyacetate, 35-45 parts glycerin, 0.8-1.2 parts sodium carboxymethyl cellulose, 5-10 parts dragon's blood extract, 0.2-0.4 parts tartaric acid, and 45-55 parts purified water.

[0020] Preferably, the heating material is a mixture of iron powder, activated carbon, vermiculite, salt and water, with a mass ratio of iron powder:activated carbon:vermiculite:salt = 80-120:15-35:5-15:3-8, and the amount of water added is 10%-25% of the total mass of the four dry powders of iron powder, activated carbon, vermiculite and salt.

[0021] Preferably, the breathable temperature-controlling material is a breathable membrane or non-woven fabric with an oxygen permeability of 500-5000 cm³ / (m²·24h·atm) or an average pore size of 0.1-50 μm. More preferably, when the mass ratio of iron powder, activated carbon, vermiculite, and salt in the heating material is 80-120:15-35:5-15:3-8, and the amount of water added is 10%-25% of the total mass of the dry powder, the oxygen permeability of the breathable temperature-controlling material is 1000-3000 cm³ / (m²·24h·atm).

[0022] A method for preparing the above-mentioned temperature-controlled dragon's blood poultice includes the following steps:

[0023] Preparation of medicated ointment: Dragon's blood extract was dispersed in glycerin, and sodium polyacrylate was added and mixed to obtain phase A; aluminum hydroxyl and sodium carboxymethyl cellulose were mixed to obtain phase B; tartaric acid was dissolved in purified water to prepare phase C; phase B was added to phase A and mixed, and then phase C was slowly added, stirred at high speed until homogeneous, and degassed under vacuum to obtain medicated ointment;

[0024] Pre-fabrication of temperature-controlled heating layer: Iron powder, activated carbon, vermiculite and salt are mixed in proportion, water accounting for 10%-25% of the total mass of dry powder is added, and the mixture is put into a bag made of breathable temperature-controlled material to form a heating core. Then, thermal insulation material is laminated on at least one side of the heating core to form a temperature-controlled heating layer.

[0025] Overall assembly: Apply the medicated ointment obtained in step 1 onto the non-adhesive layer to form the medicated patch matrix layer; then, using edge heat sealing or dot-applying adhesive (the fixing method should avoid completely sealing the bonding surface between the backing layer and the temperature-controlled heating layer, ensuring that the breathable area of ​​the backing layer and the oxygen-inlet area of ​​the temperature-controlled heating layer remain connected), sequentially cover and fix the heat insulation and temperature control layer, the pre-made temperature-controlled heating layer, and the backing layer onto the medicated patch matrix layer; after cutting and packaging, the product is obtained.

[0026] The above-mentioned temperature-controlled Dragon's Blood Plaster is used in the preparation of external products for promoting hematoma absorption and relieving swelling and pain.

[0027] Preferably, the application is for the treatment of subacute soft tissue injuries.

[0028] Preferably, the subacute phase is from 48 hours to 2 weeks after the injury.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] 1. Stable low-temperature thermotherapy can effectively dilate local capillaries and promote blood circulation. Combined with the blood-activating and stasis-removing pharmacological effects of dragon's blood, it produces a synergistic effect of "1+1>2", which can promote the absorption of hematoma and eliminate swelling more quickly and effectively.

[0031] 2. The increase in skin temperature and dilation of pores caused by heat therapy can significantly increase the transdermal absorption rate and amount of active ingredients of dragon's blood (such as dragon's blood extract A and B), thereby enhancing the efficacy.

[0032] 3. Through the scientific formulation of the heating layer material and the quantitative control of the breathable temperature-regulating material, the heating temperature is precisely controlled within a safe and comfortable range (40-50℃), avoiding the risk of low-temperature burns that may be caused by the uncontrollable temperature of traditional hot compresses. The product is an integrated patch; patients only need to peel off the anti-adhesive layer to apply it, without the need for additional medication preparation or equipment, greatly improving patient compliance and making it suitable for home and community use.

[0033] 4. This invention is specifically designed for the subacute phase of hematoma and soft tissue injury, filling the market gap of lacking convenient and effective treatment products for this stage.

[0034] 5. Using a poultice as a drug carrier, the ointment is moist, breathable, and skin-friendly, with good adhesion to the skin, low allergenicity, and can carry a large dose of traditional Chinese medicine extracts, ensuring sufficient drug delivery. Attached Figure Description

[0035] Figure 1 This is a schematic diagram of the layered structure of the temperature-controlled Dragon's Blood Plaster in this invention.

[0036] In the diagram, 1 is the backing layer; 2 is the temperature-controlled heating layer; 3 is the heat insulation and temperature control layer; 4 is the medicated poultice matrix layer; and 5 is the anti-sticking layer. Detailed Implementation

[0037] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0038] Example 1

[0039] like Figure 1 As shown, this embodiment provides a temperature-controlled dragon's blood poultice, comprising a backing layer 1 (non-woven fabric), a temperature-controlled heating layer 2, a heat insulation and temperature control layer 3 (microporous polyethylene film, 0.5 mm thick, thermal conductivity 0.08 W / (m·K), thermal resistance approximately 0.025 m²·K / W, average pore size 50 μm, porosity 60%), a medicated poultice matrix layer 4, and an anti-adhesive layer 5 (release film).

[0040] 1. Pre-fabrication of temperature-controlled heating layer:

[0041] Iron powder (150 mesh), activated carbon (200 mesh), vermiculite (100 mesh), and salt are mixed evenly in a mass ratio of 100:25:10:5. Water, accounting for 15% of the total mass of the mixture, is then quickly packed into a small bag (slightly smaller than the backing layer) made of breathable non-woven fabric (polypropylene, 40 g / m², oxygen permeability under standard conditions of 2000 cm³ / (m²·24h·atm), average pore size of 15 μm). The bag is then sealed to form the heating core. A layer of non-woven fabric is then laminated onto the back of this heating core (not the skin-contact side) as an insulation layer, forming a temperature-controlled heating layer.

[0042] 2. Preparation of the medicated poultice matrix layer (based on 1000g of paste):

[0043] formula:

[0044] Dragon's Blood Extract: 80g;

[0045] Sodium polyacrylate: 50g;

[0046] Aluminum hydroxychloroquine: 5g;

[0047] Glycerin: 400g;

[0048] Sodium carboxymethyl cellulose (CMC-Na): 10g;

[0049] Tartaric acid: 2g;

[0050] Purified water: 453g;

[0051] Preparation steps:

[0052] Phase A: Add the dragon's blood extract (passed through a 100-mesh sieve) to glycerin, stir until it is fully dispersed, then add sodium polyacrylate, stir until it is fully dispersed, and let it swell for 12 hours to obtain phase A.

[0053] Phase B: Aluminum hydroxyl and sodium carboxymethyl cellulose are mixed evenly to obtain phase B.

[0054] Phase C: Tartaric acid is completely dissolved in purified water to obtain phase C.

[0055] Mixing: Slowly add phase B to phase A and stir until homogeneous. Then, while stirring, slowly add phase C. After the addition is complete, continue stirring at high speed (1000 rpm) for 10 minutes to allow for a complete cross-linking reaction.

[0056] Degassing: The mixed paste is subjected to vacuum degassing (-0.08MPa, 15 minutes) to obtain the medicated paste.

[0057] 3. Overall assembly:

[0058] The medicated ointment prepared in step 2 is evenly applied onto the anti-adhesive layer 5 to form the medicated patch matrix layer 4 (1.2 mm thick). Then, using an edge heat-sealing process, the heat insulation and temperature control layer 3, the pre-fabricated temperature-controlled heating layer 2, and the backing layer 1 are sequentially covered and fixed onto the medicated patch matrix layer 4, ensuring that the edges of each layer are tightly bonded to prevent slippage between layers, while also ensuring that the breathable area of ​​the temperature-controlled heating layer 2 is not blocked. Finally, it is cut into 7 cm × 10 cm pieces, sealed in an aluminum foil bag, and the finished product is obtained.

[0059] Effect verification

[0060] After removing the anti-adhesive layer, the temperature-controlled dragon's blood ointment prepared in this embodiment was applied to the inner forearm of healthy volunteers. A thermocouple thermometer was used to test the temperature change at the skin contact surface. The results showed that approximately 20 minutes after application, the temperature rose to 42°C, and remained stable between 42-48°C for the following 3.5 hours without any sudden increases or decreases. All volunteers reported a comfortable warming sensation and no burn sensation.

[0061] Example 2

[0062] This embodiment is basically the same as Embodiment 1, except that the formulation of the medicated poultice base layer is different. The formulation of this embodiment is (based on 1000g of paste):

[0063] Dragon's Blood Extract: 120g; Sodium Polyacrylate: 60g; Aluminum Hydroxyhydroxyacetic Acid: 6g; Glycerin: 420g; Sodium Carboxymethyl Cellulose (CMC-Na): 12g; Tartaric Acid: 2.5g; Purified Water: 379.5g.

[0064] The preparation method is the same as in Example 1. The prepared poultice was tested and found to have a stable heating temperature of 45-50℃, with a continuous heating time of approximately 3 hours.

[0065] Comparative Example 1

[0066] Commercially available ordinary Dragon's Blood Balm (without heating layer).

[0067] Comparative Example 2

[0068] This embodiment is basically the same as Embodiment 1, except that the formulation of the medicated poultice matrix layer and the breathable material of the temperature-controlled heating layer are different.

[0069] The formula for the medicated poultice base layer is as follows (based on 1000g of paste):

[0070] Dragon's Blood Extract: 120g;

[0071] Sodium polyacrylate: 60g;

[0072] Aluminum hydroxychloroquine: 6g;

[0073] Glycerin: 420g;

[0074] Sodium carboxymethyl cellulose (CMC-Na): 12g;

[0075] Tartaric acid: 2.5g;

[0076] Purified water: 379.5g;

[0077] The breathable nonwoven fabric of the temperature-controlled heating layer is selected with an oxygen permeability of 1000 cm³ / (m²·24h·atm).

[0078] The preparation method is the same as in Example 1. The prepared poultice was tested and found to have a stable heating temperature of 45-50℃, with a continuous heating time of approximately 3 hours.

[0079] Breathable material matching experiment example

[0080] To clarify the relationship between the oxygen permeability and heating temperature of the breathable temperature-controlled material, the applicant conducted a series of matching experiments. The heating material ratio for the fixed temperature-controlled heating layer was: 100 parts iron powder, 25 parts activated carbon, 10 parts vermiculite, and 5 parts salt, with 15% water added to the total dry powder mass. This mixture was then placed into identically sized pouches made of breathable non-woven fabric (all made of polypropylene, 40 g / m²) with different oxygen permeability, and assembled into a complete plaster (the remaining structure was the same as in Example 1). Each sample was applied to the inner forearm of healthy volunteers, and the average temperature of the skin contact surface during the steady-state period was measured. The results are as follows:

[0081] Oxygen permeability of breathable nonwoven fabric (cm³ / (m²·24h·atm)) Average temperature of skin contact surface during the stable period (°C) 500 38-41 1000 41-44 2000 44-47 3000 47-50 5000 50-55 (Some subjects felt overheated)

[0082] Experimental results show that, under the heating material formulation of this invention, when the oxygen permeability is within the range of 1000-3000 cm³ / (m²·24h·atm), the skin contact surface temperature can be stably controlled within the target range of 40-50℃. Below 1000℃, the temperature is too low; above 3000℃, there is a risk of overheating. Therefore, the preferred oxygen permeability range is 1000-3000 cm³ / (m²·24h·atm).

[0083] It should be noted that when the dry powder ratio or total amount of the heating material changes, the required oxygen permeation rate must also be adjusted accordingly to achieve the same target temperature range. Generally speaking, the larger the amount of heating material or the higher its reactivity, the lower the required oxygen permeation rate; and vice versa. Those skilled in the art can determine the optimal oxygen permeation rate range for a specific formulation through limited conventional experiments based on the teachings of this embodiment.

[0084] Example 3

[0085] This embodiment is basically the same as Embodiment 1, except that the connection method between each layer is different.

[0086] This embodiment uses a dot-matrix adhesive application method to fix the layers. Specifically, medical pressure-sensitive adhesive is applied in a dot matrix pattern (dot diameter 2mm, spacing 10mm) to the edges and center of the heat insulation and temperature control layer 3, as well as the inner surface of the backing layer 1. Then, the layers are aligned and bonded together in sequence, and light pressure is applied to ensure adhesion. This method ensures the stability of the interlayer bond while minimizing the risk of adhesive clogging the breathable material.

[0087] Comparative Example 1

[0088] Commercially available ordinary Dragon's Blood Balm (without heating layer).

[0089] Comparative Example 2

[0090] Commercially available self-heating patches (heat packs, without medication).

[0091] clinical trials

[0092] Sixty patients with subacute subcutaneous hematoma following trauma were randomly divided into three groups of 20 each. Group A used the temperature-controlled dragon's blood plaster prepared in Example 1 of this invention, Group B used the ordinary dragon's blood plaster of Comparative Example 1, and Group C used the self-heating patch of Comparative Example 2. The plaster was applied once daily for 4 hours each time, for 7 consecutive days. Changes in hematoma area and pain score (VAS) before and after treatment were observed and recorded.

[0093] The results showed that group A (the invention group) was significantly better than groups B and C in both hematoma area reduction rate and pain relief (P<0.05). This indicates that the temperature-controlled dragon's blood plaster of the present invention achieves a significant synergistic therapeutic effect by organically combining the pharmacological effects of dragon's blood with the physical effects of controllable thermotherapy.

[0094] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A temperature-controlled dragon's blood poultice, characterized in that: It has a layered composite structure, consisting of the following components from the side furthest from the skin to the side applied to the skin: Backing layer (1); The temperature-controlled heating layer (2) is composed of heating material and breathable temperature-controlled material. The breathable temperature-controlled material is used to control the oxygen entry rate so that the temperature of the skin contact surface is stably maintained between 40°C and 50°C during application and can continue to generate heat for 2 to 4 hours. The heat insulation and temperature control layer (3) is located between the temperature control and heating layer (2) and the drug-containing poultice matrix layer (4). It is made of microporous material or low thermal conductivity material and is used to homogenize heat flow. The medicated poultice matrix layer (4) is a poultice paste containing dragon's blood extract; Anti-stick layer (5).

2. The temperature-controlled dragon's blood poultice according to claim 1, characterized in that: The mass percentage of the dragon's blood extract in the drug-containing poultice matrix layer (4) is 1% to 20%.

3. The temperature-controlled dragon's blood poultice according to claim 1 or 2, characterized in that: The drug-containing poultice matrix layer (4) comprises the following components by weight: 2-8 parts of sodium polyacrylate, 0.2-1.0 parts of aluminum hydroxyl, 30-50 parts of glycerin, 0.5-2.0 parts of sodium carboxymethyl cellulose, 3-15 parts of dragon's blood extract, 0.1-0.5 parts of tartaric acid, and 40-60 parts of purified water.

4. The temperature-controlled dragon's blood poultice according to claim 3, characterized in that: The drug-containing poultice matrix layer (4) comprises the following components by weight: 4-6 parts sodium polyacrylate, 0.4-0.6 parts aluminum hydroxyl, 35-45 parts glycerin, 0.8-1.2 parts sodium carboxymethyl cellulose, 5-10 parts dragon's blood extract, 0.2-0.4 parts tartaric acid, and 45-55 parts purified water.

5. The temperature-controlled dragon's blood poultice according to claim 1, characterized in that: The heating material is a mixture of iron powder, activated carbon, vermiculite, salt and water, with a mass ratio of iron powder:activated carbon:vermiculite:salt = 80-120:15-35:5-15:3-8. The amount of water added is 10%-25% of the total mass of the four dry powders: iron powder, activated carbon, vermiculite and salt.

6. The temperature-controlled dragon's blood poultice according to claim 1, characterized in that, The breathable and temperature-controlled material is a breathable membrane or non-woven fabric with an oxygen permeability of 500-5000 cm³ / (m²·24h·atm) or an average pore size of 0.1-50μm.

7. A method for preparing the temperature-controlled dragon's blood poultice as described in any one of claims 1-6, characterized in that, Includes the following steps: Preparation of medicated ointment: Dragon's blood extract was dispersed in glycerin, and sodium polyacrylate was added and mixed to obtain phase A; aluminum hydroxyl and sodium carboxymethyl cellulose were mixed to obtain phase B; tartaric acid was dissolved in purified water to prepare phase C; phase B was added to phase A and mixed, and then phase C was slowly added, stirred at high speed until homogeneous, and degassed under vacuum to obtain medicated ointment; Pre-fabrication of temperature-controlled heating layer: Iron powder, activated carbon, vermiculite and salt are mixed in proportion, water accounting for 10%-25% of the total mass of dry powder is added, and the mixture is put into a bag made of breathable temperature-controlled material to form a heating core. Then, thermal insulation material is laminated on at least one side of the heating core to form a temperature-controlled heating layer. Overall assembly: The medicated ointment obtained in step 1 is applied to the anti-adhesive layer (5) to form the medicated poultice matrix layer (4); then, the heat insulation and temperature control layer (3), the pre-made temperature control and heating layer (2) and the backing layer (1) are sequentially covered and fixed on the medicated poultice matrix layer (4) by edge hot pressing or dot-applying adhesive; after cutting and packaging, it is obtained.

8. The use of the temperature-controlled Dragon's Blood Plaster according to any one of claims 1-6 in the preparation of a topical product for promoting hematoma absorption and relieving swelling and pain.

9. The application according to claim 8, characterized in that: The application is for the treatment of subacute soft tissue injuries.

10. The application according to claim 9, characterized in that: The subacute phase is defined as 48 hours to 2 weeks after injury.

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