Traditional Chinese medicine sleep-aiding eyeshade based on herbal nanometer slow-release technology

Abstract

The invention belongs to the technical field of sleep-aiding eyeshades, and particularly relates to a traditional Chinese medicine sleep-aiding eyeshade based on a herbal nano slow release technology, which comprises a backing layer, a medicine carrier and a binding belt, according to the preparation method disclosed by the invention, the traditional Chinese medicine active ingredients treated by a nano-scale wall breaking technology and the polyurethane soft foam are mixed and foamed to prepare the medicine carrier, and then the surface aperture of the medicine carrier obtained by foaming is 200-500nm; furthermore, the traditional Chinese medicine active ingredients treated by a nano-scale wall breaking technology can easily penetrate through the pore diameters of the medicine carrier to be in contact with the skin around the eyes of a human body in a particle size of less than 100nm, so that the traditional Chinese medicine active ingredients are diffused from the pore diameters of the medicine carrier in a slow release form, and on one hand, the use durability of the traditional Chinese medicine sleep-aiding eyeshade is ensured; on the other hand, the absorption effect of the human body on traditional Chinese medicine active ingredients is improved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of sleep-aiding eye masks, in particular to a traditional Chinese medicine sleep-aiding eye mask based on herbal nanoscale sustained-release technology. BACKGROUND

[0002] In the modern fast-paced life, the sleep time is greatly reduced due to the heavy work and study tasks, and the long time of eye use and the high pressure lead to the sleep quality getting worse and worse, which not only affects the next day's work and study state, but also affects the physical and mental health in the long run. Although sleeping pills and other drugs can solve the problem of insomnia, they have side effects, and long-term use will cause great harm to the human body. Therefore, wearing an eye mask to achieve the effect of sleep aid is a good way, and it also plays an important role in eliminating fatigue during life and travel.

[0003] However, the current eye mask has a single function, most of which only has the function of shading light, and cannot meet the needs of modern people for high-quality sleep, and the existing traditional Chinese medicine eye mask only adds large particle traditional Chinese medicine ingredients in the eye mask. In this case, traditional Chinese medicine only guides sleep through the form of volatile odor, and the sleep-aiding ingredients in traditional Chinese medicine are not really absorbed by the human body, and the sleep-aiding effect is poor, so it is impossible to achieve the effect of sleep aid for people who need long-term sleep aid, such as the elderly, insomnia patients, and chronic disease patients. SUMMARY

[0004] In order to make up for the shortcomings of the prior art, the application provides a traditional Chinese medicine sleep-aiding eye mask based on herbal nanoscale sustained-release technology. The application is mainly used to solve the problem that the existing traditional Chinese medicine eye mask only adds large particle traditional Chinese medicine ingredients in the eye mask, in which case traditional Chinese medicine only guides sleep through the form of volatile odor, and the sleep-aiding ingredients in traditional Chinese medicine are not really absorbed by the human body, and the sleep-aiding effect is poor.

[0005] The technical scheme adopted by the application to solve the technical problem is that the application provides a traditional Chinese medicine sleep-aiding eye mask based on herbal nanoscale sustained-release technology, which comprises a backing layer, a drug carrier and a binding belt. The backing layer is a frame-shaped structure with one side open, the drug carrier is embedded in the backing layer, the drug carrier is prepared by mixing and foaming the traditional Chinese medicine active ingredients treated by nanoscale wall-breaking technology and polyurethane soft foam, and the two ends of the backing layer are connected by the binding belt.

[0006] By mixing the active ingredients of traditional Chinese medicine treated by nanoscale wall breaking technology with polyurethane soft foam for foaming, and then using the surface pore size of the obtained drug carrier between 200-500 nm, the active ingredients of traditional Chinese medicine treated by nanoscale wall breaking technology can easily pass through the pore size of the drug carrier and contact with the skin around the human eye, and then the active ingredients of traditional Chinese medicine diffuse out of the pore size of the drug carrier in the form of slow release, on the one hand, ensuring the durability of the traditional Chinese medicine sleep aid eye mask, and on the other hand, improving the absorption effect of the human body to the active ingredients of traditional Chinese medicine. The pore size of the surface of the drug carrier can be controlled by controlling the concentration of the foaming agent. If azodicarbonamide is used as the foaming agent, the concentration of azodicarbonamide is between 1.2-1.8wt%. The frame type structure of the backing layer is used to prevent the active ingredients of traditional Chinese medicine in the drug carrier from diffusing out of the side of the drug carrier and causing the problem of loss of drug efficacy.

[0007] Preferably, the preparation process of the drug carrier comprises the following steps: S1: Put the raw material of the active ingredients of traditional Chinese medicine into a high-pressure nanocrusher, and cycle for 3-5 times under the pressure of 200-300 MPa, each time for 2-3 minutes. After the crushing is completed, collect the active ingredient suspension with a particle size of less than 100 nm; The working parameters of the high-pressure nanocrusher are: flow rate 15 L / h, temperature control at 4-8℃, and zirconium oxide beads are used as the crushing medium; S2: React polyether glycol and toluene diisocyanate at a molar ratio of 1:2 at 80-85℃ for 3-4 hours to prepare a polyurethane prepolymer with an NCO content of 8.0±0.3%; The polyether glycol can be PPG-2000 type; Toluene diisocyanate is MDI-50; S3: After the polyurethane prepolymer is cooled to 40℃, the polyurethane prepolymer and the active ingredient suspension are mixed at a mass ratio of 8:2, and are dispersed at a high speed of 1800-2000 rpm for 8-10 minutes; S4: Add foaming agent azodicarbonamide with a concentration of 1.2-1.8wt%, and foam for 30-35 minutes; S5: After curing at room temperature for 24-30 hours, cut into standard size to obtain the drug carrier.

[0008] Preferably, the drug sleep aid eye mask further comprises a temperature-sensitive controlled release layer; The temperature-sensitive controlled release layer is arranged on the open side of the backing layer, and the edge of the temperature-sensitive controlled release layer is sealingly connected with the edge of the backing layer; The preparation process of the temperature-sensitive controlled release layer comprises the following steps: N1: Dehydrate N-isopropyl acrylamide in a vacuum drying box at 50-60℃ for 3-4 hours, and at the same time, dry hydroxypropyl acrylamide in a desiccator for standby; N2: Weigh 82.5g N-isopropyl acrylamide and 12g hydroxypropyl acrylamide into a 500mL three-necked flask, inject 200mL anhydrous ethanol preheated to 50-60℃, stir by magnetic stirring until completely transparent, speed 300-350rpm, time 25±3 minutes; N3: Add 5g nanocellulose, turn on the probe ultrasonic instrument, amplitude 70% for 20-30 minutes to form a homogeneous opalescent suspension; N4: After cooling to 25-30℃, add 0.5g photoinitiator, mechanically stir in the dark for 10-15 minutes, speed 150-200rpm; N5: Transfer to a vacuum degassing tank, cycle degassing 3-5 times at -0.095MPa, 40-50℃, 5-8 minutes each time, until no bubbles escape from the liquid surface, and then obtain the prepolymer liquid; N6: Use a custom quartz mold, spray PTFE release agent on the surface; after preheating the mold to 30-35℃, inject the prepolymer liquid, and control the liquid layer thickness to 380±10μm with a scraper; N7: Irradiate the center area with 10mW / cm² ultraviolet light for 30-40 seconds to form a low crosslinking structure, the transition area with 18mW / cm² for 75-85 seconds, and the edge area with 25mW / cm² for 120-130 seconds. After curing, dehydrate by 30%-100% ethanol gradient, dry at 40℃ to obtain a 120μm gel film; N8: Spin-coat silane coupling agent on the plasma-treated PET film, then bond it with the gel film at 60℃, 0.5MPa for 30-40 seconds, control the cooling rate at 5-6℃ / min to avoid interface delamination, and then obtain the temperature-sensitive controlled release layer. The plasma treatment parameters are as follows: power 100W, argon environment for 180 seconds; When the temperature-sensitive controlled release layer just contacts the skin around the eye, the temperature around the eye is between 34-35℃, the temperature-sensitive controlled release layer maintains a contracted state, and its 50-100nm microporous structure ensures that the active ingredients of traditional Chinese medicine complete the basic drug permeation, at this time the transdermal rate is stable at 0.8mg / h, ensuring that the user enters a stable sleep state, thereby effectively avoiding the drowsiness side effects caused by the initial burst release of traditional sleep aid eye masks.

[0009] When the user enters a deep sleep stage, the body temperature rises to 36.8-37.2℃, and since the temperature-sensitive controlled release layer is still in the hydroxypropyl acrylamide-dominated expansion period at this temperature, it triggers the phase transition and expansion of the temperature-sensitive controlled release layer, the pore size of the temperature-sensitive controlled release layer expands to 300-500nm, thereby forming a high-speed channel for drug release, at this time the burst release rate reaches 2.3mg / h, which exactly matches the required blood drug concentration for the enhancement of brain electrical δ waves.

[0010] And the physical properties of the gel of the temperature-sensitive controlled release layer itself, and then the gel is more easily heat at room temperature, resulting in its temperature is relatively low, and then it is in a highly contracted state, and then the microporous pore size on it is small, and then can very good limit the diffusion of the active ingredients of traditional Chinese medicine in the drug carrier, and then prevent the active ingredients of traditional Chinese medicine in the drug carrier from diffusing and losing when not in use, and then play a protective effect. Preferably, the outer side of the temperature-sensitive controlled release layer is provided with a protective cover; the inner wall of the protective cover is tightly fitted with the outer side surface of the temperature-sensitive controlled release layer; the outer side of the opening edge of the protective cover is provided with a first circular arc flange, and the first circular arc flange and the second circular arc flange protruding inward on the outer side edge of the backing layer are mutually buckled.

[0011] By setting the protective cover which is tightly fitted with the temperature-sensitive controlled release layer on the outer side of the temperature-sensitive controlled release layer, the active ingredients of traditional Chinese medicine in the drug carrier are prevented from diffusing out through the temperature-sensitive controlled release layer, and the active ingredients of traditional Chinese medicine in the sleep aid eye mask are prevented from losing when idle, thereby improving the service life of the sleep aid eye mask. The diffusion prevention by tightly fitting the protective cover with the temperature-sensitive controlled release layer can completely retain the active ingredients of traditional Chinese medicine within the pore size of the drug carrier and the temperature-sensitive controlled release layer. Once the active ingredients of traditional Chinese medicine diffuse outside the pore size of the temperature-sensitive controlled release layer, they will diffuse into the air and cannot be utilized when the protective cover is opened next time, thereby solving the problem by tightly fitting.

[0012] Preferably, a protruding strip is arranged on the inner side of the protective cover near the edge of the temperature-sensitive controlled release layer.

[0013] When the inner wall of the protective cover is tightly fitted with the outer side surface of the temperature-sensitive controlled release layer, the protruding strip on the protective cover also extrudes the edge of the temperature-sensitive controlled release layer. Because the edge of the temperature-sensitive controlled release layer is extruded and compressed, the pores in the inner wall of the temperature-sensitive controlled release layer are extruded and closed, thereby preventing the active ingredients of traditional Chinese medicine entering the pores of the temperature-sensitive controlled release layer from diffusing out of the side of the temperature-sensitive controlled release layer, further ensuring the diffusion prevention effect of the protective cover and further improving the service life of the sleep aid eye mask.

[0014] Preferably, the sleep aid eye mask further comprises a micro-current temperature control module; the micro-current temperature control module comprises a first electric heating sheet, a battery, a wireless receiving unit and a control unit; the first electric heating sheet is arranged on the inner side of the temperature-sensitive controlled release layer at a position close to the eyes; the first electric heating sheet is electrically connected with the battery through the control unit; the wireless receiving unit is electrically connected with the control unit; and the wireless receiving unit is used for receiving control instructions from an external terminal.

[0015] By arranging the first electric heating sheet uniformly and spaced apart inside the temperature-sensitive controlled release layer at the position of fitting the eyes, and then strictly controlling the current intensity of 0.1-0.5 mA flowing into the first electric heating sheet through the control unit, the first electric heating sheet can provide heat to make the temperature-sensitive controlled release layer still in the expansion period dominated by hydroxypropyl acrylamide, and then the expansion degree of the temperature-sensitive controlled release layer can be actively regulated in the form of micro-current, and the expansion of the temperature-sensitive controlled release layer which cannot be completely stimulated by the body temperature of some cold elderly people is actively regulated, and then the current received by the first electric heating sheet is controlled through an external terminal such as a mobile phone or a special remote controller through wireless communication such as Bluetooth, and then the Joule heat conversion makes it possible to control the expansion of the temperature-sensitive controlled release layer, and then the diameter of the pore on it is controlled to increase the diffusion amount of the active ingredients of traditional Chinese medicine in the drug carrier, and then the concentration of the active ingredients of traditional Chinese medicine diffused by the sleep-aiding eye mask reaches the sleep-aiding requirement; by setting the micro-current temperature control module to assist the temperature-sensitive controlled release layer in controlling the diffusion concentration of the active ingredients of traditional Chinese medicine, the precision of controlling the diffusion concentration of the active ingredients of traditional Chinese medicine is improved, and the applicable population of the sleep-aiding eye mask is expanded.

[0016] Preferably, the micro-current temperature control module further comprises a patch-type temperature sensor; the temperature sensor is arranged inside the temperature-sensitive controlled release layer at the position of fitting the eyes.

[0017] The temperature sensor is pre-embedded inside the temperature-sensitive controlled release layer when it is formed; by arranging the patch-type temperature sensor inside the temperature-sensitive controlled release layer at the position of fitting the eyes, the size of the upper aperture of the temperature-sensitive controlled release layer at this temperature can be calculated through the temperature value measured by the temperature sensor, and then the diffusion speed of the active ingredients of traditional Chinese medicine in the drug carrier can be obtained, and then the data is fed back to the control unit, the control unit controls the current intensity flowing into the first electric heating sheet, and then the temperature-sensitive controlled release layer controls the diffusion speed of the active ingredients of traditional Chinese medicine within the range of high-quality sleep-aiding drug concentration, and then the sleep-aiding effect of the sleep-aiding eye mask is improved. Moreover, the temperature at the position of fitting the eyes is monitored in real time by the temperature sensor, and if the temperature is too high, the power supply to the first electric heating sheet is cut off in time through the control unit, and at the same time an alarm is given through the electric signal to the alarm, and then the harm to the user is reduced.

[0018] Preferably, the traditional Chinese medicine sleep-aiding eye mask further comprises an expansion module; the expansion module is arranged between the drug carrier and the backing layer at the position of fitting the eyes; the expansion module comprises an elastic film and an expansion body; the elastic film is a closed bag-shaped structure; the elastic film is filled with the expansion body.

[0019] The material of the expansion body is the same as that of the temperature-sensitive controlled release layer; by arranging the expansion body with the same material as the temperature-sensitive controlled release layer between the drug carrier and the backing layer at the position close to the eyes, the expansion body expands in volume due to the increase of body temperature after the user falls into deep sleep, thereby extruding the drug carrier outward to protrude, so that the drug carrier extrudes the temperature-sensitive controlled release layer to be more close to the eyes, and the active components of traditional Chinese medicine diffused from the drug carrier contact the skin around the eyes more quickly, thereby being absorbed through the skin more quickly, improving the drug effect of the active components of traditional Chinese medicine, and improving the sleep-aiding effect of the sleep-aiding eye mask.

[0020] Preferably, the expansion module further comprises a second electric heating sheet; the second electric heating sheet is arranged inside the expansion body; and the second electric heating sheet is connected to the control unit and the storage battery through an electrical signal.

[0021] By arranging the second electric heating sheet inside the expansion body, and strictly controlling the current intensity of 0.1-0.5 mA supplied to the second electric heating sheet through the control unit, the second electric heating sheet can provide heat to keep the expansion body in the expansion period dominated by hydroxypropyl acrylamide, so as to actively regulate the expansion degree of the expansion body in the form of a micro-current, thereby more accurately controlling the temperature-sensitive controlled release layer to be close to the eyes, not only making the active components of traditional Chinese medicine diffused from the drug carrier contact the skin around the eyes more quickly, thereby being absorbed through the skin more quickly, thereby improving the drug effect of the active components of traditional Chinese medicine, and improving the sleep-aiding effect of the sleep-aiding eye mask, but also being able to control the temperature-sensitive controlled release layer from being too close to or even extruding the skin around the eyes, thereby preventing the sleep of the user.

[0022] Preferably, the expansion module further comprises a pressure sensor; the pressure sensor is arranged between the elastic film and the drug carrier; and the pressure sensor is connected to the control unit through an electrical signal.

[0023] By arranging the pressure sensor between the elastic film and the drug carrier, the expansion module can be monitored in real time through the pressure sensor to extrude the drug carrier, thereby determining the degree of the drug carrier extruding the temperature-sensitive controlled release layer to be close to the eyes, and transmitting the data to the control unit, so that the control unit more accurately controls the expansion degree of the expansion module, thereby more accurately controlling the temperature-sensitive controlled release layer to be close to the eyes, thereby improving the drug effect of the active components of traditional Chinese medicine, and improving the sleep-aiding effect of the sleep-aiding eye mask, and more accurately controlling the temperature-sensitive controlled release layer from being too close to or even extruding the skin around the eyes, thereby preventing the sleep of the user.

[0024] The beneficial effects of the present application are as follows: 1.The application is to mix the active ingredients of traditional Chinese medicine treated by nanoscale wall breaking technology with polyurethane soft foam for foaming, and then use the surface pore size of the foamed drug carrier between 200-500nm, so that the active ingredients of traditional Chinese medicine treated by nanoscale wall breaking technology easily pass through the pore size of the drug carrier and contact with the skin around the human eye with a particle size less than 100nm, and then the active ingredients of traditional Chinese medicine diffuse out of the pore size on the drug carrier in the form of slow release, on the one hand, ensuring the durability of the use of traditional Chinese medicine sleep aid eye mask, on the other hand, improving the absorption effect of the human body to the active ingredients of traditional Chinese medicine. The pore size of the surface of the drug carrier can be controlled by controlling the concentration of the foaming agent. If azodicarbonamide is used as the foaming agent, the concentration of azodicarbonamide is between 1.2-1.8wt%. The frame type structure with one side opening is used for the backing layer to prevent the active ingredients of traditional Chinese medicine in the drug carrier from diffusing out of the side of the drug carrier and causing the problem of loss of drug efficacy.

[0025] 2.When the temperature-sensitive controlled release layer just contacts the skin around the eye, the temperature around the eye is between 34-35℃, the temperature-sensitive controlled release layer maintains the shrinkage state, and the 50-100nm microporous structure ensures the completion of the basic drug penetration of the active ingredients of traditional Chinese medicine, at this time the transdermal rate is stable at 0.8mg / h, which ensures the user to enter the sleep state smoothly, and effectively avoids the drowsiness side effect caused by the initial burst release of the traditional sleep aid eye mask. When the user enters the deep sleep stage, the body temperature rises to 36.8-37.2℃, and because the temperature-sensitive controlled release layer is still in the expansion period dominated by hydroxypropyl acrylamide at this temperature, the phase transition of the temperature-sensitive controlled release layer is triggered, and the pore size of the temperature-sensitive controlled release layer expands to 300-500nm, thereby forming a high-speed channel for drug release, at this time the burst release rate reaches 2.3mg / h, which exactly matches the blood drug concentration required for the enhancement of brain electrical δ wave. Moreover, the physical properties of the gel of the temperature-sensitive controlled release layer, and the gel is easier to dissipate heat at room temperature, resulting in a relatively low temperature, and the temperature-sensitive controlled release layer is in a highly contracted state, and the micropore size on it is small, which can well limit the diffusion of the active ingredients of traditional Chinese medicine in the drug carrier, thereby preventing the diffusion and loss of the active ingredients of traditional Chinese medicine in the drug carrier when not in use, thereby playing a protective role.

[0026] 3. The present application prevents the active ingredients of traditional Chinese medicine in the drug carrier from diffusing out through the temperature-sensitive controlled-release layer by setting a protective cover on the outside of the temperature-sensitive controlled-release layer and tightly abutting against it, thereby preventing the active ingredients of traditional Chinese medicine in the sleep-aiding eye mask from being lost when it is idle, and thereby improving the service life of the sleep-aiding eye mask. The diffusion-preventing abutting mode between the protective cover and the temperature-sensitive controlled-release layer can completely retain the active ingredients of traditional Chinese medicine within the drug carrier and the pore size of the temperature-sensitive controlled-release layer. Once the active ingredients of traditional Chinese medicine diffuse outside the pore size of the temperature-sensitive controlled-release layer, they will diffuse into the air and cannot be utilized when the protective cover is opened next time, and the abutting mode can well solve this problem. The backing layer can be integrally formed of silica gel, and the protective cover can be formed of plastic or hard silica gel.

[0027] 4. The present application uniformly arranges first electric heating sheets on the inside of the temperature-sensitive controlled-release layer at positions abutting against both eyes, and strictly controls the current intensity 0.1-0.5 mA flowing into the first electric heating sheets through a control unit. The current intensity can make the first electric heating sheets provide heat to make the temperature-sensitive controlled-release layer still be in the expansion period dominated by hydroxypropyl acrylamide, and thereby actively regulate the expansion degree of the temperature-sensitive controlled-release layer in the form of a micro-current, actively regulate the expansion of the temperature-sensitive controlled-release layer which some cold elderly people cannot completely stimulate through their body temperature, and thereby control the current received by the first electric heating sheet through an external terminal such as a mobile phone or a special remote controller through a wireless communication mode such as Bluetooth, and thereby control the expansion of the temperature-sensitive controlled-release layer through Joule heat conversion, and thereby control the diameter of the pores thereon to increase the diffusion amount of the active ingredients of traditional Chinese medicine in the drug carrier, and thereby ensure that the concentration of the diffused active ingredients of traditional Chinese medicine of the sleep-aiding eye mask reaches the sleep-aiding requirement. The micro-current temperature control module is arranged to assist the temperature-sensitive controlled-release layer in controlling the diffusion concentration of the active ingredients of traditional Chinese medicine, which not only improves the precision of controlling the diffusion concentration of the active ingredients of traditional Chinese medicine, but also expands the applicable population of the sleep-aiding eye mask. BRIEF DESCRIPTION OF DRAWINGS

[0028] The present application will be further described below with reference to the drawings.

[0029] Figure 1 is a schematic view of the overall structure of the traditional Chinese medicine sleep-aiding eye mask in the first perspective view; Figure 2 is a schematic view of the overall structure of the traditional Chinese medicine sleep-aiding eye mask in the second perspective view; Figure 3 is a schematic view of the internal structure of the traditional Chinese medicine sleep-aiding eye mask; Figure 4 is a semi-sectional view of the traditional Chinese medicine sleep-aiding eye mask; Figure 5 is Figure 4 is a local enlarged view of A in FIG. 8; Figure 6 is a schematic diagram of the inflation module in the inflated state in the present application; Figure 7 is a structural schematic diagram of the second electric heating sheet in the present application; Figure 8 is a schematic diagram of the drug carrier after being deformed by extrusion in the present application; Figure 9 is a structural schematic diagram of the first electric heating sheet in the present application; In the figure: backing layer 1, second circular-arc flange 11, drug carrier 2, restraint belt 3, temperature-sensitive controlled-release layer 4, protective cover 5, first circular-arc flange 51, protruding strip 52, first electric heating sheet 6, second electric heating sheet 7. DETAILED DESCRIPTION

[0030] In order to make the technical means, creative features, purposes and effects achieved by the present application easy to understand, the present application is further described below in combination with specific embodiments.

[0031] As shown in Figures 1 to 5 A traditional Chinese medicine sleep-aiding eye mask based on herbal nanoscale slow-release technology includes a backing layer 1, a drug carrier 2 and a restraint belt 3. The backing layer 1 is a frame-shaped structure with one side open, and the drug carrier 2 is embedded in the backing layer 1. The drug carrier 2 is prepared by mixing and foaming a traditional Chinese medicine active ingredient treated by nanoscale wall-breaking technology and polyurethane soft foam. The two ends of the backing layer 1 are connected by the restraint belt 3.

[0032] By mixing and foaming the traditional Chinese medicine active ingredient treated by nanoscale wall-breaking technology and polyurethane soft foam, the surface pore size of the drug carrier 2 obtained by foaming is between 200-500 nm, so that the traditional Chinese medicine active ingredient treated by nanoscale wall-breaking technology easily passes through the pore size of the drug carrier 2 to contact the skin around the human eye, and the traditional Chinese medicine active ingredient diffuses out of the pore size of the drug carrier 2 in the form of slow release, which ensures the durability of the traditional Chinese medicine sleep-aiding eye mask and improves the absorption of the traditional Chinese medicine active ingredient by the human body. The pore size of the surface of the drug carrier 2 can be controlled by controlling the concentration of the foaming agent. If azodicarbonamide is used as the foaming agent, the concentration of azodicarbonamide is between 1.2-1.8 wt%. The backing layer 1 adopts a frame-shaped structure with one side open to prevent the traditional Chinese medicine active ingredient in the drug carrier 2 from diffusing out of the side of the drug carrier 2 and causing loss of drug efficacy.

[0033] The preparation process of the drug carrier 2 includes the following steps: S1: The raw material of the active ingredient of traditional Chinese medicine is placed in a high-pressure nanocrystalline crusher, and is treated for 3-5 times under a pressure of 200-300 MPa, each time for 2-3 minutes. After the crushing is completed, the active ingredient suspension with a particle size of less than 100 nm is collected. The working parameters of the high-pressure nanocrystalline crusher are as follows: a flow rate of 15 L / h, a temperature control at 4-8°C, and zirconium oxide beads as the crushing medium; S2: The polyether glycol and toluene diisocyanate are reacted at a molar ratio of 1:2 at 80-85°C for 3-4 hours to prepare a polyurethane prepolymer with an NCO content of 8.0±0.3%; the polyether glycol can be PPG-2000 type; and the toluene diisocyanate is MDI-50; S3: After the polyurethane prepolymer is cooled to 40°C, the polyurethane prepolymer and the active ingredient suspension are mixed at a mass ratio of 8:2, and are dispersed at a high speed of 1800-2000 rpm for 8-10 minutes; S4: The foaming agent azodicarbonamide is added at a concentration of 1.2-1.8 wt%, and is foamed for 30-35 minutes; S5: After being cured at room temperature for 24-30 hours, the drug carrier 2 is cut into standard sizes.

[0034] As shown in Figures 3 to 5 The drug-assisted sleep eye mask further includes a temperature-sensitive controlled-release layer 4. The temperature-sensitive controlled-release layer 4 is arranged on one side of the opening of the backing layer 1, and the edge of the temperature-sensitive controlled-release layer 4 is sealingly connected with the edge of the backing layer 1. The preparation process of the temperature-sensitive controlled-release layer 4 includes the following steps: N1: Dehydrate N-isopropyl acrylamide in a vacuum drying box at 50-60°C for 3-4 hours, and dry hydroxypropyl acrylamide in a desiccator for standby; N2: Weigh 82.5g of N-isopropyl acrylamide and 12g of hydroxypropyl acrylamide into a 500mL three-necked flask, inject 200mL of anhydrous ethanol preheated to 50-60°C, and stir by magnetic stirring until completely transparent, at a speed of 300-350rpm for 25±3 minutes; N3: Add 5g of nanocellulose, turn on the probe ultrasonic instrument, and process for 20-30 minutes at an amplitude of 70% to form a homogeneous opalescent suspension; N4: After being cooled to 25-30°C, 0.5g of a photoinitiator is added, and mechanical stirring is performed under light shielding conditions for 10-15 minutes at a speed of 150-200rpm; N5: Transfer to a vacuum defoaming tank, and defoam for 3-5 times at -0.095MPa and 40-50°C, each time for 5-8 minutes, until no bubbles escape from the liquid surface, and then obtain a prepolymer liquid; N6: Adopt custom quartz mold, surface spray PTFE release agent; the mold is preheated to 30-35℃, then the prepolymer liquid is injected, the scraper controls the liquid layer thickness to be 380±10μm; N7: The center area is irradiated by 10mW / cm² ultraviolet light for 30-40 seconds to form a low cross-linked structure, the transition area is irradiated by 18mW / cm² for 75-85 seconds, and the edge area is irradiated by 25mW / cm² for 120-130 seconds. After curing, it is dehydrated by 30%-100% ethanol gradient, and dried at 40℃ to obtain a 120μm gel film; N8: The PET film treated by plasma is spin-coated with silane coupling agent, and then bonded with the gel film at 60℃ and 0.5MPa for 30-40 seconds. The cooling rate is controlled at 5-6℃ / min to avoid interface delamination, and then the temperature-sensitive controlled release layer 4 is prepared. The plasma treatment parameters are as follows: power 100W, argon environment treatment for 180 seconds; When the temperature-sensitive controlled release layer 4 just contacts the skin around the eyes, the temperature around the eyes is between 34-35℃, the temperature-sensitive controlled release layer 4 maintains the contraction state, and the 50-100nm microporous structure ensures that the active ingredients of traditional Chinese medicine complete the basic drug permeation, at this time the transdermal rate is stable at 0.8mg / h, which ensures that the user enters the sleep state smoothly, and effectively avoids the drowsiness side effect caused by the initial burst release of the traditional sleep aid eye mask.

[0035] When the user enters the deep sleep stage, the body temperature rises to 36.8-37.2℃, and because the temperature-sensitive controlled release layer 4 is still in the expansion period dominated by hydroxypropyl acrylamide at this temperature, it triggers the phase change expansion of the temperature-sensitive controlled release layer 4, and the pore size of the temperature-sensitive controlled release layer 4 expands to 300-500nm, thereby forming a high-speed channel for drug release, at this time the burst release rate reaches 2.3mg / h, which exactly matches the required blood drug concentration for the enhancement of brain electrical δ wave.

[0036] Moreover, the physical properties of the temperature-sensitive controlled release layer 4 itself, and the gel are more easily heat dissipated at room temperature, resulting in a relatively lower temperature, which makes it in a highly contracted state, and the microporous pore size on it is smaller, which can well limit the diffusion of the active ingredients of traditional Chinese medicine in the drug carrier 2, thereby preventing the diffusion and loss of the active ingredients of traditional Chinese medicine in the drug carrier 2 when not in use, thereby playing a protective role. As shown in Figures 4 to 5 The outer side of the temperature-sensitive controlled release layer 4 is provided with a protective cover 5; the inner wall of the protective cover 5 is tightly fitted with the outer side surface of the temperature-sensitive controlled release layer 4; the opening edge of the protective cover 5 is provided with a first circular arc flange 51, and the first circular arc flange 51 and the second circular arc flange 11 protruding inward on the outer side edge of the backing layer 1 are mutually buckled.

[0037] By setting the protective cover 5 on the outside of the temperature-sensitive controlled release layer 4 and tightly abutting it, the active ingredients of traditional Chinese medicine in the drug carrier 2 are prevented from diffusing out through the temperature-sensitive controlled release layer 4, thereby preventing the loss of active ingredients of traditional Chinese medicine in the sleep-aiding eye mask when it is idle, and thereby improving the service life of the sleep-aiding eye mask. The diffusion-preventing abutting mode between the protective cover 5 and the temperature-sensitive controlled release layer 4 can completely retain the active ingredients of traditional Chinese medicine within the pore size of the drug carrier 2 and the temperature-sensitive controlled release layer 4. Once the active ingredients of traditional Chinese medicine diffuse outside the pore size of the temperature-sensitive controlled release layer 4, they will diffuse into the air and cannot be utilized when the protective cover 5 is opened next time. Therefore, the abutting mode can effectively solve this problem. The backing layer 1 can be integrally formed of silica gel; and the protective cover 5 can be formed of plastic or hard silica gel.

[0038] As shown in Figure 5 , a protruding strip 52 is arranged on the inner side of the protective cover 5 close to the edge of the temperature-sensitive controlled release layer 4.

[0039] When the inner wall of the protective cover 5 and the outer surface of the temperature-sensitive controlled release layer 4 are tightly abutted, the protruding strip 52 on the protective cover 5 also extrudes the edge of the temperature-sensitive controlled release layer 4. Because the edge of the temperature-sensitive controlled release layer 4 is extruded and compressed, the pores in the inner wall are extruded and closed, so that the active ingredients of traditional Chinese medicine entering the pores of the temperature-sensitive controlled release layer 4 cannot diffuse out from the side edge of the temperature-sensitive controlled release layer 4, further ensuring the diffusion-preventing effect of the protective cover 5 and further improving the service life of the sleep-aiding eye mask.

[0040] As shown in Figure 9 , the sleep-aiding eye mask of traditional Chinese medicine further comprises a micro-current temperature control module; the micro-current temperature control module comprises a first electric heating sheet 6, a battery, a wireless receiving unit and a control unit; the first electric heating sheet 6 is uniformly and spacedly arranged on the inner side of the temperature-sensitive controlled release layer 4 at the positions abutting the eyes; the first electric heating sheet 6 is electrically connected to the battery through the control unit; the wireless receiving unit is electrically connected to the control unit; and the wireless receiving unit is used for receiving control instructions from an external terminal.

[0041] The first electric heating sheet 6 is arranged in the warm-sensitive controlled release layer 4 in a uniform interval at a position close to the eyes, and the current intensity flowing into the first electric heating sheet 6 is strictly controlled by the control unit to be 0.1-0.5 mA, so that the first electric heating sheet 6 can provide heat to make the warm-sensitive controlled release layer 4 still in the expansion period dominated by hydroxypropyl acrylamide, and then the expansion degree of the warm-sensitive controlled release layer 4 can be actively regulated in the form of a micro-current, so that the expansion of the warm-sensitive controlled release layer 4 cannot be completely stimulated by the body temperature of some elderly people with cold bodies, and then the current received by the first electric heating sheet 6 is controlled by an external terminal such as a mobile phone or a special remote controller through a wireless communication method such as Bluetooth, so that the expansion of the warm-sensitive controlled release layer 4 can be controlled through Joule heat conversion, and then the diameter of the pores on the warm-sensitive controlled release layer 4 is controlled to increase the diffusion amount of the active ingredients of traditional Chinese medicine in the drug carrier 2, so that the concentration of the active ingredients of traditional Chinese medicine diffused by the sleep-aiding eye mask meets the sleep-aiding requirement; the micro-current temperature control module is arranged to assist the warm-sensitive controlled release layer 4 in controlling the diffusion concentration of the active ingredients of traditional Chinese medicine, which not only improves the accuracy of controlling the diffusion concentration of the active ingredients of traditional Chinese medicine, but also expands the application population of the sleep-aiding eye mask.

[0042] The micro-current temperature control module further comprises a patch-type temperature sensor; the temperature sensor is arranged inside the warm-sensitive controlled release layer 4 at a position close to the eyes.

[0043] The temperature sensor is pre-embedded in the warm-sensitive controlled release layer 4 when the warm-sensitive controlled release layer 4 is formed; the patch-type temperature sensor is arranged inside the warm-sensitive controlled release layer 4 at a position close to the eyes, and then the size of the upper aperture of the warm-sensitive controlled release layer 4 at this temperature can be calculated according to the temperature value measured by the temperature sensor, so that the diffusion speed of the active ingredients of traditional Chinese medicine in the drug carrier 2 can be obtained, and then the data is fed back to the control unit, the control unit controls the current intensity flowing into the first electric heating sheet 6, so that the warm-sensitive controlled release layer 4 controls the diffusion speed of the active ingredients of traditional Chinese medicine within the drug concentration range of high-quality sleep-aiding, and then the sleep-aiding effect of the sleep-aiding eye mask is improved. Moreover, the temperature at the position close to the eyes is monitored in real time by the temperature sensor, and if the temperature is too high, the power supply to the first electric heating sheet 6 is cut off in time by the control unit, and an alarm is given by transmitting an electric signal to an alarm, so as to reduce the harm to the user.

[0044] As shown in Figure 6 and Figure 8 The sleep-aiding eye mask of traditional Chinese medicine further comprises an expansion module; the expansion module is arranged between the drug carrier 2 and the backing layer 1 at a position close to the eyes; the expansion module comprises an elastic film and an expansion body; the elastic film is a closed bag-shaped structure; and the elastic film is filled with the expansion body.

[0045] The material of the expansion body is the same as that of the temperature-sensitive controlled release layer 4; by arranging the expansion body with the same material as the temperature-sensitive controlled release layer 4 between the drug carrier 2 and the backing layer 1 at the position close to the eyes, the expansion body expands in volume due to the increase of body temperature after the user falls into deep sleep, thereby extruding the drug carrier 2 outward to protrude, so that the drug carrier 2 at this position extrudes the temperature-sensitive controlled release layer 4 to be more close to the eyes, thereby making the active ingredients of traditional Chinese medicine in the drug carrier 2 diffuse out to be more quickly in contact with the skin around the eyes, thereby more quickly being transdermally absorbed, thereby improving the drug effect efficiency of the active ingredients of traditional Chinese medicine, and thereby improving the sleep-aiding effect of the sleep-aiding eye mask.

[0046] As shown in Figures 6 to 8 The expansion module further comprises a second electric heating sheet 7; the second electric heating sheet 7 is arranged inside the expansion body; the second electric heating sheet 7 is connected with the control unit and the storage battery through an electrical signal.

[0047] By arranging the second electric heating sheet 7 inside the expansion body, and strictly controlling the current intensity 0.1-0.5 mA flowing into the second electric heating sheet 7 through the control unit, the second electric heating sheet 7 can provide heat to keep the expansion body in the expansion period dominated by hydroxypropyl acrylamide, thereby actively regulating the expansion degree of the expansion body in the form of micro-current, and more accurately controlling the temperature-sensitive controlled release layer 4 to be close to the eyes, not only making the active ingredients of traditional Chinese medicine in the drug carrier 2 diffuse out to be more quickly in contact with the skin around the eyes, thereby more quickly being transdermally absorbed, thereby improving the drug effect efficiency of the active ingredients of traditional Chinese medicine, and thereby improving the sleep-aiding effect of the sleep-aiding eye mask; but also being able to control the temperature-sensitive controlled release layer 4 not to be too close to or even extrude the eyes, thereby preventing the user's sleep from being affected.

[0048] The expansion module further comprises a pressure sensor; the pressure sensor is arranged between the elastic film and the drug carrier 2; the pressure sensor is connected with the control unit through an electrical signal.

[0049] By arranging the pressure sensor between the elastic film and the drug carrier 2, the expansion module can monitor the extrusion force of the drug carrier 2 in real time through the pressure sensor, thereby determining the degree of the drug carrier 2 extruding the temperature-sensitive controlled release layer 4 to be close to the eyes, and transmitting the data to the control unit, thereby the control unit more accurately controlling the expansion degree of the expansion module, thereby more accurately controlling the temperature-sensitive controlled release layer 4 to be close to the eyes, thereby improving the drug effect efficiency of the active ingredients of traditional Chinese medicine, and thereby improving the sleep-aiding effect of the sleep-aiding eye mask; and being able to more accurately control the temperature-sensitive controlled release layer 4 not to be too close to or even extrude the eyes, thereby preventing the user's sleep from being affected.

[0050] The embodiments of the present application are described above with reference to the accompanying drawings, but the present application is not limited to the above-described specific embodiments, and the above-described specific embodiments are merely illustrative, but not restrictive, and a person of ordinary skill in the art can make many forms under the inspiration of the present application without departing from the purpose of the present application and the scope protected by the claims, and these all belong to the protection of the present application.

Claims

1. A traditional Chinese medicine sleep-aiding eye mask based on herbal nanoslow-release technology, characterized in that: It comprises a backing layer (1), a drug carrier (2) and a binding belt (3); the backing layer (1) is a frame-shaped structure with one side open, the drug carrier (2) is embedded in the backing layer (1); the drug carrier (2) is prepared by mixing and foaming the active ingredients of traditional Chinese medicine treated by nanoscale wall breaking technology and polyurethane soft foam; the two ends of the backing layer (1) are connected by the binding belt (3). ​ 2. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 1, characterized in that: The preparation process of the drug carrier (2) comprises the following steps: S1: Put the raw material of the active ingredient of traditional Chinese medicine into a high-pressure nanometer crusher, and cycle for 3-5 times under the pressure of 200-300 MPa, each time for 2-3 minutes, and collect the active ingredient suspension with a particle size of less than 100 nm after crushing; S2: React polyether glycol and toluene diisocyanate at a molar ratio of 1:2 at 80-85°C for 3-4 hours to prepare a polyurethane prepolymer with an NCO content of 8.0±0.3%; S3: After cooling the polyurethane prepolymer to 40°C, mix the polyurethane prepolymer and the active ingredient suspension at a mass ratio of 8:2, and disperse at a high speed of 1800-2000 rpm for 8-10 minutes; S4: Add foaming agent azobisformamide with a concentration of 1.2-1.8wt%, and foam for 30-35 minutes; S5: After curing at room temperature for 24-30 hours, cut into standard size to obtain the drug carrier (2).

3. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 1, characterized in that: It also comprises a temperature-sensitive controlled-release layer (4); the temperature-sensitive controlled-release layer (4) is arranged on the open side of the backing layer (1), the edge of the temperature-sensitive controlled-release layer (4) is sealingly connected with the edge of the backing layer (1); the preparation process of the temperature-sensitive controlled-release layer (4) comprises the following steps: N1: Dehydrate N-isopropyl acrylamide in a vacuum drying box at 50-60°C for 3-4 hours, and dry hydroxypropyl acrylamide in a desiccator for standby; N2: Weigh 82.5g N-isopropyl acrylamide and 12g hydroxypropyl acrylamide into a 500mL three-necked flask, inject 200mL anhydrous ethanol preheated to 50-60°C, and stir by magnetic stirring until completely transparent, at a speed of 300-350rpm for 25±3 minutes; N3: Add 5g nanocellulose, start the probe ultrasonic instrument, amplitude 70% for 20-30 minutes, form a homogeneous opalescent suspension; N4: After cooling to 25-30°C, add 0.5g photoinitiator, and mechanically stir for 10-15 minutes under light-proof conditions at a speed of 150-200rpm; N5: Transfer to a vacuum defoaming tank, cycle defoaming 3-5 times at -0.095MPa and 40-50°C for 5-8 minutes each time, until no bubbles escape from the liquid surface, and then obtain a prepolymer liquid; N6: Use a customized quartz mold, spray PTFE release agent on the surface; preheat the mold to 30-35°C, inject the prepolymer liquid, and control the liquid layer thickness to be 380±10μm with a scraper. N7: the center zone is irradiated with 10 mW / cm2 ultraviolet light for 30-40 seconds to form a low cross-linking structure, the transition zone is irradiated with 18 mW / cm2 for 75-85 seconds, and the edge zone is irradiated with 25 mW / cm2 for 120-130 seconds, and after curing, the gel film is dehydrated by a gradient of 30%-100% ethanol and dried at 40°C to obtain a 120-μm gel film; N8: the plasma-treated PET film is spin-coated with a silane coupling agent, and then bonded with the gel film at 60°C and 0.5 MPa for 30-40 seconds to obtain a temperature-sensitive controlled-release layer (4).

4. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 3, characterized in that: An outer side of the temperature-sensitive controlled-release layer (4) is provided with a protective cover (5); an inner wall of the protective cover (5) is tightly attached to an outer side surface of the temperature-sensitive controlled-release layer (4); an opening edge of the protective cover (5) is provided with a first circular-arc flange (51) which is mutually buckled with a second circular-arc flange (11) protruding inward from an outer edge of the backing layer (1).

5. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 4, characterized in that: A week raised strip (52) is arranged on the inner side of the protective cover (5) near the edge of the temperature-sensitive controlled-release layer (4).

6. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 3, characterized in that: A micro-current temperature control module is further included; the micro-current temperature control module includes a first electric heating sheet (6), a battery, a wireless receiving unit, and a control unit; the first electric heating sheet (6) is uniformly and spacedly arranged on the inner side of the temperature-sensitive controlled-release layer (4) at a position attached to the eyes; the first electric heating sheet (6) is electrically connected to the battery through the control unit; the wireless receiving unit is electrically connected to the control unit; and the wireless receiving unit is used to receive control instructions from an external terminal.

7. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 6, characterized in that: The micro-current temperature control module further includes a patch-type temperature sensor; the temperature sensor is arranged inside the temperature-sensitive controlled-release layer (4) at a position attached to the eyes.

8. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 6, characterized in that: An expansion module is further included; the expansion module is arranged between the drug carrier (2) and the backing layer (1) at a position attached to the eyes; the expansion module includes an elastic film and an expansion body; the elastic film has a closed bag-like structure; and the elastic film is filled with the expansion body.

9. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 8, characterized in that: The expansion module further includes a second electric heating sheet (7); the second electric heating sheet (7) is arranged inside the expansion body; and the second electric heating sheet (7) is electrically connected to the battery through the control unit.

10. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 9, characterized in that: The expansion module further includes a pressure sensor; the pressure sensor is arranged between the elastic film and the drug carrier (2); and the pressure sensor is electrically connected to the control unit.

Images