A traditional Chinese medicine sleep-aiding eye mask based on herbal nano-slow release technology

Abstract

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 nano slow-release technology, which comprises a backing layer, a drug carrier and a binding belt; the drug carrier is prepared by mixing and foaming the active ingredients of traditional Chinese medicine treated by nanoscale wall-breaking technology and polyurethane soft foam, the surface pore size of the foamed drug carrier is 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 the skin around the human eye with a particle size less than 100 nm, and the active ingredients of traditional Chinese medicine are diffused out of the pore size of the drug carrier 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 active ingredients of traditional Chinese medicine by the human body.

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 with a particle size less than 100 nm, 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 with one side open 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.

[0007] Preferably, the preparation process of the drug carrier comprises the following steps:

[0008] 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 a 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 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;

[0009] 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;

[0010] 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;

[0011] S4: Add foaming agent azodicarbonamide with a concentration of 1.2-1.8wt%, and foam for 30-35 minutes;

[0012] S5: After curing at room temperature for 24-30 hours, cut into standard size to obtain the drug carrier.

[0013] 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:

[0014] N1: Dehydrate N-isopropyl acrylamide in a vacuum drying oven at 50-60℃ for 3-4 hours, and dry hydroxypropyl acrylamide in a desiccator for standby;

[0015] 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℃, and stir magnetically until completely transparent, at a speed of 300-350rpm for 25±3 minutes;

[0016] N3: Add 5g of nanocellulose, turn on the probe ultrasonic instrument, amplitude 70% for 20-30 minutes, and form a homogeneous opalescent suspension;

[0017] N4: After cooling to 25-30℃, add 0.5g of photoinitiator, and mechanically stir in the dark for 10-15 minutes at a speed of 150-200rpm;

[0018] N5: Transfer to a vacuum defoaming tank, and defoam at -0.095MPa, 40-50℃ for 3-5 times, each time for 5-8 minutes, until no bubbles escape from the liquid surface, and then obtain a prepolymer liquid;

[0019] N6: Use a custom quartz mold, spray PTFE release agent on the surface; preheat the mold to 30-35℃, inject the prepolymer liquid, and control the liquid layer thickness to be 380±10μm with a scraper;

[0020] 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, gradiently dehydrate with 30%-100% ethanol, and dry at 40℃ to obtain a 120μm gel film;

[0021] N8: Spin-coat silane coupling agent on the plasma-treated PET film, and then bond the gel film at 60℃, 0.5MPa for 30-40 seconds, and control the cooling rate at 5-6℃ / min to avoid interface delamination, and then obtain a temperature-sensitive controlled release layer. The plasma treatment parameters are as follows: power 100W, argon environment for 180 seconds;

[0022] When the temperature-sensitive controlled release layer just contacts the skin around the eyes, the temperature around the eyes 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, which ensures that the user enters a stable sleep state, and thus effectively avoids the drowsiness side effects caused by the initial burst release of traditional sleep-aiding eye masks.

[0023] When the user enters the 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 change expansion of the temperature-sensitive controlled release layer, and the pore size of the temperature-sensitive controlled release layer itself expands to 300-500nm, thereby forming a high-speed channel for drug release, and the burst release rate reaches 2.3mg / h, which exactly matches the blood drug concentration required for the enhancement of brain electrical δ wave.

[0024] Moreover, the physical properties of the temperature-sensitive controlled release layer itself gel, which makes the gel easier to dissipate heat at room temperature, resulting in a relatively low temperature, which makes it 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.

[0025] 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.

[0026] By setting a protective cover on the outer side of the temperature-sensitive controlled release layer, which is tightly fitted with the temperature-sensitive controlled release layer, thereby preventing the active ingredients of traditional Chinese medicine in the drug carrier from diffusing out through the temperature-sensitive controlled release layer, thereby preventing the loss of the active ingredients of traditional Chinese medicine in the sleep aid eye mask when it is 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 beyond 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.

[0027] Preferably, a protruding strip is arranged on the inner side of the protective cover near the edge of the temperature-sensitive controlled release layer.

[0028] 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, thereby closing the pores on the inner wall, and 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.

[0029] Preferably, the traditional Chinese medicine sleep-aiding eye mask further comprises a micro-current temperature control module; the micro-current temperature control module comprises a first electric heating sheet, a storage battery, a wireless receiving unit and a control unit; the first electric heating sheet is uniformly and spacedly arranged on the inboard of the temperature-sensitive controlled-release layer at positions that fit the eyes; the first electric heating sheet is electrically connected with the storage battery through the control unit; the control unit is electrically connected with the wireless receiving unit; and the wireless receiving unit is used for receiving control instructions from an external terminal.

[0030] By uniformly and spacedly arranging the first electric heating sheet on the inboard of the temperature-sensitive controlled-release layer at positions that fit the eyes, and then strictly controlling the current intensity 0.1-0.5mA 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, so as to actively regulate the expansion degree of the temperature-sensitive controlled-release layer in the form of micro-current, and actively regulate the expansion of the temperature-sensitive controlled-release layer which cannot be completely stimulated by the body temperature of some elderly people with cold body, so as to 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 method such as Bluetooth, and then convert the heat through Joule to control the expansion of the temperature-sensitive controlled-release layer, and then control the diameter of the pores thereon to increase the diffusion amount of the active ingredients of traditional Chinese medicine in the drug carrier, so as to ensure that the concentration of the active ingredients of traditional Chinese medicine diffused by the sleep-aiding eye mask meets the sleep-aiding requirements; 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.

[0031] Preferably, the micro-current temperature control module further comprises a patch-type temperature sensor; the temperature sensor is arranged on the inboard of the temperature-sensitive controlled-release layer at positions that fit the eyes.

[0032] The temperature sensor is pre-embedded in the temperature-sensitive controlled-release layer when the temperature-sensitive controlled-release layer is formed; by arranging the patch-type temperature sensor on the inboard of the temperature-sensitive controlled-release layer at positions that fit 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 the drug concentration for high-quality sleep-aiding, and then the sleep-aiding effect of the sleep-aiding eye mask is improved. Moreover, the temperature at the positions that fit 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 electrical signal transmitted to the alarm, so as to reduce the harm to the user.

[0033] Preferably, the traditional Chinese medicine sleep-aiding eye mask further comprises an inflation module; the inflation module is arranged between the drug carrier and the backing layer at a position adhering to the eyes; the inflation module comprises an elastic film and an inflation body; the elastic film is a closed bag-shaped structure; the inflation body is filled in the elastic film.

[0034] The material of the inflation body is the same as that of the temperature-sensitive controlled release layer; by arranging the inflation body with the same material as the temperature-sensitive controlled release layer between the drug carrier and the backing layer at the position adhering to the eyes, the inflation body expands in volume due to the increase of body temperature when the user enters deep sleep, thereby extruding the drug carrier outward to protrude, so that the drug carrier at this position extrudes the temperature-sensitive controlled release layer to adhere to the skin around the eyes more closely, so that the active ingredients of traditional Chinese medicine diffused in the drug carrier contact the skin around the eyes more quickly, thereby more quickly 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.

[0035] Preferably, the inflation module further comprises a second electric heating sheet; the second electric heating sheet is arranged inside the inflation body; the second electric heating sheet is electrically connected to the control unit and the battery through the control unit.

[0036] By arranging the second electric heating sheet inside the inflation body, and strictly controlling the current intensity of 0.1-0.5 mA flowing into the second electric heating sheet through the control unit, the second electric heating sheet can provide heat to keep the inflation body in the hydroxypropyl acrylamide-dominated inflation period, thereby actively regulating the inflation degree of the inflation body in the form of micro-current, and more accurately controlling the temperature-sensitive controlled release layer to adhere to the skin around the eyes, so that the active ingredients of traditional Chinese medicine diffused in the drug carrier contact the skin around the eyes more quickly, thereby more quickly 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; moreover, the temperature-sensitive controlled release layer can be controlled not to adhere to or even extrude the skin around the eyes too much, thereby preventing affecting the user's sleep.

[0037] Preferably, the inflation module further comprises a pressure sensor; the pressure sensor is arranged between the elastic film and the drug carrier; the pressure sensor is electrically connected to the control unit.

[0038] By setting a pressure sensor between the elastic film and the drug carrier, the pressure sensor can monitor the extrusion force of the inflation module on the drug carrier in real time, thereby determining the degree to which the drug carrier extrudes the temperature-sensitive controlled release layer around the eye, and by transmitting this data to the control unit, the control unit can more accurately control the inflation degree of the inflation module, thereby more accurately controlling the temperature-sensitive controlled release layer around the eye, thereby improving the drug effect of the active ingredients of traditional Chinese medicine, thereby improving the sleep aid effect of the sleep aid eye mask; Moreover, the temperature-sensitive controlled release layer can be more accurately controlled to not excessively adhere to or even extrude around the eye, thereby preventing affecting the user's sleep.

[0039] The beneficial effects of the present application are as follows:

[0040] 1. The present application mixes and foams the active ingredients of traditional Chinese medicine treated by nanoscale wall breaking technology with polyurethane soft foam, and then uses the surface pore size of the obtained drug carrier to be between 200-500nm, so that 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 the skin around the human eye with a particle size of less than 100nm, and then the active ingredients of traditional Chinese medicine are diffused from the pore size on 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 back layer adopts a frame-shaped structure with one side open 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 effect.

[0041] 2.The application maintains the temperature-sensitive controlled release layer in a contracted state when the temperature around the eye is between 34-35℃ during the initial contact stage, and the 50-100nm microporous structure of the temperature-sensitive controlled release layer ensures that the active ingredients of traditional Chinese medicine complete the basic drug permeation, at which time the transdermal rate is stabilized 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-aiding eye masks. When the user enters a 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, it triggers the phase change expansion of the temperature-sensitive controlled release layer, 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 which time the burst release rate reaches 2.3mg / h, which exactly matches the blood drug concentration required for the enhancement of brain electrical δ waves. Moreover, the physical properties of the temperature-sensitive controlled release layer itself, and the gel at room temperature, result in a relatively low temperature, which causes it to be in a highly contracted state, and the microporous pore 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.

[0042] 3.The application sets a protective cover on the outside of the temperature-sensitive controlled release layer, which is in close contact with the temperature-sensitive controlled release layer, thereby preventing the active ingredients of traditional Chinese medicine in the drug carrier from diffusing out through the temperature-sensitive controlled release layer, thereby preventing the loss of the 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 close contact 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 beyond 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 through close contact.

[0043] 4. The application is by arranging the first electric heating sheet uniformly spaced in the inside of the temperature-sensitive controlled release layer at the position of the doublet, and then strictly controlling the current intensity of 0.1-0.5mA into the first electric heating sheet through the control unit, which can make the first electric heating sheet provide heat to make the temperature-sensitive controlled release layer still in the expansion period dominated by hydroxypropyl acrylamide, and then actively regulate the expansion degree of the temperature-sensitive controlled release layer in the form of micro-current, actively regulate the expansion of the temperature-sensitive controlled release layer which cannot be completely stimulated by the body temperature of some cold elderly people, and then control the current received by the first electric heating sheet through the external terminal such as mobile phone or special remote controller through wireless communication such as Bluetooth, and then convert the heat through Joule to control the expansion of the temperature-sensitive controlled release layer, and then control the diameter of the pore on it to increase the diffusion amount of the active ingredients of traditional Chinese medicine in the drug carrier, and then ensure 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 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 application population of the sleep-aiding eye mask. BRIEF DESCRIPTION OF DRAWINGS

[0044] The application will be further described below with reference to the drawings.

[0045] Figure 1 is the overall structure schematic diagram of the traditional Chinese medicine sleep-aiding eye mask in the first perspective view in the application;

[0046] Figure 2 is the overall structure schematic diagram of the traditional Chinese medicine sleep-aiding eye mask in the second perspective view in the application;

[0047] Figure 3 is the internal structure schematic diagram of the traditional Chinese medicine sleep-aiding eye mask in the application;

[0048] Figure 4 is the semi-sectional view of the traditional Chinese medicine sleep-aiding eye mask in the application;

[0049] Figure 5 is Figure 4 the local enlarged view of A in the traditional Chinese medicine sleep-aiding eye mask in the application;

[0050] Figure 6 is the schematic diagram of the expansion module in the application in the expansion state;

[0051] Figure 7 is the structure schematic diagram of the second electric heating sheet in the application;

[0052] Figure 8 is the schematic diagram of the drug carrier in the application after being extruded and deformed;

[0053] Figure 9 is the structure schematic diagram of the first electric heating sheet in the application;

[0054] In the figure: backing layer 1, second arc flange 11, drug carrier 2, restraint band 3, temperature-sensitive controlled release layer 4, protective cover 5, first arc flange 51, raised strip 52, first heating element 6, second heating element 7. Detailed Implementation

[0055] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below in conjunction with specific embodiments.

[0056] like Figures 1 to 5 As shown, a traditional Chinese medicine sleep aid eye mask based on herbal nano-sustaining technology includes a backing layer 1, a drug carrier 2, and a binding strap 3; the backing layer 1 is a frame structure with one open side, and 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 with nano-level cell wall breaking technology with polyurethane soft foam; the two ends of the backing layer 1 are connected by the binding strap 3.

[0057] By mixing and foaming the active ingredients of traditional Chinese medicine treated with nanoscale cell wall disruption technology with polyurethane flexible foam, the surface pore size of the resulting drug carrier 2 is between 200-500 nm. This allows the active ingredients of the traditional Chinese medicine, with a particle size of less than 100 nm, to easily pass through the pores of the drug carrier 2 and come into contact with the skin around the eyes. The active ingredients then diffuse out from the pores of the drug carrier 2 in a slow release manner, ensuring the longevity of the traditional Chinese medicine sleep mask and improving the absorption effect of the active ingredients by the human body. The pore size of the drug carrier 2 can be controlled by controlling the concentration of the foaming agent. For example, 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 structure with one open side to prevent the active ingredients of the traditional Chinese medicine in the drug carrier 2 from diffusing out from the side of the drug carrier 2, thus preventing the loss of efficacy.

[0058] The preparation process of the drug carrier 2 includes the following steps:

[0059] S1: Place the raw materials of active ingredients of traditional Chinese medicine in a high-pressure nano-crusher and circulate them 3-5 times under a pressure of 200-300MPa, each time for 2-3 minutes. After crushing, collect the active ingredient suspension with a particle size of less than 100nm. The working parameters of the high-pressure nano-crusher are: flow rate 15L / h, temperature controlled at 4-8℃, and zirconium oxide beads as the crushing medium.

[0060] S2: polyether glycol is reacted with 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%; the polyether glycol can be PPG-2000 type; the toluene diisocyanate is MDI-50;

[0061] S3: after the polyurethane prepolymer is cooled to 40°C, the polyurethane prepolymer is mixed with the active ingredient suspension at a mass ratio of 8:2, and is dispersed at a high speed of 1800-2000 rpm for 8-10 minutes;

[0062] S4: a foaming agent azobisdimethylamide is added at a concentration of 1.2-1.8 wt%, and is foamed for 30-35 minutes;

[0063] S5: after being cured at room temperature for 24-30 hours, the polyurethane prepolymer is cut into standard sizes to obtain the drug carrier 2.

[0064] As shown in Figures 3 to 5 the drug-assisted sleep eye mask further comprises 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 comprises the following steps:

[0065] N1: N-isopropyl acrylamide is dehydrated in a vacuum drying box at 50-60°C for 3-4 hours, and hydroxypropyl acrylamide is dried in a desiccator and reserved;

[0066] N2: 82.5 g of N-isopropyl acrylamide and 12 g of hydroxypropyl acrylamide are weighed into a 500 mL three-necked flask, 200 mL of anhydrous ethanol preheated to 50-60°C is injected, and magnetic stirring is performed until complete transparency is achieved, at a speed of 300-350 rpm for 25±3 minutes;

[0067] N3: 5 g of nanocellulose is added, a probe ultrasonic instrument is turned on, an amplitude of 70% is processed for 20-30 minutes, and a homogeneous opalescent suspension is formed;

[0068] N4: after being cooled to 25-30°C, 0.5 g of a photoinitiator is added, and mechanical stirring is performed in the dark for 10-15 minutes at a speed of 150-200 rpm;

[0069] N5: it is transferred to a vacuum defoaming tank, and is defoamed for 3-5 times at -0.095 MPa and 40-50°C, each time for 5-8 minutes, until no bubbles escape from the liquid surface, and a prepolymer liquid is obtained;

[0070] N6: a customized quartz mold is used, the surface is sprayed with PTFE release agent; the mold is preheated to 30-35°C, the prepolymer liquid is injected, and a scraper is used to control the thickness of the liquid layer to be 380±10 μm;

[0071] N7: the center zone is irradiated with 10 mW / cm2ultraviolet light for 30-40 seconds to form a low cross-linked structure, the transition zone is irradiated with 18 mW / cm2for 75-85 seconds, and the edge zone is irradiated with 25 mW / cm2for 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;

[0072] 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, with a cooling rate controlled at 5-6°C / min to avoid interface delamination, thereby obtaining the temperature-sensitive controlled-release layer 4. The plasma treatment parameters are as follows: power 100 W, argon environment, and treatment time 180 seconds;

[0073] When the temperature-sensitive controlled-release layer 4 just comes into contact with the skin around the eyes, the temperature around the eyes is between 34-35°C, and the temperature-sensitive controlled-release layer 4 maintains a contracted state, and its 50-100-nm 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 0.8 mg / 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-aiding eye masks.

[0074] When the user enters a deep sleep stage, the body temperature rises to 36.8-37.2°C, and since the temperature-sensitive controlled-release layer 4 is still in the expansion period dominated by hydroxypropyl acrylamide at this temperature, it triggers the phase transition and expansion of the temperature-sensitive controlled-release layer 4, and the pore size of the temperature-sensitive controlled-release layer 4 expands to 300-500 nm, thereby forming a high-speed channel for drug release, at this time the burst release rate reaches 2.3 mg / h, which exactly matches the blood drug concentration required for the enhancement of brain electrical δ waves.

[0075] Moreover, the physical properties of the gel of the temperature-sensitive controlled-release layer 4 make the gel more easily dissipate heat at room temperature, resulting in a relatively low temperature, which makes it in a highly contracted state, and thus 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 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.

[0076] 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 attached to the outer side surface of the temperature-sensitive controlled-release layer 4; the outer side of 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 from the outer side edge of the backing layer 1 are mutually buckled.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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 close 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 for receiving control instructions from an external terminal.

[0081] 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.

[0082] 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.

[0083] 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 hole diameter 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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); ​ 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 a NCO content of 8.0±0.3%; 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 high-speed dispersion is carried out at 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); The herb-based nanoscale slow-release technology-based traditional Chinese medicine sleep-aiding eye mask further 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 magnetically until completely transparent, at a speed of 300-350rpm for 25±3 minutes; N3: Add 5g 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 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, and defoam 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 thickness of the liquid layer 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).

2. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 1, 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).

3. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 2, 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).

4. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 1, 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.

5. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 4, 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.

6. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 4, 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.

7. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 6, 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.

8. The traditional Chinese medicine sleep-aid eye mask based on herbal nanoslow-release technology according to claim 7, 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.

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