Sustained release device and sustained release system

Abstract

This application provides a sustained-release device and a sustained-release system. The sustained-release device includes a main unit and multiple contact units connected to the main unit. Each contact unit includes an electrode element for contacting the skin, used to mount and fix the sustained-release unit. The main unit includes a main control unit electrically connected to the electrode elements. The main control unit generates a current signal and transmits it to the electrode elements to induce electromigration of the active ingredient in the sustained-release unit. By incorporating a main control unit and multiple electrode elements into the sustained-release device, after the user mounts the sustained-release unit onto the electrode elements and wears it, the current signal generated by the main control unit can be transmitted to the electrode elements, driving the active ingredient within the sustained-release unit to undergo electromigration, thereby effectively improving the absorption efficiency of the active ingredient.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a sustained-release device and sustained-release system. Background Technology

[0002] In the field of active ingredient (such as nicotine and caffeine) ingestion products, oral supplements are a common delivery method, primarily relying on the oral mucosa for the absorption of active ingredients. However, the physiological environment within the human oral cavity is constantly changing. Fluctuations in saliva secretion, changes in oral pH, and differences in the surface condition of the oral mucosa can all interfere with the absorption of active ingredients in the oral mucosa. Furthermore, some unabsorbed active ingredients may be swallowed with saliva and enter the digestive tract, resulting in absorption loss and waste. Utility Model Content

[0003] In view of this, the main technical problem to be solved by this application is how to improve the absorption efficiency of active ingredients.

[0004] To address the aforementioned technical problems, this application provides a sustained-release device, which includes a main unit and a plurality of contact units connected to the main unit; the contact units include electrode elements for contacting the skin, and the electrode elements are used to mount and fix the sustained-release unit; the main unit includes a main control unit, which is electrically connected to the electrode elements, and the main control unit is used to generate a current signal and transmit the current signal to the electrode elements so as to cause electro-migration of the active ingredient in the sustained-release unit.

[0005] In some embodiments, the main control unit includes a control module, which includes a pulse width modulation module; an adjustment component is provided on the host, and the adjustment component is connected to the pulse width modulation module; the adjustment component is used to generate a first adjustment command signal, and the pulse width modulation module is used to adjust the magnitude of the current, the pulse frequency and / or the duty cycle output to the electrode element based on the first adjustment command signal.

[0006] In some embodiments, the control module further includes a wireless control module for communicating with a mobile terminal; the wireless control module is connected to a pulse width modulation module, and the wireless control module is used to receive a second adjustment command signal sent by the mobile terminal; the pulse width modulation module is used to adjust the magnitude of the current output to the electrode element, the pulse frequency, and / or the duty cycle based on the second adjustment command signal.

[0007] In some embodiments, the main control unit further includes an H-bridge polarity switching module, which is connected to the control module. The control module is used to control the H-bridge polarity switching module to switch between a first state and a second state to adjust the direction of the current output to the electrode element.

[0008] In some embodiments, the main control unit further includes a constant current control module, which is connected to the control module. The constant current control module is used to control the current output to the electrode element to be 100μA to 2mA.

[0009] In some embodiments, the contact unit further includes a connecting portion, through which the electrode element is movably connected to the host, and the electrode element is disposed at the end of the connecting portion away from the host and spaced apart from the host.

[0010] In some embodiments, the electrode element includes a recessed space for mounting and securing the sustained-release unit.

[0011] In some embodiments, the electrode element includes a bottom wall and an annular sidewall connected to the bottom wall, the bottom wall and the annular sidewall enclosing a recessed space.

[0012] In some embodiments, the host has an arc-shaped outline.

[0013] This application also provides a sustained-release system, which includes a sustained-release device and a sustained-release unit.

[0014] The beneficial effects of this application are: by setting a main control unit and multiple electrode elements on the sustained-release device, after the user installs the sustained-release unit on the electrode elements and wears it, the current signal generated by the main control unit can be transmitted to the electrode elements and drive the active ingredients in the sustained-release unit to undergo electro-migration, thereby effectively improving the absorption efficiency of the active ingredients. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a schematic diagram of the structure of the sustained-release system provided in the embodiments of this application;

[0017] Figure 2 This is a schematic diagram of the main control unit provided in an embodiment of this application;

[0018] Figure 3 This is a schematic flowchart of the preparation method of the sustained-release unit provided in the embodiments of this application.

[0019] Explanation of key figure labels:

[0020] Sustained-release system 1000; sustained-release device 100; main unit 10; main control unit 11; control module 111; pulse width modulation module 111a; adjustment component 111b; wireless control module 111c; power management module 112; H-bridge polarity switching module 113; constant current control module 114; contact unit 20; electrode element 21; bottom wall 211; annular side wall 212; connecting part 22; sustained-release unit 200. Detailed Implementation

[0021] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0022] In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified. All directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of this application are only used to explain the relative positional relationships and movement of the components in a specific posture (as shown in the figures). If the specific posture changes, the directional indication will also change accordingly. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices.

[0023] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0024] In the description of the embodiments in this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0025] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0026] In the field of active ingredient (such as nicotine and caffeine) ingestion products, oral supplements are a common delivery method, primarily relying on the oral mucosa for the absorption of active ingredients. However, the physiological environment within the human oral cavity is constantly changing. Fluctuations in saliva secretion, changes in oral pH, and differences in the surface condition of the oral mucosa can all interfere with the absorption of active ingredients in the oral mucosa. Furthermore, some unabsorbed active ingredients may be swallowed with saliva and enter the digestive tract, resulting in absorption loss and waste.

[0027] To solve the above problem, please refer to Figure 1 , Figure 1 This is a schematic diagram of the structure of a sustained-release system 1000 provided in an embodiment of this application. The sustained-release system 1000 includes a sustained-release device 100 and a sustained-release unit 200. The sustained-release device 100 includes a main unit 10 and a plurality of contact units 20 connected to the main unit 10. The contact units 20 include electrode elements 21, which are used to mount and fix the sustained-release unit 200. The main unit 10 includes a main control unit 11, which is electrically connected to the electrode elements 21. The main control unit 11 is used to generate a current signal and transmit the current signal to the electrode elements 21 to cause electro-migration of the active ingredient in the sustained-release unit 200.

[0028] In the technical solution of this application embodiment, the contact unit 20 is used to contact human skin. The physiological environment of human skin is relatively more stable than that of the oral cavity. However, the stratum corneum of the skin has a natural barrier effect on drug penetration, and passive diffusion relying solely on concentration gradients is inefficient. In addition, the hydrophobic and lipophilic environment formed by the skin also has a certain degree of repulsion against polar or ionic active ingredients (such as nicotine, caffeine, etc.), thereby reducing their absorption efficiency. This application embodiment provides a sustained-release device 100, which uses an electric current signal to direct the active ingredient through the stratum corneum of the skin under the action of an electric field, which can significantly accelerate its penetration rate and absorption efficiency. Specifically, when a user needs to ingest active ingredients such as nicotine or caffeine, the sustained-release unit 200 carrying the active ingredient can be installed and fixed onto the electrode element 21 of the sustained-release device 100, and then the sustained-release device 100 with the sustained-release unit 200 installed can be worn on the body (such as the neck, arm, etc.) so that the sustained-release unit 200 is in close contact with the skin. At this point, the active ingredient is gradually released onto the skin based on the principle of concentration diffusion. The user then turns on the power to the sustained-release device 100 and inputs a command signal, causing the current signal generated by the main control unit 11 to be transmitted to the electrode element 21. This causes the electrode element 21, the sustained-release unit 200, the skin, another electrode element 21, and the power module to form a closed current loop. Under the influence of the current, the active ingredient undergoes electromigration, allowing it to quickly penetrate the stratum corneum of the skin. Simultaneously, the low-intensity current temporarily opens the lipid channels between the cells of the stratum corneum, thereby increasing skin permeability without damaging the integrity of the skin. These mechanisms collectively enhance the absorption efficiency of the active ingredient, thus improving the user experience.

[0029] The number of contact units 20 can be set to 2, 3, or 4, etc., according to actual needs. Each contact unit 20 includes an electrode element 21. There are multiple contact units 20, and a circuit is formed between any two electrode elements 21. For example, when the number of contact units 20 is set to 2, it can be understood that the electrode element 21 of one contact unit 20 is used as a current output terminal (positive electrode), and the electrode element 21 of the other contact unit 20 is used as a current input terminal (negative electrode). A potential difference is formed between the two electrode elements 21, so that when the sustained-release unit 200 installed on the electrode element 21 comes into contact with the skin, a current circuit can be formed with the skin to achieve the delivery and rapid absorption of the active ingredient. As another example, when there are two or more contact units 20, the electrode element 21 of one contact unit 20 can be used as the positive electrode, and the electrode elements 21 of all the remaining contact units 20 can be used as the negative electrode. In this configuration, the current starts from the positive electrode, flows through the skin to multiple negative electrodes, thereby achieving multi-point synchronous action of the active ingredient. Alternatively, the multiple contact units 20 can be grouped in pairs, that is, the electrode elements 21 in each group form an independent positive and negative electrode pair. In this configuration, each group forms an independent current loop to support multi-region synchronous or differentiated control. Those skilled in the art can flexibly choose the configuration method according to the effective range of the sustained-release unit 200, the skin impedance characteristics, or the treatment needs.

[0030] In some embodiments, please refer to Figure 2 , Figure 2 This is a schematic diagram of the main control unit 11 provided in this application embodiment. The main control unit 11 includes a control module 111, which includes a pulse width modulation module 111a. An adjustment component 111b is provided on the host 10, and the adjustment component 111b is used to connect to the pulse width modulation module 111a. The adjustment component 111b is used to generate a first adjustment command signal, and the pulse width modulation module 111a is used to adjust the current magnitude, pulse frequency, and / or duty cycle output to the electrode element 21 based on the first adjustment command signal.

[0031] In this embodiment, by setting the adjustment component 111b, the user can directly input operation commands through the adjustment component 111b to manually adjust the current parameters (such as current magnitude, pulse frequency, duty cycle, etc.). This allows the sustained-release device 100 to adapt to different users' skin characteristics, active ingredient types, or usage scenarios, meeting personalized needs and improving usage flexibility. Simultaneously, the pulse width modulation module 111a dynamically adjusts the output current parameters based on the first adjustment command signal generated by the adjustment component 111b, precisely controlling the current intensity, frequency, and duty cycle, thereby more effectively driving the active ingredient through the stratum corneum of the skin, thus improving the absorption efficiency of the active ingredient.

[0032] In some embodiments, the main control unit 11 further includes a power management module 112 for providing voltage. The power management module 112 includes a battery, such as a lithium battery or a coin cell battery. The power management module 112 may also include a boost element, an overcurrent protection element, or a low battery detection element, thereby improving the safety and lifespan of the slow-release device 100.

[0033] In some embodiments, the control module 111 further includes a wireless control module 111c, which is used to communicate with a mobile terminal; the wireless control module 111c is connected to a pulse width modulation module 111a, which is used to receive a second adjustment command signal sent by the mobile terminal, and the pulse width modulation module 111a is used to adjust the magnitude of the current output to the electrode element 21, the pulse frequency and / or the duty cycle based on the second adjustment command signal.

[0034] In the technical solution of this embodiment, by setting up a wireless control module 111c, the slow-release device 100 can achieve communication connection with a mobile terminal (such as a mobile phone, tablet, etc.). Users can remotely adjust current parameters (such as current magnitude, pulse frequency, duty cycle, etc.) through a mobile application, which helps to improve the user experience.

[0035] In some embodiments, the main control unit 11 further includes an H-bridge polarity switching module 113, which is connected to the control module 111. The control module 111 is used to control the H-bridge polarity switching module 113 to switch between a first state and a second state to adjust the direction of the current output to the electrode element 21.

[0036] In this embodiment, during the electromigration of active ingredients, an electrochemical reaction may be triggered when current passes through the skin. If the current direction is fixed, prolonged exposure can easily cause the local skin pH to deviate significantly from the normal range, thereby damaging the skin barrier and causing irritation, redness, and swelling. By setting the H-bridge polarity switching module 113, the direction of the current output to the electrode element 21 can be switched, allowing the electrode element 21 to alternate between positive and negative states. This dynamic switching can effectively reduce the excessive accumulation of local acid and alkali caused by a single electrode reaction, helping to maintain the relative stability of the skin surface pH and reducing the damage of electrochemical reactions to the skin microenvironment.

[0037] In some embodiments, the control module 111 is used to control the H-bridge polarity switching module 113 to switch from a first state to a second state or from a second state to a first state at each preset time.

[0038] In this embodiment, after the sustained-release device 100 has been operating continuously for more than a preset time, the control module 111 can control the H-bridge polarity switching module 113 to change its state, thereby changing the direction of the current. By switching the current direction at each preset time, on the one hand, the effective driving time of the current on the active ingredient under a single polarity is ensured, that is, the active ingredient can fully complete electromigration under the drive of a stable current. On the other hand, the current polarity can be switched in time before the local pH of the skin deviates significantly, and the accumulated acidic or alkaline substances are neutralized through a reverse electrochemical reaction, thereby maintaining the pH of the skin surface within the normal physiological range.

[0039] In some embodiments, the preset time is 5s to 30s. For example, the preset time can be 5s, 10s, 15s, 20s, 25s, 30s, etc., and the user can set it according to actual needs.

[0040] In some embodiments, the main control unit 11 further includes a constant current control module 114, which is connected to the control module 111. The constant current control module 114 is used to control the current output to the electrode element 21 to be 100μA to 2mA.

[0041] For example, the constant current control module 114 can be used to control the current output to the electrode element 21 to be 100μA, 200μA, 500μA, 1mA, 1.5mA, 2mA, etc., and the user can set it according to actual needs.

[0042] In the technical solution of this embodiment, by setting a constant current control module 114 to control the current output to the electrode element 21 within the above-mentioned range, on the one hand, the current intensity in this range can effectively drive the active ingredient to generate electromigration, thereby improving the absorption efficiency of the active ingredient; on the other hand, the current magnitude in this range is not likely to damage human skin cells under long-term action, thereby improving the safety of use.

[0043] In some embodiments, the host 10 has a display module on its surface. The display module can intuitively present information related to the operating status of the sustained-release device 100. For example, the display module can be used to display information such as current parameters (e.g., current magnitude, pulse frequency, duty cycle, etc.), active ingredient release rate, cumulative release amount of active ingredient, device runtime, and battery level, making it convenient for users to monitor the device's operating status in real time. In some embodiments, the host 10 is equipped with a voice module. The voice module can be used to announce information such as current parameters (e.g., current magnitude, pulse frequency, duty cycle, etc.), active ingredient release rate, cumulative release amount of active ingredient, device runtime, and battery level, providing users with a more convenient way to obtain information through auditory feedback, especially suitable for visually impaired users or scenarios requiring dynamic monitoring of the device.

[0044] In some embodiments, the contact unit 20 further includes a connecting portion 22, through which the electrode element 21 is movably connected to the host 10. The electrode element 21 is disposed at the end of the connecting portion 22 away from the host 10 and spaced apart from the host 10. The electrode element 21 has a recessed space that can accommodate the sustained-release unit 200. The electrode element 21 includes a bottom wall 211 and an annular sidewall 212 connected to the bottom wall 211. The recessed space formed by the bottom wall 211 and the annular sidewall 212 is used to install the sustained-release unit 200.

[0045] In this embodiment, the connecting part 22 can be in the form of a hinge, flexible wire, or elastic structure, allowing the electrode element 21 to be adjusted in angle or moved in position independently of the host 10, thereby better conforming to irregular parts of the human body (such as joints, neck, and torso curves). Simultaneously, the bottom wall 211 and the annular side wall 212 of the electrode element 21 form an installation space, providing physical constraints for the sustained-release unit 200, enabling the sustained-release unit 200 to effectively conform to the conductive surface of the electrode element 21, reducing the problem of poor current contact caused by the offset of the sustained-release unit 200.

[0046] In some embodiments, the space formed by the bottom wall 211 and the annular sidewall 212 is flat.

[0047] In this embodiment, by setting the spatial shape formed by the bottom wall 211 and the annular sidewall 212 to a flat shape, the height of the annular sidewall 212 is smaller, which can effectively shorten the physical migration path required for the active ingredient to move from the sustained-release unit 200 to the skin surface, thereby improving the absorption efficiency of the active ingredient.

[0048] In some embodiments, the material of electrode element 21 includes at least one selected from silver, silver chloride, platinum, titanium, gold, iridium, rhodium, tantalum, and graphite.

[0049] In the technical solution of this embodiment, the materials used in the electrode element 21 all have good biocompatibility and chemical stability, which can effectively reduce the irritation of the electrode element 21 to human skin and maintain the long-term stability of the current.

[0050] In some embodiments, the material of electrode element 21 includes a conductive polymer.

[0051] In some embodiments, the conductive polymer includes at least one of polypyrrole, polyaniline, and polythiophene.

[0052] In the technical solution of this embodiment, the high molecular conductive polymers such as polypyrrole, polyaniline, and polythiophene also have good flexibility, which can better fit the curvature of human skin, thereby further improving the comfort when wearing them.

[0053] In some embodiments, the host 10 has an arc-shaped outline.

[0054] In the technical solution of this embodiment, by setting the outline of the host 10 to be arc-shaped, the host 10 can be highly matched with the natural curve of common human wearing parts (such as arms, necks, etc.), which is conducive to improving the user's wearing comfort.

[0055] This application also provides a sustained-release unit 200, which includes an active layer. The active layer comprises, by weight parts: 2 to 10 parts of active ingredient, 5 to 13 parts of sustained-release matrix, 0.5 to 1 part of pH adjuster, 5 to 18 parts of moisturizer, and 3 to 16 parts of penetrant.

[0056] In this embodiment, the sustained-release matrix controls the diffusion rate of the active ingredient, enabling continuous and slow release, effectively reducing the problems of rapid or insufficient release. The pH adjuster helps convert the active ingredient into a highly mobile ionic state by regulating the pH of the active layer. It is understood that if the active ingredient is not ionized, the electromigration effect will be very weak, and its transport will mainly rely on passive diffusion. However, after ionization induced by the pH adjuster, the active ingredient can undergo electromigration driven by an electric current, significantly improving its migration rate compared to passive diffusion. Specifically, taking nicotine as an example, because the nicotine molecule contains basic nitrogen atoms, it can be protonated (i.e., combined with hydrogen ions) in a weakly acidic environment to form a cation state, thereby enabling the active ingredient to undergo electromigration driven by an electric current. The moisturizer maintains the sustained-release unit at 200°C, reducing the phenomenon of dryness and cracking of the active layer, while also assisting the penetration enhancer in improving skin permeability, which is beneficial for further improving the absorption efficiency of the active ingredient. Penetrants, on the other hand, significantly improve the absorption efficiency of active ingredients by disrupting the structure of the stratum corneum and reducing the skin barrier function.

[0057] In some embodiments, the active layer further includes 0.5 to 1 part of a conductive agent, which includes at least one of sodium chloride, potassium chloride, sodium citrate, sodium gluconate, and sodium lactate.

[0058] In the technical solution of this embodiment, by adding a conductive agent that can dissociate into free ions to the active layer, the transmission resistance of the active layer can be reduced, thereby constructing a good ion conduction pathway, which is beneficial to the stable transmission of current and effectively improves the efficiency of electromigration.

[0059] In some embodiments, the active ingredient includes at least one of nicotine, nicotine derivatives, and caffeine. In some embodiments, the active ingredient may also include other ingredients with medicinal properties, which will not be elaborated upon in this application.

[0060] It should be noted that nicotine includes both natural and synthetic nicotine. Nicotine derivatives include one or more of the following: nicotine salts, nicotine in a matrix such as a glycobase or organometallic complex, nicotine-resin combinations, nicotine inclusion complexes, and non-covalently bound nicotine. Non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin-encapsulated complexes, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, zinc nicotine chloride, and nicotine benzoate. Nicotine derivatives also include nicotine containing substituents, such as one or more mixtures of hexamethylnicotine, hexamethylnicotine lactate, hexamethylnicotine malate, hexamethylnicotine salicylate, hexamethylnicotine cyclodextrin encapsulated complex, hexamethylnicotine hydrochloride, hexamethylnicotine dihydrochloride, hexamethylnicotine tartrate, hexamethylnicotine tartrate dihydrate, hexamethylnicotine sulfate, hexamethylnicotine zinc chloride, and hexamethylnicotine benzoate.

[0061] In some embodiments, the sustained-release matrix includes at least one of polyvinylpyrrolidone, hydroxypropyl methylcellulose, ethylcellulose, sodium alginate, chitosan, gelatin, and sodium carboxymethyl cellulose.

[0062] In some embodiments, the acid-base regulator includes at least one of lactic acid, sodium carbonate, sodium bicarbonate, citric acid, and phosphate buffer.

[0063] In some embodiments, the moisturizer includes at least one of propylene glycol, glycerin, butylene glycol, and sorbitol.

[0064] In some embodiments, the penetrant includes at least one of ethanol, isopropanol, propylene glycol, isopropyl myristate, ethyl oleate, and laurocapram.

[0065] In some embodiments, the sustained-release unit 200 further includes a substrate, and an active layer is disposed on the surface of the substrate.

[0066] In the technical solution of this embodiment, the substrate serves as the basic carrier of the sustained-release unit 200, which can provide physical support for the active layer and reduce the probability of deformation or damage to the active layer due to external forces (such as pressure when adhering to the skin, movement during use, etc.), thereby maintaining the integrity and functional stability of the active layer.

[0067] In some embodiments, the substrate includes polyethylene terephthalate (PET) or silicone.

[0068] In some embodiments, the sustained-release unit 200 further includes an encapsulation layer that covers the surface of the active layer. The encapsulation layer may be, for example, an aluminum foil, an aluminum-plastic film, etc.

[0069] In the technical solution of this embodiment, since the active ingredients, moisturizers, penetrants and other substances contained in the active layer are easily deteriorated by air, moisture or temperature, a physical barrier can be formed by setting an encapsulation layer, which is beneficial to extending the shelf life of the sustained-release unit 200.

[0070] In some embodiments, the sustained-release unit 200 includes two main surfaces, one of which is in contact with the bottom wall 211 of the electrode element 21, and the other main surface is flush with the end face of the annular sidewall 212 of the electrode element 21.

[0071] Please refer to Figure 3 , Figure 3 This is a schematic flowchart of the preparation method of the sustained-release unit 200 provided in the embodiments of this application, specifically including:

[0072] S110: The raw materials are mixed to obtain a gel, wherein, by mass parts, the raw materials include: 5-13 parts of slow-release matrix, 0.5-1 parts of pH adjuster, 5-18 parts of moisturizer, and 3-16 parts of penetrant.

[0073] In some embodiments, the raw materials further include 0.5 to 1 part of a conductive agent.

[0074] S120: Add the active ingredient to the gel and mix to obtain an active gel.

[0075] S130: The active gel is coated onto the substrate and dried to obtain the sustained-release unit 200.

[0076] In some embodiments, the coating thickness of the active gel is 200 μm to 600 μm. Exemplarily, the coating thickness of the active gel can be 200 μm, 250 μm, 300 μm, 400 μm, 500 μm, 600 μm, etc., and those skilled in the art can set it according to actual needs.

[0077] In some embodiments, after coating the active gel onto the substrate and drying it to obtain the sustained-release unit 200, the method further includes covering the surface of the sustained-release unit 200 with an encapsulation layer.

[0078] The following describes embodiments of this application. The embodiments described below are exemplary and are only used to explain this application, and should not be construed as limiting this application. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Reagents or instruments used, unless otherwise specified, are all conventional products that can be obtained commercially.

[0079] Example 1:

[0080] The components and their contents used in the sustained-release unit of Example 1 are shown in Table 1:

[0081] Table 1: Components and their amounts used in the sustained-release unit of Example 1

[0082] name Material Number of parts by weight Active ingredients nicotine 2.5 Sustained-release matrix Polyvinylpyrrolidone 5 Sustained-release matrix Hydroxypropyl methylcellulose 3.5 Moisturizer Propylene glycol 8 Penetrant ethanol 8 Penetrant Isopropyl myristate 3 acid-base regulators Phosphate buffer 1 conductive agent Sodium chloride 0.5 solvent Purified water 68.5

[0083] The process steps are as follows: Polyvinylpyrrolidone, hydroxypropyl methylcellulose, propylene glycol, ethanol, isopropyl myristate, phosphate buffer, and sodium chloride are dissolved in an appropriate amount of water and stirred at 45°C until homogeneous to obtain a gel; Nicotine is added dropwise while stirring at 100 rpm for 15 min to obtain an active gel; The active gel is coated onto a PET substrate with a coating thickness of 300 μm and dried in a hot air oven at 60°C for 1 h to obtain a sustained-release unit.

[0084] The components and contents used in the sustained-release units of Examples 2-5 and Comparative Example 1 are the same as those in Example 1.

[0085] The difference between the components and contents used in the sustained-release unit of Comparative Example 2 and Example 1 is that the mass fraction of purified water used in Comparative Example 2 is 69.5, and no acid-base adjuster is used. The remaining components and contents are the same as those in Example 1.

[0086] Nicotine onset time test: Nicotine onset time is defined as the time when a person first feels dizziness, rapid heartbeat, or other obvious abnormal physical changes. This test uses the sustained-release device provided in the embodiments of this application, wherein the sustained-release device has two contact units. The sustained-release units of Examples 1-5 and Comparative Examples 1-2 are installed on the electrode element, and the nicotine onset time of the sustained-release units of Examples 1-5 and Comparative Examples 1-2 under different current intensities is tested respectively. The test results are shown in Table 2.

[0087] Table 2: Test results of Examples 1-5 and Comparative Examples 1-2

[0088]

[0089]

[0090] Based on Table 2 above, a brief analysis is as follows:

[0091] By comparing Examples 1-5 and Comparative Example 1, it can be seen that as the current intensity increases, the time for the user to first experience nicotine intoxication tends to shorten, indicating that the effect of current is beneficial to improving the absorption efficiency of nicotine. By comparing Examples 1 and Comparative Example 2, it can be seen that adding an acid-base regulator to the sustained-release unit can promote the electromigration of nicotine under the drive of current, thereby improving the absorption efficiency of nicotine.

[0092] The above description is merely a preferred embodiment of this application and does not limit the patent scope of this application. Any equivalent structural transformations made based on the concept of this application and the contents of the specification and drawings of this application, or direct / indirect applications in other related technical fields, are included within the patent protection scope of this application.

Claims

1. A sustained-release device, characterized in that, include: A host computer and multiple contact units connected to the host computer; The contact unit includes an electrode element for contacting the skin, the electrode element being used to mount and fix the sustained-release unit; The host includes a main control unit, which is electrically connected to the electrode element. The main control unit is used to generate a current signal and transmit the current signal to the electrode element so as to cause electromigration of the active ingredient in the sustained-release unit.

2. The sustained-release device according to claim 1, characterized in that, The main control unit includes a control module, which includes a pulse width modulation module; the host is equipped with an adjustment component, which is connected to the pulse width modulation module. The adjustment component is used to generate a first adjustment command signal, and the pulse width modulation module is used to adjust the current magnitude, pulse frequency and / or duty cycle output to the electrode element based on the first adjustment command signal.

3. The sustained-release device according to claim 2, characterized in that, The control module further includes a wireless control module, which is used to communicate with a mobile terminal; the wireless control module is connected to the pulse width modulation module, and the wireless control module is used to receive a second adjustment command signal sent by the mobile terminal; the pulse width modulation module is used to adjust the current magnitude, pulse frequency and / or duty cycle output to the electrode element based on the second adjustment command signal.

4. The sustained-release device according to claim 2, characterized in that, The main control unit also includes an H-bridge polarity switching module, which is connected to the control module. The control module is used to control the H-bridge polarity switching module to switch between a first state and a second state to adjust the direction of the current output to the electrode element.

5. The sustained-release device according to claim 2, characterized in that, The main control unit also includes a constant current control module, which is connected to the control module. The constant current control module is used to control the current output to the electrode element to be 100μA to 2mA.

6. The sustained-release device according to claim 1, characterized in that, The contact unit further includes a connecting portion, through which the electrode element is movably connected to the host. The electrode element is located at the end of the connecting portion away from the host and is spaced apart from the host.

7. The sustained-release device according to claim 1, characterized in that, The electrode element includes a recessed space for mounting and fixing the sustained-release unit.

8. The sustained-release device according to claim 7, characterized in that, The electrode element includes a bottom wall and an annular side wall connected to the bottom wall, the bottom wall and the annular side wall forming the groove space.

9. The sustained-release device according to claim 1, characterized in that, The host has an arc-shaped outline.

10. A sustained-release system, characterized in that, The system includes the sustained-release device as described in any one of claims 1 to 9, and the sustained-release system further includes the sustained-release unit.

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