Superficial epidermal iontophoresis drug delivery method and device

Abstract

The invention relates to the technical field of transdermal iontophoresis drug delivery, and discloses a superficial epidermal iontophoresis drug delivery method and a superficial epidermal iontophoresis drug delivery device, and the superficial epidermal iontophoresis drug delivery device is researched according to the superficial epidermal iontophoresis drug delivery method. The electric potential energy generated by the first dielectric layer on the third dielectric layer under the action of current can be limited through the second dielectric layer, so that an active agent of the third dielectric layer permeates into the shallow epidermis of an administrated area, and the effect of active agent epidermis retention is achieved.

Description

Technical Field

[0001] The present application relates to the technical field of transdermal iontophoresis drug delivery, and more specifically to a superficial epidermal iontophoresis drug delivery method and device thereof. Background Art

[0002] Ion electropermeation drug delivery technology is a non-invasive method that uses electromotive force to pass active substances with certain polarity through the skin at a certain rate and enter the systemic circulation to produce systemic or local therapeutic effects. Since this drug delivery method avoids the first-pass effect (the phenomenon that some drugs are administered through the gastrointestinal tract and are metabolized in the intestinal mucosa and liver before being absorbed into the blood circulation, which ultimately leads to a decrease in the amount of the original drug entering the blood circulation), it has the advantages of stable plasma drug concentration and has broad application prospects.

[0003] The existing iontophoresis drug delivery methods usually use electrically driven single-point electrodes or multiple drug delivery carriers with electrodes for drug delivery. The above methods either have low transdermal efficiency or are prone to safety issues such as skin burns. More importantly, due to the mechanism of action of iontophoresis drug delivery, the depth of drug penetration is relatively deep. For drug delivery mechanisms that require enrichment in the superficial skin and reach a certain concentration to have a therapeutic effect, the existing technology cannot meet the drug delivery requirements.

[0004] Based on the above reasons, in the direction of superficial skin drug delivery, the drug delivery method is still in the relatively low penetration efficiency of drug delivery such as chemical penetration and hot compress penetration. Therefore, it is very important to study an efficient and safe device and method for superficial skin drug delivery. Summary of the invention

[0005] The purpose of the present application is to provide a superficial epidermal iontophoresis drug delivery method and device thereof, so as to achieve efficient and safe superficial epidermal iontophoresis drug delivery and make the drug penetration depth relatively shallow.

[0006] The present application discloses a superficial epidermal ion electrophoresis drug delivery method, in which an active agent in a third medium layer is electro-permeated into a drug-delivered area under the action of an electric current; a second medium layer and a first medium layer are provided on the third medium layer, and the second medium layer can limit the electric potential energy generated by the first medium layer on the third medium layer under the action of an electric current, so that the active agent in the third medium layer penetrates into the superficial epidermis of the drug-delivered area, thereby achieving an epidermal retention effect.

[0007] In a preferred example, the first dielectric layer, the second dielectric layer, and the third dielectric layer each have a resistor for matching the current intensity passing through the drug-administered region.

[0008] In a preferred example, the resistance value of the second dielectric layer is greater than the resistance values ​​of the first dielectric layer and the third dielectric layer.

[0009] In a preferred embodiment, the second dielectric layer is filled with materials of different resistance values ​​according to the requirements for the drug penetration depth of the superficial epidermis of the drug administration area.

[0010] In a preferred embodiment, the following implementation steps are included:

[0011] S1. A third medium layer, a second medium layer and a first medium layer are stacked on the surface of the drug administration area;

[0012] S2. energizing the first dielectric layer through a power source so that the first dielectric layer obtains electric potential energy under the action of the current;

[0013] S3. The second medium layer can weaken the current passing through the first medium layer, so that the active agent in the third medium layer obtains a driving force to move toward the superficial epidermis of the administration area.

[0014] In a preferred embodiment, the superficial epidermal iontophoresis drug delivery device comprises a conductive layer, an isolation layer, and a drug-carrying layer;

[0015] The conductive layer includes a conductive electrode region and the first dielectric layer; the isolation layer includes the second dielectric layer; and the drug-carrying layer includes the third dielectric layer;

[0016] The isolation layer is located between the conductive layer and the drug-carrying layer;

[0017] The drug-carrying layer is arranged below the isolation layer;

[0018] The conductive electrode region is arranged above the first dielectric layer.

[0019] In a preferred embodiment, the conductive layer, the isolation layer, and the drug-carrying layer are an integrally formed structure; or the conductive layer, the isolation layer, and the drug-carrying layer are independently separated from each other before use, and are connected to each other when administering the drug to the administration area.

[0020] In a preferred embodiment, the conductive layer and the isolation layer are integrally formed, and the drug-carrying layer is independent of the conductive layer and the isolation layer;

[0021] Alternatively, the conductive layer is an independent structure, and the isolation layer and the drug-carrying layer are integrally formed.

[0022] In a preferred example, the drug-carrying layer includes a protective film, which is arranged on the lower surface of the third dielectric layer. At least one spacer is arranged in the third dielectric layer, and the spacer is arranged to correspond one-to-one to the predetermined interval in the conductive electrode of the first dielectric layer, so that the electrical polarities obtained by the parts of the third dielectric layer separated by the spacer are different and do not interfere with each other.

[0023] In a preferred embodiment, the drug-carrying layer can attach different active agents through the third medium layer to achieve different drug delivery effects. Compared with the prior art, the main differences and effects of the embodiments of the present application are:

[0024] Achieve efficient and safe superficial epidermal ion electropermeation drug delivery, making the drug penetration depth relatively shallow;

[0025] Furthermore, when the drug-carrying layer is an independent structure, different drugs can be attached through the third medium layer to achieve different drug administration and different effects;

[0026] Furthermore, it can be efficiently mass-produced to meet the needs of extensive market promotion and application.

[0027] The specification of the present application records a large number of technical features, which are distributed in various technical solutions. If all possible combinations of technical features of the present application (i.e., technical solutions) are to be listed, the specification will be too long. In order to avoid this problem, the various technical features disclosed in the above-mentioned invention content of the present application, the various technical features disclosed in the various embodiments and examples below, and the various technical features disclosed in the accompanying drawings can be freely combined with each other to form various new technical solutions (these technical solutions should all be regarded as having been recorded in this specification), unless the combination of such technical features is technically infeasible. For example, in one example, feature A+B+C is disclosed, and in another example, feature A+B+D+E is disclosed, and features C and D are equivalent technical means that play the same role. Technically, only one can be used, and it is impossible to use them at the same time. Feature E can be combined with feature C technically. Then, the solution of A+B+C+D should not be regarded as having been recorded because it is technically infeasible, and the solution of A+B+C+E should be regarded as having been recorded. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0029] Figure 1 is a schematic structural diagram of a superficial epidermal iontophoresis drug delivery device according to one embodiment of the present application;

[0030] Figure 2 It is a schematic structural diagram of a second medium layer and a third medium layer of a superficial epidermal iontophoresis drug delivery device separated from each other according to one embodiment of the present application;

[0031] Figure 3This is a schematic structural diagram of the current drug delivery process of the superficial epidermal iontophoresis drug delivery device in one embodiment of the present application;

[0032] Figure 4 It is a schematic structural diagram of a convex upper surface of the superficial epidermal iontophoresis drug delivery device according to the first embodiment of the present application;

[0033] Figure 5 is a schematic top view of an isolation layer containing through holes according to the second embodiment of the present application;

[0034] Figure 6 It is a schematic diagram of the implementation steps of the superficial epidermal iontophoresis drug delivery method in one embodiment of the present application.

[0035] In the accompanying drawings, the symbols are as follows:

[0036] 1- Power supply;

[0037] 2-conductive layer;

[0038] 201-conductive electrode area;

[0039] 202-predetermined interval;

[0040] 203-first dielectric layer;

[0041] 204- a first electrode;

[0042] 205- second electrode;

[0043] 3-Isolation layer;

[0044] 301- second dielectric layer;

[0045] 302-through hole;

[0046] 303- third peeling film;

[0047] 4-drug loading layer;

[0048] 401- second dielectric layer;

[0049] 402-interval zone;

[0050] 403-first peeling film;

[0051] 404- second peeling film;

[0052] 5- backing layer;

[0053] 6-Connector;

[0054] 701-703-steps of the method; DETAILED DESCRIPTION

[0055] In the following description, many technical details are provided to help readers better understand the present application. However, those skilled in the art can understand that the technical solution claimed in the present application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0056] Description of some concepts:

[0057] Ion electrophoresis: Ion electrophoresis is a physical process in which ions diffuse in a medium under the drive of an electric field. The principle of direct current ion introduction is to introduce drug ions into the human body through intact skin or mucous membranes based on the principle that like charges repel each other and opposite charges attract each other in a direct current electric field. Ions of different charges can be introduced into the body, with cations introduced from the anode and anions from the cathode.

[0058] Superficial epidermis: Generally speaking, the structure of the skin is divided into three layers, from outside to inside, the epidermis, dermis, and subcutaneous tissue. The drug delivery depth of general ion electro-permeation drug delivery technology is at least below the dermis, and may even reach the subcutaneous tissue, making it difficult to achieve drug retention in the outermost layer of the skin, namely the epidermis. The superficial epidermis of the present invention refers to the outermost layer of the skin, the epidermis, with an average thickness of about 0.2 mm. The drug delivery effect of the present invention can achieve the drug retention effect of the drug to be penetrated in the superficial epidermis, and achieve effective drug delivery in the epidermis of the skin.

[0059] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below in conjunction with the accompanying drawings.

[0060] In one embodiment of the present application, a superficial epidermal iontophoresis drug delivery device is provided, and its structure is as follows: Figure 1 and Figure 2 As shown, the structure includes a power source 1, a conductive layer 2, an isolation layer 3 and a drug-carrying layer 4.

[0061] The power source 1 is used to generate the electricity required to infiltrate the drug to be infiltrated into the drug-administered area; the drug to be infiltrated may also be referred to as an active agent. The electricity may be direct current, alternating current, or pulse current, and the direct current, alternating current, or pulse current intensity ranges from 0.1 mA to 5 mA. In some embodiments, a voltage / current control device may be provided so that the present embodiment may adjust the voltage / current output according to the real-time state of the drug-administered area to achieve adaptive ion permeation.

[0062] The drug-carrying layer 4 includes a third medium layer 401 , which covers the drug-administered region, wherein each third medium layer 401 includes a filling material and a drug to be infiltrated.

[0063] In another embodiment, at least one spacer 402 is further provided in each third dielectric layer 401 to divide the third dielectric layer 401 into independent areas. The resistance of the spacer 402 is greater than the resistance of the third dielectric layer 401. The gap of the spacer 402 in the third dielectric layer 401 is 1 mm to 10 mm, preferably 2 mm to 6 mm. The spacer 402 can be made of gap materials such as air, polymer materials (such as plastic, rubber, etc.).

[0064] The isolation layer 3 includes a second dielectric layer 301 , and the second dielectric layer 301 is located above the third dielectric layer 401 , wherein the second dielectric layer 301 includes a filling material, and the resistance of the second dielectric layer 301 is greater than the resistance of the third dielectric layer 401 .

[0065] The conductive layer 2 includes a first dielectric layer 203 and a conductive electrode area 201 located above the first dielectric layer 203. The first dielectric layer 203 is located above the second dielectric layer 301. The first dielectric layer 203 includes a filling material, and the resistance of the first dielectric layer 203 is less than the resistance of the second dielectric layer 301. The conductive electrode area 201 is used to electrically connect the power source 1 and the first dielectric layer 203 respectively. After the conductive layer 2 is energized, the drug to be infiltrated in the third dielectric layer 401 is electrically infiltrated into the superficial epidermis of the drug administration area through the second dielectric layer 301.

[0066] Since the resistance of the second dielectric layer 301 is greater than that of the first dielectric layer 203 and the third dielectric layer 401, the current passing through the second dielectric layer 301 to reach the third dielectric layer 401 can be extremely small, ensuring that the third dielectric layer 401 can obtain a certain limit of voltage generated by the electric potential energy of the first dielectric layer 203, so that the drug to be infiltrated in the third dielectric layer 401 obtains a driving force to move toward the superficial skin of the medicated area, effectively ensuring the efficient retention of the drug to be infiltrated in the superficial skin.

[0067] The conductive electrode area 201 and the first dielectric layer 203 can be integrally formed. Specifically, the thickness of the first dielectric layer is 0.01 mm to 50 mm, preferably 0.2 mm to 0.8 mm. In addition, the conductive electrode area 201 and the first dielectric layer 203 can also be independent of each other to meet market application requirements.

[0068] The operating status of this device is as follows Figure 3As shown in the figure, the arrows represent the flow of current. Each dielectric layer has different currents flowing in the dielectric layer and entering the next dielectric layer. The magnitude of the current will also be affected by the resistance in the dielectric layer and the resistance of the next layer. In addition, through multiple experiments, it is found that in the drug-administered area, the closer to the predetermined interval 202 between the two conductive electrodes, the less the amount of drug to be infiltrated is, and the farther away from the predetermined interval 202 between the two conductive electrodes, the more the amount of drug to be infiltrated is, resulting in uneven input of the drug to be infiltrated in the drug-administered area. Therefore, in some embodiments, the second dielectric layer 301 is structurally improved.

[0069] In one embodiment, Figure 4 As shown, the conductive electrode area 201 includes a first electrode 204, a second electrode 205, and a predetermined interval 202 separating the first electrode 204 and the second electrode 205. The first electrode 204 is electrically connected to the first end of the power source 1, and the second electrode 205 is electrically connected to the second end of the power source 1. The upper and lower surfaces of the second dielectric layer 301 and the upper surface of the third dielectric layer 401 are convex curved surfaces with a certain curvature, and the convex position of the curved surface corresponds to the predetermined interval 202.

[0070] The convex surface increases the contact area of ​​ions in the area near the predetermined interval 202 of the second dielectric layer 301, and also increases the content of the drug to be infiltrated in the third dielectric layer 401 at the position corresponding to the area near the predetermined interval 202, thereby increasing the amount of the drug to be infiltrated in the third dielectric layer 401 in the convex surface area in the administered area, thereby achieving a balanced amount of the drug to be infiltrated in the administered area.

[0071] In another embodiment, Figure 5 As shown, the conductive electrode region 201 includes a first electrode 204, a second electrode 205, and a predetermined interval 202 separating the first electrode 204 and the second electrode 205. The first electrode 204 is electrically connected to the first end of the power source 1, and the second electrode 205 is electrically connected to the second end of the power source 1. The second dielectric layer 301 has a plurality of through holes 302, and the number of through holes 302 at positions close to the predetermined interval 202 is greater than the number of through holes 302 at positions far from the predetermined interval 202. The closer to the predetermined interval 202, the greater the number of through holes 302. For example, multiple columns of through holes 302 are formed in the second dielectric layer 301, and the number of through holes 302 decreases by one-half from the column closest to the predetermined interval 202 to the column at the edge.

[0072] By increasing the number of through holes 302, the resistance value of the corresponding position is reduced, so that the drug to be infiltrated in the third dielectric layer 401 corresponding to the position can more easily penetrate into the drug administration area, thereby increasing the penetration amount of the drug to be infiltrated in the position, thereby achieving a balance between the amount of drug to be infiltrated in the entire drug administration area.

[0073] In one embodiment, the conductive electrode area 201 includes a first electrode 204, a second electrode 205, and a predetermined interval 202 that separates the first electrode 204 and the second electrode 205, the first electrode 204 is electrically connected to the first end of the power source 1, and the second electrode 205 is electrically connected to the second end of the power source 1. The interval 402 and the predetermined interval 202 are arranged at corresponding positions. In other words, the positions of the interval 402 and the predetermined interval 202 overlap in a direction perpendicular to the drug-administered area. It can be understood that the third dielectric layer 401 in the figure is divided into two independent areas by the interval 402, and the two independent areas correspond to the two electrodes respectively. In other embodiments, the number of electrodes in the conductive electrode area 201 can be greater than 2, for example, including 3 or 4 electrodes.

[0074] The electrodes separated by the predetermined interval 202 can make the positive and negative ions in the first dielectric layer 203 move in a directional manner after being energized, reducing the disordered movement of the ions in the first dielectric layer 203, thereby greatly improving the effect of the electric potential energy. When the interval area 402 is set to correspond to the predetermined interval 202 in the conductive electrode of the first dielectric layer 203, the interval area 302 can make the left and right parts of the third dielectric layer 401 not interfere with each other, improve the electro-permeation efficiency of the drug to be permeated, and achieve the best skin permeation effect.

[0075] In one embodiment, Figure 1 and Figure 2 As shown, the conductive layer 2 further includes a backing layer 5 and a plurality of connectors 6. The backing layer 5 is used to cover the plurality of electrodes. The backing layer 5 is an insulating material, which can effectively prevent the conductive electrode area 201 from being exposed to the outside. The plurality of connectors 6 are used to electrically connect the power source 1 and the plurality of electrodes respectively. Each of the plurality of connectors 6 is at least partially disposed in the backing layer 5.

[0076] In one embodiment, the resistance of the first dielectric layer 203 is between 1KΩ and 20KΩ, and the resistance of the first dielectric layer 203 is 10% to 80% of the resistance of the second dielectric layer 301. The resistance of the second dielectric layer 301 is greater than the resistance of the first dielectric layer 203 and the third dielectric layer 401. The first dielectric layer 203, the second dielectric layer 301, and the third dielectric layer 401 can shunt the current intensity passing through the drug administration area.

[0077] In one embodiment, Figure 6 As shown, the implementation method steps include:

[0078] Step 701, covering the surface of the drug-administered area with a stacked third medium layer 401, a second medium layer 301 and a first medium layer 203;

[0079] Step 702, energizing the first dielectric layer 203 through a power source, so that the first dielectric layer 203 obtains electric potential energy under the action of the current;

[0080] Step 703: The active agent in the second medium layer 301 moves in a directional manner under the action of the electric potential energy and electro-permeates into the drug-administered area.

[0081] like Figure 2 As shown, the conductive layer 2, the isolation layer 3, and the drug-carrying layer 4 can be integrally formed, or they can be independent of each other, or a hybrid structure can be adopted, which can meet a wide range of market application needs. Specifically, the hybrid structure is that the conductive layer 2 and the isolation layer 3 are integrated, and the drug-carrying layer 4 is a separate structure; or the conductive layer 2 is an independent structure, and the isolation layer 3 and the drug-carrying layer 4 are an integral structure. When the isolation layer 3 and the drug-carrying layer 4 are an integral structure, a protective layer is provided between the isolation layer 3 and the drug-carrying layer 4. Preferably, the horizontal surface of the protective layer can cover the horizontal surface of the second dielectric layer 301 and the third dielectric layer 401, so that the third dielectric layer 401 and the second dielectric layer 301 do not penetrate each other before use. When any of the conductive layer 2, the isolation layer 3, and the drug-carrying layer 4 is an independent structure, the independent structure and the other structure can be connected to each other by adhesion, magnetic attraction or other methods when in use. In particular, when the drug-carrying layer 4 is an independent structure, different active agents can be attached through the third medium layer 401 to achieve different drug administration purposes and realize different medication effects; for example, in the medicinal field of superficial skin, different anesthetic drugs, analgesics, etc. can be used as active agents to achieve superficial skin anesthesia, analgesia and other effects.

[0082] The drug-carrying layer 4 also includes a peeling film as a protective layer, which is arranged on the lower surface of the third medium layer 401 for convenient storage and transportation. When administering the drug, the peeling film is torn off, and then the third medium layer 401 is covered on the administered area.

[0083] In one embodiment, the conductive layer 2, the isolation layer 3, and the drug-carrying layer 4 are an integrally formed structure. In this case, a release film is disposed on the lower surface of the drug-carrying layer 4.

[0084] In another embodiment, the conductive layer 2, the isolation layer 3, and the drug-carrying layer 4 are independent structures before use, and are connected to each other when the drug is administered to the administrated area. The lower surface of the conductive layer 2, the upper and lower surfaces of the isolation layer 3, and the upper and lower surfaces of the drug-carrying layer 4 are all provided with a peeling film.

[0085] In another embodiment, the conductive layer 2 and the isolation layer 3 are integrally formed, and the drug-carrying layer 4 is an independent structure, and they are connected to each other when administering the drug to the administration area. The lower surface of the isolation layer 3 and the upper and lower surfaces of the drug-carrying layer 4 are both provided with a release film.

[0086] In another embodiment, the conductive layer 2 is an independent structure, and the isolation layer 3 and the drug-carrying layer 4 are an integrally formed structure and are connected to each other when administering the drug to the administrated area. The lower surface of the conductive layer 2, the upper surface of the isolation layer 3 and the lower surface of the drug-carrying layer 4 are all provided with a peeling film.

[0087] In one embodiment, the iontophoresis drug delivery device includes a plurality of drug-carrying layers 4 (e.g., M), and each third dielectric layer 401 in the plurality of drug-carrying layers 3 covers the drug-to-be-delivered area in the form of vertical stacking, or horizontal arrangement, or a combination of vertical stacking and horizontal arrangement. Each third dielectric layer 401 may include the same or different drugs to be infiltrated, so that in the same drug delivery procedure, simultaneous electroosmosis of different drug delivery areas (when vertically stacked); or simultaneous electroosmosis of different drugs to be infiltrated of a certain drug delivery area (when horizontally arranged).

[0088] In one embodiment, the pharmaceutical agent to be infiltrated has polarity and a molecular weight of less than 5000 Daltons, and may include a combination of one or more of β-nicotinamide mononucleotide, glutathione, tranexamic acid, nicotine, analgesics, anesthetics, antibiotics, insulin, and trace elements required by the human body (such as vitamins, calcium, iron, etc.).

[0089] In one embodiment, the filling materials of the first dielectric layer 203 and the third dielectric layer 401 include a combination of one or more of gel materials, paste materials, liquid materials, and polymer materials. The gel materials include a combination of one or more of polyethylene glycol, polyvinyl alcohol, polyhydroxyethyl methacrylate, polyacrylic acid, polymethacrylic acid, gelatin, alginic acid, etc. with a porous network structure. The paste material can be grease, etc., the liquid material can be water or alcohol, etc., and the polymer material can be a combination of one or more of rubber, PET, PP, PVC, and PE. In particular, the pores in the porous network structure contain a material that can dissolve a solvent for the drug to be infiltrated. The filling material of the second dielectric layer 301 of the isolation layer 3 is required to have a large resistance value, and an isolation film with a close insulation effect can be used.

[0090] A method for using the device of the present application by removing the physical protection is described in detail below, wherein the conductive layer 2 and the isolation layer 3 are an integrally formed structure, and the drug-carrying layer 4 is an independent structure, such as Figure 2 As shown, including:

[0091] Step 801, providing a drug-carrying layer 4, the drug-carrying layer 4 includes a third medium layer 401, wherein the upper surface and the lower surface of each third medium layer 401 are respectively covered with a first peeling film 403 and a second peeling film 404, the third medium layer 401 covers the drug-to-be-administered area, wherein each third medium layer 401 includes a filling material and a drug to be infiltrated.

[0092] Next, the first peeling film 403 and the second peeling film 404 on the upper surface and the lower surface of one or more third medium layers 401 are removed, and each third medium layer 401 is made to cover the drug-administered area.

[0093] Step 802, providing an isolation layer 3 and a conductive layer 2, wherein the conductive layer 2 and the isolation layer 3 are an integrally formed structure, the isolation layer 2 includes a second dielectric layer 301, the conductive layer 2 includes a first dielectric layer 203 and a conductive electrode region 201 located above the first dielectric layer 203, the first dielectric layer 203 is located above the second dielectric layer 301, wherein the second dielectric layer 301 and the third dielectric layer 401 each include a filling material, the resistance of the second dielectric layer 301 is greater than the resistance of the third dielectric layer 401, the resistance of the first dielectric layer 203 is greater than the resistance of the third dielectric layer 401, and a third peeling film 303 is provided on the lower surface of the second dielectric layer 301.

[0094] Then, the third release film 303 on the lower surface of the second dielectric layer 301 is removed, and the second dielectric layer 301 is attached to the third dielectric layer 303 .

[0095] Step 803, electrically connecting the conductive electrode area 201 to a power source, and the power source 1 generates the electricity required to penetrate the drug to be penetrated into the administration area.

[0096] In one embodiment, the second dielectric layer 301 uses filling materials with different resistance values ​​according to the requirements of the superficial skin drug penetration depth of the drug administration area. When the depth requirement is shallower, the filling material with a larger resistance value needs to be used.

[0097] The present invention provides a superficial epidermal ion electrophoresis drug delivery method, in which a drug to be infiltrated in a third dielectric layer 401 is electro-infiltrated into a drug delivery area through a first dielectric layer 203 under the action of an electric current, and a second dielectric layer 301 is provided between the first dielectric layer 203 and the third dielectric layer 401, and the second dielectric layer 301 can limit the electric potential energy generated by the first dielectric layer 203 on the third dielectric layer 401 under the action of an electric current, so that the drug to be infiltrated in the third dielectric layer 401 penetrates into the superficial epidermis of the drug delivery area, thereby achieving an epidermal retention effect.

[0098] Finally, when vitamin C (VC) was used as the drug to be penetrated for transdermal testing, we were pleasantly surprised to find that compared with the prior art of superficial skin penetration through chemical or hot compress, the present invention was superior to the prior art in terms of both the amount of drug to be penetrated and the penetration efficiency, with the increase being 3.8 times or even higher. Such an effect is very gratifying in the field of superficial skin penetration drug delivery technology. The increase in the amount of drug to be penetrated and the efficiency means that in actual applications, the time for the drug to be penetrated to penetrate can be greatly shortened, and the medicinal effect produced in the drug administration area is more obvious, which has great application prospects in the field of beauty and even other medicinal fields.

[0099] It should be noted that in the claims and description of this patent, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "including one" do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0100] All documents mentioned in this application are cited as references in this application, just as each document is cited as reference individually. In addition, it should be understood that after reading the above teaching content of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope defined by the claims attached to this application.

[0101] In some cases, the actions or steps described in the claims may be performed in a different order than in the embodiments and still achieve the desired results. In addition, the processes depicted in the drawings do not necessarily require the specific order or sequential order shown to achieve the desired results. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

Claims

1. A superficial epidermal iontophoresis drug delivery method, characterized in that: Under the action of electric current, the active agent of the third dielectric layer is electrically infiltrated into the drug-administered area; a second dielectric layer and a first dielectric layer are provided on the third dielectric layer, and the second dielectric layer can limit the electric potential energy generated by the first dielectric layer on the third dielectric layer under the action of electric current, so that the active agent of the third dielectric layer penetrates into the superficial epidermis of the drug-administered area, thereby achieving the effect of epidermal retention.

2. The superficial epidermal iontophoresis drug delivery method according to claim 1, characterized in that: The first medium layer, the second medium layer and the third medium layer each have a resistor for matching the current intensity passing through the drug administration area.

3. The superficial epidermal iontophoresis drug delivery method according to claim 2, characterized in that: The resistance value of the second dielectric layer is greater than the resistance values ​​of the first dielectric layer and the third dielectric layer.

4. The superficial epidermal iontophoresis drug delivery method according to claim 2, characterized in that: The second dielectric layer is filled with materials of different resistance values ​​according to the requirements of the superficial skin drug penetration depth of the drug-administered area.

5. The superficial epidermal iontophoresis drug delivery method according to claim 1, characterized in that: The implementation steps include: S1. A third medium layer, a second medium layer and a first medium layer are stacked on the surface of the drug administration area; S2. energizing the first dielectric layer through a power source so that the first dielectric layer obtains electric potential energy under the action of the current; S3. The second medium layer can weaken the current passing through the first medium layer, so that the active agent in the third medium layer obtains a driving force to move toward the superficial epidermis of the administration area.

6. A superficial epidermal iontophoresis drug delivery device, characterized in that: The superficial skin iontophoresis drug delivery method according to claims 1 to 5 is adopted, wherein the superficial skin iontophoresis drug delivery device comprises an electrical conductive layer, an isolation layer, and a drug-carrying layer; The conductive layer includes a conductive electrode region and the first dielectric layer; the isolation layer includes the second dielectric layer; and the drug-carrying layer includes the third dielectric layer; The isolation layer is located between the conductive layer and the drug-carrying layer; The drug-carrying layer is arranged below the isolation layer; The conductive electrode region is arranged above the first dielectric layer.

7. The superficial epidermal iontophoresis drug delivery device according to claim 6, characterized in that: The conductive layer, the isolation layer, and the drug-carrying layer are an integrally formed structure; or the conductive layer, the isolation layer, and the drug-carrying layer are independently separated from each other before use, and are connected to each other when administering the drug to the administration area.

8. The superficial epidermal iontophoresis drug delivery device according to claim 6, characterized in that: The conductive layer and the isolation layer are integrally formed, and the drug-carrying layer is independent of the conductive layer and the isolation layer; Alternatively, the conductive layer is an independent structure, and the isolation layer and the drug-carrying layer are integrally formed.

9. The superficial epidermal iontophoresis drug delivery device according to claim 6, characterized in that: The drug-carrying layer includes a protective film, which is arranged on the lower surface of the third dielectric layer. At least one spacing area is arranged in the third dielectric layer, and the spacing area is arranged to correspond one-to-one with the predetermined spacing in the conductive electrode of the first dielectric layer, so that the electrical polarities obtained by the parts of the third dielectric layer separated by the spacing area are different and do not interfere with each other.

10. The superficial epidermal iontophoresis drug delivery device according to claim 6, characterized in that: The drug-carrying layer can be attached with different active agents through the third medium layer to achieve different drug delivery effects.

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