An iontophoresis device and method of iontophoretic delivery of an active composition

Abstract

This invention discloses an iontophoresis device and a method for iontophoresis delivery of an active composition, relating to the field of active ingredient penetration technology. The method includes: delivering a skin active composition to a target area using a composite pulse wave and / or a biphasic compensated pulse wave output by the iontophoresis device; the composite pulse wave, within a single cycle, sequentially includes a positive gradual rise segment, a negative main action segment, and a zero-recovery segment; the biphasic compensated pulse wave, within a single cycle, includes a negative main pulse and a positive compensated pulse. By employing a composite pulse wave and / or a biphasic compensated pulse wave to deliver the skin active composition to the target area, the problem of interfacial polarization accumulation is improved, and the delivery stability of the active substance is enhanced; by matching the waveform parameters of the active composition with the composite pulse wave and / or the biphasic compensated pulse wave used, the skin penetration of the active ingredient is increased; and by mixing the first and second substances immediately before use, the risk of inactivation of some active ingredients in a long-term aqueous environment is reduced.

Description

Technical Field

[0001] This invention relates to the field of active ingredient permeation technology, and in particular to an iontophoresis device and an iontophoresis delivery method for an active composition. Background Technology

[0002] The stratum corneum of the skin is an important barrier structure in the human body, and its main function is to defend against the entry of external substances, rather than to promote the absorption of active ingredients. For hydrophilic active ingredients, charged active ingredients, or active ingredients with limited stability on the skin surface, simply relying on topical application often fails to achieve ideal skin penetration efficiency. In particular, active ingredients such as vitamin C and its derivatives are easily limited by stability, solubility, and transdermal ability in conventional systems.

[0003] Currently, common methods to promote transdermal absorption include topical application alone, physical methods to enhance penetration, and electro-permeability enhancement. Among these, iontophoresis technology delivers charged or electroosmotic components through the skin by applying a current curve to the biological object.

[0004] However, iontophoresis technology still has the following problems: 1) When multiple active ingredients are mixed in an aqueous system for a long time, some components are prone to degradation, inactivation, or mutual interference in the aqueous system; 2) During single DC induction, polarization at the electrode-skin interface is prone to accumulate, resulting in insufficient delivery stability and comfort; 3) Pulse output schemes mostly use pulse stimulation with equal amplitude and width, and there is little further research on the structure of the action segment inside the pulse, the functional division of different phases within a single cycle, and its adaptation relationship with the active composition system, thus lacking a waveform parameter window suitable for the delivery of specific active compositions; 4) Existing technologies have little research on the matching relationship between waveforms and active compositions, resulting in limited skin penetration of active ingredients. Summary of the Invention

[0005] In order to solve the problems existing in the prior art, the present invention provides the following technical solution.

[0006] The first aspect of the present invention provides a method for iontophoresis delivery of an active composition, comprising: A skin-active composition is delivered to a target area using a composite pulse wave and / or a biphasic compensated pulse wave output from an iontophoresis device. Each cycle of the composite pulse wave sequentially includes a positive ramp-up phase, a negative main action phase, and a zero-recovery phase. The positive ramp-up phase is characterized by a waveform that gradually rises from a near-zero current density initial state, with the current density continuously increasing over time to a peak value. The negative main action phase is characterized by the peak value of the positive ramp-up phase switching to negative polarity within 1% to 20% of the effective pulse width, and forming a negative spike output with an absolute amplitude value higher than the absolute value of the peak value of the positive ramp-up phase within 1% to 30% of the effective pulse width. The zero-recovery phase is characterized by the waveform decaying from a negative output within 10% to 60% of the effective pulse width after the negative main action phase and returning to the zero baseline. The biphase compensation pulse wave includes a negative main pulse and a positive compensation pulse within a single cycle, wherein the absolute value of the amplitude of the negative main pulse is greater than the absolute value of the amplitude of the positive compensation pulse, and the duration of the negative main pulse is greater than the duration of the positive compensation pulse.

[0007] Preferably, the method further includes: before the iontophoresis device outputs a composite pulse wave and / or a biphasic compensated pulse wave, a first substance and a second substance constituting the skin active composition are temporarily mixed; the first substance is an aqueous substance and the second substance is a non-aqueous substance.

[0008] Preferably, the first substance comprises one or more of the following: water, betaine, 1,3-propanediol, 1,2-pentanediol, sodium hyaluronate, hydrolyzed sodium hyaluronate, 1,2-hexanediol, tranexamic acid, nicotinamide, carnosine, nonapeptide-1, lactobacillus / soybean fermentation product filtrate, and citrus fruit extract.

[0009] Preferably, the second substance comprises one or more of ascorbic acid, magnesium ascorbate phosphate, and 3-O-ethyl ascorbic acid.

[0010] Preferably, the mass ratio of the first substance to the second substance is 8:1 to 25:1, and the pH of the skin-active composition is 4.8 to 6.0.

[0011] Preferably, the current density of the composite pulse wave is 0.05–0.20 mA / cm²; the effective pulse width is 100–800 μs; the repetition frequency is 200 Hz–1500 Hz; and the total duration of a single operation is 300–1800 s.

[0012] Preferably, the current density of the biphase compensation pulse wave is 0.05–0.25 mA / cm²; the width of the negative main pulse is 0.2–2.0 ms; the width of the positive compensation pulse is less than the width of the negative main pulse; the repetition frequency is 100 Hz–1000 Hz; and the total duration of a single operation is 300–1800 s.

[0013] Another aspect of the present invention provides an iontophoresis device for iontophoresis delivery of an active composition using the method described in the first aspect. The iontophoresis device includes an iontophoresis host and a first electrode and a second electrode electrically connected thereto. The iontophoresis host is configured to output a composite pulse wave mode and / or a biphasic compensated pulse wave between the first electrode and the second electrode to form a closed loop of current through the target skin and biological tissue.

[0014] Preferably, the first electrode is a flexible electrode mask applied to the face; the second electrode is applied to at least one of the following locations: shoulder, side of neck, upper arm, or back.

[0015] Preferably, the first electrode sequentially comprises an absorbent layer, a conductive layer, and an insulating layer. The absorbent layer is used to adsorb, contain, and retain the active composition, and in use, it directly contacts the target skin surface to form a continuous active ingredient delivery interface between the skin and the conductive mask. The conductive layer is attached to the absorbent layer and is used to receive the current output by the iontophoresis device and apply the current to the area covered by the absorbent layer, forming an electric field on the target skin surface for active delivery. The insulating layer is disposed on the outside of the conductive layer to provide electrical isolation and mechanical support for the conductive layer and to limit the leakage of current away from the skin.

[0016] The iontophoresis device and iontophoresis delivery method of the active composition provided by this invention have the following beneficial effects: 1) By mixing the first and second substances immediately before use to obtain a skin-active composition and immersing it in the first electrode, it is beneficial to reduce the risk of deactivation of some active ingredients in a long-term aqueous environment; 2) By employing composite pulse waves and / or biphasic compensated pulse waves, the problem of interfacial polarization accumulation was improved, and the delivery stability of active substances was enhanced; 3) By matching the waveform parameters of the active composition with the composite pulse wave and / or biphasic compensated pulse wave used, the skin penetration of vitamin C active ingredients is improved; 4) Under the same active composition conditions, the present invention can achieve relatively high skin penetration by using biphasic compensated pulse wave, composite pulse wave and biphasic compensated pulse wave + composite pulse wave sequential output mode, among which the biphasic compensated pulse wave + composite pulse wave sequential output mode shows better delivery effect. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of a single-cycle waveform of the composite pulse wave described in this invention; Figure 2 This is a schematic diagram of a single-cycle waveform of the biphase compensation pulse wave described in this invention; Figure 3 This is a schematic diagram of the ion electroosmosis device described in this invention; Figure 4 This is a comparison chart of skin penetration amounts obtained using different delivery methods in a specific embodiment of the present invention; Figure 3 The meanings of the symbols in the text are as follows: 1. Ion electroosmosis host; 2. First electrode; 3. Second electrode. Detailed Implementation

[0018] To better understand the above technical solutions, the following will provide a detailed explanation of the technical solutions in conjunction with the accompanying drawings and specific implementation methods.

[0019] The purpose of this invention is to provide an iontophoresis delivery method for an active composition, which involves mixing a first substance and a second substance immediately to form a biphasic active composition, and actively delivering it in a composite pulse wave mode and / or a biphasic compensated pulse wave mode to increase the skin penetration of vitamin C active ingredients and improve the problems of interface polarization accumulation and insufficient delivery stability during traditional constant current direct current iontophoresis.

[0020] This invention provides a method for iontophoresis delivery of an active composition, comprising: A skin-active composition is delivered to the target area using a composite pulse wave and / or a biphasic compensated pulse wave output from an iontophoresis device. Each cycle of the composite pulse wave sequentially includes a positive ramp-up phase, a negative main action phase, and a zero-recovery phase. The positive ramp-up phase is characterized by a waveform that gradually rises from a near-zero current density initial state, with the current density continuously increasing over time to a peak value. The negative main action phase is characterized by the peak value of the positive ramp-up phase switching to negative polarity within 1% to 20% of the effective pulse width, and forming an amplitude within 1% to 30% of the effective pulse width. The phase of negative peak output with an absolute value higher than the absolute value of the peak value of the positive gradual rise phase; the zero recovery phase is the phase after the negative main action phase, where the waveform decays from negative output within 10% to 60% of the effective pulse width and returns to the zero baseline; in a preferred embodiment, the single period of the composite pulse wave is 1000 μs and the effective pulse width is 500 μs; the positive gradual rise phase lasts for about 300 to 360 μs, the negative main action phase completes the switching and negative peak formation within about 340 to 400 μs, and the negative output decays back to zero within about 380 to 500 μs.

[0021] The biphase compensation pulse wave includes a negative main pulse and a positive compensation pulse within a single cycle, wherein the absolute value of the amplitude of the negative main pulse is greater than the absolute value of the amplitude of the positive compensation pulse, and the duration of the negative main pulse is greater than the duration of the positive compensation pulse.

[0022] In this embodiment of the invention, the composite pulse wave is not a simple unipolar rectangular pulse, but a composite output structure that sequentially includes a positive ramp-up segment, a negative main action segment, and a zero-recovery segment within a single cycle. Specifically, within a single cycle, the waveform first gradually enters the positive ramp-up segment from an initial state close to zero current density, with the positive current density continuously increasing over time; then, at a predetermined time node, it rapidly switches to the negative main action segment, forming a negative spike output with a higher amplitude; afterwards, the negative output rapidly decays and returns to the zero baseline, entering the zero-recovery segment, until the start of the next cycle. The waveform of the composite pulse wave can be found in [reference needed]. Figure 1 .

[0023] In one embodiment of the present invention, within the effective pulse width, the positive ramp-up segment and the negative main action segment together constitute the main electric field action region, and the remaining period is the zero-recovery region. The absolute value of the peak value of the negative main action segment is greater than the peak value of the positive ramp-up segment, thus making the composite pulse wave exhibit a net negative polarity overall.

[0024] Unlike conventional single rectangular pulses or constant current DC outputs, the composite pulse wave in this invention introduces a combination of positive ramp-up, negative main action, and zero-recovery within the same cycle. This allows the waveform to effectively drive the target skin interface while mitigating the continuous accumulation of interfacial charge through a discontinuous constant output. Specifically, the positive ramp-up segment facilitates the establishment of an electric field distribution under relatively mild initial conditions, the negative main action segment provides the primary delivery driving force, and the zero-recovery segment helps reduce continuous polarization accumulation, thereby improving the delivery stability and penetration efficiency of vitamin C-like active ingredients in the biphasic active composition.

[0025] In this embodiment of the invention, the biphase compensation pulse wave is a periodically repeating biphase pulse output structure, with each cycle including a negative main pulse and a positive compensation pulse. The negative main pulse has a larger amplitude and a longer duration, providing the primary delivery driving force; the positive compensation pulse has a smaller amplitude and a shorter duration, used to compensate for and regulate the charge accumulation formed at the electrode-skin interface by the aforementioned negative main pulse. Because the effective area of ​​the negative main pulse is larger than that of the positive compensation pulse, the biphase compensation pulse wave still exhibits a net negative polarity overall. The waveform of the biphase compensation pulse wave can be found in [reference needed]. Figure 2 .

[0026] Unlike related technologies that only emphasize the general concept of "biphase pulse" in their output methods, the biphase compensation pulse wave in this invention is not a symmetrical biphase waveform with equal amplitude and width, but rather an asymmetrical biphase structure with a functional division between the main pulse and the compensation pulse. The negative main pulse undertakes the primary delivery function, while the positive compensation pulse undertakes the interface compensation function. The asymmetrical setting of their amplitude, width, and effective area allows the waveform to improve the interface polarization state during the output process while maintaining the overall net negative polarity.

[0027] In a preferred embodiment of the present invention, the iontophoresis delivery method of the active composition further includes: temporarily mixing a first substance and a second substance constituting the active skin composition before the iontophoresis device outputs a composite pulse wave and / or a biphasic compensated pulse wave; the first substance is an aqueous substance, and the second substance is a non-aqueous substance. This method can reduce the risk of inactivation of some active ingredients in a long-term aqueous environment and improve the utilization efficiency of the active ingredients.

[0028] In one embodiment of the present invention, the first substance includes one or more of the following: water, betaine, 1,3-propanediol, 1,2-pentanediol, sodium hyaluronate, hydrolyzed sodium hyaluronate, 1,2-hexanediol, tranexamic acid, nicotinamide, carnosine, nonapeptide-1, lactobacillus / soybean fermentation product filtrate, and citrus fruit extract.

[0029] The second substance includes one or more of ascorbic acid, magnesium ascorbate phosphate, and 3-O-ethyl ascorbic acid.

[0030] In one embodiment of the present invention, as an example, the content of each component in the first substance and the second substance may be as shown in Table 1.

[0031] Table 1 In one embodiment of the present invention, the pH of the first substance is 5.2 to 6.5, preferably 5.4 to 5.9.

[0032] In one embodiment of the present invention, the mass ratio of the first substance and the second substance is 8:1 to 25:1, and the pH of the skin-active composition composed of the first substance and the second substance is 4.8 to 6.0, preferably 5.1 to 5.6.

[0033] In one embodiment of the present invention, such as Figure 3As shown, the iontophoresis device includes an iontophoresis main unit 1 and a first electrode 2 and a second electrode 3 electrically connected thereto. The iontophoresis main unit 1 is used to output a composite pulse wave mode and / or a biphasic compensated pulse wave between the first electrode 2 and the second electrode 3, so that the current forms a closed loop through the target skin and biological tissue. The first electrode serves as the carrier interface of the active composition, and the second electrode serves as the return current interface. The iontophoresis device is used to implement the delivery method.

[0034] In one embodiment of the present invention, the first electrode 2 is a flexible electrode mask applied to the face; the second electrode 3 is applied to at least one of the following locations: shoulder, side of neck, upper arm, or back.

[0035] In the above method, by setting the first electrode as a flexible electrode mask applied to the target area of ​​the face, and setting the second electrode at non-facial body return sites such as the shoulder, neck, upper arm, or back, the present invention can form a relatively stable closed current path between the facial delivery area and the body return site. Compared with locally adjacent or handheld return electrodes, this arrangement helps to reduce the impact of unstable return electrode contact on the output process, and allows the first electrode to form a larger area and more uniform electric field interface in the target area of ​​the face, thereby improving the stability and ease of use of the delivery process. This structure, as a preferred embodiment of the delivery method of the present invention, when used in conjunction with a biphasic active composition and specific waveform parameters, helps to further improve the consistency of active ingredient delivery.

[0036] In one embodiment of the present invention, the first electrode 2 sequentially includes an absorbent layer, a conductive layer, and an insulating layer. The absorbent layer is used to adsorb, contain, and retain the active composition, and in use, it directly contacts the target skin surface to form a continuous active ingredient delivery interface between the skin and the conductive mask. The conductive layer is attached to the absorbent layer and is used to receive the current output by the iontophoresis host and apply the current to the area covered by the absorbent layer to form an electric field for active delivery on the target skin surface. The insulating layer is disposed on the outside of the conductive layer and is used to electrically isolate and mechanically support the conductive layer, and to limit the leakage of current to the side away from the skin.

[0037] In one embodiment of the present invention, the current density of the composite pulse wave is 0.05 to 0.20 mA / cm²; the effective pulse width is 100 to 800 μs; the repetition frequency is 200 Hz to 1500 Hz; and the total duration of a single operation is 300 to 1800 s.

[0038] In this embodiment of the invention, the composite pulse wave and its parameters are matched with the compositional characteristics of the active composition. Since the system formed by the immediate mixing of the first and second substances contains active ingredients such as ascorbic acid, magnesium ascorbate phosphate, and 3-O-ethyl ascorbic acid, and the overall system has a predetermined pH range and ionic environment, the net negative polarity, effective pulse width, single cycle, and repetition frequency of the composite pulse wave together constitute a parameter window suitable for the delivery of the biphasic active composition.

[0039] In one embodiment of the present invention, the current density of the biphase compensation pulse wave is 0.05 to 0.25 mA / cm²; the width of the negative main pulse is 0.2 to 2.0 ms; the width of the positive compensation pulse is less than the width of the negative main pulse; the repetition frequency is 100 Hz to 1000 Hz; and the total duration of a single operation is 300 to 1800 s.

[0040] In this invention, the biphasic compensation pulse wave and its parameters are matched with the biphasic active composition. Specifically, in the biphasic active composition system formed by the immediate mixing of the first and second substances, the asymmetric biphasic compensation pulse can provide an effective delivery driving force while adjusting the interface state during the delivery process, thereby achieving a skin penetration amount higher than that of ordinary constant current direct current iontophoresis.

[0041] In one specific embodiment of the present invention, the iontophoresis delivery method of the biphasic active composition is implemented according to the following steps: Step 1, mixing phase A essence (first substance) and phase B powder (second substance) to form a biphasic active composition; Step 2, applying the biphasic active composition to a first electrode; Step 3, applying the first electrode to the target skin area; Step 4, applying the second electrode to the body return site; Step 5, connecting the first electrode and the second electrode to the iontophoresis host; Step 6, selecting the composite pulse wave mode and / or the biphasic compensated pulse wave mode and corresponding parameters; Step 7, outputting current to complete the delivery of active ingredients.

[0042] Specifically, according to the raw material range shown in Table 1, phase A essence and phase B powder are taken. Preferably, the phase A essence and phase B powder are mixed immediately before use at a mass ratio of 12:1 to 18:1 to form a biphase active composition. After mixing, the biphase active composition is applied to the first electrode.

[0043] The first electrode is applied to the target skin area, and the second electrode is applied to the body return site and connected to the iontophoresis host. In one embodiment, a composite pulse wave mode is selected, with a current density of 0.12 mA / cm², an effective pulse width of 500 μs, a repetition frequency of 1.0 kHz, and a total run time of 1500 s. In another embodiment, a biphasic compensated pulse wave mode is selected, with a current density of 0.15 mA / cm², a negative main pulse width of 1.0 ms, a repetition frequency of 500 Hz, and a total run time of 1500 s. In a third embodiment, a sequential output mode of biphasic compensated pulse wave and composite pulse wave is selected: first, a biphasic compensated pulse wave is used for 300 s, then a composite pulse wave is used for 1200 s, with a total run time of 1500 s; wherein the current density, pulse width, and repetition frequency of the biphasic compensated pulse wave and the composite pulse wave are set using the parameters of the corresponding modes described above. This sequential output mode is used to regulate the state of the electrode-skin interface in the front end through biphasic compensated pulse waves, and to achieve the main delivery in the back end through composite pulse waves.

[0044] To verify the delivery effect of this invention on the active ingredients in biphasic active compositions, a comparative experiment was conducted using an isolated porcine skin Franz diffusion cell model. The effective area was 1.77 cm², the sample size was n=6, and the treatment time was 25 min.

[0045] The following six experimental groups were set up: 1) Simple application group; 2) Ordinary constant current DC input group; 3) Ordinary pulse input group; 4) Biphasic compensated pulse wave group of the present invention; 5) Composite pulse wave group of the present invention; 6) Sequential output group of biphasic compensated pulse wave + composite pulse wave of the present invention. Among them, the ordinary pulse input group uses equal amplitude rectangular pulse output, and the sequential output group of biphasic compensated pulse wave + composite pulse wave of the present invention uses a sequential output method of biphasic compensated pulse wave first, followed by composite pulse wave.

[0046] The A-phase essence and B-phase powder were mixed immediately before use and applied to the first electrode. After the experiment, the skin surface was cleaned and a skin tissue homogenate was collected. After extraction with methanol / water, ascorbic acid, magnesium ascorbate phosphate, and 3-O-ethyl ascorbic acid were simultaneously quantified using HPLC. The three were summed and normalized according to the effective area to calculate the skin penetration. The results are as follows: Figure 4 As shown in Table 2.

[0047] Table 2 In Table 2, R1 to R6 represent the measurement results of 6 parallel samples in the same experimental group. Each sample is an independently treated ex vivo pigskin sample, and the unit is μg / cm². "Mean ± SD" represents the mean and standard deviation of the 6 parallel samples.

[0048] Table 2 shows the skin penetration amounts for each group as follows: simple application 21.8±2.7 μg / cm²; conventional iontophoresis (constant current direct current) 29.6±3.1 μg / cm²; conventional iontophoresis (equal amplitude rectangular pulse) 30.9±3.0 μg / cm²; this invention (biphasic compensated pulse wave) 33.4±3.4 μg / cm²; this invention (composite pulse wave) 46.8±4.0 μg / cm²; this invention (biphasic compensated pulse wave + composite pulse wave sequential output) 51.1±3.9 μg / cm². The multiples relative to the simple application group were 1, 1.36, 1.42, 1.53, 2.15, and 2.34, respectively.

[0049] The above results indicate that, under the same biphasic active composition conditions, constant current DC iontophoresis, ordinary constant amplitude rectangular pulse iontophoresis, the biphasic compensated pulse wave mode of this invention, the composite pulse wave mode of this invention, and the sequential output mode of biphasic compensated pulse wave + composite pulse wave of this invention can all improve skin penetration. Among them, the sequential output mode of biphasic compensated pulse wave + composite pulse wave of this invention achieves the highest skin penetration, followed by the composite pulse wave mode, indicating that the biphasic active composition can achieve better delivery effect when matched with specific waveform parameters and their sequential combination.

[0050] While maintaining the composition of the biphasic active composition, delivery using a biphasic compensated pulse wave mode achieves a higher skin penetration rate than the constant current DC mode. The advantages of this mode are: it provides the main driving force through a negative master pulse; it reduces interfacial charge accumulation through a positive compensated pulse; and it improves the output stability of the electrode-skin interface while maintaining overall net negative polarity.

[0051] While maintaining the composition of the biphasic active composition, delivery using a composite pulse wave mode achieves higher skin penetration than both constant current DC mode and biphasic compensated pulse wave mode. This mode generates a combination of positive gradual rise, negative spike, and zero-return intervals within a single cycle, effectively driving the delivery to the target skin interface. It achieves directional migration of active ingredients through net negative polarity and mitigates interfacial polarization accumulation during continuous delivery through periodic zero-return intervals.

[0052] Furthermore, the sequential output mode of biphasic compensated pulse wave + composite pulse wave compensates and regulates the electrode-skin interface through the initial biphasic compensated pulse wave, reducing the accumulation of interfacial charge before negative delivery, and provides the main net negative polarity delivery driving force through the subsequent composite pulse wave, thus combining interface compensation with efficient delivery. In this embodiment, this mode achieves a higher skin penetration rate than the single biphasic compensated pulse wave mode and the single composite pulse wave mode.

[0053] Although preferred embodiments of the invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including both the preferred embodiments and all changes and modifications falling within the scope of the invention. Clearly, those skilled in the art can make various alterations and modifications to the invention without departing from its spirit and scope. Thus, if these modifications and modifications of the invention fall within the scope of the claims and their equivalents, the invention is also intended to include these modifications and modifications.

Claims

1. A method for iontophoresis delivery of an active composition, characterized in that, include: The skin-active composition is delivered to the target area using composite pulse waves and / or biphasic compensated pulse waves output by an iontophoresis device; The composite pulse wave comprises, sequentially within a single cycle, a positive ramp-up phase, a negative main action phase, and a zero-recovery phase. The positive ramp-up phase is characterized by the waveform gradually rising from a near-zero current density initial state, with the current density continuously increasing over time to a peak value. The negative main action phase is characterized by the peak value of the positive ramp-up phase switching to negative polarity within 1% to 20% of the effective pulse width, and forming a negative spike output with an absolute amplitude higher than the absolute value of the peak value of the positive ramp-up phase within 1% to 30% of the effective pulse width. The zero-recovery phase is characterized by the waveform decaying from a negative output within 10% to 60% of the effective pulse width after the negative main action phase and returning to the zero baseline. The biphase compensation pulse wave includes a negative main pulse and a positive compensation pulse within a single cycle, wherein the absolute value of the amplitude of the negative main pulse is greater than the absolute value of the amplitude of the positive compensation pulse, and the duration of the negative main pulse is greater than the duration of the positive compensation pulse.

2. The method for iontophoresis delivery of the active composition according to claim 1, characterized in that, The method further includes: before the iontophoresis device outputs a composite pulse wave and / or a biphasic compensated pulse wave, a first substance and a second substance constituting the skin active composition are temporarily mixed; the first substance is an aqueous substance and the second substance is a non-aqueous substance.

3. The iontophoresis delivery method of the active composition according to claim 2, characterized in that, The first substance includes one or more of the following: water, betaine, 1,3-propanediol, 1,2-pentanediol, sodium hyaluronate, hydrolyzed sodium hyaluronate, 1,2-hexanediol, tranexamic acid, nicotinamide, carnosine, nonapeptide-1, lactobacillus / soybean fermentation product filtrate, and citrus fruit extract.

4. The iontophoresis delivery method of the active composition according to claim 2, characterized in that, The second substance includes one or more of ascorbic acid, magnesium ascorbate phosphate, and 3-O-ethyl ascorbic acid.

5. The method for iontophoresis delivery of the active composition according to claim 2, characterized in that, The mass ratio of the first substance to the second substance is 8:1 to 25:1, and the pH of the skin-active composition is 4.8 to 6.

0.

6. The method for iontophoresis delivery of the active composition according to claim 1, characterized in that, The current density of the composite pulse wave is 0.05–0.20 mA / cm²; the effective pulse width is 100–800 μs; the repetition frequency is 200 Hz–1500 Hz; and the total duration of a single operation is 300–1800 s.

7. The method for iontophoresis delivery of the active composition according to claim 1, characterized in that, The current density of the biphase compensation pulse wave is 0.05–0.25 mA / cm²; the width of the negative main pulse is 0.2–2.0 ms; the width of the positive compensation pulse is less than the width of the negative main pulse; the repetition frequency is 100 Hz–1000 Hz; and the total duration of a single operation is 300–1800 s.

8. An ion electroosmosis device, characterized in that, The iontophoresis device is used for iontophoresis delivery of an active composition using the method as described in any one of claims 1-7. The iontophoresis device includes an iontophoresis host and a first electrode and a second electrode electrically connected thereto. The iontophoresis host is used to output a composite pulse wave mode and / or a biphasic compensated pulse wave between the first electrode and the second electrode to form a closed loop of current through the target skin and biological tissue.

9. The ion electroosmosis device as described in claim 8, characterized in that, The first electrode is a flexible electrode mask applied to the face; the second electrode is applied to at least one of the following locations: shoulder, side of neck, upper arm, or back.

10. The ion electroosmosis device as described in claim 9, characterized in that, The first electrode comprises an absorbent layer, a conductive layer, and an insulating layer in sequence. The absorbent layer is used to adsorb, contain, and retain the active composition, and comes into direct contact with the target skin surface during use to form a continuous active ingredient delivery interface between the skin and the conductive mask. The conductive layer is attached to the absorbent layer to receive the current output by the iontophoresis host and apply the current to the area covered by the absorbent layer, thereby forming an electric field on the target skin surface for active delivery. The insulating layer is disposed on the outside of the conductive layer to provide electrical isolation and mechanical support for the conductive layer, and to limit the leakage of current to the side away from the skin.

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