CN101920064A - Method and instrument of ultrasonic and electric field superposition target medicine penetration - Google Patents
Method and instrument of ultrasonic and electric field superposition target medicine penetration Download PDFInfo
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- CN101920064A CN101920064A CN2009103032253A CN200910303225A CN101920064A CN 101920064 A CN101920064 A CN 101920064A CN 2009103032253 A CN2009103032253 A CN 2009103032253A CN 200910303225 A CN200910303225 A CN 200910303225A CN 101920064 A CN101920064 A CN 101920064A
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Abstract
Method and instrument of ultrasonic and electric field superposition target medicine penetration are disclosed. The method comprises the steps of outputting physical energy ultrasonic and electric field in a certain form in programming and superposing way which can promote medicines to penetrate into an organism through skin; organically and jointly applying to a medicines in a certain medicine form so that the ultrasonic, the electropration and iontophoresis can jointly promote the medicines to penetrate into the organism by respective characteristics to form a certain medicine concentration in partial tissues to realize partial treatment by target medicine penetration. The instrument comprises a host and an application part, wherein the host comprises a power supply part, a signal generating and processing part, an adjusting control and display part and the like; the application part comprises an interconnecting plug, an output cable and a treatment head; the power supply part mainly comprises a net power supply connecting line, a fuse protector, a voltage-transformation and rectifying device and the like; the signal generating and processing part comprises a signal generating circuit, a signal amplifying circuit and a signal modulator circuit; the control and display part mainly comprises a parameter setting circuit, a parameter display circuit and a parameter display device; the treatment head comprises a shell, a transmission electrode; a ultrasonic transducer and the like; the power supply part inputs the current of the net power supply into the signal generating and processing part; electric signals of a driving ultrasonic transducer and a medicine penetration electric field are generated, amplified and modulated by the signal generating and processing part; the control and display part realizes the setting, the adjustment and the display of output signal parameters; the application part transmits the electric signals to the treatment head.
Description
Technical field:
The present invention relates to the method and the instrument of a kind of ultrasound wave and electric field superposition target medicine penetration, belong to medium is imported the intravital instrument field of people.
Background technology:
In many medications, oral and injection is still topmost route of administration at present.Their common feature is: after medicine enters human body by different approach, all form certain drug level in blood, and then with loop distribution each tissue to whole body, form certain tissue concentration.The medicine that is distributed in pathological tissues has been brought into play therapeutical effect, and the medicine that is distributed in normal structure often causes toxic and side effects.
During oral and drug administration by injection, the time for the curative effect that improves medicine and drug effect are kept, need to increase dosage usually and improve blood drug level, the risk of often bringing toxic and side effects to be multiplied.In order to guarantee drug safety, usually limit dosage, also limited the performance of Drug therapy effect simultaneously greatly, even many medicines with very strong therapeutical effect are eliminated because of the toxic and side effects that can't overcome.In order to overcome above-mentioned drawback, the location dispenser becomes the target that people pursue further.Medicine is directly sent to intravital diseased region, and the method for bringing into play the Drug therapy effect in the part is called as the target position Drug therapy.
The method of local positioning dispenser has advantage and characteristics such as dosage is few, drug effect remarkable, the whole body toxic and side effects is few, is clinical effective clinical drug therapy means.Adopt methods such as local puncture injection, conduit intervention, operating field sprinkling traditionally, as injecting in the local retardance of neuroganglion, joint puncture injection, the tumor vessel etc.Owing to there is the risk of pain, injured nerve blood vessel and important organ, and the doctor that complicated operation need have wide experience carries out, and also need the image-guided cost that makes very high sometimes, so these class methods fails generally to be adopted clinical.
In recent years, promote that as a class medicine penetrates intravital means through skin, (active transdermal, AT) method is by extensive concern for powerful transdermal.It is by specific physics method and means, changed skin and tissue permeability to medicine, drug molecule or particle are applied kinetic energy, under the mediation of physical energy, impel it to see through skin, entered blood circulation by subcutaneous blood capillary absorption, bring into play systemic therapeutic effect, be called as the Transdermal absorption of medicine.
Powerful transdermal effect has the not available advantage of other percutaneous dosing method: as improved drug transdermal speed, realized macromolecular drug Transdermal absorption etc.Recently the more method of research has: laser micropore technology (lasermicrodissection LMD), electroporation technology (electropration EP), ultrasonic technology (phonophoresis), iontophoresis technology (iontophoresis) and the micropin technology (microneedle) etc. of penetrating.They put in order by the lipid molecular that changes cell membrane and tissue film, thereby or reach the purpose that improves cutaneous permeability in the shallow crack of horny layer formation table.Some also can be by activation energy, the generation directed driven ability that improves drug molecule.
Powerful transdermal administration is the emerging technology of a class, has become one of the most popular subject branch of international the world of medicine since 20th century.Particularly in recent years, the various countries scholar has carried out deep research respectively to the various physical technique means of powerful transdermal, has obtained a large amount of theoretical results.By research, illustrated the mechanism of various means transdermal facilitations substantially, for the application process and the exploitation of the Related product of these methods of realization of further studying various physical means are laid a good foundation.Adopt the part treatment technology of this class methods exploitation and instrument to begin to enter the medical market and be applied to clinical treatment.
Research and practice show, above method is used separately or simple overlappingly only can be brought into play limited Transdermal absorption facilitation, as simple ultrasonic medicinal penetrate, medicine ion importing etc.Because the percutaneous rate of medicine is not high enough, most drug is difficult to form effective blood drug level, more can not form very high drug level at deep tissue.The product that only is used at present epidermis anesthesia and insulin skin absorbs is developed in the U.S., because effect is limited, is not generally accepted by clinical always.
Also having occurred a class in recent years, to adopt high pressure draught and High-Pressure Water be the Needleless injection method of driving force and the patent application of product, as: 01805865.5 has the needleless injector of two injection speed levels, restrains French Shandong Si Jiekete company; 99809804.3 needleless injector, Britain Weston Medical Ltd.; 200710144504.0 electric needleless injectors, Feng Shaowei; 200610124562.2 Needleless injection device, Banbiantian Medical Technology Development Co., Ltd., Wuhan; 200810168988.7 needleless injector, Massachusetts Institute Technology etc.Some companies of the U.S., Germany have developed relevant commercial product.Because there is the impacting with high pressure effect to tissue in this class methods, can cause tissue injury and pain, so the dosage of administration and position be subjected to strict restriction, fails so far to be widely adopted clinical.
The local targeting of drugs method of ideal needleless medicine transmission, should possess and the medicine of certain dosage form can be entered the deep pathological tissues with the speed that is fit to through skin and subcutaneous tissue, form concentrating and soaking into of medicine within the specific limits, and the tissue concentration of remaining valid within a certain period of time, thereby the curative effect that performance is big and long is avoided the whole body toxic and side effects simultaneously.The process that applies also should not have obvious pain, inorganization damage.Reach above-mentioned target, needing to seek a kind of tissue that can make improves greatly to the permeability of medicine, between body surface and target tissue, set up " artificial bio-membrane's passage " of certain limit, certain depth, then make drug particle obtain the kinetic energy of directed movement, along established " passage " directed movement, the noinvasive that arrives diseased region, painless method with implement the utensil of this method.
Summary of the invention
The objective of the invention is to set up a kind of medicine that impels and see through the specific part that skin enters human body, the performance local therapeutic effects, painless, noninvasive targeting of drugs method.The technical characterictic of this method is to impel medicine to penetrate the stack output of the physical energy ultrasound wave of body and the electric field of a definite form (comprising electroporation and iontophoresis) sequencing, organically unite the medicine that puts on human body and certain dosage form, make ultrasound wave, electroporation and iontophoresis promote jointly that with separately characteristics medicine penetrates in the body.
The mechanism of action of this method is: at first by hyperacoustic " cavitation " and electroporation pulse current " pore effect ", the tissue film of formation organization of human body and the lipid granule of cell membrane are rearranged, produce the gap of certain pore size, intensive gap has formed the penetrating district that medicine enters.Then by hyperacoustic radiation pressure and convective transport effect, and the combined effect of the electricity of iontophoresis trend puts on drug particle, make it to produce directed movement, enter human body along established penetrating district, and form certain drug level in local organization, reach the purpose (Fig. 1) of target position transdermal topical therapeutic.
Above method is to implement by a kind of instrument that can produce ultrasound wave and electric field.The composition of this instrument comprises main frame and applying portion.Main frame is graded by power pack, signal generation and processing section, adjusting and control display part and constitutes.Described applying portion is made of connecting pin, output cable and treatment head.Described power pack mainly is made of network source connecting line, fuse, transformation and fairing etc.; Described signal takes place and the processing section is made of signal generating circuit, signal amplification circuit and signal modulation circuit; Described control display part mainly is made of parameter setting circuit, parameter display circuit and device; Described treatment head is made of shell, transmission electrode and ultrasonic transducer etc.
The present invention can be achieved through the following technical solutions: adopt frequency less than 1MHz, output sound intensity is less than 3W/cm
2, output or be interrupted the ultrasound wave of output continuously; To be the pulsating current (electroporation) of 50V to 150V and voltage constitute electric field less than direct current or the pulsating current (iontophoresis) of 50V to crest voltage; The form that ultrasound wave and electric field action apply is: (1) ultrasound wave and electroporation and iontophoresis pass through output by certain formula is continuous; (2) ultrasound wave and by continuous electroporation and the iontophoresis stack output of passing through output of certain formula; (3) ultrasound wave and electroporation or iontophoresis stack output.Take place and the processing section through transformation rectification input signal by the electric current of power pack network source; Produce, amplify, modulate the signal of telecommunication that drives ultrasonic transducer and transdermal electric field by signal generation and processing section; By control and display part realization setting, adjustment and demonstration to the output signal parameter; By applying portion the signal of telecommunication is transferred to the treatment head and produce ultrasound wave, make the signal of telecommunication stack output of a ultrasound wave and a definite form produce the transdermal facilitation.
This characteristic feature of an invention is: can make the multiple transdermal facilitation replenish collaborative, stack multiplication mutually, improve the effect that medicine penetrates body greatly, painless, the noinvasive of mechanism satisfies the requirement of target position transdermal topical therapeutic.
Description of drawings
Form with functional-block diagram among Fig. 1 describes a kind of preferred parameter scheme of the present invention and configuration process.
Fig. 2, Fig. 3 are the zooperies of adopting the present invention to carry out, test rabbit vivo medicine concentration measurement result.
The specific embodiment
Below the present invention is described further with embodiment and accompanying drawing:
Embodiment 1:
The parameter scheme:
Ultrasonic frequency: 20KHz,
Ultrasonic power: 200mW/cm
2,
Ultrasonic output form: pulsating, cycle 20ms, dutycycle 1: 1,
Electroporation: square wave, dutycycle 1: 1, cycle 30ms,
Pore voltage: 100V
The iontophoresis waveform: the 2000Hz square wave, dutycycle 1: 1,
Modulation waveform: the 100Hz half-sinusoid,
Crest voltage: 30V
Output time: 30min
The electroporation guide pulse of output formula: 10s and the every 10min of ultrasonic electric conductance stack output subsequently repeat.
The configuration process of instrument is:
Network source input cable is fastened on the supply socket on the tool housing rear board, fuse is connected supply socket and is fixed between the primary input line on the shell bottom plate, the bridge rectifier of main circuit board is connected between transformer secondary output output lead and the main circuit board pulse generating circuit, the main circuit board impulse modulation is connected with the display control circuit of amplifying circuit with pulse generating circuit and display panel, and the treatment head is connected with control circuit with the accessory power outlet that is fixed on rear board by output cable.Each hardware components of Micro Controller Unit (MCU) driving in the control circuit, the instruction of execution parameter generation, setting, regulatory process software.
Embodiment 2: in the body test, with the instrument that embodiment 1 obtains, carry out the interior ultrasonic electric conductance medicine of rabbit body and penetrate and organize interior determination of drug concentration.
Get healthy rabbits, body weight 2.0 ± 0.5kg, fixing back buttocks skin of unhairing sticks the hollow paster, and hollow area adds 5% ketoprofen gel agent, will treat head and immerse in the gel, apply 5 of the pore pulses of 100V, the electric conductance pulse 10min of the ultrasound wave of 20KHz and 30V, the back that finishes is put to death rabbit rapidly, draws the medicine position and organizes milling and extracting to contain the tissue fluid of ketoprofen, reclaim through composition, high performance liquid chromatogram detects.
The oral ketoprofen with dosage of the rabbit of matched group was put to death after 10 minutes.Other are identical with experimental group.
Liquid-phase condition:
Mobile phase: KH
2PO
4(0.07M, pH4.5): acetonitrile=80: 20 (all through filtering degasification)
Flow velocity: 1ml/min
Wavelength: 210nm
Temperature: 37 degree
Instrument: LC2010
In the body experimental result be: drug level and medicament contg are apparently higher than matched group (see Table 1 and Fig. 2, Fig. 3) in the tissue of experimental group.
Tissue concentration is measured after the administration of table 1 ketoprofen
| Method | Concentration ug/cm 3 | Total amount (ug) | Cumulative volume (cm 3) |
| Local | 30.2 | 620.8 | 21.6 |
| Oral | 1.5 | 30.3 | 20.8 |
Claims (11)
1. the method for ultrasound wave and electric field superposition target medicine penetration, it is characterized in that: the physical energy form of employing is ultrasound wave and electric field.
2. according to a kind of ultrasound wave described in the claim 1 and the method for electric field superposition target medicine penetration, it is characterized in that: the ultrasound wave of indication be output frequency less than 1MHz, output sound intensity is less than 3W/cm2, continuously output or be interrupted the ultrasound wave of output.
3. according to a kind of ultrasound wave described in the claim 1 and the method for electric field superposition target medicine penetration, it is characterized in that: the electric field of indication is the crest voltage electric field that to be the pulsating current (electroporation) of 50V to 150V and voltage constitute less than direct current or the pulsating current (iontophoresis) of 50V.
4. according to a kind of ultrasound wave described in the claim 1 and the method for electric field superposition target medicine penetration, it is characterized in that: the form that ultrasound wave and electric field action apply is: (1) ultrasound wave and electroporation and iontophoresis pass through output by certain formula is continuous; (2) ultrasound wave and by continuous electroporation and the iontophoresis stack output of passing through output of certain formula; (3) ultrasound wave and electroporation or iontophoresis stack output.
5. the instrument of ultrasound wave and electric field superposition target medicine penetration, it is characterized in that: instrument is made of main frame and applying portion.
6. according to a kind of ultrasound wave described in the claim 5 and the instrument of electric field superposition target medicine penetration, it is characterized in that: main frame is graded by power pack, signal generation and processing section, adjusting and control display part and constitutes.
7. according to a kind of ultrasound wave described in the claim 5 and the instrument of electric field superposition target medicine penetration, it is characterized in that: described applying portion is made of connecting pin, output cable and treatment head.
8. according to a kind of ultrasound wave described in the claim 6 and the instrument of electric field superposition target medicine penetration, it is characterized in that: described power pack mainly is made of network source connecting line, fuse, transformation and fairing etc.
9. according to a kind of ultrasound wave described in the claim 6 and the instrument of electric field superposition target medicine penetration, it is characterized in that: described signal takes place and the processing section is made of signal generating circuit, signal amplification circuit and signal modulation circuit.
10. according to a kind of ultrasound wave described in the claim 6 and the instrument of electric field superposition target medicine penetration, it is characterized in that: described control display part mainly is made of parameter setting circuit, parameter display circuit and device.
11. according to a kind of ultrasound wave described in the claim 7 and the instrument of electric field superposition target medicine penetration, it is characterized in that: described treatment head is made of shell, transmission electrode and ultrasonic transducer etc.
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102600547A (en) * | 2012-02-06 | 2012-07-25 | 广州赛莱拉生物科技有限公司 | Device and application for promoting transdermal absorption of stem cell growth factor covered by liposome |
| CN102755692A (en) * | 2012-07-30 | 2012-10-31 | 王路 | Ultrasonic wave and ion conduction transdermal medicament or cosmetic conduction device |
| CN103330993A (en) * | 2013-07-09 | 2013-10-02 | 北京中美联医学科学研究院有限公司 | Ultrasound transmission system and method for improving skin permeability |
| CN103463732A (en) * | 2013-09-18 | 2013-12-25 | 北京中美联医学科学研究院有限公司 | Ultrasonic target position pore-forming device and method |
| CN105771081A (en) * | 2016-03-29 | 2016-07-20 | 北京中美联医学科学研究院有限公司 | Ultrasonic conductivity meter and ultrasonic delivery method thereof |
| CN106621024A (en) * | 2017-01-17 | 2017-05-10 | 湖南省健缘医疗科技有限公司 | Ultrasonic medication diagnosis and treatment device |
| CN106730333A (en) * | 2016-12-20 | 2017-05-31 | 上海狂潮医疗科技有限公司 | Flat acupuncture and moxibustion instrument is led in electronic temperature control dosing |
| CN107185107A (en) * | 2017-05-13 | 2017-09-22 | 沈阳赛镝医疗器械有限公司 | A kind of ultrasonic direct current current iontophoresis system |
| CN109513104A (en) * | 2018-11-12 | 2019-03-26 | 深圳大学 | A kind of vaccine transdermal delivery device for leading microwell array based on acousta induction |
| CN111939453A (en) * | 2019-05-17 | 2020-11-17 | 成都植行合一健康科技有限公司 | Portable transdermal absorption therapeutic apparatus and control method thereof |
| CN113577528A (en) * | 2021-08-26 | 2021-11-02 | 中国科学院深圳先进技术研究院 | Piezoelectric electret drug delivery patch for transdermal drug delivery by combining contact pressure or beating and preparation method and application thereof |
| CN114082096A (en) * | 2021-11-03 | 2022-02-25 | 湖南正清制药集团股份有限公司 | Sinomenine hydrochloride delivery device and method |
| CN115317776A (en) * | 2022-04-22 | 2022-11-11 | 南京鼎世医疗器械有限公司 | Ultrasonic conductive directional medicine-penetrating therapeutic instrument |
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Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102600547A (en) * | 2012-02-06 | 2012-07-25 | 广州赛莱拉生物科技有限公司 | Device and application for promoting transdermal absorption of stem cell growth factor covered by liposome |
| CN102755692A (en) * | 2012-07-30 | 2012-10-31 | 王路 | Ultrasonic wave and ion conduction transdermal medicament or cosmetic conduction device |
| CN103330993A (en) * | 2013-07-09 | 2013-10-02 | 北京中美联医学科学研究院有限公司 | Ultrasound transmission system and method for improving skin permeability |
| CN103330993B (en) * | 2013-07-09 | 2016-04-20 | 北京中美联医学科学研究院有限公司 | A kind of ultrasound-transmissive system and method improving skin permeability |
| CN103463732A (en) * | 2013-09-18 | 2013-12-25 | 北京中美联医学科学研究院有限公司 | Ultrasonic target position pore-forming device and method |
| CN103463732B (en) * | 2013-09-18 | 2015-07-15 | 北京中美联医学科学研究院有限公司 | Ultrasonic target position pore-forming device and method |
| CN105771081A (en) * | 2016-03-29 | 2016-07-20 | 北京中美联医学科学研究院有限公司 | Ultrasonic conductivity meter and ultrasonic delivery method thereof |
| CN106730333A (en) * | 2016-12-20 | 2017-05-31 | 上海狂潮医疗科技有限公司 | Flat acupuncture and moxibustion instrument is led in electronic temperature control dosing |
| CN106621024A (en) * | 2017-01-17 | 2017-05-10 | 湖南省健缘医疗科技有限公司 | Ultrasonic medication diagnosis and treatment device |
| CN106621024B (en) * | 2017-01-17 | 2023-11-21 | 湖南省健缘医疗科技有限公司 | Ultrasonic medicine-permeable diagnosis and treatment device |
| CN107185107A (en) * | 2017-05-13 | 2017-09-22 | 沈阳赛镝医疗器械有限公司 | A kind of ultrasonic direct current current iontophoresis system |
| CN109513104A (en) * | 2018-11-12 | 2019-03-26 | 深圳大学 | A kind of vaccine transdermal delivery device for leading microwell array based on acousta induction |
| CN111939453A (en) * | 2019-05-17 | 2020-11-17 | 成都植行合一健康科技有限公司 | Portable transdermal absorption therapeutic apparatus and control method thereof |
| CN113577528A (en) * | 2021-08-26 | 2021-11-02 | 中国科学院深圳先进技术研究院 | Piezoelectric electret drug delivery patch for transdermal drug delivery by combining contact pressure or beating and preparation method and application thereof |
| CN114082096A (en) * | 2021-11-03 | 2022-02-25 | 湖南正清制药集团股份有限公司 | Sinomenine hydrochloride delivery device and method |
| CN115317776A (en) * | 2022-04-22 | 2022-11-11 | 南京鼎世医疗器械有限公司 | Ultrasonic conductive directional medicine-penetrating therapeutic instrument |
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Application publication date: 20101222 |