CN100588438C - Therapy electrode tablet clamping self-pasting medicament film and preparation method thereof - Google Patents
Therapy electrode tablet clamping self-pasting medicament film and preparation method thereof Download PDFInfo
- Publication number
- CN100588438C CN100588438C CN200810053124A CN200810053124A CN100588438C CN 100588438 C CN100588438 C CN 100588438C CN 200810053124 A CN200810053124 A CN 200810053124A CN 200810053124 A CN200810053124 A CN 200810053124A CN 100588438 C CN100588438 C CN 100588438C
- Authority
- CN
- China
- Prior art keywords
- chitosan
- solution
- mass
- medicine
- equivalent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Images
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a physiotherapy electrode piece of a sandwiched self-sticking plaster and a preparation method thereof. The physiotherapy electrode piece of the sandwiched self-sticking plaster consists of an existing conductive electrode and a self-sticking plaster sandwiched between peel-off layers, wherein, the self-sticking plaster consists of a buffering layer and a medicine releasing layer. The preparation method of the physiotherapy electrode piece includes three processes which are preparing the gel material of the buffering layer, preparing the gel material of the medicine releasing layer, and preparing the physiotherapy electrode piece of the sandwiched self-sticking plaster; the gel material of the buffering layer and the gel material of the medicine releasing layer aremainly based on chitosan and polyvinyl alcohol. The physiotherapy electrode piece can ensure the circumstance stability of the medicine being carried, and can effectively lower the competitive delivery of the ions during electric treatment, can improve the percutaneous permeability of the medicine, and then can improve the healing effect. In addition, the preparation method of the physiotherapy electrode piece of a sandwiched self-sticking plaster is simple, can carry large amount of medicine, and is particularly applicable to the western medicine and the Chinese traditional medicine which are sensitive to the PH value.
Description
Technical field
The present invention relates to physiotherapy electrode plate of a kind of tablet clamping self-pasting medicament film and preparation method thereof, belong to the physiogherapy electrode chip technology.
Background technology
The modernization of Chinese medicine is a strategic decision of China, and medicine-feeding technology then is a key technology and effective way that realizes the modernization of Chinese medicine.External therapy of Chinese herb has had history in several thousand in the Chinese medicine development, use to relate to treatment of diseases such as surgery, orthopaedics, dermatological department.Traditional external treatment form of Chinese drug is based on powder, unguentum, paste etc., the main effective ingredient of medicine all exists in the cell, so the ingredient complexity, and various component contents are lower, exist all generally that dosage is big, onset waits shortcoming more slowly, be difficult to satisfy clinical requirement.And skin the horny layer formed by horn cell endochylema, after birth and intercellular substance lipid molecular of outermost layer especially with high-sequential arrangement architecture, prevent that as organism foreign substance from entering the intravital natural cover for defense, have characteristics such as material Transfer obstacle, sensitivity, limited many medicines especially hydrophilic medicament and for example percutaneous absorption of ferulic acid, estradiol, baicalin, insulin etc. of macromolecular drug.
For the curative effect that improves medicine, shorten onset time, medicine can be extracted, the utilization practice of pharmacy comprise use transdermal penetration promoter, the modes such as drug form such as supersaturation of adjusting carry out dosage form and improve.This method is simple relatively, is present domestic and international application percutaneous dosing technology the most widely, and common product has patch and cataplasma.But practice of pharmacy but has been subjected to the restriction of transdermal penetration promoter development, and most of drug effect is slower.The transdermal penetration promoter of clinical practice at present has azone, Borneolum Syntheticum etc., they otherwise exist hysteresis effect, or only to the short performance of oozing of the strong percutaneous of having of some drugs.Synthesis accelerant is also owing to reasons such as being difficult for katabolism causes its toxicity too big in addition, for example azone (external trade name Azone) is a current domestic and international application transdermal enhancer widely, but be difficult for being absorbed by body, it is very slow that stratum corneum barrier function recovers after removing azone, easily causes skin allergy, allergy etc. when its consumption is higher than 6%.At the form of Chinese drug technical elements, products such as traditional powder, unguentum, paste not only use inconvenience, and be limited to current material and technology cause its exist skin irritation big, easily pollute, paste shortcoming such as poor-performing; Cataplasma percutaneous dosing technology is expected to overcome these problems, it is the emphasis of Chinese medicine medicine for external use research, but, can not form scale all the time owing to many reasons such as the saturating performance of skin of catablasm base material technology and raw material supply thereof, medicine and therapeutic effect, cataplasma production equipments.
Physical method comprises iontophoresis, ultrasound wave imports method, electroporation method and electret etc., be adopt physical agent such as, light, ripples etc. induce skin to form instantaneous passage, rapid-action and remarkable to the percutaneous absorption rate enhancing of medicine, it is the emphasis of modern percutaneous dosing technical research, many in the world companies have developed E-trans at Western medicine, Micropore, transdermal administration technology such as Vyteris, and there had many products to enter to be clinical, but its at be the transdermal administration of Western medicine, wherein the electrode employing is the electrode material that does not change the surrounding pH value in the iontophoresis process, for example silver/silver chloride electrode and platinum electrode.In addition, year Western medicine pastes electrode slice certainly and electric therapeutic apparatus is normally integrated, therefore costs an arm and a leg.
About the Chinese medicine aspect, though China is the cradle of Chinese medicine, but owing to reasons such as flavour of a drug multicomponent complexity, but there is not the research of this respect substantially, only have many companies to drop into great effort develops in Taiwan, yet after carrying a large amount of Chinese medicines, the external conductive viscose just makes good product is not arranged problems such as electric conductivity and/or stickup performance reduce significantly as yet at present owing to exist to have now.
Clinically, the part traditional Chinese medical science has been drawn the advantage of doctor trained in Western medicine physical method, and the iontophoresis method of doctor trained in Western medicine is combined with Chinese medicine, implements Chinese medicine speed-raising treatment with the method that the Chinese medicine medicated bag powers up.Yet the medicated bag form can not well contact medicine with skin, and effective ingredient can't directly enter in the body, and is not really remarkable on effect.Improve on this basis, adopt following a kind of complicated operations to treat: at first traditional Chinese compound medicine is fried in shallow oil proposition liquid medicine, and ailing position and near selected two suffer very near skin, to be filled the gauze of liquid medicine again or applied on the appointment skin of cleaning, on gauze, press metal electrode board such as lead then, at last by powering up the percutaneous dosing treatment that mode realizes the Chinese medicine medicine.This therapeutic scheme is rapid-action, therapeutic effect has obtained certainly definitely, but uncontrollable factors such as concentration, quality in existing have bigger potential safety hazard; And, employing be electrodes such as metal such as lead, under the light situation of local swelling, use, and misoperation causes the injury to the patient easily, therefore only limit to hospital's short-term at present and use, do not approved by extensive patients yet.In addition, also there is maximum shortcoming in this method, promptly the pH value owing to electrochemical reaction lead electrode surrounding alters a great deal in electric therapeutic process, this medicine that greatly influences the acid-base value sensitivity is the stability of Chinese medicine especially, and the ion pair that causes thus competition transmits and will reduce the transdermal penetration performance of medicine greatly, thereby influences therapeutic effect.
People have taked different measures to simplify said process and have overcome weak point in the technology.Gao Jianqing etc. thereon directly add during use that with the medication preparation gel lead electrode plate carries out the electricity treatment again.Owing to cannot control the acid-base value of electrode surrounding in the electric therapeutic process, therefore be not suitable for the medicine of acid-base value sensitivity in this method, and because the transdermal penetration performance that also influences medicine is transmitted in the ion pair competition.Ma Guixiang etc. are prepared into substrate with traditional Chinese medicine liquid and adopt similarity method to carry out electric therapeutic effect significantly also not verified this point.Patent CN03219231.2 discloses a kind of pellet electrode, the drug storage pad that is soaked with medicinal liquid is separated at grade placing on the conductive coating with conductive viscose.This electrode oozes out but its shortcoming is a medicinal liquid, in case be exuded to the stickup performance that the conductive viscose surface will reduce conductive viscose greatly easily by improving the transdermal penetration that medicinal liquid and the situation that contacts of skin improve medicine.In addition, this electrode must adopt the electrode material that does not change the surrounding pH value in the iontophoresis process, and for example silver/silver chloride electrode and platinum electrode make its application flexibility reduce the production cost that raise simultaneously.
Summary of the invention
The object of the present invention is to provide physiotherapy electrode plate of a kind of tablet clamping self-pasting medicament film and preparation method thereof, this physiotherapy electrode plate integrates medicine carrying, release, conduction and pastes feature set certainly, and its preparation process is simple.
The present invention is realized by the following technical programs, a kind of physiotherapy electrode plate of tablet clamping self-pasting medicament film, form by conductive electrode and peel ply tablet clamping self-pasting medicament film, described conductive electrode is made up of flexible backing layer and the compliant conductive layer that has connecting pin and lead, this conductive electrode is nonwoven fabric belts tail wire electrode slice 510 products, YZ-M silicone rubber electrode product and hundred is given birth to a kind of in the silicone rubber electrode products, described peel ply is a siliconised paper, the polrvinyl chloride overlay film, polyethylene overlay film or polypropylene overlay film, it is characterized in that, self-pasting medicament film is made up of cushion and release layer, cushion wherein links to each other with the compliant conductive layer of conductive electrode, the release layer links to each other with peel ply, described buffer layer thickness is 0.1-0.6mm, form by following component and quality percentage composition: chitosan, 1-3%; Polyvinyl alcohol, 2-4%; Gelatin, 7-10%; Glycerol, 2-4%; Viscosifier, 30-42%; Antiseptic, 0.05-0.5%; Lactic acid, 0.5-2%; The inorganic salt of buffer solution, 0.3-15%; Electrolyte, 0-2%; All the other are water, and the quality percentage composition sum of above-mentioned each component is 100%; Described release layer thickness is 0.3-1mm, is made up of following component and quality percentage composition: chitosan, 1-3%; Polyvinyl alcohol, 2-4%; Gelatin, 7-10%; Glycerol, 2-4%; Viscosifier, 30-42%; Antiseptic, 0.05-0.5%; Lactic acid, 0.5-2%; Medicine, 0.1-8%; Penetrating agent, 0-6%; All the other are water, and the quality percentage composition sum of above-mentioned each component is 100%.
Chitosan in the component of above-mentioned release layer and cushion is that mean molecule quantity is 150,000-400,000 chitosan; Polyvinyl alcohol is the polyvinyl alcohol of mean molecule quantity 60,000-140,000; Gelatin is that mean molecule quantity is 20,000-200,000 gelatin; Inorganic salt buffer solution is the phosphate buffered solution of acetate buffer solution or the pH5.8-pH8.2 of pH5.5-pH6.5; Viscosifier are one or both or three kinds in maltose oligomer, sucrose oligomer, glucose oligomer and the fructose oligomer; Antiseptic is Nipagin ester or sodium benzoate; Electrolyte is NaCl or KCl; Medicine is baicalin powder or Chinese medicine extraction aqueous solution; Penetrating agent is an azone.
The preparation method of the physiotherapy electrode plate of above-mentioned tablet clamping self-pasting medicament film is characterized in that comprising following process:
1. the preparation of cushion gel rubber material:
It is to be made into the solution that mass concentration is 1-3% in 2% the lactic acid solution that chitosan is dissolved in mass concentration, polyvinyl alcohol is dissolved in to be made into mass concentration in the deionized water be 8-15% solution, with chitosan lactic acid solution and poly-vinyl alcohol solution according to mass ratio 3-4: 1 is mixed to evenly; Add in mixed solution successively while stirring: the 4-6 mass concentration doubly that is equivalent to chitosan mass is the gelatin solution of 20-30%, be equivalent to the acetate buffer solution of 15-30 pH5.5-pH6.5 doubly of chitosan mass or the phosphate buffered solution of pH5.8-pH8.2, the 1-3 maltose oligomer doubly that is equivalent to chitosan mass, the sucrose oligomer, in glucose oligomer and the fructose oligomer one or both or three kinds, the 1-3 glycerol doubly that is equivalent to chitosan mass, 0.05-0.1 Nipagin ester or the sodium benzoate antiseptic doubly that is equivalent to chitosan mass, and 5 times the mass concentration that is equivalent to chitosan mass is 10% NaCl or KCl electrolysis of solutions matter, outgasing behind the abundant mix homogeneously down at 40-45 ℃.
2. release layer gel rubber material preparation:
It is to be made into the solution that mass concentration is 1-3% in 2% the lactic acid solution that chitosan is dissolved in mass concentration, polyvinyl alcohol is dissolved in to be made into mass concentration in the deionized water be 8-15% solution, with chitosan lactic acid solution and poly-vinyl alcohol solution according to mass ratio 3-4: 1 is mixed to evenly; Add in mixed solution successively while stirring: the 4-6 mass concentration doubly that is equivalent to chitosan mass is the gelatin solution of 20-30%, be equivalent to one or both or three kinds in 10-20 maltose oligomer, sucrose oligomer, glucose oligomer and the fructose oligomer doubly of chitosan mass, the 1-3 glycerol doubly that is equivalent to chitosan mass is equivalent to the 0.05-0.1 Nipagin ester or the sodium benzoate antiseptic doubly of chitosan mass; Stir after 30 minutes, in mixed solution, add again while stirring: be equivalent to 1-30 baicalin powder or the Chinese medicine extraction aqueous solution and the 0-6 that is equivalent to chitosan mass azone penetrating agent doubly doubly of chitosan mass, outgasing behind the abundant mix homogeneously down at 40-45 ℃.
3. the preparation of the physiotherapy electrode plate of tablet clamping self-pasting medicament film:
Put one deck silication peeling paper in the open mold bottom, the cushion gel rubber material for preparing is poured in the open mold, under 30-50 ℃ of condition, be dried to moisture in the 40-50% scope, again the release layer gel rubber material for preparing is poured on the cushion, under 30-50 ℃ of condition, be dried to moisture in the 38-45% scope, remove mould, and enclose siliconised paper at the release laminar surface, the polrvinyl chloride overlay film, the peel ply material of polyethylene overlay film or polypropylene overlay film, be cut into circle then, oval, square or rectangular, peel off the silication peeling paper of buffering aspect again, and it is pasted mutually with the conductive electrode that by flexible backing layer and the compliant conductive layer group that have connecting pin and a lead is one, thereby obtain a kind of physiotherapy electrode plate of tablet clamping self-pasting medicament film.
Compared with prior art, the physiotherapy electrode plate of above-mentioned tablet clamping self-pasting medicament film can be matched with multiple physiotherapy table, can reduce the electrode cost simultaneously, can guarantee the stability of contained pharmaceutical environment on the one hand, can effectively reduce the competition transmission of electric therapeutic process intermediate ion on the other hand, improve the transdermal penetration performance of medicine, thereby improve curative effect.
The physiotherapy electrode plate of above-mentioned tablet clamping self-pasting medicament film can be used with commercial electric therapeutic apparatus (non-easily-consumed products), also can use separately.The percutaneous dosing therapeutic modality of the quick-acting safe readies that practice of pharmacy and physics method organically combine can be realized when itself and electric therapeutic apparatus are used, or the percutaneous dosing therapeutic modality of the continual and steady safe ready of pharmaceutics can be realized when using separately.And physiotherapy electrode plate of the present invention belongs to easily-consumed products, in use can change easily at any time, overcome in the external prior art and to have carried Western medicine from pasting electrode slice and the integrated problem that costs an arm and a leg that causes of electric therapeutic apparatus, thus the use cost of reduction consumer.And the physiogherapy electrode piece preparation method of tablet clamping self-pasting medicament film of the present invention is simple, and skin irritation is little, and drug loading is big, is particularly suitable for Western medicine and Chinese medicine to the acid-base value sensitivity.
Description of drawings
Fig. 1 is the structural representation of the physiotherapy electrode plate of tablet clamping self-pasting medicament film of the present invention.
Among the figure: the 1st, peel ply, the 2nd, release layer, the 3rd, cushion, the 4th, compliant conductive layer, the 5th, flexible backing, the 6th, lead, the 7th, connecting pin.
Fig. 2 is the physiotherapy electrode plate interface indicator diagram that pH value changes in electric therapeutic process that adopts tablet clamping self-pasting medicament film of the present invention.
Fig. 3 is with the interface pH value of physiotherapy electrode plate under the pulse current effect of the tablet clamping self-pasting medicament film of comparative examples 1-3 preparation change curve in time.
Fig. 4 is its interface I F when treating anode with the physiotherapy electrode plate of the tablet clamping self-pasting medicament film of embodiment 1-7 preparation as electricity
+, FCLPH value curve chart over time under the pulse current effect.
Fig. 5 is its interface I F when treating negative electrode with the physiotherapy electrode plate of the tablet clamping self-pasting medicament film of embodiment 1-7 preparation as electricity
-, FCLPH value curve chart over time under the pulse current effect.
Fig. 6 is the physiotherapy electrode plate of tablet clamping self-pasting medicament films with embodiment 3 and 4 a preparations baicalin drug accumulation transit dose curve chart over time under different square wave pulsed current effects.Wherein: a: embodiment 4 samples, electric current density are 0mA/cm
2B: embodiment 3 samples, electric current density 0.3mA/cm
2, power frequency 10Hz; C: embodiment 3 samples, electric current density 0.5mA/cm
2, power frequency 10Hz; D: embodiment 4 samples, electric current density 0.5mA/cm
2, power frequency 10Hz.
The specific embodiment
One, the preparation of the physiotherapy electrode plate of tablet clamping self-pasting medicament film
Embodiment 1:
1. the preparation of cushion gel rubber material
With 2 gram-molecular weights be 300,000 chitosan and 3 gram polyvinyl alcohol 17-99 to be dissolved in the 100mL mass concentration respectively be in 2% the lactic acid solution and 30mL deionized water, then two kinds of solution are mixed to evenly.Be 32 gram mass concentration that 25% gelatin (molecular weight is 150,000) solution, 40mLpH6.5 acetate buffer solution, 50 gram mass concentration are that 30% Oligomeric maltose, 50 gram mass concentration are that the sodium benzoate of glycerol, 0.1 gram of 40% oligomeric sucrose, 3 grams and 10 gram mass concentration are that 10% KCl solution joins in the mixed solution while stirring, outgasing behind the abundant mix homogeneously down at 40-45 ℃.
2. the preparation of release layer gel rubber material
With 2 gram-molecular weights be 300,000 chitosan and 3 gram polyvinyl alcohol 15-99 to be dissolved in the 100mL mass concentration respectively be in 2% the lactic acid solution and 30mL deionized water, then two kinds of solution are mixed to evenly.Be 32 gram mass concentration that the maltose oligomer of 25% gelatin (molecular weight is 20,000) solution, 15 grams, the sucrose oligomer of 20 grams, the glycerol of 3 grams and the sodium benzoate of 0.1 gram join in the mixed solution while stirring, the triethanolamine aqueous solution that stirs after 30 minutes baicalin (2.7 gram) joins in the system, is outgasing behind the abundant mix homogeneously down at 40-45 ℃.
3. the preparation of the physiotherapy electrode plate of tablet clamping self-pasting medicament film
Make an open mold with siliconised paper, put one deck silication peeling paper, the cushion gel rubber material for preparing is poured in this open mold, under 30-50 ℃ of condition, be dried to moisture in the 40-50% scope at mold bottom; Again the release layer gel rubber material for preparing is poured on the cushion, under 30-50 ℃ of condition, is dried to moisture in the 38-45% scope; Removing mould, and enclose siliconised paper at the release laminar surface, be cut into required shape as requested, can be circular, ellipse, square or rectangular; Peel off buffering aspect silication peeling paper then, and with its with paste mutually by commercial conductive electrode YZ-M silicone rubber electrode (Beijing Rhizoma Polygonati Odorati industrial and trading company), just obtained the physiotherapy electrode plate of tablet clamping self-pasting medicament film shown in Figure 1.Wherein the thickness of cushion is 0.5mm, and the thickness of release layer is 0.5mm, and 180 ° of peel strengths are 3.009 ± 0.214N/cm, and drug release rate is 101.3 ± 22.1 μ gcm
-2, medicine 6h release is 49.8 ± 6.6%.
Embodiment 2:
The preparation process of cushion gel rubber material is identical with the process of embodiment 1, just changes the pH6.5 acetate buffer solution into the pH7.2 phosphate buffered solution.
The preparation process of release layer gel rubber material is identical with the process of embodiment 1.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 1, makes in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, and the thickness of cushion is 0.5mm, and the thickness of release layer is 0.5mm.
Embodiment 3:
The preparation process of cushion gel rubber material is identical with the process of embodiment 1, just changes the pH6.5 acetate buffer solution into the pH7.6 phosphate buffered solution.
The preparation process of release layer gel rubber material is identical with the process of embodiment 1.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 1, makes in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, and the thickness of cushion is 0.5mm, and the thickness of release layer is 0.5mm.
Embodiment 4:
The preparation process of cushion gel rubber material is identical with the process of embodiment 3.
The preparation process of release layer gel rubber material is identical with the process of embodiment 3, has just added 5.8 grams, 50% water solublity azone solution in gel rubber system.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 3, make in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, the thickness of cushion is 0.5mm, the thickness of release layer is 0.5mm, 180 ° of peel strengths are 2.947 ± 0.102N/cm, and drug release rate is 98.1 ± 25.7 μ gcm
-2, medicine 6h release is 51.5 ± 8.4%.
Embodiment 5:
The preparation process of cushion gel rubber material is identical with the process of embodiment 1, is that concrete raw material and consumption are as follows:
The preparation process of release layer gel rubber material is identical with the process of embodiment 1, just the triethanolamine aqueous solution of baicalin in the system is replaced with the water extraction concentrated solution 40mL of kinds of traditional Chinese medicines such as Flos Carthami.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 1, make in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, the thickness of cushion is 0.2mm, and the thickness of release layer is 0.6mm, and 180 ° of peel strengths are 1.947 ± 0.102N/cm.
Embodiment 6:
The preparation process of cushion gel rubber material is identical with the process of embodiment 5, just changes the pH5.5 acetate buffer solution into the pH5.8 phosphate buffered solution.
The preparation process of release layer gel rubber material is identical with the process of embodiment 5.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 5, makes in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, and the thickness of cushion is 0.2mm, and the thickness of release layer is 0.6mm.
Embodiment 7:
The preparation process of cushion gel rubber material is identical with the process of embodiment 5, just changes the pH5.5 acetate buffer solution into the pH8.2 phosphate buffered solution.
The preparation process of release layer gel rubber material is identical with the process of embodiment 5.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 5, makes in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, and the thickness of cushion is 0.2mm, and the thickness of release layer is 0.6mm.
Comparative examples 1:
The preparation process of cushion gel rubber material is identical with the process of embodiment 1, just changes the pH6.5 acetate buffer solution into distilled water.
The preparation process of release layer gel rubber material is identical with the process of embodiment 1.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 1.Make in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, the thickness of cushion is 0.5mm, and the thickness of release layer is 0.5mm, and 180 ° of peel strengths are 3.104 ± 0.157N/cm, and drug release rate is 98.2 ± 14.3 μ gcm
-2, medicine 6h release is 48.4 ± 3.2%.
Comparative examples 2:
The preparation process of cushion gel rubber material is identical with the process of embodiment 1, just changes the pH6.5 acetate buffer solution into distilled water.
The preparation process of release layer gel rubber material is identical with the process of embodiment 1, has just added 5.8 grams, 50% water solublity azone solution in gel rubber system.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 1, make in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, the thickness of cushion is 0.5mm, the thickness of release layer is 0.5mm, 180 ° of peel strengths are 2.952 ± 0.104N/cm, and drug release rate is 103.9 ± 20.2 μ gcm
-2, medicine 6h release is 52.7 ± 3.6%.
Comparative examples 3:
The preparation process of cushion gel rubber material is identical with the process of embodiment 5, just changes the pH5.5 acetate buffer solution into distilled water.
The preparation process of release layer gel rubber material is identical with the process of embodiment 5.
The preparation process of the physiotherapy electrode plate of tablet clamping self-pasting medicament film is identical with the process of embodiment 5, make in the physiotherapy electrode plate of tablet clamping self-pasting medicament film, the thickness of cushion is 0.2mm, and the thickness of release layer is 0.6mm, and 180 ° of peel strengths are 1.952 ± 0.104N/cm.
Two, the application performance of the physiotherapy electrode plate of tablet clamping self-pasting medicament film
1, adopts the transdermal test in vitro experiment of the physiotherapy electrode plate of tablet clamping self-pasting medicament film
The transdermal test in vitro experiment adopts improved Franz diffusion cell to come the analog electrical therapeutic process.This diffusion cell has two supply pools and 1 's the public pond of accepting.The fresh depilation abdominal part Corium Mus of peeling off is fixed on two supply pools and accepts between the pond, stratum corneum side is to supply pool, and skin corium is towards accepting the pond, and the release area is 2.01cm
2, water temperature is 37 ± 0.1 ℃ in the setting temperature chamber.Add the corresponding acceptable solution of 37.5mL in accepting the pond, put into body outer osmotic disperser temperature chamber preheating 30min, setting and accepting the pond mixing speed is 400 revolutions per seconds.The physiotherapy electrode plate of getting two tablet clamping self-pasting medicament films again is individually fixed in two supply pools and accepts between two Room, pond, and the release layer is pasted mutually with the Corium Mus horny layer, and links by terminal and commercial ion introducing apparatus.Energized, selected waveform is regulated size of current and frequency, and picks up counting and carry out the transdermal test in vitro diffusion test.At predetermined sampling time point, collect 0.5mL and accept acceptable solution in the pond, and in accepting the pond, replenish the fresh acceptable solution of equivalent, and get rid of the bubble in the receiving chamber.
2, the pH of the physiotherapy electrode plate of tablet clamping self-pasting medicament film regulation and control performance in the transdermal test in vitro experimentation
In above-mentioned transdermal test in vitro experimentation, there are four interface I F as shown in Figure 2
+, FCL, IF
+, skin, IF
-, FCLAnd IF
-, skinBe respectively the interface of self-pasting medicament film and compliant conductive layer in the interface of self-pasting medicament film and compliant conductive layer in the anode, contact skin and the negative electrode, contact skin, can use accurate pH test paper to monitor these four self-pasting medicament film material surface pH value at the interface.
Fig. 3 is the interface pH value of physiotherapy electrode plate under the pulse current effect change curve in time with the tablet clamping self-pasting medicament films of comparative examples 1,2 and 3 preparations.The result shows for these three kinds of control samples shown consistent rule, anodic interface IF in application process
+, FCLPH value just constantly reduce cathode interface IF simultaneously from beginning
-, FCLPH value just constantly increase from beginning, promptly these three kinds of control samples all can not be controlled the self-pasting medicament film material surface pH value that contacts with electrode slice in application process.
Fig. 4 is its interface I F during as the anode of electricity treatment with the physiotherapy electrode plate of the tablet clamping self-pasting medicament film of embodiment 1-7 preparation
+, FCLPH value curve over time under the pulse current effect.The result show for these seven kinds of samples in application process to interface I F
+, FCLPH value has all shown certain control ability, and especially embodiment 1,5,6 samples have shown good pH value control ability.These samples are interface I F after treating through 1 hour electricity
+, FCLPH value still can remain on about 7.
Fig. 5 is its interface I F during as the negative electrode of electricity treatment with the physiotherapy electrode plate of the tablet clamping self-pasting medicament film of embodiment 1-7 preparation
-, FCLPH value curve over time under the pulse current effect.The result show for these seven kinds of samples in application process to interface I F
-, FCLPH value has also all shown certain control ability, and especially embodiment 3 samples have shown pH value control ability preferably.These samples are interface I F after treating through 1 hour electricity
+, FCLPH value can be controlled in 9 substantially.
All these results show, the introducing of cushion can effectively suppress the surface pH value that the self-pasting medicament film material contacts with electrode in the electric therapeutic process and change, thereby can effectively avoid because interface pH changes and to cause degradation harmful effect under the stability of drug, make the hydrion that the interface cell reaction produces and the competitive transmittance process of hydroxide ion and medicine ion simultaneously.
3, the drug osmotic performance of the physiotherapy electrode plate of tablet clamping self-pasting medicament film in the transdermal test in vitro experimentation
In above-mentioned transdermal test in vitro experimentation, institute's sample thief carries out HPLC and detects after disposable pin type filter membrane filters, and to determine the drug level in each sample, can calculate accumulation transit dose Q (μ g/cm by following formula
2):
Wherein S is for discharging area; V is for improving the volume of Franz diffusion cell receiving chamber, the concentration of acceptable solution (μ L/mL) when Cn is the n sub-sampling, the concentration of acceptable solution (μ L/mL) when Ci is the i sub-sampling; 0.5 be sampling amount.
Fig. 6 is physiotherapy electrode plate sample with the tablet clamping self-pasting medicament film of embodiment 3 and embodiment 4 a preparations baicalin drug accumulation transit dose curve over time under different square wave pulsed current effects.Embodiment 3 samples when not having impressed current in its transdermal test in vitro experimentation sample concentration illustrate that at the detection lower limit of instrument its percutaneous transit dose is extremely low; By contrast, embodiment 4 samples shown in curve a, have shown good in-vitro transdermal penetration performance owing to added transdermal penetrating agent azone when not having impressed current.To be embodiment 3 samples be respectively 0.3 and 0.5mA/cm in power frequency 10Hz, electric current density for curve b and curve c
2The square wave pulsed current effect under the transdermal penetration performance of baicalin medicine, curve d is that embodiment 4 samples are 0.5mA/cm in power frequency 10Hz, electric current density
2The square wave pulsed current effect under the transdermal penetration performance of baicalin medicine.With do not apply function of current situation and compare, square wave pulsed current all can obviously improve the transdermal penetration performance of baicalin in embodiment 3 samples and embodiment 4 samples, wherein sample 4 has shown the collaborative enhancing of physics electricity householder method and chemical penetrating agent method, and these results show that the physiotherapy electrode plate sample of these tablet clamping self-pasting medicament films is suitable for the physiogherapy electrode as the medicine auxiliary treatment.
Claims (3)
1. the physiotherapy electrode plate of a tablet clamping self-pasting medicament film, form by conductive electrode and peel ply tablet clamping self-pasting medicament film, described conductive electrode is made up of flexible backing layer and the compliant conductive layer that has connecting pin and lead, this conductive electrode is nonwoven fabric belts tail wire electrode slice 510 products, YZ-M silicone rubber electrode product and hundred is given birth to a kind of in the silicone rubber electrode products, described peel ply is a siliconised paper, the polrvinyl chloride overlay film, polyethylene overlay film or polypropylene overlay film, it is characterized in that, self-pasting medicament film is made up of cushion and release layer, cushion wherein links to each other with the compliant conductive layer of conductive electrode, the release layer links to each other with peel ply, described buffer layer thickness is 0.1-0.6mm, form by following component and quality percentage composition: chitosan, 1-3%; Polyvinyl alcohol, 2-4%; Gelatin, 7-10%; Glycerol, 2-4%; Viscosifier, 30-42%; Antiseptic, 0.05-0.5%; Lactic acid, 0.5-2%; The inorganic salt of buffer solution, 0.3-15%; Electrolyte, 0-2%; All the other are water, and the quality percentage composition sum of above-mentioned each component is 100%; Described release layer thickness is 0.3-1mm, is made up of following component and quality percentage composition: chitosan, 1-3%; Polyvinyl alcohol, 2-4%; Gelatin, 7-10%; Glycerol, 2-4%; Viscosifier, 30-42%; Antiseptic, 0.05-0.5%; Lactic acid, 0.5-2%; Medicine, 0.1-8%; Penetrating agent, 0-6%; All the other are water, and the quality percentage composition sum of above-mentioned each component is 100%.
2. by the physiotherapy electrode plate of the described tablet clamping self-pasting medicament film of claim 1, it is characterized in that the chitosan in the component of release layer and cushion is that mean molecule quantity is 150,000-400,000 chitosan; Polyvinyl alcohol is the polyvinyl alcohol of mean molecule quantity 60,000-140,000; Gelatin is that mean molecule quantity is 20,000-200,000 gelatin; Inorganic salt buffer solution is the phosphate buffered solution of acetate buffer solution or the pH5.8-pH8.2 of pH5.5-pH6.5; Viscosifier are one or both or three kinds in maltose oligomer, sucrose oligomer, glucose oligomer and the fructose oligomer; Antiseptic is Nipagin ester or sodium benzoate; Electrolyte is NaCl or KCl; Medicine is baicalin powder or Chinese medicine extraction aqueous solution; Penetrating agent is an azone.
3. preparation method by the physiotherapy electrode plate of the described tablet clamping self-pasting medicament film of claim 1 is characterized in that comprising following process:
1) preparation of cushion gel rubber material:
It is to be made into the solution that mass concentration is 1-3% in 2% the lactic acid solution that chitosan is dissolved in mass concentration, polyvinyl alcohol is dissolved in to be made into mass concentration in the deionized water be 8-15% solution, with chitosan lactic acid solution and poly-vinyl alcohol solution according to mass ratio 3-4: 1 is mixed to evenly; Add in mixed solution successively while stirring: the 4-6 mass concentration doubly that is equivalent to chitosan mass is the gelatin solution of 20-30%, be equivalent to the acetate buffer solution of 15-30 pH5.5-pH6.5 doubly of chitosan mass or the phosphate buffered solution of pH5.8-pH8.2, the 1-3 maltose oligomer doubly that is equivalent to chitosan mass, the sucrose oligomer, in glucose oligomer and the fructose oligomer one or both or three kinds, the 1-3 glycerol doubly that is equivalent to chitosan mass, 0.05-0.1 Nipagin ester or the sodium benzoate antiseptic doubly that is equivalent to chitosan mass, and 5 times the mass concentration that is equivalent to chitosan mass is 10% NaCl or KCl electrolysis of solutions matter, outgasing behind the abundant mix homogeneously down at 40-45 ℃;
2) release layer gel rubber material preparation:
It is to be made into the solution that mass concentration is 1-3% in 2% the lactic acid solution that chitosan is dissolved in mass concentration, polyvinyl alcohol is dissolved in to be made into mass concentration in the deionized water be 8-15% solution, with chitosan lactic acid solution and poly-vinyl alcohol solution according to mass ratio 3-4: 1 is mixed to evenly; Add in mixed solution successively while stirring: the 4-6 mass concentration doubly that is equivalent to chitosan mass is the gelatin solution of 20-30%, be equivalent to one or both or three kinds in 10-20 maltose oligomer, sucrose oligomer, glucose oligomer and the fructose oligomer doubly of chitosan mass, the 1-3 glycerol doubly that is equivalent to chitosan mass is equivalent to the 0.05-0.1 Nipagin ester or the sodium benzoate antiseptic doubly of chitosan mass; Stir after 30 minutes, in mixed solution, add again while stirring: be equivalent to 1-30 baicalin powder or the Chinese medicine extraction aqueous solution and the 0-6 that is equivalent to chitosan mass azone penetrating agent doubly doubly of chitosan mass, outgasing behind the abundant mix homogeneously down at 40-45 ℃;
3) preparation of the physiotherapy electrode plate of tablet clamping self-pasting medicament film:
Put one deck silication peeling paper in the open mold bottom, the cushion gel rubber material for preparing is poured in the open mold, under 30-50 ℃ of condition, be dried to moisture in the 40-50% scope, again the release layer gel rubber material for preparing is poured on the cushion, under 30-50 ℃ of condition, be dried to moisture in the 38-45% scope, remove mould, and enclose siliconised paper at the release laminar surface, the polrvinyl chloride overlay film, the peel ply material of polyethylene overlay film or polypropylene overlay film, be cut into circle then, oval, square or rectangular, peel off the silication peeling paper of buffering aspect again, and it is pasted mutually with the conductive electrode that by flexible backing layer and the compliant conductive layer group that have connecting pin and a lead is one, thereby obtain a kind of physiotherapy electrode plate of tablet clamping self-pasting medicament film.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810053124A CN100588438C (en) | 2008-05-14 | 2008-05-14 | Therapy electrode tablet clamping self-pasting medicament film and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810053124A CN100588438C (en) | 2008-05-14 | 2008-05-14 | Therapy electrode tablet clamping self-pasting medicament film and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101269256A CN101269256A (en) | 2008-09-24 |
| CN100588438C true CN100588438C (en) | 2010-02-10 |
Family
ID=40003645
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810053124A Expired - Fee Related CN100588438C (en) | 2008-05-14 | 2008-05-14 | Therapy electrode tablet clamping self-pasting medicament film and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100588438C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110860029B (en) * | 2019-10-09 | 2022-04-22 | 杭州未名信科科技有限公司 | Transdermal drug delivery patch and transdermal drug delivery method |
| CN111617382B (en) * | 2020-05-20 | 2023-08-25 | 四川大学华西医院 | Electric stimulation device for preventing pressure injury |
-
2008
- 2008-05-14 CN CN200810053124A patent/CN100588438C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN101269256A (en) | 2008-09-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP0509122B1 (en) | Device for the transdermal administration of protein or peptide drug | |
| Li et al. | Iontophoresis-driven porous microneedle array patch for active transdermal drug delivery | |
| Dhote et al. | Iontophoresis: a potential emergence of a transdermal drug delivery system | |
| TWI231214B (en) | Pharmaceutical hydrogel compositions, drug delivery devices and methods | |
| JP3119486B2 (en) | Electrode for iontophoresis and device using the same | |
| US7979117B2 (en) | Device and method for controlled delivery of active substance into the skin | |
| JP6446035B2 (en) | Transdermal delivery system | |
| CN102871956B (en) | Propranolol hydrochloride gel for treating infant superficial hemangioma | |
| CN107007927A (en) | A kind of microneedle array drug paste and preparation method being administered based on electric field driven | |
| TW400240B (en) | Device for iontophoresis | |
| KR101203768B1 (en) | Low-frequency stimulation electrode conductive hydrogel patch containing ingredients for alleviating pain and inflammation | |
| CN103269748B (en) | For the electronic pads of iontophoresis treatment | |
| CN108704218A (en) | A kind of painless dosing paster of skin | |
| CN101274118B (en) | Physiotherapy electrode plate clamping self-pasting medicine carrying membrane and manufacture method thereof | |
| CN100588437C (en) | Therapy electrode tablet clamping self-pasting medicament film and preparation method thereof | |
| CN106955277A (en) | A kind of transdermal drug delivery system of alcohol liposome containing hyaluronic acid and preparation method and application | |
| US11511095B2 (en) | Portable transdermal administration patch apparatus and preparation method thereof | |
| CN101862505B (en) | Self-electroosmosis hydrogel adhesive film | |
| CN100588438C (en) | Therapy electrode tablet clamping self-pasting medicament film and preparation method thereof | |
| CN103877132A (en) | Sunset abelmoschus flower general flavone gel for treating dental ulcer and preparation method of gel | |
| CN108721204A (en) | A kind of solubility alkannin microneedle patch and preparation method thereof | |
| CN109481422B (en) | Graphene oxide electrothermal film transdermal patch | |
| Lee et al. | Advancements in Skin‐Mediated Drug Delivery: Mechanisms, Techniques, and Applications | |
| CN100525751C (en) | Meridian point therapeutic plaster of high polymer multi hole energy gathering ion and its preparation method and application | |
| CN103083675A (en) | Traditional Chinese medicine vertebral cataplasm substrate and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20100210 Termination date: 20120514 |