CN101468094A - Gel patch for resisting fatigue and preparation method thereof - Google Patents
Gel patch for resisting fatigue and preparation method thereof Download PDFInfo
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- CN101468094A CN101468094A CNA2007100604675A CN200710060467A CN101468094A CN 101468094 A CN101468094 A CN 101468094A CN A2007100604675 A CNA2007100604675 A CN A2007100604675A CN 200710060467 A CN200710060467 A CN 200710060467A CN 101468094 A CN101468094 A CN 101468094A
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Abstract
The present invention relates to a traditional Chinese medicine gel plaster capable of increasing memory and postponing senility and its preparation method, composed of 5%-50% of extract of traditional Chinese medicine and 95%-5% of medicinal adjuvant. The traditional Chinese medicine plaster capable of increasing memory and postponing senility is prepared by mixing the molecule gel, the hydrogel, active ingredients of medicine extracts with the plural gel factor. Different medicine extracts enter into the skin through different channels. The oil-soluble component in molecule gel has repulsion force to the water-soluble medicine and the water-soluble component in hydrogel has repulsion force to the oil-soluble medicine therefore the medicine absorption is promoted and the medicine efficacy is increased.
Description
Technical field
The present invention relates to the up-to-date molecular gel of Percutaneously administrable preparation technical field and combine with hydrogel and make profit ampholytic gels patch, the Chinese medicine extract that adopts the Chinese medicine prescription for the basis in addition the medicinal substrate preparation have antifatigue profit ampholytic gels patch and preparation method thereof.
Background technology
Transdermal drug delivery system or percutaneous absorption patch refer to stick the mode medication through skin, and medicine enters the systemic blood circulation by skin absorbs and reaches a class preparation of effective blood drug concentration, realization disease treatment or prevention.The characteristics of percutaneous absorption patch are, transdermal drug delivery system can avoid the first pass effect of liver and medicine in the gastrointestinal deactivation, the absorption of medicine is not subjected to the influence of gastrointestinal factors, reduce the individual variation of medication, keep constant effective blood drug concentration or physiological effect, the blood drug level peak valley phenomenon of avoiding oral administration to cause reduces toxicity.Reduce administration number of times, improve therapeutic efficacy, prolong action time, avoid multiple dose administration, make most patient be easy to accept, simultaneously easy to use, independently medication of patient also can be cancelled medication at any time.
So-called profit ampholytic gels is not the zwitterion that we say usually, because molecular gel generally all is as solvent by oil-based solvent, organic solvent or the mixture of the two, it is gel with oleophilic properties, and used aqueous solvent accounts for greatly in the hydrogel, it is the gel of possess hydrophilic property matter, the two is used, so be called the profit ampholytic gels.
Molecular gel is that the gel factor (some micromolecule organic compound) is passed through non-covalent interaction in non-aqueous media, spontaneously assembles, assembles orderly three-dimensional fiber network structure, makes the medium gelation.Molecular gel has reversible characteristics of heat, and processing technology is simple, and gelinite contains a large amount of organic solvents, be fit to the storage storehouse as lipophilic medicament, but molecular gel exists cohesiveness low, and viscosity is little, with the skin poor compliance, is not suitable for making shortcomings such as patch.Hydrogel water content height is fit to the storage storehouse as hydrophilic medicament, and is strong to the skin compliance, but is subjected to the influence of self property, and colloid poor plasticity, elasticity are little.In sum, be advantage in conjunction with these two kinds of gels, adopt the pluralgel factor that two kinds of gelinites are disperseed mixing, with the molecular gel is framework material, the patch substrate that hydrogel is made as sticky stuff, both high resilience forms have good compliance with skin, can peel off repeatedly, paste again, improve the drug loading of hydrophilic medicament and hydrophobic drug simultaneously again.Two kinds of gels twine staggered uniform distribution in substrate, by non-covalent bond form combinations such as Van der Waals forces, by fully contacting with skin, the both sexes medicine continues to see through skin through passage separately, enters blood circulation, the performance drug effect.
Be in fatigue state for a long time and can make healthy people's unknown cause ground serious lassitude sense occur, with low grade fever, headache, myalgia, depression, mental symptom such as absent minded, lymphadenectasis sometimes and influence orthobiosis.Show that in the initial investigation results of ten big city tissues the probability that each city crowd falls ill because of overfatigue and presents the trend of rising between 10%～25%, be in fatigue state for a long time and can finally cause fatigue syndrome.The Center for Disease Control prediction, fatigue syndrome will become one of subject matter of 21 century human health, be to threaten human new killer.The tired method of existing treatment mainly is to use western medicine, even effects such as antiviral agents (acycloguanosine), antidepressants, Mg supplementation and use psychostimulant are all not ideal enough, and life-time service easily produces dependency.Recent years occurred some Chinese medicine preparation, all more or less had some shortcomings, and mostly be oral formulations greatly, individual variation is very big.It is definite to be of no curative effect, clinical preparation easy to use.
It is a kind of more effective, easy to use that the object of the invention is to provide, the more acceptant preparation of people.
Summary of the invention
The objective of the invention is to advantage in conjunction with up-to-date molecular gel and hydrogel, both overcome the deficiency and the ubiquitous shortcoming of oral formulations of existing anti-fatigue medicament, avoided general aqueous gel poor plasticity, oil-base gel agent again shortcomings such as big, the easy pollution clothes of skin irritation.The invention provides a kind of Transdermal absorption profit ampholytic gels patch that resisting fatigue is had positive effect and preparation method thereof.
Radix Codonopsis has QI invigorating in this prescription, promotes the production of body fluid, effect such as nourish blood; Radix Achyranthis Bidentatae has promoting blood circulation to restore menstrual flow, invigorating the liver and kidney, bone and muscle strengthening, relieving stranguria by diuresis, (blood) the descending effect of igniting; The Radix Astragali has tonifying Qi and lifting yang, stomach reinforcing consolidating superficial resistance, inducing diuresis to remove edema, the effect of holder skin ulcer granulation promoting; The Radix Rehmanniae has clearing away heat and cooling blood, the effect of YIN nourishing and the production of body fluid promoting; Rhizoma Chuanxiong has blood-activating and qi-promoting, the effect of wind-expelling pain-stopping.All medicines are harmonious, and have effects such as benefiting qi and nourishing blood, YIN nourishing and the production of body fluid promoting, promoting the circulation of QI to relieve pain, can treat preferably and the antifatigue effect.Be made into profit ampholytic gels patch, have evident in efficacy, steady slow the continuing of release.Used gel coherence is better, and the glue sample is flexible, and viscosity fastness is better, can peel off multiple subsides repeatedly; Water content is big, and is strong with the skin compliance, helps the Transdermal absorption of medicine; Preparation process is simple, convenient.
The technical solution used in the present invention is: a kind of antifatigue Chinese medicine composition profit ampholytic gels patch and preparation method thereof; it is made up of backing layer, adhesive-layer, protective layer, it is characterized in that the adhesive-layer in this patch mainly is made up of medicine, profit ampholytic gels and short penetrating agent.Said preparation is made up of following medicaments in part by weight extract, wherein, and Radix Codonopsis 20-28, Radix Achyranthis Bidentatae 18-26, Radix Astragali 18-26, Radix Rehmanniae 8-16, Rhizoma Chuanxiong 6-16; The weight part ratio of adhesive-layer Chinese medicine effective ingredient and profit ampholytic gels (molecular gel: hydrogel is 1:1-10) is 1:1-15.Transdermal enhancer 3-8 weight portions, the weight percent content of the effective ingredient of Chinese medicine mixture is 5%-50% in the gel adhesive.Transdermal penetration agent, effective ingredient extract, molecular gel and hydrogel add with order respectively in proportion, and mix homogeneously is uniformly coated on the backing layer, the compound protective layer of going up, and after the extrusion modling, sterilization, stamping-out are made product.
Described drug molecule gel can be made as follows: 1%-30% gel factor is dissolved in the mixture of specific organic solvent or organic solvent.Medicine is dissolved in the organic solvent, adds a certain amount of gel factor then and mix, promptly get molecular gel.The gel factor that is adopted is divided into two classes, the first kind is simple tertiary amine and quaternary ammonium salt thereof such as lecithin, N, N, the two octadecane amine of N-three-octadecane amine, gallbladder steroid eicosane amine, methyl, dioctadecyl dimethyl ammonium chloride and cyclodextrin derivative class as: organic molecules such as beta-schardinger dextrin-, second class are derivative of fatty acid as 12-hydroxy octadecadienoic acid and associated salts thereof, glyceryl monostearate, glyceryl tristearate, tripalmitin etc.Organic solvent comprises alkanes, arene, dimethyl sulfoxide (DMSO), acetonitrile, 1-propanol, 1-amylalcohol, 1-capryl alcohol, propylene glycol, glycerol, silicone oil, 14/isopropyl palmitate etc.
Described medicine hydrogel can be made as follows:
The first kind, 2%-15% sodium polyacrylate, 1%-30%PVP and 1%-20%CMC-NA pressed powder mix homogeneously are scattered in 15%-60% propylene glycol, the glycerol solvent, and mix homogeneously adds 40%-80% deionized water mix homogeneously promptly.The 0%-15% additive, additive comprises: Kaolin, starch, micropowder silica gel, aluminum chloride, Alumen, sodium alginate etc.
Second class, 0.1%-10% carbomer, 1%-20% sodium polyacrylate, 15%-40% glycerol, 30%-80% propylene glycol, 3%-15% ethanol, 5%-20% additive, additive comprises: Kaolin, starch, micropowder silica gel, citric acid, citric acid, ethanol, aluminum chloride, triethanolamine, ethyl hydroxybenzoate, ammonium stearate, disodium EDTA (EDTA-2Na), sodium benzoate, parabens or the like.
The above-mentioned described first kind prescription gel factor can only cooperate with first kind gel, and the second gellike factor and the second gellike agent cooperate.Because the fundamental property of two gellikes is different, intersection is combined with change or the chemical reaction that framework may take place.
Penetrating agent of the present invention comprises dimethyl sulfoxide and analog: dimethyl sulfoxide (DMSO); Azone compounds: laurocapram Azone; Alcohol compound: ethanol, propylene glycol, glycerol; Volatile oil and or their mixture etc.Described backing layer is non-woven fabrics or polyester film, and protective layer is paper or polyester film through release treatment.
Chinese crude drug extraction process of the present invention is not limited to aqueous extraction-alcohol precipitation technology, also can be that water is put forward other extraction processes such as organic solvent extractionprocess, alcohol extraction organic solvent extractionprocess and supercritical fluid extraction; Coating processes such as the also available blade coating molding of the preparation technology of patch.Gel adhesive of the present invention can be made arbitrary shape.
Process conditions:
A. extract drugs technology
(a) get a certain amount of Chinese medicine Radix Codonopsis, water decocts 3 times, for the first time with 6 times of water gagings, decoct 90min,, decoct 90min for the second time with 4 times of water gagings, use the water of 4 times of amounts for the third time, decoct 90min, filter, merging filtrate, concentrating under reduced pressure behind certain volume, evaporate to dryness, the back adds the ethanol of 50-100%, stirs, and leaves standstill placement, filter, collect filtrate decompression and be concentrated to fluid extract, standby.
(b) get a certain amount of Chinese medicine Radix Achyranthis Bidentatae, use 50-100% alcohol reflux 3 times, with 4 times of amount alcohol, extract 60min for the first time, with 3 times of amount alcohol, extract 60min for the second time, use the alcohol of 2 times of amounts for the third time, extract 30min, filter, merging filtrate, concentrating under reduced pressure is to heavy-gravity extractum, and is standby.
(c) Rhizoma Chuanxiong adopts CO
2Supercritical extraction, temperature are 30-80 ℃, pressure 15-40MP, and time 1-6 hour, carry agent: medical material=1:4-15, carrying agent was Different concentrations of alcohol, ethyl acetate, chloroform, methanol etc.
(d) get a certain amount of Chinese medicine Radix Rehmanniae, use 50%-100% alcohol reflux three times, doubly measure alcohol extraction with 3-10 respectively, temperature is 40-95 ℃, extracts 120min respectively, merging filtrate, and decompression and solvent recovery gets extractum to doing, and is standby.
(e) get a certain amount of Chinese medicine astragalus, with 50-100% alcohol reflux three times, the alcohol extraction 60min that doubly measures with 3-10 respectively, merging filtrate reclaims solvent, is concentrated into the extractum state, and is standby.
B. the preparation technology of patch:
(a) preparing process of mixed gel:
The first kind: get a certain amount of sodium polyacrylate, PVP and CMC-NA pressed powder and add in the agitator, heat 20-90 ℃, be scattered in propylene glycol, the glycerol solvent, mix homogeneously, after adding molecular gel required organic solvent and drug extract mixing behind the adding deionized water mix homogeneously, after slowly mixing after the adding mixed gel factor, progressively lower the temperature, form gel until room temperature.
Second class: get in a certain amount of carbomer, sodium polyacrylate, glycerol, propylene glycol, ethanol, the additive adding agitator, heat 20-90 ℃, behind the mix homogeneously, add required organic solvent and the drug extract mixing of molecular gel, after slowly mixing after the adding mixed gel factor, progressively lower the temperature until room temperature, form gel.
(b) preparation technology of paster
The drug matrices that is mixed is evenly coated on the backing layer non-woven fabrics, will covers on the medicine glue-line through the polyester protecting film that release treatment is crossed, enter the roller bearing extrusion modling, THICKNESS CONTROL is below 5mm.Stamping-out, screening, quality inspection, packing are carried out by specification in the sterilization back.
(c) gel adhesive application characteristic:
Respectively to hydrogel adhesive, oil-base gel agent, molecular gel agent, four kinds of gels of ampholytic gels patch from mouldability, first viscous force, peeling force, tough elastic force, seven performance indications of compliance of skin irritation, preparation stability, patient are investigated.Every definition standard is as follows.
Mouldability: four kinds of gels of equal in quality are coated on the non-woven fabrics uniformly the overall appearance of observing colloid, loosely organized degree.
First viscous force: the assay method according to the first viscous force of patch in (2005) second appendix XJ patches of Chinese Pharmacopoeia adhesive force algoscopy is measured comparison to four kinds of gels that are coated on the non-woven fabrics.
Peeling force: the assay method according to peel strength in (2005) second appendix XJ patches of Chinese Pharmacopoeia adhesive force algoscopy is measured comparison to four kinds of gels that are coated on the non-woven fabrics.
Tough elasticity: coating on the non-woven fabrics circular glass sheet of placing identical size on four kinds of gel-type vehicles, a 20g counterweight is put by sheet central authorities, after the pressure relief, observes gel shape recovery situation and compares.
Skin irritation: observe animal intact skin single and repeatedly contact gel the local excitation reaction that is produced.(300g ± 20g), male and female half and half are divided into 8 groups, 5-6 every group to choose healthy albino guinea-pig.24h is with Cavia porcellus spinal column both sides unhairing before administration, check whether skin of unhairing has wound, apply ointment or plaster in the left and right sides of every Cavia porcellus the respectively gel of same dose is observed single-dose and is removed the situation that erythema and edema appear in skin in 1h, 24h behind the gel, 48h, the 72h.Repeatedly apply ointment or plaster more than the week, observe again a week after stopping, the redness of observed and recorded skin every day and edema situation and smear the position whether pigmentation, situation such as hemorrhage are arranged.
Stability: placed at ambient temperature 1 month, the character of observing each gel changes situation.
Patient's compliance: select some normal adults, stick four kinds of gels respectively, compare from situations such as the sensation of skin, degree easy to use.
Four kinds of various performance comparison results of gel
Annotate: +++for well; ++ in; + for poor
The specific embodiment
Below example by the specific embodiment, foregoing of the present invention is described in further detail, embodiment only is indicative, means that never it limits the scope of the invention by any way.But do not breaking away under the above-mentioned technological thought situation of the present invention, the various replacements of making according to ordinary skill knowledge and habitual means or the modification of change include within the scope of the invention.
Embodiment 1:
Transdermal enhancer laurocapram Azone 3.5kg
Molecular gel 2.5% lecithin,
97.5% Semen Myristicae isopropyl ester 100kg
Hydrogel 8% sodium polyacrylate, 2% polyvinylpyrrolidone
2% sodium carboxymethyl cellulose, 20% propylene glycol
20% glycerol, 48% deionized water 400kg
Effective ingredient extract 75kg
Take by weighing 32kg sodium polyacrylate, 8kg polyvinylpyrrolidone and 8kg sodium carboxymethyl cellulose pressed powder mix homogeneously, be scattered in 80kg propylene glycol, the 80kg glycerol solvent, mix homogeneously in agitator adds the 192L deionized water, mix homogeneously, get 97.5kg Semen Myristicae isopropyl ester and place agitator, add 75Kg effective ingredient mixture, containing Radix Codonopsis extract's weight portion in the mixture is 20kg, Radix Achyranthis Bidentatae 20kg, Radix Astragali 15kg, Radix Rehmanniae 10kg, Rhizoma Chuanxiong 10kg.Add the 3.5Kg laurocapram simultaneously, 60 ℃ of heated and stirred add 2.5Kg lecithin to mixings fully, after slowly stirring with 100 rev/mins, cooling, temperature reduce to stop to stir after the room temperature leave standstill 5h gel.The drug gel substrate that is mixed is evenly sprayed cloth on the backing layer non-woven fabrics, will cover on the medicine glue-line through the polyester protecting film that release treatment is crossed, enter the roller bearing extrusion modling, THICKNESS CONTROL is below 5mm.Stamping-out is carried out by specification in the sterilization back, makes patch, and coefficient of losses 15% is pressed Chinese Pharmacopoeia patch standard through quality inspection qualification rate 85%.The certified products packing.
Embodiment 2:
Transdermal enhancer oleic acid 3.5kg
Molecular gel 5% glyceryl monostearate
95% cyclohexane extraction 150kg
Hydrogel 0.5% carbomer, 5% sodium polyacrylate
28.5% propylene glycol, 60% glycerol,
4% ethanol, 1.4% Kaolin,
0.2% citric acid, 0.4% triethanolamine 500kg
Effective ingredient extract 100kg
Take by weighing 25kg sodium polyacrylate, 2.5kg carbomer pressed powder mix homogeneously, be scattered in 142.5kg propylene glycol, the 300kg glycerol solvent, mix homogeneously in agitator adds 20Kg ethanol, 7Kg Kaolin, 1Kg citric acid, 2Kg triethanolamine, mix homogeneously, get the 142.5kg cyclohexane extraction and place agitator, add 100Kg effective ingredient mixture, containing Radix Codonopsis extract's weight portion in the mixture is 25kg, Radix Achyranthis Bidentatae 20kg, Radix Astragali 25kg, Radix Rehmanniae 15kg, Rhizoma Chuanxiong 15kg.Add 3.5Kg oleic acid, 60 ℃ of heated and stirred add the 7.5Kg glyceryl monostearate to mixings fully, after slowly stirring with 100 rev/mins, cooling, temperature reduce to stop to stir after the room temperature leave standstill 5h gel.The drug matrices that is mixed is evenly sprayed cloth on the backing layer non-woven fabrics, will cover on the medicine glue-line through the polyester protecting film that release treatment is crossed, enter the roller bearing extrusion modling, THICKNESS CONTROL is below 5mm.Stamping-out is carried out by specification in the sterilization back, makes patch, and coefficient of losses 5% is pressed Chinese Pharmacopoeia patch standard through quality inspection qualification rate 95%.The certified products packing.
Claims (7)
1. antifatigue gel adhesive and preparation method thereof; it is characterized in that: it is made up of backing layer, adhesive-layer, protective layer; adhesive-layer is mixed and made into by effective component extracts and molecular gel, hydrogel, the transdermal enhancer of Chinese medicine of the five flavours such as Radix Codonopsis, Radix Achyranthis Bidentatae; the weight portion proportioning is: effective ingredient extract 10-200 part; 3-8 parts of transdermal enhancers; 100-300 parts of molecular gels, 200-1000 parts of hydrogels.
2. according to described a kind of antifatigue gel adhesive of claim 1 and preparation method thereof, it is characterized in that: described molecular gel is formed and percentage by weight is: the gel factor 1%-30%, solvent or their mixture 50%-90%.The gel factor comprises the tertiary amine of ad hoc structure and quaternary amines organic compound thereof such as lecithin, N, N, N-three-octadecane amine, gallbladder steroid eicosane amine, the two octadecane amine of methyl, dioctadecyl dimethyl ammonium chloride; Organic molecules such as cyclodextrin derivative class such as beta-schardinger dextrin-; Derivative of fatty acid such as 12-hydroxy octadecadienoic acid and associated salts thereof, glyceryl monostearate, glyceryl tristearate, tripalmitin etc.Solvent comprises alkanes, arene, dimethyl sulfoxide (DMSO), acetonitrile, 2-ethoxy ethanol, 1-propanol, 1-amylalcohol, 1-capryl alcohol, 1,2-propylene glycol, glycerol, silicone oil, 14/isopropyl palmitate etc.
3. according to described a kind of antifatigue gel adhesive of claim 1 and preparation method thereof, it is characterized in that: the composition of described hydrogel and percentage by weight are water-soluble base, water-insoluble substrate or their mixture 5%-30%, solvent 50%-90%, additive 1%-10%.Water-soluble base and non-aqueous substrate comprise polypropylene acid, sodium polyacrylate, carbomer resin, polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, polyvinyl alcohol and/or their mixture of various models; Additive comprises Kaolin, starch, micropowder silica gel, aluminum chloride, Alumen, sodium alginate etc.; Solvent comprises deionized water, propylene glycol, glycerol, ethanol and/or their mixture.
4. according to described a kind of antifatigue gel adhesive of claim 1 and preparation method thereof, it is characterized in that: described penetrating agent comprises dimethyl sulfoxide and analog, azone class, alcohol compound, volatile oil and/or their mixture.
5. according to described a kind of antifatigue gel adhesive of claim 1 and preparation method thereof, it is characterized in that: described backing layer is non-woven fabrics or polyester film, and protective layer is paper or polyester film through release treatment.
6. according to described a kind of antifatigue gel adhesive of claim 1 and preparation method thereof, it is characterized in that: described preparation process comprises:
Getting the required organic solvent of the required mixture of a certain amount of preparation hydrogel, solvent, deionized water and preparation molecular gel adds in the agitator, heat 20-90 ℃, after mixing, add the abundant mixing of effective ingredient extract, after slowly mixing after the adding mixed gel factor, progressively lower the temperature until room temperature, form gel.
7. according to described a kind of resisting fatigue gel adhesive of claim 1 and preparation method thereof, it is characterized in that: preparation technology is spreading formation process, extrusion modling or spray mo(u)lding technology.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100604675A CN101468094A (en) | 2007-12-28 | 2007-12-28 | Gel patch for resisting fatigue and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100604675A CN101468094A (en) | 2007-12-28 | 2007-12-28 | Gel patch for resisting fatigue and preparation method thereof |
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| Publication Number | Publication Date |
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| CN101468094A true CN101468094A (en) | 2009-07-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2007100604675A Pending CN101468094A (en) | 2007-12-28 | 2007-12-28 | Gel patch for resisting fatigue and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103316078A (en) * | 2013-06-18 | 2013-09-25 | 安徽万邦医药科技有限公司 | Sleep aiding and cooling patch and preparation method thereof |
-
2007
- 2007-12-28 CN CNA2007100604675A patent/CN101468094A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103316078A (en) * | 2013-06-18 | 2013-09-25 | 安徽万邦医药科技有限公司 | Sleep aiding and cooling patch and preparation method thereof |
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Open date: 20090701 |