CN102697755A - Novel levo-carnitine hydrogel patch and preparation method thereof - Google Patents
Novel levo-carnitine hydrogel patch and preparation method thereof Download PDFInfo
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- CN102697755A CN102697755A CN2012101989680A CN201210198968A CN102697755A CN 102697755 A CN102697755 A CN 102697755A CN 2012101989680 A CN2012101989680 A CN 2012101989680A CN 201210198968 A CN201210198968 A CN 201210198968A CN 102697755 A CN102697755 A CN 102697755A
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Abstract
The invention discloses novel levo-carnitine hydrogel patch and a preparation method thereof. According to the hydrogel patch, levo-carnitine is used as an active ingredient of medicines. The levo-carnitine hydrogel patch consists of a medicine-containing matrix layer, a backing layer and a protective layer, wherein the medicine-containing matrix layer comprises the levo-carnitine, a hydrogel matrix, a transdermal enhancer and a filling agent, wherein a mass ratio of the levo-carnitine to the hydrogel matrix is 1:(20-300), the transdermal enhancer accounts for 1 to 2 mass percent of the mass of the hydrogel matrix, and a tackifier accounts for 1 to 5 mass percent of the mass of the hydrogel matrix. According to the levo-carnitine hydrogel patch, the medicines can be released stably by the specific transdermal enhancer used by the levo-carnitine, and the accumulative transit dose within 12 hours can reach 900 ug.cm<-2>. Simultaneously, the characteristics of the direct administration and multi-component and large-dose administration of lesion sites can be achieved, and the compliance of the long-term administration of patients is improved; and the using effect of the levo-carnitine hydrogel patch is obviously superior to that of other conventional preparations of the levo-carnitine.
Description
Technical field
The present invention relates to a kind of novel L-carnitine hydrogel patch and preparation method thereof.Belong to medical technical field.
Background technology
L-carnitine is claimed left Carnitine or carnitine again, is a kind of biostearin material.L-carnitine gets into mitochondrial important carrier as the transhipment fatty acid, has the energy metabolism of the sperm of participation, reduces active oxidation material in the refining, stablizes effects such as spermatid film, anti-sperm apoptosis.Be widely used in the treatment of masculine sterility in recent years.What use always in the therapeutic treatment at present is the oral formulations of L-carnitine, vitamin E and zinc, selenium and other trace elements, ATP injection etc.Because drug oral dosage is big, takes number of times and frequently wait patient treatment inconvenient.Especially oral back blood drug level is uneven, and L-carnitine mainly leans on the kidney balance, takes the safety problems such as dysfunction that can cause kidney for a long time.Therefore be necessary to develop except that other administration route oral, the injection.Especially the local skin route of administration reduces the untoward reaction of medicine simultaneously with increase medicine local concentration.
Hydrogel patch (cataplasma) is a kind of high in technological content, and novel external easy to use sticks agent, is applied to Japan the earliest.Introduce China in the eighties in 20th century, along with the continuous development of medicine, hydrogel patch is big with its drug loading in recent years, and transdermal effect is good, and ingredient can survey, good permeability, skin irritation are little etc., and characteristics become ideal transdermal administration carrier.Meanwhile comparing with traditional patch, it also has: better with the compatibility of water solublity, fat-soluble medicine active component, the substrate drug loading is big; Can satisfy the characteristics of multicomponent, heavy dose of medication.
The preparation that a lot of percutaneous absorb has been proposed in recent years.But the hydrogel patch of L-carnitine does not have open.Produce the L-carnitine hydrogel patch according to a lot of prescriptions of having announced at present in addition, can find that its transdermal effect is not satisfactory, even L-carnitine can react in substrate.And substrate loses the characteristics of viscosity easily along with the prolongation sclerosis of time.
Summary of the invention
The purpose of this invention is to provide a kind of L-carnitine hydrogel transdermal patch and preparation method thereof.It has changed traditional route of administration of L-carnitine.The advantage of bound water gel has promptly remedied the deficiency that existing dosage form exists: be not suitable for being applied to the L-carnitine administration, prolong sclerosis in time and be prone to lose problems such as viscosity.Solved the not satisfactory problem of transdermal effect.Shortcomings such as traditional patches releases such as traditional pressure sensitive glue, rubber glue are slow, chance water loses viscosity, peel strength is excessive have been overcome again.The L-carnitine hydrogel patch is through lesions position transdermal penetration administration simultaneously; Increase the medicine local concentration of lesions position, the toxicity that reduces medicine and untoward reaction, increase patient long-term prescription compliance, and can make the autonomous administration of patient, for the patient provides more excellent route of administration.
The present invention realizes through following technical scheme:
A kind of L-carnitine hydrogel patch is characterized in that, is active constituents of medicine with the L-carnitine; Be made up of pastille hypothallus, backing layer and protective layer, wherein said pastille substrate comprises hydrogel matrix, L-carnitine, penetration enhancer and viscosifier, wherein; The ratio of quality and the number of copies of L-carnitine and hydrogel matrix is 1: 20～300; Preferred 1: 50～150, the quality of penetration enhancer accounts for 1%～2% of hydrogel matrix, and the quality of viscosifier accounts for 1%～5% of hydrogel quality;
Said penetration enhancer is selected from one or more in vitamin, phospholipid, fatty acid and fat thereof, polyhydric alcohol, amine, cyclodextrin, aminoacid and fat thereof, the macrocyclic compound; Preferred water soluble vitamin E, menthol;
Said viscosifier are selected from one or more in Konjac glucomannan, sodium alginate, gelatin, pectin, chitosan, the hyaluronic acid; Preferred sodium alginate or Konjac glucomannan;
Said hydrogel matrix is by the crosslinked framework material of 5%-20%, 15%-35% wetting agent, 0.05%-1% cross-linking regulator, 0.05%-1% cross-linking agent, 1%-5% filler and 50%-70% distilled water; The preferred crosslinked framework material of 5%-10%, 20%-30% wetting agent, 0.12%-1.0% cross-linking agent, 0.08%-1.0% cross-linking regulator, 1%-2.5% filler and 60%-70% distilled water.The equal representation quality percentage composition of % wherein.
Wherein said crosslinked framework material is selected from following at least a: the polyacrylic acid of various models, sodium polyacrylate, polyacrylic acid potassium, carbomer resin, sodium carboxymethyl cellulose, methylcellulose, polyvinyl pyrrolidone, polyacrylamide.
Said wetting agent is selected from following at least a: glycerin, propylene glycol, sorbitol, butanediol, Polyethylene Glycol and/or their mixture.
Said cross-linking regulator is selected from following at least a: citric acid, malic acid, lactic acid, tartaric acid, disodiumedetate, butene dioic acid and/or their mixture.
Said cross-linking agent is selected from following at least a: aluminum chloride, dihydroxyaluminum aminoacetate, starch aluminum, Alumen, aluminium hydroxide, calcium sulfate, calcium chloride, calcium hydroxide.
Said filler is selected from following at least a: Kaolin, starch, micropowder silica gel, ceramics.
Said backing layer is processed by following any one material: spun rayon cloth, non-woven fabrics, clad aluminum foil and flannel etc.
Said protective layer is processed by following any one material: polypropylene screen, polyethylene film, cellophane, polyester, separate paper and fluorine material etc.
The present invention also provides a kind of method for preparing the L-carnitine hydrogel patch, it is characterized in that, said method comprises the steps:
1, according to the above ratio crosslinked framework material, filler, cross-linking agent, cross-linking regulator in the said hydrogel matrix are joined in the wetting agent, stir under the room temperature and obtained the homodisperse phase in 5～35 minutes;
2, according to the above ratio viscosifier, L-carnitine, penetration enhancer are joined in the distilled water, constant speed stirs and obtained consoluet solution phase in 20～45 minutes under 60 ℃～95 ℃ conditions;
3, the solution that stirs down gained in the homodisperse of gained in the step 1 and the step 2 of constant speed mixes mutually, and constant speed stirs 10～35 minutes to mix homogeneously, dries in 75 ℃ then and obtains pastille substrate in 5～20 minutes;
4, the pastille substrate that step 3 is made is uniformly coated on the backing layer, prepares molding after covering protective layer, again through the sterilization back according to specification prepare, screening, quality inspection and packing.
Described preparation is shaped to: compression molding, coated and molded or extrusion modling.Preferred compression molding, coated and molded.
Remarkable result
Clinical practice shows, waits administering mode with respect to oral and injection, and L-carnitine hydrogel patch according to the invention has following remarkable result:
1) better with the compatibility of water soluble drug, the substrate drug loading is big, can satisfy the demand of multicomponent, heavy dose of administration.
2) first pass effect and the gastrointestinal tract that can avoid liver make the effect of medicine not receive the influence of gastrointestinal factors to the degraded of medicine.
3) can control medicine near constant release, absorb steadily relatively, avoid the repeatedly blood medicine peak valley undulatory property that causes of medication of other preparations.
4) can regulate dosage through changing the administration area, reduce individual variation, and the patient can self-medication, also can stop at any time.
Description of drawings
Fig. 1 is the in-vitro percutaneous cumulative release curve of L-carnitine hydrogel patch among the embodiment of the invention 1-4.
The specific embodiment
Below through practical implementation; Example is done further to specify to foregoing of the present invention, and it is indicative that embodiment is merely, and means that never it limits scope of the present invention by any way.Do not breaking away from the above-mentioned technical thought of the present invention basis, the various replacements of making according to ordinary skill knowledge and customary means or the modification of change include within the scope of the invention.
Embodiment 1:
1, get sodium polyacrylate 6.00g, Kaolin 1.00g, dihydroxyaluminum aminoacetate 0.57g, EDTA0.40g, be scattered in the mixture of 35.00g glycerol and propylene glycol, constant speed stirs and obtained homodisperse phase I in 30 minutes under the room temperature condition.
2, get sodium alginate 1.00g, L-carnitine 5.00g, tartaric acid 1.50g, be dissolved in the 60.00g distilled water.Constant speed stirs and obtained solution phase II in 30 minutes under 90 ℃ of conditions.
3, with homodisperse phase I and solution II mixing mutually, constant speed stirs 30 minutes to mix homogeneously.Dry down for 75 ℃ and obtained pastille substrate in 15 minutes.
4, pastille substrate is uniformly coated on the backing layer non-woven fabrics, covers compression molding behind the protective layer, be cut into required sample size then as required.
Embodiment 2:
1, get sodium polyacrylate 6.00g, Kaolin 1.00g, dihydroxyaluminum aminoacetate 0.57g, EDTA0.40g, vitamin E 0.5g, be scattered in the mixture of 35.00g glycerol and propylene glycol, constant speed stirs and obtained homodisperse phase I in 30 minutes under the room temperature condition.
2, getting sodium alginate 1.00g, L-carnitine 5.00g, tartaric acid 1.50g is dissolved in the 60.00g distilled water.Constant speed stirs and obtained solution phase II in 30 minutes under 90 ℃ of conditions.
3, with homodisperse phase I and solution II mixing mutually, constant speed stirs 30 minutes to mix homogeneously.Dry down for 75 ℃ and obtained pastille substrate in 15 minutes.
4, pastille substrate is uniformly coated on the backing layer non-woven fabrics, covers compression molding behind the protective layer, be cut into required sample size then as required.
Embodiment 3:
1, get sodium polyacrylate 6.00g, Kaolin 1.00g, dihydroxyaluminum aminoacetate 0.57g, EDTA0.40g, be scattered in the mixture of 35.00g glycerol and propylene glycol, constant speed stirs and obtained homodisperse phase I in 30 minutes under the room temperature condition.
2, getting sodium alginate 1.00g, L-carnitine 5.00g, tartaric acid 1.50g, menthol 0.5g is dissolved in the 60.00g distilled water.Constant speed stirs and obtained solution phase II in 30 minutes under 90 ℃ of conditions.
3, with homodisperse phase I and solution II mixing mutually, constant speed stirs 30 minutes to mix homogeneously.Dry down for 75 ℃ and obtained pastille substrate in 15 minutes.
4, pastille substrate is uniformly coated on the backing layer non-woven fabrics, covers compression molding behind the protective layer, be cut into required sample size then as required.
Embodiment 4:
1, get sodium polyacrylate 6.00g, Kaolin 1.00g, dihydroxyaluminum aminoacetate 0.57g, EDTA0.40g, vitamin E 0.5g, be scattered in the mixture of 35.00g glycerol and propylene glycol, constant speed stirs and obtained homodisperse phase I in 30 minutes under the room temperature condition.
2, get sodium alginate 1.00g, L-carnitine 5.00g, menthol 0.5g, tartaric acid 1.50g, be dissolved in the 60.00g distilled water.Constant speed stirs and obtained solution phase II in 30 minutes under 90 ℃ of conditions.
3, with homodisperse phase I and solution II mixing mutually, constant speed stirs 30 minutes to mix homogeneously.Dry down for 75 ℃ and obtained pastille substrate in 15 minutes.
4, pastille substrate is uniformly coated on the backing layer non-woven fabrics, covers compression molding behind the protective layer, be cut into required sample size then as required.
Embodiment 5:
1, get sodium polyacrylate 6.00g, Kaolin 1.00g, dihydroxyaluminum aminoacetate 0.57g, EDTA0.40g, azone 0.5g, be scattered in the mixture of 35.00g glycerol and propylene glycol, constant speed stirs and obtained homodisperse phase I in 30 minutes under the room temperature condition.
2, get sodium alginate 1.00g, L-carnitine 5.00g, tartaric acid 1.50g, be dissolved in the 60.00g distilled water.Constant speed stirs and obtained solution phase II in 30 minutes under 90 ℃ of conditions.
3, with homodisperse phase I and solution II mixing mutually, constant speed stirs 30 minutes to mix homogeneously.Dry down for 75 ℃ and obtained pastille substrate in 15 minutes.
4, pastille substrate is uniformly coated on the backing layer non-woven fabrics, covers compression molding behind the protective layer, be cut into required sample size then as required.
Specify the process and the result of the main performance test that L-carnitine hydrogel patch according to the invention carries out below.
1, percutaneous penetration of drugs performance
The present invention adopts transdermal diffusion instrument to carry out the screening technique of transdermal test in vitro experiment as the patch penetration enhancer with isolated mouse skin, as evaluation index, carries out pharmacodynamic study with the accumulation transit dose of L-carnitine.The result confirms the release medicine that the L-carnitine hydrogel patch can be continual and steady at the appointed time, and the release amount is big, has prolonged action time.So safe ready, side effect is little.Can also regulate dosage through changing the administration area simultaneously, reduce individual variation, can make the autonomous administration of patient.Experimental technique is following: under the constant temperature (37 ± 0.5) ℃ the medicine carrying gel is placed on the Transdermal absorption experimental provision.Add the 6ml normal saline in the reception tank as receiving liquid, carry out the transdermal test in vitro experiment.With take a sample respectively 1ml and to replenish the release medium of equal volume therein constant to keep cumulative volume of 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h.Calculate the content of L-carnitine in the release medium then with Agenlient 1200 high performance liquid chromatographs.Cumulative release rate Q calculates by following formula:
Table 1: different penetration enhancer are to L-carnitine patch transdermal test in vitro Effect on Performance among the embodiment 1-5
2, skin irritation test
The not medicated patches of preparation is processed the size of 3cm * 3cm, be attached at the experimenter and get 48h on the arm, observe skin and have or not whiting and anaphylactic reaction.
The result shows that experimenter's arm card attaches position skin and do not have the immersion blushing, does not also have tangible anaphylactic reaction and zest.Experimental result explanation L-carnitine hydrogel patch has advantages of good skin biocompatibility and ventilative, water permeability.
Claims (6)
1. a L-carnitine hydrogel patch is characterized in that, is active constituents of medicine with the L-carnitine; Be made up of pastille hypothallus, backing layer and protective layer, wherein said pastille substrate comprises hydrogel matrix, L-carnitine, penetration enhancer and viscosifier, wherein; The ratio of quality and the number of copies of L-carnitine and hydrogel matrix is 1: 20～300; Preferred 1: 50～150, the quality of penetration enhancer accounts for 1%～2% of hydrogel matrix, and the quality of viscosifier accounts for 1%～5% of hydrogel quality;
Said penetration enhancer is to be selected from vitamin, phospholipid, fatty acid and fat thereof, polyhydric alcohol, amine, cyclodextrin, aminoacid and fat thereof, the macrocyclic compound one or more;
Said viscosifier are selected from and are in Konjac glucomannan, sodium alginate, gelatin, pectin, chitosan, the hyaluronic acid one or more;
The component of said hydrogel matrix and mass percent are: the crosslinked framework material of 5%-20%, 15%-35% wetting agent, 0.05%-1% cross-linking regulator, 0.05%-1% cross-linking agent, 1%-5% filler and 50%-70% distilled water;
Wherein said crosslinked framework material is selected from following at least a: the polyacrylic acid of various models, sodium polyacrylate, polyacrylic acid potassium, carbomer resin, sodium carboxymethyl cellulose, methylcellulose, polyvinyl pyrrolidone, polyacrylamide;
Said wetting agent is selected from following at least a: glycerin, propylene glycol, sorbitol, butanediol, Polyethylene Glycol and/or their mixture;
Said cross-linking regulator is selected from following at least a: citric acid, malic acid, lactic acid, tartaric acid, disodiumedetate, butene dioic acid and/or their mixture;
Said cross-linking agent is selected from following at least a: aluminum chloride, dihydroxyaluminum aminoacetate, starch aluminum, Alumen, aluminium hydroxide, calcium sulfate, calcium chloride, calcium hydroxide;
Said filler is selected from following at least a: Kaolin, starch, micropowder silica gel, ceramics;
The material of said backing layer is selected from a kind of in spun rayon cloth, non-woven fabrics, clad aluminum foil, the flannel;
The material of said protective layer is selected from a kind of in polypropylene screen, polyethylene film, cellophane, polyester, separate paper, the fluorine material.
2. L-carnitine hydrogel patch as claimed in claim 1 is characterized in that, said penetration enhancer is watermiscible vitamin E and/or menthol.
3. L-carnitine hydrogel patch as claimed in claim 1 is characterized in that, said viscosifier are sodium alginate or Konjac glucomannan.
4. L-carnitine hydrogel patch as claimed in claim 1; It is characterized in that the component of said hydrogel matrix and mass percent are: the crosslinked framework material of 5%-10%, 20%-30% wetting agent, 0.12%-1.0% cross-linking agent, 0.08%-1.0% cross-linking regulator, 1%-2.5% filler and 60%-70% distilled water.
5. a method for preparing L-carnitine hydrogel patch as claimed in claim 1 is characterized in that, said method comprises the steps:
1), according to the described ratio of claim 1, crosslinked framework material, filler, cross-linking agent, cross-linking regulator in the said hydrogel matrix are joined in the wetting agent, stir under the room temperature and obtained the homodisperse phase in 5～35 minutes;
2), according to the described ratio of claim 1, viscosifier, L-carnitine, penetration enhancer are joined in the distilled water, constant speed stirs and to obtain consoluet solution phase in 20～45 minutes under 60 ℃～95 ℃ conditions;
3), constant speed stirs down homodisperse and step 2 with gained in the step 1)) in the solution of gained mix mutually, constant speed stirs 10～35 minutes to mix homogeneously, dries in 75 ℃ then and obtains pastille substrate in 5～20 minutes;
4), pastille substrate that step 3) is made is uniformly coated on the backing layer, prepares molding after covering protective layer, again through the sterilization back according to specification prepare, screening, quality inspection and packing.
6. the method for preparing the L-carnitine hydrogel patch as claimed in claim 5 is characterized in that the preparation in the said step 4) is shaped to compression molding, coated and molded or extrusion modling.
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Cited By (7)
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| CN103191184A (en) * | 2013-04-16 | 2013-07-10 | 王怀伟 | Novel nasal strip gel layer, novel nasal strip and preparation method of nasal strip |
| CN105079861A (en) * | 2015-09-09 | 2015-11-25 | 青岛高新区尚达医药研究所 | Preparation process of modified chitosan composite gel moisture retention adhesive bandage |
| CN108641104A (en) * | 2018-04-11 | 2018-10-12 | 中国人民解放军第七医院 | A kind of water base cross-linked polymer and its preparation method and application |
| CN109248232A (en) * | 2018-11-15 | 2019-01-22 | 武汉轻工大学 | A kind of hydrogel fat-reducing plaster and preparation method thereof |
| CN109528628A (en) * | 2018-12-14 | 2019-03-29 | 北京中医药大学 | A kind of Pharmaceutical composition and its preparation method and application comprising levocarnitine |
| CN110859793A (en) * | 2019-12-24 | 2020-03-06 | 广州市和一医疗科技有限公司 | High-affinity gel mask and preparation method thereof |
| US11103588B2 (en) | 2017-06-06 | 2021-08-31 | Wayne State University | Methods and compositions relating to carnitine-derived materials |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191184A (en) * | 2013-04-16 | 2013-07-10 | 王怀伟 | Novel nasal strip gel layer, novel nasal strip and preparation method of nasal strip |
| CN103191184B (en) * | 2013-04-16 | 2015-01-14 | 王怀伟 | Novel nasal strip gel layer, novel nasal strip and preparation method of nasal strip |
| CN105079861A (en) * | 2015-09-09 | 2015-11-25 | 青岛高新区尚达医药研究所 | Preparation process of modified chitosan composite gel moisture retention adhesive bandage |
| US11103588B2 (en) | 2017-06-06 | 2021-08-31 | Wayne State University | Methods and compositions relating to carnitine-derived materials |
| US11591287B2 (en) | 2017-06-06 | 2023-02-28 | Wayne State University | Antifouling zwitterionic polymer coating and reverse coating method |
| CN108641104A (en) * | 2018-04-11 | 2018-10-12 | 中国人民解放军第七医院 | A kind of water base cross-linked polymer and its preparation method and application |
| CN109248232A (en) * | 2018-11-15 | 2019-01-22 | 武汉轻工大学 | A kind of hydrogel fat-reducing plaster and preparation method thereof |
| CN109528628A (en) * | 2018-12-14 | 2019-03-29 | 北京中医药大学 | A kind of Pharmaceutical composition and its preparation method and application comprising levocarnitine |
| CN109528628B (en) * | 2018-12-14 | 2022-02-08 | 北京中医药大学 | Medicinal composition containing levocarnitine and preparation method and application thereof |
| CN110859793A (en) * | 2019-12-24 | 2020-03-06 | 广州市和一医疗科技有限公司 | High-affinity gel mask and preparation method thereof |
| CN110859793B (en) * | 2019-12-24 | 2022-01-14 | 广州市和一医疗科技有限公司 | High-affinity gel mask and preparation method thereof |
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Application publication date: 20121003 |