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CN102284012A - Gel plaster containing curcumin and bletilla hyacinthina gum and preparation method thereof - Google Patents

Gel plaster containing curcumin and bletilla hyacinthina gum and preparation method thereof Download PDF

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Publication number
CN102284012A
CN102284012A CN201110227364XA CN201110227364A CN102284012A CN 102284012 A CN102284012 A CN 102284012A CN 201110227364X A CN201110227364X A CN 201110227364XA CN 201110227364 A CN201110227364 A CN 201110227364A CN 102284012 A CN102284012 A CN 102284012A
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curcumin
preparation
adhesive
glue
polyvinylpyrrolidone
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CN102284012B (en
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高振坤
张晓丽
王建夺
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Shandong Fuyang Technology Development Co ltd
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Linyi University
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Abstract

本发明提供一种含有姜黄素和白芨胶的凝胶贴剂，包括以下重量配比的组分：姜黄素0.2～0.5、白芨胶1.0～2.5、聚丙烯酸2.0～5.0、胶粘剂0.4～1.4、保湿剂25.0～65.0、氢氧化铝0.1～0.2、固体分散材料0～5.0、促渗剂0～1.5和水35.0～58.0，胶粘剂选自聚乙烯吡咯烷酮、羟丙甲纤维素和聚乙烯醇等，保湿剂选自甘油、丙二醇、聚乙二醇等，固体分散材料选自聚乙烯吡咯烷酮、甘露醇、聚乙二醇、泊洛沙姆等，促渗剂选自羟丙基-β-环糊精、冰片、薄荷油、橄榄油等。该凝胶贴剂中姜黄素能够透皮吸收并缓慢持续释放，长时间稳定给药，并且白芨胶可以保护皮肤，减少药物对皮肤的刺激性。The invention provides a gel patch containing curcumin and bletilla striata gum, which comprises the following components in weight ratio: curcumin 0.2-0.5, bletilla striata gum 1.0-2.5, polyacrylic acid 2.0-5.0, adhesive 0.4-1.4, moisturizing Agent 25.0-65.0, aluminum hydroxide 0.1-0.2, solid dispersion material 0-5.0, penetration enhancer 0-1.5 and water 35.0-58.0, adhesive selected from polyvinylpyrrolidone, hypromellose and polyvinyl alcohol, etc., moisturizing The agent is selected from glycerin, propylene glycol, polyethylene glycol, etc., the solid dispersion material is selected from polyvinylpyrrolidone, mannitol, polyethylene glycol, poloxamer, etc., and the penetration enhancer is selected from hydroxypropyl-β-cyclodextrin , borneol, peppermint oil, olive oil, etc. The curcumin in the gel patch can be transdermally absorbed and released slowly and continuously, and can be administered stably for a long time, and the bletilla striata glue can protect the skin and reduce the irritation of the drug to the skin.

Description

A kind of gel adhesive that contains curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue and preparation method thereof
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of gel adhesive that contains curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue and preparation method thereof.
Background technology
Curcumin is a kind of natural pigment, is mainly derived from zingiberaceous plant Rhizoma Curcumae Longae Curcuma longa L. rhizome, is the main active in the Rhizoma Curcumae Longae.Modern pharmacological research shows, curcumin has physiological function and effects such as function of gallbladder promoting, blood fat reducing, antiinflammatory, rheumatism, antibiotic, anticancer, antioxidation, removing free radical, can be widely used in medical science, food, cosmetic field (Mei Quanxi etc., modern Chinese medicine pharmacology handbook, China Traditional Chinese Medicine Publishing House, 1998,490-491).Yet, curcumin has unstability and water-insoluble, in air, be easy to fade, existing pharmaceutical dosage form is mainly ejection preparation, microemulsion formulation and soft capsule preparation (Cui Jing etc., the development of curcumin microemulsion and property research thereof, Chinese Pharmaceutical Journal, 2005,40 (24): 1877-1880), bioavailability is also unsatisfactory, has limited its applying in food industry and pharmaceutical preparation.
Transdermal delivery system has been obtained remarkable progress adhering to the short aspect such as means and methods of oozing of controlled-release material and percutaneous in recent years, and some of them have been used for clinical and have formed commodity, have shown gratifying prospect.Percutaneous dosing is for the whole body therapeutic of local skin treatment of diseases and some disease all significant (Liang Wenquan etc., percutaneous dosing product development present situation, external treatment with Chinese medicine magazine, 2005,14 (1): 3).And the curcumin percutaneous drug administration preparation, the key issue of existence is how to guarantee stability of drug, the percutaneous rate of medicine and the adhesion property of patch.In addition, medicine is discharged from substrate and promote drug transdermal to absorb, be still the person that needs the preparation work further problem (Cui Fude, pharmaceutics, People's Health Publisher, the 2005:425-433 of research; Pan Weisan, the new drug preparation technique, Chemical Industry Press, 2004:201-202).And the application success of curcumin in transdermal delivery system is to the development and use of Chinese medicine significant (Liu Qiang etc., the progress of Chinese medicine percutaneous drug administration preparation and development trend, external treatment with Chinese medicine magazine, 2004,13 (1): 31-33).
The Pseudobulbus Bletillae (Rhizoma Bletillae) is the dry tuber of the orchid Pseudobulbus Bletillae (Rhizoma Bletillae) (Bletilla striata (Thunb) Reichb.f); has astringing to arrest bleeding; effects such as detumescence and promoting granulation can be treated hemorrhage, pneumonopathy, burn etc., also can be used for having in the cosmetics effect of protection skin, slow down aging.Pseudobulbus Bletillae (Rhizoma Bletillae) glue is the water-soluble polysaccharide that is rich in the Pseudobulbus Bletillae (Rhizoma Bletillae), and the glucose that it is made up of 4 molecule mannose and 1 molecule glucose is joined mannan, and relative molecular mass is about 100,000-200,000.Pseudobulbus Bletillae (Rhizoma Bletillae) glue has multiple biological activity, clinically is used for effects such as antiinflammatory coagulant blood, antitumor, anticomplementary activity, immunosuppressant, can be used as pharmaceutical adjunct; as filmogen, suspending agent, emulsifying agent etc.; also can be used in the daily chemical products, the instead of chemical thickening agent, and have functions such as the zest of minimizing, protection skin, slow down aging; be extremely promising biomedical material (Wang Jun etc.; the clinical practice of Pseudobulbus Bletillae (Rhizoma Bletillae) glue, Chinese Hospitals pharmaceutical journal, 2004; 24 (9), 556-557).
Summary of the invention
The object of the present invention is to provide a kind ofly to be distributed in skin surface the gel adhesive that contains curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue that good stability, dissolubility height, bioavailability be good, improve patient's medication compliance with higher concentration.
Another object of the present invention provides the above-mentioned preparation method that contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue.
For achieving the above object, the technical solution used in the present invention is:
A kind of gel adhesive that contains curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue comprises the component of following weight proportion:
Curcumin 0.2～0.5 Pseudobulbus Bletillae (Rhizoma Bletillae) glue 1.0～2.5 framework materials 2.0～5.0
Adhesive 0.4～1.4 wetting agent 25.0～65.0 cross-linking agent 0.1～0.2
Solid dispersion material 0～5.0 penetrating agent 0～1.5 water 35.0～58.0
Wherein said framework material is a polyacrylic acid.Described adhesive is for being selected from polyvinylpyrrolidone (PVP), hypromellose (HPMC), starch, polyvinyl alcohol (PVA), gelatin, arabic gum, the Polyethylene Glycol one or more; Described wetting agent is to be selected from glycerol, propylene glycol, sorbitol, Polyethylene Glycol, ethylene glycol, the 1,3 butylene glycol one or more.Described cross-linking agent is an aluminium hydroxide.Described solid dispersion material is to be selected from polyvinylpyrrolidone, hypromellose, chitosan, mannitol, Polyethylene Glycol, the poloxamer one or more, preferably polyethylene ketopyrrolidine or mannitol.Described penetrating agent is to be selected from HP-, Borneolum Syntheticum, Oleum menthae, olive oil, the carbamide one or more.The weight proportion of above-mentioned solid dispersion material is preferably 1.0～5.0, penetrating agent preferred 0.5～1.5.
In a kind of preferred implementation, described gel adhesive comprises the component of following weight proportion:
Figure BSA00000553919600021
Figure BSA00000553919600031
Wherein the weight proportion of solid dispersion material more preferably 1.0～5.0, and penetrating agent is 0.5～1.5.
Pseudobulbus Bletillae (Rhizoma Bletillae) glue of the present invention can prepare by the following method: will add in the distilled water of 10～12 times of volumes (in ml) after 1 weight portion (in the g) Pseudobulbus Bletillae (Rhizoma Bletillae) pulverizing medicinal materials, be heated to 50 ℃ and stirred 1 hour, filter, collect extracting solution; The medicinal residues distilled water that adds 5～6 times of volumes (in ml) respectively repeats to extract 1～3 time then; Merge extractive liquid, is concentrated into half volume, adds 95% ethanol and regulates ethanol mass concentration to 70%, separates out precipitation, and centrifugal, collecting precipitation is used washing with alcohol, in 80 ℃ of dryings, obtains Pseudobulbus Bletillae (Rhizoma Bletillae) glue.
The present invention also provides the above-mentioned preparation method that contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue, comprises step:
1) preparation of curcumin solid dispersion: according to the prescription consumption proportion, curcumin is dissolved in an amount of organic solvent, with the solid dispersion material mixing, fully stir under 60 ℃ of condition of water bath heating, organic solvent is removed in evaporation, puts and is chilled to room temperature, dry 5h in 45～55 ℃ of vacuum drying ovens again, pulverize, sieve, promptly;
2) preparation of substrate: according to the prescription consumption proportion, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, wetting agent, cross-linking agent are stirred under 25 ℃～35 ℃ water bath condition, add framework material, adhesive, penetrating agent then, fully stir, promptly;
3) preparation of pastille glue: according to the prescription consumption proportion, the curcumin solid dispersion of curcumin or step 1) preparation is added in the substrate after with an amount of solvent (water or glycerol) dissolving dispersion, adds remaining water, stir, de-bubbled, promptly;
4) preparation of gel adhesive: pastille glue is applied on the backing layer, and in 40～60 ℃ of down dry 0.5～3.5h, the loam cake protective layer cuts, promptly.
In one embodiment, curcumin can be dissolved in volatile organic solvents such as dehydrated alcohol, acetone in the step 1), and vacuum drying normally carried out about 5 hours at about 50 ℃, and sieving can be the sieve in 80 orders, 100 orders or other different apertures.
In one embodiment, step 2) the aqueous solution form of 0.5～10wt% that adhesive can be prepared in advance in is added, and by its dilution is gluey aqueous solution, helps each component and mixes quickly and evenly.For example, preferably, polyvinylpyrrolidone is to add with the aqueous solution form of 1.5～8.5wt%, and polyvinyl alcohol is to add with the aqueous solution form of 1.5～9.5wt%, and hypromellose is to add with the aqueous solution form of 0.5～3.5wt%.
In one embodiment, Pseudobulbus Bletillae (Rhizoma Bletillae) glue also can directly add in the described gel adhesive with the form of Pseudobulbus Bletillae (Rhizoma Bletillae) medicinal powder without extraction step 2).When using with the form of common bletilla, its consumption is about as much as 3～4 times of Pseudobulbus Bletillae (Rhizoma Bletillae) glue consumption.
In one embodiment, in the step 3) de-bubbled can adopt ultrasonic, leave standstill or method such as centrifugal is carried out.
In one embodiment, backing layer can be cellulose acetate, spun rayon cloth or medical adhesive-bonded fabric etc. in the step 4), and protective layer can be polypropylene film, polyethylene film, cellophane or mylar etc.
Beneficial effect of the present invention is, mechanism such as matrix type and adhesive decentralized are combined, and promotes the Transdermal absorption of medicine and continues to discharge.As active component, synergism strengthens drug effect with curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue, and Pseudobulbus Bletillae (Rhizoma Bletillae) glue can be protected skin simultaneously, and reducing stimulates; Gelatinous Pseudobulbus Bletillae (Rhizoma Bletillae) glue also can be used as adhesion material, adheres on the skin with the framework material polyacrylic acid and as drug depot sustained release medicine, makes the active component effect of described gel adhesive lasting, can stablize administration for a long time.In addition, can also add solid dispersion material and penetrating agent by selectivity.The solid dispersion material makes medicine that higher dissolubility be arranged in the substrate when guaranteeing to make medicine stability, is discharged into skin surface by substrate smoothly; Penetrating agent makes medicine see through horny layer from skin surface, diffuses into corium.The use in conjunction of above-mentioned each component, the purpose that makes the curcumin in the gel adhesive reach Transdermal absorption and slowly continue to discharge, and reduce the zest of medicine to skin, reach the purpose of protection skin.
The gel adhesive that contains curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue of the present invention can be used for the treatment of multiple disease, comprises the auxiliary treatment of arthroncus, arthritis, skin carcinoma or the auxiliary treatment of breast carcinoma etc.The in-vitro evaluation experimental result shows that preparation of the present invention reaches more than 93% at the 2h medicine realeasing rate; Drug accumulation transdermal amount reaches 40 μ gcm -2More than, accumulation transdermal amount reached 347 μ gcm after medication preparation became solid dispersion -2, significantly improve the accumulation transdermal amount of medicine.Said preparation can be stablized administration in 32h.
Description of drawings
Fig. 1 is the cumulative release percentage rate Q-t curve of gel adhesive sample of the present invention.
Fig. 2 is the accumulation transdermal amount Q-time t curve of gel adhesive sample of the present invention.
Fig. 3 is the accumulation transdermal amount Q-t of gel adhesive sample of the present invention 1/2Curve.
The specific embodiment
Following preferred embodiment only is provided for further understanding characteristics of the present invention and advantage, and should not be construed as limitation of the present invention.Wherein curcumin is provided by Tianjin recovery fine chemistry industry institute, lot number CBO346-5G-N, available from branch, pharmacy of Tongrentang Linyi, Beijing, other materials and reagent are common commercially available prod to the Pseudobulbus Bletillae (Rhizoma Bletillae) (Bletilla striata (Thunb) Reichb.f) unless otherwise specified.
[embodiment 1] preparation Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Take by weighing the about 20g of common bletilla, adding distil water 240mL, heating in water bath to 50 ℃ insulation dipping stirs and extracted 1 hour, through four layers of filtered through gauze, gets extracting solution.The medicinal residues about 80～120ml of adding distil water again repeat to extract twice as stated above, merge three times filtrate, be concentrated into half volume, add 95% ethanol and make the alcohol amount of containing reach 70wt%, separate out a large amount of white precipitates this moment rapidly, centrifugal, reclaim ethanol, the collecting precipitation thing, with small amount of ethanol washing 3 times, volatilize ethanol, and dry about 80 ℃, obtain the about 5.6g of Pseudobulbus Bletillae (Rhizoma Bletillae) glue.
[embodiment 2] preparation contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Prescription:
Component Consumption (g) Effect
Curcumin ?0.4 Active component
Pseudobulbus Bletillae (Rhizoma Bletillae) glue ?2.5 Active component, adhesive
Polyacrylic acid ?3.0 Framework material, adhesive
Polyvinylpyrrolidone (PVP) ?0.8 Substrate, adhesive
Polyvinyl alcohol (PVA) ?0.3 Substrate, adhesive
Hypromellose (HPMC) ?0.2 Substrate, adhesive
Glycerol ?15.0 Substrate, wetting agent
Propylene glycol ?15.0 Substrate, wetting agent
Polyethylene Glycol ?5.0 Substrate, wetting agent
Aluminium hydroxide (Al (OH) 3) ?0.1 Substrate, cross-linking agent
Water ?57.7 Substrate
Amount to ?100
Preparation method:
1) preparation of substrate: according to above-mentioned prescription consumption proportion, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, glycerol (can stay the solvent of a little glycerol as step 3), propylene glycol, Polyethylene Glycol, aluminium hydroxide are stirred under 35 ℃ of water bath condition, add polyacrylic acid again, PVP (can be formulated as the PVP aqueous solution form of about 5wt% in advance, also claim " glue "), PVA (can be formulated as the PVA aqueous solution form of about 5wt% in advance), HPMC (can be formulated as the HPMC aqueous solution form of about 2wt% in advance), stir, obtain substrate.
2) preparation of pastille glue: after curcumin disperseed with an amount of solvent (dehydrated alcohol, water or glycerol) dissolving, be added in the substrate, add remaining water, stir, ultrasonic or leave standstill de-bubbled, obtain pastille glue.
3) preparation of gel adhesive: pastille glue is applied on the medical adhesive-bonded fabric, and in 60 ℃ of dry about 0.5h, loam cake cellophane protective layer cuts promptly.
[embodiment 3] preparation contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Prescription:
Component Consumption (g) Effect
Curcumin ?0.4 Active component
Pseudobulbus Bletillae (Rhizoma Bletillae) glue ?2.0 Active component, adhesive
?PVP?k-30 ?4.0 The solid dispersion material
Polyacrylic acid ?4.0 Framework material, adhesive
Polyvinylpyrrolidone (PVP) ?0.6 Substrate, adhesive
Polyvinyl alcohol (PVA) ?0.1 Substrate, adhesive
Hypromellose (HPMC) ?0.3 Substrate, adhesive
Glycerol ?25.0 Substrate, wetting agent
Propylene glycol ?15.0 Substrate, wetting agent
Polyethylene Glycol ?10.0 Substrate, wetting agent
Aluminium hydroxide ?0.2 Substrate, cross-linking agent
Water ?38.4 Substrate
Amount to ?100
Preparation method:
1) preparation of curcumin solid dispersion: according to above-mentioned prescription consumption proportion, curcumin is dissolved in an amount of dehydrated alcohol, add PVPk-30 and mix, ultrasonic 5min makes dissolving, fully stirs under 60 ℃ of condition of water bath heating, dehydrated alcohol is removed in evaporation, put and be chilled to room temperature, dry 5h in 50 ℃ of vacuum drying ovens takes out and pulverizes again, cross 80 mesh sieves, be stored in the exsiccator standby.
2) preparation of substrate: according to above-mentioned prescription consumption proportion, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, glycerol (can stay the solvent of a little glycerol as step 3), propylene glycol, Polyethylene Glycol, aluminium hydroxide are stirred under 25 ℃ of water bath condition, the HPMC of glue form of PVA, 2wt% of glue form that adds glue form PVP, the 5wt% of polyacrylic acid, 5wt% again, stir, obtain substrate.
3) preparation of pastille glue: after curcumin solid dispersion disperseed with an amount of solvent (water or glycerol) dissolving, be added in the substrate, add remaining water, stir, the ultrasonic degas bubble obtains pastille glue.
4) preparation of gel adhesive: pastille glue is applied on the medical adhesive-bonded fabric, and in 60 ℃ of dry about 0.5h, loam cake cellophane protective layer cuts promptly.
[embodiment 4] preparation contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Prescription:
Component Consumption (g) Effect
Curcumin ?0.4 Active component
Pseudobulbus Bletillae (Rhizoma Bletillae) glue ?1.0 Active component
Mannitol ?3.0 The solid dispersion material
Polyacrylic acid ?5.0 Framework material, adhesive
Polyvinylpyrrolidone (PVP) ?0.3 Substrate, adhesive
Polyvinyl alcohol (PVA) ?0.1 Substrate, adhesive
Hypromellose (HPMC) ?0.1 Substrate, adhesive
Glycerol ?35 Substrate, wetting agent
Propylene glycol ?10 Substrate, wetting agent
Polyethylene Glycol ?10 Substrate, wetting agent
Aluminium hydroxide ?0.1 Substrate, cross-linking agent
Water ?35.0 Substrate
Amount to ?100
Preparation method:
1) preparation of curcumin solid dispersion: according to above-mentioned consumption proportion, curcumin is dissolved in an amount of dehydrated alcohol, add mannitol, fully stir under 60 ℃ of condition of water bath heating, dehydrated alcohol is removed in evaporation, puts and is chilled to room temperature, dry 5h in 50 ℃ of vacuum drying ovens again, take out and pulverize, cross 80 mesh sieves, be stored in the exsiccator standby.
2) preparation of substrate: according to above-mentioned consumption proportion, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, glycerol, propylene glycol, Polyethylene Glycol, aluminium hydroxide are stirred under 30 ℃ of water bath condition, the HPMC of glue form of PVA, 1wt% of glue form of PVP, 6wt% that adds the glue form of polyacrylic acid, 5wt% again, stir, obtain substrate.
3) preparation of pastille glue: after curcumin solid dispersion disperseed with an amount of solvent (water or glycerol) dissolving, be added in the substrate, add remaining water, stir, the ultrasonic degas bubble obtains pastille glue.
4) preparation of gel adhesive: pastille glue is applied on the medical adhesive-bonded fabric, and in 40 ℃ of down dry about 3.0h, loam cake cellophane protective layer cuts promptly.
[embodiment 5] preparation contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Prescription:
Component Consumption (g) Effect
Curcumin ?0.2 Active component
Pseudobulbus Bletillae (Rhizoma Bletillae) glue ?1.5 Active component
Polyethylene glycol 6000 ?2.0 The solid dispersion material
Polyacrylic acid ?3.5 Framework material, adhesive
Polyvinylpyrrolidone (PVP) ?0.1 Substrate, adhesive
Polyvinyl alcohol (PVA) ?0.3 Substrate, adhesive
Hypromellose (HPMC) ?0.3 Substrate, adhesive
Glycerol ?20 Substrate, wetting agent
Propylene glycol ?5 Substrate, wetting agent
Polyethylene Glycol ?15 Substrate, wetting agent
Oleum menthae ?1.0 Substrate, penetrating agent
Borneolum Syntheticum ?0.5 Substrate, penetrating agent
Aluminium hydroxide ?0.1 Substrate, cross-linking agent
Water ?50.5 Substrate
Amount to ?100
Preparation method:
1) preparation of curcumin solid dispersion: according to above-mentioned consumption proportion, curcumin is dissolved in an amount of dehydrated alcohol, add polyethylene glycol 6000, fully stir under 60 ℃ of condition of water bath heating, dehydrated alcohol is removed in evaporation, puts and is chilled to room temperature, dry 5h in 50 ℃ of vacuum drying ovens again, take out and pulverize, cross 80 mesh sieves, be stored in the exsiccator standby.
2) preparation of substrate: according to above-mentioned consumption proportion, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, glycerol, propylene glycol, Polyethylene Glycol, aluminium hydroxide are stirred under 30 ℃ of water bath condition, the HPMC of glue form of PVA, 3.5wt% of glue form of PVP, 8wt% that adds the glue form of polyacrylic acid, 5wt% again, Oleum menthae, Borneolum Syntheticum, stir, obtain substrate.
3) preparation of pastille glue: after curcumin solid dispersion disperseed with an amount of solvent (water or glycerol) dissolving, be added in the substrate, add remaining water, stir, the ultrasonic degas bubble obtains pastille glue.
4) preparation of gel adhesive: pastille glue is applied on the medical adhesive-bonded fabric, and in 40 ℃ of down dry about 3.0h, loam cake cellophane protective layer cuts promptly.
[embodiment 6] preparation contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Prescription:
Component Consumption (g) Effect
Curcumin ?0.5 Active component
Pseudobulbus Bletillae (Rhizoma Bletillae) glue ?2.0 Active component
Poloxamer 188 ?5.0 The solid dispersion material
Polyacrylic acid ?4.5 Framework material, adhesive
Polyvinylpyrrolidone (PVP) ?0.2 Substrate, adhesive
Polyvinyl alcohol (PVA) ?0.2 Substrate, adhesive
Hypromellose (HPMC) ?0.2 Substrate, adhesive
Glycerol ?30.0 Substrate, wetting agent
Propylene glycol ?5.0 Substrate, wetting agent
Polyethylene Glycol ?5.0 Substrate, wetting agent
HP- ?0.5 Substrate, penetrating agent
Olive oil ?0.5 Substrate, penetrating agent
Aluminium hydroxide ?0.2 Substrate, cross-linking agent
Water ?46.2 Substrate
Amount to ?100
Preparation method:
1) preparation of curcumin solid dispersion: according to above-mentioned consumption proportion, curcumin is dissolved in an amount of dehydrated alcohol, add polyethylene glycol 6000, fully stir under 60 ℃ of condition of water bath heating, dehydrated alcohol is removed in evaporation, puts and is chilled to room temperature, dry 5h in 50 ℃ of vacuum drying ovens again, take out and pulverize, cross 80 mesh sieves, be stored in the exsiccator standby.
2) preparation of substrate: according to above-mentioned consumption proportion, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, glycerol, propylene glycol, Polyethylene Glycol, aluminium hydroxide are stirred under 25 ℃ of water bath condition, HPMC, HP-, the olive oil of glue form of PVA, 1wt% of glue form of PVP, 6wt% that adds the glue form of polyacrylic acid, 5wt% again, stir, obtain substrate.
3) preparation of pastille glue: after curcumin solid dispersion disperseed with an amount of solvent (water or glycerol) dissolving, be added in the substrate, add remaining water, stir, the ultrasonic degas bubble obtains pastille glue.
4) preparation of gel adhesive: pastille glue is applied on the medical adhesive-bonded fabric, and in 50 ℃ of down dry about 2.0h, loam cake cellophane protective layer cuts promptly.
[embodiment 7] preparation contains the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Prescription:
Component Consumption (g) Effect
Curcumin ?0.3 Active component
Pseudobulbus Bletillae (Rhizoma Bletillae) glue ?1.5 Active component, adhesive
Polyacrylic acid ?3.0 Framework material, adhesive
Polyvinylpyrrolidone (PVP) ?0.6 Substrate, adhesive
Polyvinyl alcohol (PVA) ?0.3 Substrate, adhesive
Hypromellose (HPMC) ?0.3 Substrate, adhesive
Glycerol ?20.0 Substrate, wetting agent
Propylene glycol ?10.0 Substrate, wetting agent
Polyethylene Glycol ?10.0 Substrate, wetting agent
Oleum menthae ?1.0 Substrate, penetrating agent
Aluminium hydroxide ?0.2 Substrate, cross-linking agent
Water ?52.8 Substrate
Amount to ?100
Preparation method:
1) preparation of substrate: according to above-mentioned consumption proportion, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, glycerol, propylene glycol, Polyethylene Glycol, aluminium hydroxide are stirred under 30 ℃ of water bath condition, the HPMC of glue form of PVA, 1wt% of glue form of PVP, 6wt% that adds the glue form of polyacrylic acid, Oleum menthae, 5wt% again, stir, obtain substrate.
2) preparation of pastille glue: after curcumin disperseed with the dissolving of suitable quantity of water or glycerol, be added in the substrate, add remaining water, stir, the ultrasonic degas bubble obtains pastille glue.
3) preparation of gel adhesive: pastille glue is applied on the medical adhesive-bonded fabric, and in 50 ℃ of down dry about 2.0h, loam cake cellophane protective layer cuts promptly.
The recruitment evaluation of [embodiment 8] gel adhesive
1, extracorporeal releasing experiment (Chinese Pharmacopoeia 2005 editions, two appendix XD, the three therapeutic methods of traditional Chinese medicine)
The gel adhesive of getting embodiment 1,2,3 is denoted as sample A, B and C, throws off protective layer and is fixed between the two-layer video disc, and emission surface up.As accepting medium, accepting medium temperature is 32 ± 0.5 ℃ with 30% ethanol-normal saline solution, and accepting the medium volume is 200mL, and mixing speed is 100rmin -1In experiment beginning back sampling, behind 0.45 μ m filtering with microporous membrane, after each sampling, add the blank acceptable solution of isothermal.Calculate the cumulative release amount of each time period by the analysis result of each sample point.Each time point drug accumulation discharges percentage rate Q and is listed in the table below 1.With time t each point cumulative release percentage rate Q is figure, obtains the release in vitro curve, as shown in Figure 1.
Table 1 contains the extracorporeal releasing experiment result (n=6) of the gel adhesive of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Figure BSA00000553919600111
2, the transdermal performance is investigated
The gel adhesive of getting embodiment 1,2,3 is denoted as sample A, B and C, carries out the transdermal test.
Adopt the Franze diffusion cell of improvement, device transdermal area is 1.766cm 2, the volume of accepting the pond is 17mL, ON cycle water-bath, 32 ± 1 ℃ of constant temperature.Get mouse skin and be fixed on and accept between pond and the supply pool, patch is cut into suitable size, be affixed on the above-mentioned synthetic membrane, accept the pond with the normal saline of 30% dehydrated alcohol for accepting medium, make itself and contact skin.It is closely fixing to accept pond and supply chamber, drains bubble, adds stirrer with 150rmin -1Speed stir, respectively at 1,2,4,6,8,12,20, the 32h 3mL that take a sample from accept the pond places test tube, need further dilute with constant temperature (32 ℃) acceptable solution by the patch of solid dispersion making, add 32 ℃ of acceptable solution 3mL simultaneously.Measure absorbance in the 425nm place, substitution regression equation calculation concentration, and try to achieve unit are accumulative total infiltration capacity according to following formula, Q=(CnVn+ ∑ CiVi)/S, wherein Cn is the concentration of n sub-sampling, and Vn is the volume of n sub-sampling, and Ci is the concentration of i sub-sampling, Vi is the volume of i sub-sampling, and S is the transdermal area.To time (t) mapping, obtain equation with unit are accumulative total infiltration capacity (Qr), calculate percutaneous rate Js.
The accumulation transdermal amount Q of each time point t is as shown in table 2 below in each gel adhesive.With the time (t) to the accumulation transdermal amount (Qr) mapping, obtain the release in vitro curve, see Fig. 2.With time t 1/2To each point accumulation transdermal amount Q mapping, see Fig. 3.Unit are accumulative total infiltration capacity (Qr)-t curve is pressed zero level Q-t and Higuchi equation Q-t respectively 1/2Carry out the model match, calculate infiltration rate, the results are shown in Table 3.
Table 2 contains the gel adhesive transdermal test in vitro experimental result (n=6) of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Table 3 contains the gel adhesive model The regression equation of curcumin and Pseudobulbus Bletillae (Rhizoma Bletillae) glue
Prescription The zero level equation R 2 Js/μg.cm -2.h -1 The Higuchi equation R 2 Js/μg.cm -2.h -1
A Q＝1.189t+1.819 0.9828 1.189 ?Q＝66.269t 1/2-0.444 0.9697 66.269
B Q＝3.999t+31.391 0.8813 3.999 ?Q＝28.33t 1/2-8.638 0.9721 28.33
C Q＝9.075t+96.907 0.7898 9.075 ?Q＝7.978t 1/2-8.769 0.9231 7.987
From The above results as can be seen, gel adhesive of the present invention can reach more than 93% at the 2h medicine realeasing rate; Drug accumulation transdermal amount reaches 40 μ gcm -2More than, accumulation transdermal amount reached 347 μ gcm after medication preparation became solid dispersion -2, significantly improve the accumulation transdermal amount of medicine.Said preparation can be stablized administration in 32h.
Gel adhesive of the present invention can be cut into suitable size in clinical practice, every subsides contain different sizes such as curcumin 10mg, 20mg, and each one pastes the external application affected part.
More than be that description to preferred embodiment of the present invention does not limit the present invention, those skilled in the art can make various changes and distortion according to the present invention, only otherwise break away from spirit of the present invention, all should belong to the category of claims of the present invention.

Claims (9)

1.一种含有姜黄素和白芨胶的凝胶贴剂，其特征在于，包括以下重量配比的组分：1. a gel patch containing curcumin and bletilla striata gum, is characterized in that, comprises the component of following weight ratio: 姜黄素0.2～0.5      白芨胶1.0～2.5    骨架材料2.0～5.0Curcumin 0.2～0.5 Bletilla striata gum 1.0～2.5 Skeleton material 2.0～5.0 胶粘剂0.4～1.4      保湿剂25.0～65.0  交联剂0.1～0.2Adhesive 0.4～1.4 Moisturizing agent 25.0～65.0 Crosslinking agent 0.1～0.2 固体分散材料0～5.0  促渗剂0～1.5      水35.0～58.0Solid dispersion material 0～5.0 Penetration enhancer 0～1.5 Water 35.0～58.0 其中所述骨架材料为聚丙烯酸；所述胶粘剂为选自聚乙烯吡咯烷酮、羟丙甲纤维素、淀粉、聚乙烯醇、明胶、阿拉伯胶、聚乙二醇中的一种或多种；所述保湿剂为选自甘油、丙二醇、山梨醇、聚乙二醇、乙二醇、1，3-丁二醇中的一种或多种；所述交联剂为氢氧化铝；所述固体分散材料为选自聚乙烯吡咯烷酮、羟丙甲纤维素、壳聚糖、甘露醇、聚乙二醇、泊洛沙姆中的一种或多种；所述促渗剂为选自羟丙基-β-环糊精、冰片、薄荷油、橄榄油、尿素中的一种或多种。Wherein the skeleton material is polyacrylic acid; the adhesive is one or more selected from polyvinylpyrrolidone, hypromellose, starch, polyvinyl alcohol, gelatin, gum arabic, polyethylene glycol; the The moisturizing agent is one or more selected from glycerin, propylene glycol, sorbitol, polyethylene glycol, ethylene glycol, and 1,3-butanediol; the crosslinking agent is aluminum hydroxide; the solid dispersion The material is one or more selected from polyvinylpyrrolidone, hypromellose, chitosan, mannitol, polyethylene glycol, and poloxamer; the penetration enhancer is selected from hydroxypropyl- One or more of β-cyclodextrin, borneol, peppermint oil, olive oil, and urea. 2.如权利要求1所述的凝胶贴剂，其特征在于，所述凝胶贴剂包括以下重量配比的组分：2. The gel patch according to claim 1, wherein the gel patch comprises the following components by weight:
Figure FSA00000553919500011
Figure FSA00000553919500011
 3.如权利要求1所述的凝胶贴剂，其特征在于，所述白芨胶是通过以下方法制备：将1重量份白芨药材粉碎后加入10～12倍体积的蒸馏水中，加热至50℃搅拌1小时，过滤，收集提取液；然后药渣分别加5～6倍体积的蒸馏水重复提取1～3次；合并提取液，浓缩至一半体积，加入95％乙醇调节乙醇质量浓度至70％，析出沉淀，离心，收集沉淀，用乙醇洗涤，于80℃干燥，得到白芨胶。3. The gel patch according to claim 1, wherein the bletilla striata glue is prepared by the following method: after pulverizing 1 part by weight of bletilla striata medicinal material, add 10 to 12 times the volume of distilled water, and heat to 50°C Stir for 1 hour, filter, and collect the extract; then add 5-6 times the volume of distilled water to the medicinal residues and repeat the extraction 1-3 times; combine the extracts, concentrate to half the volume, add 95% ethanol to adjust the ethanol mass concentration to 70%, The precipitate was precipitated, centrifuged, the precipitate was collected, washed with ethanol, and dried at 80°C to obtain Bletilla striata gum. 4.如权利要求1所述的凝胶贴剂，其特征在于，所述凝胶贴剂包括以下重量配比的组分：4. The gel patch as claimed in claim 1, characterized in that, the gel patch comprises the following components by weight: 姜黄素0.4、白芨胶2.5、聚丙烯酸3.0、聚乙烯吡咯烷酮0.8、聚乙烯醇0.3羟丙甲纤维素0.2、甘油15.0、丙二醇15.0、聚乙二醇5.0、氢氧化铝0.1、水57.7。Curcumin 0.4, Bletilla striata gum 2.5, polyacrylic acid 3.0, polyvinylpyrrolidone 0.8, polyvinyl alcohol 0.3 hypromellose 0.2, glycerin 15.0, propylene glycol 15.0, polyethylene glycol 5.0, aluminum hydroxide 0.1, water 57.7. 5.如权利要求1所述的凝胶贴剂，其特征在于，所述凝胶贴剂包括以下重量配比的组分：5. The gel patch as claimed in claim 1, characterized in that, the gel patch comprises the following components by weight: 姜黄素0.4、白芨胶2.0、聚丙烯酸4.0、聚乙烯吡咯烷酮0.6、聚乙烯醇0.1、羟丙甲纤维素0.3、甘油25.0、丙二醇15.0、聚乙二醇10.0、氢氧化铝0.2、聚乙烯吡咯烷酮k-304.0、水38.4。Curcumin 0.4, Bletilla striata gum 2.0, polyacrylic acid 4.0, polyvinylpyrrolidone 0.6, polyvinyl alcohol 0.1, hypromellose 0.3, glycerin 25.0, propylene glycol 15.0, polyethylene glycol 10.0, aluminum hydroxide 0.2, polyvinylpyrrolidone k -304.0, water 38.4. 6.如权利要求1所述的凝胶贴剂，其特征在于，所述凝胶贴剂包括以下重量配比的组分：6. The gel patch as claimed in claim 1, characterized in that, the gel patch comprises the following components by weight: 姜黄素0.4、白芨胶1.0、聚丙烯酸5.0、聚乙烯吡咯烷酮0.3、聚乙烯醇0.1、羟丙甲纤维素0.1、甘油35.0、丙二醇10.0、聚乙二醇10.0、氢氧化铝0.1、甘露醇3.0、水35.0。Curcumin 0.4, Bletilla striata gum 1.0, polyacrylic acid 5.0, polyvinylpyrrolidone 0.3, polyvinyl alcohol 0.1, hypromellose 0.1, glycerin 35.0, propylene glycol 10.0, polyethylene glycol 10.0, aluminum hydroxide 0.1, mannitol 3.0, Water 35.0. 7.一种制备权利要求1所述的凝胶贴剂的方法，包括步骤：7. A method for preparing the gel patch according to claim 1, comprising the steps of: 1)姜黄素固体分散体的制备：按照处方用量配比，将姜黄素溶于适量有机溶剂无水乙醇或丙酮中，与固体分散材料混合，于60℃水浴加热条件下充分搅拌，蒸发除去有机溶剂，放冷至室温，再于45～55℃真空干燥箱中干燥5h，取出粉碎，过筛，即得；1) Preparation of curcumin solid dispersion: Dissolve curcumin in an appropriate amount of organic solvent absolute ethanol or acetone according to the dosage ratio of the prescription, mix it with solid dispersion materials, stir fully under the condition of heating in a water bath at 60°C, and evaporate to remove organic matter. Let the solvent cool down to room temperature, then dry it in a vacuum oven at 45-55°C for 5 hours, take it out, pulverize it, and sieve it to obtain it; 2)基质的制备：按照处方用量配比，将白芨胶、保湿剂、交联剂在25℃～35℃水浴条件下搅拌均匀，然后加入骨架材料、胶粘剂、促渗剂，充分搅拌，即得；2) Preparation of matrix: according to the dosage ratio of the prescription, mix bletilla striata gum, humectant, and cross-linking agent evenly in a water bath at 25°C to 35°C, then add skeleton materials, adhesives, and penetration enhancers, and stir thoroughly to obtain ; 3)含药胶的制备：按照处方用量配比，将姜黄素或者步骤1)制备的姜黄素固体分散体用适量水或甘油溶解分散后加到基质中，加入剩余的水，充分搅拌均匀，脱气泡，即得；3) Preparation of drug-containing gel: Dissolve and disperse curcumin or the curcumin solid dispersion prepared in step 1) with an appropriate amount of water or glycerin according to the dosage ratio of the prescription, add to the matrix, add the remaining water, and stir well, Degassing, that is; 4)凝胶贴剂的制备：将含药胶涂于背衬层上，于40～60℃下干燥0.5～3.5h，上盖保护层，裁切，即得。4) Preparation of gel patch: apply the drug-containing gel on the backing layer, dry at 40-60°C for 0.5-3.5 hours, cover with a protective layer, and cut to obtain the product. 8.如权利要求7所述的方法，其特征在于，所述步骤2)中胶粘剂是以0.5～10wt％的水溶液形式添加。8. The method according to claim 7, characterized in that, in the step 2), the adhesive is added in the form of a 0.5-10 wt% aqueous solution. 9.如权利要求8所述的方法，其特征在于，所述步骤2)中胶粘剂选自聚乙烯吡咯烷酮、聚乙烯醇和羟丙甲纤维素，并且聚乙烯吡咯烷酮是以1.5～8.5wt％的水溶液形式添加，聚乙烯醇是以1.5～9.5wt％的水溶液形式添加，羟丙甲纤维素是以0.5～3.5wt％的水溶液形式添加。9. method as claimed in claim 8 is characterized in that, in described step 2), tackiness agent is selected from polyvinylpyrrolidone, polyvinyl alcohol and hypromellose, and polyvinylpyrrolidone is the aqueous solution of 1.5～8.5wt% The polyvinyl alcohol is added in the form of an aqueous solution of 1.5 to 9.5 wt%, and the hypromellose is added in the form of an aqueous solution of 0.5 to 3.5 wt%.
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CN108379643A (en) * 2018-02-13 2018-08-10 云南宁康生物科技有限公司 A kind of hydrogel woundplast of the active constituent containing American cockroach
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CN110201216A (en) * 2019-07-24 2019-09-06 中国人民解放军陆军军医大学第二附属医院 One kind is for through and through wound rapid hemostatic material and preparation method thereof
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