CN115554276A - Joint maintenance patch composition and preparation method thereof - Google Patents

Joint maintenance patch composition and preparation method thereof Download PDF

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Publication number
CN115554276A
CN115554276A CN202111663575.8A CN202111663575A CN115554276A CN 115554276 A CN115554276 A CN 115554276A CN 202111663575 A CN202111663575 A CN 202111663575A CN 115554276 A CN115554276 A CN 115554276A
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China
Prior art keywords
patch composition
patch
joint
cross
sodium
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CN202111663575.8A
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Chinese (zh)
Inventor
尹威
李栋
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Shanghai Dazhou Health Technology Co ltd
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Shanghai Dazhou Health Technology Co ltd
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Priority to CN202111663575.8A priority Critical patent/CN115554276A/en
Publication of CN115554276A publication Critical patent/CN115554276A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention provides a joint maintenance patch composition and a preparation method thereof, the patch composition is prepared from glucosamine sulfate, chondroitin sulfate and sodium hyaluronate as active ingredients and a polymer framework material, a cross-linking agent, a filling agent, a moisturizing ingredient, a preservative, a pH regulator, a cooling substance and deionized water as auxiliary ingredients, and the patch composition can effectively relieve the joint sore and stabbing pain by virtue of a physical cooling effect and a repairing and maintenance effect of the active ingredients caused by volatilization of the raw materials such as the cooling ingredient, is particularly suitable for enthusiasts such as lovers, fitness and running to relieve joint sore and stabbing pain, has good air permeability, selects safe and non-allergenic ingredients, and can reduce the probability of skin redness, swelling, heating, pruritus and the like of the patch in the using process.

Description

Joint maintenance patch composition and preparation method thereof
Technical Field
The invention belongs to the technical field of A61K9/06, and particularly relates to a joint maintenance patch composition and a preparation method thereof.
Background
The muscle or the bone joint is easily damaged due to improper hot body or improper exercise posture in the exercise and fitness process, the muscle damage or the joint damage caused by exercise in the prior art is generally treated in an ice compress cooling mode, however, the ice compress needs to prepare an ice bag or ice blocks, the optimal ice compress time is easily missed, and the ice compress process easily causes secondary frostbite of the damaged part.
Chinese patent CN110478334A discloses an analgesic and analgesic plaster for muscles and joints, which has the effects of relieving pain and easing pain for muscles and joints by releasing medicines and quickly cooling, but the plaster prepared by the patent has excessive content of ice substance and strong irritation to skin.
Chinese patent CN110548003B discloses a nano composition using chondroitin sulfate as a medicinal component, which proves that the chondroitin sulfate external liquid can quickly reach bone joint and has certain effect on maintenance and repair of joints.
Based on the above, the application provides a joint care patch composition and a preparation method thereof.
Disclosure of Invention
The invention provides a joint maintenance patch composition in a first aspect, which is prepared from the following raw materials: functional components, a high-molecular framework material, a cross-linking agent, a filling agent, a moisturizing component, a preservative, a pH regulator, a cool substance and deionized water.
In a preferred embodiment, the functional ingredients are compound substances of glucosamine sulfate, chondroitin sulfate and sodium hyaluronate.
In a preferred embodiment, the mass ratio of glucosamine sulfate, chondroitin sulfate and sodium hyaluronate is (35-50): (10-25): 1.
in a preferred embodiment, the mass ratio of glucosamine sulfate, chondroitin sulfate and sodium hyaluronate is 40:20:1.
in a preferred embodiment, the mass ratio of the functional component to the cross-linking agent is 1: (3-30).
In a preferred embodiment, the mass ratio of the efficacy component to the cross-linking agent is 1:3.
in a preferred embodiment, the preparation raw materials comprise, by mass, 0.1-0.5% of an effective component, 3-10% of a polymer framework material, 0.2-1.5% of a cross-linking agent, 5-15% of a filling agent, 10-20% of a moisture retention component, 0.3-0.8% of a preservative, 0.1-1% of a pH regulator, 0.1-1% of a cooling substance, and the balance of deionized water.
In a preferred embodiment, the polymer skeleton material is selected from at least one of sodium alginate, polyacrylamide, sodium polyacrylate, cross-linked polyacrylate, carboxymethyl chitosan and hydroxyethyl chitosan.
In a preferred embodiment, the polymer framework material is a compound substance of sodium alginate and sodium polyacrylate.
In a preferred embodiment, the mass ratio of sodium alginate to sodium polyacrylate is (5-10): 1, more preferably, the mass ratio of the sodium alginate to the sodium polyacrylate is 8:1.
in a preferred embodiment, the crosslinking agent is at least one selected from the group consisting of glycidyl ethers and derivatives thereof, polyvalent metal compounds, aldehydes, EDTA-2 Na.
In a preferred embodiment, the polyvalent metal compound is selected from at least one of magnesium aluminum silicate, magnesium sulfate, aluminum succinate, aluminum chloride, calcium sulfate, magnesium carbonate, dihydroxyaluminum aminoacetate.
In a preferred embodiment, the glycidyl ether and its derivatives are selected from at least one of 1, 4-butanediol diglycidyl ether, neopentyl glycol diglycidyl ether, ethylene glycol diglycidyl ether, n-butyl glycidyl ether, octyl glycidyl ether.
In a preferred embodiment, the crosslinking agent comprises a complex of glycidyl ethers and derivatives thereof, polyvalent metal compounds.
In a preferred embodiment, the cross-linking agent is a compound substance of dihydroxyaluminum aminoacetate and ethylene glycol diglycidyl ether, and more preferably, the mass ratio of the dihydroxyaluminum aminoacetate to the ethylene glycol diglycidyl ether is 2:1.
in a preferred embodiment, the filler is at least one selected from mineral powder, bamboo charcoal powder, silica gel micropowder, gelatin, alkyl cellulose and its derivatives, and polyvinyl alcohol.
In a preferred embodiment, the filler is polyvinyl alcohol and aerosil.
In a preferred embodiment, the polyvinyl alcohol has an average degree of polymerization of 500 to 600; the specific surface area of the micropowder silica gel is 200 +/-25 m 2 /g。
In a preferred embodiment, the mass ratio of the polyvinyl alcohol to the aerosil is 3:1.
in a preferred embodiment, the moisturizing component is selected from at least one of glycerin, polyethylene glycol, propylene glycol, butylene glycol, pentylene glycol, dipropylene glycol.
In a preferred embodiment, the moisturizing component is 1, 3-butanediol and glycerin.
In a preferred embodiment, the mass ratio of glycerol to 1, 3-butanediol is 1:1.
in a preferred embodiment, the cooling substance is at least one selected from the group consisting of menthol, menthyl acetate, menthyl lactate, and borneol.
In a preferred embodiment, the cooling substance is menthol.
In a preferred embodiment, the preservative is selected from at least one of sorbitol, ethylparaben, methylparaben, ethanol, benzoic acid, and paraben.
In a preferred embodiment, the preservative is ethylparaben.
In a preferred embodiment, the pH adjusting agent is sodium citrate.
In a preferred embodiment, the preparation raw materials comprise, by mass, 0.5% of an effective component, 9% of a polymer framework material, 1.5% of a cross-linking agent, 8% of a filling agent, 20% of a moisturizing component, 0.5% of a preservative, 0.3% of a pH regulator, 0.8% of a cooling substance, and the balance deionized water.
In a preferred embodiment, the preparation raw materials comprise, by mass, 0.5% of an effective component, 8% of sodium alginate, 1% of sodium polyacrylate, 1% of dihydroxyaluminum aminoacetate, 0.5% of ethylene glycol diglycidyl ether, 6% of polyvinyl alcohol, 2% of aerosil, 10% of 1, 3-butanediol, 10% of glycerol, 0.5% of a preservative, 0.3% of a pH regulator, 0.8% of menthol and the balance deionized water.
In the application, the polyvinyl alcohol and the micropowder silica gel can be combined with a three-dimensional support structure formed by cross-linking raw materials such as sodium alginate, sodium polyacrylate and the like, so that the stability of the micropowder silica gel in a system is improved, the storage stability of the composition is improved, and the formed stable three-dimensional support structure adsorbs effective components, moisturizing components, cool substances and water in the composition in the three-dimensional structure, thereby playing a mild and lasting effect.
Meanwhile, the polyvinyl alcohol and the micropowder silica gel are added to play a role in adjusting the viscosity of the composition, so that the problems that a patch formed by the composition is not easy to tear from the surface of skin and easy to remain after use are solved, and the use feeling of the patch is improved.
In a second aspect, the present invention provides a method for preparing a joint care patch composition, comprising the steps of:
(1) Adding the moisture-keeping components and the high-molecular framework material into a stirring container, and uniformly stirring;
(2) Adding the filler, the cross-linking agent and the functional components, and uniformly stirring;
(3) And finally, adding a preservative, a pH regulator, a cool substance and deionized water, and uniformly stirring to obtain the composition.
Compared with the prior art, the beneficial effect that this application has:
1. the patch composition prepared by the invention can effectively relieve the joint sore and stabbing pain feeling by virtue of the physical cooling effect and the repairing and maintaining effect of the functional substances brought by volatilization of the raw materials such as the cool feeling components, and is particularly suitable for the sports enthusiasts such as lovely balls, fitness, running and the like to relieve the joint sore and stabbing pain.
2. The patch composition prepared by the invention has good skin attaching and fitting effect, no binding feeling in the using process, no influence on normal movement, excellent skin attaching force in the initial using stage, reduced adhesive capacity between the patch and the skin contact surface along with the use of the patch, convenient tearing of the patch, and no residue formed on the skin surface.
3. The patch composition prepared by the invention has good air permeability, selects safe and non-allergic components, and can reduce the probability of skin red swelling, fever, pruritus and the like in the use process of the patch.
Detailed Description
Example 1
In the first aspect of this embodiment, a joint care patch composition is provided, where raw materials include, by mass, 0.5% of an active ingredient, 8% of sodium alginate, 1% of sodium polyacrylate, 1% of dihydroxyaluminum aminoacetate, 0.5% of ethylene glycol diglycidyl ether, 6% of polyvinyl alcohol, 2% of aerosil, 10% of 1, 3-butanediol, 10% of glycerol, 0.5% of ethylparaben, 0.3% of sodium citrate, 0.8% of menthol, and the balance deionized water.
The functional components are compound substances of glucosamine sulfate, chondroitin sulfate and sodium hyaluronate, and the mass ratio of the glucosamine sulfate, the chondroitin sulfate and the sodium hyaluronate is 40:20:1.
in a second aspect, this embodiment provides a method for preparing a joint care patch composition, comprising the steps of:
(1) Adding 1, 3-butanediol, glycerol, sodium alginate and sodium polyacrylate into a stirring container, and uniformly stirring;
(2) Adding micro silica gel powder, polyvinyl alcohol, dihydroxyaluminum aminoacetate, ethylene glycol diglycidyl ether and functional components, and stirring uniformly;
(3) And finally, adding ethylparaben, sodium citrate, menthol and deionized water, and uniformly stirring to obtain the composition.
Sodium polyacrylate, model NP700, was purchased from Biotechnology Inc. of Byao.
Polyvinyl alcohol is purchased from Xiantian pure pharmaceutical excipients Co., ltd, and has an average degree of polymerization of 500 to 600.
The silica gel micropowder is purchased from Xian Tianzheng pharmaceutic adjuvant Co Ltd, and has a specific surface area of 200 +/-25 m 2 The model is VK-SP30S.
Example 2
The first aspect of this example proposes a joint care patch composition, and the second aspect of this example proposes a method for producing a joint care patch composition, specifically using the same raw materials as in example 1, except that: sodium polyacrylate was not added and the total amount of sodium alginate added was 9%.
Example 3
The first aspect of this example proposes a joint care patch composition, and the second aspect of this example proposes a method for producing a joint care patch composition, specifically using the same raw materials as in example 1, except that: no ethylene glycol diglycidyl ether was added.
Example 4
The first aspect of this example proposes a joint care patch composition, and the second aspect of this example proposes a method for producing a joint care patch composition, specifically using the same raw materials as in example 1, except that: the polyvinyl alcohol has an average degree of polymerization of 2000 to 2500.
Performance testing
The patch composition prepared in example was coated on a non-woven fabric, the thickness of the patch composition was 1.5mm, and a vinyl film was attached to the other side of the composition to prepare an articular care patch. And testing the storage stability, the adhesion and the residues of the prepared joint nursing plaster. The data are recorded in table 1.
1. Adhesion force
The polyethylene film is removed from the joint maintenance sticker, the non-woven fabric surface of the joint maintenance sticker is flatly attached to an NLT-30 adhesion tester by using double faced adhesive tape, and the adhesion is tested.
2. Storage stability
The joint maintenance patch is placed at 4 ℃ and 54 ℃ for 3 months respectively, then the maintenance patch is heated at 25 ℃ and the adhesion force is tested according to the adhesion force test method.
3. Residue testing
Tearing off the polyethylene film from the joint maintenance patch, pasting the sticky surface on a black plastic plate, placing in a thermostat with the temperature of 37 +/-2 ℃ and the humidity of 40%, placing for 30min, taking out, tearing off the joint maintenance patch, and observing the residual condition of the patch on the black plastic plate. When no patch remained on the black plastic plate, it was marked as "excellent"; when the area of the patch remained on the black plastic plate does not reach 10% of the total area of the patch, the patch is marked as 'good'; when the area of the patch remaining on the black plastic plate exceeds 10% of the total area of the patch, it is recorded as "poor".
TABLE 1
Figure BDA0003450378030000061

Claims (10)

1. The joint maintenance patch composition is characterized by being prepared from the following raw materials: functional components, a high-molecular framework material, a cross-linking agent, a filling agent, a moisturizing component, a preservative, a pH regulator, a cool substance and deionized water.
2. The patch composition of claim 1, wherein the active ingredient is a combination of glucosamine sulfate, chondroitin sulfate, and sodium hyaluronate.
3. The patch composition of claim 1, wherein said polymeric backbone material is selected from at least one of sodium alginate, polyacrylamide, sodium polyacrylate, cross-linked polyacrylate, carboxymethyl chitosan, hydroxyethyl chitosan.
4. The patch composition of claim 3, wherein the polymer skeleton material is a compound substance of sodium alginate and sodium polyacrylate, and the mass ratio of sodium alginate to sodium polyacrylate is (5-10): 1.
5. the patch composition according to claim 1, wherein the filler is at least one selected from the group consisting of mineral powder, bamboo charcoal powder, silica gel, gelatin, alkyl cellulose and its derivatives, and polyvinyl alcohol.
6. The patch composition of claim 5, wherein said filler is polyvinyl alcohol and aerosil.
7. The patch composition according to claim 1, wherein said crosslinking agent is at least one selected from the group consisting of glycidyl ethers and derivatives thereof, polyvalent metal compounds, aldehydes, and EDTA-2 Na.
8. The patch composition of claim 7, wherein said cross-linking agent comprises a complex of glycidyl ethers and derivatives thereof, and polyvalent metal compounds.
9. The patch composition according to claim 8, wherein said glycidyl ether and its derivative are at least one selected from the group consisting of 1, 4-butanediol diglycidyl ether, neopentyl glycol diglycidyl ether, ethylene glycol diglycidyl ether, n-butyl glycidyl ether, and octyl glycidyl ether.
10. A method of manufacturing a joint care patch composition according to any one of claims 1-9, comprising the steps of:
(1) Adding the moisture-keeping components and the high-molecular framework material into a stirring container, and uniformly stirring;
(2) Adding the filler, the cross-linking agent and the functional components, and uniformly stirring;
(3) And finally, adding a preservative, a pH regulator, a cool substance and deionized water, and uniformly stirring to obtain the composition.
CN202111663575.8A 2021-12-31 2021-12-31 Joint maintenance patch composition and preparation method thereof Pending CN115554276A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116459238A (en) * 2023-05-08 2023-07-21 乐明药业(苏州)有限公司 Composition for promoting sustained release of glucosamine and application thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116459238A (en) * 2023-05-08 2023-07-21 乐明药业(苏州)有限公司 Composition for promoting sustained release of glucosamine and application thereof
CN116459238B (en) * 2023-05-08 2023-12-05 乐明药业(苏州)有限公司 Composition for promoting sustained release of glucosamine and application thereof

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