CN113827579A - Preparation method and equipment of slow-release gel medicine patch - Google Patents
Preparation method and equipment of slow-release gel medicine patch Download PDFInfo
- Publication number
- CN113827579A CN113827579A CN202111294650.8A CN202111294650A CN113827579A CN 113827579 A CN113827579 A CN 113827579A CN 202111294650 A CN202111294650 A CN 202111294650A CN 113827579 A CN113827579 A CN 113827579A
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- China
- Prior art keywords
- base film
- slow
- release gel
- roller
- glue
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Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 21
- 239000003814 drug Substances 0.000 title claims description 63
- 238000004026 adhesive bonding Methods 0.000 claims abstract description 89
- 239000003292 glue Substances 0.000 claims abstract description 69
- 239000011248 coating agent Substances 0.000 claims abstract description 20
- 238000000576 coating method Methods 0.000 claims abstract description 20
- 230000007246 mechanism Effects 0.000 claims abstract description 20
- 230000001681 protective effect Effects 0.000 claims abstract description 19
- 238000000926 separation method Methods 0.000 claims abstract description 12
- 239000000499 gel Substances 0.000 claims description 89
- 229940079593 drug Drugs 0.000 claims description 49
- 239000000017 hydrogel Substances 0.000 claims description 44
- 238000013268 sustained release Methods 0.000 claims description 35
- 239000012730 sustained-release form Substances 0.000 claims description 35
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 27
- 239000000853 adhesive Substances 0.000 claims description 24
- 230000001070 adhesive effect Effects 0.000 claims description 24
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 22
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 22
- 239000011975 tartaric acid Substances 0.000 claims description 22
- 235000002906 tartaric acid Nutrition 0.000 claims description 22
- 238000001125 extrusion Methods 0.000 claims description 20
- 239000002390 adhesive tape Substances 0.000 claims description 17
- 239000000463 material Substances 0.000 claims description 17
- 239000000178 monomer Substances 0.000 claims description 16
- 239000003961 penetration enhancing agent Substances 0.000 claims description 16
- 239000002243 precursor Substances 0.000 claims description 15
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims description 14
- 239000007864 aqueous solution Substances 0.000 claims description 13
- 239000003431 cross linking reagent Substances 0.000 claims description 13
- 239000003054 catalyst Substances 0.000 claims description 12
- 239000000243 solution Substances 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 11
- PQUXFUBNSYCQAL-UHFFFAOYSA-N 1-(2,3-difluorophenyl)ethanone Chemical compound CC(=O)C1=CC=CC(F)=C1F PQUXFUBNSYCQAL-UHFFFAOYSA-N 0.000 claims description 10
- 239000004925 Acrylic resin Substances 0.000 claims description 10
- -1 maleic anhydride tetradecyl sodium propanesulfonate Chemical compound 0.000 claims description 10
- 238000002156 mixing Methods 0.000 claims description 10
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 10
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 10
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 10
- 229940047670 sodium acrylate Drugs 0.000 claims description 10
- 239000002904 solvent Substances 0.000 claims description 10
- 238000004519 manufacturing process Methods 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- AXTGDCSMTYGJND-UHFFFAOYSA-N 1-dodecylazepan-2-one Chemical group CCCCCCCCCCCCN1CCCCCC1=O AXTGDCSMTYGJND-UHFFFAOYSA-N 0.000 claims description 8
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 claims description 8
- 229960003639 laurocapram Drugs 0.000 claims description 8
- 210000002469 basement membrane Anatomy 0.000 claims description 6
- 229960000905 indomethacin Drugs 0.000 claims description 6
- 239000011505 plaster Substances 0.000 claims description 5
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims description 3
- 238000000748 compression moulding Methods 0.000 claims description 3
- 229960001680 ibuprofen Drugs 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- QUVCFQAHXXKABX-UHFFFAOYSA-K C(CO)(=O)[O-].O[Al+]O Chemical compound C(CO)(=O)[O-].O[Al+]O QUVCFQAHXXKABX-UHFFFAOYSA-K 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- HDVDLQFPDLTOSI-UHFFFAOYSA-L O[AlH]O Chemical compound O[AlH]O HDVDLQFPDLTOSI-UHFFFAOYSA-L 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 230000001678 irradiating effect Effects 0.000 description 3
- 238000003825 pressing Methods 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 238000010073 coating (rubber) Methods 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 239000000693 micelle Substances 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 239000005995 Aluminium silicate Substances 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- BWZOPYPOZJBVLQ-UHFFFAOYSA-K aluminium glycinate Chemical group O[Al+]O.NCC([O-])=O BWZOPYPOZJBVLQ-UHFFFAOYSA-K 0.000 description 1
- 235000012211 aluminium silicate Nutrition 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229920006037 cross link polymer Polymers 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 238000003754 machining Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
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- 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
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0259—Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
- A61F13/0289—Apparatus or processes for manufacturing adhesive dressings or bandages manufacturing of adhesive dressings
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- 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
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M35/00—Devices for applying media, e.g. remedies, on the human body
- A61M35/10—Wearable devices, e.g. garments, glasses or masks
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
- A61F2013/0296—Apparatus or processes for manufacturing adhesive dressings or bandages for making transdermal patches (chemical processes excluded)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
- A61M2207/10—Device therefor
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Vascular Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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Abstract
The invention relates to a preparation method and equipment of slow-release gel, which comprises a glue feeding device, wherein a separation mechanism is arranged at the outlet position of the glue feeding device, the separation mechanism is used for separating a protective film of a glue from the glue, a base film feeding device is arranged at the outlet position of the glue feeding device and is used for continuously guiding out a base film, a gluing device is arranged at the outlet position of the base film feeding device and is used for uniformly coating the slow-release gel on the base film, and the base film guided out by the base film feeding device is combined with the glue guided out by the glue feeding device.
Description
Technical Field
The invention relates to the technical field of patch processing, in particular to a preparation method and equipment of a slow-release gel patch.
Background
The hydrogel is a cross-linked polymer taking a water-soluble high molecular polymer as a matrix framework material, and has the characteristics of large drug loading capacity, strong moisture retention, good compatibility with skin, aging resistance and the like, so the hydrogel can be widely applied to the fields of tissue repair, artificial organs, drug sustained release, sensors and the like.
The hydrogel plaster commonly used as a drug slow-release carrier can be repeatedly uncovered and the drug administration can be stopped at any time; the dosage is accurate, the blood concentration is balanced without peak-valley phenomenon, and the toxic and side effects can be reduced; the method has no organic solvent pollution in industrial production, meets the requirement of environmental protection, and becomes one of the popular teaching and research.
The drug release process of hydrogel is a complex process of kinetics and thermodynamics, and in order to make the release of hydrogel more stable, powder is usually added to prolong the diffusion channel of the product, and the process of stabilizing drug release, for example, the hydrogel drug sold in japan pharmacy has been regulated to add kaolin for stabilizing drug release. However, the conventional hydrogel still has problems such as poor sustained-release effect and instability, and the active ingredient cannot exert the desired drug effect, and therefore, there is still room for further investigation of the stability of the hydrogel in drug release. And the problem that the adhesive plaster utilizing the hydrogel is not easy to fall off due to the fact that the adhesive degree of the hydrogel and the adhesive plaster is not enough in the actual manufacturing process is solved.
Disclosure of Invention
The invention aims to: the slow-release gel medicine patch prepared by the method and the equipment can ensure the firm bonding between hydrogel and the medicine action surface in use, thereby improving the stability of medicine property release of the medicine patch.
The technical problem to be solved in the invention is as follows:
a preparation method of a slow-release gel medicine patch comprises the steps of preparing slow-release gel and uniformly coating the prepared slow-release gel on a basement membrane to prepare the slow-release gel medicine patch;
the preparation method of the sustained-release gel comprises the following steps: the sustained-release gel comprises the following raw materials in percentage by weight:
drug molecules: 0.5-1.0%; penetration enhancer: 3.0-5.0%; 0.4-1.0% of maleic anhydride tetradecyl sodium propanesulfonate; 30.0-45.0% of a solvent; 10.0-15.0% of sodium acrylate resin; 0.01 to 1.0 percent of cross-linking agent; 7.0-15.0% of a tackifier; 0.2-0.4% of a catalyst; the balance of water;
the preparation method of the drug sustained-release hydrogel comprises the following steps:
uniformly mixing 0.2-2.0% of maleic anhydride tetradecyl sodium propanesulfonate, 6.0-45.0% of solvent, 1.0-5.0% of penetration enhancer and 0.1-1.0% of drug molecules to form monomer-coated drug solution, wherein the penetration enhancer is laurocapram or dimethyl sulfoxide;
dissolving 0.01-0.5% of tartaric acid catalyst in water to prepare tartaric acid aqueous solution;
step three, sequentially adding 1.0-15.0% of sodium acrylate resin, 0.01-1.0% of cross-linking agent dihydroxyaluminum glycolate, 1.0-15.0% of tackifier polyvinylpyrrolidone and the tartaric acid aqueous solution obtained in the step two into the monomer-coated drug solution obtained in the step one, and uniformly mixing to obtain a thick hydrogel precursor;
step four, carrying out compression molding on the hydrogel precursor, and taking out the hydrogel precursor after irradiation under 60Co gamma rays, wherein the irradiation amount of the 60Co gamma rays is 0.5-8 kGy, so as to obtain the drug sustained-release hydrogel product; the total amount of the components in the first step and the third step is 100 percent.
The weight percentage of the ethanol is 1.0-5.0%;
putting the prepared slow-release gel into a charging barrel continuously, and slowly guiding the slow-release gel into a gluing device through an extruding device; then, the preparation of the slow-release gel patch is implemented, and the preparation method of the slow-release gel patch comprises the following steps:
firstly, placing a glue roll material in a glue feeding device, and separating a glue of the glue roll from a protective film;
secondly, placing the base film roll material in a base film feeding device, and drawing out the base film to a gluing device;
thirdly, starting the gluing equipment to enable the slow-release gel to be close to the base film, so that the slow-release gel is uniformly coated on the base film;
fourthly, guiding the glue paste to a position below the base film coated with the slow release gel, and guiding the protective film to a position above the base film coated with the slow release gel;
and fifthly, starting the combination equipment to combine the base film, the protective film and the adhesive plaster, and further producing the slow-release gel patch.
The weight percentage of the ethanol is 1.0-5.0%, and the weight percentage of the glycerol is 5.0-40.0%.
The penetration enhancer is laurocapram or dimethyl sulfoxide, and the cross-linking agent is aluminum glycoxide.
The tackifier is polyvinylpyrrolidone.
The catalyst is tartaric acid.
The drug molecules are indometacin or ibuprofen, and the solvent is a mixture of ethanol and glycerol.
The invention also has the following technical characteristics:
the device comprises a glue feeding device, a separation mechanism is arranged at the outlet position of the glue feeding device, the separation mechanism is used for separating a glue protection film from the glue, a base film feeding device is arranged at the outlet position of the glue feeding device and used for continuously guiding out a base film, a gluing device is arranged at the outlet position of the base film feeding device and used for uniformly coating slow-release gel on the base film, and the base film guided out by the base film feeding device is combined with the glue guided out by the glue feeding device.
The outlet of the base film feeding device and the outlet of the adhesive tape feeding device are provided with combination equipment, and the combination equipment is used for combining the base film and the adhesive tape into a whole.
The adhesive tape feeding device comprises a first horizontally-arranged feeding roller, the separating mechanism comprises a separating roller arranged beside the first feeding roller, and the separating roller and the first feeding roller are arranged in parallel.
The separation roller separates the adhesive of the adhesive roller from the protective film and guides the adhesive to the upper and lower positions of the base film through the guide unit.
The guiding and conveying unit comprises two groups of first guiding and conveying rollers arranged beside the separating roller, the two groups of first guiding and conveying rollers are parallel to the separating roller, two groups of second guiding and conveying rollers are arranged at the outlet position of the base film feeding device, and the two groups of second guiding and conveying rollers are arranged in parallel to the two groups of first guiding and conveying rollers.
The base film feeding device comprises a second feeding roller which is horizontally arranged, the second feeding roller is arranged in parallel with the first feeding roller, the gluing equipment comprises a gluing head which is arranged beside the second feeding roller, and the gluing head vertically moves and is used for gluing the slow-release gel on the base film.
The lower position of gluing the head is provided with pastes the offset plate, it is horizontal to paste the offset plate face, the base film that the second feed roller was derived passes through and pastes the offset plate.
The upper plate surface of the rubberizing plate is provided with a guide groove, the guide groove is arranged along the length direction of the rubberizing plate, and the base film led out by the second feeding roller is located in the guide groove.
The glue coating head is integrally of a large-end-up tubular structure, a rectangular outlet is formed in the lower end of the glue coating head, the rectangular outlet is flat and is arranged along the width direction of the guide groove of the glue pasting plate, and the tube cavity of the glue coating head is communicated with the outlet of the glue supply equipment.
And the upper end of the gluing head is provided with an extrusion mechanism, and the extrusion mechanism is used for guiding the slow-release gel in the lumen of the gluing head out of the rectangular outlet.
The extrusion mechanism comprises an extrusion piston arranged in a pipe cavity at the upper end of the gluing head, the extrusion piston divides the gluing head into an upper chamber and a lower chamber, an outlet of the gluing equipment is communicated with the lower chamber of the gluing head, and the upper chamber of the gluing head is communicated with an air outlet of a high-pressure air source.
The upper end of extrusion piston is provided with vertical slide bar, vertical slide bar vertical slip sets up on the support in the rubber coating head pipe wall, the cover is equipped with vertical spring on the vertical slide bar, the both ends of vertical spring support with the upper end and the support of vertical slide bar respectively and lean on.
The gluing device is characterized in that the gluing head is vertically arranged on a lifting slide bar of a lifting frame in a sliding mode, the lifting slide bar is vertically arranged, a lifting spring is sleeved on the lifting slide bar, two ends of the lifting spring are respectively abutted against the lifting frame and the gluing head, a lifting driving head is arranged on the lifting frame and connected with a piston rod of a lifting cylinder, and the lifting cylinder is vertically arranged.
The lifting driving head is connected with a piston rod of the lifting cylinder through a spring, and the spring is vertically arranged.
The lower extreme rectangle export of gluing the head is provided with and catches up with the flitch, the both ends of catching up with the flitch are passed through the articulated shaft and are connected with the lower extreme both sides wall of gluing the head, the articulated shaft level of catching up with the flitch just exports length direction with the lower extreme rectangle of gluing the head parallel, the articulated shaft of catching up with the flitch is gone up the cover and is equipped with the torsional spring, the both ends and the articulated shaft of torsional spring and the lower extreme of gluing the head are connected, catch up with the flitch and arrange along the lower extreme rectangle export length direction of gluing the head, and catch up with the flitch and support with the rubberizing plate and lean on.
The two sides of the material driving plate are provided with surrounding plate strips, the surrounding plate strips are arranged along the two sides of the width direction of the lower rectangular outlet of the gluing head, the lower plate surface of each surrounding plate strip is lower than the lower rectangular outlet of the gluing head, and the surrounding plate strips, the lower rectangular outlet surface of the gluing head and the upper plate surface of the adhesive plate form an area for coating the slow-release gel.
The exit position of rubberizing board is provided with the carry over pinch rolls, the carry over pinch rolls level and with the length direction vertical arrangement of rubberizing board, the carry over pinch rolls is arranged from top to bottom and is implemented the traction to the base film.
The combination equipment comprises two groups of combination rollers arranged at the outlet of the traction roller, the combination rollers are parallel to the traction roller and are used for clamping and drawing the two sides of the base film and the adhesive tape, a roller brush is arranged in the middle of each combination roller, and the roller brush and the combination rollers are arranged in parallel.
Compared with the prior art, the invention has the beneficial effects that: in the invention, the monomer is taken as a self-emulsifying monomer, and is firstly blended with drug molecules, a solvent and a penetration enhancer to generate a monomer-coated drug with surface activity, then the monomer-coated drug is irradiated and polymerized in a hydrogel matrix composed of sodium acrylate resin, cross-linking agent dihydroxyaluminum glycollate, tackifier polyvinylpyrrolidone and tartaric acid aqueous solution, and maleic anhydride tetradecyl sodium propanesulfonate is cross-linked to form micelle particles through irradiation, so that stable slow-release drug hydrogel coated by the micelle particles is obtained, and the release stability of the drug is improved.
Drawings
FIGS. 1 and 2 are schematic views of two visual structures of a device for manufacturing a gel-sustained patch
FIG. 3 is a front view of a patch manufacturing apparatus for sustained release of gel;
FIGS. 4 and 5 are schematic views of two visual structures of the gluing device;
fig. 6 is a schematic sectional structure of the glue application apparatus.
Detailed Description
In order that the objects and advantages of the invention will be more clearly understood, the invention will now be described in detail with reference to the following examples. It is to be understood that the following text is merely illustrative of one or more specific embodiments of the invention and does not strictly limit the scope of the invention as specifically claimed. As used herein, the terms "parallel" and "perpendicular" are not limited to their strict geometric definitions, but include tolerances for machining or human error legitimacy and inconsistency:
the preparation method of the sustained-release gel and the production equipment of the sustained-release gel patch of the present invention are explained in detail below with reference to the accompanying drawings 1 to 6:
the preparation method of the sustained-release gel comprises the following raw materials in percentage by weight:
drug molecules: 0.5-1.0%; penetration enhancer: 3.0-5.0%; 0.4-1.0% of maleic anhydride tetradecyl sodium propanesulfonate; 30.0-45.0% of a solvent; 10.0-15.0% of sodium acrylate resin; 0.01 to 1.0 percent of cross-linking agent; 7.0-15.0% of a tackifier; 0.2-0.4% of a catalyst; the balance of water;
the penetration enhancer is laurocapram or dimethyl sulfoxide, the cross-linking agent is dihydroxyaluminum glycinate, the tackifier is polyvinylpyrrolidone, the catalyst is tartaric acid, the drug molecules are indomethacin or ibuprofen, and the solvent is a mixture of ethanol and glycerol;
the preparation method of the drug sustained-release hydrogel comprises the following steps:
uniformly mixing 0.2-2.0% of maleic anhydride tetradecyl sodium propanesulfonate, 6.0-45.0% of solvent, 1.0-5.0% of penetration enhancer and 0.1-1.0% of drug molecules to form monomer-coated drug solution, wherein the penetration enhancer is laurocapram or dimethyl sulfoxide;
dissolving 0.01-0.50% of tartaric acid catalyst in water to prepare tartaric acid aqueous solution;
step three, sequentially adding 1.0-15.0% of sodium acrylate resin, 0.01-1.0% of cross-linking agent dihydroxyaluminum, 1.0-15.0% of tackifier polyvinylpyrrolidone and the tartaric acid aqueous solution obtained in the step two into the monomer-coated drug solution obtained in the step one, and uniformly mixing to obtain a thick hydrogel precursor;
step four, carrying out compression molding on the hydrogel precursor, and taking out the hydrogel precursor after irradiation under 60Co gamma rays, wherein the irradiation amount of the 60Co gamma rays is 0.5-8 kGy, so as to obtain the drug sustained-release hydrogel product; the total amount of the components in the first step and the third step is 100 percent.
The weight percentage of the ethanol is 1.0-5.0%, and the weight percentage of the glycerol is 5.0-40.0%.
Example one
The preparation method of the drug sustained-release hydrogel comprises the following steps:
(1) according to the proportion of the formula, 0.50g of maleic anhydride tetradecyl sodium propanesulfonate, 3.00g of ethanol, 15.00g of glycerol and 0.35g of
Mixing indomethacin and 2.00g penetration enhancer laurocapram uniformly to form monomer-coated drug solution;
(2) 0.10g of catalyst tartaric acid is dissolved in 64.03g of water to prepare tartaric acid aqueous solution;
(3) sequentially adding 10.00g of sodium acrylate resin, 0.02g of cross-linking agent dihydroxyaluminum, 5.00g of tackifier polyvinylpyrrolidone and the tartaric acid aqueous solution obtained in the step (2) into the monomer-coated drug solution obtained in the step (1), and uniformly mixing to obtain a thick hydrogel precursor;
(4) and (3) pressing the hydrogel precursor into a sheet, irradiating under 60Co gamma rays, and taking out, wherein the irradiation dose of the 60Co gamma rays is 4kGy, thus obtaining the drug sustained-release hydrogel product.
In order to better demonstrate the sustained-release effect of the drug sustained-release hydrogel, the drug sustained-release hydrogel (a) was compared with a commercially available hydrogel cataplasm (B) having the same content of drug molecules, and the results are shown in fig. 1, in which the x-axis represents time (h) and the y-axis represents percentage release (%). The results show that: the drug sustained-release hydrogel product has good sustained-release effect and stability.
Example two
The preparation method of the drug sustained-release hydrogel comprises the following steps:
(1) according to the formula proportion, 0.80g of maleic anhydride tetradecyl sodium propanesulfonate, 3.00g of ethanol, 20.00g of glycerol, 0.50g of indometacin and 2.50g of penetration enhancer laurocapram are uniformly mixed to form monomer-coated medicine solution;
(2) 0.10g of catalyst tartaric acid is dissolved in 55.08g of water to prepare tartaric acid aqueous solution;
(3) sequentially adding 10.00g of sodium acrylate resin, 0.02g of cross-linking agent dihydroxyaluminum, 8.00g of tackifier polyvinylpyrrolidone and the tartaric acid aqueous solution obtained in the step (2) into the monomer-coated drug solution obtained in the step (1), and uniformly mixing to obtain a thick hydrogel precursor;
(4) and (3) pressing the hydrogel precursor into a sheet, irradiating under 60Co gamma rays, and taking out, wherein the irradiation amount of the 60Co gamma rays is 0.5kGy, thus obtaining the drug sustained-release hydrogel product.
EXAMPLE III
The preparation method of the drug sustained-release hydrogel comprises the following steps:
(1) according to the formula proportion, 2.00g of maleic anhydride tetradecyl sodium propanesulfonate, 3.00g of ethanol, 10.00g of glycerol, 0.50g of indometacin and 3.00g of penetration enhancer dimethyl sulfoxide are uniformly mixed to form monomer-coated drug solution;
(2) dissolving 0.10g of catalyst tartaric acid in 54.35g of water to prepare tartaric acid aqueous solution;
(3) adding 15.00g of sodium acrylate resin, 0.05g of cross-linking agent dihydroxyaluminum, 12.00g of tackifier polyvinylpyrrolidone and the tartaric acid aqueous solution obtained in the step (2) into the monomer-coated drug solution obtained in the step (1) in sequence, and uniformly mixing to obtain a thick hydrogel precursor;
(4) and (3) pressing the hydrogel precursor into a sheet, irradiating under 60Co gamma rays, and taking out, wherein the irradiation dose of the 60Co gamma rays is 2kGy, thus obtaining the drug sustained-release hydrogel product.
The following describes in detail the medicine patch production equipment adopting the slow-release gel, and the medicine patch production equipment adopting the slow-release gel comprises a glue supply device 100, a separation mechanism is arranged at the outlet position of the glue supply device 100, the separation mechanism is used for separating a glue protection film from the glue, a base film supply device 200 is arranged at the outlet position of the glue supply device 100, the base film supply device 200 is used for continuously guiding out a base film, a gluing device 300 is arranged at the outlet position of the base film supply device 200, the gluing device 300 is used for uniformly coating the slow-release gel on the base film, and the base film guided out by the base film supply device 200 is combined with the glue guided out by the glue supply device 100.
After the glue is delivered by the glue delivery device 100, the protective film of the glue is separated from the glue, the two base films are delivered by the base film delivery device 200, the slow release gel is uniformly coated on the base films by the glue coating device 300, and the base films are fixed with the glue delivered by the glue roll, so that the production of the medicine patch of the slow release gel is realized, the slow release gel is prevented from falling off from the glue patch at will by the combination mode of the base films and the glue patches, and the reliability of the combination of the slow release gel and the skin of a patient is ensured.
Further, in order to combine the sticker with the base film, a combining device 400 is disposed at an outlet of the base film feeding device 200 and an outlet of the sticker feeding device 100, and the combining device 400 is used for combining the base film and the sticker into a whole.
Further, to achieve continuous feeding of the adhesive labels, the adhesive label feeding device 100 includes a first feeding roller 110 arranged horizontally, the separating mechanism includes a separating roller 120 disposed beside the first feeding roller 110, and the separating roller 120 is arranged in parallel with the first feeding roller 110.
In order to separate the adhesive sheet and the protective film of the adhesive sheet roll, the separation roller 120 separates the adhesive sheet and the protective film of the adhesive sheet roller, and guides the adhesive sheet and the protective film to the upper and lower positions of the base film by the guide unit.
Specifically, to guide the adhesive tape so that the adhesive tape is guided to the position of the bonding apparatus 400, the guiding unit includes two sets of first guiding rollers 130 disposed beside the separating roller 120, the two sets of first guiding rollers 130 are parallel to the separating roller 120, two sets of second guiding rollers 140 are disposed at the outlet position of the base film feeding device 200, and the two sets of second guiding rollers 140 are parallel to the two sets of first guiding rollers 130.
After the adhesive tape roll separates the adhesive tape from the protective film by the separation roller 120, the adhesive tape roll is respectively guided to the combination device 400 by the first guide roller 130 and the second guide roller 140, so that the combination of the adhesive tape, the base film and the protective film is realized.
Preferably, the base film supplying device 200 includes a horizontally arranged second supply roller 210, the second supply roller 210 is arranged in parallel with the first supply roller 110, and the gluing apparatus 300 includes a gluing head 310 disposed beside the second supply roller 210, the gluing head 310 vertically moves and applies the sustained release gel to the base film.
When the base film is gummed, the slow release gel is uniformly coated on the base film through the gumming head 310.
Specifically, in order to facilitate stable combination of the gluing head 310 and the base film and further achieve uniform guiding and coating of the slow-release gel on the base film, a glue pasting plate 320 is arranged below the gluing head 310, the surface of the glue pasting plate 320 is horizontal, and the base film guided out by the second feeding roller 210 passes through the glue pasting plate 320.
In order to realize stable guiding and conveying of the base film, the upper plate surface of the adhesive sheet 320 is provided with a guide groove 321, the guide groove 321 is arranged along the length direction of the adhesive sheet 320, and the base film guided out by the second feeding roller 210 is located in the guide groove 321.
The base film passes through the guide slot 321 that the face set up on the rubberizing plate 320 for the base film can be stable pass through the guide slot 321, realize the restraint to the base film, make the base film present straight state and lead and send.
Further, in order to ensure that the sustained-release gel is uniformly and slightly released, the whole gluing head 310 is of a tubular structure with a large upper part and a small lower part, a rectangular outlet is arranged at the lower end of the gluing head 310, the rectangular outlet is of a flat tube shape and is arranged along the width direction of the guide groove 321 of the gluing plate 320, and a tube cavity of the gluing head 310 is communicated with an outlet of a glue supply device.
The slow release gel is led out through a flat-mouth-shaped rectangular outlet at the lower end of the gluing head 310, so that the slow release gel is conveniently and uniformly coated on the basement membrane.
Furthermore, the upper end of the gluing head 310 is provided with a squeezing mechanism for guiding the sustained-release gel in the lumen of the gluing head 310 out of the rectangular outlet.
The extrusion mechanism extrudes the gluing head 310, so that the slow-release gel is conveniently and uniformly led out from the rectangular outlet at the lower end of the gluing head 310 and is uniformly coated on the base film.
Preferably, in order to uniformly guide out the sustained-release gel in the extrusion head 310, the extrusion mechanism includes an extrusion piston 330 disposed in a lumen at the upper end of the gluing head 310, the extrusion piston 330 divides the gluing head 310 into an upper chamber and a lower chamber, an outlet of the glue supply device is communicated with the lower chamber of the gluing head 310, and the upper chamber of the gluing head 310 is communicated with an air outlet of a high-pressure air source.
Specifically, in order to realize slow and uniform release of the sustained-release gel and uniformly coat the sustained-release gel on the base film, the upper end of the extrusion piston 330 is provided with a vertical slide bar 331, the vertical slide bar 331 is vertically and slidably arranged on a support in the tube wall of the gluing head 310, a vertical spring 332 is sleeved on the vertical slide bar 331, and two ends of the vertical spring 332 are respectively abutted to the upper end of the vertical slide bar 331 and the support.
More preferably, the gluing head 310 is vertically slidably disposed on a lifting slide bar 341 of the lifting frame 340, the lifting slide bar 341 is vertically disposed, a lifting spring 342 is sleeved on the lifting slide bar 341, two ends of the lifting spring 342 respectively abut against the lifting frame 340 and the gluing head 310, a lifting driving head 343 is disposed on the lifting frame 340, the lifting driving head 343 is connected with a piston rod of a lifting cylinder 344, and the lifting cylinder 344 is vertically disposed.
The lifting driving head 343 is connected with the piston rod of the lifting cylinder 344 through a spring 345, and the spring 345 is vertically arranged.
When the slow-release gel and the base film are coated, the lifting cylinder 344 is started, so that the lower sheet of the gluing head 310 is in contact with the base film, the elastic combination of the gluing head 310 and the base film is realized through the spring 345, the uniform combination of the slow-release gel and the base film can be effectively ensured, the extrusion piston 330 is slowly and uniformly extruded by starting the high-pressure air source, the slow-release gel is uniformly extruded, and the slow-release gel is uniformly coated on the base film.
Specifically, for further even the paining on the base film with the slowly-releasing gel, the lower extreme rectangle export of gluing head 310 is provided with and catches up with flitch 350, the both ends of catching up with flitch 350 are passed through the articulated shaft and are connected with the lower extreme both sides wall of gluing head 310, the articulated shaft level of catching up with flitch 350 just is parallel with the lower extreme rectangle export length direction of gluing head 310, the cover is equipped with the torsional spring on the articulated shaft of catching up with flitch 350, the both ends and the articulated shaft of torsional spring and the lower extreme of gluing head 310 are connected, catch up with flitch 350 and arrange along the lower extreme rectangle export length direction of gluing head 310, and catch up with flitch 350 and paste flitch 320 and support and lean on.
Catch up flitch 350 and rubberizing board 320 and support and lean on, the in-process that the base film removed along rubberizing board 320 for the even string of the slowly-releasing gel that is located rubberizing head 310 lower extreme position establishes on the base film, reaches the purpose of evenly scribbling the base film.
More preferably, surrounding strips 351 are arranged on two sides of the material driving plate 350, the surrounding strips 351 are arranged along two sides of the width direction of the lower rectangular outlet of the gluing head 310, the lower plate surface of the surrounding strips 351 is lower than the lower rectangular outlet of the gluing head 310, and the surrounding strips 351, the lower rectangular outlet surface of the gluing head 310 and the upper plate surface of the gluing plate 320 form a region for coating the slow-release gel.
The gathering of slowly-releasing gel is implemented in the region that encloses between the lower extreme rectangle export face of battens 351, rubber coating head 310 and the rubberizing board 320, passes through this region along with the base film for hang that slowly-releasing gel can be even establishes at the base film, and then realize evenly smearing slowly-releasing gel.
In order to implement the traction of the slow release gel, a traction roller 360 is arranged at the outlet of the rubberizing plate 320, the traction roller 360 is horizontal and is perpendicular to the length direction of the rubberizing plate 320, and the traction roller 360 is arranged up and down and implements the traction of the base film.
The pulling roll 360 is started to realize the pulling of the base film coated with the slow-release gel and the leading to the position of the combination equipment 400 so as to realize the combination of the base film and the adhesive sticker.
More specifically, in order to combine the base film and the sticker, the combining apparatus 400 includes two sets of combining rollers 410 disposed at an outlet of the drawing roller 360, the combining rollers 410 are parallel to the drawing roller 360 and perform clamping traction on both sides of the base film and the sticker, a roller brush 420 is disposed at a middle position of the combining rollers 410, and the roller brush 420 and the combining rollers 410 are disposed in parallel.
The roller brush 420 is made of flexible material, the roller 410 is combined to compress the base film and the adhesive tape, and the roller brush 420 is synchronously started, so that the bristles of the roller brush 420 are elastically abutted against the base film, the slow release gel is prevented from being extruded, and the normal production of the patch is ensured.
A preparation method of a slow-release gel patch comprises the steps of preparing slow-release gel and uniformly coating the prepared slow-release gel on a basement membrane;
firstly, placing a glue roll material in a glue feeding device 100, and separating a glue of the glue roll from a protective film;
secondly, placing the base film roll material in a base film feeding device 200, and drawing out the base film to a gluing device 300;
thirdly, starting the gluing equipment 300, and enabling the slow-release gel to be close to the base film so as to be uniformly coated on the base film;
fourthly, guiding the glue paste to a position below the base film coated with the slow release gel, and guiding the protective film to a position above the base film coated with the slow release gel;
and a fifth step of starting the combination device 400 to combine the base film, the protective film and the adhesive patch, thereby producing the sustained-release gel patch.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (10)
1. A preparation method of a slow-release gel medicine patch is characterized by comprising the following steps: comprises the steps of preparing the slow-release gel and evenly coating the prepared slow-release gel on a basement membrane to prepare a slow-release gel medicine patch;
the preparation method of the sustained-release gel comprises the following steps: the sustained-release gel comprises the following raw materials in percentage by weight:
drug molecules: 0.5-1.0%; penetration enhancer: 3.0-5.0%; 0.4-1.0% of maleic anhydride tetradecyl sodium propanesulfonate; 30.0-45.0% of a solvent; 10.0-15.0% of sodium acrylate resin; 0.01 to 1.0 percent of cross-linking agent; 7.0-15.0% of a tackifier; 0.2-0.4% of a catalyst; the balance of water;
the preparation method of the drug sustained-release hydrogel comprises the following steps:
uniformly mixing 0.2-2.0% of maleic anhydride tetradecyl sodium propanesulfonate, 6.0-45.0% of solvent, 1.0-5.0% of penetration enhancer and 0.1-1.0% of drug molecules to form monomer-coated drug solution, wherein the penetration enhancer is laurocapram or dimethyl sulfoxide;
dissolving 0.01-0.5% of tartaric acid catalyst in water to prepare tartaric acid aqueous solution;
step three, sequentially adding 1.0-15.0% of sodium acrylate resin, 0.01-1.0% of cross-linking agent dihydroxyaluminum glycolate, 1.0-15.0% of tackifier polyvinylpyrrolidone and the tartaric acid aqueous solution obtained in the step two into the monomer-coated drug solution obtained in the step one, and uniformly mixing to obtain a thick hydrogel precursor;
step four, carrying out compression molding on the hydrogel precursor, and taking out the hydrogel precursor after irradiation under 60Co gamma rays, wherein the irradiation amount of the 60Co gamma rays is 0.5-8 kGy, so as to obtain the drug sustained-release hydrogel product; the total amount of the components in the first step and the third step is 100 percent.
The weight percentage of the ethanol is 1.0-5.0%;
putting the prepared slow-release gel into a charging barrel continuously, and slowly guiding the slow-release gel into a gluing device (300) through an extrusion device; then, the preparation of the slow-release gel patch is implemented, and the preparation method of the slow-release gel patch comprises the following steps:
firstly, placing a glue roll material in a glue feeding device (100) and separating a glue of the glue roll from a protective film;
secondly, placing the base film roll material in a base film feeding device (200) so that the base film is drawn out to a gluing device (300);
thirdly, starting the gluing equipment (300) to enable the slow-release gel to be close to the basement membrane so that the slow-release gel is evenly coated on the basement membrane;
fourthly, guiding the glue paste to a position below the base film coated with the slow release gel, and guiding the protective film to a position above the base film coated with the slow release gel;
and fifthly, starting the combination equipment (400) to combine the base film, the protective film and the adhesive plaster, and further producing the slow-release gel patch.
2. The method for preparing a slow-release gel patch as claimed in claim 1, wherein: the weight percentage of the ethanol is 1.0-5.0%, and the weight percentage of the glycerol is 5.0-40.0%.
3. The method for preparing a slow-release gel patch as claimed in claim 1, wherein: the penetration enhancer is laurocapram or dimethyl sulfoxide, and the cross-linking agent is aluminum glycoxide.
4. The method for preparing a slow-release gel patch as claimed in claim 1, wherein: the tackifier is polyvinylpyrrolidone.
5. The method for preparing a slow-release gel patch as claimed in claim 1, wherein: the catalyst is tartaric acid.
6. The method for preparing a slow-release gel patch as claimed in claim 1, wherein: the drug molecules are indometacin or ibuprofen, and the solvent is a mixture of ethanol and glycerol.
7. An apparatus for use in a method of manufacturing a slow release gel patch according to any one of claims 1 to 6, wherein: the device comprises a glue paste feeding device (100), wherein a separation mechanism is arranged at the outlet position of the glue paste feeding device (100), the separation mechanism is used for separating a protective film of a glue paste from the glue paste, a base film feeding device (200) is arranged at the outlet position of the glue paste feeding device (100), the base film feeding device (200) is used for continuously guiding out a base film, a gluing device (300) is arranged at the outlet position of the base film feeding device (200), the gluing device (300) is used for uniformly coating slow-release gel on the base film, and the base film guided out by the base film feeding device (200) is combined with the glue paste guided out by the glue paste feeding device (100); the outlet of the base film feeding device (200) and the outlet of the adhesive tape feeding device (100) are provided with combination equipment (400), and the combination equipment (400) is used for combining the base film and the adhesive tape into a whole.
8. The apparatus of claim 7, wherein: the adhesive tape feeding device (100) comprises a first feeding roller (110) which is horizontally arranged, the separating mechanism comprises a separating roller (120) which is arranged beside the first feeding roller (110), and the separating roller (120) is arranged in parallel with the first feeding roller (110); the separation roller (120) separates the adhesive of the adhesive roller from the protective film and guides the adhesive roller to the upper position and the lower position of the base film through the guide unit; the guiding and conveying unit comprises two groups of first guiding and conveying rollers (130) arranged beside the separating roller (120), the two groups of first guiding and conveying rollers (130) are parallel to the separating roller (120), two groups of second guiding and conveying rollers (140) are arranged at the outlet position of the base film feeding device (200), and the two groups of second guiding and conveying rollers (140) are arranged in parallel with the two groups of first guiding and conveying rollers (130); the base film feeding device (200) includes a horizontally arranged second feeding roller (210), the second feeding roller (210) is arranged in parallel with the first feeding roller (110), the coating apparatus (300) includes a coating head (310) provided at a side of the second feeding roller (210), and the coating head (310) moves vertically and coats the sustained-release gel on the base film.
9. The apparatus of claim 8, wherein: a rubberizing plate (320) is arranged below the gluing head (310), the surface of the rubberizing plate (320) is horizontal, and a base film led out by the second feeding roller (210) passes through the rubberizing plate (320); the upper plate surface of the adhesive tape sticking plate (320) is provided with a guide groove (321), the guide groove (321) is arranged along the length direction of the adhesive tape sticking plate (320), and the base film led out by the second feeding roller (210) is positioned in the guide groove (321); the glue coating head (310) is integrally of a tubular structure with a large upper part and a small lower part, a rectangular outlet is formed in the lower end of the glue coating head (310), the rectangular outlet is in a flat tube shape and is arranged along the width direction of a guide groove (321) of a glue pasting plate (320), and a tube cavity of the glue coating head (310) is communicated with an outlet of glue supply equipment; the upper end of the gluing head (310) is provided with an extrusion mechanism, and the extrusion mechanism is used for guiding the slow-release gel in the lumen of the gluing head (310) out of the rectangular outlet; the extrusion mechanism comprises an extrusion piston (330) arranged in a pipe cavity at the upper end of the gluing head (310), the extrusion piston (330) divides the gluing head (310) into an upper chamber and a lower chamber, an outlet of the glue supply device is communicated with the lower chamber of the gluing head (310), and the upper chamber of the gluing head (310) is communicated with an air outlet of a high-pressure air source; the upper end of the extrusion piston (330) is provided with a vertical sliding rod (331), the vertical sliding rod (331) is vertically and slidably arranged on a support in the pipe wall of the gluing head (310), a vertical spring (332) is sleeved on the vertical sliding rod (331), and two ends of the vertical spring (332) are respectively abutted against the upper end of the vertical sliding rod (331) and the support; the gluing head (310) is vertically arranged on a lifting slide rod (341) of a lifting rack (340) in a sliding mode, the lifting slide rod (341) is vertically arranged, a lifting spring (342) is sleeved on the lifting slide rod (341), two ends of the lifting spring (342) are respectively abutted against the lifting rack (340) and the gluing head (310), a lifting driving head (343) is arranged on the lifting rack (340), the lifting driving head (343) is connected with a piston rod of a lifting cylinder (344), and the lifting cylinder (344) is vertically arranged; the lifting driving head (343) is connected with a piston rod of a lifting cylinder (344) through a spring (345), and the spring (345) is vertically arranged.
10. The apparatus of claim 9, wherein: the lower end rectangular outlet of the gluing head (310) is provided with a material driving plate (350), two ends of the material driving plate (350) are connected with two side walls of the lower end of the gluing head (310) through hinged shafts, the hinged shafts of the material driving plate (350) are horizontal and parallel to the length direction of the lower end rectangular outlet of the gluing head (310), the hinged shafts of the material driving plate (350) are sleeved with torsion springs, two ends of the torsion springs are connected with the hinged shafts and the lower end of the gluing head (310), the material driving plate (350) is arranged along the length direction of the lower end rectangular outlet of the gluing head (310), and the material driving plate (350) is abutted against the gluing plate (320); surrounding laths (351) are arranged on two sides of the material driving plate (350), the surrounding laths (351) are arranged along two sides of the width direction of a lower rectangular outlet of the gluing head (310), the lower plate surface of the surrounding laths (351) is lower than the lower rectangular outlet of the gluing head (310), and the surrounding laths (351), the lower rectangular outlet surface of the gluing head (310) and the upper plate surface of the adhesive plate (320) form a region coated with slow-release gel; a traction roller (360) is arranged at the outlet of the rubberized plate (320), the traction roller (360) is horizontal and is vertical to the length direction of the rubberized plate (320), and the traction roller (360) is arranged up and down and is used for traction of the base film; the combination equipment (400) comprises two groups of combination rollers (410) arranged at the outlet of a traction roller (360), the combination rollers (410) are parallel to the traction roller (360) and used for clamping and drawing the two sides of the base film and the adhesive tape, a roller brush (420) is arranged in the middle of each combination roller (410), and the roller brush (420) and the combination rollers (410) are arranged in parallel.
Priority Applications (1)
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