CN113827579B - Preparation method and equipment of sustained-release gel patch - Google Patents
Preparation method and equipment of sustained-release gel patch Download PDFInfo
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- CN113827579B CN113827579B CN202111294650.8A CN202111294650A CN113827579B CN 113827579 B CN113827579 B CN 113827579B CN 202111294650 A CN202111294650 A CN 202111294650A CN 113827579 B CN113827579 B CN 113827579B
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- base film
- release gel
- slow
- roller
- feeding device
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- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 238000013268 sustained release Methods 0.000 title claims description 36
- 239000012730 sustained-release form Substances 0.000 title claims description 36
- 238000004026 adhesive bonding Methods 0.000 claims abstract description 58
- 239000003814 drug Substances 0.000 claims abstract description 58
- 229940079593 drug Drugs 0.000 claims abstract description 40
- 230000007246 mechanism Effects 0.000 claims abstract description 19
- 230000001681 protective effect Effects 0.000 claims abstract description 19
- 239000000499 gel Substances 0.000 claims description 89
- 239000003292 glue Substances 0.000 claims description 47
- 239000000017 hydrogel Substances 0.000 claims description 43
- 239000000853 adhesive Substances 0.000 claims description 28
- 230000001070 adhesive effect Effects 0.000 claims description 28
- 238000003892 spreading Methods 0.000 claims description 28
- 230000007480 spreading Effects 0.000 claims description 28
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 27
- 239000002390 adhesive tape Substances 0.000 claims description 26
- 239000011505 plaster Substances 0.000 claims description 26
- 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
- 238000001125 extrusion Methods 0.000 claims description 22
- 235000002906 tartaric acid Nutrition 0.000 claims description 22
- 239000011975 tartaric acid Substances 0.000 claims description 22
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 20
- 239000000178 monomer Substances 0.000 claims description 15
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims description 14
- 239000002243 precursor Substances 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
- 238000002156 mixing Methods 0.000 claims description 12
- 239000000243 solution Substances 0.000 claims description 12
- 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
- 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
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical group CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 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
- YADMSCZEQAZFKU-UHFFFAOYSA-N C(CC)S(=O)(=O)OCCCCCCCCCCCCCC.[Na].C1(\C=C/C(=O)O1)=O Chemical compound C(CC)S(=O)(=O)OCCCCCCCCCCCCCC.[Na].C1(\C=C/C(=O)O1)=O YADMSCZEQAZFKU-UHFFFAOYSA-N 0.000 claims description 8
- 229960003639 laurocapram Drugs 0.000 claims description 8
- 238000000926 separation method Methods 0.000 claims description 8
- 239000003961 penetration enhancing agent Substances 0.000 claims description 7
- 229960000905 indomethacin Drugs 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 5
- HDVDLQFPDLTOSI-UHFFFAOYSA-L O[AlH]O Chemical compound O[AlH]O HDVDLQFPDLTOSI-UHFFFAOYSA-L 0.000 claims description 4
- 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
- BWZOPYPOZJBVLQ-UHFFFAOYSA-K aluminium glycinate Chemical group O[Al+]O.NCC([O-])=O BWZOPYPOZJBVLQ-UHFFFAOYSA-K 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
- 239000003973 paint Substances 0.000 claims description 2
- -1 sodium tetradecyl maleic anhydride Chemical compound 0.000 claims description 2
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 8
- 238000010073 coating (rubber) Methods 0.000 description 9
- 239000011248 coating agent Substances 0.000 description 8
- 238000000576 coating method Methods 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 8
- 230000000694 effects Effects 0.000 description 6
- 230000008569 process Effects 0.000 description 5
- 210000002469 basement membrane Anatomy 0.000 description 4
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 3
- 230000001678 irradiating effect Effects 0.000 description 3
- 238000000465 moulding Methods 0.000 description 3
- 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
- 230000032683 aging Effects 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
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 229920006037 cross link polymer Polymers 0.000 description 1
- 238000004132 cross linking Methods 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
- 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
- 238000003475 lamination Methods 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
- 239000006223 plastic coating Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 239000000843 powder Substances 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
Classifications
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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
- 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
-
- 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
- A61F13/0259—Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer
-
- 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
-
- 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
- A61K31/185—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
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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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- A61K47/00—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
- A61K47/20—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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- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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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
- A61K47/30—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
-
- 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)
-
- 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
-
- 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
-
- 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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- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
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- Dermatology (AREA)
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- Medicinal Preparation (AREA)
Abstract
The invention relates to a preparation method and equipment of slow-release gel, comprising a gumming feeding device, wherein a separating mechanism is arranged at the outlet position of the gumming feeding device, the separating mechanism is used for separating a gumming protective film from the gumming, a base film feeding device is arranged at the outlet position of the gumming feeding device, the base film feeding device is used for continuously guiding out the base film, a gluing device is arranged at the outlet position of the base film feeding device, the slow-release gel is uniformly smeared on the base film, the base film guided out by the base film feeding device is combined with the gumming guiding-out paste of the gumming feeding device, and the slow-release gel patch prepared by the method and the equipment can ensure the bonding firmness of the gel and a medicine acting surface in use, thereby improving the stability of drug property release of the patch.
Description
Technical Field
The invention relates to the technical field of medicine patch processing, in particular to a preparation method and equipment of a slow-release gel medicine patch.
Background
The hydrogel is a cross-linked polymer taking a water-soluble high molecular polymer as a matrix framework material, has the characteristics of large drug loading capacity, strong moisture retention, good compatibility with skin, aging resistance and the like, and can be widely applied to various fields such as tissue repair, artificial organs, drug slow release, sensors and the like.
The hydrogel patch which is commonly used as a drug slow-release carrier can be repeatedly uncovered and stuck, and the drug administration can be stopped at any time; the dosage is accurate, the blood concentration balance has no peak valley phenomenon, and the toxic and side effects can be reduced; no organic solvent pollution exists in industrial production, and the environment protection requirement is met, so that the method becomes one of the current teaching research.
The drug release process of hydrogels is a kinetic and thermodynamic compound process, and in order to make the release effect of hydrogels more stable, powder is generally added to extend the diffusion channel of the product, and a process of stabilizing drug release, for example, a process of adding kaolin for stabilizing drug release is prescribed for hydrogel agents sold in Japanese pharmacies. However, the conventional hydrogel still has the problems of poor slow release effect, instability and the like, so that the effective components cannot exert the due drug effect, and therefore, the problem of stability of drug release of the hydrogel still has room for further investigation. In addition, the adhesive plaster using the hydrogel has the problem that the adhesive degree of the hydrogel and the adhesive plaster is not easy to fall off in the actual manufacturing process.
Disclosure of Invention
The invention aims at: provides a preparation method and equipment of a slow-release gel patch, and the slow-release gel patch prepared by the method and equipment can ensure the firmness of the lamination of hydrogel and a medicine acting surface, thereby improving the patch
Stability of drug release.
The technical scheme adopted in the invention is as follows:
a preparation method of a sustained-release gel patch comprises the steps of preparing sustained-release gel and uniformly coating the prepared sustained-release gel on a base film to prepare the sustained-release gel patch;
the preparation method of the sustained-release gel comprises the following steps: the slow-release gel comprises the following raw materials in percentage by weight:
drug molecules: 0.5 to 1.0 percent; permeation promoter: 3.0 to 5.0 percent; maleic anhydride sodium tetradecyl propane sulfonate 0.4% to the whole
1.0%; 30.0 to 45.0 percent of solvent; 10.0 to 15.0 percent of sodium acrylate resin; 0.01 to 1.0 percent of cross-linking agent; 7.0 to 15.0 percent of tackifier; 0.2 to 0.4 percent of catalyst; the balance being water;
the preparation method of the drug sustained-release hydrogel comprises the following steps:
uniformly mixing 0.2-2.0% of sodium maleic anhydride tetradecyl propane sulfonate, 6.0-45.0% of solvent, 1.0-5.0% of permeation promoter and 0.1-1.0% of medicine molecules to form monomer coated medicine solution, wherein the permeation promoter is laurocapram or dimethyl sulfoxide;
step two, 0.01 to 0.5 percent of catalyst tartaric acid is dissolved in water to prepare tartaric acid aqueous solution;
sequentially adding 1.0-15.0% of sodium acrylate resin, 0.01-1.0% of crosslinking 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, the hydrogel precursor is molded, and is taken out after being irradiated under 60Co gamma rays, wherein the irradiation amount of the 60Co gamma rays is 0.5-8 kGy, and the drug slow-release hydrogel product is obtained; the sum of the dosages of the components in the steps one to three is 100 percent.
The weight percentage of the ethanol is 1.0-5.0 percent;
the prepared slow release gel is thrown into a charging barrel continuously, and the slow release gel is slowly led out into a gluing device through an extrusion device; then the preparation of the sustained-release gel patch is implemented, and the preparation method of the sustained-release gel patch comprises the following steps:
firstly, placing a roll of adhesive plaster in an adhesive plaster feeding device, and separating the adhesive plaster of the adhesive plaster roll from a protective film;
secondly, placing the base film coil stock in a base film feeding device so that the base film is pulled out to the position of the gluing equipment;
thirdly, starting the gluing equipment, and approaching the slow-release gel to the base film to uniformly paint the slow-release gel on the base film;
fourthly, guiding out the adhesive tape to the position below the base film coated with the slow-release gel, and guiding out the protective film to the position above the base film coated with the slow-release gel;
fifth, starting the combination equipment to combine the base film, the protective film and the adhesive tape, and further to implement the slow-release coagulation
And (3) producing the adhesive plaster.
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 glycinate.
The tackifier is polyvinylpyrrolidone.
The catalyst is tartaric acid.
The drug molecule is indomethacin or ibuprofen, and the solvent is a mixture of ethanol and glycerol.
The invention also has the following technical characteristics:
the utility model provides an be applied to equipment of slowly-releasing gel medicine preparation method of subsides, includes subsides feedway, subsides feedway's exit position is provided with separating mechanism, separating mechanism is used for separating the protection film and the subsides of subsides, subsides feedway's exit position is provided with basic film feedway, basic film feedway is used for continuously leading out the basic film, basic film feedway's exit position is provided with the rubber coating equipment, the rubber coating equipment is used for evenly smearing the slowly-releasing gel on the basic film, basic film and subsides feedway that basic film feedway led out derive the subsides and combine.
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 feeding roller which is horizontally arranged, the separating mechanism comprises a separating roller which is arranged beside the first feeding roller, and the separating roller is arranged in parallel with the first feeding roller.
The separating roller separates the adhesive tape and the protective film of the adhesive tape roller and is guided to the upper and lower positions of the base film by the guide unit.
The guide unit comprises two groups of first guide rollers arranged beside the separation roller, the two groups of first guide rollers are parallel to the separation roller, two groups of second guide rollers are arranged at the outlet position of the base film feeding device, and the two groups of second guide rollers are arranged in parallel with the two groups of first guide 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 device comprises a gluing head which is arranged beside the second feeding roller, and the gluing head moves vertically and smears slow-release gel on the base film.
The lower position of the gluing head is provided with a gluing plate, the plate surface of the gluing plate is horizontal, and the base film led out by the second feeding roller passes through the gluing 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 a base film led out by the second feeding roller is positioned in the guide groove.
The gluing head is integrally in 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, the rectangular outlet is in a flat tubular shape and is arranged along the width direction of a guide groove of a rubberizing plate, and a pipe cavity of the gluing head and a gluing device are arranged on the gluing head
The outlets are communicated.
The upper end of the gluing head is provided with an extrusion mechanism, and the extrusion mechanism is used for guiding out the slow release gel in the pipe cavity of the gluing head from the rectangular outlet.
The extrusion mechanism comprises an extrusion piston arranged in the upper end pipe cavity of the gluing head, the extrusion piston divides the gluing head into an upper cavity and a lower cavity, an outlet of the glue supply device is communicated with the lower cavity of the gluing head, and the upper cavity of the gluing head is communicated with an air outlet of a high-pressure air source.
The upper end of the extrusion piston is provided with a vertical sliding rod, the vertical sliding rod is vertically arranged on a support in the pipe wall of the gluing head in a sliding manner, a vertical spring is sleeved on the vertical sliding rod, and two ends of the vertical spring are respectively abutted to the upper end of the vertical sliding rod and the support.
The glue spreading head is vertically arranged on a lifting slide rod of the lifting frame in a sliding manner, the lifting slide rod is vertically arranged, a lifting spring is sleeved on the lifting slide rod, two ends of the lifting spring respectively abut against the lifting frame and the glue spreading head, a lifting driving head is arranged on the lifting frame, the lifting driving head is 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 rectangular outlet of rubber coating head is provided with and drives the flitch, the both ends that drive the flitch are connected with the lower extreme both sides wall of rubber coating head through the articulated shaft, the articulated shaft level that drives the flitch is parallel with the lower extreme rectangular outlet length direction of rubber coating head, the cover is equipped with the torsional spring on the articulated shaft that drives the flitch, the both ends and the articulated shaft of torsional spring and the lower extreme of rubber coating head are connected, it arranges along the lower extreme rectangular outlet length direction of rubber coating head to drive the flitch, and drives the flitch and paste the flitch and support and lean on.
The plastic coating machine is characterized in that the two sides of the material driving plate are provided with the shroud-plate strips, the shroud-plate strips are arranged along the two sides of the width direction of the rectangular outlet at the lower end of the glue coating head, the lower plate surface of the shroud-plate strips is lower than the rectangular outlet at the lower end of the glue coating head, and the shroud-plate strips, the rectangular outlet surface at the lower end of the glue coating head and the upper plate surface of the glue coating plate form a region for coating slow-release gel.
The outlet position of the rubberizing plate is provided with a traction roller, the traction roller is horizontally arranged and is vertical to the length direction of the rubberizing plate, and the traction roller is arranged up and down and is used for traction of the base film.
The combination equipment comprises two groups of combination rollers arranged at the outlet position of the traction roller, the combination rollers are parallel to the traction roller and clamp and drag the two sides of the base film and the adhesive tape, roller brushes are arranged at the middle position of the combination rollers, and the roller brushes are arranged in parallel with the combination rollers.
Compared with the prior art, the invention has the beneficial effects that: in the invention, the self-emulsifying monomer is firstly mixed with drug molecules, solvent and permeation enhancer to generate monomer coating drug with surface activity, and then the monomer coating drug is coated
And (3) performing irradiation polymerization in a hydrogel matrix formed by sodium acrylate resin, a cross-linking agent of dihydroxyaluminum, a tackifier of polyvinylpyrrolidone and an aqueous solution of tartaric acid, and crosslinking sodium maleic anhydride tetradecyl propane sulfonate by irradiation to form micelle particles, so that stable micelle particle-coated slow-release drug hydrogel is obtained, and the stability of drug release is improved.
Drawings
FIGS. 1 and 2 are schematic views of two visual angle structures of a patch production device for sustained release gel;
FIG. 3 is a front view of a patch production apparatus for sustained release of gel;
fig. 4 and 5 are schematic views of two visual angle structures of the gumming device;
fig. 6 is a schematic cross-sectional structure of the gumming device.
Detailed Description
The present invention will be specifically described with reference to examples below in order to make the objects and advantages of the present invention more apparent. It should be understood that the following text is intended to describe only one or more specific embodiments of the invention and does not limit the scope of the invention strictly as claimed. As used herein, the terms "parallel" and "perpendicular" are not limited to their strict geometric definition, but include tolerances for machining or human error, both reasonable and inconsistent:
the following describes in detail the preparation method of the sustained-release gel and the production equipment of the sustained-release gel patch according to the present invention with reference to fig. 1 to 6:
the preparation method of the sustained-release gel comprises the following raw materials in percentage by weight:
drug molecules: 0.5 to 1.0 percent; permeation promoter: 3.0 to 5.0 percent; 0.4 to 1.0 percent of sodium tetradecyl maleic anhydride sulfonate; 30.0 to 45.0 percent of solvent; 10.0 to 15.0 percent of sodium acrylate resin; 0.01 to 1.0 percent of cross-linking agent; 7.0 to 15.0 percent of tackifier; 0.2 to 0.4 percent of catalyst; the balance being water;
the penetration enhancer is laurocapram or dimethyl sulfoxide, the cross-linking agent is aluminum glycinate, the tackifier is polyvinylpyrrolidone, the catalyst is tartaric acid, the drug molecule is 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 sodium maleic anhydride tetradecyl propane sulfonate, 6.0-45.0% of solvent, 1.0-5.0% of permeation promoter and 0.1-1.0% of medicine molecules to form monomer coated medicine solution, wherein the permeation promoter is laurocapram or dimethyl sulfoxide;
step two, 0.01 to 0.50 percent of catalyst tartaric acid is dissolved in water to prepare tartaric acid aqueous solution;
sequentially adding 1.0-15.0% of sodium acrylate resin, 0.01-1.0% of crosslinking 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, the hydrogel precursor is molded, and is taken out after being irradiated under 60Co gamma rays, wherein the irradiation amount of the 60Co gamma rays is 0.5-8 kGy, and the drug slow-release hydrogel product is obtained; the sum of the dosages of the components in the steps one to three 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 1
The preparation method of the drug sustained-release hydrogel comprises the following steps:
(1) According to the formula proportion, uniformly mixing 0.50g of sodium maleic anhydride tetradecyl propane sulfonate, 3.00g of ethanol, 15.00g of glycerol, 0.35g of indometacin and 2.00g of penetration enhancer laurocapram to form monomer coated drug solution;
(2) 0.10g of catalyst tartaric acid was dissolved in 64.03g of water to prepare an aqueous solution of tartaric acid;
(3) Sequentially adding 10.00g of sodium acrylate resin, 0.02g of crosslinking agent aluminum hydroxide, 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 molding the hydrogel precursor into a sheet shape, irradiating the sheet shape under 60Co gamma rays, and taking out the sheet shape, wherein the irradiation amount of the 60Co gamma rays is 4kGy, thus obtaining the drug sustained-release hydrogel product.
In order to better prove the slow release effect of the medicine slow release hydrogel, the medicine slow release hydrogel (A) is compared with the commercial hydrogel cataplasma (B), the contents of medicine molecules of the medicine slow release hydrogel (A) and the commercial hydrogel cataplasma (B) are the same, and the result shows that: the sustained-release hydrogel product has better 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, uniformly mixing 0.80g of sodium maleic anhydride tetradecyl propane sulfonate, 3.00g of ethanol, 20.00g of glycerol, 0.50g of indometacin and 2.50g of penetration enhancer laurocapram to form monomer coated drug solution;
(2) 0.10g of catalyst tartaric acid was dissolved in 55.08g of water to prepare an aqueous solution of tartaric acid;
(3) Sequentially adding 10.00g of sodium acrylate resin, 0.02g of crosslinking agent aluminum hydroxide, 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 molding the hydrogel precursor into a sheet shape, irradiating the sheet-shaped hydrogel precursor with 60Co gamma rays, and taking out the sheet-shaped hydrogel precursor, wherein the irradiation quantity 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, uniformly mixing 2.00g of sodium maleic anhydride tetradecyl propane sulfonate, 3.00g of ethanol, 10.00g of glycerol, 0.50g of indometacin and 3.00g of penetration enhancer dimethyl sulfoxide to form monomer-coated drug solution;
(2) An aqueous solution of tartaric acid was prepared by dissolving 0.10g of the catalyst tartaric acid in 54.35g of water;
(3) Sequentially adding 15.00g of sodium acrylate resin, 0.05g of crosslinking agent aluminum hydroxide, 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), and uniformly mixing to obtain a thick hydrogel precursor;
(4) And molding the hydrogel precursor into a sheet shape, irradiating the sheet shape under 60Co gamma rays, and taking out the sheet shape, wherein the irradiation amount of the 60Co gamma rays is 2kGy, thus obtaining the drug sustained-release hydrogel product.
The following describes the patch production facility that adopts this slowly-releasing gel in detail, a slowly-releasing gel's patch production facility, including the patch feedway 100, the exit position of patch feedway 100 is provided with separating mechanism, separating mechanism is used for separating the protection film and the patch of patch, the exit position of patch feedway 100 is provided with base film feedway 200, base film feedway 200 is used for continuously leading out the base film, the exit position of base film feedway 200 is provided with rubber coating equipment 300, rubber coating equipment 300 is used for evenly smearing the slowly-releasing gel on the base film, the base film that base film feedway 200 led out and the patch combination of patch feedway 100 leading out.
After the adhesive plaster is led out by the adhesive plaster feeding device 100, the protective film and the adhesive plaster are separated, the two base films of the base film feeding device 200 are led out, the slow-release gel is uniformly smeared on the base films by using the gluing equipment 300, and the base films and the adhesive plaster led out by the adhesive plaster roll are fixed together, so that the medicine plaster production of the slow-release gel is realized, the slow-release gel is prevented from falling off the adhesive plaster randomly by the combination mode of the base films and the adhesive plaster, and the combination reliability of the slow-release gel and the skin of a patient is ensured.
Further, in order to achieve the combination of the adhesive tape and the base film, a combination device 400 is disposed at the outlet of the base film feeding device 200 and the outlet of the adhesive tape feeding device 100, and the combination device 400 is used for combining the base film and the adhesive tape into a whole.
Further, in order to realize continuous feeding of the adhesive tape, the adhesive tape feeding device 100 includes a first feeding roller 110 arranged horizontally, and the separating mechanism includes a separating roller 120 disposed beside the first feeding roller 110, and the separating roller 120 is arranged parallel to the first feeding roller 110.
In order to separate the adhesive tape and the protective film of the roll of adhesive tape, the separation roller 120 separates the adhesive tape and the protective film of the roll of adhesive tape and guides the adhesive tape and the protective film to the upper and lower positions of the base film by the guide unit.
Specifically, in order to achieve the guiding of the sticker, the guiding unit includes two sets of first guiding rollers 130 disposed beside the separation roller 120, the two sets of first guiding rollers 130 are parallel to the separation roller 120, and two sets of second guiding rollers 140 are disposed at the outlet of the base film feeding device 200, and the two sets of second guiding rollers 140 are disposed parallel to the two sets of first guiding rollers 130.
The adhesive roll separates the adhesive from the protective film by the separation roller 120, and then is respectively guided to the bonding device 400 by the first guide roller 130 and the second guide roller 140, so as to bond the adhesive, the base film and the protective film.
Preferably, the base film feeding device 200 includes a second feeding roller 210 horizontally arranged, the second feeding roller 210 is arranged parallel to the first feeding roller 110, and the spreading device 300 includes a spreading head 310 disposed beside the second feeding roller 210, and the spreading head 310 moves vertically and spreads the slow-release gel on the base film.
In performing the gumming operation of the base film, the slow-release gel is uniformly applied to the base film by the gumming head 310.
Specifically, in order to facilitate stable combination of the glue spreading head 310 and the base film, and further achieve uniform guiding-out of the slow-release gel and smearing on the base film, a glue sticking plate 320 is disposed below the glue spreading head 310, the surface of the glue sticking plate 320 is horizontal, and the base film guided out by the second feeding roller 210 passes through the glue sticking plate 320.
In order to realize stable guiding of the base film, a guide groove 321 is disposed on the upper plate surface of the rubberizing plate 320, the guide groove 321 is disposed along the length direction of the rubberizing plate 320, and the base film guided out by the second feeding roller 210 is located in the guide groove 321.
The basal lamina passes through the guide slot 321 that the face set up on the rubberizing board 320 for the basal lamina can be stable through guide slot 321, realizes the restraint to the basal lamina, makes the basal lamina appear the state of flatness and lead and send.
Further, to ensure a small and uniform release of the slow release gel, the whole of the glue spreading head 310 is in a tubular structure with a large top and a small bottom, a rectangular outlet is arranged at the lower end of the glue spreading head 310, the rectangular outlet is in a flat tubular shape and is arranged along the width direction of the guide slot 321 of the glue spreading plate 320, and the lumen of the glue spreading head 310 is communicated with the outlet of the glue supplying device.
The slow release gel is guided out through a flat rectangular outlet at the lower end of the glue spreading head 310, so that the slow release gel can be conveniently and uniformly smeared on the base film.
Further, an extrusion mechanism is disposed at the upper end of the applicator head 310, and is used for guiding the slow release gel in the lumen of the applicator head 310 out of the rectangular outlet.
The extrusion mechanism performs extrusion of the glue spreading head 310, so that the slow-release gel is conveniently and uniformly guided out from a rectangular outlet at the lower end of the glue spreading head 310 and uniformly smeared on the base film.
Preferably, in order to implement uniform delivery of the slow release gel in the extrusion head 310, the extrusion mechanism includes an extrusion piston 330 disposed in the upper end lumen of the glue head 310, the extrusion piston 330 divides the glue head 310 into an upper chamber and a lower chamber, the outlet of the glue supplying device is communicated with the lower chamber of the glue head 310, and the upper chamber of the glue head 310 is communicated with the air outlet of the high pressure air source.
Specifically, in order to realize the slow and even release of the slow release gel, the slow release gel is evenly smeared on the base film, the upper end of the extruding piston 330 is provided with a vertical sliding rod 331, the vertical sliding rod 331 is vertically arranged on a bracket in the pipe wall of the gluing head 310 in a sliding manner, the vertical sliding rod 331 is sleeved with a vertical spring 332, and two ends of the vertical spring 332 are respectively abutted to the upper end of the vertical sliding rod 331 and the bracket.
More preferably, the glue spreading 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 glue spreading 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 spreading of the slow-release gel and the base film is implemented, the lifting cylinder 344 is started to enable the ordering of the glue spreading head 310 to be in contact with the base film, the elastic combination of the glue spreading 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 through starting the high-pressure air source, the uniform extrusion of the slow-release gel is realized, and the uniform spreading of the slow-release gel on the base film is ensured.
Specifically, for further evenly smearing the slow-release gel on the base film, a rectangular outlet at the lower end 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 at the lower end of the gluing head 310 through hinge shafts, the hinge shafts of the material-driving plate 350 are horizontal and parallel to the length direction of the rectangular outlet at the lower end of the gluing head 310, torsion springs are sleeved on the hinge shafts of the material-driving plate 350, two ends of each torsion spring are connected with the hinge shafts and the lower end of the gluing head 310, the material-driving plate 350 is arranged along the length direction of the rectangular outlet at the lower end of the gluing head 310, and the material-driving plate 350 abuts against the rubberizing plate 320.
The material driving plate 350 abuts against the rubberizing plate 320, and in the process that the base film moves along the rubberizing plate 320, the slow-release gel positioned at the lower end of the rubberizing head 310 is uniformly hung on the base film, so that the aim of uniformly smearing the base film is fulfilled.
More preferably, the two sides of the material-driving plate 350 are provided with a shroud-plate 351, the shroud-plate 351 is arranged along two sides of the width direction of the rectangular outlet at the lower end of the glue spreading head 310, the lower plate surface of the shroud-plate 351 is lower than the rectangular outlet at the lower end of the glue spreading head 310, and the shroud-plate 351, the rectangular outlet surface at the lower end of the glue spreading head 310 and the upper plate surface of the glue spreading plate 320 form a region coated with slow release gel.
The area enclosed between the shroud plate 351, the rectangular outlet surface at the lower end of the glue spreading head 310 and the glue spreading plate 320 is used for gathering the slow-release gel, and the slow-release gel can be uniformly hung on the base film along with the base film passing through the area, so that the slow-release gel is uniformly spread.
In order to implement the traction for the slow release gel, the traction roller 360 is disposed at the outlet of the rubberizing plate 320, the traction roller 360 is horizontally disposed and vertically disposed with respect to the length direction of the rubberizing plate 320, and the traction roller 360 is disposed up and down and implements the traction for the base film.
The traction roller 360 is started to realize traction of the base film coated with the slow-release gel, and the base film is guided out to the position of the combining equipment 400 so as to realize combination of the base film and the adhesive tape.
More specifically, to achieve the combination of the base film and the adhesive tape, the combination apparatus 400 includes two sets of combination rollers 410 disposed at the outlet of the pulling roller 360, the combination rollers 410 are parallel to the pulling roller 360 and perform clamping pulling on both sides of the base film and the adhesive tape, a roller brush 420 is disposed at the middle position of the combination rollers 410, and the roller brush 420 is disposed parallel to the combination rollers 410.
The roller brush 420 is made of flexible materials, the roller 410 is combined to compress the base film and the adhesive plaster, 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 adhesive plaster is ensured.
A preparation method of a sustained-release gel patch comprises the steps of preparing sustained-release gel and uniformly smearing the prepared sustained-release gel on a base film;
a first step of placing a roll of a sticker in a sticker feeding device 100 and separating the sticker of the roll of the sticker from a protective film;
secondly, placing the base film coil stock in the base film feeding device 200 so that the base film is pulled out to the position of the gluing equipment 300;
starting the gluing equipment 300, and approaching the slow-release gel to the base film so that the slow-release gel is uniformly smeared on the base film;
fourthly, guiding out the adhesive tape to the position below the base film coated with the slow-release gel, and guiding out the protective film to the 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 to produce the sustained-release gel medicine plaster.
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 characteristics 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 disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is provided for clarity only, and that the disclosure is not limited to the embodiments described in detail below, and that the embodiments described in the examples may be combined as appropriate to form other embodiments that will be apparent to those skilled in the art.
Claims (2)
1. The preparation equipment of the sustained-release gel patch is characterized in that: the slow-release gel patch comprises the following preparation method, which comprises the steps of preparing slow-release gel and uniformly smearing the prepared slow-release gel on a base film to prepare the slow-release gel patch;
the slow-release gel comprises the following raw materials in percentage by weight:
drug molecules: 0.5 to 1.0 percent; permeation promoter: 3.0 to 5.0 percent; 0.4 to 1.0 percent of sodium tetradecyl maleic anhydride sulfonate; 30.0 to 45.0 percent of solvent; 10.0 to 15.0 percent of sodium acrylate resin; 0.01 to 1.0 percent of cross-linking agent; 7.0 to 15.0 percent of tackifier; 0.2 to 0.4 percent of catalyst; the balance being water;
the penetration enhancer is laurocapram or dimethyl sulfoxide, and the cross-linking agent is aluminum glycinate;
the tackifier is polyvinylpyrrolidone;
the catalyst is tartaric acid;
the drug molecule is indomethacin or ibuprofen, and the solvent is a mixture of ethanol and glycerol;
the weight percentage of the ethanol is 1.0-5.0%, and the weight percentage of the glycerol is 5.0-40.0%;
the preparation method of the sustained-release gel comprises the following steps:
uniformly mixing 0.2-2.0% of sodium maleic anhydride tetradecyl propane sulfonate, 6.0-45.0% of solvent, 1.0-5.0% of permeation promoter and 0.1-1.0% of medicine molecules to form monomer coated medicine solution, wherein the permeation promoter is laurocapram or dimethyl sulfoxide;
step two, 0.01 to 0.5 percent of catalyst tartaric acid is dissolved in water to prepare tartaric acid aqueous solution;
sequentially adding 1.0-15.0% of sodium acrylate resin, 0.01-1.0% of crosslinking 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, the hydrogel precursor is molded, and is taken out after being irradiated under 60Co gamma rays, wherein the irradiation amount of the 60Co gamma rays is 0.5-8 kGy, and the drug slow-release hydrogel product is obtained; the sum of the dosages of the components in the first step to the third step is 100 percent;
the prepared slow release gel is thrown into a charging barrel continuously, and the slow release gel is slowly led out into a gluing device (300) through an extrusion device; then the preparation of the sustained-release gel patch is implemented, and the preparation method of the sustained-release gel patch comprises the following steps:
firstly, placing a roll of adhesive plaster into an adhesive plaster feeding device (100) and separating the adhesive plaster of the roll of adhesive plaster from a protective film;
secondly, placing the base film coil stock in a base film feeding device (200) so that the base film is pulled out to the position of a gluing device (300);
starting the gluing equipment (300), and approaching the slow-release gel to the base film to uniformly paint the slow-release gel on the base film;
fourthly, guiding out the adhesive tape to the position below the base film coated with the slow-release gel, and guiding out the protective film to the position above the base film coated with the slow-release gel;
fifthly, starting a combination device (400) to combine the base film, the protective film and the adhesive plaster, and further to produce the sustained-release gel patch;
the preparation equipment of the sustained-release gel medicine patch comprises a glue patch feeding device (100), a separating mechanism is arranged at the outlet position of the glue patch feeding device (100), the separating mechanism is used for separating a protective film of the glue patch from the glue patch, a base film feeding device (200) is arranged at the outlet position of the glue patch feeding device (100), the base film feeding device (200) is used for continuously guiding out the 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 smearing sustained-release gel on the base film, and the base film guided out by the base film feeding device (200) is combined with the glue patch guiding out by the glue patch feeding device (100); the outlet of the base film feeding device (200) and the outlet of the adhesive plaster feeding device (100) are provided with a combination device (400), and the combination device (400) is used for combining the base film and the adhesive plaster into a whole;
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 separating roller (120) separates the adhesive tape of the adhesive tape roller from the protective film and guides the adhesive tape to the upper and lower positions of the base film through the guide unit; the guide unit comprises two groups of first guide rollers (130) arranged beside the separation roller (120), the two groups of first guide rollers (130) are parallel to the separation roller (120), two groups of second guide rollers (140) are arranged at the outlet position of the base film feeding device (200), and the two groups of second guide rollers (140) are arranged in parallel with the two groups of first guide rollers (130); the base film feeding device (200) comprises a second feeding roller (210) which is horizontally arranged, the second feeding roller (210) is arranged in parallel with the first feeding roller (110), the gluing device (300) comprises a gluing head (310) arranged beside the second feeding roller (210), and the gluing head (310) moves vertically and smears slow-release gel on the base film;
a rubberizing plate (320) is arranged below the rubberizing head (310), the surface of the rubberizing plate (320) is horizontal, and the base film led out by the second feeding roller (210) passes through the rubberizing plate (320); the upper plate surface of the rubberizing plate (320) is provided with a guide groove (321), the guide groove (321) is arranged along the length direction of the rubberizing plate (320), and a base film led out by the second feeding roller (210) is positioned in the guide groove (321); the gluing head (310) is integrally in 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 in a flat tubular shape and is arranged along the width direction of a guide groove (321) of the rubberizing plate (320), and a pipe cavity of the gluing head (310) is communicated with an outlet of the glue supply equipment; the upper end of the gluing head (310) is provided with an extrusion mechanism which is used for guiding out the slow release gel in the tube cavity of the gluing head (310) from a rectangular outlet; the extrusion mechanism comprises an extrusion piston (330) arranged in the upper end pipe cavity of the gluing head (310), the extrusion piston (330) divides the gluing head (310) into an upper cavity and a lower cavity, an outlet of the glue supply device is communicated with the lower cavity of the gluing head (310), and the upper cavity 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 arranged on a bracket in the pipe wall of the gluing head (310) in a sliding manner, the vertical sliding rod (331) is sleeved with a vertical spring (332), and two ends of the vertical spring (332) are respectively abutted against the upper end of the vertical sliding rod (331) and the bracket; the glue spreading head (310) is vertically arranged on a lifting slide rod (341) of the lifting frame (340) in a sliding manner, the lifting slide rod (341) is vertically arranged, lifting springs (342) are sleeved on the lifting slide rod (341), two ends of each lifting spring (342) respectively abut against the lifting frame (340) and the glue spreading head (310), a lifting driving head (343) is arranged 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 arranged; the lifting driving head (343) is connected with a piston rod of the lifting cylinder (344) through a spring (345), and the spring (345) is vertically arranged;
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 hinge shafts, the hinge 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), torsion springs are sleeved on the hinge shafts of the material-driving plate (350), two ends of each torsion spring are connected with the hinge 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) abuts against the rubberizing plate (320); the two sides of the material driving plate (350) are provided with the shroud-plate strips (351), the shroud-plate strips (351) are arranged along two sides of the width direction of the rectangular outlet at the lower end of the gluing head (310), the lower plate surface of the shroud-plate strips (351) is lower than the rectangular outlet at the lower end of the gluing head (310), and the shroud-plate strips (351), the rectangular outlet surface at the lower end of the gluing head (310) and the upper plate surface of the rubberizing plate (320) form a region coated with slow-release gel.
2. The apparatus for preparing a sustained-release gel patch according to claim 1, wherein: the outlet position of the rubberizing plate (320) is provided with a traction roller (360), the traction roller (360) is horizontally arranged and is vertical to the length direction of the rubberizing 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 position of the traction roller (360), the combination rollers (410) are parallel to the traction roller (360) and are used for clamping and traction on two sides of a base film and a glue, a roller brush (420) is arranged at the middle position of the combination rollers (410), and the roller brush (420) is arranged in parallel with the combination rollers (410).
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| Application Number | Priority Date | Filing Date | Title |
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| CN202111294650.8A CN113827579B (en) | 2021-11-03 | 2021-11-03 | Preparation method and equipment of sustained-release gel patch |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202111294650.8A CN113827579B (en) | 2021-11-03 | 2021-11-03 | Preparation method and equipment of sustained-release gel patch |
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| CN113827579A CN113827579A (en) | 2021-12-24 |
| CN113827579B true CN113827579B (en) | 2023-12-05 |
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