CN110354104A - Clonidine hydrochloride transdermal patch and preparation method thereof - Google Patents
Clonidine hydrochloride transdermal patch and preparation method thereof Download PDFInfo
- Publication number
- CN110354104A CN110354104A CN201910696161.1A CN201910696161A CN110354104A CN 110354104 A CN110354104 A CN 110354104A CN 201910696161 A CN201910696161 A CN 201910696161A CN 110354104 A CN110354104 A CN 110354104A
- Authority
- CN
- China
- Prior art keywords
- resin
- clonidine hydrochloride
- transdermal patch
- tpe
- triethylamine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- ZNIFSRGNXRYGHF-UHFFFAOYSA-N Clonidine hydrochloride Chemical compound Cl.ClC1=CC=CC(Cl)=C1NC1=NCCN1 ZNIFSRGNXRYGHF-UHFFFAOYSA-N 0.000 title claims abstract description 30
- 229960002925 clonidine hydrochloride Drugs 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims description 19
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 claims abstract description 72
- 239000011347 resin Substances 0.000 claims abstract description 48
- 229920005989 resin Polymers 0.000 claims abstract description 48
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 claims abstract description 24
- 150000003505 terpenes Chemical class 0.000 claims abstract description 24
- 235000007586 terpenes Nutrition 0.000 claims abstract description 24
- 239000003963 antioxidant agent Substances 0.000 claims abstract description 12
- 230000003078 antioxidant effect Effects 0.000 claims abstract description 12
- 229940043237 diethanolamine Drugs 0.000 claims description 22
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 12
- 235000006708 antioxidants Nutrition 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 10
- BGYHLZZASRKEJE-UHFFFAOYSA-N [3-[3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoyloxy]-2,2-bis[3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoyloxymethyl]propyl] 3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoate Chemical compound CC(C)(C)C1=C(O)C(C(C)(C)C)=CC(CCC(=O)OCC(COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)(COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)=C1 BGYHLZZASRKEJE-UHFFFAOYSA-N 0.000 claims description 8
- 239000004745 nonwoven fabric Substances 0.000 claims description 5
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 4
- 150000001412 amines Chemical class 0.000 claims description 4
- 239000006210 lotion Substances 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 229930003427 Vitamin E Natural products 0.000 claims description 2
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 2
- 235000019165 vitamin E Nutrition 0.000 claims description 2
- 229940046009 vitamin E Drugs 0.000 claims description 2
- 239000011709 vitamin E Substances 0.000 claims description 2
- 239000003292 glue Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 18
- 229940079593 drug Drugs 0.000 abstract description 16
- 239000011505 plaster Substances 0.000 abstract 2
- 230000000052 comparative effect Effects 0.000 description 16
- 239000000853 adhesive Substances 0.000 description 5
- 230000001070 adhesive effect Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- 229940086542 triethylamine Drugs 0.000 description 4
- 229960002896 clonidine Drugs 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- GJSURZIOUXUGAL-UHFFFAOYSA-N Clonidine Chemical compound ClC1=CC=CC(Cl)=C1NC1=NCCN1 GJSURZIOUXUGAL-UHFFFAOYSA-N 0.000 description 2
- 206010020772 Hypertension Diseases 0.000 description 2
- 239000006071 cream Substances 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000005457 optimization Methods 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 230000002889 sympathetic effect Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- 229920000178 Acrylic resin Polymers 0.000 description 1
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 description 1
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 description 1
- 208000005171 Dysmenorrhea Diseases 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 208000019695 Migraine disease Diseases 0.000 description 1
- MKYBYDHXWVHEJW-UHFFFAOYSA-N N-[1-oxo-1-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propan-2-yl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(C(C)NC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 MKYBYDHXWVHEJW-UHFFFAOYSA-N 0.000 description 1
- KHPCPRHQVVSZAH-HUOMCSJISA-N Rosin Natural products O(C/C=C/c1ccccc1)[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 KHPCPRHQVVSZAH-HUOMCSJISA-N 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- -1 clonidine hydrochlorides Chemical class 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000007872 degassing Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 210000003016 hypothalamus Anatomy 0.000 description 1
- GNYKPRZVSYJFIV-UHFFFAOYSA-N imidazolidin-1-ium;chloride Chemical compound Cl.C1CNCN1 GNYKPRZVSYJFIV-UHFFFAOYSA-N 0.000 description 1
- 125000001841 imino group Chemical group [H]N=* 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000009245 menopause Effects 0.000 description 1
- 239000011859 microparticle Substances 0.000 description 1
- 206010027599 migraine Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000008035 nerve activity Effects 0.000 description 1
- 210000002569 neuron Anatomy 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 230000007096 poisonous effect Effects 0.000 description 1
- 230000001242 postsynaptic effect Effects 0.000 description 1
- 230000001376 precipitating effect Effects 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 230000008337 systemic blood flow Effects 0.000 description 1
- 230000036228 toxication Effects 0.000 description 1
- KHPCPRHQVVSZAH-UHFFFAOYSA-N trans-cinnamyl beta-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OCC=CC1=CC=CC=C1 KHPCPRHQVVSZAH-UHFFFAOYSA-N 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
Classifications
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4168—1,3-Diazoles having a nitrogen attached in position 2, e.g. clonidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
- G06K17/00—Methods or arrangements for effecting co-operative working between equipments covered by two or more of main groups G06K1/00 - G06K15/00, e.g. automatic card files incorporating conveying and reading operations
- G06K17/0022—Methods or arrangements for effecting co-operative working between equipments covered by two or more of main groups G06K1/00 - G06K15/00, e.g. automatic card files incorporating conveying and reading operations arrangements or provisions for transferring data to distant stations, e.g. from a sensing device
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
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- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
- H04L67/00—Network arrangements or protocols for supporting network services or applications
- H04L67/01—Protocols
- H04L67/12—Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
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- Chemical Kinetics & Catalysis (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Pain & Pain Management (AREA)
- Addiction (AREA)
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- Dermatology (AREA)
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Abstract
The invention provides a clonidine hydrochloride transdermal patch, which comprises a backing layer and a plaster layer, wherein the backing layer comprises an identification code with a unique code, the identification code comprises a product display information module and a user character and/or photo information input module, the plaster layer comprises 5-15wt% of clonidine hydrochloride, 2-5wt% of triethylamine, 3-7wt% of diethanolamine, 0.3-0.6wt% of antioxidant, 42-64wt% of TPE-S resin and 10-22wt% of terpene resin, the mass ratio of triethylamine to diethanolamine is 1:1-1:1.3, the mass ratio of TPE-S resin to terpene resin is 3:1-4.5:1, the transdermal patch can effectively improve the medication smoothness of a patient through Internet of things management, meanwhile, the follow-up medication course can be optimized through the management of the Internet of things.
Description
Technical field
The present invention relates to a kind of transdermal cream and preparation method thereof, and in particular to a kind of clonidine hydrochloride transdermal patch and its system
Preparation Method.
Background technique
Clonidine hydrochloride, entitled 2_ [(2, the 6- dichlorophenyl) imino group] imidazolidine hydrochloride of chemistry, molecular formula:
C9H9C12N3HCl molecular weight: the central postsynaptic membrane α of the directly exciting hypothalamus of 266.56 clonidine hydrochlorides and medulla oblongata2By
Body keeps inhibitory neuron excited, central sympathetic impulsion outflow is reduced, to inhibit periphery sympathetic nerve activity.Hydrochloric acid
Laughable stator, prescribed drugs.It is mainly used for treating hypertension, hypertension emergency, migraine, children's hyperkinetic syndrome, menopause tide
Heat and abstains paregorism toxication shape at dysmenorrhea.
Transdermal patch is that drug enters systemic blood circulation through capillary absorbance by skin and reaches effective concentration, most
A kind of pharmaceutical preparations of whole body or local therapeutic effects are generated eventually.It can be improved without the destruction of liver and gastrointestinal tract
Bioavilability, provide reservation or longer action time, poisonous side effect of medicine is reduced, it is dense that lasting blood medicine is stablized in maintenance
Degree reduces administration number of times and improves therapeutic effect, and easy to use, easy to operate.
Summary of the invention
For the not ideal enough problem of existing transdermal patch permeability, administration duration, the present invention provides a kind of hydrochloric acid can
Happy fixed transdermal patch and preparation method, it is therefore intended that improve the permeability, adhesiveness and raising administration duration of drug.
One of the objects of the present invention is to provide a kind of transdermal patch of clonidine hydrochloride, the patch include laying and
Paste layer, the laying include the identification code with unique code, and the identification code includes product introduction information module, uses
Person's text and/or photographic intelligence recording module, the paste layer include the clonidine hydrochloride of 5-15wt%, 2-5wt% triethylamine,
The diethanol amine of 3-7wt%, the antioxidant of 0.3-0.6wt%, the TPE-S resin of 42-64wt%, 10-22wt% terpene resin,
Described in the mass ratio of triethylamine and diethanol amine be 1:1-1:1.3, the mass ratio of the TPE-S resin and terpene resin is 3:
1-4.5:1。
Further, the antioxidant includes one or more of antioxidant 1010, vitamin E.
Further, the mass ratio of the triethylamine and diethanol amine is 1:1.2.
Further, the paste layer includes the diethanol of the clonidine hydrochloride of 15wt%, the triethylamine of 5wt%, 6.5wt%
Amine, the antioxidant 1010 of 0.6 wt %, the TPE-S resin of 56.5wt%, 16.4wt% terpene resin.
Another object of the present invention is to provide a kind of preparation method of aforementioned transdermal patch, the preparation method includes such as
Lower step:
1) TPE-S resin and terpene resin are dissolved in acetone in proportion, clonidine hydrochloride, three second is separately added into solution
Amine, diethanol amine and antioxidant are ultrasonically treated with the power of 1000-1200w.
2) solution step 1) obtained with the Power Processing 2-5min of 200-300w, will mixing paste be evenly coated in it is anti-sticking
On paper, by 50-70 DEG C of drying.
Further, the preparation method further includes that the paste after drying is adhesive on PVC or non-woven fabrics, and is cut into
A certain size specification.
Further, the time being ultrasonically treated in the step 1) is 30min or more.
Further, the drying time of the step 2 is 1-2h.
Another object of the present invention is to provide a kind of application of aforementioned transdermal patch in management system for internet of things.
TPE-S resin, acrylic resin and terpene resin, rosin, gelatin etc. be the common framework material of lagging agent and
Tackifier, but the framework material and tackifier of variety classes and different content have the adhesion property of lagging agent apparent
Difference, in system of the invention, when framework material is selected as the TPE-S resin of 42-64wt%, tackifier are selected as 10-
The terpene resin of 22wt%, and when the two mass ratio can be controlled in 3:1-4.5:1, there is ideal adhesion property.
The transdermal penetration effect of drug is an important factor for influencing drug effectiveness, in system of the present invention, by transdermal rush
Into Systematic selection be 2-5wt% triethylamine, 3-7wt% diethanol amine and the mass ratio of triethylamine and diethanol amine be 1:1-1:
When 1.3, clonidine hydrochloride has ideal osmotic effect.
In system of the present invention, low power ultrasound processing is carried out again after degassing processing, can make the solid of supersaturated solution
Solute generates rapid and gentle precipitating, while can strengthen crystal growth, it is possible thereby to contain same thickness lotion more
Drug, and drug granule is evenly distributed in lotion, does not protrude past lotion surface, does not influence the adhesion strength of patch, is suffered from
Person uses absolutely not foreign body sensation.
The application of transdermal patch of the invention in management system for internet of things realizes that user is logical in the following way
It crosses and identifies transdermal patch using identification code identification end, such as matched mobile phone app, wechat small routine, wechat public platform etc.
After identification code in agent, identification end shows the modules such as product information, the user's data input window of transdermal patch to user,
User uses time started, using effect by text information typing window typing, and/or passes through photographic intelligence typing window
Typing use state, and be uploaded to remote server, remote server can according to the set use course for the treatment of by above-mentioned port to
User sends prompt information, guarantees optimal drug curative effect so that user replaces drug in time, on the other hand passes through big data
The using effect for statisticalling analyze user, provides data basis using the optimization of the course for the treatment of to be subsequent.
Compared with the existing technology, technical solution of the present invention has the advantages that
1, the infiltration rate of transdermal patch of the invention is 31.024 ~ 36.435 μ g/(cm2× h);
2, the initial bonding strength of transdermal patch of the invention is not less than No. 15 balls, and holding power is in 140min or more;
3, the content of drug is 1.5 times or more of common transdermal patch in transdermal patch of the invention, stablizes administration time and maintains 36h
More than.
4, transdermal patch of the invention can effectively improve the medication smoothness of patient by Internet of Things management, while can lead to
Cross the Internet of Things management optimization subsequent administrations course for the treatment of.
Detailed description of the invention
The transdermal patch use state diagram that Fig. 1 present invention obtains
1, laying;2, layer of paste;3, skin;4, drug granule;5, drug microparticles
Specific embodiment
In order to better illustrate the present invention, it is easy to understand technical solution of the present invention, below to of the invention further detailed
Explanation.But following embodiments be only it is of the invention simply enumerate, do not represent or limit the scope of the present invention, this
Invention protection scope is subject to claims.The present invention will be further explained with reference to the examples below.
Embodiment 1
A kind of transdermal patch of clonidine hydrochloride, the patch include laying and paste layer, and the laying includes having only
The identification code of one code, the identification code include product introduction information module, user's text and/or photographic intelligence typing mould
Block, the paste layer include the antioxidant of the clonidine hydrochloride of 7wt%, the triethylamine of 4wt%, the diethanol amine of 4wt%, 0.3wt%
1010, the terpene resin of the TPE-S resin of 64wt%, 20wt%.The preparation method of aforementioned transdermal patch, the preparation method include
Following steps:
1) prepare each component raw material by aforementioned paste components, TPE-S resin and terpene resin are dissolved in acetone, divide into solution
Not Jia Ru clonidine hydrochloride, triethylamine, diethanol amine and antioxidant 1010,30min is ultrasonically treated with the power of 1200w.
2) mixing paste is evenly coated on separate paper by the solution obtained to step 1) with the Power Processing 5min of 200w,
By 50 dry 1.5h.
3) paste after drying is adhesive on PVC, and is cut into a certain size specification.
Embodiment 2
A kind of transdermal patch of clonidine hydrochloride, the patch include laying and paste layer, and the laying includes having only
The identification code of one code, the identification code include product introduction information module, user's text and/or photographic intelligence typing mould
Block, the paste layer include the dimension life of the clonidine hydrochloride of 10wt%, the triethylamine of 4wt%, the diethanol amine of 5.2wt%, 0.5wt%
The terpene resin of the TPE-S resin of plain E, 60wt%, 20wt%.The preparation method of aforementioned transdermal patch, the preparation method include
Following steps:
1) prepare each component raw material by aforementioned paste components, TPE-S resin and terpene resin are dissolved in acetone, divide into solution
Not Jia Ru clonidine hydrochloride, triethylamine, diethanol amine and antioxidant, 45min is ultrasonically treated with the power of 1000w.
2) mixing paste is evenly coated on separate paper by the solution obtained to step 1) with the Power Processing 3min of 300w,
By 70 dry 1h.
3) paste after drying is adhesive on non-woven fabrics, and is cut into a certain size specification.
Embodiment 3
A kind of transdermal patch of clonidine hydrochloride, the patch include laying and paste layer, and the laying includes having only
The identification code of one code, the identification code include product introduction information module, user's text and/or photographic intelligence typing mould
Block, the paste layer include the dimension life of the clonidine hydrochloride of 15wt%, the triethylamine of 5wt%, the diethanol amine of 6.5wt%, 0.6wt%
The terpene resin of the TPE-S resin of plain E, 58wt%, 14.9wt%.The preparation method of aforementioned transdermal patch, the preparation method packet
Include following steps:
1) prepare each component raw material by aforementioned paste components, TPE-S resin and terpene resin are dissolved in acetone, divide into solution
Not Jia Ru clonidine hydrochloride, triethylamine, diethanol amine and antioxidant, 40min is ultrasonically treated with the power of 1100w.
2) mixing paste is evenly coated on separate paper by the solution obtained to step 1) with the Power Processing 3min of 300w,
By 70 dry 1h.
3) paste after drying is adhesive on non-woven fabrics, and is cut into a certain size specification.
Embodiment 4
A kind of transdermal patch of clonidine hydrochloride, the patch include laying and paste layer, and the laying includes having only
The identification code of one code, the identification code include product introduction information module, user's text and/or photographic intelligence typing mould
Block, the paste layer include the clonidine hydrochloride of 15wt%, the triethylamine of 5wt%, the diethanol amine of 6.5wt%, 0.6 wt % it is anti-
Oxygen agent 1010, the TPE-S resin of 56.5wt%, 16.4wt% terpene resin.The preparation method of aforementioned transdermal patch, the preparation
Method includes the following steps:
1) prepare each component raw material by aforementioned paste components, TPE-S resin and terpene resin are dissolved in acetone, divide into solution
Not Jia Ru clonidine hydrochloride, triethylamine, diethanol amine and antioxidant, 40min is ultrasonically treated with the power of 1100w.
2) mixing paste is evenly coated on separate paper by the solution obtained to step 1) with the Power Processing 3min of 300w,
By 70 dry 1h.
3) paste after drying is adhesive on non-woven fabrics, and is cut into a certain size specification.
Comparative example 1
In this comparative example in addition to the following conditions, remaining condition is same as Example 1, and paste layer includes the salt of 7wt% in this comparative example
Sour clonidine, the triethylamine of 2wt%, the diethanol amine of 2wt%, the antioxidant 1010 of 0.3wt%, 66wt% TPE-S resin,
The terpene resin of 22wt%.
Comparative example 2
In this comparative example in addition to the following conditions, remaining condition is same as Example 1, and paste layer includes the salt of 7wt% in this comparative example
Sour clonidine, the triethylamine of 4wt%, the diethanol amine of 6wt%, the antioxidant 1010 of 0.3wt%, 62wt% TPE-S resin,
The terpene resin of 20wt%.
Comparative example 3
In this comparative example in addition to the following conditions, remaining condition is same as Example 4, the clonidine hydrochloride of 15wt% in this comparative example,
The triethylamine of 5wt%, the diethanol amine of 6.5wt%, the antioxidant 1010 of 0.6 wt %, the TPE-S resin of 50.9wt%, 22wt%
Terpene resin.
Comparative example 4
In this comparative example in addition to the following conditions, remaining condition is same as Example 4, and step 3) is to obtain to step 2 in this comparative example
To mixed liquor be evenly coated on separate paper, by 70 dry 1h.
Comparative example 5
In this comparative example in addition to the following conditions, remaining condition is same as Example 1, and paste layer described in this comparative example includes 7wt%
Clonidine hydrochloride, the triethylamine of 4wt%, the diethanol amine of 4wt%, the antioxidant 1010 of 0.3wt%, 64wt% TPE-S resin,
The terpene resin of 20wt%.
The transdermal penetration rates of 1-4 of the embodiment of the present invention and comparative example 1-4, initial bonding strength, holding power and unit thickness cream
Body drug content is as shown in table 1.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
Limitations on the scope of the patent of the present invention therefore cannot be interpreted as.It should be pointed out that for those of ordinary skill in the art
For, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to guarantor of the invention
Protect range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.
Claims (9)
1. a kind of transdermal patch of clonidine hydrochloride, it is characterised in that: the patch includes laying and paste layer, the liner
Layer includes the identification code with unique code, and the identification code includes product introduction information module, user's text and/or photo
Data input module, the paste layer include the diethanol of the clonidine hydrochloride of 5-15wt%, the triethylamine of 2-5wt%, 3-7wt%
Amine, the antioxidant of 0.3-0.6wt%, the TPE-S resin of 42-64wt%, 10-22wt% terpene resin, wherein the triethylamine with
The mass ratio of diethanol amine is 1:1-1:1.3, and the mass ratio of the TPE-S resin and terpene resin is 3:1-4.5:1.
2. transdermal patch as described in claim 1, it is characterised in that: the antioxidant includes antioxidant 1010, in vitamin E
More than one.
3. transdermal patch as claimed in claim 1 or 2, it is characterised in that: the mass ratio of the triethylamine and diethanol amine is
1:1.2。
4. a kind of transdermal patch of clonidine hydrochloride, it is characterised in that: the patch includes laying and paste layer, the lotion
Layer include the clonidine hydrochloride of 15wt%, the triethylamine of 5wt%, the diethanol amine of 6.5wt%, 0.6 wt% antioxidant 1010,
The terpene resin of the TPE-S resin of 56.5wt%, 16.4wt%.
5. a kind of preparation method of the described in any item transdermal patches of claim 1-4, the preparation method include the following steps:
1) TPE-S resin and terpene resin are dissolved in acetone in proportion, clonidine hydrochloride, three second is separately added into solution
Amine, diethanol amine and antioxidant are ultrasonically treated with the power of 1000-1200w;
2) solution obtained to step 1) is evenly coated in separate paper with the Power Processing 2-5min of 200-300w, by mixing paste
On, by 50-70 DEG C of drying.
6. a kind of method described in claim 5, it is characterised in that: the preparation method further includes, by the paste glue after drying
It is sticked on PVC or non-woven fabrics, and is cut into a certain size specification.
7. a kind of method described in claim 5 or 6, it is characterised in that: the time being ultrasonically treated in the step 1) is 30min
More than.
8. a kind of method described in claim 5 or 6, it is characterised in that: the drying time of the step 2 is 1-2h.
9. a kind of application of described in any item transdermal patches of claim 1-4 in management system for internet of things.
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CN201910696161.1A CN110354104A (en) | 2019-07-30 | 2019-07-30 | Clonidine hydrochloride transdermal patch and preparation method thereof |
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CN201910696161.1A CN110354104A (en) | 2019-07-30 | 2019-07-30 | Clonidine hydrochloride transdermal patch and preparation method thereof |
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Family
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002332228A (en) * | 2001-05-11 | 2002-11-22 | Yuutoku Yakuhin Kogyo Kk | Percutaneous absorption cataplasm and method for producing the same |
US6517936B1 (en) * | 1997-12-29 | 2003-02-11 | Cryovac, Inc. | Multi-layer stretch film |
WO2015087755A1 (en) * | 2013-12-09 | 2015-06-18 | 久光製薬株式会社 | Clonidine-containing adhesive patch |
-
2019
- 2019-07-30 CN CN201910696161.1A patent/CN110354104A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6517936B1 (en) * | 1997-12-29 | 2003-02-11 | Cryovac, Inc. | Multi-layer stretch film |
JP2002332228A (en) * | 2001-05-11 | 2002-11-22 | Yuutoku Yakuhin Kogyo Kk | Percutaneous absorption cataplasm and method for producing the same |
WO2015087755A1 (en) * | 2013-12-09 | 2015-06-18 | 久光製薬株式会社 | Clonidine-containing adhesive patch |
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Application publication date: 20191022 |