CN116327740A - Lactoferrin patch and application thereof in preparation of medicines for treating recurrent respiratory tract infection of children - Google Patents
Lactoferrin patch and application thereof in preparation of medicines for treating recurrent respiratory tract infection of children Download PDFInfo
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- CN116327740A CN116327740A CN202310211417.1A CN202310211417A CN116327740A CN 116327740 A CN116327740 A CN 116327740A CN 202310211417 A CN202310211417 A CN 202310211417A CN 116327740 A CN116327740 A CN 116327740A
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- Prior art keywords
- lactoferrin
- patch
- chitosan
- stirring
- solution
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- CSSYQJWUGATIHM-IKGCZBKSSA-N l-phenylalanyl-l-lysyl-l-cysteinyl-l-arginyl-l-arginyl-l-tryptophyl-l-glutaminyl-l-tryptophyl-l-arginyl-l-methionyl-l-lysyl-l-lysyl-l-leucylglycyl-l-alanyl-l-prolyl-l-seryl-l-isoleucyl-l-threonyl-l-cysteinyl-l-valyl-l-arginyl-l-arginyl-l-alanyl-l-phenylal Chemical compound C([C@H](N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CS)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CC=CC=C1 CSSYQJWUGATIHM-IKGCZBKSSA-N 0.000 title claims abstract description 60
- 102000010445 Lactoferrin Human genes 0.000 title claims abstract description 59
- 108010063045 Lactoferrin Proteins 0.000 title claims abstract description 59
- 229940078795 lactoferrin Drugs 0.000 title claims abstract description 59
- 235000021242 lactoferrin Nutrition 0.000 title claims abstract description 59
- 239000003814 drug Substances 0.000 title claims abstract description 23
- 229940079593 drug Drugs 0.000 title claims abstract description 18
- 206010057190 Respiratory tract infections Diseases 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 229920001661 Chitosan Polymers 0.000 claims description 46
- 238000003756 stirring Methods 0.000 claims description 34
- 239000000243 solution Substances 0.000 claims description 32
- 239000004005 microsphere Substances 0.000 claims description 31
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 22
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 20
- 239000000839 emulsion Substances 0.000 claims description 15
- 239000012071 phase Substances 0.000 claims description 15
- 239000002904 solvent Substances 0.000 claims description 13
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims description 11
- -1 polyethylene, ethylene Polymers 0.000 claims description 11
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims description 10
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 10
- 229960000583 acetic acid Drugs 0.000 claims description 10
- 239000012362 glacial acetic acid Substances 0.000 claims description 10
- 238000002156 mixing Methods 0.000 claims description 9
- 229920002367 Polyisobutene Polymers 0.000 claims description 7
- 239000011248 coating agent Substances 0.000 claims description 7
- 238000000576 coating method Methods 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 7
- 229920000728 polyester Polymers 0.000 claims description 7
- 239000000758 substrate Substances 0.000 claims description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 6
- 239000005662 Paraffin oil Substances 0.000 claims description 5
- 239000004698 Polyethylene Substances 0.000 claims description 5
- 101710194948 Protein phosphatase PhpP Proteins 0.000 claims description 5
- NWGKJDSIEKMTRX-AAZCQSIUSA-N Sorbitan monooleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O NWGKJDSIEKMTRX-AAZCQSIUSA-N 0.000 claims description 5
- 239000008346 aqueous phase Substances 0.000 claims description 5
- 238000004140 cleaning Methods 0.000 claims description 5
- 239000012154 double-distilled water Substances 0.000 claims description 5
- 238000004108 freeze drying Methods 0.000 claims description 5
- 229940057995 liquid paraffin Drugs 0.000 claims description 5
- HWGNBUXHKFFFIH-UHFFFAOYSA-I pentasodium;[oxido(phosphonatooxy)phosphoryl] phosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])(=O)OP([O-])([O-])=O HWGNBUXHKFFFIH-UHFFFAOYSA-I 0.000 claims description 5
- 239000003208 petroleum Substances 0.000 claims description 5
- 229920000573 polyethylene Polymers 0.000 claims description 5
- 239000002861 polymer material Substances 0.000 claims description 5
- 229920001296 polysiloxane Polymers 0.000 claims description 5
- 235000019832 sodium triphosphate Nutrition 0.000 claims description 5
- 239000004094 surface-active agent Substances 0.000 claims description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 4
- 239000004480 active ingredient Substances 0.000 claims description 4
- 239000007864 aqueous solution Substances 0.000 claims description 4
- 238000005520 cutting process Methods 0.000 claims description 4
- 238000007872 degassing Methods 0.000 claims description 4
- 238000012377 drug delivery Methods 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 238000004080 punching Methods 0.000 claims description 3
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
- 239000004743 Polypropylene Substances 0.000 claims description 2
- 229920002301 cellulose acetate Polymers 0.000 claims description 2
- 229920001577 copolymer Polymers 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 229920001155 polypropylene Polymers 0.000 claims description 2
- 229920000915 polyvinyl chloride Polymers 0.000 claims description 2
- 239000004800 polyvinyl chloride Substances 0.000 claims description 2
- 229920002379 silicone rubber Polymers 0.000 claims description 2
- 239000004945 silicone rubber Substances 0.000 claims description 2
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 208000024891 symptom Diseases 0.000 abstract description 10
- 208000015181 infectious disease Diseases 0.000 abstract description 6
- 239000002552 dosage form Substances 0.000 abstract description 5
- 230000035876 healing Effects 0.000 abstract description 4
- 230000004888 barrier function Effects 0.000 abstract description 3
- 229940100691 oral capsule Drugs 0.000 abstract description 3
- 239000002775 capsule Substances 0.000 description 6
- 230000006872 improvement Effects 0.000 description 6
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 4
- 206010024971 Lower respiratory tract infections Diseases 0.000 description 4
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 description 4
- 239000008280 blood Substances 0.000 description 4
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- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000009472 formulation Methods 0.000 description 3
- 210000001035 gastrointestinal tract Anatomy 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 230000036737 immune function Effects 0.000 description 3
- 235000016709 nutrition Nutrition 0.000 description 3
- ZVOLCUVKHLEPEV-UHFFFAOYSA-N Quercetagetin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=C(O)C(O)=C(O)C=C2O1 ZVOLCUVKHLEPEV-UHFFFAOYSA-N 0.000 description 2
- HWTZYBCRDDUBJY-UHFFFAOYSA-N Rhynchosin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=CC(O)=C(O)C=C2O1 HWTZYBCRDDUBJY-UHFFFAOYSA-N 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 230000008034 disappearance Effects 0.000 description 2
- 238000001647 drug administration Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000002955 immunomodulating agent Substances 0.000 description 2
- 229940121354 immunomodulator Drugs 0.000 description 2
- 230000002584 immunomodulator Effects 0.000 description 2
- 229910052742 iron Inorganic materials 0.000 description 2
- MWDZOUNAPSSOEL-UHFFFAOYSA-N kaempferol Natural products OC1=C(C(=O)c2cc(O)cc(O)c2O1)c3ccc(O)cc3 MWDZOUNAPSSOEL-UHFFFAOYSA-N 0.000 description 2
- 230000000474 nursing effect Effects 0.000 description 2
- 230000035764 nutrition Effects 0.000 description 2
- 235000018102 proteins Nutrition 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 229960001285 quercetin Drugs 0.000 description 2
- 235000005875 quercetin Nutrition 0.000 description 2
- 238000007086 side reaction Methods 0.000 description 2
- 229920001817 Agar Polymers 0.000 description 1
- 208000005623 Carcinogenesis Diseases 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 102000008857 Ferritin Human genes 0.000 description 1
- 108050000784 Ferritin Proteins 0.000 description 1
- 238000008416 Ferritin Methods 0.000 description 1
- 102000001554 Hemoglobins Human genes 0.000 description 1
- 108010054147 Hemoglobins Proteins 0.000 description 1
- 101000798114 Homo sapiens Lactotransferrin Proteins 0.000 description 1
- 206010027476 Metastases Diseases 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 208000032023 Signs and Symptoms Diseases 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000008272 agar Substances 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 230000036952 cancer formation Effects 0.000 description 1
- 231100000504 carcinogenesis Toxicity 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 238000009509 drug development Methods 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 235000013350 formula milk Nutrition 0.000 description 1
- 102000050459 human LTF Human genes 0.000 description 1
- 210000000987 immune system Anatomy 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000005075 mammary gland Anatomy 0.000 description 1
- 230000009401 metastasis Effects 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
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- 239000000047 product Substances 0.000 description 1
- 150000003254 radicals Chemical class 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 208000023504 respiratory system disease Diseases 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000006228 supernatant Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 230000000699 topical 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
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/40—Transferrins, e.g. lactoferrins, ovotransferrins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
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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
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Pulmonology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides a lactoferrin patch and application thereof in preparing medicines for treating children recurrent respiratory tract infection, and the lactoferrin patch has a plurality of advantages as a dosage form different from a conventional oral capsule preparation, and greatly improves the safety of patient medication. Compared with a control group, the lactoferrin patch of the invention can effectively improve clinical symptoms of the infant and quickly recover the immune barrier in the infant, the incidence rate of repeated respiratory tract infection of the patient is only 0.06%, and the hospitalization rate after infection is also only 0.03%. Effectively relieves clinical symptoms of children patients and accelerates the healing process.
Description
Technical Field
The invention relates to the technical field of lactoferrin, in particular to application of lactoferrin patches in preparing medicines for treating recurrent respiratory tract infections of children.
Background
Lactoferrin (LF) is a multifunctional protein that can be used as a source of nutrition for humans, supplements iron and amino acids, and as a drug for the prevention and treatment of various diseases in humans, for maintaining the balance of flora in the intestinal tract, preventing infection and virus resistance, inhibiting tumorigenesis and metastasis, hindering free radical production in the body, and the like. Currently, lactoferrin has become one of the hot spots in protein drug development. Infant milk powder added with lactoferrin is marketed in japan in 1988, and human lactoferrin produced by GenPharming corporation using a mammary gland bioreactor has also entered clinical trials in 1997.
Recurrent respiratory tract infection of children is common in global clinic, has higher morbidity, is easy to influence the growth and development of children patients due to complex disease cause and recurrent disease attack, and reduces the health level of patients. In recent years, repeated lower respiratory tract infection is studied quite much at home and abroad, etiology treatment is widely considered as a fundamental treatment means, but the effect is often not ideal enough, and in order to quickly improve the health condition of the infant, an immunomodulator is also required to be used for treatment, the immune function of the infant is enhanced through the immunomodulator, the repeated attack rate of diseases is reduced, and the treatment aim is fulfilled. WO2022219643A1 discloses a nutritional composition comprising a molecular complex of lactoferrin and quercetin, wherein the molecular complex of lactoferrin (Lf) and quercetin is suitably formulated as a topical transdermal formulation, a subcutaneous formulation, an ophthalmic otic formulation or a transdermal patch. However, the patent specification does not disclose a specific patch preparation method.
In addition, lactoferrin capsules are commonly used clinically for treating repeated lower respiratory tract infection of children, and although the immune system of children patients can be improved, the lactoferrin capsules inevitably have the defects of short biological half-life, easy loss of biological activity and the like, and the capsule preparation also has poor drug compliance and is easy to form fear of children taking drugs.
Disclosure of Invention
In view of the above-described situation, the present invention provides the use of a lactoferrin patch in the preparation of a medicament for the treatment of recurrent respiratory tract infections in children. The lactoferrin patch is proved to have a plurality of advantages as a dosage form different from a conventional oral capsule preparation, and the safety of the medication of patients is greatly improved. Compared with a control group, the lactoferrin patch of the invention can effectively improve clinical symptoms of the infant and quickly recover the immune barrier in the infant, the incidence rate of repeated respiratory tract infection of the patient is only 0.06%, and the hospitalization rate after infection is also only 0.03%. Effectively relieves clinical symptoms of children patients and accelerates the healing process.
Specifically, the invention provides a lactoferrin patch, which is characterized in that the lactoferrin patch takes lactoferrin-chitosan microspheres as the active ingredients of medicines.
Specifically, the lactoferrin patch consists of effective components of medicines, a solvent, a high polymer material and a pressure-sensitive adhesive.
Preferably, the solvent is selected from: ethanol, propylene glycol, water or a combination of the three, and the solvent is mainly used for dissolving the active ingredients of the medicine.
Preferably, the polymer material is selected from: polyester, polyethylene, ethylene/vinyl acetate copolymer, polyvinyl chloride, polypropylene, cellulose acetate and the like, and mainly plays a role in bearing medicines.
Preferably, the pressure sensitive adhesive is selected from: polyisobutene, acrylic acid, silicone rubber and the like, so that the drug delivery system is tightly combined with skin, and has biocompatibility and certain compatibility with the drug delivery system.
Specifically, the invention also provides a preparation method of the lactoferrin patch, which is characterized by comprising the following steps:
1) Preparing lactoferrin-chitosan microspheres;
2) Dissolving the lactoferrin-chitosan microsphere in the step 1) by adopting a solvent, adding a pressure-sensitive adhesive, uniformly stirring, coating on a substrate containing a high polymer material, drying, and punching to obtain the lactoferrin patch.
Preferably, the preparation of the lactoferrin-chitosan microsphere of step 1) comprises the following steps:
preparing an aqueous phase: dissolving 200-400mg of chitosan powder in 20-40ml of glacial acetic acid water solution at the temperature of 4 ℃ to prepare a chitosan solution; 10-30 μg lactoferrin was dissolved in 2-6ml PBS aqueous solution (pH 7.4) to prepare lactoferrin solution; fully mixing chitosan solution and lactoferrin solution;
preparing an oil phase: 200-400ml of liquid paraffin oil and a surfactant Span80 are sequentially injected into a three-neck flask, and are mechanically stirred uniformly at the stirring speed: 1000rmp/min;
preparing lactoferrin-chitosan microspheres: dropwise adding the water phase into the oil phase at the temperature of 4 ℃, mechanically stirring for 2-6h, and stirring at a speed of: 1000rmp/min, preparing water/oil emulsion; dropwise adding 20-40ml of 5% (w/v) STPP solution into the water/oil emulsion, mechanically stirring for 2-6h at a stirring speed: 1000rmp/min; repeatedly cleaning the emulsion with petroleum ether, isopropanol and double distilled water in sequence to obtain lactoferrin-chitosan microspheres; after freeze-drying, lactoferrin-chitosan microspheres were stored in a refrigerator at 4 ℃.
Preferably, step 2) further comprises the steps of: dissolving lactoferrin-chitosan microsphere 20-40mg in glacial acetic acid 20-40ml, stirring to dissolve in solvent, mixing with polyisobutene pressure sensitive adhesive 996-998mg, stirring, ultrasonic degassing, and uniformly coating on silicone-treated polyester anti-adhesion substrate (dry weight 6 mg/cm) 2 Size 5cm×5 cm), drying, covering with polyethylene backing film layer with thickness of 10 μm, and die cutting to obtain lactoferrin patch.
In particular, the invention also provides application of the lactoferrin patch or the preparation method thereof in preparing medicines for treating recurrent respiratory tract infections of children.
Further preferably, the lactoferrin patch is applied to the chest of the patient.
The invention has the following advantages:
1) The invention firstly constructs a sustained-release system containing lactoferrin-chitosan microspheres, and then successfully prepares the lactoferrin patch on the basis of the system, thereby realizing continuous controllable slow release of the lactoferrin with biological activity.
2) Lactoferrin patch as a dosage form different from conventional oral capsule preparation has many advantages: the first pass effect of the liver and the stimulation to the gastrointestinal tract can be avoided, and the drug absorption is not influenced by gastrointestinal tract factors, so that the individual difference of the drug administration is reduced; the release rate of the medicine can be effectively controlled, the stable blood concentration can be maintained for a long time, the peak-valley phenomenon of the blood concentration caused by oral administration is avoided, the blood concentration is kept stable within an effective concentration range, the administration times and the incidence rate of side reactions are obviously reduced, the administration can be timely interrupted when the side reactions occur, and the medication safety of patients is greatly improved.
3) Compared with a control group, the lactoferrin patch of the invention can effectively improve clinical symptoms of the infant and quickly recover the immune barrier in the infant, the incidence rate of repeated respiratory tract infection of the patient is only 0.06%, and the hospitalization rate after infection is also only 0.03%. Effectively relieves clinical symptoms of children patients and accelerates the healing process. In addition, compared with the capsule dosage form, the patch has better drug compliance, and can be only applied to the chest of the infant.
Detailed Description
The present invention will be described in further detail with reference to specific examples so as to more clearly understand the present invention by those skilled in the art.
The following examples are given by way of illustration of the invention and are not intended to limit the scope of the invention. All other embodiments obtained by those skilled in the art without creative efforts are within the protection scope of the present invention based on the specific embodiments of the present invention.
In the examples of the present invention, all raw material components are commercially available products well known to those skilled in the art unless specified otherwise; in the embodiments of the present invention, unless specifically indicated, all technical means used are conventional means well known to those skilled in the art.
Example 1
Lactoferrin patch preparation:
1) Preparing an aqueous phase: under the condition of 4 ℃, 200mg of chitosan powder is dissolved in 20m l glacial acetic acid water solution to prepare chitosan solution; a lactoferrin solution was prepared by dissolving 10. Mu.g of lactoferrin in 2ml of PBS aqueous solution (pH 7.4); fully mixing chitosan solution and lactoferrin solution;
2) Preparing an oil phase: 200ml of liquid paraffin oil and a surfactant Span80 are sequentially injected into a three-neck flask, and are mechanically stirred uniformly at the stirring speed: 1000rmp/min;
3) Preparing lactoferrin-chitosan microspheres: dropwise adding the water phase into the oil phase at the temperature of 4 ℃, mechanically stirring for 2 hours at the stirring speed: 1000rmp/min, preparing water/oil emulsion; 20ml of 5% (w/v) STPP solution was added dropwise to the water/oil emulsion, mechanically stirred for 2h at stirring speed: 1000rmp/min; repeatedly cleaning the emulsion with petroleum ether, isopropanol and double distilled water in sequence to obtain lactoferrin-chitosan microspheres; after freeze-drying, lactoferrin-chitosan microspheres were stored in a refrigerator at 4 ℃.
4) Taking 20mg of lactoferrin-chitosan microsphere in the step 3) to be dissolved in 20ml of glacial acetic acid, stirring to ensure that the lactoferrin-chitosan microsphere is fully dissolved in a solvent, continuously mixing with 998mg of polyisobutene pressure-sensitive adhesive, stirring, performing ultrasonic degassing, and uniformly coating on a silicone-treated polyester anti-sticking substrate (dry weight 6 mg/cm) 2 Size 5cm×5 cm), drying, covering with polyethylene backing film layer with thickness of 10 μm, and die cutting to obtain lactoferrin patch.
Example 2
Lactoferrin patch preparation:
1) Preparing an aqueous phase: under the condition of 4 ℃, 300mg of chitosan powder is dissolved in 30ml of glacial acetic acid water solution to prepare chitosan solution; a lactoferrin solution was prepared by dissolving 20. Mu.g of lactoferrin in 4ml of PBS aqueous solution (pH 7.4); fully mixing chitosan solution and lactoferrin solution;
2) Preparing an oil phase: 300ml of liquid paraffin oil and a surfactant Span80 are sequentially injected into a three-neck flask, and are mechanically stirred uniformly at the stirring speed: 1000rmp/min;
3) Preparing lactoferrin-chitosan microspheres: dropwise adding the water phase into the oil phase at the temperature of 4 ℃, mechanically stirring for 4 hours at the stirring speed: 1000rmp/min, preparing water/oil emulsion; 30ml of 5% (w/v) STPP solution was added dropwise to the water/oil emulsion, mechanically stirred for 4h at stirring speed: 1000rmp/min; repeatedly cleaning the emulsion with petroleum ether, isopropanol and double distilled water in sequence to obtain lactoferrin-chitosan microspheres; after freeze-drying, lactoferrin-chitosan microspheres were stored in a refrigerator at 4 ℃.
4) Taking 30mg of lactoferrin-chitosan microsphere in the step 3), dissolving in 30ml of glacial acetic acid, stirring to enable the lactoferrin-chitosan microsphere to be fully dissolved in a solvent, continuously mixing with 997mg of polyisobutene pressure-sensitive adhesive, stirring, performing ultrasonic degassing, and uniformly coating on a silicone-treated polyester anti-sticking substrate (dry weight 6 mg/cm) 2 Size 5cm×5 cm), drying, covering with polyethylene backing film layer with thickness of 10 μm, and die cutting to obtain lactoferrin patch.
Example 3
Lactoferrin patch preparation:
1) Preparing an aqueous phase: at 4 ℃, 400mg of chitosan powder is dissolved in 40ml of glacial acetic acid water solution to prepare chitosan solution; lactoferrin was dissolved in 6ml of aqueous PBS (p H7.4.7.4) to prepare a lactoferrin solution; fully mixing chitosan solution and lactoferrin solution;
2) Preparing an oil phase: 400ml of liquid paraffin oil and a surfactant Span80 are sequentially injected into a three-neck flask, and are mechanically stirred uniformly at the stirring speed: 1000rmp/min;
3) Preparing lactoferrin-chitosan microspheres: dropwise adding the water phase into the oil phase at the temperature of 4 ℃, mechanically stirring for 6 hours at the stirring speed: 1000rmp/min, preparing water/oil emulsion; 40ml of 5% (w/v) STPP solution was added dropwise to the water/oil emulsion, mechanically stirred for 6h at stirring speed: 1000rmp/min; repeatedly cleaning the emulsion with petroleum ether, isopropanol and double distilled water in sequence to obtain lactoferrin-chitosan microspheres; after freeze-drying, lactoferrin-chitosan microspheres were stored in a refrigerator at 4 ℃.
4) Dissolving 40mg of lactoferrin-chitosan microsphere in step 3) in 40ml of glacial acetic acid, stirring to make it fully dissolved in solvent, and continuing to makeMixing with 996mg polyisobutylene pressure sensitive adhesive, stirring, ultrasonic deaerating, and uniformly coating on silicone-treated polyester anti-sticking substrate (dry weight 6 mg/cm) 2 ) And (3) drying, covering a polyethylene backing film layer with the thickness of 10 mu m, and punching to obtain the lactoferrin patch.
Example 4
90 cases of children with repeated respiratory tract infection from 2021 month 1 to 2022 month 1 are randomly selected for study, and are divided into a control group, an observation group 1 and an observation group 2 according to the selection of treatment modes, wherein 30 cases of each group are three groups of ages, body mass, sex, lower respiratory tract infection times, hemoglobin, total body iron content and serum ferritin are not obviously different (P is more than 0.05). Wherein, the control group is not treated by any administration; the observation group 1 is to take lactoferrin capsules (Shanghai Boer Biotech Co., ltd., chinese character of health: G20060117, specification: 0.25G. Times.12 grains. Times.5 plates) three times a day, 0.5 grains each time; the observation group 2 was to attach the patch of example 1 of the present invention to the chest and replace the patch daily in the early morning. Before the patient is fully recovered, the patient is subjected to nutrition support, other special treatment and nursing are not performed on the basis of conventional treatment and nursing, and the clinical symptoms of the patient are continuously monitored.
Observing improvement or disappearance of indexes such as defervescence time, cough vanishing time, lung inflammation vanishing time, repeated respiratory tract infection incidence rate, hospitalization rate after infection and the like of the infant; (2) recording improvement condition of immune function index in early morning empty stomach state 1 week after administration, respectively extracting 3ml venous blood, taking supernatant after anticoagulation centrifugation treatment, and measuring IgG, igM, igA level by agar single diffusion method;
the experimental results are as follows:
as can be seen from table 1, both the clinical symptoms of groups 1 and 2 were observed to have some improvement compared to the control group; however, the clinical symptoms of group 2 were significantly shorter in disappearance than group 1, and the incidence of recurrent respiratory tract infections was only 0.06% and the hospitalization rate after infection was also only 0.03%. Effectively relieves clinical symptoms of children patients and accelerates the healing process. In addition, compared with the capsule dosage form, the patch has better drug compliance, and can be only applied to the chest of the infant.
Table 1 comparison of improvement of clinical symptoms and signs of infants
In clinical respiratory diseases, lower respiratory tract infections often cause a decrease in the level of immune indicators such as lgg, lgm, lga in patients. In order to further examine the curative effect of the patch of the invention, the inventor respectively monitors the change condition of the immune index levels of IgG, igM, igA and the like in the bodies of the infants under different treatment groups, the results are shown in a table 2, in a control group which is not treated by the drug administration, the I gG, the I gM and the IgA levels in the bodies of the infants obviously decrease within 1 week, in an observation group, the immune index level in the bodies of the infants obviously rises, and particularly, the observation group 2 is extremely remarkable, and further proves that the patch of the invention can effectively improve the immunity of patients and realize the purpose of effectively treating the recurrent respiratory tract infection of children.
TABLE 2 comparison of improvement of immune function index of infant
| Group of | Number of examples | IgA(g/L) | IgM(g/L) | IgG(g/L) |
| Control group | 30 | 0.05±0.12 | 0.21±0.09 | 3.40±0.23 |
| Observation group 1 | 30 | 0.21±0.42 | 0.35±0.25 | 3.55±0.64 |
| Observation group 2 | 30 | 0.35±0.05 | 0.53±0.78 | 3.98±0.55 |
It should be noted that the above examples are only for further illustration and description of the technical solution of the present invention, and are not intended to limit the technical solution of the present invention, but the method of the present invention is only a preferred embodiment and is not intended to limit the scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The lactoferrin patch for treating the recurrent respiratory tract infection of children is characterized by comprising lactoferrin-chitosan microspheres as active pharmaceutical ingredients.
2. The patch of claim 1, wherein the lactoferrin patch is composed of a pharmaceutical active ingredient, a solvent, a polymer material, and a pressure-sensitive adhesive.
3. The patch of claim 2, wherein the solvent is selected from the group consisting of: ethanol, propylene glycol, water or a combination of the three, and the solvent is mainly used for dissolving the active ingredients of the medicine.
4. The patch of claim 2, wherein the polymeric material is selected from the group consisting of: polyester, polyethylene, ethylene/vinyl acetate copolymer, polyvinyl chloride, polypropylene, cellulose acetate, which mainly plays a role of drug bearing.
5. The patch of claim 2, wherein the pressure sensitive adhesive is selected from the group consisting of: polyisobutylene, acrylic acid and silicone rubber, which make the drug delivery system closely combined with skin, and have biocompatibility and a certain compatibility with the drug delivery system.
6. A method for preparing a lactoferrin patch as claimed in any one of claims 1 to 5, characterized in that it comprises the steps of:
1) Preparing lactoferrin-chitosan microspheres;
2) Dissolving the lactoferrin-chitosan microsphere in the step 1) by adopting a solvent, adding a pressure-sensitive adhesive, uniformly stirring, coating on a substrate containing a high polymer material, drying, and punching to obtain the lactoferrin patch.
7. The method of claim 6, wherein the preparation of lactoferrin-chitosan microspheres in step 1) comprises the steps of:
preparing an aqueous phase: dissolving 200-400mg of chitosan powder in 20-40ml of glacial acetic acid water solution at the temperature of 4 ℃ to prepare a chitosan solution; 10-30 μg lactoferrin was dissolved in 2-6ml PBS aqueous solution (pH 7.4) to prepare lactoferrin solution; fully mixing chitosan solution and lactoferrin solution;
preparing an oil phase: 200-400ml of liquid paraffin oil and a surfactant Span80 are sequentially injected into a three-neck flask, and are mechanically stirred uniformly at the stirring speed: 1000rmp/min;
preparing lactoferrin-chitosan microspheres: dropwise adding the water phase into the oil phase at the temperature of 4 ℃, mechanically stirring for 2-6h, and stirring at a speed of: 1000rmp/min, preparing water/oil emulsion; dropwise adding 20-40ml of 5% (w/v) STPP solution into the water/oil emulsion, mechanically stirring for 2-6h at a stirring speed: 1000rmp/min; repeatedly cleaning the emulsion with petroleum ether, isopropanol and double distilled water in sequence to obtain lactoferrin-chitosan microspheres; after freeze-drying, lactoferrin-chitosan microspheres were stored in a refrigerator at 4 ℃.
8. The use of claim 6, wherein step 2) further comprises the steps of: dissolving lactoferrin-chitosan microsphere 20-40mg in glacial acetic acid 20-40ml, stirring to dissolve in solvent, mixing with polyisobutene pressure sensitive adhesive 996-998mg, stirring, ultrasonic degassing, and uniformly coating on silicone-treated polyester anti-adhesion substrate (dry weight 6 mg/cm) 2 Size 5cm×5 cm), drying, covering with polyethylene backing film layer with thickness of 10 μm, and die cutting to obtain lactoferrin patch.
9. Use of a lactoferrin patch according to any one of claims 1 to 5 or a method according to any one of claims 6 to 10 for the manufacture of a medicament for the treatment of recurrent respiratory tract infections in children.
10. The use of claim 9, wherein the lactoferrin patch is applied to the chest of the patient.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117462657A (en) * | 2023-11-13 | 2024-01-30 | 广州见华医学科技有限公司 | Application of lactoferrin capsule in bacteriostasis and anti-inflammation |
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| US20040208916A1 (en) * | 2003-04-15 | 2004-10-21 | Nick Abbott | Patch for the transdermal administration of beneficial substances |
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| WO2021220136A1 (en) * | 2020-04-29 | 2021-11-04 | TDC Technology Dedicated to Care srl | Compositions for the prevention and/or treatment of respiratory tract infections |
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| WO1998006425A1 (en) * | 1996-08-12 | 1998-02-19 | A+ Science Invest Ab | Treatment and prevention of infections, inflammations and/or tumours with lactoferrin and/or lactoferricin |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117462657A (en) * | 2023-11-13 | 2024-01-30 | 广州见华医学科技有限公司 | Application of lactoferrin capsule in bacteriostasis and anti-inflammation |
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