HRP20171079T1 - Terapijska nadopuna i poboljšanje vlaženja površine oka - Google Patents
Terapijska nadopuna i poboljšanje vlaženja površine oka Download PDFInfo
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- HRP20171079T1 HRP20171079T1 HRP20171079TT HRP20171079T HRP20171079T1 HR P20171079 T1 HRP20171079 T1 HR P20171079T1 HR P20171079T T HRP20171079T T HR P20171079TT HR P20171079 T HRP20171079 T HR P20171079T HR P20171079 T1 HRP20171079 T1 HR P20171079T1
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- prg4
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- ophthalmically
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- 238000005461 lubrication Methods 0.000 title claims 8
- 230000001225 therapeutic effect Effects 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 22
- 101001123332 Homo sapiens Proteoglycan 4 Proteins 0.000 claims 14
- 102100028965 Proteoglycan 4 Human genes 0.000 claims 14
- 239000012634 fragment Substances 0.000 claims 12
- 239000000243 solution Substances 0.000 claims 8
- 230000001050 lubricating effect Effects 0.000 claims 7
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims 4
- 229920002385 Sodium hyaluronate Polymers 0.000 claims 4
- 229920002674 hyaluronan Polymers 0.000 claims 4
- 229960003160 hyaluronic acid Drugs 0.000 claims 4
- 229940010747 sodium hyaluronate Drugs 0.000 claims 4
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 150000003904 phospholipids Chemical class 0.000 claims 3
- KILNVBDSWZSGLL-KXQOOQHDSA-N 1,2-dihexadecanoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCC KILNVBDSWZSGLL-KXQOOQHDSA-N 0.000 claims 2
- 208000003556 Dry Eye Syndromes Diseases 0.000 claims 2
- JZNWSCPGTDBMEW-UHFFFAOYSA-N Glycerophosphorylethanolamin Natural products NCCOP(O)(=O)OCC(O)CO JZNWSCPGTDBMEW-UHFFFAOYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- 206010020751 Hypersensitivity Diseases 0.000 claims 2
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 208000026935 allergic disease Diseases 0.000 claims 2
- 230000007815 allergy Effects 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 230000007812 deficiency Effects 0.000 claims 2
- 239000003792 electrolyte Substances 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- WTJKGGKOPKCXLL-RRHRGVEJSA-N phosphatidylcholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCC=CCCCCCCCC WTJKGGKOPKCXLL-RRHRGVEJSA-N 0.000 claims 2
- 150000008104 phosphatidylethanolamines Chemical class 0.000 claims 2
- 238000001356 surgical procedure Methods 0.000 claims 2
- 230000000699 topical effect Effects 0.000 claims 2
- 206010002261 Androgen deficiency Diseases 0.000 claims 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- 206010013774 Dry eye Diseases 0.000 claims 1
- 208000009319 Keratoconjunctivitis Sicca Diseases 0.000 claims 1
- 108091005804 Peptidases Proteins 0.000 claims 1
- 239000004365 Protease Substances 0.000 claims 1
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims 1
- 208000021386 Sjogren Syndrome Diseases 0.000 claims 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- 230000032683 aging Effects 0.000 claims 1
- 239000003855 balanced salt solution Substances 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 208000037976 chronic inflammation Diseases 0.000 claims 1
- 230000006020 chronic inflammation Effects 0.000 claims 1
- 230000001010 compromised effect Effects 0.000 claims 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000003974 emollient agent Substances 0.000 claims 1
- 238000009164 estrogen replacement therapy Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 1
- 210000004175 meibomian gland Anatomy 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000002953 phosphate buffered saline Substances 0.000 claims 1
- 239000011736 potassium bicarbonate Substances 0.000 claims 1
- 235000015497 potassium bicarbonate Nutrition 0.000 claims 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 claims 1
- 239000001103 potassium chloride Substances 0.000 claims 1
- 235000011164 potassium chloride Nutrition 0.000 claims 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 208000024891 symptom Diseases 0.000 claims 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims 1
- 229940038773 trisodium citrate Drugs 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- 239000005526 vasoconstrictor agent Substances 0.000 claims 1
- 238000009736 wetting Methods 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
-
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- 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
- A61K38/18—Growth factors; Growth regulators
- A61K38/1841—Transforming growth factor [TGF]
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/688—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols both hydroxy compounds having nitrogen atoms, e.g. sphingomyelins
-
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
- A61K38/13—Cyclosporins
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- 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
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
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- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- A61K9/00—Medicinal preparations characterised by special physical form
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- 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
- A61K9/0048—Eye, e.g. artificial tears
- A61K9/0051—Ocular inserts, ocular implants
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
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- A61P27/04—Artificial tears; Irrigation solutions
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- A—HUMAN NECESSITIES
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- Pain & Pain Management (AREA)
- Pulmonology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
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- Peptides Or Proteins (AREA)
Claims (16)
1. Farmaceutski pripravak koji sadrži PRG4, ili njegov fragment za podmazivanje, naznačen time da je za uporabu za liječenje, putem topikalne primjene na površinu oka, deficijencija podmazivanja oka ili s njima povezanih simptoma.
2. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da se farmaceutski pripravak koji sadrži PRG4, ili njegov fragment za podmazivanje, primjenjuje u kombinaciji s oftalmički prikladnom formulacijom koja sadrži jedno ili više oftalmički prikladnih sredstava izabranih iz skupine koja sadrži oftalmički prikladno sredstvo za ublažavanje, oftalmički prikladnu pomoćnu tvar, oftalmički prikladan astringent, oftalmički prikladan vazokonstriktor, oftalmički prikladan emolijens, te oftalmički prikladan elektrolit.
3. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da se farmaceutski pripravak koji sadrži PRG4, ili njegov fragment za podmazivanje, primjenjuje u kombinaciji s oftalmološki prihvatljivom otopinom koja obuhvaća terapijski učinkovitu koncentraciju natrijevog hijaluronata ili hijaluronske kiseline.
4. Farmaceutski pripravak za uporabu prema zahtjevu 3, naznačen time da oftalmološki prihvatljiva otopina sadrži natrijev hijaluronat ili hijaluronsku kiselinu u terapijski učinkovitoj koncentraciji od 10-100,000 µg/mL.
5. Farmaceutski pripravak za uporabu prema zahtjevu 3, naznačen time da oftalmološki prihvatljiva otopina sadrži natrijev hijaluronat ili hijaluronsku kiselinu u terapijski učinkovitoj koncentraciji od 500-5,000 µg/mL.
6. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da se farmaceutski pripravak koji sadrži PRG4, ili njegov fragment za podmazivanje, primjenjuje u kombinaciji s oftalmološki prihvatljivom otopinom koja obuhvaća terapijski učinkovitu koncentraciju površinski aktivnog fosfolipida izabranog iz skupine koja obuhvaća L-α-dipalmitoilfosfatidilkolin, fosfatidilkolin, fosfatidiletanolamin i sfingomijelin.
7. Farmaceutski pripravak za uporabu prema zahtjevu 6, naznačen time da oftalmološki prihvatljiva otopina sadrži površinski aktivan fosfolipid u terapijski učinkovitoj koncentraciji od 10-10,000 µg/mL.
8. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da se farmaceutski pripravak koji sadrži PRG4, ili njegov fragment za podmazivanje, primjenjuje u kombinaciji s fosfatnom puferiranom fiziološkom otopinom koja sadrži barem natrijev fosfat i natrijev klorid.
9. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da se farmaceutski pripravak koji sadrži PRG4, ili njegov fragment za podmazivanje, primjenjuje u kombinaciji s oftalmički prikladnom uravnoteženom fiziološkom otopinom koja sadrži jedan ili više elektrolita izabranih iz skupine koja obuhvaća kalijev klorid, natrijev bikarbonat, kalijev bikarbonat, kalcijev klorid, magnezijev klorid, trinatrijev citrat, klorovodičnu kiselinu i natrijev hidroksid.
10. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da PRG4, ili njegov podmazujući fragment je rekombinantni PRG4 protein, ili njegov podmazujući fragment.
11. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da PRG4 je pročišćeni prirodni PRG4 protein.
12. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da se farmaceutski pripravak koji sadrži PRG4, ili njegov fragment za podmazivanje, primjenjuje u kombinaciji s oftalmički prihvatljivom otopinom koja sadrži terapijski učinkovitu koncentraciju natrijevog hijaluronata ili hijaluronske kiseline, i površinski aktivan fosfolipid izabran iz skupine koja obuhvaća L-α-dipalmitoilfosfatidilkolin, fosfatidilkolin, fosfatidiletanolamin i sfingomijelin.
13. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da je navedena deficijencija podmazivanja oka uzrokovana s bolesti vlaženja ili evaporativnog suhog oka, Sjogrenovim sindromom, suhim keratokonjunktivitisom, nedostatkom androgena, bolest meibomske žlijezde, zamjenska terapijom estrogenom, nošenjem kontaktnih leća, kirurškim refrakcijskim zahvatom, alergijom, smanjenim vremenom razbijanja suznog filma, kompromitiranim suznim filmom, alergijom, povećanim razinama proteaze u suznom filmu i na površini očiju, kroničnom upalom, hiperosmolarnošću, starenjem, ili njihovim kombinacijama.
14. Farmaceutski pripravak pogodan za topikalnu primjenu na površinu oka naznačen time da sadrži terapijski učinkovitu koncentraciju PRG4, ili njegovog fragmenta za podmazivanje, suspendiranu u oftalmički prihvatljivoj uravnoteženoj otopini soli.
15. Farmaceutski pripravak, za uporabu prema zahtjevu 1, ili farmaceutski pripravak prema zahtjevu 14, naznačen time da podmazujući fragment od PRG4 sadrži manje ponavljanja unutar središnje mucinu slične KEPAPTT-ponavljajuće domene (SEQ ID NO:4).
16. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time da farmaceutski pripravak sadrži PRG4, ili njegov fragment za podmazivanje, u koncentraciji od 50-500 µg/mL.
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