CN101683532A - Ophthalmic compound medicinal preparation containing hyaluronic acid or sodium hyaluronate - Google Patents
Ophthalmic compound medicinal preparation containing hyaluronic acid or sodium hyaluronate Download PDFInfo
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- CN101683532A CN101683532A CN200810197064A CN200810197064A CN101683532A CN 101683532 A CN101683532 A CN 101683532A CN 200810197064 A CN200810197064 A CN 200810197064A CN 200810197064 A CN200810197064 A CN 200810197064A CN 101683532 A CN101683532 A CN 101683532A
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- Prior art keywords
- salt
- compound medicinal
- eye
- medicinal formulation
- used compound
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- 150000001875 compounds Chemical class 0.000 title claims abstract description 22
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 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 title abstract description 6
- 229920002385 Sodium hyaluronate Polymers 0.000 title abstract description 4
- 229940010747 sodium hyaluronate Drugs 0.000 title abstract description 4
- 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 title abstract 3
- 229920002674 hyaluronan Polymers 0.000 title abstract 3
- 229960003160 hyaluronic acid Drugs 0.000 title abstract 3
- 210000001508 eye Anatomy 0.000 claims abstract description 32
- 230000003637 steroidlike Effects 0.000 claims abstract description 17
- 229940124599 anti-inflammatory drug Drugs 0.000 claims abstract description 15
- 239000003120 macrolide antibiotic agent Substances 0.000 claims abstract description 12
- 239000002253 acid Substances 0.000 claims description 18
- 239000011521 glass Substances 0.000 claims description 18
- 150000003839 salts Chemical class 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 13
- 239000004599 antimicrobial Substances 0.000 claims description 12
- 238000009472 formulation Methods 0.000 claims description 12
- 230000000844 anti-bacterial effect Effects 0.000 claims description 6
- MQTOSJVFKKJCRP-BICOPXKESA-N azithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)N(C)C[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 MQTOSJVFKKJCRP-BICOPXKESA-N 0.000 claims description 6
- 229960004099 azithromycin Drugs 0.000 claims description 6
- 229960003957 dexamethasone Drugs 0.000 claims description 6
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 5
- 159000000000 sodium salts Chemical class 0.000 claims description 5
- 239000002671 adjuvant Substances 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 239000003381 stabilizer Substances 0.000 claims description 4
- 239000004094 surface-active agent Substances 0.000 claims description 4
- PLCQGRYPOISRTQ-FCJDYXGNSA-L dexamethasone sodium phosphate Chemical class [Na+].[Na+].C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)COP([O-])([O-])=O)(O)[C@@]1(C)C[C@@H]2O PLCQGRYPOISRTQ-FCJDYXGNSA-L 0.000 claims description 3
- 229960001048 fluorometholone Drugs 0.000 claims description 3
- FAOZLTXFLGPHNG-KNAQIMQKSA-N fluorometholone Chemical compound C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@]2(F)[C@@H](O)C[C@]2(C)[C@@](O)(C(C)=O)CC[C@H]21 FAOZLTXFLGPHNG-KNAQIMQKSA-N 0.000 claims description 3
- 230000003204 osmotic effect Effects 0.000 claims description 3
- 229960005205 prednisolone Drugs 0.000 claims description 3
- OIGNJSKKLXVSLS-VWUMJDOOSA-N prednisolone Chemical compound O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 OIGNJSKKLXVSLS-VWUMJDOOSA-N 0.000 claims description 3
- VJZLQIPZNBPASX-OJJGEMKLSA-L prednisolone sodium phosphate Chemical class [Na+].[Na+].O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)COP([O-])([O-])=O)[C@@H]4[C@@H]3CCC2=C1 VJZLQIPZNBPASX-OJJGEMKLSA-L 0.000 claims description 3
- RXZBMPWDPOLZGW-XMRMVWPWSA-N (E)-roxithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=N/OCOCCOC)/[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 RXZBMPWDPOLZGW-XMRMVWPWSA-N 0.000 claims description 2
- LRJOMUJRLNCICJ-JZYPGELDSA-N Prednisolone acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)C[C@@H]2O LRJOMUJRLNCICJ-JZYPGELDSA-N 0.000 claims description 2
- FPVRUILUEYSIMD-RPRRAYFGSA-N [(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(OC(C)=O)[C@@]1(C)C[C@@H]2O FPVRUILUEYSIMD-RPRRAYFGSA-N 0.000 claims description 2
- 239000004480 active ingredient Substances 0.000 claims description 2
- 150000003863 ammonium salts Chemical class 0.000 claims description 2
- UREBDLICKHMUKA-DVTGEIKXSA-N betamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-DVTGEIKXSA-N 0.000 claims description 2
- 229950006991 betamethasone phosphate Drugs 0.000 claims description 2
- PLCQGRYPOISRTQ-LWCNAHDDSA-L betamethasone sodium phosphate Chemical class [Na+].[Na+].C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COP([O-])([O-])=O)(O)[C@@]1(C)C[C@@H]2O PLCQGRYPOISRTQ-LWCNAHDDSA-L 0.000 claims description 2
- 159000000007 calcium salts Chemical class 0.000 claims description 2
- 229960002626 clarithromycin Drugs 0.000 claims description 2
- AGOYDEPGAOXOCK-KCBOHYOISA-N clarithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@](C)([C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)OC)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 AGOYDEPGAOXOCK-KCBOHYOISA-N 0.000 claims description 2
- 229960003657 dexamethasone acetate Drugs 0.000 claims description 2
- 239000002552 dosage form Substances 0.000 claims description 2
- 159000000003 magnesium salts Chemical class 0.000 claims description 2
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 2
- 229960002800 prednisolone acetate Drugs 0.000 claims description 2
- 229960005224 roxithromycin Drugs 0.000 claims description 2
- 150000003751 zinc Chemical class 0.000 claims description 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 16
- 229940079593 drug Drugs 0.000 abstract description 7
- 206010061218 Inflammation Diseases 0.000 abstract description 6
- 230000000694 effects Effects 0.000 abstract description 5
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- 230000000845 anti-microbial effect Effects 0.000 abstract 1
- 230000007794 irritation Effects 0.000 abstract 1
- 239000003889 eye drop Substances 0.000 description 13
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 210000003683 corneal stroma Anatomy 0.000 description 5
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- OVBJJZOQPCKUOR-UHFFFAOYSA-L EDTA disodium salt dihydrate Chemical compound O.O.[Na+].[Na+].[O-]C(=O)C[NH+](CC([O-])=O)CC[NH+](CC([O-])=O)CC([O-])=O OVBJJZOQPCKUOR-UHFFFAOYSA-L 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 239000003242 anti bacterial agent Substances 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 229960000686 benzalkonium chloride Drugs 0.000 description 3
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 3
- 230000003115 biocidal effect Effects 0.000 description 3
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- 239000011780 sodium chloride Substances 0.000 description 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 2
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- 102000008186 Collagen Human genes 0.000 description 2
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- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 2
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- 239000001257 hydrogen Substances 0.000 description 1
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- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 210000002189 macula lutea Anatomy 0.000 description 1
- 150000002730 mercury Chemical class 0.000 description 1
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
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- PDTFCHSETJBPTR-UHFFFAOYSA-N phenylmercuric nitrate Chemical compound [O-][N+](=O)O[Hg]C1=CC=CC=C1 PDTFCHSETJBPTR-UHFFFAOYSA-N 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
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- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
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- 235000002639 sodium chloride Nutrition 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 239000004328 sodium tetraborate Substances 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- RMLUKZWYIKEASN-UHFFFAOYSA-M sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate Chemical compound [Na+].O=C1[N-]C(N)=NC2=C1N=CN2COCCO RMLUKZWYIKEASN-UHFFFAOYSA-M 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
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- 229960003080 taurine Drugs 0.000 description 1
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 1
- 229940033663 thimerosal Drugs 0.000 description 1
- 229940035274 tobradex Drugs 0.000 description 1
- 229960000707 tobramycin Drugs 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 210000003954 umbilical cord Anatomy 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 208000005494 xerophthalmia Diseases 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229960001763 zinc sulfate Drugs 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to an ophthalmic compound medicinal preparation containing hyaluronic acid or sodium hyaluronate, which is characterized in that the preparation comprises macrolide antimicrobialdrugs and steroidal anti-inflammatory drugs, can be antimicrobial and anti-inflammatory and obviously improves the treatment effects of ophthalmic infection and inflammation. The preparation takes the hyaluronic acid and sodium hyaluronate as carries, not only lengthens the residence time of medicines on the eyes so as to improve the bioavailability, but also lightens the irritation of the medicines to the eyes and improves the comfort after administration.
Description
Technical field:
The present invention relates to a kind of eye compound medicinal formulation that contains glass acid or its salt.
Technical background:
Eye inflammation is an ophthalmology common disease, and the anti-inflammatory agent of steroidal classes such as dexamethasone commonly used clinically is as medicine.Steroidal anti-inflammatory drugs to the various serious nonsuppurative inflammation of immunity oculopathy, eye connective tissue disease, eye, contusion of eyeball, corneal transplantation after the prevention and the treatment of immunological rejection, there is significant effect the aspects such as auxiliary treatment of various intraocular surgeries and ocular tumor.But the steroidal anti-inflammatory drugs corneal has tangible dual character.It can alleviate inflammatory reaction and histologic lesion in the pathological process, reduce cornea cicatrization and angiogenesis, suppress the antigen antibody reaction of corneal stroma, alleviate the edema and the infiltration of corneal stroma, corneal stroma inflammatory reaction process is shortened, for recovering the transparent condition of having created of cornea, this is favourable one side.The immunologic mechanism of its infringement body causes the double infection of fungus and antibacterial simultaneously; Strengthen the corneal collagen enzymatic activity, accelerate the dissolving of corneal stroma, ulcer is enlarged; It is synthetic to suppress corneal stroma fibroblast hypertrophy and collagen fiber and mucopolysaccharide, hinders the ulcer reparation.Therefore, in clinical practice, be necessary to be used antimicrobial drug and reduce the possibility that infects generation.The compound preparation that utilization antimicrobial drug and steroidal anti-inflammatory drugs are formed is a kind of method of using always.Aspect compound preparation, tobramycin/dexamethasone eye drop that existing U.S. Ai Erkang (Alcon) company produces, commodity allusion quotation by name is (TOBRADEX) very; Gentamycin sulfate/fluorometholone eye drop that Novartis Pharma AG produces, commodity are called Infectoflam.Ai Erkang (Alcon) company has applied for the patent of the part of fluoroquinolone antibacterial agent and dexamethasone composition with suspension at home.See Chinese patent CN1158994C, ON Singh, HG Bai Qute. contain the local mixed suspension preparation of ciprofloxacin and dexamethasone.The compound preparation that above-mentioned compound preparation mainly is made up of aminoglycoside or fluoroquinolone antibacterial agent and steroidal anti-inflammatory drugs.The aminoglycoside antimicrobial drug has kidney and ototoxicity.Intravitreal injection, poisonous to retina, can cause the macula lutea necrosis.Local excessive application can cause the conjunctiva necrosis.Fluoroquinolone antibacterial agent has certain phototoxicity.And the Macrolide antimicrobial drug is having its special advantages aspect the treatment ocular disease.Macrolide antibiotics is a broad ectrum antibiotic, and is all effective to multiple gram negative bacteria and positive bacteria, mycoplasma, the fine and close spirillum of chlamydia and rickettsia.Its main adverse reactions is a digestive tract reaction.Therefore, the mode of employing dosing eyes had both reduced the generation of untoward reaction, had improved therapeutic efficiency again.The macrolide antibiotic of ophthalmology topical application has only erythromycin eye ointment at home at present, and the compound preparation that Macrolide antimicrobial drug and steroidal anti-inflammatory drugs are formed lacks especially.Therefore, the low toxicity of development of new, efficient, broad-spectrum anti-inflammation compound preparation have its realistic meaning.
Because the particularity of eyeball on physiological structure easily produces local excitation behind the dosing eyes, and open ended liquid of ophthalmic and semisolid finite volume.After using traditional eye drop, solution is very short in the time of eye surface detention, and most of medicine runs off with tear, and absorbed medication amount only is the sub-fraction of dosage usually.Therefore, prolong drug is necessary to the stimulation of eye to improve bioavailability and to alleviate medicine in the time that eye is detained.Practice of pharmacy commonly used is the viscosity that adopts macromolecular material to improve the toleration of eye and improve eye drop.This natural macromolecular material of glass acid and salt thereof has its unique advantage as the carrier of ophthalmic preparation.
(hyaluronic aicd HA), is a kind of linear macromolecule mucopolysaccharide of uniqueness, alternately is formed by connecting repeatedly by the disaccharidase unit of D-glucuronic acid and the helio glucose of N-acetyl in glass acid.Commonly used is its sodium-salt form (sodium hyaluronate, SH), SH is distributed widely in animal and human's body connective tissue cell epimatrix, and content is higher in vitreum, umbilical cord, skin, cartilage and synovial fluid.SH is because of viscoelasticity, false plasticity, permeability and the excellent biological compatibility of its height, as a kind ofly absorb, the degradable biological material, at ophthalmology extensive use.Reported that as far back as Balazs in 1979 etc. SH is in the perform the operation application in this field of ophthalmology viscoelasticity.At present the kind operation needs to use SH surplus the ophthalmology 20, and is anti-blind and control blind and waved important effect for the mankind.
Fig. 1: the structure of glass acid
Early 1980s, there is the people that SH is applied in the eye drop as carrier.The SH weak solution is similar to tear, has identical viscosity of biology synovial fluid and retractility, and all have a good biological tolerance, can alleviate the stimulation of medicine to eye, promotes the healing of eye wound.SH with the antibiotic compatibility, is used for the treatment of xerophthalmia and eye bacterial infection, has obtained good effect.The eye drop product of domestic listing has chloromycetin+SH eye drop, ofloxacin+SH eye drop, taurine+SH eye drop, chondroitin sulfate+SH eye drop, acyclovir+SH eye drop, allantoin+zinc sulfate+SH eye drop etc.SH is applied in the eye drop, not only plays the tackifier effect, still good drug media.By to observing under animal and the people's keratocyte Electronic Speculum, find that corneal epithelium has the binding site medicine of SH and SH molecule with hydrogen bonded, by the binding site of SH on the cornea, closely be distributed in the surface again, its bioavailability is obviously increased.Generally acknowledged, SH is the best media of present ophthalmic preparation, both can increase bioavailability of medicament, also can alleviate the stimulation of medicine to eye, promotes the healing of eye wound, alleviates the ophthalmic uncomfortable symptom rapidly.
Summary of the invention:
The object of the present invention is to provide a kind of is carrier with glass acid or its salt, use compound preparation by the eye that macrolide antimicrobial drug and steroidal anti-inflammatory drugs are formed, in the time that eye is detained, improve bioavailability with prolong drug, alleviate after the administration medicine the stimulation of eye.
Technical scheme of the present invention realizes by following manner:
Ophthalmic preparation involved in the present invention comprises glass acid and salt thereof, and steroidal anti-inflammatory drugs and Macrolide antimicrobial drug.Described glass acid and salt thereof comprise the various salt of glass acid and glass acid, comprise potassium salt, sodium salt, calcium salt, magnesium salt, zinc salt and ammonium salt; Preferred its sodium salt.Glass acid and salt thereof concentration range in preparation of the present invention is 0.05%～2%.
Steroidal anti-inflammatory drugs involved in the present invention is dexamethasone, dexamethasone acetate, dexamethasone sodium phosphate salt, prednisolone acetate, prednisolone, Inflamase salt, fluorometholone, betamethasone and betamethasone sodium phosphate salt etc., and the concentration range of steroidal anti-inflammatory drugs in preparation of the present invention is 0.05%～5%.The Macrolide antimicrobial drug is azithromycin, clarithromycin, Roxithromycin; Preferred azithromycin, Macrolide antimicrobial drug concentration range in preparation of the present invention is 0.5%～5%.
Ophthalmic preparation involved in the present invention can add acceptable auxiliary on the pharmaceutics as required, as surfactant, osmotic pressure regulator, antibacterial, pH regulator agent, stabilizing agent etc.Surfactant is tween 20, Tween-60, tween 80, pluronic F-68, pluronic F-84, pluronic P-103 etc., and its concentration range is 0.01%～2%.Osmotic pressure regulator is electrolyteses such as sodium chloride, sodium dihydrogen phosphate, boric acid, Borax, and non-electrolyte class such as glucose, glycerol.Antibacterial is an antibacterial commonly used in ophthalmology, and its concentration range is 0.005%～1%, comprising: quaternary ammonium salt, as benzalkonium chloride, benzalkonium bromide, cetrimonium bromide; Esters is as Metagin, second, third, butyl ester; Alcohols is as chlorobutanol; The organic mercury class is as thimerosal, phenylmercuric nitrate etc.; Acids: sorbic acid etc.The pH regulator agent is a phosphate buffer, borate buffer, borate buffer solution, acetate buffer, citrate buffer etc.Stabilizing agent is vitamin C, disodiumedetate etc., and its concentration range is 0.01%～1%.
Preparation method of the present invention is that active ingredient and adjuvant are made suitable dosage form by method in common on the pharmaceutics.
The invention has the advantages that:
1. after a kind of the share in the steroidal anti-inflammatory drugses such as azithromycin and dexamethasone, dexamethasone sodium phosphate, prednisolone and Inflamase, can be antibiotic, again can antiinflammatory, significantly improved the therapeutic effect of ocular infection and inflammation.
2. the present invention is a carrier with glass acid and salt thereof, not only prolong drug time that eye is detained to have improved bioavailability but also to have alleviated the stimulation of medicine to eye, increased the comfort after the administration.
3. the present invention is a compound preparation, uses convenient clinically.
Further describe the present invention below in conjunction with specific embodiment, it should be understood that scope of the present invention is not limited only to the scope of these embodiment.
The specific embodiment:
Embodiment 1～4
Method for making: the hyaluronic acid sodium of recipe quantity and disodiumedetate, benzalkonium chloride, tween 80 be dissolved in advance in about 40% the injection water, the citric acid of the water for injection dissolving recipe quantity of reuse about 50%, add again azithromycin, sodium chloride,, stirring makes dissolving, regulate pH to 6.0～6.5 with sodium hydroxide, two kinds of solution are mixed add to the full amount of water for injection, stir.After the filter membrane Entkeimung with 0.22um, add the micronization steroidal anti-inflammatory drugs powder of sterilizing, stir, middle inspection, aseptic subpackaged, promptly.
Embodiment 5～7
Method for making: the hyaluronic acid sodium of recipe quantity and steroidal anti-inflammatory drugs be dissolved in advance in about 40% the injection water, standby; The citric acid of the water for injection dissolving recipe quantity of reuse about 50% adds azithromycin, sodium chloride, disodiumedetate, benzalkonium chloride again, stirs and makes dissolving, regulates pH to 6.0～6.5 with sodium hydroxide.Two kinds of solution are mixed add to the full amount of water for injection, stir.Middle inspection, aseptic subpackaged with the filter membrane Entkeimung of 0.22um, promptly.
Claims (10)
1. an eye that contains glass acid or its salt use compound medicinal formulation, it is characterized in that by glass sour or its salt and macrolide antimicrobial drug and steroidal anti-inflammatory drugs form.
2. the described eye of claim 1 is used compound medicinal formulation, it is characterized in that glass acid and salt thereof are selected from the various salt that comprise glass acid and glass acid, comprise potassium salt, sodium salt, calcium salt, magnesium salt, zinc salt and ammonium salt; Preferred its sodium salt.
3. the described eye of claim 1 is used compound medicinal formulation, it is characterized in that glass acid and salt thereof concentration range in preparation of the present invention is 0.05%～2%.
4. the described eye of claim 1 is used compound medicinal formulation, it is characterized in that the macrolide antimicrobial drug is selected from azithromycin, clarithromycin, Roxithromycin.
5. the described eye of claim 1 is used compound medicinal formulation, and the concentration that it is characterized in that the macrolide antimicrobial drug is 0.5%～5%.
6. the described eye of claim 1 is used compound medicinal formulation, it is characterized in that steroidal anti-inflammatory drugs is selected from dexamethasone, dexamethasone acetate, dexamethasone sodium phosphate salt, fluorometholone, prednisolone acetate, prednisolone, Inflamase salt, betamethasone and betamethasone sodium phosphate salt.
7. the described eye of claim 1 is used compound medicinal formulation, and the concentration that it is characterized in that steroidal anti-inflammatory drugs is 0.05%～5%.
8. claim 1,2,3,4,5,6,7 described eyes compound medicinal formulations, it is characterized in that described pharmaceutical preparation is included in the adjuvant of acceptable necessity on the pharmaceutics, comprise surfactant, osmotic pressure regulator, antibacterial, pH regulator agent, stabilizing agent etc.
9. the described treatment of claim 8 eye compound medicinal formulation, be included in the adjuvant of acceptable necessity on the pharmaceutics, the consumption that it is characterized in that surfactant is 0.01%～2%, and the consumption of antibacterial is 0.005%～1.0%, and the consumption of stabilizing agent is 0.01%～1%.
10. the described eye of claim 1 is used compound medicinal formulation, it is characterized in that it is that active ingredient and adjuvant are made suitable dosage form by method in common on the pharmaceutics.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810197064A CN101683532A (en) | 2008-09-25 | 2008-09-25 | Ophthalmic compound medicinal preparation containing hyaluronic acid or sodium hyaluronate |
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| Application Number | Priority Date | Filing Date | Title |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104470502A (en) * | 2012-06-08 | 2015-03-25 | 维克-佐罗威治弗特肯有限责任公司 | Antibacterial pharmaceutical composition |
| CN107205926A (en) * | 2015-01-21 | 2017-09-26 | 塞姆努尔药物公司 | Pharmaceutical preparation |
| CN116850351A (en) * | 2023-05-29 | 2023-10-10 | 苏州理想眼科医院有限公司 | A viscoelastic agent with strong antibacterial effect |
-
2008
- 2008-09-25 CN CN200810197064A patent/CN101683532A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104470502A (en) * | 2012-06-08 | 2015-03-25 | 维克-佐罗威治弗特肯有限责任公司 | Antibacterial pharmaceutical composition |
| CN107205926A (en) * | 2015-01-21 | 2017-09-26 | 塞姆努尔药物公司 | Pharmaceutical preparation |
| CN116850351A (en) * | 2023-05-29 | 2023-10-10 | 苏州理想眼科医院有限公司 | A viscoelastic agent with strong antibacterial effect |
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