CN101313899B - Medicament composition for eyes containing sodium bromfenac - Google Patents
Medicament composition for eyes containing sodium bromfenac Download PDFInfo
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- CN101313899B CN101313899B CN 200710099948 CN200710099948A CN101313899B CN 101313899 B CN101313899 B CN 101313899B CN 200710099948 CN200710099948 CN 200710099948 CN 200710099948 A CN200710099948 A CN 200710099948A CN 101313899 B CN101313899 B CN 101313899B
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- sodium
- ahr
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- containing sodium
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- 239000000203 mixture Substances 0.000 title claims abstract description 29
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 title claims description 7
- 239000011734 sodium Substances 0.000 title claims description 7
- 229910052708 sodium Inorganic materials 0.000 title claims description 7
- 239000003814 drug Substances 0.000 title abstract description 5
- 229960003655 bromfenac Drugs 0.000 title description 4
- ZBPLOVFIXSTCRZ-UHFFFAOYSA-N bromfenac Chemical compound NC1=C(CC(O)=O)C=CC=C1C(=O)C1=CC=C(Br)C=C1 ZBPLOVFIXSTCRZ-UHFFFAOYSA-N 0.000 title description 3
- HZFGMQJYAFHESD-UHFFFAOYSA-M bromfenac sodium Chemical compound [Na+].NC1=C(CC([O-])=O)C=CC=C1C(=O)C1=CC=C(Br)C=C1 HZFGMQJYAFHESD-UHFFFAOYSA-M 0.000 claims abstract description 14
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims abstract description 8
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims abstract description 8
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims abstract description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 239000008215 water for injection Substances 0.000 claims description 6
- 239000002131 composite material Substances 0.000 claims description 5
- 229940101006 anhydrous sodium sulfite Drugs 0.000 claims description 2
- 229910021538 borax Inorganic materials 0.000 claims description 2
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 2
- 239000004327 boric acid Substances 0.000 claims description 2
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 2
- 235000010339 sodium tetraborate Nutrition 0.000 claims description 2
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 claims description 2
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 6
- 150000003180 prostaglandins Chemical class 0.000 abstract description 5
- 238000002360 preparation method Methods 0.000 abstract description 3
- 229960002716 bromfenac sodium Drugs 0.000 abstract description 2
- 206010061218 Inflammation Diseases 0.000 abstract 2
- 230000004054 inflammatory process Effects 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000002980 postoperative effect Effects 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 18
- 239000002671 adjuvant Substances 0.000 description 7
- 229940071826 hydroxyethyl cellulose Drugs 0.000 description 6
- 206010015943 Eye inflammation Diseases 0.000 description 5
- 238000005374 membrane filtration Methods 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000006184 cosolvent Substances 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 description 2
- RDOXTESZEPMUJZ-UHFFFAOYSA-N anisole Chemical compound COC1=CC=CC=C1 RDOXTESZEPMUJZ-UHFFFAOYSA-N 0.000 description 2
- 230000002421 anti-septic effect Effects 0.000 description 2
- 239000003963 antioxidant agent Substances 0.000 description 2
- 230000003078 antioxidant effect Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- DKGAVHZHDRPRBM-UHFFFAOYSA-N tertiry butyl alcohol Natural products CC(C)(C)O DKGAVHZHDRPRBM-UHFFFAOYSA-N 0.000 description 2
- 208000002177 Cataract Diseases 0.000 description 1
- QDHHCQZDFGDHMP-UHFFFAOYSA-N Chloramine Chemical class ClN QDHHCQZDFGDHMP-UHFFFAOYSA-N 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 125000001797 benzyl group Chemical group [H]C1=C([H])C([H])=C(C([H])=C1[H])C([H])([H])* 0.000 description 1
- AXCZMVOFGPJBDE-UHFFFAOYSA-L calcium dihydroxide Chemical compound [OH-].[OH-].[Ca+2] AXCZMVOFGPJBDE-UHFFFAOYSA-L 0.000 description 1
- 239000000920 calcium hydroxide Substances 0.000 description 1
- 229910001861 calcium hydroxide Inorganic materials 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 239000003889 eye drop Substances 0.000 description 1
- -1 hydroxyl tert-butyl Chemical group 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- UZKWTJUDCOPSNM-UHFFFAOYSA-N methoxybenzene Substances CCCCOC=C UZKWTJUDCOPSNM-UHFFFAOYSA-N 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
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 1
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920001983 poloxamer Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- DJEHXEMURTVAOE-UHFFFAOYSA-M potassium bisulfite Chemical compound [K+].OS([O-])=O DJEHXEMURTVAOE-UHFFFAOYSA-M 0.000 description 1
- RWPGFSMJFRPDDP-UHFFFAOYSA-L potassium metabisulfite Chemical compound [K+].[K+].[O-]S(=O)S([O-])(=O)=O RWPGFSMJFRPDDP-UHFFFAOYSA-L 0.000 description 1
- 229940043349 potassium metabisulfite Drugs 0.000 description 1
- 235000010263 potassium metabisulphite Nutrition 0.000 description 1
- 239000000473 propyl gallate Substances 0.000 description 1
- 229940075579 propyl gallate Drugs 0.000 description 1
- 235000010388 propyl gallate Nutrition 0.000 description 1
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 1
- 229960003415 propylparaben Drugs 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 1
- 235000010262 sodium metabisulphite Nutrition 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses an ocular medicine composition containing bromfenac sodium and a preparation method thereof. The medicine composition takes hydroxyethyl cellulose as a latent solvent, has a simple preparation technique, is suitable for industrialized production, and is mainly used for treating ocular inflammation caused by prostaglandin and cataracta postoperative ocular inflammation.
Description
Technical field
The present invention relates to a kind of medical composite for eye that contains AHR 10282B sesquialter hydrate and preparation method thereof, this medical composite for eye is mainly used in eye inflammation and the postcataract eye inflammation that the treatment prostaglandin causes.
Background technology
AHR 10282B (Bromfenac sodium) is a kind of nonsteroidal antiinflammatory drug with anti-inflammatory activity.Mechanism of action is through the inhibition Cycloxygenase, thereby the blocking-up prostaglandin is synthetic.In most of animal models, prostaglandin is considered to the inflammatory mediator of some eye inflammation.Simultaneously, can also be used for pain management behind the cataract operation.
The 0.09% bromfenac sesquialter hydrate eye drop of the trade name Xibrom (TM) that American I STA company produces; Obtain FDA approval listing on March 24th, 2005; But this medicine has small crystal to separate out after long-term placement a period of time, and the inventor is through having added the cosolvent sodium hydroxyethyl cellulose; Increase the dissolubility of bromfenac sesquialter hydrate, solved the long-term stability problem of placing of this medicine.
Summary of the invention
The present invention relates to a kind of medical composite for eye, the active ingredient that contains is an acceptable salt on AHR 10282B sesquialter hydrate and the pharmacology thereof, also contains other adjuvants in addition.
This compositions that the present invention relates to, the shared percentage by weight of acceptable salt is 0.05～2% on AHR 10282B sesquialter hydrate and the pharmacology thereof.
This compositions that the present invention relates to, other contained adjuvants comprise surfactant, pH regulator agent, antioxidant, antiseptic and cosolvent.
This compositions that the present invention relates to, cosolvent are hydroxyethyl-cellulose, and its percentage by weight is 0.2～8%, preferred 1～5%.
This compositions that the present invention relates to, surfactant are one or more the mixture in Polysorbate series, poloxamer, the span, and its percentage by weight is 0.05～5%, preferred 0.05～2%.
This compositions that the present invention relates to, pH regulator agent are one or more the mixture in boric acid, sodium hydroxide, natrium carbonicum calcinatum, hydrochloric acid, sodium borate, calcium hydroxide, citric acid, sodium citrate, sodium dihydrogen phosphate, the phosphoric acid.
This compositions that the present invention relates to; Antioxidant is anhydrous sodium sulfite, to one or more the mixture in hydroxyl tert-butyl alcohol methoxybenzene, propyl hydroxybenzoate, potassium metabisulfite, sodium pyrosulfite, Potassium acid sulfite, the propyl gallate; Its percentage by weight is 0.2～8%, preferred 0.1～2%.
This compositions that the present invention relates to, antiseptic are one or more the mixture in BZK, benzyl rope chloramines, sodium benzoate, the methyl hydroxybenzoate, and its percentage by weight is 0.001～0.1%.
This compositions that the present invention relates to, method for preparing is following:
1) with AHR 10282B sesquialter hydrate and the sodium hydroxyethyl cellulose equivalent mix homogeneously that progressively increases, mixture;
2) this mixture is mixed with other adjuvant, with the dissolving of an amount of water for injection, with gained solution with 0.22 micron membrane filtration;
3) after-teeming is penetrated water to full dose, between sodium hydroxide adjust pH to 7.5～8.5, and fill.
This compositions that the present invention relates to, eye inflammation and postcataract eye inflammation that its purposes causes for the treatment prostaglandin.
The specific embodiment
Below in conjunction with embodiment the present invention is done further detailed description, but be not limited to following embodiment.Wherein " % " is meant " weight % ".
Embodiment one
Method for preparing:
1) with AHR 10282B sesquialter hydrate and the sodium hydroxyethyl cellulose equivalent mix homogeneously that progressively increases, mixture;
2) this mixture is mixed with other adjuvant, with the dissolving of an amount of water for injection, with gained solution with 0.22 micron membrane filtration;
3) after-teeming is penetrated water to full dose, between sodium hydroxide adjust pH to 7.5～8.5, and fill.
Embodiment two
Method for preparing:
1) with AHR 10282B sesquialter hydrate and the sodium hydroxyethyl cellulose equivalent mix homogeneously that progressively increases, mixture;
2) this mixture is mixed with other adjuvant, with the dissolving of an amount of water for injection, with gained solution with 0.22 micron membrane filtration;
3) after-teeming is penetrated water to full dose, between sodium hydroxide adjust pH to 7.5～8.5, and fill.
Embodiment three
Method for preparing:
1) with AHR 10282B sesquialter hydrate and the sodium hydroxyethyl cellulose equivalent mix homogeneously that progressively increases, mixture;
2) this mixture is mixed with other adjuvant, with the dissolving of an amount of water for injection, with gained solution with 0.22 micron membrane filtration;
3) after-teeming is penetrated water to full dose, between sodium hydroxide adjust pH to 7.5～8.5, and fill.
The comparative example
Method for preparing:
AHR 10282B sesquialter hydrate is mixed with other adjuvant, with the dissolving of an amount of water for injection, with gained solution with 0.22 micron membrane filtration;
After-teeming is penetrated water to full dose, between sodium hydroxide adjust pH to 7.5～8.5, and fill.
Claims (1)
1. a medical composite for eye is characterized in that, by weight percentage; Said composition is made up of following material: AHR 10282B sesquialter hydrate 0.103%, BZK 0.001%, boric acid 0.025%; Sodium borate 0.025%, sodium hydroxyethyl cellulose 5.006%, polyoxyethylene sorbitan monoleate 2.000%; Anhydrous sodium sulfite 2.000%, water for injection 90.84%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710099948 CN101313899B (en) | 2007-06-01 | 2007-06-01 | Medicament composition for eyes containing sodium bromfenac |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710099948 CN101313899B (en) | 2007-06-01 | 2007-06-01 | Medicament composition for eyes containing sodium bromfenac |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101313899A CN101313899A (en) | 2008-12-03 |
| CN101313899B true CN101313899B (en) | 2012-02-29 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200710099948 Active CN101313899B (en) | 2007-06-01 | 2007-06-01 | Medicament composition for eyes containing sodium bromfenac |
Country Status (1)
| Country | Link |
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| CN (1) | CN101313899B (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102557976B (en) * | 2010-12-15 | 2015-06-10 | 辽宁盛京制药有限公司 | Bromfenac organic salt, and preparation method thereof, composition thereof and application thereof |
| WO2012099142A1 (en) * | 2011-01-18 | 2012-07-26 | 千寿製薬株式会社 | Bromfenac aqueous liquid composition having preservative efficiency |
| CN102988278A (en) * | 2011-09-19 | 2013-03-27 | 娄飞 | Bromfenac sodium hydrate eye drops and preparation method thereof |
| TWI604858B (en) * | 2012-03-28 | 2017-11-11 | 參天製藥股份有限公司 | Aqueous composition containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid and method of producing the same |
| JP2015086222A (en) * | 2013-09-26 | 2015-05-07 | 参天製薬株式会社 | Stabilized 2-amino-3-(4-bromobenzoyl)phenylacetate-containing aqueous composition |
| CN110664737A (en) * | 2018-07-02 | 2020-01-10 | 盘锦雨源新创意开发推广有限公司 | Bromfenac sodium eye drops and preparation process thereof |
| CN111743858B (en) * | 2019-03-29 | 2023-06-27 | 天津药业研究院股份有限公司 | Pharmaceutical composition of bromfenac sodium |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1700913A (en) * | 2003-01-21 | 2005-11-23 | 千寿制药株式会社 | Aqueous liquid preparations containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
| WO2006049250A1 (en) * | 2004-11-05 | 2006-05-11 | Senju Pharmaceutical Co., Ltd. | Aqueous eye drops with accelerated intraocular migration |
| CN1823754A (en) * | 2006-03-28 | 2006-08-30 | 卢秀莲 | Sodium bromophenolate eye drops and its preparation method |
| CN1882349A (en) * | 2003-11-14 | 2006-12-20 | 千寿制药株式会社 | Aqueous solution preparation containing aminoglycoside antibiotic and bromfenac |
-
2007
- 2007-06-01 CN CN 200710099948 patent/CN101313899B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1700913A (en) * | 2003-01-21 | 2005-11-23 | 千寿制药株式会社 | Aqueous liquid preparations containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
| CN1882349A (en) * | 2003-11-14 | 2006-12-20 | 千寿制药株式会社 | Aqueous solution preparation containing aminoglycoside antibiotic and bromfenac |
| WO2006049250A1 (en) * | 2004-11-05 | 2006-05-11 | Senju Pharmaceutical Co., Ltd. | Aqueous eye drops with accelerated intraocular migration |
| CN1823754A (en) * | 2006-03-28 | 2006-08-30 | 卢秀莲 | Sodium bromophenolate eye drops and its preparation method |
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| Publication number | Publication date |
|---|---|
| CN101313899A (en) | 2008-12-03 |
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Effective date of registration: 20201127 Address after: No. 279 Nanhai Road, Xiuying District 570314 Hainan city of Haikou Province Patentee after: AVENTIS PHARMA (HAINAN) Co.,Ltd. Address before: 100097, Wanquan mansion, 3 Jin Zhuang, Haidian District, Beijing, Sijiqing Patentee before: BEIJING D-VENTUREPHARM TECHNOLOGY DEVELOPMENT Co.,Ltd. |
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Addressee: Song Xuemei Document name: Notice of conformity |