CN101313899A - Medicament composition for eyes containing sodium bromfenac - Google Patents
Medicament composition for eyes containing sodium bromfenac Download PDFInfo
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- CN101313899A CN101313899A CN 200710099948 CN200710099948A CN101313899A CN 101313899 A CN101313899 A CN 101313899A CN 200710099948 CN200710099948 CN 200710099948 CN 200710099948 A CN200710099948 A CN 200710099948A CN 101313899 A CN101313899 A CN 101313899A
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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 bromfenac sodium 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
Bromfenac sodium (Bromfenac sodium) is a kind of nonsteroidal antiinflammatory drug with anti-inflammatory activity.Mechanism of action is by 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 is after long-term placement a period of time, there is small crystal to separate out, the inventor is by 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 bromfenac sodium 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 bromfenac sodium 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 Benzalkonii Chloridum, 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, preparation method is as follows:
1) bromfenac sodium sesquialter hydrate and sodium hydroxyethyl cellulose equivalent are progressively increased mix homogeneously, 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
The present invention is described in further detail below in conjunction with embodiment, but be not limited to following embodiment.Wherein " % " is meant " weight % ".
Embodiment one
Preparation method:
1) bromfenac sodium sesquialter hydrate and sodium hydroxyethyl cellulose equivalent are progressively increased mix homogeneously, 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
Preparation method:
1) bromfenac sodium sesquialter hydrate and sodium hydroxyethyl cellulose equivalent are progressively increased mix homogeneously, 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
Preparation method:
1) bromfenac sodium sesquialter hydrate and sodium hydroxyethyl cellulose equivalent are progressively increased mix homogeneously, 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
Preparation method:
Bromfenac sodium 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 (10)
1. a medical composite for eye is characterized in that containing its pharmaceutically acceptable salt of bromfenac sodium, also contains other pharmaceutically acceptable auxiliaries in addition.
2. according to the described compositions of claim 1, it is characterized in that the shared percentage by weight of acceptable salt is 0.05～2% on bromfenac sodium and the pharmacology thereof.
3. according to the described compositions of claim 1, it is characterized in that described pharmaceutic adjuvant comprises surfactant, pH regulator agent, antioxidant, antiseptic and cosolvent.
4. according to the described compositions of claim 3, it is characterized in that cosolvent is a hydroxyethyl-cellulose, its percentage by weight is 0.2～8%, preferred 1～5%.
5. according to the described compositions of claim 3, it is characterized in that surfactant is one or more the mixture in Polysorbate series, poloxamer, the span, its percentage by weight is 0.05～5%, preferred 0.05～2%.
6. according to the described compositions of claim 3, it is characterized in that the pH regulator agent is 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.
7. according to the described compositions of claim 3, it is characterized in that antioxidant be 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 0.05～8%, preferred 0.1～2%.
8. according to the described compositions of claim 3, it is characterized in that antiseptic is one or more the mixture in Benzalkonii Chloridum, benzyl rope chloramines, sodium benzoate, the methyl hydroxybenzoate, its percentage by weight is 0.001～0.1%.
9. according to the described compositions of claim 1, it is characterized in that preparation method is as follows:
1) bromfenac sodium sesquialter hydrate and sodium hydroxyethyl cellulose equivalent are progressively increased mix homogeneously, 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.
10. according to the described compositions of claim 1, its purposes is for treating eye inflammation and the postcataract eye inflammation that prostaglandin causes.
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 |
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| Publication Number | Publication Date |
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| CN101313899A true CN101313899A (en) | 2008-12-03 |
| CN101313899B CN101313899B (en) | 2012-02-29 |
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| CN 200710099948 Active CN101313899B (en) | 2007-06-01 | 2007-06-01 | Medicament composition for eyes containing sodium bromfenac |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012079497A1 (en) * | 2010-12-15 | 2012-06-21 | 沈阳兴齐眼药股份有限公司 | Bromfenac organic salts and preparation method, composition and use 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 |
| WO2013147000A1 (en) * | 2012-03-28 | 2013-10-03 | 参天製薬株式会社 | Aqueous composition containing 2-amino-3-(4-bromobenzoyl)- phenylacetic acid |
| WO2015046281A1 (en) * | 2013-09-26 | 2015-04-02 | 参天製薬株式会社 | Aqueous composition containing stabilized 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
| 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 |
| CN111743858A (en) * | 2019-03-29 | 2020-10-09 | 天津药业研究院有限公司 | Pharmaceutical composition of bromfenac sodium |
| RU2776062C2 (en) * | 2011-01-18 | 2022-07-13 | Сэндзю Фармасьютикал Ко., Лтд. | Water-based liquid composition with bromfenac, having preserving efficiency |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4500261B2 (en) * | 2003-01-21 | 2010-07-14 | 千寿製薬株式会社 | 2-Amino-3- (4-bromobenzoyl) phenylacetic acid-containing aqueous solution |
| PL1683526T3 (en) * | 2003-11-14 | 2012-09-28 | Senju Pharma Co | Aqueous solution preparation containing aminoglycoside antibiotic and bromfenac |
| ATE520394T1 (en) * | 2004-11-05 | 2011-09-15 | Senju Pharma Co | 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 |
-
2007
- 2007-06-01 CN CN 200710099948 patent/CN101313899B/en active Active
Cited By (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012079497A1 (en) * | 2010-12-15 | 2012-06-21 | 沈阳兴齐眼药股份有限公司 | Bromfenac organic salts and preparation method, composition and use thereof |
| RU2625755C2 (en) * | 2011-01-18 | 2017-07-18 | Сэндзю Фармасьютикал Ко., Лтд. | Water-based liquid composition with bromfenac possessing preservative effectiveness |
| KR20140012061A (en) | 2011-01-18 | 2014-01-29 | 센주 세이야꾸 가부시키가이샤 | Bromfenac aqueous liquid composition having preservative efficiency |
| US9107888B2 (en) | 2011-01-18 | 2015-08-18 | Senju Pharmaceutical Co., Ltd. | Aqueous liquid bromfenac composition having preservative efficacy |
| CN103379904A (en) * | 2011-01-18 | 2013-10-30 | 千寿制药株式会社 | Bromfenac aqueous liquid composition having preservative efficiency |
| RU2776062C2 (en) * | 2011-01-18 | 2022-07-13 | Сэндзю Фармасьютикал Ко., Лтд. | Water-based liquid composition with bromfenac, having preserving efficiency |
| JPWO2012099142A1 (en) * | 2011-01-18 | 2014-06-30 | 千寿製薬株式会社 | Bromfenac aqueous liquid composition having storage efficacy |
| WO2012099142A1 (en) * | 2011-01-18 | 2012-07-26 | 千寿製薬株式会社 | Bromfenac aqueous liquid composition having preservative efficiency |
| US9561280B2 (en) | 2011-01-18 | 2017-02-07 | Senju Pharmaceutical Co., Ltd. | Aqueous liquid bromfenac composition having preservative efficacy |
| CN102988278A (en) * | 2011-09-19 | 2013-03-27 | 娄飞 | Bromfenac sodium hydrate eye drops and preparation method thereof |
| WO2013147000A1 (en) * | 2012-03-28 | 2013-10-03 | 参天製薬株式会社 | Aqueous composition containing 2-amino-3-(4-bromobenzoyl)- phenylacetic acid |
| 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 |
| WO2015046281A1 (en) * | 2013-09-26 | 2015-04-02 | 参天製薬株式会社 | Aqueous composition containing stabilized 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
| CN105451731B (en) * | 2013-09-26 | 2019-01-18 | 参天制药株式会社 | Water-based composition containing stabilized 2- amino -3- (4- benzoyl bromide) phenylacetic acid |
| CN105451731A (en) * | 2013-09-26 | 2016-03-30 | 参天制药株式会社 | Aqueous composition containing stabilized 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
| 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 |
| CN111743858A (en) * | 2019-03-29 | 2020-10-09 | 天津药业研究院有限公司 | Pharmaceutical composition of bromfenac sodium |
| 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 |
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| Publication number | Publication date |
|---|---|
| CN101313899B (en) | 2012-02-29 |
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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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