Summary of the invention
The object of the invention provides the gel for eye that a kind of active ingredient is a bromfenac sodium hydrate, soluble in water according to bromfenac sodium, aqueous solution is alkaline physicochemical property, and bromfenac sodium sodium salt in acid solution dissociates, become bromfenac, and further be decomposed into the bromfenac sodium precursor, and lose its drug action, influenced its stability and drug action to a great extent.Therefore the bromfenac sodium gel for eye use is that bromfenac sodium is mixed in the aqueous gel substrate, by regulating pH value stability with the assurance active ingredient in alkaline range, regulate the ophthalmic preparation that the osmotic pressure scope makes by osmotic pressure regulator, so that ocular absorption and reduction ophthalmic administration to the eye mucous membrane irritation, also further increase the stability of gel by antibacterial, antioxidant and complexing of metal ion agent; And bromfenac sodium hydrate is prepared into gel for eye to have easy to use, particularly gel has certain viscosity retention time is longer within the eye, improved eye drop to be diluted and caused the low and short shortcoming of the time of staying within the eye of drug level, played the therapeutical effect of continuous and effective by tear.
Another object of the present invention provides the preparation method that a kind of active ingredient is the gel for eye of bromfenac sodium hydrate.
The zest of the size of gel for eye pH patient's eye to medicine stability with when using all can have certain influence, therefore in the present invention's research by a large amount of experiments to pH regulator agent select, make its pH value remain on 7-10, both guaranteed the stability of active ingredient bromfenac sodium hydrate, alleviated the zest of preparation again eye.Carried out the research of eye irritation test with 6 prepared samples of embodiment of the present invention in 14 days with every group of 3 single-doses of regular grade large ear rabbit and successive administration, bromine phenolic acid sodium gel for eye use single and continuous 14 days eye drips contrast to dripping same dosage 0.9% sodium chloride injection.The single-dose group after twice administration 1,2,4,24h, 48,72h, the successive administration group before administration every day and after the last administration 1,2,4,24,48 and 72h eye checked and given a mark.Single and continuous 14 days eye drips as a result, the irritant reaction situation score value of animal eye cornea, iris and conjunctiva is 0, does not have any irritation and occurs, and the results are shown in Table 1.
Table 1
Observe item |
Embodiment 3 score values |
Embodiment 4 score values |
Embodiment 6 score values |
Embodiment 13 score values |
Embodiment 14 score values |
Embodiment 16 score values |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
Secretions |
0 |
0 |
0 |
0 |
0 |
0 |
Total score value |
0 |
0 |
0 |
0 |
0 |
0 |
Ophthalmic preparation is very high to the requirement of osmotic pressure, hyperosmotic solution absorbs moisture within the eye easily, make eye dryness and discomfort, hypisotonic solution then can make keratectasia and produce pain, we guarantee that by the selection to osmotic pressure regulator the osmotic pressure of bromfenac sodium gel for eye use is equivalent to 0.9%NaCl solution osmotic pressure, ooze state with tear formation etc., to reduce the stimulation of eye and to promote that medicine is absorbed better.
Aseptic requirement is one of the important quality of ophthalmic preparation and security requirement, in process of the present invention by adding suitable antibacterial and sterilizing, adopt direct inoculation to carry out 14 days steriling tests and the method for inspection is verified that strict control reaches the aseptic requirement of ophthalmic preparation.
PH characteristic according to the bromfenac sodium gel for eye use, the phosphate buffered solution of selecting pH=7.4 is as its release medium, mucosa characteristic according to eye, select the semipermeable membrane bag filter of molecular cut off 14000 to make simulation test, product sodium bromophenolate eye drops with 6 prepared samples of embodiment of the present invention and prior art is done contrast, the result is in identical release medium, contrast release test with eye drop in the bag filter shows that both in-vitro release are close, but the release of gel will be a little less than eye drop in the dispose procedure, and it is slower that release descends, and demonstrates the gel advantage of slow release effect in the long similar ophthalmic preparation of retention time within the eye.The results are shown in Table 2 and accompanying drawing.
Table 2
Time (h) |
Eye drop |
Embodiment 3 |
Embodiment 4 |
Embodiment 6 |
Embodiment 13 |
Embodiment 14 |
Embodiment 16 |
0.5 |
37.93 |
28.96 |
27.82 |
29.12 |
28.15 |
27.67 |
28.95 |
1 |
55.38 |
46.84 |
46.17 |
47.08 |
45.97 |
43.59 |
48.17 |
2 |
76.51 |
66.93 |
64.89 |
66.34 |
65.61 |
64.27 |
67.29 |
3 |
85.03 |
77.86 |
76.18 |
76.92 |
78.03 |
76.08 |
78.13 |
5 |
90.19 |
83.05 |
82.56 |
83.97 |
83.99 |
82.45 |
83.32 |
8 |
93.20 |
86.77 |
84.48 |
85.04 |
85.37 |
83.97 |
85.95 |
10 |
91.06 |
80.82 |
78.85 |
79.35 |
78.65 |
77.99 |
79.89 |
12 |
86.98 |
76.51 |
75.13 |
75.76 |
74.92 |
74.53 |
76.54 |
24 |
70.27 |
73.18 |
73.49 |
74.22 |
73.86 |
72.87 |
73.96 |
The present invention relates to a kind of bromfenac sodium hydrate eye-gel preparation and preparation method thereof, it is characterized in that comprising active ingredient bromfenac sodium hydrate, polymer waterborne gel-type vehicle, osmotic pressure regulator, antibacterial, pH regulator agent, water for injection.
Described eye-gel preparation is characterized in that comprising antioxidant, complexing of metal ion agent.
Described eye-gel preparation is characterized in that its active ingredient bromfenac sodium hydrate content is 0.1-10mg/g.
Described eye-gel preparation is characterized in that described polymer waterborne gel-type vehicle comprises carbomer, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose, hyaluronic acid sodium, glycerol, propylene glycol, tween 80, Sodium Tvlose, polyethylene pyrrole network alkane ketone.
Described eye-gel preparation is characterized in that the content of described polymer waterborne gel-type vehicle can be 1-100mg/g.
Described eye-gel preparation is characterized in that described osmotic pressure regulator comprises sodium chloride, mannitol, boric acid, Borax, sodium chromoglicate.
Described eye-gel preparation is characterized in that the content of described osmotic pressure regulator can be 1-50mg/g.
Described eye-gel preparation is characterized in that described antibacterial comprises benzalkonium bromide, benzalkonium chloride, methyl hydroxybenzoate, ethyl hydroxybenzoate, thimerosal, phenethanol, phenoxyethanol.
Described eye-gel preparation is characterized in that the content of described antibacterial can be 0.1-10mg/g.
Described eye-gel preparation is characterized in that described antioxidant comprises anhydrous sodium sulfite, potassium sorbate, sodium thiosulfate, sodium pyrosulfite, sodium sulfite.
Described eye-gel preparation is characterized in that the content of described antioxidant can be 0-30mg/g.
Described eye-gel preparation is characterized in that described complexing of metal ion agent comprises disodium edetate, edetic acid sodium salt, edetate trisodium salt.
Described eye-gel preparation is characterized in that the content of described complexing of metal ion agent can be 0-30mg/g.
Described eye-gel preparation, it is characterized in that described pH regulator agent comprises sodium hydrate aqueous solution, sodium bicarbonate aqueous solution, ethylenediamine, lauryl amine, triethanolamine, diethanolamine, sodium hydrogen phosphate-phosphate sodium dihydrogen buffer solution, aqueous sodium carbonate, wherein sodium hydrate aqueous solution concentration can be the concentration of any suitable adjusting pH.
The preparation method of described eye-gel preparation is characterized in that polymer waterborne gel-type vehicle, osmotic pressure regulator and antibacterial, adds in the part water for injection, stir, make its abundant swelling, make blank gel, with bromfenac sodium hydrate be dissolved in the part water for injection in the dissolving after join in the blank gel, stir, transfer pH to 7-10, add the injection water to amount of formulation with the pH regulator agent, be stirred to even gel, sterilization is filtered, and promptly gets the bromfenac sodium hydrate gel for eye use; Or with polymer waterborne gel-type vehicle, osmotic pressure regulator and antibacterial, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, transfer pH to 7-10 with the pH regulator agent, add the injection water to amount of formulation, be stirred to even gel, sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use; Or osmotic pressure regulator, antibacterial added in the part water for injection, stir, transfer pH to 7-10 with the pH regulator agent, add the polymer waterborne gel-type vehicle, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part dissolving, after join in the blank gel, add the injection water to amount of formulation, keep pH to 7-10, be stirred to even gel, sterilization is filtered, and promptly gets the bromfenac sodium hydrate gel for eye use; Or osmotic pressure regulator, antibacterial added in the part water for injection, stir, transfer pH to 7-10 with the pH regulator agent, add the polymer waterborne gel-type vehicle, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, add the injection water to amount of formulation, keep pH to 7-10 to be stirred to even gel, sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
The preparation method of described eye-gel preparation is characterized in that also can adding in the blank gel antioxidant or complexing of metal ion agent or antioxidant and complexing of metal ion agent.
With meeting the examination requirements of Chinese Pharmacopoeia embodiments of the invention are carried out the check of pH, uniformity, viscosity, sterility test to the bromfenac sodium hydrate eye-gel preparation, wherein 6 embodiment the results are shown in Table 3:
Table 3
Inspection item |
Embodiment 3 |
Embodiment 4 |
Embodiment 6 |
Embodiment 13 |
Embodiment 14 |
Embodiment 16 |
PH value |
8.2 |
8.0 |
7.9 |
8.0 |
7.8 |
7.9 |
Uniformity |
Evenly, exquisiteness |
Evenly, exquisiteness |
Evenly, exquisiteness |
Evenly, exquisiteness |
Evenly, exquisiteness |
Evenly, exquisiteness |
Viscosity mPa.s |
28.8 |
27.5 |
28.1 |
26.9 |
30.2 |
29.6 |
Sterility test |
Meet the pharmacopeia regulation |
Meet the pharmacopeia regulation |
Meet the pharmacopeia regulation |
Meet the pharmacopeia regulation |
Meet the pharmacopeia regulation |
Meet the pharmacopeia regulation |
The specific embodiment
The embodiment that to enumerate several active substances of the present invention be the bromfenac sodium hydrate eye-gel preparation is used to further specify the present invention, but the present invention does not mean and only is confined to following examples.
Embodiment 1
Bromfenac sodium hydrate: 0.1g
Carbomer: 15.0g
Thimerosal: 0.5g
Boric acid: 10.0g
Borax: 5.0g
Sodium carbonate liquor: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with carbomer, thimerosal, boric acid and Borax, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, transfer about pH to 8.0 with sodium carbonate liquor, add the injection water to amount of formulation, be stirred to even gel, radiation sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 2
Bromfenac sodium hydrate: 10.00g
Methylcellulose: 10.00g
Hyaluronic acid sodium: 10.00g
Benzalkonium bromide: 0.25g
Edetic acid sodium salt 1.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with methylcellulose, hyaluronic acid sodium, benzalkonium bromide, edetic acid sodium salt and sodium chloride, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, transfer about pH to 8.0, add the injection water to amount of formulation with the 0.1mol/L sodium hydroxide solution, be stirred to even gel, dry heat sterilization is filtered, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 3
Bromfenac sodium hydrate: 10.00g
Hydroxypropyl methylcellulose: 14.00g
Benzalkonium bromide: 0.25g
Disodium edetate 1.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium bromide, disodium edetate and sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add the hydroxypropyl methylcellulose stirring and make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, moist heat sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 4
Bromfenac sodium hydrate: 1.00g
Hydroxypropyl methylcellulose: 12.00g
Benzalkonium chloride: 0.05g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with hydroxypropyl methylcellulose, benzalkonium chloride and sodium chloride, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, transfer about pH to 8.0, add the injection water to amount of formulation with the 0.1mol/L sodium hydroxide solution, be stirred to even gel, moist heat sterilization filters, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 5
Bromfenac sodium hydrate: 1.00g
Hydroxypropyl methylcellulose: 12.00g
Benzalkonium chloride: 0.05g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium chloride and sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add hydroxypropyl methylcellulose and stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, moist heat sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 6
Bromfenac sodium hydrate: 1.00g
Hydroxypropyl methylcellulose: 12.00g
Benzalkonium bromide: 0.05g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium bromide and sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add hydroxypropyl methylcellulose and stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, dry heat sterilization is filtered, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 7
Bromfenac sodium hydrate: 10.00g
Hydroxypropyl methylcellulose: 14.00g
Benzalkonium bromide: 0.25g
Disodium edetate 1.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium bromide, disodium edetate and sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add the hydroxypropyl methylcellulose stirring and make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, radiation sterilization is filtered, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 8
Bromfenac sodium hydrate: 10.00g
Carbomer 18.00g
Benzalkonium bromide: 0.25g
Edetic acid sodium salt 1.2g
Sodium chloride: 9.00g
Sodium bicarbonate solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with carbomer, benzalkonium bromide, edetic acid sodium salt and sodium chloride, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, transfer about pH to 8.0 with sodium bicarbonate solution, add the injection water to amount of formulation, be stirred to even gel, dry heat sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 9
Bromfenac sodium hydrate: 1.00g
Carbomer: 15.00g
Benzalkonium bromide: 0.2g
Sodium sulfite: 1.5g
Sodium chloride: 9.00g
Sodium hydrogen phosphate-phosphate sodium dihydrogen buffer solution is an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with carbomer, benzalkonium bromide, sodium sulfite and sodium chloride, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, transfer about pH to 8.0 with sodium hydrogen phosphate-phosphate sodium dihydrogen buffer solution, add the injection water to amount of formulation, be stirred to even gel, moist heat sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 10
Bromfenac sodium hydrate: 5.00g
Hydroxypropyl methylcellulose: 10.00g
Polyethylene pyrrole network alkane ketone: 2.0g
Benzalkonium bromide: 0.2g
Anhydrous sodium sulfite: 1.5g
Edetic acid sodium salt 1.0g
Boric acid: 5.0g
Borax: 5.0g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with hydroxypropyl methylcellulose, polyethylene pyrrole network alkane ketone, benzalkonium bromide, anhydrous sodium sulfite, edetic acid sodium salt, boric acid and Borax, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add the injection water to amount of formulation, be stirred to even gel, moist heat sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 11
Bromfenac sodium hydrate: 5.00g
Hydroxypropyl methylcellulose: 14.00g
Phenethanol: 0.6g
Sodium pyrosulfite: 1.5g
Disodium edetate 1g
Boric acid: 5.0g
Borax: 5.0g
Ethylenediamine: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with hydroxypropyl methylcellulose, phenethanol, sodium pyrosulfite, disodium edetate, boric acid and Borax, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, transfer about pH to 8.0, add the injection water to amount of formulation with ethylenediamine, be stirred to even gel, radiation sterilization is filtered, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 12
Bromfenac sodium hydrate: 5.00g
Hydroxypropyl methylcellulose: 12.00g
Benzalkonium bromide: 0.2g
Anhydrous sodium sulfite: 1.5g
Disodium edetate: 1.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium bromide, anhydrous sodium sulfite, disodium edetate, sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mo1/L sodium hydroxide solution, add the hydroxypropyl methylcellulose stirring and make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, dry heat sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 13
Bromfenac sodium hydrate: 5.00g
Hydroxypropyl methylcellulose: 12.00g
Benzalkonium chloride: 0.2g
Anhydrous sodium sulfite: 1.5g
Disodium edetate: 1.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium chloride, anhydrous sodium sulfite, disodium edetate, sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add the hydroxypropyl methylcellulose stirring and make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, moist heat sterilization filters, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 14
Bromfenac sodium hydrate: 2.00g
Hydroxypropyl methylcellulose: 15.00g
Benzalkonium chloride: 0.1g
Anhydrous sodium sulfite: 2.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with hydroxypropyl methylcellulose, benzalkonium chloride, anhydrous sodium sulfite and sodium chloride, add in the part water for injection, stir, make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, transfer about pH to 8.0, add the injection water to amount of formulation with the 0.1mol/L sodium hydroxide solution, be stirred to even gel, moist heat sterilization filters, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 15
Bromfenac sodium hydrate: 2.00g
Hydroxypropyl methylcellulose: 15.00g
Benzalkonium chloride: 0.1g
Anhydrous sodium sulfite 2.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium chloride, anhydrous sodium sulfite and sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add the hydroxypropyl methylcellulose stirring and make its abundant swelling, make blank gel, bromfenac sodium hydrate is joined in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, radiation sterilization, filter, promptly get the bromfenac sodium hydrate gel for eye use.
Embodiment 16
Bromfenac sodium hydrate: 2.00g
Hydroxypropyl methylcellulose: 15.00g
Benzalkonium chloride: 0.1g
Anhydrous sodium sulfite 2.0g
Sodium chloride: 9.00g
0.1mol/L sodium hydroxide solution: an amount of
Water for injection adds to 1000g
Make 1000g
Method for making: with benzalkonium chloride, anhydrous sodium sulfite and sodium chloride, add in the part water for injection, stir, transfer about pH to 8.0 with the 0.1mol/L sodium hydroxide solution, add the hydroxypropyl methylcellulose stirring and make its abundant swelling, make blank gel, bromfenac sodium hydrate is dissolved in the water for injection of part, join after the dissolving in the blank gel, stir, add the injection water to amount of formulation, be stirred to even gel, dry heat sterilization is filtered, and promptly gets the bromfenac sodium hydrate gel for eye use.
Embodiment 17
With 32 uniform rats of body weight, prepare sample and 2 rats of the every group model of prior art eye drop with 6 embodiment of the present invention, two each 1 of rat, 4 rats of normal saline blank, adopt arachidonic acid profile and carrageenin model to carry out the comparative study of rat model antiinflammatory experimental observation, difference result shows that embodiment of the invention sample all can obviously suppress rat conjunctiva edema, has significant antiinflammatory action, the results are shown in Table 4.
Table 4
The preparation method of above-mentioned bromfenac sodium gel for eye also is applicable to the preparation of the bromfenac sodium gel for eye of other prescription.
Therefore, bromfenac sodium gel for eye zest of the present invention is low, safety good, be used for outer eye and before the inflammation treatment of eye (treatment of blepharitis, conjunctivitis, strong film inflammation (comprising strong film inflammation) and post-operation inflammatory has definite curative effect lastingly.