CN1843503A - Eye drops - Google Patents
Eye drops Download PDFInfo
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- CN1843503A CN1843503A CN 200610038088 CN200610038088A CN1843503A CN 1843503 A CN1843503 A CN 1843503A CN 200610038088 CN200610038088 CN 200610038088 CN 200610038088 A CN200610038088 A CN 200610038088A CN 1843503 A CN1843503 A CN 1843503A
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- eye
- eye drop
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- growth factor
- nerve growth
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Abstract
Disclosed is an eye drop, which is an aqueous solution containing 50-8000AU/ml of nerve growth factor, it can also comprises freeze-dried powder containing nerve growth factor and specific liquid used as solvent, or eye tablet containing nerve growth factor and specific liquid used as solvent, or eye powder containing nerve growth factor and specific liquid used as solvent. The eye drop has the functions of improving vision, eliminating eye strain, and restoring cornea damage.
Description
One, technical field
The present invention relates to a kind of eye drop, particularly a kind of is the clear and bright eye drop of solvent with water for injection, and specifically a kind of corneal and optic nerve injury have the eye drop that promotes repair.
Two, background technology
Existing eye drop is normally treated diseases such as eye inflammation, glaucoma, alleviation eye be dry and astringent, does not still promote the ophthalmic administration that the active of the ophthalmic injuries of corneal injury and optic nerve injury etc. is repaired at present.
In the component of eye drop, except that active component, also contain antibacterial lost efficacy to guarantee that medicinal liquid is in use contaminated, rotten, also have pH regulator agent and osmotic pressure regulator, make the pH value of medicinal liquid and osmotic pressure within the tolerance range of eyeball.In addition, can also select to add according to the difference of physical and chemical properties of drugs as antioxidant, thickening agent, cosolvent etc.Eye drop is processed into the form of eye drop usually, is packaged in after the preparation under gnotobasis in the eye drop bottle of sterilization, to being the eye drop of solvent with water for injection, requires outward appearance clarification, transparent.
Three, summary of the invention
The object of the present invention is to provide eye drop of a kind of nerve growth factor (Nerve Growth Factor) and preparation method thereof, the ophthalmic injuries of damage of said preparation corneal and optic nerve injury etc. has its effect of initiatively repairing of promotion.
This eye drop is solvent with water for injection, comprise active component, antibacterial, pH regulator agent, osmotic pressure regulator and water for injection, with the difference of existing eye drop be that the content of nerve growth factor is 50～8000AU/ml with the eye drop of active component nerve growth factor processing.
The water soluble adjuvant that in above-mentioned eye drop, can also add following percentage by weight: the mannitol of 0.5～10% glucosides and/or 0.05～2% albumin and/or 0.5～10% and/or the sodium chondroitin sulfate of 0.01～0.5% hyaluronate sodium and/or 0.05～0.5% and/or 0.1～0.9% water soluble adjuvants such as sodium chloride.
This eye drop is solvent with water for injection, comprise active component, antibacterial, pH regulator agent, osmotic pressure regulator and water for injection, difference with the prior art is to be made up of with the special-purpose liquid that powder and antibacterial, pH regulator agent, osmotic pressure regulator are dissolved in the water for injection with sheet or Private Eye the special-purpose lyophilized powder or the Private Eye of the processing of active component nerve growth factor.After lyophilized powder and special-purpose liquid mix back or eye and mixes with special-purpose liquid with sheet or use in powder and the mixed eye drop of special-purpose liquid, the content of nerve growth factor is 50～8000AU/ml.
Can also add glucosides and/or albumin and/or mannitol at above-mentioned special-purpose lyophilized powder or eye respectively with sheet or in powder, when lyophilized powder or the eye with sheet or the eye with powder respectively with the mixed eye drop of special-purpose liquid in, its weight percentage is followed successively by 0.5～10% and/or 0.05～2% and/or 0.5～10%.
In above-mentioned special-purpose liquid, can also add hyaluronate sodium and/or sodium chondroitin sulfate and/or sodium chloride, when special-purpose liquid respectively with lyophilized powder or the eye with sheet or the eye with the eye drop after the powder mixes in, its percentage by weight is followed successively by 0.01～0.5% and/or 0.05～0.5% and/or 0.1～0.9%.
The antibacterial that uses among the present invention, pH regulator agent, osmotic pressure regulator all are known adjuvants commonly used.
Antibacterial is ethyl hydroxybenzoate, chlorhexidine acetate, benzalkonium bromide etc., other water soluble adjuvant is glucosides, glucose, lactose, citric acid, boric acid, Borax, sodium dihydrogen phosphate, sodium hydrogen phosphate, polyethylene glycol 6000, carbomer and polyvidone etc., is used for regulating the pH value and the osmotic pressure of eye drop.
Prepare the method for eye drop of the present invention, form by following steps:
(1) preparation of eye drop:
The antibacterial and other the water soluble adjuvant of conventional amount used in the nerve growth factor of formula ratio and/or glucosides and/or albumin and/or mannitol and/or hyaluronate sodium and/or sodium chondroitin sulfate and/or sodium chloride and/or the eye drop are dissolved in the water for injection separately or after cooperating, filtration sterilization then, fill under cleaning condition, cover beyond the Great Wall in adding, promptly.
Being directly used in eye during use gets final product.
(2) contain the lyophilized powder of nerve growth factor and the special-purpose liquid that uses when solvent is formed,
A, contain the lyophilized powder preparation of nerve growth factor: separately or mix the back and dissolve with water for injection with the nerve growth factor of formula ratio and/or glucosides and/or albumin and/or mannitol and other water soluble adjuvant, filtration sterilization then, fill under aseptic condition, tamponade after the last lyophilization, roll lid, promptly get lyophilized powder.
B, when the preparation of the special-purpose liquid that solvent uses: the antibacterial and other the water soluble adjuvant of conventional amount used in the hyaluronate sodium of formula ratio and/or sodium chondroitin sulfate and/or sodium chloride and/or the eye drop are dissolved in the water for injection, filtration sterilization, solvent is made in fill under cleaning condition.
During use, lyophilized powder is poured in the solvent, clarified after the jolting dissolving, transparent solution, be directly used in eye and get final product.
(3) eye that contains nerve growth factor is used sheet and is worked as the special-purpose liquid composition that solvent uses
A, the eye that contains nerve growth factor prepare with sheet: with the nerve growth factor of formula ratio with a small amount of albumin absorption after, and/or glucosides and/or other water soluble adjuvant such as albumin and/or mannitol with " equivalent progressively increase method " mixing after, cold drying, direct powder compression promptly gets the eye sheet.
B, when the preparation of the special-purpose liquid that solvent uses: antibacterial and other water soluble adjuvant of conventional amount used in the hyaluronate sodium of formula ratio and/or sodium chondroitin sulfate and/or sodium chloride and/or the eye drop are dissolved in the water for injection, filtration sterilization, solvent is made in fill under cleaning condition.
During use, eye is poured in the solvent with sheet, clarified after the jolting dissolving, transparent solution, be directly used in eye and get final product.
(4) eye that contains nerve growth factor is used powder and is worked as the special-purpose liquid composition that solvent uses.
A, the eye that contains nerve growth factor use powder preparation: with the nerve growth factor of formula ratio with a small amount of albumin absorption after, and/or glucosides and/or other water soluble adjuvant such as albumin and/or mannitol behind the mixing, are crossed 80 mesh sieves with " equivalent progressively increase method ", cold drying promptly gets the eye powder.
B, when the preparation of the special-purpose liquid that solvent uses: with hyaluronate sodium and or sodium chondroitin sulfate and or sodium chloride and or eye drop in antibacterial and other water soluble adjuvant of conventional amount used be dissolved in the water for injection, filtration sterilization, solvent is made in fill under cleaning condition.
During use, eye is poured in the solvent with powder, clarified after the jolting dissolving, transparent solution, be directly used in eye and get final product.
The present invention (1) contains the eye drop of nerve growth factor and other water soluble adjuvant, stores stable in properties at 4 ℃, is valid for one year half.
The present invention (2) contains the lyophilized powder of nerve growth factor and the special-purpose liquid that uses when solvent is formed.The lyophilized powder that contains nerve growth factor is wherein stored stable in properties, 2 years effect duration at 4 ℃.This contains nerve growth factor lyophilized powder input in the special-purpose liquid that solvent uses, and rapidly dissolvable, and solution clarification, transparent, pH value and ooze with tear etc. between 5.0-7.0, the stable in properties that (keeps cool 2～10 ℃) in use.
The special-purpose liquid that the eye that the present invention (3) contains nerve growth factor uses with sheet with when solvent is formed.The eye sheet that contains nerve growth factor is wherein stored stable in properties, 2 years effect duration at 4 ℃.This contain the nerve growth factor eye with the sheet input in the special-purpose liquid that solvent uses, rapidly dissolvable, and solution clarification, transparent, pH value and ooze with tear etc. between 5.0-7.0, the stable in properties that (keeps cool 2～10 ℃) in use.
The special-purpose liquid that the eye that the present invention (4) contains nerve growth factor uses with powder with when solvent is formed.The eye powder that contains nerve growth factor is wherein stored stable in properties, 2 years effect duration at 4 ℃.This contain the nerve growth factor eye with the powder input in the special-purpose liquid that solvent uses, rapidly dissolvable, and solution clarification, transparent, pH value and ooze with tear etc. between 5.0-7.0, the stable in properties that (keeps cool 2～10 ℃) in use.
NGF keeps sympathetic neuron and the necessary trophic factors of sensory neuron growth, growth and function.Therefore eye drop of the present invention have corneal damage and optic nerve injury etc. ophthalmic injuries have its function of initiatively repairing of promotion.
Eye drop of the present invention is compared with existing eye drop, and advantage of the present invention is: the function that having preserves moisture makes eye bright, eliminate eye fatigue etc., and the ophthalmic injuries of corneal damage and optic nerve injury etc. has its function of initiatively repairing of promotion.And the eye direct drug injection, dosage is economized, and can reach effective treatment concentration fast directly in ocular absorption, reaches therapeutical effect rapidly, and at instant effect, low-consuming two aspects play the effect of highly significant.
The specific embodiment:
Eye drop of the present invention, contain in per 1 part (calculating) by 10ml 500～80000AU nerve growth factor, 0.05～1g glucosides and or the albumin of 0.005～0.2g and or the mannitol of 0.05～1g and or the hyaluronate sodium of 0.001～0.05g and or the sodium chondroitin sulfate of 0.005～0.05g and or 0.01～0.09g sodium chloride and or eye drop in the antibacterial of conventional amount used and other water soluble adjuvant be dissolved in water for injection and make.Antibacterial is ethyl hydroxybenzoate, chlorhexidine acetate, benzalkonium bromide etc., and other water soluble adjuvant is glucosides, glucose, lactose, citric acid, boric acid, Borax, sodium dihydrogen phosphate, sodium hydrogen phosphate, polyethylene glycol 6000, carbomer and polyvidone etc.
By above proportioning metering, non-limiting examples is described below:
Embodiment 1
With 1.2 * 10
5The nerve growth factor of AU, 2g albumin and 8.9g sodium chloride dissolve with 1000ml water for injection, filtration sterilization then, and fill under cleaning condition is covered in adding beyond the Great Wall, that is, and every 10ml (portion).
Embodiment 2
With 1.2 * 10
5The nerve growth factor of AU, 2g albumin, 2g sodium chondroitin sulfate, 2.1g citric acid, 0.001g benzalkonium bromide and 8.2g sodium chloride dissolve with 1000ml water for injection, regulating pH value is 6.0 ± 0.5, filtration sterilization then, fill under cleaning condition, cover beyond the Great Wall in adding, promptly.Every 10ml (portion).
Embodiment 3
(1) with 2.4 * 10
6The nerve growth factor of AU, 10g albumin and 50g mannitol dissolve with 1000ml water for injection, filtration sterilization then, and fill under aseptic condition, lid is rolled in tamponade after the last lyophilization, promptly makes lyophilized powder, every bottle of 1000AU.(2) be dissolved in the 10ml water for injection with 0.015g hyaluronate sodium, 0.021g citric acid and 0.077g sodium chloride, regulating pH value is 6.0 ± 0.5, filtration sterilization, and a solvent is made in fill under cleaning condition.(3) time spent is dissolved in a lyophilized powder in the solvent, promptly gets (portion).
Embodiment 4
(1) with 1.2 * 10
5After the nerve growth factor of AU absorbs with the 2g albumin, again with 5g mannitol and 5g sodium chloride with " equivalent progressively increase method " mixing after, cold drying, direct powder compression, promptly.Every sheet heavily is about 0.12g.(2) be dissolved in the 10ml water for injection with 0.015g hyaluronate sodium, 0.02g sodium chloride and 0.1g polyethylene glycol 6000, regulating pH value is 6.0, filtration sterilization, and a solvent is made in fill under cleaning condition.(3) time spent is dissolved in a slice in the solvent, promptly gets (portion).
Embodiment 5
(1) with 1.2 * 10
5After the nerve growth factor of AU absorbs with the 2g albumin, again with 5g mannitol and 5g sodium chloride with " equivalent progressively increase method " mixing after, mistake 80 mesh sieves, cold drying, promptly.Every bag heavily is about 0.12g.(2) be dissolved in the 10ml water for injection with 0.02g sodium chloride and 0.001g benzalkonium bromide, filtration sterilization, a solvent is made in fill under cleaning condition.(3) time spent is dissolved in one bag of powder in the solvent, promptly gets (portion).
Stability of this eye drop and zoopery result are as follows:
Embodiment 6
(1) 4 ℃ of long-term investigation test that keeps sample
The solid sample (1) and the placement of embodiment 2 samples of embodiment 1,3,4 and 5 are kept sample for 4 ℃, and,, investigate active variation with result's comparison of 0 month in March, June, JIUYUE, December, sampling detection respectively in 18 months, 24 months.
Activity change under 4 ℃ of long-term investigation that keep sample
This shows that when preserving 24 months down for 4 ℃, its activity of each embodiment remains unchanged, above result of the test illustrates the foregoing description under 4 ℃, 2 years effect duration.
(2) the NGF eye drop is under Leng Chu (2～10 ℃), and the investigation that kept sample in 15 days is tested
The eye drop of embodiment 1,2,3,4 and 5 is placed under the cold place (2～10 ℃), kept sample in 15 days, and detect with sampling in 1 day, 3 days, 5 days, 10 days, investigate its activity change, the result is as follows:
The activity change of NGF eye drop under Leng Chu (2～10 ℃)
| Embodiment 3 | 020307 | 1000 | 1000 | 1000 | 1000 |
| 020308 | 1000 | 1000 | 1000 | 1000 | |
| 020309 | 1000 | 1000 | 1000 | 1000 | |
| Embodiment 4 | 020310 | 1000 | 1000 | 1000 | 1000 |
| 020211 | 1000 | 1000 | 1000 | 1000 | |
| 020312 | 1000 | 1000 | 1000 | 1000 | |
| Embodiment 5 | 020310 | 1000 | 1000 | 1000 | 1000 |
| 020311 | 1000 | 1000 | 1000 | 1000 | |
| 020312 | 1000 | 1000 | 1000 | 1000 |
This shows that when Leng Chu (2～10 ℃) preserved 15 days down, its activity of each embodiment remained unchanged, above result of the test explanation the foregoing description is stable in properties in use.
Embodiment 7 eye irritation tests
Splash into the eye drop of embodiment 1 to 5 for the left eye of rabbit, right eye splashes into normal saline in contrast, administration in continuous ten days, and the scoring of record irritative response, its last integration such as integration see the following form.
According to eye irritation evaluation criterion table, the nonirritant scope is 0～3.00, and the score value of above-mentioned test shows that eye drop of the present invention is to rabbit eye nonirritant all in this model.
The test of embodiment 8 optic nerve injuries
Eye drop with embodiment 1 to 5 is treated the optic nerve lesion that is caused by Carbon bisulfide respectively.
Give 40 Wistar adult rat lumbar injection Carbon bisulfide, duplicated the model of optic nerve lesion, divide high (NGF1000U/KG), in (200U/KG), low (20U/KG) dosage group and matched group, 10 every group, male and female half and half.Administration group retrobulbar injection nerve growth factor, every day 1 time, 6 times weekly, totally 3 weeks; Blank group retrobulbar injection equivalent normal saline.In forward and backward upset of rat pattern and the flash visual evoked potential measured of treatment.
Result of the test shows, the eye drop of embodiment 1 to 5 is treated the height of the optic nerve lesion that is caused by Carbon bisulfide, middle dosage group rat each ripple when treatment 10 days and 20 days respectively and is hidden and all have obviously or very significantly shorten than matched group, and low dose group (except that P1) there is no notable difference.Confirm that thus 1 to 5 pair of optic neuropathy such as rat contusion of optic nerve of embodiment has the obvious treatment effect.
Claims (9)
1, a kind of eye drop comprises active component, antibacterial, pH regulator agent, osmotic pressure regulator and water for injection, it is characterized in that: by active component is the eye drop of nerve growth factor processing, and content is 50～8000AU/ml.
2, eye drop according to claim 1 is characterized in that: the hyaluronate sodium and/or 0.05～0.5% sodium chondroitin sulfate and/or 0.1～0.9% the sodium chloride that also contain the albumin of 0.5～10% glucosides and/or 0.05～2% and/or 0.5～10% mannitol and/or 0.01～0.5% in the eye drop.
3, a kind of eye drop, comprise active component, antibacterial, pH regulator agent, osmotic pressure regulator and water for injection, it is characterized in that: by active component is that the special-purpose lyophilized powder of nerve growth factor processing and special-purpose liquid that antibacterial, pH regulator agent, osmotic pressure regulator are dissolved in water for injection are formed, and nerve growth factor content is 50～8000AU/ml in lyophilized powder and the mixed eye drop of special-purpose liquid.
4, eye drop according to claim 3, it is characterized in that: contain glucosides and/or albumin and/or mannitol in the lyophilized powder, when with the mixed eye drop of special-purpose liquid in its weight percentage be followed successively by 0.5～10% and/or 0.05～2% and/or 0.5～10%.
5, a kind of eye drop, comprise active component, antibacterial, pH regulator agent, osmotic pressure regulator and water for injection, it is characterized in that: by active component is that the Private Eye that nerve growth factor is processed is formed with the special-purpose liquid that sheet and antibacterial, pH regulator agent, osmotic pressure regulator are dissolved in water for injection, and eye is 50～8000AU/ml with nerve growth factor content in sheet and the mixed eye drop of special-purpose liquid.
6, eye drop according to claim 5, it is characterized in that: eye is with containing glucosides and/or albumin and/or mannitol in the sheet, when with the mixed eye drop of special-purpose liquid in its percentage by weight be followed successively by 0.5～10% and/or 0.05～2% and/or 0.5～10%.
7, a kind of eye drop, comprise active component, antibacterial, pH regulator agent, osmotic pressure regulator and water for injection, it is characterized in that: by active component is that the Private Eye that nerve growth factor is processed is formed with the special-purpose liquid that powder and antibacterial, pH regulator agent, osmotic pressure regulator are dissolved in water for injection, and eye is 50～8000AU/ml with nerve growth factor content in powder and the mixed eye drop of special-purpose liquid.
8, according to the described eye drop of right claim 7, it is characterized in that: eye is with containing usefulness glucosides and/or albumin and/or mannitol in the powder, when with the mixed eye drop of special-purpose liquid in its weight percentage be followed successively by 0.5～10% and/or 0.05～2% and/or 0.5～10%.
9, according to claim 3 or 5 or 7 described eye drop, it is characterized in that: contain hyaluronate sodium and/or sodium chondroitin sulfate and/or sodium chloride in the special-purpose liquid, when special-purpose liquid respectively with lyophilized powder or the eye with sheet or the eye with the eye drop after the powder mixes in, its weight percentage is followed successively by 0.01～0.5% and/or 0.05～0.5% and/or 0.1～0.9%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610038088 CN1843503A (en) | 2006-01-25 | 2006-01-25 | Eye drops |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610038088 CN1843503A (en) | 2006-01-25 | 2006-01-25 | Eye drops |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1843503A true CN1843503A (en) | 2006-10-11 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610038088 Pending CN1843503A (en) | 2006-01-25 | 2006-01-25 | Eye drops |
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| CN (1) | CN1843503A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101961486A (en) * | 2010-10-13 | 2011-02-02 | 厦门大学 | Eye drops and preparation method thereof |
| CN101972224A (en) * | 2010-09-13 | 2011-02-16 | 舒泰神（北京）生物制药股份有限公司 | Eye in-situ gel |
| CN105797165A (en) * | 2016-03-25 | 2016-07-27 | 厦门大学附属厦门眼科中心 | NGF and hydroxypropyl-beta-cyclodextrin inclusion compound ophthalmic gel and preparation method thereof |
| EP3287140B1 (en) | 2015-04-21 | 2021-06-02 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Nerve growth factor composition and powder injection |
| EP3287139B1 (en) | 2015-04-21 | 2021-08-11 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Nerve growth factor composition and injection powder |
-
2006
- 2006-01-25 CN CN 200610038088 patent/CN1843503A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101972224A (en) * | 2010-09-13 | 2011-02-16 | 舒泰神（北京）生物制药股份有限公司 | Eye in-situ gel |
| CN101972224B (en) * | 2010-09-13 | 2012-01-04 | 舒泰神（北京）生物制药股份有限公司 | Eye in-situ gel |
| CN101961486A (en) * | 2010-10-13 | 2011-02-02 | 厦门大学 | Eye drops and preparation method thereof |
| EP3287140B1 (en) | 2015-04-21 | 2021-06-02 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Nerve growth factor composition and powder injection |
| EP3287139B1 (en) | 2015-04-21 | 2021-08-11 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Nerve growth factor composition and injection powder |
| CN105797165A (en) * | 2016-03-25 | 2016-07-27 | 厦门大学附属厦门眼科中心 | NGF and hydroxypropyl-beta-cyclodextrin inclusion compound ophthalmic gel and preparation method thereof |
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