CN107812243A - A kind of corneal protection viscoelastic liquid - Google Patents
A kind of corneal protection viscoelastic liquid Download PDFInfo
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- CN107812243A CN107812243A CN201710858456.5A CN201710858456A CN107812243A CN 107812243 A CN107812243 A CN 107812243A CN 201710858456 A CN201710858456 A CN 201710858456A CN 107812243 A CN107812243 A CN 107812243A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
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Abstract
The invention provides a kind of corneal protection viscoelastic liquid.The corneal protection viscoelastic liquid is made up of bulk composition, osmotic pressure regulator, pH value regulator and water, wherein：Bulk composition is selected from：Single hydroxypropyl methyl cellulose, single chondroitin sulfate, single Sodium Hyaluronate, hydroxypropyl methyl cellulose and the combination of chondroitin sulfate or the combination of hydroxypropyl methyl cellulose and Sodium Hyaluronate；Wherein, counted using the quality of the corneal protection viscoelastic liquid as 100%, the content of hydroxypropyl methyl cellulose is 10% 30%, and the content of chondroitin sulfate is 0.5% 10%, and the content of Sodium Hyaluronate is 0.2% 5%；PH value regulator includes：Lactic acid 1% 5%, sodium hydroxide 0.5% 1.5%, tartaric acid 0 3%, citric acid 0 5%；The osmotic pressure of the corneal protection viscoelastic liquid is 265 330mOsmol/kg, and pH value is 6.8 7.6.The corneal protection viscoelastic liquid can either maintain cornea to moisten, and effectively protect anterior corneal surface, additionally it is possible to effectively reduce the appearance of the cornea relevant issues such as post-operative cornea drying, art source property dry eyes.
Description
Technical field
The present invention relates to a kind of corneal protection viscoelastic liquid, belong to medical product technical field.
Background technology
In the most operations of ophthalmology, such as cataract, vitrectomy and refractive surgery, all need
Otch structure is then carried out on cornea or carries out related surgical from exposure cornea.But after being fixed with eye speculum, due to
Tear by just normally closed activity of eyelid, can not limit the moistening of the normal diffusion maintenance cornea of corneal epithelium microvillus,
Therefore can cause bitot's patches occurs in art, corneal damage and the postoperative complications for causing correlation.
In addition, there is document report：Due to such as cataract operation, Liquid Perflurocarbon and angle in all kinds of operations of ophthalmology
Otch is constructed in corneal position in film lasik surgery, can cause postoperative art source property dry eyes, such late complication is more and more general
Time, receive the attention of oculist.Art source property dry eye signs show as tear film stability decline more, and corneal epithelium point-like is broken
Damage, corneal epithelium microvillus structure are destroyed, the coating obstacle of tear film, and eyelid structure is destroyed etc..
It is such to control and the main method of iatrotechnics source property dry eyes is exactly that postoperative use artificial tears carries out therapeutic intervention at present
It is long the time required to treatment method, it is costly, and patients ' life quality can be influenceed.And in the preoperative or in art, corneal epithelial is protected
Shield, then reducing such art source property dry eyes ratio does not have report.
How the moistening of cornea is maintained in the preoperative and in art, and reducing postoperative corneal complication turns into the heat medically studied
Point problem.Simultaneously because cornea is the important operation index for building ophthalmologic operation otch, therefore how to be protected in surgical procedure
Corneal epithelium function maintains clearly surgical field of view simultaneously, and it is particularly critical not influence operation development.So oculist compels to be essential
Wanting a can maintain cornea to moisten in art, while not interfere with the product of surgical field of view again.
In existing ophthalmologic operation, in order to maintain the cornea in art to moisten, the most frequently used is exactly to be rushed using BSS
Wash.BSS scientific names are ophthalmically acceptable balanced salt solution, usually all kinds of inorganic salts such as sodium chloride, calcium chloride, the composition such as magnesium chloride it is water-soluble
Liquid.Because the aqueous solution that BSS is inorganic salts composition is readily volatilized, maintain the time of cornea moistening very short, therefore in ophthalmologic operation
In particularly time longer ophthalmologic operation such as Liquid Perflurocarbon and corneal laser surgery, it is necessary to which substantial amounts of BSS is carried out
Constantly rinse, then can bring about problems with：1) the cornea MEBO ribbon gauze that BSS is maintained is very short, needs constantly to enter in operation
Row rinses, and required BSS amounts are very big, and cost is very high.2) due to needing constantly to carry out BSS flushings in surgical procedure, perform the operation
Doctor will suspend operation technique, allow assistant to carry out again to maintain anterior corneal surface to moisten, extend operating time and reduce
Procedure efficiency, patient feel uncomfortable, are also a very cumbersome thing for assistant.3) due to most of ophthalmologic operation
For local anaesthesia, patient, which can clearly feel, is repeated continuously flushing in surgical procedure, significantly reduce surgical procedure
Comfort and postoperative patient to the compliance of doctor.4) due to a large amount of fluffy cells for rinsing BSS, ring anterior corneal surface being broken,
Substantial amounts of protein is taken away, goblet cell is destroyed, the symptoms such as postoperative bitot's patches, dry eyes can be caused.5) BSS compositions are inorganic
The aqueous solution of salt, it is a large amount of rinse it is lower can cause anterior corneal surface generation refraction effect, and the high-precision end hand of ophthalmologic operation multidigit microscope
Art, easily cause surgical field of view unintelligible, doctor can not accurately be operated, and extend operating time.
In the ophthalmologic operation of part, oculist may require that more times to complete to perform the operation, and BSS can not meet to want
Ask, so corneal protection can be carried out partly to substitute BSS using viscoelastic agent, to maintain cornea to moisten.Viscoelastic agent has for one kind
The high molecular polymer medicine equipment of viscoelastic property, is used in intraocular, plays filling anterior chamber, maintains anterior chamber depth, meets hand
Art is needed, or the effect of endothelial cell is protected in surgical procedure.It possesses following 2 principal characters：1) active position
For intraocular, all ophthalmically acceptable viscoelastic agent its applicable position when CFDA ratifies is intraocular on the market at present, not ocular；2) its
It is multi-purpose to maintain anterior chamber space and operation technique space within the eye, do not refer to how applying in anterior corneal surface maintenance cornea wetting agent
Protect corneal epithelium.Viscoelastic agent is divided into two kinds of cohesion type and diffusion-type, and its main component is Sodium Hyaluronate (HA).If will
Such products application can cause problems with ocular：1) HA is high viscosity thick liquid, can not effectively spread covering and protect comprehensively
Corner protector film, if artificially spread using external force such as operating theater instruments, scratch cornea can be possible to.2) due to being difficult to spread,
Uneven thick film is easily formed, can greatly cause light refraction effect, surgical field of view is unintelligible, can not correctly and efficiently enter
Row ophthalmologic operation.3) because HA viscosity is big, postoperative period is difficult to thoroughly remove, and entering intraocular if any residual HA can then cause in short-term
Between intraocular pressure increase, cause secondary complication such as part tissue of eye to be damaged.
The content of the invention
In order to solve the above technical problems, it is an object of the invention to provide a kind of composition and cornea for being used to protect cornea
Viscoelastic liquid is protected, the composition for being used to protect cornea and corneal protection viscoelastic liquid have good protecting effect, can make hand
The art visual field has higher definition and brightness.
To obtain above-mentioned purpose, present invention firstly provides a kind of composition for being used to protect cornea, the corneal protection glues
Liquid is played to be made up of bulk composition, osmotic pressure regulator, pH value regulator and water, wherein：
The bulk composition is selected from：Single hydroxypropyl methyl cellulose, single chondroitin sulfate, single hyalomitome
Sour sodium, the combination of hydroxypropyl methyl cellulose and chondroitin sulfate or hydroxypropyl methyl cellulose and the group of Sodium Hyaluronate
Close；Wherein, counted using the quality of the corneal protection viscoelastic liquid as 100%, the content of the hydroxypropyl methyl cellulose is 10%-
30%, the content of the chondroitin sulfate is 0.5%-10%, and the content of the Sodium Hyaluronate is 0.2%-5%；It is no matter single
Solely using being still applied in combination, the content of hydroxypropyl methyl cellulose, the content of chondroitin sulfate, the content of Sodium Hyaluronate are equal
Control is within above-mentioned number range；
The pH value regulator includes：Lactic acid 1%-5%, sodium hydroxide 0.5%-1.5%, tartaric acid 0-3%, citric acid
0-5%；
The osmotic pressure of the corneal protection viscoelastic liquid is 265-330mOsmol/kg, pH value 6.8-7.6.
HPMC is a kind of non-ionic celluloses ether, and odorless, tasteless is white powdered, can be dissolved in less than 40 DEG C of water.
The corneal protection viscoelastic liquid of the present invention can be produced the advantage that using HPMC as main part：With good greasy property,
Stable chemical performance, it is not easy to wreck；Light irradiation will not be had an impact, do not influence light of performing the operation；Biological safety is good, resists
Microbial performance is outstanding, no cytotoxicity, non-stimulated allergic reaction and propagation toxicity；HPMC good water solubilities, even if accidentally a small amount of
Into intraocular, also it is easy to the flushing at anterior chamber and goes out, residual will not be caused；Possess good false plasticity, be 3- in pH value
Stable (pH of aqueous 6.5-7.8) can be kept in the range of 11, easily high osmosis is combined to form with all kinds of inorganic salts and glues
Thick liquid, and then possess many new application performance such as water-retaining propertys, anti-vertical fluidity.
In above-mentioned corneal protection viscoelastic liquid, it is preferable that in the combination of hydroxypropyl methyl cellulose and chondroitin sulfate,
The mass ratio of the hydroxypropyl methyl cellulose and chondroitin sulfate is 3:1；In hydroxypropyl methyl cellulose and Sodium Hyaluronate
Combination in, the mass ratio of the hydroxypropyl methyl cellulose and Sodium Hyaluronate is 3:1.
In above-mentioned corneal protection viscoelastic liquid, it is preferable that the molecular weight of used hydroxypropyl methyl cellulose is
200000-300000 dalton, its nominal viscosity are 2500-5000mPas, and the pH value for the aqueous solution that its concentration is 2wt% is
5-8。
In above-mentioned corneal protection viscoelastic liquid, it is preferable that counted using the quality of the corneal protection viscoelastic liquid as 100%, it is described
The content of hydroxypropyl methyl cellulose is 18%-24%, and the content of the chondroitin sulfate is 1%-5%, the hyaluronic acid
The content of sodium is 0.5%-3%.
In above-mentioned corneal protection viscoelastic liquid, it is preferable that the osmotic pressure regulator includes sodium chloride, potassium chloride and two water
Close one or more of combinations in calcium chloride；Preferably, counted using the quality of the corneal protection viscoelastic liquid as 100%, the chlorine
The content for changing sodium is 3%-8%, and the content of the potassium chloride is 0.1%-1%, and the content of the CALCIUM CHLORIDE DIHYDRATE is
0.1%-0.5%.
In above-mentioned corneal protection viscoelastic liquid, it is preferable that counted using the quality of the corneal protection viscoelastic liquid as 100%, it is described
PH value regulator includes：Lactic acid 2%-3%, sodium hydroxide 0.8%-1.2%, tartaric acid 0-1%, citric acid 0-1%.By adding
The surface tension and disperse degree of corneal protection viscoelastic liquid of the present invention can be increased by entering lactic acid, to maintain the wet characteristic of product.
Due to property caused by its unique formula, the enough rapid Cover pupil regions of corneal protection viscoelastic liquid energy of the invention,
Prolonged corneal protection is provided and maintains cornea moistening, at the same can specially offered clearly bright surgical field of view, this is current institute
Have not available for existing procucts.
In above-mentioned corneal protection viscoelastic liquid, it is preferable that the lactic acid is the lactic acid aqueous solution that concentration is 90wt%；It is preferred that
Ground, the molecular weight of the lactic acid is 90.08g/mol.
In the selection of permeable components, present invention selection inorganic salts (preferably with the sodium chloride of physiological saline identical component and/
Or calcium chloride) formed infiltration component, while be equipped with lactic acid carry out corneal nutrition, promote corneal epithelial cell self-regeneration (because
It is slower without blood vessel coverage, otch normal healing for cornea).
In above-mentioned corneal protection viscoelastic liquid, it is preferable that in 25 ± 1 DEG C, shear rate 5s-1Under conditions of, the cornea
The dynamic viscosity for protecting viscoelastic liquid is 3000-6000mPas.
According to specific embodiments of the present invention, it is preferable that corneal protection viscoelastic liquid provided by the present invention can have
Form in detail below：The corneal protection viscoelastic liquid is made up of bulk composition, osmotic pressure regulator, pH value regulator and water；With this
The quality of corneal protection viscoelastic liquid is 100% meter, and the bulk composition is hydroxypropyl methyl cellulose, and its content is 10-30%；
The pH adjusting agent includes lactic acid aqueous solution, the sodium hydroxide that concentration is 90wt%, and the concentration is that 90wt% lactic acid is water-soluble
The content of liquid is 1%-5%, and the content of the sodium hydroxide is 0.5%-1.5%；The osmotic pressure of the corneal protection viscoelastic liquid is
265-330mOsmol/kg, pH value 6.8-7.6；In 25 ± 1 DEG C, shear rate 5s-1Under conditions of, the corneal protection viscoelastic
The dynamic viscosity of liquid is 3000-6000mPas.The corneal protection viscoelastic liquid is that the strong cornea of a kind of clear, plasticity is protected
Protect viscoelastic liquid product.
According to specific embodiments of the present invention, water is preferably pure water, medicine used by above-mentioned corneal protection viscoelastic liquid
With/other the water for injection of medical grade.
The corneal protection viscoelastic liquid of the present invention can be prepared in the following manner：Composition in addition to HMPC is dissolved in water
In and stir, while by HMPC at 70-80 DEG C and water mix 30 minutes after, be added into containing other compositions
In the aqueous solution, continue after being well mixed 36 hours, carrying out secondary repetition using filter membrane (0.1-2 microns) filters, and resulting is clear
Clear solution carries out sterilization treatment (121 DEG C, 35min) in steam sterilization pan and can obtain corneal protection viscoelastic liquid.
Corneal protection viscoelastic liquid provided by the present invention can either maintain cornea to moisten, and effectively protect anterior corneal surface, simultaneously
The appearance of the cornea relevant issues such as post-operative cornea drying, art source property dry eyes can also effectively be reduced.Cornea provided by the present invention
Protection viscoelastic liquid has advantages below：Anterior corneal surface can be effectively and rapidly covered, maintains cornea moistening to avoid bitot's patches, protects
Corneal epithelium is protected, further, it is possible to increase patient and patient's operation comfort；There is certain viscosity, property is stable in the short time,
It will not in a short time volatilize and influence its performance；Transmitance is high, easily forms clearly surgical field of view, do not interfere with perform the operation into
Degree；Doctor is liberated, makes operation one man operation, lifts procedure efficiency；Can meet on a small quantity perform the operation needs, reduce surgery cost into
This, patient can receive.And prepared in technique using the high temperature process of innovation, simple to operate easily-controllable, cost is cheap.It is comprehensive
Consider, corneal protection viscoelastic liquid of the invention is clinical prioritizing selection.
Embodiment
In order to which technical characteristic, purpose and the beneficial effect of the present invention is more clearly understood, now to the skill of the present invention
Art scheme carry out it is described further below, but it is not intended that to the present invention can practical range restriction.
Embodiment 1-4
Embodiment 1-4 each provides a kind of corneal protection viscoelastic liquid, and it forms as shown in table 1.
The composition of the embodiment 1-4 of table 1 corneal protection viscoelastic liquid, content is using the quality of corneal protection viscoelastic liquid as 1000g
Count (unit：g)
Viscosity is in (25 ± 1) DEG C, shear rate 5s-1Under conditions of determine.
Preparation method：
Composition in addition to HMPC is dissolved in water for injection and stirred, at the same by HMPC at 70-80 DEG C and
After water mixes 30 minutes, it is added into the aqueous solution containing other compositions, continues after being well mixed 36 hours, using filter
Film (0.1-2 microns) carries out secondary repetition and filtered, and resulting settled solution carries out sterilization treatment (121 in steam sterilization pan
DEG C, 35min) can obtain corneal protection viscoelastic liquid.
The performance test of the corneal protection viscoelastic liquid of embodiment and safety evaluatio：
Properties of product test is carried out using the corneal protection viscoelastic liquid of embodiment 1,2, while chooses the cornea listed and protects
Protect agent (Austrian CROMA-PHARMAGmbH companies production, model：Cornea Protect, comparative example 1) and CN
Product (comparative example 2) prepared by the embodiment 1 in 105749360A carries out parameter comparison.The parameter contrasted include outward appearance,
Osmotic pressure, shear viscosity, particulate matter, bacterial endotoxin, Eye irritation and cytotoxicity.
In, Eye irritation is according to the parts of GB/T 16886.10-2005 the 10th：Stimulate in being reacted with Delayed hypersensitivity
Method is carried out, and cytotoxicity is according to the parts of GB/T 16886.5-2008 the 5th：Method in vitro cytotoxicity test is carried out.
Dependence test result is as shown in table 2.
Table 2
It can be seen that by the contrasting detection result of performance parameter：Embodiment 1,2 is with comparative example 1,2 in safety indexes (eye
Damage score) and bacterial endotoxin on approach, without obvious toxic reaction.The dynamic viscosity of embodiment 1,2 is than comparative example 1
Viscosity is low, with more mobility and dispersivity, and is approached with the viscosity of comparative example 2.
And in terms of the particulate matter of product, embodiment 1,2 is better than comparative example 1,2, and this effectively can reduce or drop
Low blocking girder screen distance causes the elevated risk of intraocular pressure, reduces the generation of secondary complication.
It these results suggest that the corneal protection viscoelastic liquid of the present invention strictly controls on composition and technique, reduce risk,
It is not less than commercialized product, and be higher than existing product in security in performance.
Eye injury criterion is specific as shown in table 3 according to the standard formulations of GB/T 16886.
Table 3
The optical test of corneal protection viscoelastic liquid
By corneal protection viscoelastic drop on simulation cornea, observation period dispersivity and permeability, its dimension of high spot reviews
Hold the clarity of surgical field of view and bright function.Dependence test contrast is evaluated according to the standard shown in table 4：
Table 4
Standard requirement according to table 1, chooses corneal protection thing (ophthalmically acceptable balance usually used in current ophthalmologic operation
Liquid BSS, viscoelastic agent and corneal protection agent) and the embodiment of the present invention 1, the corneal protection viscoelastic liquid progress lateral comparison of embodiment 2,
Wherein, ophthalmically acceptable equilibrium liquid main component be 0.9% sodium chloride physiological saline (hereinafter referred to as BSS), viscoelastic agent using 2% it is saturating
Bright matter acid sodium (hereinafter referred to as 2%HA) and 2% hydroxypropyl methyl cellulose (hereinafter referred to as 2%HPMC) and CRONEA
(Austrian CROMA-PHARMA companies production, existing market face is uniquely a to be able to maintain that cornea moistening and shielding angle to PROTECT
The product of film epithelial cell, hereinafter referred to as CP).
Evaluation method：Acquisition mode is drawn 2 drops (0.5mL) with collector tube and dropped on eyeball phantom, enters under the microscope
Row observation, and test data is recorded, specifically as shown in table 5-9.
The moistening degree of the cornea of table 5
Table 6
It can be seen that by the content of table 5, table 6：BSS in 1 minute moistening for being just unable to maintain that cornea later of operating time,
And 2% HPMC is also unable to maintain that the moistening degree of cornea when 5 minutes, 2% HA were at 10 minutes, comparative example 2 is at 20 points
Maintenance cornea moistening degree during clock has declined, and CP and the corneal protection viscoelastic liquid of the present invention can be more than 20 minutes
Cornea moistening degree is maintained in time.
The degree of getting a clear view of table 7
It can be seen that by the content of table 7：In terms of surgical field of view definition is maintained, the corneal protection viscoelastic of CP and the present invention
Liquid can maintain the clear surgical field of view of 20 minutes or so, under the limpid degree of the surgical field of view of comparative example 2 after 10 minutes starts
Drop, the visual field obscures.And in the observation of 25 minutes, under the microscope, the visual field corresponding to the present invention is still clear, saturating
It is bright, light permeability is neat, without scattering light and irregular reflection region under microscope.And can see the present invention with when
Between it is longer, the visual field becomes more and more brighter, can directly high-visible fundus tissue and complete red surgical field of view, this and this
The specific composition composition and special nature (false plasticity) of the corneal protection viscoelastic liquid of invention are closely related.
The spread of table 8
It can be seen that by the content of table 8：, can be fast in the 3s most started because BSS is the aqueous solution in terms of the spread
Speed diffusion, whole corneal epithelium is covered, but due to its readily volatilized property, corneal epithelium is again exposed to sky after 30s
In gas.And viscoelastic agent (2%HA and 2%HPMC), due to its cohesion and HMW feature, poor fluidity is, it is necessary to by apparatus
Covering could be completed, and easily produces bubble in the process.CP completes covering for corneal epithelium with comparative example 2 in the 5s times
Lid, and the whole dispersivity of event is uniform more than 1 minute, no visible bubble in bubble.The present invention corneal protection viscoelastic liquid in 3s i.e.
The covering of whole corneal epithelium can be completed, forms uniform semi-spherical shape layer, no visible bubble in bubble and particulate.
The bright property in the visual field of table 9 is held time
It can be seen that by the content of table 9：The 2 drop BSS aqueous solution can provide clearly operation in the 30s most started and regard
Open country, but growth over time, surgical field of view become that worse and worse, it is necessary to frequently supplemented, the saturating of the visual field could be maintained
Bright property.
2 eye drip viscoelastic agents easily form uneven reflecting layer, cause the visual field to occur due to its cohesion and HMW
There is white dot and sediment with fuzzy because its open-assembly time is long in missing, and surgical field of view thickens, Wu Fajin
OK.
And surgical field of view of the 2 drop CP in 20 minutes is very bright, but at 25 minutes, there is whiteness in edge, the visual field
There is marginality reflectivity light.And the limpid degree of surgical field of view at 20 minutes of comparative example 2 declines, declined at 25 minutes
Obvious, there is white dot thing in edge.
The corneal protection viscoelastic liquid of the 2 drop present invention is in the observation of whole 25 minutes, and surgical field of view is very clear bright, symbol
Close operation to require, and reflection-free area light occurs.Most of ophthalmologic operation needs can be met.
Therefore can be seen that from above across comparison：The corneal protection viscoelastic liquid energy of the present invention is enough to be formed in corneal epithelium
One layer of stabilization, it is transparent, uniformly moisten film, maintain the clear visual field of operation of more than 25 minutes, disclosure satisfy that most of ophthalmology hand
Art needs.Corneal protection thing than commonly using on the market at present is intended to outstanding.
The further comparison of smoothness and the spread：
2 drop sample drops are taken on animal corneal, are observed under 100X power microscopes and record data.When record retains
Between (drip to the time that cornea to liquid level ruptures/occurred bubble), done using the reflection to red light area situation in cornea iris area after instillation
Judge for smooth level, 0 grade is smooth, and 1 grade smooth for part, and 2 grades are unsmooth.Correlated results is as shown in table 10：
Table 10
It can be seen that by the content of table 10：Sample provided by the present invention can cover pupil region in 3 seconds, be formed flat
Sliding clear liquid layer, while the corneal protection time more than 20 minutes can be provided, there is obvious advantage than existing product.
Claims (10)
1. a kind of corneal protection viscoelastic liquid, the corneal protection viscoelastic liquid by bulk composition, osmotic pressure regulator, pH value regulator and
Water forms, wherein：
The bulk composition is selected from：Single hydroxypropyl methyl cellulose, single chondroitin sulfate, single hyaluronic acid
Sodium, the combination of hydroxypropyl methyl cellulose and chondroitin sulfate or the combination of hydroxypropyl methyl cellulose and Sodium Hyaluronate；
Wherein, to be counted using the quality of the corneal protection viscoelastic liquid as 100%, the content of the hydroxypropyl methyl cellulose is 10%-30%,
The content of the chondroitin sulfate is 0.5%-10%, and the content of the Sodium Hyaluronate is 0.2%-5%；
The pH value regulator includes：Lactic acid 1%-5%, sodium hydroxide 0.5%-1.5%, tartaric acid 0-3%, citric acid 0-
5%；
The osmotic pressure of the corneal protection viscoelastic liquid is 265-330mOsmol/kg, pH value 6.8-7.6.
2. corneal protection viscoelastic liquid according to claim 1, wherein, in hydroxypropyl methyl cellulose and chondroitin sulfate
In combination, the mass ratio of the hydroxypropyl methyl cellulose and chondroitin sulfate is 3:1；
In the combination of hydroxypropyl methyl cellulose and Sodium Hyaluronate, the hydroxypropyl methyl cellulose and Sodium Hyaluronate
Mass ratio is 3:1.
3. corneal protection viscoelastic liquid according to claim 1 or 2, wherein, the molecular weight of the hydroxypropyl methyl cellulose
For 200000-300000 dalton, its nominal viscosity is 2500-5000mPas, and its concentration is the pH value of the 2wt% aqueous solution
For 5-8.
4. the corneal protection viscoelastic liquid according to claim any one of 1-3, wherein, with the quality of the corneal protection viscoelastic liquid
For 100% meter, the content of the hydroxypropyl methyl cellulose is 18%-24%, and the content of the chondroitin sulfate is 1%-
5%, the content of the Sodium Hyaluronate is 0.5%-3%.
5. the corneal protection viscoelastic liquid according to claim any one of 1-4, wherein, the osmotic pressure regulator includes chlorination
One or more of combinations in sodium, potassium chloride and CALCIUM CHLORIDE DIHYDRATE；
Preferably, counted using the quality of the corneal protection viscoelastic liquid as 100%, the content of the sodium chloride is 3%-8%, the chlorine
The content for changing potassium is 0.1%-1%, and the content of the CALCIUM CHLORIDE DIHYDRATE is 0.1%-0.5%.
6. the corneal protection viscoelastic liquid according to claim any one of 1-5, wherein, with the quality of the corneal protection viscoelastic liquid
For 100% meter, the pH value regulator includes：Lactic acid 2%-3%, sodium hydroxide 0.8%-1.2%, tartaric acid 0-1%, citron
Sour 0-1%.
7. the corneal protection viscoelastic liquid according to claim any one of 1-6, wherein, the lactic acid is that concentration is 90wt%'s
Lactic acid aqueous solution.
8. corneal protection viscoelastic liquid according to claim 7, wherein, the molecular weight of the lactic acid is 90.08g/mol.
9. the corneal protection viscoelastic liquid according to claim any one of 1-8, wherein, in 25 ± 1 DEG C, shear rate 5s-1
Under conditions of, the dynamic viscosity of the corneal protection viscoelastic liquid is 3000-6000mPas.
10. a kind of corneal protection viscoelastic liquid, the corneal protection viscoelastic liquid is by bulk composition, osmotic pressure regulator, pH value regulator
Formed with water；
Counted using the quality of the corneal protection viscoelastic liquid as 100%, the bulk composition is hydroxypropyl methyl cellulose, and its content is
10-30%；The pH adjusting agent includes lactic acid aqueous solution, the sodium hydroxide that concentration is 90wt%, and the concentration is 90wt%'s
The content of lactic acid aqueous solution is 1%-5%, and the content of the sodium hydroxide is 0.5%-1.5%；
The osmotic pressure of the corneal protection viscoelastic liquid is 265-330mOsmol/kg, pH value 6.8-7.6；
In 25 ± 1 DEG C, shear rate 5s-1Under conditions of, the dynamic viscosity of the corneal protection viscoelastic liquid is 3000-
6000mPa·s。
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710858456.5A CN107812243A (en) | 2017-09-21 | 2017-09-21 | A kind of corneal protection viscoelastic liquid |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710858456.5A CN107812243A (en) | 2017-09-21 | 2017-09-21 | A kind of corneal protection viscoelastic liquid |
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| CN201710858456.5A Pending CN107812243A (en) | 2017-09-21 | 2017-09-21 | A kind of corneal protection viscoelastic liquid |
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| WO2019223748A1 (en) * | 2018-05-25 | 2019-11-28 | 爱博诺德(北京)医疗科技股份有限公司 | Viscoelastic agent material |
| CN113876800A (en) * | 2021-11-11 | 2022-01-04 | 天津晶明新技术开发有限公司 | Cornea protective agent and its preparation method and use |
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