CN102973594B - A kind of ophthalmic preparation and preparation method containing oxygen microcapsule - Google Patents
A kind of ophthalmic preparation and preparation method containing oxygen microcapsule Download PDFInfo
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- CN102973594B CN102973594B CN201210554214.4A CN201210554214A CN102973594B CN 102973594 B CN102973594 B CN 102973594B CN 201210554214 A CN201210554214 A CN 201210554214A CN 102973594 B CN102973594 B CN 102973594B
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Abstract
The present invention relates to a kind of ophthalmic preparation field containing oxygen microcapsule, be mainly used in the various ocular disease prevented and treated because anoxia causes, be particularly useful for corneal injury.It is characterized in that: said preparation is the semi-solid gel preparation of flowing, and said preparation is made up of following component: oxygen accounts for 5 ~ 70% of said preparation cumulative volume, and oxygen concentration is 5 ~ 100%; Surfactant accounts for 0.1 ~ 50% of said preparation gross weight, and isoosmotic adjusting agent accounts for 0.1 ~ 2.5% of said preparation gross weight, and thickening agent accounts for 0.1 ~ 40% of said preparation gross weight, and pH adjusting agent regulates preparation pH value to be the amount of 6.8 ~ 8.6, and surplus is water.Object of the present invention is that cornea sustains damage, causes because of contact lens cornea to contact amount of oxygen minimizing, and can cause cornea edema, muddiness, the present invention to eye oxygen supply, solves cornea anoxia problem by oxygen microcapsule.
Description
Technical field
The present invention relates to a kind of ophthalmic preparation field containing oxygen microcapsule, be mainly used in the various ocular disease prevented and treated because anoxia causes, be particularly useful for corneal injury.
Background technology
Cornea (Cornea) is the transparent part of eyes foremost, covers iris, pupil and anterior chamber, and provides most of refractive power for eyes.Add the refractive power of crystal, light just can focus on exactly and form image on the retina.
Cornea has very responsive teleneuron, and if any foreign object contact cornea, eyelid just can close to protect eyes in spite of oneself.Because cornea does not have blood vessel, in order to keep transparent, obtain nutrient and oxygen by tear and aqueous humor.
Cornea is divided into five layers, is followed successively by by after forward direction: epithelium layer (epithelium), bowman's lamina (laminaelasticaanterior is also known as Bowman film), hypothallus (stroma), descemet's membrane (laminaelasticaporterior is also known as Descemet film), endothelial layer (endothelium).Epithelial cell thickness about 50 μm, accounts for 10% of whole corneal thickness, is made up of 5 ~ 6 confluent monolayer cells, and cornea periphery epithelium thickens, and cell is increased to 8 ~ 10 layers.
Keratitis is because of ocular surface burns, the inflammation that antibacterial and Virus entry cornea cause.Unsuitable the wearing of contact lens also can disturb normal metabolic pathway, causes change and the corneal edema of cellular morphology.
Keratopathy is a kind of common oculopathy, because the sensor of pain is distributed in superficial keratectomy, causes the pain that eye is violent, shows as photophobia, sheds tears, very painful.Although there is multiple remedy measures clinically, curative effect is unsatisfied with, and main manifestations is slow for curing, and analgesic effect is poor.
Cornea metabolic requirement oxygen, because cornea does not have blood vessel, required oxygen about 80% is from outside air, and 15% from limbal vascular net, and 5% is supplied by aqueous humor.During anoxia, can make the corneal opacity, swelling, thickness increases.But cornea directly can not use the oxygen in air, the oxygen in air must be dissolved in tear and could be utilized by cornea.So xerophthalmia patient and long periods of wear contact lens crowd all can cause cornea discomfort or damage due to cornea anoxia.
The most important link of glucose metabolism of cornea carries out glycolysis by tricarboxylic acids or tricarboxylic acid cycle, raw 8 the ATP molecules of common property in aerobic glycolysis, and in anerobic glycolysis, only produce 2 ATP molecules.Secondly. be by defending sugared phosphate pathway or hexose phosphate shunt direct oxidation glucose.
Because the eubolism of cornea and tissue repair all need oxygen to participate in, oxygen is considered to cornea and maintains the most important material of normal physiological function, even the supply of very little minimizing oxygen, all may hurt the health of cornea.Have research to point out, the required critical dissolved oxygen concentration of cornea is 20.9%, and the oxygen concentration namely in air, any contact lens wearers, is less than the oxygen supply of this concentration, finally all can affects cornea physiology.
Based on the importance of oxygen corneal, present contact lens all needs high oxygen transmitance, and must take in bed.When the various cornea inflammation of clinical treatment, some doctors adopt to the method suffering from eye oxygen blast gas, increase curative effect, Shorten the Treatment Process.
State-owned 4,500 ten thousand people's contact lens at present, there are 3,800 ten thousand people in the U.S..The patient causing keratitis because wearing contact lens accounts for keratitis morbidity total number of persons 65%, the ocular surface burns caused accounts for 32% of morbidity total number of persons, cause the number of ocular nerve palsy to account for 44% of morbidity total number of persons, the number causing corneal degeneration accounts for 59% of morbidity total number of persons.The main cause of morbidity is cornea anoxia, and the principle of solution is the oxygen supply amount farthest increasing anterior corneal surface.Solution one is the oxygen transmission rate increasing contact lens, and two is exogenous oxygen supplys.When contact lens oxygen transmission rate is difficult to improve again, exogenous oxygen supply just seems very important, is also following development trend.
But up to the present, also do not find at home and abroad by oxygen microcapsule to the precedent of cornea oxygen supply and report.
Summary of the invention
Goal of the invention: a kind of ophthalmic preparation containing oxygen microcapsule of the present invention and preparation method, its object is to by oxygen microcapsule as cornea provides oxygen to increase a new approach.
Technical scheme:
An ophthalmic preparation containing oxygen microcapsule, is characterized in that: said preparation is the semi-solid gel preparation of flowing, and said preparation is made up of following component:
Oxygen accounts for 5 ~ 70% of said preparation cumulative volume, and oxygen concentration is 5 ~ 100%; Surfactant accounts for 0.1 ~ 50% of said preparation gross weight, and isoosmotic adjusting agent accounts for 0.1 ~ 2.5% of said preparation gross weight, and thickening agent accounts for 0.1 ~ 40% of said preparation gross weight, and pH adjusting agent regulates preparation pH value to be the amount of 6.8 ~ 8.6, and surplus is water.
Described surfactant be selected from following: one or more the mixture in poloxamer, soybean phospholipid, lecithin, Polysorbate, glycerin mono-fatty acid ester.
Described thickening agent be selected from following: one or more the mixture in carbomer, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone, hyaluronic acid sodium, sodium alginate, chitosan, methylcellulose, hydroxypropyl emthylcellulose.
Described isoosmotic adjusting agent is one or more the mixture be selected from sodium chloride, potassium chloride, glycerol, glucose, mannitol.
Described pH adjusting agent is selected from the one in sodium hydroxide, hydrochloric acid, citric acid, sodium citrate, phosphoric acid, sodium ascorbyl phosphate, boric acid, borate.
The concentration of oxygen is 5 ~ 100%, in oxygen wherein or add nitrogen or other gas.
A preparation method as mentioned above containing oxygen microcapsule ophthalmic preparation, is characterized in that: the thickening agent getting recipe quantity is soaked in certain hour in water, makes its abundant swelling; Separately get isoosmotic adjusting agent, surfactant is dissolved in water or makes it dispersed, merging with thickener soln, add water to full dose, stir, is 6.8 ~ 8.6 with pH adjusting agent adjust pH; Be 5 ~ 100% by oxygen furnishing oxygen content, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make in solution, to form the tiny microcapsules including a large amount of oxygen, then use high pressure homogenizer homogenizing, form stable oxygen microcapsule; Be dispensed in plastic bottles, sterilization method is overall process sterile working or finished product Co60 radiation sterilization.
Advantageous effect:
Oxygen is the required material maintaining cornea normal physiological function.Rehabilitation after cornea sustains damage needs oxygen to participate in metabolism; Reduce because contact lens causes cornea to contact amount of oxygen, cornea edema, muddiness can be caused.The present invention to eye oxygen supply by oxygen microcapsule, is solved cornea anoxia problem, works out a kind of safe and effective, simple and practical offering oxygen way, the various pathological changes that control cornea causes because of anoxia.
The present invention containing the eye drop of a large amount of oxygen microcapsule by preparation, is provided sufficient oxygen to eye, improves cornea anaerobic condition, accelerates the treatment of keratitis, the cornea anoxia that control Yin Peidai cornea contact lenses causes and the corneal injury that causes.Preparation of oxygen microcapsule is to cornea oxygen supply first both at home and abroad in the present invention, and method safety is effective, convenient and practical, creatively provides a kind of cornea offering oxygen way.
embodiment:
The present invention is a kind of ophthalmic preparation containing oxygen microcapsule, in said preparation, containing a large amount of oxygen microcapsules, also saturatedly in liquid has dissolved oxygen.During instillation ophthalmic, there are sufficient oxygen and Corneal Contact, can be absorbed to maintain its normal physiological function by cornea.Contact lens wearers is because of the minimizing of Corneal Contact amount of oxygen, and can cause cornea edema, muddiness, the present invention just can solve this kind of cornea anoxia problem.
The present invention also instills by external eyes, oxygen molecule is made to enter vitreous body by external eyes, thus give retina oxygen supply, improve the state of diabetics optical fundus anoxia, suppress the expression of hypoxia-inducible factor-1 alpha (HIF-1 α), and then suppress the expression of vascular endothelial cell growth factor (VEGF), prevent the generation of diabetic retina new vessels, stop generation and the development of diabetic renal papillary necrosis.
An ophthalmic preparation containing oxygen microcapsule, is characterized in that: said preparation is made up of following component:
Oxygen accounts for 5 ~ 70% of said preparation cumulative volume, and oxygen concentration is 5 ~ 100%; Surfactant accounts for 0.1 ~ 50% of said preparation gross weight, and isoosmotic adjusting agent accounts for 0.1 ~ 2.5% of said preparation gross weight, and thickening agent accounts for 0.1 ~ 40% of said preparation gross weight, and pH adjusting agent regulates preparation pH value to be the amount of 6.8 ~ 8.6; Surplus is water.
Described surfactant be selected from following: one or more the mixture in poloxamer, soybean phospholipid, lecithin, Polysorbate, glycerin mono-fatty acid ester.Described thickening agent be selected from following: one or more the mixture in carbomer, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone, hyaluronic acid sodium, sodium alginate, chitosan, methylcellulose, hydroxypropyl emthylcellulose.Described isoosmotic adjusting agent is one or more the mixture be selected from sodium chloride, potassium chloride, glycerol, glucose, mannitol.Described pH adjusting agent adopts the one in sodium hydroxide, hydrochloric acid, citric acid, sodium citrate, phosphoric acid, sodium ascorbyl phosphate, boric acid, borate.
A preparation method containing oxygen microcapsule ophthalmic preparation, is characterized in that: the thickening agent getting recipe quantity is soaked in water; Separately get isoosmotic adjusting agent, surfactant is dissolved in water or makes it dispersed, merging with thickener soln, add water to full dose, stir, is 6.8 ~ 8.6 with pH adjusting agent adjust pH; Be 5 ~ 100% by medical oxygen furnishing oxygen content, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make in solution, to form the tiny microcapsules including a large amount of oxygen, then use high pressure homogenizer homogenizing, form stable oxygen microcapsule; Be dispensed in plastic bottles, sterilization method is overall process sterile working or finished product Co60 radiation sterilization.
Below in conjunction with embodiment, the present invention is further elaborated, but protection scope of the present invention not limit by embodiment.
Embodiment 1:
Prescription:
30% oxygen 500ml
Poloxamer 20.0g
Soybean phospholipid 12.0g
Glycerol 12.5g
Carbomer 2.0g
Sodium hydroxide solution adjust ph is 7.2
Water surplus
Make 1000ml.
Method for making: the carbomer getting recipe quantity to be soaked in water 12 hours; Separately get glycerol, poloxamer, soybean phospholipid be dispersed in water, merging with carbomer solution, add water to 500ml, stir, is 7.3 with sodium hydroxide solution adjust pH, filters with 200 order stainless (steel) wires.Be 30% concentration by medical oxygen furnishing oxygen content, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make in solution, to form the tiny microcapsules including a large amount of oxygen, volume stops to 1000ml, then uses high pressure homogenizer homogenizing, forms stable oxygen microcapsule, be dispensed in plastic bottles, finished product Co60 radiation sterilization.
Embodiment 2:
Prescription:
45% oxygen 300ml
Poloxamer 15.0g
Soybean phospholipid 12.0g
Sodium chloride 4.9g
Carbomer 2.0g
Sodium hydroxide solution adjust ph is 7.7
Water 700ml
Make 1000ml.
Method for making: the carbomer getting recipe quantity to be soaked in water 12 hours, separately get sodium chloride, poloxamer, soybean phospholipid dissolving and be dispersed in water, merge with carbomer solution, add water to 700ml, stirring, is 7.4 with sodium hydroxide solution adjust pH, filters with 200 order stainless (steel) wires, 121 DEG C of sterilizings 30 minutes, are cooled to room temperature.Be 45% concentration by medical oxygen furnishing oxygen content, cross 0.22 μm of microporous filter membrane, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make to form the tiny microcapsules including a large amount of oxygen in solution, volume stops to 1000ml, then high pressure homogenizer homogenizing is used, form stable oxygen microcapsule, be dispensed in plastic bottles, this process is sterile working.
Embodiment 3:
Prescription:
90% oxygen 700ml
Poloxamer 18.0g
Lecithin 12.0g
Glycerol 7.5g
Hyaluronic acid sodium 6.0g
Sodium hydroxide solution adjust ph is 8.2
Water 300ml
Make 1000ml.
Method for making: the hyaluronic acid sodium getting recipe quantity to be soaked in water 15 hours, separately get glycerol, poloxamer, lecithin is dispersed in water, merge with hyaluronic acid sodium solution, add water to 300ml, stirring, is 7.2 with sodium hydroxide solution adjust pH, filters with 200 order stainless (steel) wires, 121 DEG C of sterilizings 30 minutes, are cooled to room temperature.Be 90% concentration by medical oxygen furnishing oxygen content, cross 0.22 μm of microporous filter membrane, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make to form the tiny microcapsules including a large amount of oxygen in solution, volume stops to 1000ml, then high pressure homogenizer homogenizing is used, form stable oxygen microcapsule, be dispensed in plastic bottles, this process is sterile working.
Embodiment 4:
Prescription:
21% oxygen 700ml
Poloxamer 12.0g
Soybean phospholipid 6.0g
Glycerol 7.5g
Oxybenzene methylcellulose 3.0g
Sodium hydroxide solution adjust ph is 6.8
Water 300ml
Make 1000ml.
Method for making: the oxybenzene methylcellulose getting recipe quantity to be soaked in water 10 hours, separately get glycerol, poloxamer, soybean phospholipid be dispersed in water, merge with oxybenzene methylcellulose solution, add water to 300ml, stirring, is 6.8 with sodium hydroxide solution adjust pH, filters with 200 order stainless (steel) wires, 121 DEG C of sterilizings 30 minutes, are cooled to room temperature.Be 21% concentration by medical oxygen furnishing oxygen content, cross 0.22 μm of microporous filter membrane, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make to form the tiny microcapsules including a large amount of oxygen in solution, volume stops to 1000ml, then high pressure homogenizer homogenizing is used, form stable oxygen microcapsule, be dispensed in plastic bottles, this process is sterile working.
Embodiment 5:
Prescription:
40% oxygen 500ml
Poloxamer 3.0g
Soybean phospholipid 5.0g
Glycerol 7.5g
PEG400 1.0g
Carbomer 2.0g
Sodium hydroxide solution adjust ph is 7.2
Water 500ml
Make 1000ml
Method for making: get the carbomer of recipe quantity, Polyethylene Glycol to be soaked in water 12 hours, separately get glycerol, poloxamer, soybean phospholipid be dispersed in water, merge with carbomer, polyglycol solution, add water to 500ml, stirring, is 7.2 with sodium hydroxide solution adjust pH, filters with 200 order stainless (steel) wires, 121 DEG C of sterilizings 30 minutes, are cooled to room temperature.Be 40% concentration by medical oxygen furnishing oxygen content, cross 0.22 μm of microporous filter membrane, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make to form the tiny microcapsules including a large amount of oxygen in solution, volume stops to 1000ml, then high pressure homogenizer homogenizing is used, form stable oxygen microcapsule, be dispensed in plastic bottles, this process is sterile working.
It is like this measuring and calculating that oxygen accounts for 5 ~ 70% of said preparation cumulative volume, that is: pass into the volume of said preparation increase part after oxygen.The concentration of oxygen is too high, makes said preparation be oxidized sometimes, adds and stores and the difficulty of transport, so in oxygen or be mixed with nitrogen or other gas, as noble gas, carbon dioxide etc.
application example and Contrast on effect:
Animal experiment: get Japanese white big ear rabbit, body weight 2 kilograms, male and female regardless of, worn in rabbit eyes by the contact lens without refractive diopter, round the clock is worn.Random packet, often organizes 10 rabbit, point oxygen enrichment eye drop group, matched group.Oxygen enrichment eye drop group takes contact lens to side lagophthalmos, instills oxygen enrichment eye drop every day 4 times, each 2, and after instillation, passive closed 30 seconds of lagophthalmos, puts on contact lens afterwards again.Matched group takes contact lens to side lagophthalmos, instills normal saline every day 4 times, each 2, and after instillation, passive closed 30 seconds of lagophthalmos, puts on contact lens afterwards again.Within every 7 days, press cornea and stimulate standards of grading marking, and measure corneal thickness, Schirmer method measures lacrimal secretion, measures breakup time of tear film, long run test 28 days.Result of the test shows, oxygen enrichment eye drop group cornea indices is obviously better than matched group.
Preparation of the present invention is applicable to various corneal injury, wears the crowd of contact lens and patients with diabetic retinopathy, all has the effect of health care and treatment.
Claims (3)
1. the ophthalmic preparation containing oxygen microcapsule, is characterized in that: said preparation is the semi-solid gel preparation of flowing, and said preparation is made up of following component:
Oxygen accounts for 5 ~ 70% of said preparation cumulative volume, and oxygen concentration is 5 ~ 100%; Surfactant accounts for 0.1 ~ 50% of said preparation gross weight, and isoosmotic adjusting agent accounts for 0.1 ~ 2.5% of said preparation gross weight, and thickening agent accounts for 0.1 ~ 40% of said preparation gross weight, and the amount of pH adjusting agent is regulate preparation pH value to be the amount of 6.8 ~ 8.6, and surplus is water;
Described surfactant be selected from following: one or more the mixture in poloxamer, soybean phospholipid, lecithin;
Described thickening agent be selected from following: one or more the mixture in carbomer, Polyethylene Glycol, hyaluronic acid sodium;
Described isoosmotic adjusting agent is glycerol;
Described pH adjusting agent is sodium hydroxide.
2. the ophthalmic preparation containing oxygen microcapsule according to claim 1, is characterized in that: the concentration of oxygen is 5 ~ 100%, in oxygen wherein or add nitrogen or other gas.
3. the preparation method as claimed in claim 1 containing oxygen microcapsule ophthalmic preparation, is characterized in that: the thickening agent getting recipe quantity is soaked in certain hour in water, makes its abundant swelling; Separately get isoosmotic adjusting agent, surfactant is dissolved in water or makes it dispersed, merging with thickener soln, add water to full dose, stir, is 6.8 ~ 8.6 with pH adjusting agent adjust pH; Be 5 ~ 100% by oxygen furnishing oxygen content, pass in above-mentioned solution, ventilation limit, limit high-speed stirred, make in solution, to form the tiny microcapsules including a large amount of oxygen, then use high pressure homogenizer homogenizing, form stable oxygen microcapsule; Be dispensed in plastic bottles, sterilization method is overall process sterile working or finished product Co60 radiation sterilization.
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| CN201210554214.4A CN102973594B (en) | 2012-12-19 | 2012-12-19 | A kind of ophthalmic preparation and preparation method containing oxygen microcapsule |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1383383A (en) * | 2000-06-29 | 2002-12-04 | 老笃制药株式会社 | Oxygen-contg. ophthalmic compsn. |
| WO2009043031A2 (en) * | 2007-09-27 | 2009-04-02 | Children's Medical Center Corporation | Microbubbles and methods for oxygen delivery |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1383383A (en) * | 2000-06-29 | 2002-12-04 | 老笃制药株式会社 | Oxygen-contg. ophthalmic compsn. |
| WO2009043031A2 (en) * | 2007-09-27 | 2009-04-02 | Children's Medical Center Corporation | Microbubbles and methods for oxygen delivery |
Non-Patent Citations (1)
| Title |
|---|
| Interfacial Polygonal Nanopatterning of Stable Microbubbles;Emilie Dressaire etal;《Science》;20080530;第320卷;第1198-1201页 * |
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