CN100463681C - Artificial tears for treating xerophthalmia - Google Patents
Artificial tears for treating xerophthalmia Download PDFInfo
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- CN100463681C CN100463681C CNB2006101140103A CN200610114010A CN100463681C CN 100463681 C CN100463681 C CN 100463681C CN B2006101140103 A CNB2006101140103 A CN B2006101140103A CN 200610114010 A CN200610114010 A CN 200610114010A CN 100463681 C CN100463681 C CN 100463681C
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- carnitine
- dextran
- artificial tears
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- 239000000607 artificial tear Substances 0.000 title claims abstract description 66
- 208000005494 xerophthalmia Diseases 0.000 title claims description 13
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- FZWBNHMXJMCXLU-UHFFFAOYSA-N 2,3,4,5-tetrahydroxy-6-[3,4,5-trihydroxy-6-[[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxyhexanal Chemical compound OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OCC(O)C(O)C(O)C(O)C=O)O1 FZWBNHMXJMCXLU-UHFFFAOYSA-N 0.000 claims abstract description 60
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- GDWRKZLROIFUML-UHFFFAOYSA-N 4-phenylbutan-2-ol Chemical compound CC(O)CCC1=CC=CC=C1 GDWRKZLROIFUML-UHFFFAOYSA-N 0.000 description 1
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- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 description 1
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Abstract
The invention discloses an artificial tears comprising two active components, hydroxypropyl methylcellulose phthalate, dextran -70 and a non-active component ,osmotic pressure protective agent L - Carnitine, percent by weight of said three components is 3:1:2.5 . Said compound can mix up with carrier acceptable by pharmacology and prepare into xanthan gum, emul, or pharmaceutical solutions acceptable by clinical medicine. Said artificial tears may or may not contain preservative.
Description
Technical field
The present invention relates to a kind of artificial tears, particularly a kind of containing and the protectant novel artificial tear of ocular tissue's osmotic pressure compatible.
Background technology
People and other mammiferous eyes can lubricate eyes timely and appropriately makes it comfortable, provides good effectively, clear sight.In general, be to come from tear to being exposed to extraneous eye the lubricated of surface portion.And tear results from lachrymal gland, and eyelid is pulled gland and other bodies of gland.Under normal situation, the generation of tear is discharged and evaporation is equilibrated, thereby important moisture is provided and supplies nutrient substance for the eye surface.Except covering and protection eye surface, the part that tear contacts with outside air also provides initial reflecting surface for eyes.The normal value of eye osmotic pressure is at 290 to 310 milliosmol/kilograms.Under normal circumstances, the nerve feedback regulation from the eye surface to lachrymal gland the generation of tear to keep the stable of a Surface runoff amount of liquid.Osmotic pressure that there are some researches prove tear film is one of this principal element of regulating feedback mechanism.Xerophthalmia, or claim keratitis sicca to be because tear film is unusual, one group of illness that the moistening degree of cornea and conjunctiva causes inadequately.The factor that causes the xerophthalmia symptom is a lot, mainly contains the age, the side effect that eye occurs after treatment, and dust, smog etc. are to the stimulation of eye, and the humidity in the environment is not enough.In addition, at television set, all can cause xerophthalmia symptom before the computer after for a long time.The xerophthalmia symptom varies with each individual, and is that eyes have foreign body or sense of discomfort such as burn substantially, and the scraping sense being arranged when serious, pain or grains of sand friction sense.Someone also has photophobia, intermittent fuzzy or other visual disorder.
At present had some medicines to be used for treating and improving the symptom of xerophthalmia, that with the most use is the artificial tears.The artificial tears is the normal physiology tear of imitation from chemical composition and function.Initial artificial tears is often owing to the short use that needs repeated multiple times of the time that retains in eye.Though wettable eyes lack lubrication.
As previously mentioned, the osmotic pressure of tear film is one of principal element of feedback regulation mechanism.Under normal circumstances, the osmotic pressure of the tear on human eye surface is to wait to open basically, in the scope of 290 to 310 milliosmol/kilograms.And xerophthalmia follows the height of having in mind outside the superficial cell to ooze environment usually.The osmotic pressure of xerophthalmia patient's tear film is usually at 320 to 400 milliosmol/kilograms or higher.Too high when the osmotic pressure of tear film, the cell on eye surface then is exposed under the environment that height oozes, and causes losing of a superficial epithelium cell moisture, and cell volume reduces.Though eyes itself have certain compensation ability, act on limited.If osmotic pressure is too high for a long time, the eye cell can constantly lose moisture content.Ooze under the environment at height that the function of some enzymes also can reduce in the cell, intracellular metabolism meeting is affected, and can cause the death of cell when serious.
Can alleviate a superficial epithelium extracellular height with hypotonic eye drop and ooze the damage of environment, obviously improve the discomfort that ooze height on the eye surface such as water flushing eye surface energy to eyes.The height that uses hypotonic artificial tears can change a superficial cell fast oozes situation, and very fast but hypotonic artificial tears passes in and out the speed of cell, action time is very short, the very fast hyperosmotic state of getting back to again of cell after the medication.Repeated multiple times uses hypotonic artificial tears can reduce the tolerance that cell oozes height.In addition; cell is oozed environment from height to be changed to a grade and oozes or hypotonic environment; the transporting mechanism that pair cell is accumulated compatible material also has negative influence, and the cell compatibility solute can increase the tolerance that the eye superficial cell oozes height, and height is oozed the eye table cell injury that causes protective effect.
Discover that in a large number biological intravital many cells can and be accumulated compatible solute by preparation and alleviate the height in the cell external world and ooze environment.The molecular weight of this class compatible solute is less, can retain in cell, can also carry out metabolism simultaneously with normal cell.Osmotic pressure in cell inside and outside this class compatible solute energy statocyte has and protects the effect of oozing, and cell is survived under the condition that height oozes.It is better than waiting when oozing to it is found that the auspicious Gram-positive bacillus of Liszt oozes under the condition highly compressed tolerance at height.Its reason is that height oozes the picked-up that can make this bacterium increase relative consistency solute, and the compatible solute of picked-up has increased the auspicious Gram-positive bacillus of Liszt to highly compressed tolerance.People also find some marine organisms, as halophilic microorganism, contain the compatible solute of high concentration in its cell, therefore can be in the environment such as the salt lake of high salt, and the local existence such as pond of bottom, deep-sea and evaporation.These microorganisms have plenty of eucaryon, have plenty of protokaryon, and can synthesize or put aside multiple compatible material, as polyalcohols, saccharide, aminoacid and derivant thereof.Though compatible solute under the condition of hyperosmosis, protect biological cell really cutter system also imperfectly understand; but discover that compatible solute can protect that the stereochemical structure of some enzymes under condition of high voltage do not change in the organism, played the effect of stabilized enzyme albumen stereochemical structure.In addition, compatible solute can also increase flowability of cell membranes, and the increase of membrane fluidity can improve the tolerance of cell to high pressure.
L-carnitine is one of basis of human body, mainly is distributed in the tissues such as skeletal muscle, heart flesh, liver, testis, and wherein content is the highest in the cardiac muscle.L-carnitine can promote the metabolic rate of mitochondrion to fat.Long-chain fatty acid is transported to outside mitochondrial membrane in the film and promotes therefore important effect is arranged oxidation of fatty acids in fat oxidation as carrier.L-carnitine is a kind of nutrient substance of needed by human, and its importance can be equal to vitamin commonly used fully.Because its important physical function has purposes widely on medical science and threpsology.In the eighties, L-carnitine is just as the commodity listing, and quilt income " American Pharmacopeia " the 22nd edition.The clear and definite L-carnitine of the U.S. in 1984 is a kind of very important nutriment.In the international nutrition academic conference that 1985 hold in Chicago L-carnitine is appointed as the multifunctional and nutritional product.The Committee of Experts of Food and Drug Administration (FDA) in 1993 assert that L-carnitine is a safety non-toxic.German Ministry of Public Health regulation carnitine use amount need not set upper limit in 1994.The 16 national food additive technical committee for standardization (TCST) of China in 1996 allows to use L-carnitine in beverage, milk beverage, cookies, solid beverage, milk powder.At present, existing many in the world countries and regions allow to add L-carnitine with the prevention carntine deficiency in baby milk.Though L-carnitine is widely accepted as a kind of nutrient substance of needed by human, and biological intravital many cells are alleviated the height in the cell external world and are oozed environment by accumulating or preparing compatible solute, the function of equilibrium osmotic pressure, the ability that makes cell improve the adaptation external world under the condition that height oozes then are the further understanding to the L-carnitine function.L-carnitine is again a kind of antioxidant except under the external environment of hyperosmosis the eye superficial cell being had the protective effect simultaneously.Can not only promote the wound healing of eye, the protection retina neural, with the artificial tears in after the combination of widely used lubricant hypromellose and dextran-70, also have comfortable with lubricated characteristics.The more important thing is, during the compound use of hypromellose and dextran-70 and L-carnitine, unexpectedly can strengthen the picked-up of a superficial epithelium cell, make artificial tears based on hypromellose and dextran-70 increase antagonism xerophthalmia patient height and ooze the tear film eye is shown cells injury L-carnitine.Contain suitable electrolyte in this artificial tears's the composition with the salinity in the imitation normal tear fluid.In addition, contain antiseptic commonly used in a kind of medicament for the eyes in the prescription, to guarantee artificial tears's repeatedly use.In a word, burn feeling can be effectively alleviated in this combination, and eye do to stimulate the discomfort that causes, multiple efficacies such as preserve moisture and lubricate.Life-time service also can play the effect of protection eyes owing to compatible solute antioxidative ability.
Except containing the compatible solute of abundant amount, present composition also contains proper amount of lubricating agent and the viscous agent provides comfortable and lubrication, thereby is keeping the compatible solute component to improve the picked-up of anterior corneal surface cell with adequate time on the eye surface effectively.Final tension force is to regulate and control with ocular tissue's compatible solute L-carnitine.Because used lubricant hypromellose and dextran-70 can increase the ability of keratocyte picked-up compatible solute, therefore improved the protective effect that hyperosmosis is stimulated, increased alleviation to clinical symptoms.Also because L-carnitine is regulated and angle of stability theca cell osmotic pressure, thereby the effect of preserving moisture is arranged, reduced the number of times of xerophthalmia people's medication, prolonged the protective effect of lubricant the eye surface texture.L-carnitine Wheat Protein also particularly, the therefore normal phase uses this artificial tears can improve the health on eye surface.This prescription has also comprised buffer system, keeps the tension force composition, anti-corrosion composition, and acid-base value is regulated composition.
Summary of the invention
The object of the invention is to provide a kind of artificial tears; The object of the invention also is to provide this artificial tears's compound method.
The present invention seeks to be achieved through the following technical solutions.
The artificial tear of the present invention comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 0.30-30.00 weight portion, dextran-70 are the 0.10-10 weight portion, L-carnitine 0.1-50 weight portion.
Above-mentioned three kinds of composition hydroxypropyl methylcellulose, dextran-70 and L-carnitine preferred weight part are: hydroxypropyl methylcellulose 0.50-8 weight portion, dextran-70 are the 8-8.8 weight portion, L-carnitine 0.2-10 weight portion;
Above-mentioned three kinds of composition hydroxypropyl methylcellulose, dextran-70 and L-carnitines also preferred weight part are:
5 weight portion 8.8 weight portions, 0.2 weight portions or 8 weight portions, 8 weight portions, 10 weight portions.
Above-mentioned three kinds of composition hydroxypropyl methylcellulose, dextran-70 and L-carnitine preferred weight part are: hydroxypropyl methylcellulose 10-18 weight portion, dextran-70 0.20-2 weight portion, L-carnitine 40-50 weight portion;
Above-mentioned three kinds of composition hydroxypropyl methylcellulose, dextran-70 and L-carnitines also preferred weight part are:
10 weight portion 2 weight portions, 40 weight portions or 18 weight portions, 0.20 weight portion, 50 weight portions.
Above-mentioned three kinds of composition hydroxypropyl methylcellulose, dextran-70 and L-carnitine preferred weight part are:
Hydroxypropyl methylcellulose 20-28 weight portion, dextran-70 are the 4-6 weight portion, L-carnitine 20-30 weight portion.
Above-mentioned three kinds of composition hydroxypropyl methylcellulose, dextran-70 and L-carnitines also preferred weight part are:
20 weight portion 6 weight portions, 20 weight portions or 28 weight portions, 4 weight portions, 30 weight portions.
The best proportioning of above-mentioned three kinds of composition hydroxypropyl methylcellulose, dextran-70 and L-carnitine is: 0.3:0.1:0.25.
Above-mentioned L-carnitine can be that any its chemically can be accepted the derivant of form.
The concentration that hydroxypropyl methylcellulose, stone revolve sugared acid anhydride-70 and L-carnitine in the artificial tear of the present invention is by weight being 0.03%～3%, 0.01%～1.0% and 0.01%～5.0% respectively; Hydroxypropyl methylcellulose, dextran-70 and L-carnitine concentration summation are 0.05% ~ 9% by weight in the artificial tear of the present invention.The optium concentration of hydroxypropyl methylcellulose, dextran-70 and L-carnitine is 0.3%, 0.1 and 0.25% respectively by weight in the artificial tear of the present invention; Hydroxypropyl methylcellulose, dextran-70 and L-carnitine concentration summation are 0.65% by weight in the artificial tear of the present invention.
Prepare above-mentioned artificial tears and 450mL pure water and 0.3-30g hydroxypropyl methylcellulose stirring and dissolving at 120-130 degrees centigrade of heating disinfection 30-60 minutes, can be made solution 1; With the 450mL pure water, 0.1-50g L-carnitine, 0.1-10g dextran-70, and an amount of boric acid, the boric acid sodium salt, potassium chloride, sodium chloride, benzalkonium chloride, sodium hydroxide/mixed in hydrochloric acid is filtered, and makes solubilize 2, then above-mentioned two solution is mixed in a container, filter, and add pure water to 1000mL.The artificial tear of the present invention is mixed with pharmaceutically acceptable carrier, can be mixed with clinical acceptable various dosage forms such as gluey agent, Emulsion or pharmaceutical solutions etc.The acid-base value scope of compound preparation solution is between pH5 to pH8.
Pharmaceutically acceptable carrier described in the above-mentioned preparation method can be to be applicable to the desired reagent of ophthalmic preparation, comprises antibiotic antiseptic, cosolvent and viscous agent etc.
Described antibiotic antiseptic can be a benzalkonium chloride, and the west softens this, methaform, methyl butex, propylparaben, phenethyl ethanol, disodium edetate, 2,4-hexadienoic acid, M or other known reagent in the Europe.Employed concentration range is 0.001% to 1.0% by weight in the artificial tears.
Described cosolvent can be Polyoxyethylene Sorbitol Fatty Acid Esters 20,60 and 80, the addition polymers F-68 of polypropylene glycol and oxirane, F-84 and P-103, cyclodextrin or other available reagents.Employed concentration range is from 0.01% to 2% by weight in the artificial tears.
Described viscous agent can be a polyvinyl alcohol, and polyethylene arsenic is coughed up alkane or other available reagents.Employed concentration range is from 0.01% to 2% by weight in the artificial tears.
The present invention finds first; employed lubricant hypromellose and dextran-70 can obviously increase the ability of keratocyte picked-up compatible solute L-carnitine in this artificial tear; this discovery is being exsomatized and all is being confirmed in the body experiment. because the ability of keratocyte picked-up compatible solute L-carnitine improves; therefore increased of the protective effect of eye surface, increased alleviation clinical symptoms to the hyperosmosis stimulation.Known L-carnitine can be regulated and angle of stability theca cell osmotic pressure, thereby has played the effect of preserving moisture, and has reduced the number of times of xerophthalmia people's medication, has prolonged the protective effect of lubricant to the eye surface texture.L-carnitine Wheat Protein also particularly, the therefore normal phase uses the artificial tear of the present invention can improve the health on eye surface.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
Experimental example 1
Test objective: by in isolated cells is cultivated, detecting hypromellose and dextran-70 the best prescription that is used for screening three kinds of compositions to rabbit cornea epithelial cell picked-up L-carnitine.
Test preparation: matched group: L-carnitine concentration is 0.1,2.5,50mg/mL;
Test group: hypromellose concentration is 0.3,3,30mg/mL, dextran-70 concentration is 0.1,1,10mg/mL, L-carnitine concentration is 0.1,2.5,50mg/mL. test method: separate the rabbit cornea epithelial cell, cell culture placed hyperosmotic solution (380 milliosmol/kilogram) with cultured cells after five days. adding concentration in high sepage respectively is 0.1,2.5, the L-carnitine of 50mg/mL or adding mix with the L-carnitine of matched group same concentrations and the hypromellose/dextran-70 of three groups of variable concentrations: 0.3/0.1,3/1,30/10mg/mL (combination sees Table 1). after each is organized cell hatch 24 hours in high sepage, collecting cell, and the content of the interior L-carnitine of mensuration cell part.The numerical value that mensuration obtains sees Table 1.
Table 1
Result of the test shows, under hyperosmotic state, the combination of the hypromellose/dextran-70 of three groups of variable concentrations all has the effect of good increase rabbit cornea epithelial cell to the picked-up of the L-carnitine of three concentration. and, concentration at hypromellose/dextran-70 is 3/1mg/mL, and L-carnitine concentration increases rabbit cornea epithelial cell effect the best to the picked-up of L-carnitine during for 2.5mg/mL. its hypromellose: dextran-70: the concentration ratio of L-carnitine is 0.3%:0.1%:0.25%.
Experimental example 2
Test objective: the hypromellose of selecting the isolated test gained for use: dextran-70: the optium concentration ratio of L-carnitine, test this combination to effect at body rabbit cornea epithelial cell picked-up L-carnitine.
Test preparation: matched group: L-carnitine concentration is 0.25% eye drop;
Test group: hypromellose concentration is 0.3%, and dextran-70 concentration is 0.1%, and L-carnitine concentration is 0.25% eye drop.
Test method: two groups of male new zealand rabbits, six every group, right eye is put concentration respectively to be the L-carnitine solution of 0.25% L-carnitine solution or 0.25% and to contain 0.3% hypromellose and 0.1% dextran-70 eye drop.Eye drip twice on 1st, each 25 microlitres, continuous use 7 days.Left eye is a blank.Get eyeball after 7 days, the separation of corneal epithelium cell is measured L-carnitine content in the cell homogenates.The numerical value that mensuration obtains sees Table 2
Table 2
This result of the test shows, gives two group reagents after 7 days at body rabbit eye drip, compares with the eye drop that contains L-carnitine merely, and the eye drop that contains hypromellose and dextran-70 has significant facilitation to rabbit cornea epithelial cell picked-up L-carnitine.
Following embodiment all can reach the effect of above-mentioned experimental example.
The specific embodiment
Embodiment 1:(pharmaceutical solutions)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.1 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. preparing above-mentioned composition can be with 45 ml pure waters and 0.3 gram hydroxypropyl methylcellulose stirring and dissolving, 120-130 degrees centigrade heating disinfection 30-60 minute, make solution 1;
B. with 45 ml pure waters and 0.1 gram L-carnitine, 0.1 restrains dextran-70, and boric acid, the boric acid sodium salt, and potassium chloride, sodium chloride, benzalkonium chloride, hybrid filtering is made solubilize 2;
C. the solution that A and B step are made mixes until even and becomes a phase, adds hydrochloric acid or sodium hydroxide to regulate acid-base value between the 5-8, with pure water volume is transferred to 100 milliliters, filters.
Embodiment 2:(pharmaceutical solutions)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.25 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. preparing above-mentioned composition can be with 45 ml pure waters and 0.3 gram hydroxypropyl methylcellulose stirring and dissolving, 120-130 degrees centigrade heating disinfection 30-60 minute, make solution 1;
B. with 45 ml pure waters and 0.25 gram L-carnitine, 0.1 restrains dextran-70, and boric acid, the boric acid sodium salt, and potassium chloride, sodium chloride, benzalkonium chloride, hybrid filtering is made solubilize 2;
C. the solution that A and B step are made mixes until even and becomes a phase, adds hydrochloric acid or sodium hydroxide to regulate acid-base value between the 5-8, with pure water volume is transferred to 100 milliliters, filters.
Embodiment 3:(pharmaceutical solutions)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.5 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. preparing above-mentioned composition can be with 45 ml pure waters and 0.3 gram hydroxypropyl methylcellulose stirring and dissolving, 120-130 degrees centigrade heating disinfection 30-60 minute, make solution 1;
B. with 45 ml pure waters and 0.5 gram L-carnitine, 0.1 restrains dextran-70, and boric acid, the boric acid sodium salt, and potassium chloride, sodium chloride, benzalkonium chloride, hybrid filtering is made solubilize 2;
C. the solution that A and B step are made mixes until even and becomes a phase, adds hydrochloric acid or sodium hydroxide to regulate acid-base value between the 5-8, with pure water volume is transferred to 100 milliliters, filters.
Embodiment 4:(pharmaceutical solutions)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.1 gram, benzalkonium chloride 0.005 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. preparing above-mentioned composition can be with 45 ml pure waters and 0.3 gram hydroxypropyl methylcellulose stirring and dissolving, 120-130 degrees centigrade heating disinfection 30-60 minute, make solution 1;
B. with 45 ml pure waters and 0.1 gram L-carnitine, 0.1 restrains dextran-70, and boric acid, the boric acid sodium salt, and potassium chloride, sodium chloride, benzalkonium chloride, hybrid filtering is made solubilize 2;
C. the solution that A and B step are made mixes until even and becomes a phase, adds hydrochloric acid or sodium hydroxide to regulate acid-base value between the 5-8, with pure water volume is transferred to 100 milliliters, filters.
Embodiment 5:(pharmaceutical solutions)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.25 gram, benzalkonium chloride 0.005 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. preparing above-mentioned composition can be with 45 ml pure waters and 0.3 gram hydroxypropyl methylcellulose stirring and dissolving, 120-130 degrees centigrade heating disinfection 30-60 minute, make solution 1;
B. with 45 ml pure waters and 0.25 gram L-carnitine, 0.1 restrains dextran-70, and boric acid, the boric acid sodium salt, and potassium chloride, sodium chloride, benzalkonium chloride, hybrid filtering is made solubilize 2;
C. the solution that A and B step are made mixes until even and becomes a phase, adds hydrochloric acid or sodium hydroxide to regulate acid-base value between the 5-8, with pure water volume is transferred to 100 milliliters, filters.
Embodiment 6:(pharmaceutical solutions)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.5 gram, benzalkonium chloride 0.005 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. preparing above-mentioned composition can be with 45 ml pure waters and 0.3 gram hydroxypropyl methylcellulose stirring and dissolving, 120-130 degrees centigrade heating disinfection 30-60 minute, make solution 1;
B. with 45 ml pure waters and 0.5 gram L-carnitine, 0.1 restrains dextran-70, and boric acid, the boric acid sodium salt, and potassium chloride, sodium chloride, benzalkonium chloride, hybrid filtering is made solubilize 2;
C. the solution that A and B step are made mixes until even and becomes a phase, adds hydrochloric acid or sodium hydroxide to regulate acid-base value between the 5-8, with pure water volume is transferred to 100 milliliters, filters.
Embodiment 7:(Emulsion)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.1 gram, polyvinyl alcohol 0.2 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. with boric acid, sodium borate, potassium chloride, benzalkonium chloride, dextran-70, L-carnitine and sodium chloride add in the 45 gram pure water successively, dissolve and stir to limpid; Solution filters, aseptic sterilization.
B. 45 gram pure water are heated to 90 degree, add hydroxypropyl methylcellulose and polyvinyl alcohol, be stirred to evenly; When stirring, be heated to the aseptic sterilization of 121 degree 30 to 45 minutes; Be cooled to 50 to 55 degree, add the solution of A step preparation; Continue to be stirred to room temperature, add hydrochloric acid or sodium hydroxide, volume is transferred to 100 milliliters with pure water to regulate acid-base value between the 5-8, filter aqueous emulsion.
Embodiment 8:(Emulsion)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.25 gram, polyvinyl alcohol 0.2 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. with boric acid, sodium borate, potassium chloride, benzalkonium chloride, dextran-70, L-carnitine and sodium chloride add in the 45 gram pure water successively, dissolve and stir to limpid; Solution filters, aseptic sterilization.
B. 45 gram pure water are heated to 90 degree, add hydroxypropyl methylcellulose and polyvinyl alcohol, be stirred to evenly; When stirring, be heated to the aseptic sterilization of 121 degree 30 to 45 minutes; Be cooled to 50 to 55 degree, add the solution of A step preparation; Continue to be stirred to room temperature, add hydrochloric acid or sodium hydroxide, volume is transferred to 100 milliliters with pure water to regulate acid-base value between the 5-8, filter aqueous emulsion.
Embodiment 9:(Emulsion)
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 0.3 gram, dextran-70 0.1 gram, L-carnitine 0.5 gram, polyvinyl alcohol 0.2 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. with boric acid, sodium borate, potassium chloride, benzalkonium chloride, dextran-70, L-carnitine and sodium chloride add in the 45 gram pure water successively, dissolve and stir to limpid; Solution filters, aseptic sterilization.
B. 45 gram pure water are heated to 90 degree, add hydroxypropyl methylcellulose and polyvinyl alcohol, be stirred to evenly; When stirring, be heated to the aseptic sterilization of 121 degree 30 to 45 minutes; Be cooled to 50 to 55 degree, add the solution of A step preparation; Continue to be stirred to room temperature, add hydrochloric acid or sodium hydroxide, volume is transferred to 100 milliliters with pure water to regulate acid-base value between the 5-8, filter aqueous emulsion.
The gluey agent of embodiment 10:()
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 1.0 grams, dextran-70 0.1 gram, L-carnitine 0.1 gram, polyvinyl alcohol 0.2 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. with boric acid, sodium borate, potassium chloride, benzalkonium chloride, dextran-70, L-carnitine and sodium chloride add in the 45 gram pure water successively, dissolve and stir to limpid; Solution filters, aseptic sterilization.
B. 45 gram pure water are heated to 90 degree, add hydroxypropyl methylcellulose and polyvinyl alcohol, be stirred to evenly; When stirring, be heated to the aseptic sterilization of 121 degree 30 to 45 minutes; Be cooled to 50 to 55 degree, add the solution of A step preparation; Continue to be stirred to room temperature, add hydrochloric acid or sodium hydroxide, volume is transferred to 100 milliliters, filter with pure water to regulate acid-base value between the 5-8.
The gluey agent of embodiment 11:()
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 1.0 grams, dextran-70 0.1 gram, L-carnitine 0.25 gram, polyvinyl alcohol 0.2 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. with boric acid, sodium borate, potassium chloride, benzalkonium chloride, dextran-70, L-carnitine and sodium chloride add in the 45 gram pure water successively, dissolve and stir to limpid; Solution filters, aseptic sterilization.
B. 45 gram pure water are heated to 90 degree, add hydroxypropyl methylcellulose and polyvinyl alcohol, be stirred to evenly; When stirring, be heated to the aseptic sterilization of 121 degree 30 to 45 minutes; Be cooled to 50 to 55 degree, add the solution of A step preparation; Continue to be stirred to room temperature, add hydrochloric acid or sodium hydroxide, volume is transferred to 100 milliliters, filter with pure water to regulate acid-base value between the 5-8.
The gluey agent of embodiment 12:()
The artificial tear of the present invention, in 100 milliliters, hydroxypropyl methylcellulose 1.0 grams, dextran-70 0.1 gram, L-carnitine 0.5 gram, polyvinyl alcohol 0.2 gram, benzalkonium chloride 0.01 gram, boric acid 0.7 gram, sodium borate 0.2 gram, sodium chloride 0.4 gram, potassium chloride 0.04 gram.
A. with boric acid, sodium borate, potassium chloride, benzalkonium chloride, dextran-70, L-carnitine and sodium chloride add in the 45 gram pure water successively, dissolve and stir to limpid; Solution filters, aseptic sterilization.
B. 45 gram pure water are heated to 90 degree, add hydroxypropyl methylcellulose and polyvinyl alcohol, be stirred to evenly; When stirring, be heated to the aseptic sterilization of 121 degree 30 to 45 minutes; Be cooled to 50 to 55 degree, add the solution of A step preparation; Continue to be stirred to room temperature, add hydrochloric acid or sodium hydroxide, volume is transferred to 100 milliliters, filter with pure water to regulate acid-base value between the 5-8.
Claims (12)
1. artificial tears is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 0.30-30.00 weight portion dextran-70 0.10-10 weight portion L-carnitine 0.1-50 weight portion.
2. artificial tears as claimed in claim 1 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 0.50-8 weight portion dextran-70 is a 8-8.8 weight portion L-carnitine 0.2-10 weight portion.
3. artificial tears as claimed in claim 1 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 10-18 weight portion dextran-70 0.20-2 weight portion L-carnitine 40-50 weight portion.
4. artificial tears as claimed in claim 1 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 20-28 weight portion dextran-70 is a 4-6 weight portion L-carnitine 20-30 weight portion.
5. artificial tears as claimed in claim 2 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 0.5 weight portion dextran-70 8.8 weight portion L-carnitines 0.2 weight portion.
6. artificial tears as claimed in claim 2 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 8 weight portion dextran-70s 8 weight portion L-carnitines 10 weight portions.
7. artificial tears as claimed in claim 3 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 10 weight portion dextran-70s 2 weight portion L-carnitines 40 weight portions.
8. artificial tears as claimed in claim 3 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 18 weight portion dextran-70s 0.2 weight portion L-carnitine 50 weight portions.
9. artificial tears as claimed in claim 4 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 20 weight portion dextran-70s 6 weight portion L-carnitines 20 weight portions.
10. artificial tears as claimed in claim 4 is characterized in that this artificial tears comprises the composition of following weight portion:
Hydroxypropyl methylcellulose 28 weight portion dextran-70s 4 weight portions, L-carnitine 30 weight portions.
11., it is characterized in that this artificial tears mixes with the carrier of pharmaceutically accepting, and is mixed with the preparation of clinical acceptance: gluey agent, Emulsion or pharmaceutical solutions as described any one artificial tears of claim 1-10.
12. as the application of described any one artificial tears of claim 1-10 in preparation treatment xerophthalmia medicine.
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| CN105560586B (en) * | 2014-10-09 | 2019-07-16 | 澳门大学 | A kind of artificial tears' gel composition and artificial tears' gel prepared therefrom |
| CN105030817A (en) * | 2015-06-26 | 2015-11-11 | 江西禾氏美康药业有限公司 | Bi-component compound dextran 70 eye drops and preparation method thereof |
Citations (4)
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|---|---|---|---|---|
| US6153582A (en) * | 1998-11-05 | 2000-11-28 | Bausch & Lomb Surgical, Inc. | Defined serumfree medical solution for ophthalmology |
| CN1400870A (en) * | 2000-02-04 | 2003-03-05 | 艾博特公司 | Improved pediatric formula and methods for providing nutrition and improving tolerance |
| US6761903B2 (en) * | 1999-06-30 | 2004-07-13 | Lipocine, Inc. | Clear oil-containing pharmaceutical compositions containing a therapeutic agent |
| JP2005053835A (en) * | 2003-08-04 | 2005-03-03 | Kanebo Ltd | Emulsifiable skin care preparation |
-
2006
- 2006-10-24 CN CNB2006101140103A patent/CN100463681C/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6153582A (en) * | 1998-11-05 | 2000-11-28 | Bausch & Lomb Surgical, Inc. | Defined serumfree medical solution for ophthalmology |
| US6761903B2 (en) * | 1999-06-30 | 2004-07-13 | Lipocine, Inc. | Clear oil-containing pharmaceutical compositions containing a therapeutic agent |
| CN1400870A (en) * | 2000-02-04 | 2003-03-05 | 艾博特公司 | Improved pediatric formula and methods for providing nutrition and improving tolerance |
| JP2005053835A (en) * | 2003-08-04 | 2005-03-03 | Kanebo Ltd | Emulsifiable skin care preparation |
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