CN106963770B - Eye drops for preventing and treating keratoconjunctivitis sicca and preparation method and application thereof - Google Patents
Eye drops for preventing and treating keratoconjunctivitis sicca and preparation method and application thereof Download PDFInfo
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- CN106963770B CN106963770B CN201710208392.4A CN201710208392A CN106963770B CN 106963770 B CN106963770 B CN 106963770B CN 201710208392 A CN201710208392 A CN 201710208392A CN 106963770 B CN106963770 B CN 106963770B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
Abstract
The invention relates to eye drops for preventing and treating keratoconjunctivitis sicca and a preparation method and application thereof, wherein the eye drops comprise cycloalliin, anthocyanin, dextran, hydroxypropyl methylcellulose, sodium chloride, potassium chloride, sodium borate, pH regulator and purified water. After being applied, the eye drops can supplement water for eyes, form a protective film on the surfaces of the eyes, slow down the evaporation of the water, effectively relieve the symptoms of xerophthalmia/conjunctivitis, such as dry eyes and the like, stimulate the secretion of lacrimal glands, increase the blinking times, and inhibit the secretion of inflammatory factors by the cyclic alliin, so that the clinical symptoms of the dry eyes are relieved, the xerophthalmia/conjunctivitis is fundamentally treated, and the eye drops do not contain preservatives, are safe and non-irritant to eyes, have high long-term stability, and can be widely used for preventing and treating various types of xerophthalmia/conjunctivitis.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to eye drops for preventing and treating keratoconjunctivitis sicca and a preparation method and application thereof.
Background
Dry keratoconjunctivitis, also called dry eye disease, is a general term for a group of diseases characterized by abnormal quality and quantity or dynamics of tears caused by various reasons, unstable tear film, pathological changes of ocular surface tissues and symptoms of ocular discomfort, and is one of the most common ocular diseases in the modern society, wherein the most common symptoms comprise dry and astringent feeling, foreign body sensation, asthenopia, more serious congestion of eyes and corneal epithelial exfoliation, and progressive corneal opacity and even blindness can be developed if the treatment is not timely. Factors causing keratoconjunctivitis sicca/conjunctivitis are many, and mainly include aging, excessive tear evaporation due to improper use of the eye, lacrimal gland blockage, viral infection, environmental pollution, and the like.
At present, aiming at preventing and treating the keratoconjunctivitis sicca clinically, exogenous artificial tears are supplemented, clinical symptoms of the keratoconjunctivitis sicca are relieved, or steroid hormone or nonsteroidal anti-inflammatory drug is locally used for relieving ocular surface inflammation, the treatment method can relieve part of clinical symptoms of the keratoconjunctivitis sicca to a certain extent, but only can treat symptoms and cannot treat the root causes, and even can cause dependence on exogenous eye drops, and the eye drops are stored for a long time, so that eye infection caused by the application of the eye drops is avoided, the eye drops often contain preservative, and the long-term use of the eye drops containing preservative is not only unfavorable for treating the keratoconjunctivitis sicca, and even can cause dry eyes and pain and itch, so that the clinical symptoms of the keratoconjunctivitis sicca are aggravated, and severe people can cause damage to corneal epithelium.
At present, the tear and new tear eye drops widely used clinically can supplement artificial tears exogenously, and can only slow down the evaporation of liquid on the surface of eyeballs by forming a protective film on the surface of the eyeballs, so that the tear and new tear eye drops have the treatment effect of relieving uncomfortable symptoms on the sicca/conjunctivitis, and can not treat the sicca/conjunctivitis fundamentally.
Therefore, the present application aims to develop a pharmaceutical composition for fundamentally treating keratoconjunctivitis sicca while relieving clinical discomfort thereof, and aims to develop a pharmaceutical composition for preventing and treating keratoconjunctivitis sicca, which can treat both symptoms and root causes, on the basis of the existing keratoconjunctivitis sicca treatment drugs in the field.
Disclosure of Invention
An object of the present invention is to provide an ophthalmic solution for preventing and treating keratoconjunctivitis sicca, which comprises: the composition comprises cycloalliin, anthocyanin, dextran 70, hydroxypropyl methyl cellulose, osmotic pressure regulator, pH regulator and purified water.
Preferably, the osmotic pressure regulator is selected from potassium chloride, sodium chloride or a mixture thereof, the pH regulator is selected from sodium borate, hydrochloric acid or sodium hydroxide, and the pH of the eye drop is adjusted to 7.2.
Furthermore, the eye drop contains 0.2 percent of cyclic alliin, 0.1 percent of anthocyanin, 700.2 percent of dextran and 0.2 percent of hydroxypropyl methylcellulose.
Another object of the present invention is to provide a method for preparing eye drops for preventing and treating keratoconjunctivitis sicca, comprising the steps of:
(1) weighing the raw materials of the eye drops according to the formula for later use;
(2) adding hydroxypropyl methylcellulose and dextran 70 into purified water, and stirring strongly until completely dissolved;
(3) adding anthocyanin and cycloalliin into the solution obtained in the step (2) and uniformly stirring;
(4) regulating the solution to be isotonic solution by using an osmotic pressure regulator;
(5) adjusting the pH of the solution to 7.2 by using a pH regulator;
(6) after filtering, sterilizing by irradiation, and filling aseptically to obtain the eye drop for preventing and treating keratoconjunctivitis sicca.
Still another object of the present invention is to provide use of a combination of cycloalliin, anthocyanin, dextran 70 and hydroxypropylmethylcellulose for preparing an eye drop for preventing and treating keratoconjunctivitis sicca.
Preferably, the eye drop contains 0.2% of cycloalliin, 0.1% of anthocyanin, 700.2% of dextran and 0.2% of hydroxypropyl methylcellulose.
The cycloalliin is a main component of lacrimation substances in the onions, is easy to volatilize, can cause eye stinging, stimulates eye lacrimation and winking, and the modern pharmacological research shows that the cycloalliin has the effects of resisting bacteria, hepatotoxicity, aging and the like, and can also enhance the activity of plasminogen so as to be beneficial to the dissolution of thrombus, but no report of the application of the cycloalliin in preventing and treating the keratoconjunctivitis sicca is available.
Anthocyanin, a water-soluble pigment widely existing in plants, belongs to flavonoid substances, is a powerful antioxidant, can protect the organism from being damaged by oxygen free radicals, has the effects of resisting oxidation, resisting mutation, resisting aging, regulating the immune function of the organism, preventing and treating cardiovascular and cerebrovascular diseases, protecting the liver, resisting radiation, preventing myopia, protecting and preventing eye diseases, enhancing eyesight and the like, and has been reported clinically at present for preventing and treating keratoconjunctivitis sicca.
Advantageous effects
The eye drops for preventing and treating the keratoconjunctivitis sicca can supplement moisture of eyes from the outside, form a protective film on the surface of the eyes, slow down the evaporation of the moisture, effectively relieve the symptoms of dry eyes and the like of the keratoconjunctivitis sicca, simultaneously stimulate the secretion of lacrimal glands by the combination of the cyclic alliin and the anthocyanin, increase the blinking times, inhibit the secretion of inflammatory factors by the cyclic alliin, fundamentally treat the xerophthalmia, contain no preservative, are safe and non-irritant to the eyes, have high long-term stability, and can be widely used for preventing and treating the keratoconjunctivitis sicca.
Detailed Description
The present invention is described in more detail below to facilitate an understanding of the present invention.
It should be understood that the terms or words used in the specification and claims should not be construed as having meanings defined in dictionaries, but should be interpreted as having meanings that are consistent with their meanings in the context of the present invention on the basis of the following principles: the concept of terms may be defined appropriately by the inventors for the best explanation of the invention.
Example 1: eye drops for preventing and treating keratoconjunctivitis sicca
2g of cyclic alliin;
1g of anthocyanin;
dextran 702 g;
2g of hydroxypropyl methyl cellulose;
proper amount of potassium chloride and sodium chloride;
a proper amount of pH regulator;
adding purified water to 1L;
the preparation method comprises the following steps:
(1) weighing the raw materials of the eye drops according to the formula amount for later use;
(2) adding hydroxypropyl methylcellulose and dextran 70 into purified water, and stirring strongly until completely dissolved;
(3) adding anthocyanin and cycloalliin into the solution obtained in the step (2) and uniformly stirring;
(4) regulating the solution to be isotonic solution by using potassium chloride and sodium chloride;
(5) adjusting the pH of the solution to 7.2 by using a pH regulator;
(6) filtering the solution, performing irradiation sterilization, and sterile filling to obtain the eye drop for preventing and treating keratoconjunctivitis sicca.
Comparative example 1: cycloallicin eye drops
An ophthalmic solution of cycloalliin, in which the anthocyanidin was replaced with the same amount of cycloalliin, was prepared according to the formulation and preparation method of example 1.
Comparative example 2: anthocyanin eye drops
An ophthalmic solution of cycloalliin, in which cycloalliin was replaced with an equal amount of anthocyanin, was prepared according to the formulation and preparation method of example 1.
Comparative example 3: eye drops containing cycloalliin and vitamin C
Alanine-exchanging eye drops in which anthocyanidin was replaced with an equal amount of vitamin C were prepared according to the formulation and preparation method of example 1.
Effect example 1: effect on tear secretion in clinical symptoms of Angle of dryness/conjunctivitis due to vitamin A deficiency
1.1 Experimental methods
65 New Zealand white rabbits (4 weeks old) with male and female halves and weight of 550 +/-100 g are normally bred for 2 days, and then subjected to a Schirmer test to determine the tear secretion, specifically, tear detection filter paper strips are taken, one end of each tear detection filter paper strip is folded by 5mm, the tear detection filter paper strips are placed at the position 1/3 in the middle and outer parts of the lower eyelid of the rabbit eyes, the tear detection filter paper strips are taken out after 5min to measure the wet length from the folded positions and record the wet length as the normal tear secretion, then vitamin A deficiency feed is fed for 6 months, a sicca angle/conjunctivitis model is prepared, the Schirmer test is performed after molding is completed to determine the tear secretion, 50 new Zealand white rabbits (10 mm in wet length) with the filter paper strips are selected and randomly divided into five groups, wherein 10 new Zealand white rabbits are selected, each group is specifically a blank group, an example 1 group and a comparison example 1-3 group, wherein the example 1-3 groups use corresponding eye drops, the blank group uses example 1 eye drops which do not, dripping 3 times daily for 20 days, and performing Schirmer test 24 hr after the last administration, measuring tear secretion, and calculating tear secretion increase rate, wherein the specific test results are shown in Table 1
The tear secretion increase rate is (length of wetting after administration-length of wetting before administration)/length of wetting before administration × 100%.
1.2 test results
TABLE 1 Effect on vitamin A deficiency induced tear secretion in dry horn/conjunctivitis
Note: comparison with pre-dose wet length: p < 0.01.
The experimental results in table 1 show that the amount of the tear secretion of the new zealand white rabbit is obviously reduced after being fed with the feed lacking vitamin a for 6 months, which indicates that the modeling of the dry keratoconjunctivitis of the application is successful, the new zealand white rabbit does not increase the independent tear secretion but decreases to a certain extent after the blank group without anthocyanin and cycloallic acid eye drops is applied for the last 24 hours of administration, thereby indicating that the eye drops without anthocyanin and cycloallic acid do not have the function of stimulating the tear secretion, the clinical symptoms of the dry keratoconjunctivitis can be only alleviated by applying the eye drops of the type, after the drug is stopped, the dry keratoconjunctivitis can not be cured or alleviated, and even aggravated, the amount of the independent tear secretion of the new zealand white rabbit is improved to a certain extent after the eye drops which contain the cycloallic acid, the anthocyanin or the allic acid and other antioxidant vitamin C are applied independently, in the group of example 1 to which the eye drops containing the anthocyanin and the cycloalliin of the invention are applied, after the eye drops are stopped, the autonomous tear secretion of the new zealand white rabbit is obviously increased, so that the eye drops have a treatment effect on the sicca/conjunctivitis while relieving the clinical symptoms of the sicca/conjunctivitis, and after the combination of the cycloalliin and the anthocyanin, the autonomous tear secretion of the new zealand white rabbit is obviously increased compared with the independent cycloalliin or the anthocyanin or the combination of the cycloalliin and other antioxidants such as vitamin C.
Effect example 2: effect on tear secretion in clinical symptoms of atropine-induced keratosicca/conjunctivitis
2.1 Experimental methods
20 new zealand white rabbits with 10 weeks old, half male and female, the body weight of 2300 +/-200 g, randomly divided into two groups, specifically a blank group and a group of example 1, after adaptive feeding for 2 days, a Schirmer test is carried out to determine the tear secretion, specifically, tear detection filter paper strips are taken, one end of each tear detection filter paper strip is folded by 5mm, the tear detection filter paper strips are placed at 1/3 positions outside the lower eyelid of the rabbit eyes, after 5min, the tear detection filter paper strips are taken out to measure the wet length from the folded position and record the normal tear secretion, then 1% atropine sulfate eye drops are started to be administered for 2 weeks and 3 times per day, and after 1 week of administration of the atropine sulfate eye drops, experimental medicaments are started to be administered, wherein the eye drops of example 1, which do not contain cyclallic acid and anthocyanin, are dripped on the blank group, the eye drops of example 1, are dripped on the group of example 1, the experimental medicaments are administered 2h after the atropine sulfate, the secretion of tears of atropine sulfate eye drops after 1 week of administration (1 week of molding), 5 days and 10 days of administration is determined by Schirmer test, and the specific test results are shown in Table 2.
2.2 test results
TABLE 2 Effect on tear secretion of atropine xerotic horn/conjunctivitis
Note: comparison with normal wet length: p < 0.01; comparison with blank group: # P < 0.05; # P < 0.01.
Table 2 shows that tear secretion of new zealand white rabbits is significantly reduced by the administration of atropine sulfate eye drops, and the administration of corresponding eye drops shows experimental results similar to the model of keratoconjunctivitis sicca caused by vitamin a deficiency in effect example 1, indicating that the eye drops of the present invention can be widely used for the treatment of various types of keratoconjunctivitis sicca.
In addition, after the Schirmer test is finished, the New Zealand white rabbits are killed, the right eye tissues are taken, proteins are extracted after homogenization, each histone extract is quantitatively adjusted to 4mg/ml through BCA, then IL-6 and TNF- α in the protein extract are detected by adopting an ELISA kit, and the results are shown in the following table:
TABLE 3 inhibitory Activity of Cycloallicin on inflammatory factors
Note: comparison with blank group: p < 0.05; p < 0.01.
Effect example 4: long-term stability test of the eye drops of the present invention
The eye drops for preventing and treating keratoconjunctivitis sicca of example 1 were packaged in a polyurethane bottle, placed under moderate conditions of 25 ± 2 ℃ and 60% ± 5% for 18 months, and changes in appearance, pH, active ingredient content and related substance content of the eye drops during long-term placement were examined, so as to examine the long-term stability of the eye drops of the present invention, and the specific experimental results are shown in table 4.
TABLE 4 Long-term stability of eye drops of the invention
The experimental results in table 4 show that the eye drops of the present invention have no obvious change in each index after being placed for 18 months compared with the eye drops before being placed, and the eye drops of the present invention have long-term stability.
Claims (3)
1. An eye drop for treating keratoconjunctivitis sicca, which is characterized by comprising the following raw materials: 0.2% of cycloalliin, 0.1% of anthocyanin, 0.2% of dextran 70, 0.2% of hydroxypropyl methylcellulose, an osmotic pressure regulator, a pH regulator and purified water, wherein the osmotic pressure regulator is selected from potassium chloride, sodium chloride or a mixture thereof, the pH regulator is selected from sodium borate, hydrochloric acid or sodium hydroxide, and the pH of the eye drop is adjusted to 7.2.
2. The method for preparing eye drops for treating keratoconjunctivitis sicca according to claim 1, wherein the eye drops are prepared by the steps of:
(1) weighing the raw materials of the eye drops according to the formula for later use;
(2) adding hydroxypropyl methylcellulose and dextran 70 into purified water, and stirring strongly until completely dissolved;
(3) adding anthocyanin and cycloalliin into the solution obtained in the step (2) and uniformly stirring;
(4) regulating the solution to be isotonic solution by using an osmotic pressure regulator;
(5) adjusting the pH of the solution to 7.2 by using a pH regulator;
(6) filtering, sterilizing by irradiation, and aseptically packaging.
Use of a combination of 3.0.2% cycloalliin, 0.1% anthocyanins, 0.2% dextran 70 and 0.2% hydroxypropyl methylcellulose in the preparation of an eye drop for the treatment of keratoconjunctivitis sicca.
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| CN201710208392.4A CN106963770B (en) | 2017-03-31 | 2017-03-31 | Eye drops for preventing and treating keratoconjunctivitis sicca and preparation method and application thereof |
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| CN106963770B true CN106963770B (en) | 2020-03-27 |
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| CN109956169B (en) * | 2017-12-14 | 2021-05-07 | 四川科伦药物研究院有限公司 | Dextran eye drop product with stable pH and preparation method thereof |
| CN113038932A (en) * | 2018-10-25 | 2021-06-25 | (株)纳斯摩仕 | Eye drop composition containing Aptamin C as active ingredient |
| CN112076152A (en) * | 2020-09-23 | 2020-12-15 | 江苏地韵医疗科技有限公司 | Ophthalmic composition, preparation method and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101890116A (en) * | 2010-02-11 | 2010-11-24 | 姚俊英 | Anthocyanin health-care eye drops and preparation method thereof |
| CN102871794A (en) * | 2012-10-24 | 2013-01-16 | 崔浩 | Adjustable volatile cell for ocular surface medication |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101890116A (en) * | 2010-02-11 | 2010-11-24 | 姚俊英 | Anthocyanin health-care eye drops and preparation method thereof |
| CN102871794A (en) * | 2012-10-24 | 2013-01-16 | 崔浩 | Adjustable volatile cell for ocular surface medication |
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