CN107137698A - A kind of being used for comprising GDNF treats the pharmaceutical composition of corneal epithelial wound - Google Patents
A kind of being used for comprising GDNF treats the pharmaceutical composition of corneal epithelial wound Download PDFInfo
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- CN107137698A CN107137698A CN201710217006.8A CN201710217006A CN107137698A CN 107137698 A CN107137698 A CN 107137698A CN 201710217006 A CN201710217006 A CN 201710217006A CN 107137698 A CN107137698 A CN 107137698A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/185—Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
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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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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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
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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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- 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
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- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
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Abstract
The invention discloses a kind of being used for comprising GDNF treat the pharmaceutical composition of corneal epithelial wound, described pharmaceutical composition contains GDNF (preferably people source), and preferably also containing OPG (preferably people source).The pharmaceutical composition (being preferably the form of eye drops) of the present invention can not only promote limbal stem cell to breed and clonality, the injury repair of corneal epithelium can also be effectively facilitated, includes reparation, the treatment of diabetes keratopathy, the treatment of nerve keratitis, the treatment of limbal stem cell deficiencies of persistent corneal epithelial damage.
Description
Technical field
The present invention relates to pharmaceutical technology field, and in particular to it (is preferably diabetes that one kind, which is used to treat corneal epithelial wound,
The corneal epithelial wound of induction) pharmaceutical composition.
Background technology
Transparent and function the complete structure depending on each layer tissue of cornea of cornea is normal with metabolism, and positioned at outermost
The corneal epithelial tissue of layer undoubtedly plays considerable effect to this.Various physical damnifications, chemical damage, mechanical damage, disease
Pathogenic microorganism, endocrine and immune sexual factor can cause corneal epithelial wound.Corneal epithelium is that the extraneous virulence factor of defence is invaded
The physical barriers of criminal, the maintenance of its integrality depends on the iuntercellular of epithelial cell, the close connection between cell and basilar memebrane
With grappling connection and the continuous self-renewing of epithelial cell.Corneal epithelium is impaired can to influence intercellular connection, cause cell
The permeability and selectivity of film change, so as to influence its barrier function, cause cornea easily to be encroached on by extraneous virulence factor
Cause inflammation to cause the opacity of the cornea, or even cause blindness.Persistent corneal epithelial damage is made due to normal complete epithelial barrier
With destroyed, pathogenic microorganism can be caused easily to pass through in bowman's lamina, intrusion cornea essential layer, cause Corneal inflammation, cornea
Matrix is muddy, and collagen melts to form ulcer of the cornea, perforation of cornea, or even eyeball is lost, and consequence is serious.
At present, persistent corneal epithelial damage traditional therapy includes：Tear substitute, contact lens, eyelid seam
Art, growth factor, autoserum etc. are closed, therapeutic effect is not good.
The glial derived neurotrophic factor (GDNF) is a kind of important neurotrophic factor, patent document
96198645.X discloses one kind gdnf protein product treatment retinal ganglial cells damage, and (especially glaucoma is related
Optic nerve injury) method.OPG (osteoprotegerin) is generally used for treating osteoporosis.But do not see also containing GDNF and OPG combinations
It is exclusively used in the report of repairing corneal epithelial damage.
The content of the invention
The present invention provides a kind of pharmaceutical composition for being used to treat corneal epithelial wound, and described pharmaceutical composition includes
GDNF and OPG.
It is preferred that, GDNF content is 0.001-1wt% in described pharmaceutical composition；
It is preferred that, OPG content is 0.001-0.1wt% in described pharmaceutical composition；
It is preferred that, described GDNF is mouse source GDNF or people source GDNF, is more preferably people source GDNF；
In a preferred embodiment of the invention, the people source GDNF is that people recombinates GDNF.
It is preferred that, described OPG is mouse source OPG or people source OPG, is more preferably people source OPG；
In a preferred embodiment of the invention, the people source OPG is that people recombinates OPG.
It is preferred that, aforementioned pharmaceutical compositions can be prepared into through local administration, gastrointestinal administration or parenteral administration
Various preparations；Described local administration preparation is the preparation by dosing eyes, such as：Eye drops, injection, powder-injection, eye ointment
Agent, emulsion, liposome, microcapsules, gel, implant, inserting agent, ocular inserts, inclusion eye drops and other can be used for eye
The formulation of portion's administration；Described parenterals are suitable intravenous injection, intramuscular injection, hypodermic injection, marrow note
Penetrate, the formulation such as cutaneous penetration, mucosa delivery, inhalation；
In a preferred embodiment of the invention, described pharmaceutical composition is the preparation of dosing eyes, preferably is selected from：Drop
Eye agent, Eye ointments, gel and ocular inserts.
When the pharmaceutical composition of the invention for treating xerophthalmia is a kind of ophthalmic solution, it is provided as any use
It is (such as aqueous ophthalmic solution, aqueous suspension ophthalmic solution, sticky ophthalmically acceptable for example, a kind of aqueous eye drops in the formulation of ophthalmic solution
Ophthalmic solution etc. of solution, solubilising) or a kind of non-aqueous eye drops (such as non-aqueous ophthalmic solution and non-aqueous suspension are ophthalmically acceptable molten
Liquid).
It is preferred that, described pharmaceutical composition is aqueous eye drops, wherein, GDNF content is 1ng/ml-1000 μ g/
Ml, preferably 10-5000ng/ml, more preferably 100-1000ng/ml；And/or, OPG content is 1ng/ml-100ng/ml,
Preferably 10-50ng/ml；
It is preferred that, pharmaceutically acceptable additive is also included in aforementioned pharmaceutical compositions；
It is preferred that, described additive is selected from：Bacteriostatic agent, pH adjusting agent, osmotic pressure regulator, solubilizer (stabilizer),
One or more in thickener, chelating agent etc.；
It is preferred that, described bacteriostatic agent includes but is not limited to：Thimerosal, quaternary ammonium salt, Domiphen, chlorohexidene, trichlorine uncle
One or more combinations in butanol, parabens, sorbic acid；It is preferred that, described quaternary ammonium salt bacteriostatic agent such as benzene pricks chlorine
Ammonium, benzalkonium bromide, parabens such as ethyl hydroxy benzoate etc.；
It is preferred that, antiseptic content is 0.001-1.0% in described pharmaceutical composition；
It is preferred that, the pH adjusting agent includes but is not limited to：Phosphate, acetate, citric acid and its salt, carbonate are molten
One or more in liquid, sodium hydroxide, potassium hydroxide, hydrochloric acid, boric acid, phosphoric acid etc.；
It is preferred that, pH is 5.5-7.5 in described pharmaceutical composition；
It is preferred that, described osmotic pressure regulator includes but is not limited to：It is carbohydrate (such as sorbierite, glucose, mannitol), many
First alcohols (such as glycerine, polyethylene glycol, polypropylene glycol), salt such as sodium chloride；
It is preferred that, described solubilizer includes but is not limited to：Cyclodextrin and its derivative, water-soluble polymer (such as poly- second
Alkene pyrrolidone), surfactant (such as polysorbate80, trade name：Tween 80)；
It is preferred that, described thickener is selected from：Methylcellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose hydroxyl second
The one or more of base cellulose, hydroxypropyl cellulose and its esters；
It is preferred that, described chelating agent includes but is not limited to：Edetate sodium, sodium citrate, Vitrafos.
In one embodiment of the invention, described pharmaceutical composition is gel for eye use, ophthalmic ointment, wherein also including base
Matter compound；
It is preferred that, described ointment bases includes vegetable oil, animal tallow, and the semisolid hydrocarbons obtained from oil, such as：
Lanolin, vaseline, atoleine, mineral oil etc.；
It is preferred that, described gel-type vehicle compound is that biocompatibility is good, can form the polymer substance of gel,
Such as：Poloxamer, gellan gum, chitosan, sodium alginate, Sodium Hyaluronate, hydroxypropyl methylcellulose, xanthans, carbomer etc.；
It is preferred that, the preparation of aforementioned pharmaceutical compositions includes ordinary preparation, controlled release preparation, targeting preparation etc..
Above-mentioned Pharmaceutical composition can also be cooperateed with other known corneal epithelial wound treatment method and/or therapeutic agent to be made
With another aspect of the present invention provides a kind of synergistic pharmaceutical combination treated and/or prevent corneal epithelial wound, including above-mentioned medicine
Compositions and corneal epithelial wound therapeutic agent.
It is preferred that, described corneal epithelial wound includes persistent corneal epithelial damage, diabetes keratopathy, nerve
Keratitis, limbal stem cell deficiencies.
Another aspect of the present invention also provides a kind of contact lenses, and it includes, carries or be connected with aforementioned pharmaceutical compositions,
Patient can reach the purpose of drug treatment by wearing the contact lenses.
The pharmaceutical composition that the present invention is provided can not only promote limbal stem cell to breed and clonality, moreover it is possible to have
Effect promotes the injury repair of corneal epithelium, including the reparation of persistent corneal epithelial damage, the treating of diabetes keratopathy, god
The treatment for the treatment of, limbal stem cell deficiencies through property keratitis.And in the pharmaceutical composition that provides of the present invention, GDNF and
The preferred people sources of OPG, adverse reaction is small, is greatly improved the compliance of patient.
Embodiment
Active principle is present with an effective dose in the pharmaceutical composition of the present invention.As used herein, the term
" effective dose " refers to a kind of value, is enough to treat (therapeutically or preventative when it is given with an appropriate dosage regimen
Ground) this target imbalance.For example, an effective dose is enough to reduce or improves the order of severity of the treated imbalance, continues
Time or progress, prevent the propulsion of the treated imbalance, cause the degeneration or enhancing of the treated imbalance or improve another
A kind of preventative or curative effect of therapy.
Term " treatment " includes therapeutic treatment and preventative process (possibility for lowering development).The term refers to drop
Development that is low, suppressing, weaken, reduce, stop or stablize a kind of disease (such as disease or illness described here) or progress, subtract
The seriousness of the light disease improves the symptom related to the disease.
Another embodiment of the invention is related to the medicine in a kind of swab or sponge that can be used for eye surface
Compositions.
Below in conjunction with the embodiment of the present invention, technical scheme is clearly and completely described, it is clear that institute
The embodiment of description is only a part of embodiment of the invention, rather than whole embodiments.Based on the embodiment in the present invention, sheet
The every other embodiment that field those of ordinary skill is obtained under the premise of creative work is not made, belongs to the present invention
The scope of protection.
GDNF and OPG used of the invention can be commercially available, can also be extracted according to disclosed method in the prior art, such as from hero
Property the tissue such as mouse, Human plactnta in extract, or prepared according to disclosed method in the prior art, as can be by genetic engineering
Prepared by method, or using the medicine substitute of GDNF or OPG disclosed in prior art, it does not limit the scope of the invention, to the greatest extent
It is people's restructuring GDNF and OPG to manage GDNF and OPG used in following embodiments.
The eye drops of embodiment 1
Eye drops is prepared according to preparation method known in the art, its key component and content are as follows：
The eye drops of embodiment 2
Eye drops is prepared according to preparation method known in the art, its key component and content are as follows：
The eye drops of embodiment 3
Eye drops is prepared according to preparation method known in the art, its key component and content are as follows：
The eye drops of embodiment 4
Eye drops is prepared according to preparation method known in the art, its key component and content are as follows：
The gel for eye use of embodiment 5
Gel for eye use is prepared according to preparation method known in the art, its key component and content are as follows：
The ophthalmically acceptable paste of embodiment 6
Ophthalmically acceptable paste is prepared according to preparation method known in the art, its key component and content are as follows：
The ocular inserts of embodiment 7
Ocular inserts is prepared according to preparation method known in the art, its key component and content are as follows：
The test of pesticide effectiveness of embodiment 8
1. normal cornea epithelial damage repairing test
1.1 experiment materials and condition
Given the test agent：Eye drops prepared by embodiment 1-4；
Comparative sample：Eliminate eye drops prepared by OPG embodiment 1-4；
Control sample：Physiological saline；
Experimental animal：C57BL/6 mouse, 6-8 week old.
1.2 experimental method
The epithelium in the 3mm regions of mouse cornea of right eye center is struck off using 3mm trepans and epithelium scraper, is administered.Using glimmering
Taken a picture under light element sodium dyeing and slit-lamp, the epithelial damage of observation mouse repairs situation.
1.3 experimental result
As a result show, compared with control sample, given the test agent and comparative sample can effectively facilitate corneal epithelial wound
Repair, but the repairing effect of test sample group is significantly better than comparative sample group.
2. the diabetes corneal epithelial wound repairing test of STZ inductions
2.1 experiment materials and condition
Given the test agent：Eye drops prepared by embodiment 1-4；
Comparative sample：Eliminate eye drops prepared by OPG embodiment 1-4；
Control sample：Physiological saline；
Experimental animal：The C57BL/6 diabetic mices of STZ inductions, 6-8 week old.
2.2 experimental method
The epithelium in the 3mm regions of mouse cornea of right eye center is struck off using 3mm trepans and epithelium scraper, is administered.Using glimmering
Taken a picture under light element sodium dyeing and slit-lamp, the epithelial damage of observation mouse repairs situation.
2.3 experimental result
As a result show, compared with control sample, given the test agent and comparative sample can effectively facilitate the glycosuria of STZ inductions
Sick corneal epithelial wound reparation, but the repairing effect of test sample group is significantly better than comparative sample group.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
God is with principle, and any modification, equivalent substitution for being made etc. should be included in the scope of the protection.
Claims (10)
1. a kind of pharmaceutical composition for being used to treating and/or preventing corneal epithelial wound, described pharmaceutical composition includes
GDNF, and preferably, the pharmaceutical composition also contains OPG.
2. pharmaceutical composition as claimed in claim 1, it is characterised in that described GDNF is mouse source GDNF or people source GDNF；
And/or, described OPG is mouse source OPG or people source OPG.
3. pharmaceutical composition as claimed in claim 1, it is characterised in that described people source GDNF is that people recombinates GDNF；With/
Or, described people source OPG is that people recombinates OPG.
4. pharmaceutical composition as claimed in claim 1, it is characterised in that described pharmaceutical composition is local administration, stomach and intestine
The preparation of canal drug administration or parenteral administration.
5. pharmaceutical composition as claimed in claim 4, it is characterised in that described pharmaceutical composition is the system of dosing eyes
Agent, preferably is selected from：Eye drops, Eye ointments, gel and ocular inserts.
6. pharmaceutical composition as claimed in claim 5, it is characterised in that described pharmaceutical composition is ophthalmic solution, including
Aqueous eye drops and non-aqueous eye drops.
7. pharmaceutical composition as claimed in claim 6, it is characterised in that described pharmaceutical composition is aqueous eye drops, its
In, GDNF content is 1ng/ml-1000 μ g/ml, more preferably preferably 10-5000ng/ml, 100-1000ng/ml；With/
Or, OPG content is 1ng/ml-100ng/ml, preferably 10-50ng/ml.
8. the pharmaceutical composition as described in claim any one of 1-7, it is characterised in that also include in described pharmaceutical composition
Pharmaceutically acceptable additive；
It is preferred that, described additive is selected from：Bacteriostatic agent, pH adjusting agent, osmotic pressure regulator, solubilizer, thickener and chelating
One or more in agent；
It is preferred that, described bacteriostatic agent is selected from：Thimerosal, quaternary ammonium salt, Domiphen, chlorohexidene, anesin, parabens
With the one or more in sorbic acid；
It is preferred that, antiseptic content is 0.001-1.0wt% in described pharmaceutical composition；
It is preferred that, the pH adjusting agent is selected from：Phosphate, acetate, citric acid and its salt, carbonate solution, sodium hydroxide, hydrogen
One or more in potassium oxide, hydrochloric acid, boric acid and phosphoric acid；
It is preferred that, described osmotic pressure regulator is selected from：One or more in carbohydrate, polyalcohols and salt；
It is preferred that, described solubilizer is selected from：One kind in cyclodextrin and its derivative, water-soluble polymer and surfactant
Or it is a variety of；
It is preferred that, described thickener is selected from：Methylcellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose, ethoxy are fine
One or more in dimension element, hydroxypropyl cellulose and its esters；
It is preferred that, described chelating agent is selected from：One or more in edetate sodium, sodium citrate and Vitrafos.
OPG is being prepared for treating corneal epithelial wound (being preferably fro diabetic corneal epithelial wound) 9.GDNF alone or in combination
Medicine in purposes.
10. purposes as claimed in claim 9, wherein the medicine is eye drops.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710122832 | 2017-03-03 | ||
| CN2017101228324 | 2017-03-03 |
Publications (1)
| Publication Number | Publication Date |
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| CN107137698A true CN107137698A (en) | 2017-09-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201710217006.8A Pending CN107137698A (en) | 2017-03-03 | 2017-04-05 | A kind of being used for comprising GDNF treats the pharmaceutical composition of corneal epithelial wound |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108379558A (en) * | 2018-05-28 | 2018-08-10 | 暨南大学 | Application of the interleukin 22 in the drug for preparing treatment persistent corneal epithelial defects |
| CN111317814A (en) * | 2020-04-23 | 2020-06-23 | 中国中医科学院眼科医院 | Borneol and neurotrophic factor combined composition and application |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6537808B2 (en) * | 1997-04-24 | 2003-03-25 | Anabasis S.R.L. | Use of nerve growth factor for the storage, culture or treatment of cornea |
| US20030166537A1 (en) * | 1999-10-29 | 2003-09-04 | Biopharm Gesellschaft Zur Biotechnologischen Entwicklung Von Pharmaka Mbh | Use of GDNF for treating corneal defects |
-
2017
- 2017-04-05 CN CN201710217006.8A patent/CN107137698A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6537808B2 (en) * | 1997-04-24 | 2003-03-25 | Anabasis S.R.L. | Use of nerve growth factor for the storage, culture or treatment of cornea |
| US20030166537A1 (en) * | 1999-10-29 | 2003-09-04 | Biopharm Gesellschaft Zur Biotechnologischen Entwicklung Von Pharmaka Mbh | Use of GDNF for treating corneal defects |
Non-Patent Citations (3)
| Title |
|---|
| 《 TRENDS IN ENDOCRINOLOGY AND METABOLISM》 * |
| 《BIOMED RES INT.》 * |
| 《INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108379558A (en) * | 2018-05-28 | 2018-08-10 | 暨南大学 | Application of the interleukin 22 in the drug for preparing treatment persistent corneal epithelial defects |
| CN111317814A (en) * | 2020-04-23 | 2020-06-23 | 中国中医科学院眼科医院 | Borneol and neurotrophic factor combined composition and application |
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