CN114869862A - Glaucoma surgery slow-release anti-scar membrane with drainage function and preparation method thereof - Google Patents
Glaucoma surgery slow-release anti-scar membrane with drainage function and preparation method thereof Download PDFInfo
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- 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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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61P27/06—Antiglaucoma agents or miotics
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Abstract
A glaucoma surgery slow-release anti-scar membrane with a drainage function and a preparation method thereof. Solves the problem of scar formation of the filtration channel in the existing glaucoma operation. The membrane body is integrally formed by adopting biomedical materials, a first medicine, a second medicine and a third medicine are loaded on the membrane body, and a drainage channel is arranged on the membrane body. The preparation method comprises the following steps: the method comprises the following steps: preparing bevacizumab-chitosan nanoparticles and dexamethasone-chitosan nanoparticles by using a nano-spray technology; step two: loading the bevacizumab-chitosan nanoparticles, the dexamethasone-chitosan nanoparticles and the 5-FU onto a PLGA membrane together to construct a multi-drug loaded membrane; step three: and processing a drainage channel on the multi-drug loading membrane. By applying the anti-scar membrane, the success rate of long-term operation of glaucoma trabeculectomy is improved, the visual function of innumerable late-stage glaucoma patients is saved, and the life quality of the patients is improved.
Description
Technical Field
The invention relates to a glaucoma surgery implant material, in particular to a glaucoma surgery slow-release anti-scar membrane with a drainage function and a preparation method thereof.
Background
In the 'gold standard' operation trabeculectomy of glaucoma and various drainage devices such as drainage valves, drainage nails and XEN implantation, the scarring of a filtration channel such as scleral scarring is the main reason of the operation failure, the previous researches and applications of various anti-scarring drugs such as mitomycin, 5-fluorouracil (5-FU) and the like are independently applied or combined with various biological membranes such as amniotic membrane implantation, the operation success rate is improved to a certain extent, but the clinical effect is not obvious, the failure main reason is that the anti-scarring drugs are single, the targeted treatment cannot be carried out aiming at the mechanism and time of scarring, in addition, the drug action time is short, and the anti-scarring effect is poor. The inability of aqueous humor to flow continuously as the scar forms exacerbates scarring of the filtration pathway. There is therefore a need for a device that can be loaded with drugs of different anti-scarring mechanisms, that performs different anti-scarring effects at different stages of the post-operative period, such as early anti-neovascularization, late anti-scarring, and that is slowly released to achieve effective drug concentrations and duration of action. In addition, the device has a certain aqueous humor drainage function, resists the scarring of the filtering channel and assists the formation of the filtering channel.
Disclosure of Invention
In order to solve the problem that the success of the operation is affected by the scarring of a filtering channel in the existing glaucoma operation in the background art, the invention provides a glaucoma operation slow-release anti-scarring membrane with a drainage function and a preparation method thereof.
The technical scheme of the invention is as follows: the utility model provides a take glaucoma operation slow release anti scar membrane of drainage function, includes the membrane body, the membrane body adopt biomedical material integrated into one piece, the membrane body on load have the first medicine of anti neogenesis vascular endothelial growth factor, be used for immunosuppression's second medicine and the third medicine of antimetabolite class, the membrane body on be equipped with drainage channel.
As a further improvement of the invention, the membrane body is integrally formed by adopting degradable high molecular compounds or biological materials.
As a further improvement of the invention, the membrane body is integrally molded by polylactic acid-glycolic acid, collagen, chitosan or polyesters.
As a further improvement of the invention, the first medicament is bevacizumab and/or combretacept.
As a further improvement of the invention, the second medicament is a corticosteroid hormone medicament, and the corticosteroid hormone medicament is triamcinolone acetonide or dexamethasone (dexamethasone, methylprednisolone and/or triamcinolone acetonide).
As a further improvement of the invention, the third drug is 5-FU and/or mitomycin.
As a further improvement of the invention, the drainage channel is in the form of a groove and/or a hole.
As a further improvement of the invention, the thickness of the membrane body is 100-500 um.
A preparation method of the glaucoma surgery slow-release anti-scar membrane with the drainage function comprises the following steps:
the method comprises the following steps: preparing bevacizumab-chitosan nanoparticles and dexamethasone-chitosan nanoparticles by using a nano-spray technology;
step two: loading bevacizumab-chitosan nanoparticles, dexamethasone-chitosan nanoparticles and 5-FU onto a polylactic acid-glycolic acid copolymer membrane together to construct a multi-drug loaded membrane;
step three: and processing a drainage channel on the multi-drug loading membrane.
As a further improvement of the invention, in the step one, chitosan is dissolved in 2% glacial acetic acid solution, bevacizumab and dexamethasone are added, after uniform mixing, nanoparticles are obtained by using a nano spray dryer, wherein the spray flow rate of the spray dryer is as follows: 115 ml/min; inlet temperature: 120 ℃; gas mode: air;
step two, uniformly dispersing the nanoparticles obtained in the step one in a PLGA dichloromethane solution containing tacrolimus with a certain concentration, coating the mixed solution on a heated tetrafluoroethylene substrate by using a spraying device, and fully drying to obtain a multi-drug loaded film;
in the third step, a laser is used for uniformly punching through holes on the prepared multi-medicine loading film, and the diameter of the light beam of the laser is adjusted to be 0-1000 nm.
The invention has the advantages that by applying the anti-scar membrane, the success rate of long-term operations of glaucoma trabeculectomy is improved, the visual function of innumerable patients with late-stage glaucoma is saved, and the life quality of the patients is improved.
Drawings
Fig. 1 is a schematic structural diagram of an embodiment of the present invention.
Fig. 2 is a schematic structural diagram of another embodiment of the present invention.
In the figure, 1, a membrane body; 2. a first drug; 3. a second drug; 4. a third drug; 5. a drainage channel.
Detailed Description
The embodiments of the invention will be further described with reference to the accompanying drawings in which:
the utility model provides a take glaucoma operation slow release anti scar membrane of drainage function, includes the membranous body 1, the membranous body adopt biomedical material integrated into one piece, membranous body 1 on load have anti neovascular endothelial growth factor's first medicine 2, be used for immunosuppressive second medicine 3 and the third medicine 4 of anti metabolic class, the membranous body on be equipped with drainage channel 5. The invention has the advantages that by applying the anti-scar membrane, the success rate of long-term operations of glaucoma trabeculectomy is improved, the visual function of innumerable patients with late-stage glaucoma is saved, and the life quality of the patients is improved. The invention aims to prepare the drug-loaded membrane by adopting a biodegradable high polymer material with good histocompatibility, combining a nano-medicine technology, and simultaneously loading multi-target drugs such as 5-FU (5-fluorouracil) and anti-VEGF (vascular endothelial growth factor) drugs. The formation of scars is resisted through the controllable release and the synergistic effect of the medicines, so that the side effect caused by single large-dose application of the medicines can be avoided, and the anti-scarring effect can be further achieved through mechanical separation. Meanwhile, the membrane is loaded with a nanometer micro-catheter function (drainage channel), aqueous humor can continuously flow out of eyes through the micro-catheter, and the double functions of the medicine and the micro-catheter can play a good role in resisting scars. Thereby improving the success rate of long-term operation of glaucoma trabeculectomy, saving the visual function of innumerable patients with late-stage glaucoma and improving the life quality of the patients. The invention has the advantages that by applying the anti-scar membrane, the success rate of long-term operations of glaucoma trabeculectomy is improved, the visual function of innumerable patients with late-stage glaucoma is saved, and the life quality of the patients is improved.
The membrane body is integrally formed by adopting degradable high molecular compounds or biological materials. Specifically, the membrane body is integrally formed by polylactic acid-glycolic acid, collagen, chitosan or polyesters.
The first medicine is bevacizumab and/or combretacept. Specifically, the first drug is bevacizumab or combretacept, and may be used in combination.
The second medicine is a corticosteroid hormone medicine, and the corticosteroid hormone medicine is dexamethasone, methylprednisolone and/or triamcinolone acetonide. Specifically, the corticosteroid hormone drug is dexamethasone, methylprednisolone, triamcinolone acetonide or the like, and the corticosteroid hormone drug can be used in combination.
The third medicine is 5-FU and/or mitomycin, specifically, the third medicine is 5-FU, mitomycin and the like, and can be combined for use.
The drainage channel is a groove and/or a hole. Thus, the product is convenient to process and drain, and scarring is avoided.
The thickness of the membrane body is 100-500 um.
The preparation method of the glaucoma surgery slow-release anti-scar membrane with the drainage function comprises the following steps:
the method comprises the following steps: preparing bevacizumab-chitosan nanoparticles and dexamethasone-chitosan nanoparticles by using a nano-spray technology;
step two: commonly loading bevacizumab-chitosan nanoparticles, dexamethasone-chitosan nanoparticles and 5-FU on a poly (lactic-co-glycolic acid) (PLGA) membrane to construct a multi-drug loading membrane;
step three: and processing a drainage channel on the multi-drug loading membrane. The invention aims to prepare the drug-loaded membrane by adopting a biodegradable high polymer material with good histocompatibility, combining a nano-medicine technology, and simultaneously loading multi-target drugs such as 5-FU (5-fluorouracil) and anti-VEGF (vascular endothelial growth factor) drugs. Because the drug carrier materials are different, the encapsulation states are different, and the release rates of different drugs are different, the formation of scars can be resisted through the controllable release and the synergistic effect of the drugs, so that the side effect caused by single large-dose application of the drugs can be avoided, and the anti-scarring effect can be further realized through mechanical barrier. Specifically, the controllable release of the medicine is realized by the following principles: drug carriers (materials, membrane materials and the like of the drug-loaded nanoparticles) with different performances are reasonably selected for different drugs, so that the initial release time, release rate, release period and other parameters of the different drugs are adjusted, and the release sequence, concentration and the like of the drugs at different time nodes are adjusted.
Meanwhile, the membrane is loaded with a nanometer micro-catheter function (drainage channel), aqueous humor can continuously flow out of the eye through the micro-catheter, and the double functions of the medicine and the micro-catheter can play a good role in resisting scars. Thereby improving the success rate of long-term operation of glaucoma trabeculectomy, saving the visual function of innumerable patients with late-stage glaucoma and improving the life quality of the patients.
Dissolving chitosan in a 2% glacial acetic acid solution, adding bevacizumab and dexamethasone, uniformly mixing, and obtaining nanoparticles by using a nano spray dryer, wherein the spray flow rate of the spray dryer is as follows: 115 ml/min; inlet temperature: 120 ℃; gas mode: air;
step two, uniformly dispersing the nanoparticles obtained in the step one in a PLGA dichloromethane solution (polylactic acid-glycolic acid copolymer is dissolved in dichloromethane, and the concentration is 1-30% (w/v)) containing tacrolimus (5-FU) with a certain concentration, coating the mixed solution on a heated tetrafluoroethylene substrate through a spraying device, and fully drying to obtain a multi-drug loaded film;
in the third step, a laser is used for uniformly punching through holes on the prepared multi-medicine loading film, and the diameter of the light beam of the laser is adjusted to be 0-1000 nm.
In the description of the present invention, it should be noted that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the referred apparatus or element must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.
The skilled person should understand that: although the invention has been described in terms of the above specific embodiments, the inventive concept is not limited thereto and any modification applying the inventive concept is intended to be included within the scope of the patent claims.
Claims (10)
1. The glaucoma surgery slow-release anti-scar membrane with the drainage function is characterized by comprising a membrane body, wherein the membrane body is integrally formed by adopting biomedical materials, a first medicine for resisting a new vascular endothelial growth factor, a second medicine for immunosuppression and a third medicine for resisting metabolism are loaded on the membrane body, and a drainage channel is arranged on the membrane body.
2. The glaucoma surgery slow-release anti-scar membrane with the drainage function according to claim 1, characterized in that the membrane body is integrally formed by degradable high molecular compounds or biological materials.
3. The glaucoma-surgery slow-release anti-scar membrane with the drainage function is characterized in that the membrane body is integrally formed by polylactic acid-glycolic acid, collagen, chitosan or polyesters.
4. The glaucoma surgery slow-release anti-scar membrane with the drainage function is characterized in that the first medicine is bevacizumab and/or combaici cept.
5. The glaucoma surgery slow-release anti-scar film with the drainage function is characterized in that the second medicine is a corticosteroid hormone medicine, and the corticosteroid hormone medicine is dexamethasone, methylprednisolone and/or triamcinolone acetonide.
6. The glaucoma surgery slow-release anti-scar membrane with drainage function according to claim 1, characterized in that the third drug is 5-FU and/or mitomycin.
7. The glaucoma-surgery slow-release anti-scar membrane with the drainage function according to claim 1, characterized in that the drainage channel is a groove and/or a hole.
8. The glaucoma surgery slow-release anti-scar membrane with the drainage function as claimed in claim 1, wherein the thickness of the membrane body is 100-500 um.
9. A method for preparing the glaucoma surgery slow-release anti-scar membrane with the drainage function according to any one of claims 1 to 8, which is characterized in that: the method comprises the following steps:
the method comprises the following steps: preparing bevacizumab-chitosan nanoparticles and dexamethasone-chitosan nanoparticles by using a nano-spray technology;
step two: loading bevacizumab-chitosan nanoparticles, dexamethasone-chitosan nanoparticles and 5-FU onto a polylactic acid-glycolic acid copolymer membrane together to construct a multi-drug loaded membrane;
step three: and processing a drainage channel on the multi-drug loading membrane.
10. The method of claim 9, wherein:
dissolving chitosan in a 2% glacial acetic acid solution, adding bevacizumab and dexamethasone, uniformly mixing, and obtaining nanoparticles by using a nano spray dryer, wherein the spray flow rate of the spray dryer is as follows: 115 ml/min; inlet temperature: 120 ℃; gas mode: air;
in the second step, the nanoparticles obtained in the first step are uniformly dispersed in a PLGA dichloromethane solution containing tacrolimus with a certain concentration, and the mixed solution is coated on a heated tetrafluoroethylene substrate through a spraying device, and after the mixed solution is fully dried, a multi-drug loaded film is obtained;
in the third step, a laser is used for uniformly punching through holes on the prepared multi-medicine loading film, and the diameter of the light beam of the laser is adjusted to be 0-1000 nm.
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| CN202210449952.6A CN114869862A (en) | 2022-04-24 | 2022-04-24 | Glaucoma surgery slow-release anti-scar membrane with drainage function and preparation method thereof |
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| CN202210449952.6A CN114869862A (en) | 2022-04-24 | 2022-04-24 | Glaucoma surgery slow-release anti-scar membrane with drainage function and preparation method thereof |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101417144A (en) * | 2008-11-19 | 2009-04-29 | 首都医科大学附属北京同仁医院 | Eye medicine-loaded implantation film and preparation method thereof |
| US20150250891A1 (en) * | 2012-09-06 | 2015-09-10 | Nanyang Technological University | Hyaluronic acid-based drug delivery systems |
| US20170296483A1 (en) * | 2014-09-06 | 2017-10-19 | Integral Biosystems Llc | Methods and biocompatible compositions to achieve sustained drug release in the eye |
| CN110051650A (en) * | 2019-04-29 | 2019-07-26 | 南京锐利施生物技术有限公司 | The nanoparticle pharmaceutical that bevacizumab and dexamethasone for intravitreal injection carry altogether |
| WO2021180867A1 (en) * | 2020-03-11 | 2021-09-16 | Universität Regensburg | A nanoparticle for use in the treatment of an ocular disease |
| CN113855862A (en) * | 2020-06-30 | 2021-12-31 | 四川大学华西医院 | Anti-scar membrane for glaucoma filtration surgery and material thereof |
-
2022
- 2022-04-24 CN CN202210449952.6A patent/CN114869862A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101417144A (en) * | 2008-11-19 | 2009-04-29 | 首都医科大学附属北京同仁医院 | Eye medicine-loaded implantation film and preparation method thereof |
| US20150250891A1 (en) * | 2012-09-06 | 2015-09-10 | Nanyang Technological University | Hyaluronic acid-based drug delivery systems |
| US20170296483A1 (en) * | 2014-09-06 | 2017-10-19 | Integral Biosystems Llc | Methods and biocompatible compositions to achieve sustained drug release in the eye |
| CN110051650A (en) * | 2019-04-29 | 2019-07-26 | 南京锐利施生物技术有限公司 | The nanoparticle pharmaceutical that bevacizumab and dexamethasone for intravitreal injection carry altogether |
| WO2021180867A1 (en) * | 2020-03-11 | 2021-09-16 | Universität Regensburg | A nanoparticle for use in the treatment of an ocular disease |
| CN113855862A (en) * | 2020-06-30 | 2021-12-31 | 四川大学华西医院 | Anti-scar membrane for glaucoma filtration surgery and material thereof |
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