CN113413484A - Implant material for human soft tissue filling - Google Patents
Implant material for human soft tissue filling Download PDFInfo
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- CN113413484A CN113413484A CN202110684146.2A CN202110684146A CN113413484A CN 113413484 A CN113413484 A CN 113413484A CN 202110684146 A CN202110684146 A CN 202110684146A CN 113413484 A CN113413484 A CN 113413484A
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- implant material
- sodium hyaluronate
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- soft tissue
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- 239000007943 implant Substances 0.000 title claims abstract description 58
- 239000000463 material Substances 0.000 title claims abstract description 49
- 210000004872 soft tissue Anatomy 0.000 title claims abstract description 42
- 238000011049 filling Methods 0.000 title abstract description 35
- 229920002385 Sodium hyaluronate Polymers 0.000 claims abstract description 58
- 229940010747 sodium hyaluronate Drugs 0.000 claims abstract description 58
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims abstract description 58
- 230000000975 bioactive effect Effects 0.000 claims abstract description 26
- 229910052909 inorganic silicate Inorganic materials 0.000 claims abstract description 26
- 238000000034 method Methods 0.000 claims abstract description 24
- 239000002245 particle Substances 0.000 claims abstract description 21
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims abstract description 18
- 229960003957 dexamethasone Drugs 0.000 claims abstract description 18
- 229960004393 lidocaine hydrochloride Drugs 0.000 claims abstract description 18
- YECIFGHRMFEPJK-UHFFFAOYSA-N lidocaine hydrochloride monohydrate Chemical compound O.[Cl-].CC[NH+](CC)CC(=O)NC1=C(C)C=CC=C1C YECIFGHRMFEPJK-UHFFFAOYSA-N 0.000 claims abstract description 18
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 42
- 238000010438 heat treatment Methods 0.000 claims description 28
- DLYUQMMRRRQYAE-UHFFFAOYSA-N tetraphosphorus decaoxide Chemical compound O1P(O2)(=O)OP3(=O)OP1(=O)OP2(=O)O3 DLYUQMMRRRQYAE-UHFFFAOYSA-N 0.000 claims description 25
- BRPQOXSCLDDYGP-UHFFFAOYSA-N calcium oxide Chemical compound [O-2].[Ca+2] BRPQOXSCLDDYGP-UHFFFAOYSA-N 0.000 claims description 21
- 239000000292 calcium oxide Substances 0.000 claims description 21
- ODINCKMPIJJUCX-UHFFFAOYSA-N calcium oxide Inorganic materials [Ca]=O ODINCKMPIJJUCX-UHFFFAOYSA-N 0.000 claims description 21
- 239000000377 silicon dioxide Substances 0.000 claims description 21
- KKCBUQHMOMHUOY-UHFFFAOYSA-N sodium oxide Chemical compound [O-2].[Na+].[Na+] KKCBUQHMOMHUOY-UHFFFAOYSA-N 0.000 claims description 21
- 229910001948 sodium oxide Inorganic materials 0.000 claims description 21
- 235000012239 silicon dioxide Nutrition 0.000 claims description 20
- 239000000243 solution Substances 0.000 claims description 17
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 16
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 12
- 239000003431 cross linking reagent Substances 0.000 claims description 12
- 238000002156 mixing Methods 0.000 claims description 11
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims description 8
- 229910052697 platinum Inorganic materials 0.000 claims description 8
- 238000001816 cooling Methods 0.000 claims description 5
- 239000002504 physiological saline solution Substances 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 230000001954 sterilising effect Effects 0.000 claims description 5
- 238000004659 sterilization and disinfection Methods 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 5
- SHKUUQIDMUMQQK-UHFFFAOYSA-N 2-[4-(oxiran-2-ylmethoxy)butoxymethyl]oxirane Chemical group C1OC1COCCCCOCC1CO1 SHKUUQIDMUMQQK-UHFFFAOYSA-N 0.000 claims description 4
- 239000008055 phosphate buffer solution Substances 0.000 claims description 4
- AFOSIXZFDONLBT-UHFFFAOYSA-N divinyl sulfone Chemical compound C=CS(=O)(=O)C=C AFOSIXZFDONLBT-UHFFFAOYSA-N 0.000 claims description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-N carbonic acid Chemical compound OC(O)=O BVKZGUZCCUSVTD-UHFFFAOYSA-N 0.000 claims description 2
- 230000003416 augmentation Effects 0.000 claims 10
- 230000015556 catabolic process Effects 0.000 abstract description 9
- 238000006731 degradation reaction Methods 0.000 abstract description 9
- 230000000694 effects Effects 0.000 abstract description 5
- 238000006073 displacement reaction Methods 0.000 abstract description 3
- 150000001875 compounds Chemical class 0.000 abstract description 2
- 239000003814 drug Substances 0.000 abstract description 2
- 238000002513 implantation Methods 0.000 abstract description 2
- 238000002347 injection Methods 0.000 abstract description 2
- 239000007924 injection Substances 0.000 abstract description 2
- 239000012567 medical material Substances 0.000 abstract description 2
- 230000000704 physical effect Effects 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 18
- YWEUIGNSBFLMFL-UHFFFAOYSA-N diphosphonate Chemical compound O=P(=O)OP(=O)=O YWEUIGNSBFLMFL-UHFFFAOYSA-N 0.000 description 17
- 238000002360 preparation method Methods 0.000 description 7
- 238000000498 ball milling Methods 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- 238000010791 quenching Methods 0.000 description 6
- 230000000171 quenching effect Effects 0.000 description 6
- 238000012216 screening Methods 0.000 description 6
- 238000007792 addition Methods 0.000 description 5
- 238000004132 cross linking Methods 0.000 description 3
- 102000008186 Collagen Human genes 0.000 description 2
- 108010035532 Collagen Proteins 0.000 description 2
- 229920001436 collagen Polymers 0.000 description 2
- 238000002316 cosmetic surgery Methods 0.000 description 2
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 description 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 108010003272 Hyaluronate lyase Proteins 0.000 description 1
- 102000001974 Hyaluronidases Human genes 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- FXHOOIRPVKKKFG-UHFFFAOYSA-N N,N-Dimethylacetamide Chemical compound CN(C)C(C)=O FXHOOIRPVKKKFG-UHFFFAOYSA-N 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- 150000001718 carbodiimides Chemical class 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 229920002674 hyaluronan Polymers 0.000 description 1
- 229960003160 hyaluronic acid Drugs 0.000 description 1
- 229960002773 hyaluronidase Drugs 0.000 description 1
- 229910000041 hydrogen chloride Inorganic materials 0.000 description 1
- IXCSERBJSXMMFS-UHFFFAOYSA-N hydrogen chloride Substances Cl.Cl IXCSERBJSXMMFS-UHFFFAOYSA-N 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229920002401 polyacrylamide Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/402—Anaestetics, analgesics, e.g. lidocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/43—Hormones, e.g. dexamethasone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to the technical field of medical materials, in particular to an implant material for filling human soft tissues. Aiming at the problems of high degradation speed, easy displacement, incapability of well keeping the filling effect and repeated injection and filling for many times in the prior art, the invention provides an implant material for filling human soft tissues, which comprises sodium hyaluronate, bioactive inorganic silicate, lidocaine hydrochloride and dexamethasone. The invention constructs a method which takes the cross-linked sodium hyaluronate gel as an implantation carrier, compounds the components of the bioactive inorganic silicate particles, is matched with medicaments such as lidocaine hydrochloride, dexamethasone and the like to be injected into collapsed soft tissues to be filled, recovers the collapsed soft tissues of a patient, can greatly prolong the degradation time through the physical properties and excellent biocompatibility of the cross-linked sodium hyaluronate and the bioactive inorganic silicate particles, is 5-8 times of the degradation time of the sodium hyaluronate gel in the prior art, and can keep the filling effect for a long time.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to an implant material for filling human soft tissues.
Background
The materials used in the field of soft tissue filling such as animal collagen, recombinant collagen, sodium hyaluronate gel and the like have good effects, but still have the problems of high degradation speed, easy displacement, poor filling effect maintenance and repeated injection and filling, thereby increasing the medical operation cost of patients and wasting a large amount of time cost of medical care personnel and patients.
For example, the chinese patent application discloses a soft tissue filling material and a method for preparing the same [ application No.: 201510308687.X ], the invention application comprises 36-51 parts of polyvinyl alcohol, 12-28 parts of polyacrylamide, 13-23 parts of hyaluronic acid, 3-11 parts of sodium sulfite, 2-9 parts of BBP, 9-17 parts of dimethylacetamide, 1-14 parts of polyvinylpyrrolidone and 3-13 parts of carbodiimide.
The application of the invention has good biocompatibility and is suitable for soft tissue filling in the cosmetic and plastic surgery, such as face wrinkle removal and depression filling, but the invention still does not solve the problems.
Disclosure of Invention
The invention aims to solve the problems and provides an implant material which is not easy to degrade and displace and can be used for filling human soft tissues.
In order to achieve the purpose, the invention adopts the following technical scheme:
an implant material for human soft tissue filling comprises sodium hyaluronate, bioactive inorganic silicate, lidocaine hydrochloride and dexamethasone.
In the above implant material for human soft tissue filling, the sodium hyaluronate is a cross-linked sodium hyaluronate gel.
In the above implant material for human soft tissue filling, the bioactive inorganic silicate comprises silica, sodium oxide, calcium oxide and phosphorus pentoxide.
In the implant material for filling the human soft tissue, the implant material comprises, by mass, 20-50 parts of cross-linked sodium hyaluronate gel, 14-24 parts of silicon dioxide, 8-13 parts of sodium oxide, 5-18 parts of calcium oxide, 1-4 parts of phosphorus pentoxide, 0.3-3 parts of lidocaine hydrochloride and 0.75-3 parts of dexamethasone.
In the implant material for human soft tissue filling, the implant material comprises 35 parts by mass of cross-linked sodium hyaluronate gel, 19 parts by mass of silicon dioxide, 10 parts by mass of sodium oxide, 12 parts by mass of calcium oxide, 2.5 parts by mass of phosphorus pentoxide, 1.5 parts by mass of lidocaine hydrochloride and 2 parts by mass of dexamethasone.
In the above implant material for human soft tissue filling, the crosslinked sodium hyaluronate gel is prepared by the following steps: mixing sodium hyaluronate powder with physiological saline 1: 15-20, adding an acid-base regulator to adjust the pH value of the solution to 8-10, adding a cross-linking agent, slowly stirring and heating to 60-80 ℃, continuing for 5-12 hours, cooling to room temperature, adding a phosphate buffer solution to purify the product for 12-24 hours, granulating by using a granulating device, controlling the particle size to be between 100 and 300 mu m, subpackaging, and performing wet heat sterilization to obtain the cross-linked sodium hyaluronate gel.
In the above implant material for human soft tissue filling, the pH regulator comprises KOH, NaOH, HCl and H2CO3。
In the implant material for filling human soft tissue, the cross-linking agent is 1, 4-butanediol diglycidyl ether or divinyl sulfone, and the addition amount of the cross-linking agent is 1-5% of the mass of the sodium hyaluronate solution.
In the above implant material for human soft tissue filling, the bioactive inorganic silicate is prepared by the following method: adding silicon dioxide, sodium oxide, calcium oxide and phosphorus pentoxide into a platinum crucible according to a proportion, heating to 1300-.
In the above-mentioned implant material for human soft tissue filling, the heating method is multi-stage high temperature heating.
Compared with the prior art, the invention has the advantages that:
1. the invention constructs a method which takes the cross-linked sodium hyaluronate gel as an implantation carrier, compounds the components of the bioactive inorganic silicate particles, is matched with medicaments such as lidocaine hydrochloride, dexamethasone and the like to be injected into collapsed soft tissues to be filled, recovers the collapsed soft tissues of a patient, can greatly prolong the degradation time through the physical properties and excellent biocompatibility of the cross-linked sodium hyaluronate and the bioactive inorganic silicate particles, is 5-8 times of the degradation time of the sodium hyaluronate gel in the prior art, and can keep the filling effect for a long time.
2. The invention has the advantages of simple and easily obtained raw materials and lower production cost.
Detailed Description
The present invention will be described in further detail with reference to specific embodiments.
Example 1
The embodiment provides an implant material for human soft tissue filling, which comprises 50 parts by mass of cross-linked sodium hyaluronate gel, 14 parts by mass of silicon dioxide, 8 parts by mass of sodium oxide, 5 parts by mass of calcium oxide, 1 part by mass of phosphorus pentoxide, 0.3 part by mass of lidocaine hydrochloride and 0.75 part by mass of dexamethasone.
Wherein the crosslinked sodium hyaluronate gel is prepared by the following method: mixing sodium hyaluronate powder with physiological saline 1: 18 to obtain a sodium hyaluronate solution, adding sodium hydroxide to adjust the pH value of the solution to 9, then adding a cross-linking agent 1, 4-butanediol diglycidyl ether, wherein the addition amount of the cross-linking agent is 3% of the mass of the sodium hyaluronate solution, slowly stirring and heating to 70 ℃, cooling to room temperature after 8 hours, then crosslinking the sodium hyaluronate solution to a gel state, adding a phosphate buffer solution to purify the product for 18 hours, granulating by using a granulating device, controlling the particle size to be between 100 and 300 mu m, subpackaging, and performing moist heat sterilization to obtain the cross-linked sodium hyaluronate gel.
The bioactive inorganic silicate is prepared by the following method: adding silicon dioxide, sodium oxide, calcium oxide and phosphorus pentoxide into a platinum crucible according to the proportion, heating to 1400 ℃ through multistage heating and multistage high temperature heating, screening out particles with the particle diameters of 80-200um, 200-550um and 550-710um after quenching and ball milling, and mixing the three according to the mass fractions of 10%, 80% and 10% to obtain the bioactive inorganic silicate.
Example 2
The embodiment provides an implant material for human soft tissue filling, which comprises 20 parts by mass of crosslinked sodium hyaluronate gel, 24 parts by mass of silicon dioxide, 13 parts by mass of sodium oxide, 18 parts by mass of calcium oxide, 4 parts by mass of phosphorus pentoxide, 3 parts by mass of lidocaine hydrochloride and 3 parts by mass of dexamethasone.
Wherein the crosslinked sodium hyaluronate gel is prepared by the following method: mixing sodium hyaluronate powder with physiological saline 1: 20 to obtain a sodium hyaluronate solution, adding potassium hydroxide to adjust the pH value of the solution to 10, then adding a cross-linking agent divinyl sulfone, wherein the addition amount of the cross-linking agent is 5% of the mass of the sodium hyaluronate solution, slowly stirring and heating to 80 ℃, cooling to room temperature after 12 hours, then crosslinking the sodium hyaluronate solution into a gel state, adding a phosphate buffer solution to purify the product for 12 hours, granulating by a granulating device, controlling the particle size to be between 100 and 300 mu m, and performing moist heat sterilization after subpackaging to obtain the cross-linked sodium hyaluronate gel.
The bioactive inorganic silicate is prepared by the following method: adding silicon dioxide, sodium oxide, calcium oxide and phosphorus pentoxide into a platinum crucible according to the proportion, heating to 1530 ℃ through multistage heating and multistage high temperature heating, screening out particles with the particle diameters of 80-200um, 200-550um and 550-710um after quenching and ball milling, and mixing the three according to the mass fractions of 20%, 75% and 5% to obtain the bioactive inorganic silicate.
Example 3
The embodiment provides an implant material for human soft tissue filling, which comprises 35 parts by mass of crosslinked sodium hyaluronate gel, 19 parts by mass of silicon dioxide, 10 parts by mass of sodium oxide, 12 parts by mass of calcium oxide, 2.5 parts by mass of phosphorus pentoxide, 1.5 parts by mass of lidocaine hydrochloride and 2 parts by mass of dexamethasone.
The preparation method of the cross-linked sodium hyaluronate gel and the bioactive inorganic silicate is the same as that of example 1, and thus, detailed description thereof is omitted.
Comparative example 1
The comparative example provides an implant material for filling human soft tissues, which comprises 35 parts of sodium hyaluronate gel, 19 parts of silicon dioxide, 10 parts of sodium oxide, 12 parts of calcium oxide, 2.5 parts of phosphorus pentoxide, 1.5 parts of lidocaine hydrochloride and 2 parts of dexamethasone in parts by mass.
The preparation method of the bioactive inorganic silicate is the same as that in example 1, and thus, the detailed description thereof is omitted.
Comparative example 2
The comparative example provides an implant material for human soft tissue filling, which comprises 35 parts of cross-linked sodium hyaluronate gel, 10 parts of sodium oxide, 12 parts of calcium oxide, 2.5 parts of phosphorus pentoxide, 1.5 parts of lidocaine hydrochloride and 2 parts of dexamethasone in parts by mass.
The preparation method of the crosslinked sodium hyaluronate gel is the same as that of example 1, and thus, it is not described herein again.
The bioactive inorganic silicate is prepared by the following method: adding sodium oxide, calcium oxide and phosphorus pentoxide into a platinum crucible according to the proportion, heating to 1400 ℃ through multistage heating and multistage high temperature heating, screening out particles with the particle diameters of 80-200um, 200-550um and 550-710um after quenching and ball milling, and mixing the three according to the mass fractions of 10%, 80% and 10% to obtain the bioactive inorganic silicate.
Comparative example 3
The comparative example provides an implant material for human soft tissue filling, which comprises 35 parts of cross-linked sodium hyaluronate gel, 19 parts of silicon dioxide, 12 parts of calcium oxide, 2.5 parts of phosphorus pentoxide, 1.5 parts of lidocaine hydrochloride and 2 parts of dexamethasone in parts by mass.
The preparation method of the crosslinked sodium hyaluronate gel is the same as that of example 1, and thus, it is not described herein again.
The bioactive inorganic silicate is prepared by the following method: adding silicon dioxide, calcium oxide and phosphorus pentoxide into a platinum crucible according to the proportion, heating to 1400 ℃ through multistage heating and multistage high temperature heating, quenching, ball milling, screening out particles with the particle diameters of 80-200um, 200-550um and 550-710um, and mixing the three according to the mass fractions of 10%, 80% and 10% to obtain the bioactive inorganic silicate.
Comparative example 4
The comparative example provides an implant material for human soft tissue filling, which comprises 35 parts of cross-linked sodium hyaluronate gel, 19 parts of silicon dioxide, 10 parts of sodium oxide, 2.5 parts of phosphorus pentoxide, 1.5 parts of lidocaine hydrochloride and 2 parts of dexamethasone in parts by mass.
The preparation method of the crosslinked sodium hyaluronate gel is the same as that of example 1, and thus, it is not described herein again.
The bioactive inorganic silicate is prepared by the following method: adding silicon dioxide, sodium oxide and phosphorus pentoxide into a platinum crucible according to the proportion, heating to 1400 ℃ through multistage heating and multistage high temperature heating, quenching, ball milling, screening out particles with the particle diameters of 80-200um, 200-550um and 550-710um, and mixing the three according to the mass fractions of 10%, 80% and 10% to obtain the bioactive inorganic silicate.
Comparative example 5
The comparative example provides an implant material for human soft tissue filling, which comprises 35 parts of cross-linked sodium hyaluronate gel, 19 parts of silicon dioxide, 10 parts of sodium oxide, 12 parts of calcium oxide, 1.5 parts of lidocaine hydrochloride and 2 parts of dexamethasone in parts by mass.
The preparation method of the crosslinked sodium hyaluronate gel is the same as that of example 1, and thus, it is not described herein again.
The bioactive inorganic silicate is prepared by the following method: adding silicon dioxide, sodium oxide and calcium oxide into a platinum crucible according to the proportion, heating to 1400 ℃ through multi-stage heating and multi-stage high temperature, screening out particles with the particle diameters of 80-200um, 200-550um and 550-710um after quenching and ball milling, and mixing the three according to the mass fractions of 10%, 80% and 10% to obtain the bioactive inorganic silicate.
Comparative example 6
The comparative example provides an implant material for human soft tissue filling, which comprises 35 parts of cross-linked sodium hyaluronate gel, 19 parts of silicon dioxide, 10 parts of sodium oxide, 12 parts of calcium oxide, 2.5 parts of phosphorus pentoxide, 1.5 parts of lidocaine hydrochloride and 2 parts of dexamethasone in parts by mass.
The preparation method of the bioactive inorganic silicate is the same as that in example 1, and thus, the detailed description thereof is omitted.
The cross-linked sodium hyaluronate gel is prepared by the following method: mixing sodium hyaluronate powder with physiological saline 1: 18 to obtain a sodium hyaluronate solution, adding sodium hydroxide to adjust the pH value of the solution to 9, then adding a cross-linking agent 1, 4-butanediol diglycidyl ether, wherein the addition amount of the cross-linking agent is 3% of the mass of the sodium hyaluronate solution, slowly stirring and heating to 70 ℃, cooling to room temperature after 8 hours, then crosslinking the sodium hyaluronate solution into a gel state, granulating by using a granulating device, controlling the particle size to be between 100 and 300 mu m, and performing wet heat sterilization after subpackaging to obtain the crosslinked sodium hyaluronate gel.
Application example 1
Implant material 1 was prepared with the components and method described in example 3;
implant material 2 was prepared with the composition and method described in comparative example 1;
an implant material 3 was prepared in the composition and method described in comparative example 2;
implant material 4 was prepared with the composition and method described in comparative example 3;
an implant material 5 was prepared in the composition and method described in comparative example 4;
an implant material 6 was prepared in the composition and method described in comparative example 5;
implant material 7 was prepared in the composition and method described in comparative example 6;
respectively injecting the implant materials 1-7 into the same forming die for forming to obtain implant products 1-7, respectively placing the implant products 1-7 into hyaluronidase solutions of 10U/mL, 20U/mL, 30U/mL, 40U/mL, 50U/mL and 60U/mL for accelerated degradation, respectively measuring the degradation rate of the corresponding implant products after 5h, 24h and 72h, and the results are shown in the following table:
and (4) analyzing results: from the above results, it can be seen that the enzyme degradation resistance of the implant product 1 is much better than that of the implant products 2-7, so that the product provided by the present invention can be stably maintained for a long time after being implanted into a human body, and the intended purpose of the present invention is achieved.
Application example 2
The implant products 1 to 7 prepared in application example 1 were taken, square tablets having weights of 2g, 4g, 6g, 8g, 10g and 20g, respectively, were pressed on the implant products 1 to 7, respectively, the tilt angles of the implant products 1 to 7 before pressing were all 70 degrees, and the tilt angles of the corresponding implant products were measured after 10 days, 30 days and 60 days, respectively, and the results are shown in the following table:
and (4) analyzing results: from the above results, it can be seen that the compressive capacity of the implant product 1 is much better than that of the implant products 2-7, so that after being implanted into a human body, the product provided by the invention can be kept stable for a long time without displacement, thereby achieving the intended purpose of the invention.
The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments or alternatives may be employed by those skilled in the art without departing from the spirit or ambit of the invention as defined in the appended claims.
Claims (10)
1. An implant material for human soft tissue augmentation, comprising: comprises sodium hyaluronate, bioactive inorganic silicate, lidocaine hydrochloride and dexamethasone.
2. An implant material useful for human soft tissue augmentation as claimed in claim 1, wherein: the sodium hyaluronate is cross-linked sodium hyaluronate gel.
3. An implant material useful for human soft tissue augmentation as claimed in claim 1, wherein: the bioactive inorganic silicate comprises silicon dioxide, sodium oxide, calcium oxide and phosphorus pentoxide.
4. An implant material useful for human soft tissue augmentation as claimed in claim 1, wherein: the implant material comprises, by mass, 20-50 parts of cross-linked sodium hyaluronate gel, 14-24 parts of silicon dioxide, 8-13 parts of sodium oxide, 5-18 parts of calcium oxide, 1-4 parts of phosphorus pentoxide, 0.3-3 parts of lidocaine hydrochloride and 0.75-3 parts of dexamethasone.
5. An implant material useful for human soft tissue augmentation as claimed in claim 4, wherein: the implant material comprises 35 parts by mass of crosslinked sodium hyaluronate gel, 19 parts by mass of silicon dioxide, 10 parts by mass of sodium oxide, 12 parts by mass of calcium oxide, 2.5 parts by mass of phosphorus pentoxide, 1.5 parts by mass of lidocaine hydrochloride and 2 parts by mass of dexamethasone.
6. An implant material useful for human soft tissue augmentation as claimed in claim 4, wherein: the cross-linked sodium hyaluronate gel is prepared by the following method: mixing sodium hyaluronate powder with physiological saline 1: 15-20, adding an acid-base regulator to adjust the pH value of the solution to 8-10, adding a cross-linking agent, slowly stirring and heating to 60-80 ℃, continuing for 5-12 hours, cooling to room temperature, adding a phosphate buffer solution to purify the product for 12-24 hours, granulating by using a granulating device, controlling the particle size to be between 100 and 300 mu m, subpackaging, and performing wet heat sterilization to obtain the cross-linked sodium hyaluronate gel.
7. An implant material useful for human soft tissue augmentation as claimed in claim 6, wherein: the pH regulator comprises KOH, NaOH, HCl and H2CO3。
8. An implant material useful for human soft tissue augmentation as claimed in claim 6, wherein: the crosslinking agent is 1, 4 butanediol diglycidyl ether or divinyl sulfone, and the addition amount of the crosslinking agent is 1-5% of the mass of the sodium hyaluronate solution.
9. An implant material useful for human soft tissue augmentation as claimed in claim 4, wherein: the bioactive inorganic silicate is prepared by the following method: adding silicon dioxide, sodium oxide, calcium oxide and phosphorus pentoxide into a platinum crucible according to a proportion, heating to 1300-.
10. An implant material useful for human soft tissue augmentation as claimed in claim 9, wherein: the heating method is multi-stage high-temperature heating.
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