CN110327497A - A kind of injection gel and preparation method thereof containing microballoon - Google Patents
A kind of injection gel and preparation method thereof containing microballoon Download PDFInfo
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- CN110327497A CN110327497A CN201910699379.2A CN201910699379A CN110327497A CN 110327497 A CN110327497 A CN 110327497A CN 201910699379 A CN201910699379 A CN 201910699379A CN 110327497 A CN110327497 A CN 110327497A
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- Prior art keywords
- injection gel
- carrier
- injection
- material particle
- degradable polyester
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- 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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
-
- 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
- A61L27/52—Hydrogels or hydrocolloids
-
- 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
- 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
- A61L27/58—Materials at least partially resorbable by the body
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Engineering & Computer Science (AREA)
- Dispersion Chemistry (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Composite Materials (AREA)
- Materials Engineering (AREA)
- Medicinal Preparation (AREA)
- Materials For Medical Uses (AREA)
Abstract
The present invention relates to a kind of injection gel containing microballoon comprising carrier and be dispersed in the carrier for undertaking the degradable polyester microsphere of filling support function, wherein carrier is formulated by macromolecule material particle and physiological buffer.The preparation method of the invention further relates to a kind of injection gel containing microballoon, includes the following steps: S1, is prepared by macromolecule material particle and physiological buffer and forms carrier；Degradable polyester microsphere is dispersed in injection gel of the formation containing microballoon in the carrier by S2.Injection gel containing microballoon of the invention, short-term filling support function is provided by macromolecule material particle, long-term filling support function is provided by degradable polyester microsphere, and, the problems such as degradable polyester microsphere is evenly dispersed in the carrier, can be uneven to avoid filler caused by locally injecting.
Description
Technical field
The present invention relates to U.S. gel is cured, relate more specifically to a kind of injection gel and preparation method thereof containing microballoon.
Background technique
Currently, injection gel is widely used in beauty or medically, especially injection site realize minimally-invasive treatment or
Play the role of beauty filling.Relative to the material of animal origin, injection gel belongs to the macromolecule material of artificial chemistry synthesis
Material, can effectively reduce the risk of disease infection, and improve the stability of material, have a wide range of applications.
But the mobile performance of existing injection gel is often bad, aggregation, blocking pin hole when being easy to cause injection,
Even form tubercle.
Summary of the invention
Mobile performance in order to solve the problems, such as above-mentioned existing injection gel of the existing technology is bad, the present invention
It is intended to provide a kind of injection gel and preparation method thereof containing microballoon.
Injection gel of the present invention containing microballoon comprising carrier and be dispersed in filling out for undertaking in the carrier
Fill the degradable polyester microsphere of support function, wherein carrier is formulated by macromolecule material particle and physiological buffer.
In the present invention, degradable polyester microsphere dispersion in the carrier, so as to wrap up in attached increase by means of carrier
Add the mobility of the degradable polyester microsphere, while reducing the hydrolysis of degradable polyester microsphere, to preferably undertake filling branch
The function of support.Particularly, which generates collagen in later period stimulation tissue, and macromolecule material particle is then
Tissue is filled before generating collagen to play the role of supporting in short term.In addition, act not only as can for macromolecule material particle
The role of the carrier of degradation polyester microsphere, and have the function of evenly dispersed degradable polyester microsphere simultaneously.
Preferably, the weight ratio of macromolecule material particle and degradable polyester microsphere is 50-90%:10-50%.More preferably
The weight ratio of ground, macromolecule material particle and degradable polyester microsphere is 60-80%:20-40%.
Preferably, content of the macromolecule material particle in physiological buffer is 10-60mg/ml.It should be understood that physiology is slow
The content of macromolecule material particle in fliud flushing is different, the crosslinking degree of injection gel is influenced, to influence injection gel
Mobility and dispersion degree.
Preferably, which is sodium chloride or phosphate physiological buffer.It is highly preferred that the physiological buffer is
Concentration is the sodium chloride or phosphate physiological buffer of 0.5%-1.5%.Most preferably, which is that concentration is
The sodium chloride physiological buffer of 0.9%-1.1%.
Preferably, the molecular weight ranges of degradable polyester microsphere are 10,000-80 ten thousand.It is highly preferred that degradable polyester microsphere
Molecular weight ranges are 100,000-50 ten thousand.
Preferably, the average particle size range of degradable polyester microsphere is 5-200um.It is highly preferred that degradable polyester microsphere
Average particle size range be 10-100um.Most preferably, 30G syringe needle thrust < 15N.It should be understood that can be dropped in injection process
The partial size for solving polyester microsphere is bigger, and the syringe needle and thrust used is bigger, will cause the sense of discomfort of user, seriously will lead to needle
Head blocking.Preferably, the granular size of degradable polyester microsphere is in normal distribution, and dispersed stability is more preferable after injection.
Preferably, degradable polyester include but are not limited to glycolide-lactide copolymer (PLGA), polylactic acid (PLA),
The mixing of one or more of polycaprolactone (PCL), polyglycolic acid (PGA) or copolymerization.
Preferably, high molecular material includes but are not limited to polyvinyl alcohol (PVA), gelatin, Arabic gum, guar gum, sulphur
Aching and limp ossein, hyaluronic acid (HA), sodium carboxymethylcellulose (CMC), polyvinylpyrrolidone (PVP), methylcellulose (MC),
Hydroxypropyl methyl cellulose (HPMC), starch, pectic acid, heparin, glucose, beta-cyclodextrin, chitosan, sodium alginate etc., on
State substance modified forms and copolymer and or above-mentioned substance one or more kinds of mixtures.It is highly preferred that macromolecule
Material is hyaluronic acid, sodium carboxymethylcellulose.
Preferably, the injection gel containing microballoon further includes the drug of active ingredient.
Preferably, the weight ratio of macromolecule material particle and drug is 50-90%:0-1%.
Preferably, drug includes but are not limited to lidocaine, anti-inflammatory, anti-inflammatory drug, cell growth inhibition, antithrombotic shape
At at least one of equal drugs.
The preparation method of injection gel containing microballoon of the invention, includes the following steps: S1, by macromolecule material particle
It prepares to form carrier with physiological buffer；Degradable polyester microsphere is dispersed in note of the formation containing microballoon in the carrier by S2
It penetrates and uses gel.
Preferably, in step sl, macromolecule material particle is sufficiently swollen and is balanced in physiological buffer to be formed and be carried
Body.
Preferably, in step s 2, degradable polyester microsphere, which is added to, is sufficiently mixed to obtain the injection containing microballoon in carrier
Use gel.
Preferably, in step s 2, degradable polyester microsphere is added to be sufficiently mixed in carrier after vacuumize and the place that sterilizes
Reason.
Injection gel containing microballoon of the invention provides short-term filling support function by macromolecule material particle, leads to
It crosses degradable polyester microsphere and long-term filling support function is provided, moreover, the degradable polyester microsphere is evenly dispersed in the carrier, it can
The problems such as uneven to avoid filler caused by locally injecting.Particularly, injection gel provided by the invention has excellent
Mobile performance, aggregation, blocking pin hole and the defects of form tubercle when can be avoided injection.
Specific embodiment
Presently preferred embodiments of the present invention is given below, and is described in detail.
Embodiment 1
Hyaluronic acid 2g is weighed, addition is sufficiently swollen into the sodium chloride physiological buffer of 200ml0.9%, balances, obtaining
Hyaluronic acid derivatives；The PLA microballoon 1.3g that molecular weight is 80,000-15 ten thousand, average grain diameter is 10-50um is weighed, hyalomitome is mixed into
In acid gel, mixed liquor is stirred into 10min at 800r/min, vacuumizes and obtains the hyaluronic acid derivatives containing microballoon for 24 hours；110
DEG C high pressure steam sterilization 30min, it is filling in disposable syringe.
Embodiment 2
Hyaluronic acid 6g is weighed, addition is sufficiently swollen into the sodium chloride physiological buffer of 200ml1.1%, balances, obtaining
Hyaluronic acid derivatives；Weighing molecular weight is 120,000-20 ten thousand, average grain diameter is 10-80um PLA microballoon 1.3g and molecular weight is 10
Ten thousand -22 ten thousand, average grain diameter is the PCL microballoon 1.3g of 20-90um, is mixed into hyaluronic acid derivatives, by mixed liquor in 800r/
10min is stirred under min, vacuumizes and obtains the hyaluronic acid derivatives containing microballoon for 24 hours；110 DEG C of high pressure steam sterilization 30min, it is filling
In disposable syringe.
Embodiment 3
Hyaluronic acid 12g is weighed, addition is sufficiently swollen into the sodium chloride physiological buffer of 200ml0.9%, balances, obtaining
To hyaluronic acid derivatives；Weigh the PLGA microballoon 3.6g and molecular weight that molecular weight is 250,000-50 ten thousand, average grain diameter is 50-160um
The PLA microballoon 8.4g for being 80-180um for 300,000-60 ten thousand, average grain diameter, is mixed into hyaluronic acid derivatives, mixed liquor is existed
30min is stirred under 1200r/min, vacuumizes and obtains the hyaluronic acid derivatives containing microballoon for 24 hours；110 DEG C of high pressure steam sterilizations
30min, it is filling in disposable syringe.
Embodiment 4
Gelatin 10g is weighed, addition is sufficiently swollen into the sodium chloride physiological buffer of 200ml1.5%, balances, obtaining bright
Glue gel；The PLGA microballoon 10g in normal distribution that molecular weight is 10,000-5 ten thousand, average grain diameter is 5-10um is weighed, is mixed into bright
In glue gel, mixed liquor is stirred into 30min at 1200r/min, vacuumizes and obtains the gelatin gel containing microballoon for 24 hours；110℃
High pressure steam sterilization 30min, it is filling in disposable syringe.
Embodiment 5
Pectic acid 90g is weighed, addition is sufficiently swollen into the sodium chloride physiological buffer of 200ml0.5%, balances, obtaining
Pectin acid gel；The PGA microballoon 10g in normal distribution that molecular weight is 700,000-80 ten thousand, average grain diameter is 190-200um is weighed,
It is mixed into pectin acid gel, mixed liquor is stirred into 30min at 1200r/min, vacuumizes and obtains the pectin containing microballoon for 24 hours
0.1g lidocaine is added in the pectin acid gel by acid gel；110 DEG C of high pressure steam sterilization 30min, it is filling disposable
In syringe.
The obtained sample of embodiment 1-5 is placed in 2-8 ° of refrigerating box and is saved 3 months, places 2 under the conditions of 37 DEG C after taking-up
Week, gained gel are homogenous suspension, do not occur significantly sedimentation, solid-liquid lamination.
Sample is made in embodiment 1-5 and loads onto 27G syringe needle, in the case where average thrust is 5N-15N thrust, gel is easier to release.
Take the sample of 1ml embodiment 1-5 for sub-dermal soft tissue Implantation Test respectively, the sample of implantation do not occur it is red,
Phenomena such as swollen, suppuration, fever, implant site has obvious occupy-place filling full, after implantation 12 months, 1 sample implanting portion of embodiment
The degradation of bit position filler, the part not being degraded is fully wrapped around by surrounding new life connective tissue, forms fixed support structure, week
It is without exception to enclose tissue.Implantation 24 months, embodiment 2 and 3 sample implant site of embodiment are partially filled with object degradation, are not degraded
Part is fully wrapped around by surrounding new life connective tissue, forms fixed support structure, and surrounding tissue is without exception.
Comparative example 1
Hyaluronic acid 1.6g is weighed, addition is sufficiently swollen into the sodium chloride physiological buffer of 200ml0.9%, balances, obtaining
To hyaluronic acid derivatives；The PLA microballoon 1.3g that molecular weight is 80,000-15 ten thousand, average grain diameter is 10-50um is weighed, is mixed into transparent
In matter acid gel, mixed liquor is stirred into 10min at 800r/min, vacuumizes and obtains the hyaluronic acid derivatives containing microballoon for 24 hours；
110 DEG C of high pressure steam sterilization 30min, it is filling in disposable syringe.
Although experiment shows that the hyaluronic acid of comparative example 1 is equally capable of forming suspension, since hyaluronic acid is in life
The content managed in buffer is 8mg/ml, and there are slight laminations for the suspension.
Comparative example 2
Hyaluronic acid 4g is weighed, addition is sufficiently swollen into the sodium chloride physiological buffer of 200ml0.9%, balances, obtaining
Hyaluronic acid derivatives；The PLA microballoon 2.7g that molecular weight is 80,000-15 ten thousand, average grain diameter is 160-250um is weighed, is mixed into transparent
In matter acid gel, mixed liquor is stirred into 20min at 1200r/min, vacuumizes and obtains the hyaluronic acid derivatives containing microballoon for 24 hours；
110 DEG C of high pressure steam sterilization 30min, it is filling in disposable syringe.
Although experiment shows that the hyaluronic acid derivatives of comparative example 2 can be equally pushed out, due to putting down for PLA microballoon
Equal partial size is 160-250um, and biggish thrust is needed to release syringe needle.
Above-described, only presently preferred embodiments of the present invention, the range being not intended to limit the invention, of the invention is upper
Stating embodiment can also make a variety of changes.Made by i.e. all claims applied according to the present invention and description
Simply, equivalent changes and modifications fall within the claims of the invention patent.The not detailed description of the present invention is
Routine techniques content.
Claims (10)
1. a kind of injection gel containing microballoon, which is characterized in that the injection gel includes carrier and is dispersed in the carrier
For undertake filling support function degradable polyester microsphere, wherein carrier is by macromolecule material particle and physiological buffer
It is formulated.
2. injection gel according to claim 1, which is characterized in that macromolecule material particle and degradable polyester microsphere
Weight ratio be 50-90%:10-50%.
3. injection gel according to claim 1, which is characterized in that macromolecule material particle is in physiological buffer
Content is 10-60mg/ml.
4. injection gel according to claim 1, which is characterized in that the physiological buffer is that sodium chloride or phosphate are raw
Manage buffer.
5. injection gel according to claim 1, which is characterized in that degradable polyester is selected from: glycolide-lactide is total
Polymers, polylactic acid, polycaprolactone, polyglycolic acid.
6. injection gel according to claim 1, which is characterized in that high molecular material is selected from: polyvinyl alcohol, gelatin,
Arabic gum, guar gum, chondroitin sulfate, hyaluronic acid, sodium carboxymethylcellulose, polyvinylpyrrolidone, methylcellulose,
Hydroxypropyl methyl cellulose, starch, pectic acid, heparin, glucose, beta-cyclodextrin, chitosan, sodium alginate.
7. injection gel according to claim 1, which is characterized in that the injection gel containing microballoon further includes active
The drug of ingredient.
8. injection gel according to claim 7, which is characterized in that drug is selected from: lidocaine, anti-inflammatory, anti-inflammatory
Medicine, cell growth inhibition, antithrombotic reagent.
9. a kind of preparation method of injection gel according to claim 1 to 8, which is characterized in that including such as
Lower step:
S1 is prepared by macromolecule material particle and physiological buffer and is formed carrier；
Degradable polyester microsphere is dispersed in injection gel of the formation containing microballoon in the carrier by S2.
10. preparation method according to claim 9, which is characterized in that in step sl, macromolecule material particle is in physiology
It is sufficiently swollen and balances to form carrier in buffer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910699379.2A CN110327497A (en) | 2019-07-31 | 2019-07-31 | A kind of injection gel and preparation method thereof containing microballoon |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910699379.2A CN110327497A (en) | 2019-07-31 | 2019-07-31 | A kind of injection gel and preparation method thereof containing microballoon |
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| CN110327497A true CN110327497A (en) | 2019-10-15 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113209370A (en) * | 2020-01-21 | 2021-08-06 | 北京四环制药有限公司 | Biodegradable injection filler, preparation method and application thereof |
| CN113230451A (en) * | 2021-04-02 | 2021-08-10 | 长春圣博玛生物材料有限公司 | Injectable dermal filler and preparation method thereof |
| CN113476663A (en) * | 2021-07-07 | 2021-10-08 | 杭州科腾生物制品有限公司 | Preparation method of medical modified sodium hyaluronate polyhexamethylene lactone gel |
| CN114053487A (en) * | 2020-08-02 | 2022-02-18 | 广州益诚生物科技有限公司 | Mechanical bionic absorption filler and manufacturing method thereof |
| CN114099771A (en) * | 2020-08-27 | 2022-03-01 | 杭州协合医疗用品有限公司 | Gradient injection containing mixed polymer microspheres |
| CN114177352A (en) * | 2021-12-22 | 2022-03-15 | 西安德诺海思医疗科技有限公司 | Gradient degradable skin filler and preparation method thereof |
| CN115282336A (en) * | 2022-08-26 | 2022-11-04 | 浙江天妍生物科技有限公司 | Polysaccharide mixed gel containing aliphatic polyester microspheres as well as preparation method and application thereof |
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| CN108744054A (en) * | 2018-06-15 | 2018-11-06 | 北京水元生生物科技有限公司 | A kind of injection-type beauty and shaping facial bulking agent compositions gel and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113209370A (en) * | 2020-01-21 | 2021-08-06 | 北京四环制药有限公司 | Biodegradable injection filler, preparation method and application thereof |
| CN113209370B (en) * | 2020-01-21 | 2023-11-28 | 渼颜空间(河北)生物科技有限公司 | Biodegradable injection filler, preparation method and application thereof |
| CN114053487A (en) * | 2020-08-02 | 2022-02-18 | 广州益诚生物科技有限公司 | Mechanical bionic absorption filler and manufacturing method thereof |
| CN114099771A (en) * | 2020-08-27 | 2022-03-01 | 杭州协合医疗用品有限公司 | Gradient injection containing mixed polymer microspheres |
| CN113230451A (en) * | 2021-04-02 | 2021-08-10 | 长春圣博玛生物材料有限公司 | Injectable dermal filler and preparation method thereof |
| CN113476663A (en) * | 2021-07-07 | 2021-10-08 | 杭州科腾生物制品有限公司 | Preparation method of medical modified sodium hyaluronate polyhexamethylene lactone gel |
| CN114177352A (en) * | 2021-12-22 | 2022-03-15 | 西安德诺海思医疗科技有限公司 | Gradient degradable skin filler and preparation method thereof |
| CN115282336A (en) * | 2022-08-26 | 2022-11-04 | 浙江天妍生物科技有限公司 | Polysaccharide mixed gel containing aliphatic polyester microspheres as well as preparation method and application thereof |
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