CN110354300A - A kind of mobility gelfoam and preparation method thereof - Google Patents
A kind of mobility gelfoam and preparation method thereof Download PDFInfo
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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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
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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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0031—Hydrogels or hydrocolloids
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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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0036—Porous materials, e.g. foams or sponges
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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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0042—Materials resorbable by the body
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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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/10—Polypeptides; Proteins
- A61L24/104—Gelatin
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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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
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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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
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Abstract
The present invention relates to biomedical material technology, a kind of mobility gelfoam and preparation method thereof is disclosed.Obtained gelfoam crude product be crushed and be crushed again by the method, is dehydrated, and is washed to content of formaldehyde lower than 0.6%, and control the content of water in product.The present invention directly crushes gelfoam crude product, avoids gelfoam in dry grinding and exists by the risk of mechanical damage, improve the physical property and stability of product, is conducive to the comprehensive performance for promoting product；It is repeatedly washed again after gelfoam is crushed, effectively removes residues of formaldehyde, improve the safety of product.The present invention is using the gelatin of good biocompatibility as raw material, and formaldehyde is selected to carry out cross-linking reaction as crosslinking agent, the raw material of the preparation method is easy to get, requirement to instrument and equipment is low, without high temperature or low temperature drying, energy conservation and environmental protection, it is easily operated, it is advantageously implemented the industrialized production of mobility gelfoam.
Description
Technical field
The present invention relates to biomedical material technologies, and in particular to a kind of mobility gelfoam and its preparation side
Method.
Background technique
Intraoperative hemorrhage is serious complication in surgical operation, is especially bled profusely, and the process of operation is not only interfered, and
And it can even jeopardize patient vitals when serious.Therefore, stopped blooding using hemostatic material wound caused by reasons different in art
It is necessary with closing.Currently, clinically common hemostatic material generally by material physically or chemically effect
Wound location is set to accelerate blood coagulation, such as gelfoam, absorbability is excellent, and adhesiving effect is also preferable, and rejection is low, while having very
Good histocompatbility.But gelfoam is not easy wound site to touch more deeply, bleeding surface is irregular, capillary and
The extensive bleeding haemostatic effect of veniplex is not ideal enough, and since the liquid absorption amount of gelfoam can achieve own vol
200~300%, there are potential compressing risk, especially those fine delicate tissues to bleeding area surrounding tissue in application,
Such as nerve is organized.Therefore, developing quick, safe and effective novel local hemostatic material becomes medicine and biomaterial science
Important topic in field.
The gel-like hemostatic article of injectable is cured because of its clinical ease for operation, suitable for becoming clinical due to Minimally Invasive Surgery the features such as
New lover.At present the hemostasis gel class product that clinically uses of the country relies primarily on import, wherein Johnson Co.Occupy staple market share.The product be by by the gelfoam dried through compression, pelletizing, grinding, water
The techniques such as change, filling and sterilizing are prepared.However, in dry grinding by the risk of mechanical damage, thus gelfoam exists
The physical property that product can be changed influences its haemostatic effect；In addition, in order to realize quick-setting purpose, it is general to be freeze-dried
It needs to carry out in the case where being lower than condition of ultralow temperature, energy consumption is high, is unfavorable for energy saving.
Summary of the invention
Therefore, the technical problem to be solved in the present invention is that overcome hemostasis gel class product cost in the prior art high and
The unstable defect of haemostatic effect, to provide a kind of mobility gelfoam and preparation method thereof of injectable.
In order to solve the above technical problems, the present invention provides a kind of preparation method of mobility gelfoam, including it is as follows
Step:
(1) gelatin of dissolution swelling, is added formalin, reacts at least 4h, obtains gelfoam crude product；
(2) it is crushed above-mentioned gelfoam crude product, is crushed, dehydration is washed to content of formaldehyde lower than 0.6%, and control gelatin is extra large
The mass ratio of gelatin and water is 1:(2.5~5 in silk floss) to get the mobility gelfoam.
Further, the partial size of the mobility gelfoam is 100~600 μm.
Further, step (1) includes the following steps:
55~65g gelatin is weighed, 480~520mL of distilled water is added, stands, is swollen the gelatin sufficiently, 60~65 DEG C
The gelatin of lower dissolution swelling, is cooled to 29~35 DEG C, and 8mL formalin and 50~150mL distilled water is added, closed, 30~
At 38 DEG C stand reaction 4~for 24 hours.
Further, the mass concentration of the formalin is 40%.
Further, the mass ratio of the formalin and gelatin is (0.04~0.2): 1.
Further, it is crushed described in step (2) specifically: the broken gelfoam crude product is placed in dispersion machine
Carry out shearing dispersion.
Further, it is crushed described in step (2) specifically: the broken gelfoam crude product is placed in ball mill
Wet type is carried out to grind.
Further, the abrasive media in the ball mill is zirconium oxide bead.
The present invention also provides a kind of mobility gelfoam according to made from above-mentioned preparation method.
Further, the mobility gelfoam is placed in syringe, sealing, sterilizing, packaging.
Technical solution of the present invention has the advantages that
1. obtained gelfoam crude product be crushed again by the preparation method of mobility gelfoam provided by the invention
It crushes, dehydration, is washed to content of formaldehyde lower than 0.6%, and control the content of water in product.The present invention is directly thick to gelfoam
Product are crushed, and avoid gelfoam in dry grinding and exist by the risk of mechanical damage, improve the physical property of product
And stability, be conducive to the comprehensive performance for promoting product；It is repeatedly washed again after gelfoam is crushed, effectively removes formaldehyde
Residual, improves the safety of product.The present invention uses the gelatin of good biocompatibility as raw material, and selects formaldehyde as friendship
Joining agent and carries out cross-linking reaction, the raw material of the preparation method is easy to get, and the requirement to instrument and equipment is low, it is not necessarily to high temperature or low temperature drying,
Energy conservation and environmental protection, it is easily operated, it is advantageously implemented the industrialized production of mobility gelfoam.
2. the preparation method of mobility gelfoam provided by the invention, the partial size of gained mobility gelfoam is 100
~600 μm, by control the suitable partial size of gelfoam, both ensure that the water imbibition of gelatin sponge, in turn ensure its mobility and
The convenience of operation.
3. the preparation method of mobility gelfoam provided by the invention, first heating makes the Gelatin of swelling before crosslinking,
Then cool down again, make material mixing more evenly, stabilize the structure of gelfoam product.
4. the preparation method of mobility gelfoam provided by the invention, using zirconium oxide bead as grinding medium when ball milling
Matter is not only effectively improved the grinding effect of product, but also because its stable property is also avoided that metal or the pollution of its oxide,
Substantially increase the purity and safety of product.
5. mobility gelfoam provided by the invention, biocompatibility and absorbability are good, will not generate in skin surface
Hemotoncus, degradable absorption, residues of formaldehyde is extremely low, has no toxic side effect, and safety is good, easy to use, is expected in field of biomedicine
Extensive use.
Detailed description of the invention
It, below will be to specific in order to illustrate more clearly of the specific embodiment of the invention or technical solution in the prior art
Embodiment or attached drawing needed to be used in the description of the prior art be briefly described, it should be apparent that, it is described below
Attached drawing is some embodiments of the present invention, for those of ordinary skill in the art, before not making the creative labor
It puts, is also possible to obtain other drawings based on these drawings.
Fig. 1 is the grain size distribution of different gelfoam product absorbable gelatin sponge particles.
Specific embodiment
There is provided following embodiments is to preferably further understand the present invention, it is not limited to the best embodiment party
Formula is not construed as limiting the contents of the present invention and protection scope, anyone under the inspiration of the present invention or by the present invention and its
The feature of his prior art is combined and any and identical or similar product of the present invention for obtaining, all falls within of the invention
Within protection scope.
Specific experiment step or condition person are not specified in embodiment, according to the literature in the art described routine experiment
The operation of step or condition can carry out.Reagents or instruments used without specified manufacturer, being can be by commercially available acquisition
Conventional reagent product.
Embodiment 1
A kind of mobility gelfoam, preparation method include the following steps:
It weighs 60g gelatin to be placed in enamel pan, distilled water 500mL is added, stand, be swollen the gelatin sufficiently, will fill
Gelatin after dividing swelling is placed in 60 DEG C of water-bath, is made it completely dissolved, and is taken out, is naturally cooled to 30 DEG C, pour into and get blisters in bucket,
And formalin and 100mL distilled water that 8mL mass concentration is 40% is added, bucket of getting blisters is placed in 35 DEG C of water-bath and is beaten
Bubble stands reaction 18h under confined conditions, obtains gelfoam crude product.Above-mentioned gelfoam crude product is taken out, chopping, and will chopping
The gelfoam crude product afterwards is placed in grinding in basket type ball-milling machine, and the abrasive media in ball mill basket is zirconium oxide bead, partial size
For 1mm, the hole diameter of sieve (perforated) plate of ball mill is 1mm, revolving speed 30Hz, and the partial size for being ground to absorbable gelatin sponge particle is 100~600 μm,
Filter, washed repeatedly with water for injection, until residues of formaldehyde be lower than 0.6%, control gelfoam product water content, make gelatin with
The mass ratio of water is 1:(2.5~5) to get the mobility gelfoam.The mobility gelfoam is filling to primary
In property syringe, sealing, radiation sterilization, packaging are to get mobility gelfoam finished product.
Microscope amplifies 100 times, observes the mobility gelfoam, and display grain diameter is than more uniform, narrow distribution range,
Size is 100~600 μm.
Embodiment 2
A kind of mobility gelfoam, preparation method include the following steps:
It weighs 55g gelatin to be placed in enamel pan, distilled water 480mL is added, stand, be swollen the gelatin sufficiently, will fill
Gelatin after dividing swelling is placed in 60 DEG C of water-bath, is made it completely dissolved, and is taken out, is naturally cooled to 29 DEG C, pour into and get blisters in bucket,
And formalin and 50mL distilled water that 8mL mass concentration is 40% is added, bucket of getting blisters is placed in 30 DEG C of water-bath and is got blisters,
It stands reaction for 24 hours under confined conditions, obtains gelfoam crude product.Above-mentioned gelfoam crude product is taken out, chopping, and will be after chopping
The gelfoam crude product is placed in grinding in basket type ball-milling machine, and the abrasive media in ball mill basket is zirconium oxide bead, and partial size is
1mm, the hole diameter of sieve (perforated) plate of ball mill are 1mm, revolving speed 30Hz, and the partial size for being ground to absorbable gelatin sponge particle is 100~600 μm, is taken out
Filter, is washed with water for injection repeatedly, until residues of formaldehyde is lower than 0.6%, is controlled the water content of gelfoam product, is made gelatin and water
Mass ratio be 1:(2.5~5) to get the mobility gelfoam.The mobility gelfoam is filling to disposable
In syringe, sealing, radiation sterilization, packaging are to get mobility gelfoam finished product.
Microscope amplifies 100 times, observes the mobility gelfoam, and display grain diameter is than more uniform, narrow distribution range,
Size is 100~600 μm.
Embodiment 3
A kind of mobility gelfoam, preparation method include the following steps:
It weighs 65g gelatin to be placed in enamel pan, distilled water 520mL is added, stand, be swollen the gelatin sufficiently, will fill
Gelatin after dividing swelling is placed in 65 DEG C of water-bath, is made it completely dissolved, and is taken out, is naturally cooled to 35 DEG C, pour into and get blisters in bucket,
And formalin and 150mL distilled water that 8mL mass concentration is 40% is added, bucket of getting blisters is placed in 38 DEG C of water-bath and is beaten
Bubble stands reaction 4h under confined conditions, obtains gelfoam crude product.Above-mentioned gelfoam crude product is taken out, chopping, and will be after chopping
The gelfoam crude product be placed in tell carried out in dispersing agent shearing be dispersed to absorbable gelatin sponge particle partial size be 100~600 μ
M is filtered, is washed repeatedly with water for injection, until residues of formaldehyde is lower than 0.6%, is controlled the water content of gelfoam product, is made gelatin
Mass ratio with water is 1:(2.5~5) to get the mobility gelfoam.The mobility gelfoam is filling to one
In secondary property syringe, sealing, radiation sterilization, packaging are to get mobility gelfoam finished product.
Microscope amplifies 100 times, observes the mobility gelfoam, and display grain diameter is than more uniform, narrow distribution range,
Size is 100~600 μm.
Comparative example 1
A kind of gelfoam, preparation method include the following steps:
It weighs 60g gelatin to be placed in enamel pan, distilled water 500mL is added, stand, be swollen the gelatin sufficiently, will fill
Gelatin after dividing swelling is placed in 60 DEG C of water-bath, is made it completely dissolved, and is taken out, is naturally cooled to 30 DEG C, pour into and get blisters in bucket,
And formalin and 100mL distilled water that 8mL mass concentration is 40% is added, bucket of getting blisters is placed in 35 DEG C of water-bath and is beaten
Bubble stands reaction 18h under confined conditions, obtains gelfoam crude product.The taking-up of above-mentioned gelfoam crude product is poured into mold, is set
It is put into freeze drier to be refrigerated at -55~-45 DEG C after -75~-65 DEG C of freezing 1h and be completely dried, remove mold, carry out
Slice is ground to 100~600 μm, packs to get gelfoam.
According to the operating procedure in Chinese Pharmacopoeia, detecting in the gelfoam content of formaldehyde is 8%, to the gelfoam into
Row washing, water-washing method is with the embodiment of the present invention 1, the results show that its content of formaldehyde is 2%, far more than first specified in pharmacopeia
Aldehyde residual 0.6%.
Microscope amplifies 100 times, observes the gelfoam, shows the particle of 50 μm of many partial size <, particle diameter distribution is not
It is uniform.
Comparative example 2
A kind of mobility gelfoam, preparation method include the following steps:
It weighs 60g gelatin to be placed in enamel pan, distilled water 500mL is added, stand, be swollen the gelatin sufficiently, take out,
It pours into and gets blisters in bucket, and formalin and 100mL distilled water that 8mL mass concentration is 40% is added, the bucket that will get blisters is placed in 35
DEG C water-bath in get blisters, under confined conditions stand reaction 18h, obtain gelfoam crude product.Above-mentioned gelfoam crude product is taken out, is cut
It is broken, and the gelfoam crude product after chopping is placed in basket type ball-milling machine and is ground, the abrasive media in ball mill basket is oxygen
Change zirconium pearl, partial size 1mm, the hole diameter of sieve (perforated) plate of ball mill is 1mm, revolving speed 30Hz, and the partial size for being ground to absorbable gelatin sponge particle is
It 100~600 μm, filters, is washed repeatedly with water for injection, until residues of formaldehyde is lower than 0.6%, the water of control gelfoam product contains
Amount, makes mass ratio 1:(2.5~5 of gelatin and water) to get the mobility gelfoam.By the mobility gelfoam
It is filling into disposable syringe, sealing, radiation sterilization, packaging are to get mobility gelfoam finished product.
Microscope amplifies 100 times, observes the mobility gelfoam, and display particle diameter distribution is inhomogenous, there are 50 μm of < and
The particle that 600 μm of >.
Experimental example
The gelfoam of 1-3 of the embodiment of the present invention and comparative example 1-2 are tested for the property, as a result as shown in table 1 below.
The performance of the different gelfoams of table 1
| Gelfoam | Water absorption rate/% | Bleeding stopping period/s | Amount of bleeding/g | Hemotoncus diameter/cm |
| Embodiment 1 | 13.1 | 67 | 0.32 | 0 |
| Embodiment 2 | 12.5 | 71 | 0.40 | 0 |
| Embodiment 3 | 11.8 | 69 | 0.36 | 0 |
| Comparative example 1 | 6.8 | 85 | 0.55 | 1.17 |
| Comparative example 2 | 19.2 | 90 | 0.59 | 1.22 |
| Commercially available Surgiflo | 14.3 | 69 | 0.52 | 0.64 |
Gelfoam water absorption rate produced by the present invention is high it can be seen from the data in upper table 1, and bleeding stopping period is short, bleeding
Amount is few, and hemolytic and absorbability are good, will not generate hemotoncus, are expected to clinical large scale application.
Obviously, the above embodiments are merely examples for clarifying the description, and does not limit the embodiments.It is right
For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of variation or
It changes.There is no necessity and possibility to exhaust all the enbodiments.And it is extended from this it is obvious variation or
It changes still within the protection scope of the invention.
Claims (10)
1. a kind of preparation method of mobility gelfoam, which comprises the steps of:
(1) gelatin of dissolution swelling, is added formalin, reacts at least 4h, obtains gelfoam crude product；
(2) it is crushed above-mentioned gelfoam crude product, is crushed, dehydration is washed to content of formaldehyde lower than 0.6%, controls in gelfoam
The mass ratio of gelatin and water is 1:(2.5~5) to get the mobility gelfoam.
2. preparation method according to claim 1, which is characterized in that the partial size of the mobility gelfoam be 100~
600μm。
3. preparation method according to claim 1 or 2, which is characterized in that step (1) includes the following steps:
55~65g gelatin is weighed, 480~520mL of distilled water is added, stands, is swollen the gelatin sufficiently, it is molten at 60~65 DEG C
The gelatin for solving swelling is cooled to 29~35 DEG C, and 8mL formalin and 50~150mL distilled water is added, closed, and 30~38 DEG C
Lower standing reaction 4~for 24 hours.
4. preparation method according to claim 1 to 3, which is characterized in that the mass concentration of the formalin is
40%.
5. preparation method according to claim 1 to 4, which is characterized in that the quality of the formalin and gelatin
Than for (0.04~0.2): 1.
6. -5 any preparation method according to claim 1, which is characterized in that crushed described in step (2) specifically: will
The broken gelfoam crude product, which is placed in dispersion machine, carries out shearing dispersion.
7. -5 any preparation method according to claim 1, which is characterized in that crushed described in step (2) specifically: will
The broken gelfoam crude product is placed in progress wet type in ball mill and grinds.
8. preparation method according to claim 7, which is characterized in that the abrasive media in the ball mill is zirconium oxide
Pearl.
9. mobility gelfoam made from a kind of -8 any preparation methods according to claim 1.
10. mobility gelfoam according to claim 9, which is characterized in that the mobility gelfoam to be placed in
In syringe, sealing, sterilizing, packaging.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114099766A (en) * | 2020-09-01 | 2022-03-01 | 松山湖材料实验室 | Modified gelatin hemostatic material and preparation method thereof |
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| CN114099766A (en) * | 2020-09-01 | 2022-03-01 | 松山湖材料实验室 | Modified gelatin hemostatic material and preparation method thereof |
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