CN101785873A - Biocompatible bleed-stopping and bone healing promoting material and preparation method thereof - Google Patents
Biocompatible bleed-stopping and bone healing promoting material and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a biocompatible bleed-stopping and bone healing promoting material and a preparation method thereof. The material is applied to the bone surface or bone section of a human body or an animal, and is characterized in that the biocompatible bleed-stopping and bone healing promoting material is modified starch prepared by modifying natural starch serving as a raw material, and comprises one or more than two of modified starch granules, modified starch sponges, modified starch films, modified starch foams or modified starch glues, wherein the molecular weight of the modified starch is 15,000 to 10,000,000, and the water absorption rate is 1 to 100 times; in the natural starch serving as the raw material, the content of the amylopectin is at least no less than 70 percent of the total amount of the raw material. The invention fulfills the aim of stopping bleeding through direct spraying, daubing and pasting the biocompatible bleed-stopping and bone healing promoting material to touch the bone bleeding surface of wound; meanwhile, the biocompatible bleed-stopping and bone healing promoting material has a function of promoting bone healing, and can be used in the bleed stopping in the sternotomy of Cardio-Thoracic Surgery, spinal surgeries and joint surgeries of orthopedics department, Craniotomy and maxillo-facial surgery and the bleed stopping in the process of trauma care.
Description
Technical field
The present invention relates to a kind of biocompatible hemostatic and promotion knitting material and preparation method thereof, be used for people and animal because of injuring the perform the operation bone surface that causes, the hemostasis of bone section outward, take powder that the modified starch of biocompatibility makes, cystose, spongy, film like or jelly, directly spray, smear, paste, touch the osteorrhagia wound surface and reach the hemostatic purpose; Have the effect that promotes knitting simultaneously, can be used for cardiothoracic surgery breastbone cutting operation, orthopaedics spinal column, operation on joint and open cranium and the decorative sursery operation in stop blooding in hemostasis and the trauma care process.
Background technology
The bone surface that causes in wound or the operation process, the hemostasis of bone section part are difficult problems always.For opening in breast, the operation of opening cranium of part patient such as children's, old man, particularly osteoporosis patient, hemorrhage being difficult to of breastbone, skull section controlled, how on the section of breastbone, skull, to be handled clinically as hemostatic material with bone wax (BONEWAX), bone wax is the mixture of 70% Cera Flava and 30% vaseline, stops up the hemorrhage of bone marrow portion blood capillary with physical method.Cera Flava is a kind of unsaturated fatty acid, but human body is difficult to metabolism and absorption to bone wax, and bone wax causes complication such as bone does not connect, infection easily.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of and is used for the biocompatible hemostatic on bone surface/section and promotes the knitting material, and is can replacement bone cured.Utilize its strong water sorption and high viscosity and characteristics such as easy to use, mechanical close, shutoff are played in the petechia of the bone wound surface that forms to fracture or because of operation, reach the hemostasis purpose.And, after reaching haemostatic effect, can avoid using the cured complication that causes bone does not connect, infection etc. of bone by organism metabolism, degraded in a few hours or a couple of days.
Another technical problem to be solved by this invention is to provide a kind of above-mentioned biocompatible hemostatic and promotes the knitting preparation methods.
The present invention solves the problems of the technologies described above the technical scheme of being taked: a kind of biocompatible hemostatic and promotion knitting material, act on bone surface or the bone section of human body and animal, wherein, described hemostasis and promote the knitting material for being the modified starch that raw material is made through degeneration with the native starch, comprise the modified starch granule, modified starch sponges, the modified starch film, the compositions of one or two or more kinds of modified starch foam or modified starch glue, wherein, the molecular weight of modified starch is 15,000～10,000,000, water absorbent rate is 1～100 times, in above-mentioned native starch raw material, the content ratio of amylopectin is not less than 70% of total amount at least.
Described modified starch particle grain size is 1～1000 μ m.
On the basis of such scheme, described native starch raw material is a kind of or its compositions in corn starch, wheaten starch, potato starch, tapioca, sweet potato starch, pea starch, wax corn starch, the waxy corn starch.
On the basis of such scheme, described native starch raw material comprises the wax corn starch at least, and the content of its amylopectin is not less than 95% of total amount.It is good to contain the modified starch viscosity that the high wax corn starch of amylopectin ratios makes, be easy to make softness, good springiness, be convenient to haemostatic membrane or sthptic sponge that the clinician uses.
On the basis of such scheme, described hemostasis and promote the knitting material for the native starch being a kind of or its compositions in the hydroxypropyl PASELLI EASYGEL, epichlorohydrin cross-linked starch, crosslinked carboxymethyl fecula, acrylic acid-carboxymethyl starch graft copolymer, propylene ester-carboxymethyl starch graft copolymer of the carboxymethyl starch made of raw material, hetastarch, cationic starch, pre-gelatinizing.
Biocompatible hemostatic of the present invention and promotion knitting material can be applied in surgical operation or the hemostasis, the particularly hemostasis at spongy bone position of the osseous tissue damage that causes because of wound; Material of the present invention also can be used as the biomaterial that promotes knitting simultaneously bone wound surface/section being carried out hemostatic, with the healing of the wound that promotes bone.
Its principle is:
Biocompatible hemostatic of the present invention and promotion knitting material have good water absorption character, when touching blood, and the moisture in can absorbing blood, concentrate blood forms " the gluey sludged blood " of modified starch granule-blood.Should " gluey sludged blood " higher viscosity be arranged, petechia that can shutoff bone surface/section part, thus it is hemorrhage to stop the blood vessel at bone injury place to continue, and reaches the hemostatic effect.In addition, should " gluey sludged blood " can become support, be convenient to the growth of osteocyte, thereby promote knitting.
The present invention is a raw material with the native starch of biocompatibility, but employing physics and chemistry and complex denaturation means are with its degeneration and be formed in down the room temperature water absorption and swelling, sticking modified starch, adopt granulating technique to prepare modified starch hemostasis powder again, or adopt vacuum freeze-drying technique to make cystose, spongy material, or adopt the press mold drying process to make haemostatic membrane, directly act on the purpose that the hemorrhage wound surface of human body or animal bone, section reach hemostasis and promote knitting.
Concrete, provide a kind of at above-mentioned hemostasis and promotion knitting preparation methods, being raw material with the native starch makes one or more compositions in pre-gelatinized starch, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, the composite modified starch through degeneration, modified starch is made the modified starch granule through pelletize, pill, screening, grain diameter is 1～1000 μ m, and particulate water absorbent rate is 1～100 times.
Provide another kind of at above-mentioned hemostasis and promotion knitting preparation methods, being raw material with the native starch makes one or more compositions in pre-gelatinized starch, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, the composite modified starch through degeneration, modified starch is made modified starch sponges through vacuum lyophilization, and the water absorbent rate of sponge is 1～100 times.
Provide a kind of again at above-mentioned hemostasis and promotion knitting preparation methods, a kind of or its compositions in the compositions of one or more that are raw material with the native starch in pre-gelatinized starch that degeneration is made, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, composite modified starch and gelatin, collagen protein, carboxymethyl cellulose, chitosan, hyaluronic acid, sodium alginate, coagulant, the plasticizer etc. is mixed through vacuum lyophilization and is made modified starch sponges, and the water absorbent rate of sponge is 1～100 times.
In addition,, when materials such as making sthptic sponge, colloid styptic, can in material, add known antibiotic or other antiinflammatory, make the anti-inflammation hemostasia composite and use for strengthening antiphlogistic effects.
It is a kind of at above-mentioned hemostasis and promotion knitting preparation methods that the present invention also provides, with the native starch is that raw material is made modified starch through degeneration, comprise one or more the compositions in pre-gelatinized starch, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, the composite modified starch, with modified starch through liquid diluting, swelling, dry, press mold technology is made the modified starch haemostatic membrane, and the water absorbent rate of haemostatic membrane is 1～100 times.
The biocompatible hemostatic of various forms of the present invention and promotion knitting material all go for the processing of bone injury surface, bone section, and the effect of playing the shutoff hemostasis and promoting to heal helps the doctor to operate.
For biocompatible hemostatic of the present invention and promotion knitting material are directly used in the surgical operation, can carry out disinfection to material, sterilization method includes but not limited to gamma-ray irradiation sterilization, oxirane disinfection, ozonization.
The invention has the beneficial effects as follows:
Biocompatible hemostatic of the present invention and promotion knitting material shape are flexible, meet clinical operation needs, can carry out shutoff, stickup, filling to the bone wound surface, haemostatic effect is good, and can mix with other artificial bone, as allograph bone of the same race, hydroxyapatite etc., associating directly imposes on the bone wound surface, plays the effect of hemostasis, promotion knitting.
The biocompatibility modified starch that the present invention selects for use directly acts on bone wound surface, bone section part, avoid adopting animal sources or humanized's biological hemostatic material and animal/humanized's infectious disease of bringing, allergy, infection and the complication that xenogenesis/foreign protein causes, avoid because of adopting situations such as the infection that is difficult for the bone wax for absorption of human body and causes, bone does not connect.
Have good viscosity after biocompatible hemostatic of the present invention and the suction of promotion knitting material, can play the effect of shutoff bone surface, bone section.
Play the effect that promotes knitting simultaneously in hemostatic.
Biocompatible hemostatic of the present invention and promotion knitting material are met behind the water easily swelling or are suspended in the water, are convenient to local cleaning operation is finished after, remove the unnecessary hemostatic modified starch that has neither part nor lot in.
Description of drawings
Fig. 1 is a bone wax group gross examination of skeletal muscle photo.
Fig. 2 cuts for the bone wax group and observes photo.
Fig. 3 is the X-ray photographs of blank group.
Fig. 4 is the X-ray photographs of bone wax group.
Fig. 5 is the X-ray photographs of Perclot group.
Fig. 6 is the X-ray photographs of 51-M group
Fig. 7 is the structure observation photo of blank group.
Fig. 8 is the structure observation photo of bone wax group.
Fig. 9 is the structure observation photo of Perclot group.
Figure 10 is the structure observation photo of 51-M group.
The specific embodiment
Embodiment 1
With dry, do not have rotten, do not have caking, pure tapioca is a raw material, through chemical reagent such as expoxy propane, phosphoric acid carry out etherificate, crosslinked, esterification is repeatedly made the hydroxypropyl PASELLI EASYGEL after the degeneration, the hydroxypropyl PASELLI EASYGEL of pre-gelatinizing is made in pre-gelatinizing degeneration through spray drying method again; Pass through the comminutor pelletize again, 40～50 ℃ of controller actuator temperatures, wind speed 700～800r/min adds water speed 20～30r/min; Screening then, granule mean diameter 50～200 orders; Fill modified starch granule is in bottle; The sterilization of packing back, the 51# that gets product hemostasis and knitting granule.
Embodiment 2
51# among the embodiment 1 hemostasis and knitting granule 2g are dissolved in 37 ℃ of 30ml water, under magnetic stirring apparatus constantly stirs, make the abundant swelling of starch granules and be scattered in the water, form uniform suspension.Pour into then in the rectangular tank,, put into freezer dryer again-40 ℃ of following cryopreservation casees pre-cooling 24 hours ,-50 ℃, vacuum less than 10 handkerchiefs under lyophilization 24 hours, obtain 51# hemostasis and knitting sponge.
Embodiment 3
With dry, do not have rotten, do not have caking, pure potato starch is a raw material, behind chemical modification, make crosslinked carboxymethyl fecula sodium modified starch, again by the comminutor pelletize, 40～50 ℃ of controller actuator temperatures, wind speed 700～800r/min adds water speed 20～30r/min; Screening then, grain graininess 50～200 orders; The fill granule is in bottle; The sterilization of packing back, the GND66 that gets product hemostasis and knitting granule.
Embodiment 4
GND66 among the embodiment 3 hemostasis and knitting granule 2g are dissolved under the room temperature in the 70ml water, under magnetic stirring apparatus constantly stirs, make the abundant swelling of starch granules and be scattered in the water, form uniform suspension.Pour into then in the rectangular tank,, put into freezer dryer again-40 ℃ of following cryopreservation casees pre-cooling 24 hours ,-50 ℃, vacuum less than 10 handkerchiefs under lyophilization 24 hours, obtain GND66 hemostasis and knitting sponge.
Embodiment 5
Going bad, do not have caking, pure wax corn and tapioca mixing starch with drying, nothing is raw material, make the hydroxypropyl PASELLI EASYGEL of pre-gelatinizing through complex denaturation, again by the comminutor pelletize, 40～50 ℃ of controller actuator temperatures, wind speed 700～800r/min adds water speed 20～30r/min; Screening then, grain graininess 50～200 orders; The fill granule is in bottle; The sterilization of packing back, the AN350 that gets product hemostasis and knitting granule.
Embodiment 6
AN350 among the embodiment 5 hemostasis and knitting granule 2g is dissolved in 40ml water, under constantly stirring, make the abundant swelling of starch granules and be scattered in the water at magnetic stirring apparatus, form uniform suspension.Pour into then in the rectangular tank,, put into freezer dryer again-40 ℃ of following cryopreservation casees pre-cooling 24 hours ,-50 ℃, vacuum less than 10 handkerchiefs under lyophilization 24 hours, obtain AN350 hemostasis and knitting sponge.
Embodiment 7
With dry, do not have rotten, do not have caking, pure wax corn starch is a raw material, its amylopectin content accounts for total amount more than 95%, through chemical reagent such as expoxy propane, phosphoric acid carry out etherificate, crosslinked, esterification is repeatedly made the hydroxypropyl PASELLI EASYGEL after the degeneration, the hydroxypropyl PASELLI EASYGEL of pre-gelatinizing is made in pre-gelatinizing degeneration through spray drying method again; Pass through the comminutor pelletize again, 40～50 ℃ of controller actuator temperatures, wind speed 700～800r/min adds water speed 20～30r/min; Screening then, grain graininess 50～200 orders; The fill granule is in bottle; The sterilization of packing back, the 51-M that gets product hemostasis and knitting granule.
Embodiment 8
The polysaccharide 51-M of embodiment 7 hemostasis and knitting granule 2g are dissolved under the room temperature in the 40ml water, under constantly stirring, make the abundant swelling of starch granules and be scattered in the water, form uniform suspension at magnetic stirring apparatus.Pour into then in the rectangular tank,, put into freezer dryer again-40 ℃ of following cryopreservation casees pre-cooling 24 hours ,-50 ℃, vacuum less than 10 handkerchiefs under lyophilization 24 hours, obtain polysaccharide 51-M sthptic sponge.
The physical property of four kinds of hemostasis granules of embodiment 1,3,5,7 is as shown in table 1:
Table 1
| Raw material | Viscosity (gmm) | Water absorbent rate (1ml water/g raw material) | Body density (g/cm3) |
| ??51# | ??132 | ??9 | ??0.077 |
| ??GND66 | Outrange | ??66.3 | ??0.040 |
| ??AN350 | ??120 | ??12.1 | ??0.059 |
| Raw material | Viscosity (gmm) | Water absorbent rate (1ml water/g raw material) | Body density (g/cm3) |
| ??51-M | ??130 | ??10.3 | ??0.079 |
The method of testing of adhering performance of the present invention adopts the test of viscosity merit to adopt matter structure instrument (property tester), is produced by Stable Micro System company, and product type is TA-XT plus.Experiment is with popping one's head in: A/BE (backward extrusion probe) and P36R (column type probe).
Test condition is: under the room temperature, and speed: 0.5mm/sec before the test; Test speed: 1mm/sec; Test back speed 10.0mm/sec; Stress: 100g; Answer is apart from 5.0mm; Time of contact 10.0sec; Trigger type: automatically-5g.
Application examples
1, material:
20 of healthy new zealand rabbits, male, body weight 2.5～3.0kg is available from The Fourth Military Medical University's Experimental Animal Center.
Two kinds of biocompatible materials Perclot (being carboxymethyl starch sodium) and polysaccharide 51-M sthptic sponge of the present invention are provided by U.S. Starch Medical Inc.
Be used for correlated bone wax available from German Bei Lang company.
2, method:
With 20 bull new zealand rabbits, be divided into 4 groups at random: blank group, bone wax group, Perclot group and 51-M group.All animals carry out the sternotomy, breastbone from xiphoid-process top along the center holostrome cut off to the first rib level, remove hemorrhage after, clog an amount of bone wax, Perclot sponge or 51-M sthptic sponge respectively in the breastbone opening part, the blank group does not process.Thick line is sewed up breastbone, and subcutaneous tissue and skin are sewed up in layering.28 days pusher venous air pins of conventional raising are put to death, and open former skin otch, preliminary observation breastbone healing situation, and thorax before the complete taking-up is clapped X-ray film.The breastbone specimen is cut into slices after decalcification, HE dyeing.
3, MAIN OUTCOME MEASURES:
X-ray film is observed the breastbone healing state; Light microscopic is observed breastbone healing place pathological manifestations down.
4, result
4.1 gross examination of skeletal muscle
Animal breastbone place is hemorrhage obviously in the art, the hemostasis of bone wax caulk part, and the haemostatic effect of Perclot and 51-M sthptic sponge is good, does not see oozing of blood after the stitching.Have breastbone to be crooked deformity after 28 days in the blank group, presternum is discontinuous; The oval material that is about 1cm is arranged in the middle of the bone wax group breastbone, matter softer (Fig. 1) is doubted to bone wax is residual and (is confirmed after cut, Fig. 2); Perclot and 51-M group presternum are comparatively continuous, see crooked deformity but have.
4.2X actinogram
Blank treated animal breastbone cutting section is not seen healing, and is damaged obvious, and callus formation (Fig. 3) is arranged; Bone wax group breastbone cutting section slit is bigger, and two broken ends of fractured bone form isolates no callus formation (Fig. 4); The healing of Perclot group breastbone is better, structural integrity, and neighbouring breastbone merges (Fig. 5); 51-M group breastbone broken ends of fractured bone slit is little, and obvious callus formation (Fig. 6) is arranged.
4.3 histological observation
Blank group breastbone cuts a large amount of hyperplasias of end, the complete filling slit, and have the small amount of bone girder to form (Fig. 7); Cell between the bone wax group breastbone broken ends of fractured bone, tissue lack as, the visible bone trabecula in two broken ends of fractured bone places forms (Fig. 8); Perclot organizes a large amount of bone trabecula and fibrous tissue forms, the damaged place of complete filling (Fig. 9); The visible obviously bone trabecula of 51-M group forms, and has a large amount of fibrous tissue to fill gap (Figure 10).
5, conclusion
(1) two kind of biocompatible hemostatic product P erclot, 51-M operability and haemostatic effect in the sternotomy all are better than bone wax;
(2) two kinds of biocompatible hemostatic product P erclot, 51-M all can not hinder the breastbone healing, and wherein, the Perclot sponge from X-ray film and histological observation, has the performance that promotes healing in this research;
(3) bone wax is remarkable to the inhibition of breastbone healing, and on this aspect, Perclot and 51-M all have remarkable advantages than bone wax.
Claims (9)
1. a biocompatible hemostatic and promote the knitting material, act on bone surface or the bone section of human body and animal, it is characterized in that: described hemostasis and promote the knitting material for being the modified starch that raw material is made through degeneration with the native starch, comprise the modified starch granule, modified starch sponges, the modified starch film, the compositions of one or two or more kinds of modified starch foam or modified starch glue, wherein, the molecular weight of modified starch is 15,000～10,000,000, water absorbent rate is 1～100 times, and in above-mentioned native starch raw material, the content ratio of amylopectin is not less than 70% of total amount at least.
2. biocompatible hemostatic according to claim 1 and promotion knitting material is characterized in that: described modified starch particle grain size is 1～1000 μ m.
3. biocompatible hemostatic according to claim 1 and 2 and promotion knitting material is characterized in that: described native starch raw material is a kind of or its compositions in corn starch, wheaten starch, potato starch, tapioca, sweet potato starch, pea starch, wax corn starch, the waxy corn starch.
4. biocompatible hemostatic according to claim 3 and promotion knitting material is characterized in that: described native starch raw material is the wax corn starch, and the content ratio of its amylopectin is not less than 95% of total amount.
5. biocompatible hemostatic according to claim 1 and 2 and promotion knitting material is characterized in that: described modified starch is a kind of or its compositions in the hydroxypropyl PASELLI EASYGEL, epichlorohydrin cross-linked starch, crosslinked carboxymethyl fecula, acrylic acid-carboxymethyl starch graft copolymer, propylene ester-carboxymethyl starch graft copolymer of carboxymethyl starch, hetastarch, cationic starch, pre-gelatinizing.
6. at the biocompatible hemostatic of the described surface of bone of one of claim 1 to 5 and promote the knitting preparation methods, be that raw material is made one or more the compositions in pre-gelatinized starch, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, the composite modified starch with the native starch, modified starch is made the modified starch granule through pelletize, pill, screening, grain diameter is 1～1000 μ m, and particulate water absorbent rate is 1～100 times.
7. at described biocompatible hemostatic of one of claim 1 to 5 and promotion knitting preparation methods, it is characterized in that: be that raw material is made one or more the compositions in pre-gelatinized starch, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, the composite modified starch with the native starch, modified starch is made modified starch sponges through vacuum freeze-drying technique, and the water absorbent rate of sponge is 1～100 times.
8. biocompatible hemostatic according to claim 7 and promotion knitting preparation methods, it is characterized in that: be that raw material is made pre-gelatinized starch with the native starch, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, the compositions of one or more in the composite modified starch and gelatin, collagen protein, carboxymethyl cellulose, chitosan, hyaluronic acid, sodium alginate, coagulant, a kind of or its combined hybrid in the plasticizer, make modified starch sponges through vacuum lyophilization, the water absorbent rate of sponge is 1～100 times.
9. at described biocompatible hemostatic of one of claim 1 to 5 and promotion knitting preparation methods, it is characterized in that: be that raw material is made one or more the compositions in pre-gelatinized starch, denaturated starch by acid, dextrin, Oxytarch, esterification starch, etherification starch, crosslinked starch, graft starch, the composite modified starch with the native starch, with the modified starch that makes through liquid diluting, swelling, drying, press mold are made the modified starch haemostatic membrane again, and the water absorbent rate of haemostatic membrane is 1～100 times.
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| CN103055343A (en) * | 2011-10-19 | 2013-04-24 | 袁暾 | Potato starch-hyaluronic acid composite hemostatic powder and preparation method thereof |
| CN103265641A (en) * | 2013-05-08 | 2013-08-28 | 江苏德威兰医疗器械有限公司 | Hemostasis starch and preparation method thereof |
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| CN111714686A (en) * | 2019-03-19 | 2020-09-29 | 广东博与再生医学有限公司 | Bone hemostatic material and preparation method thereof |
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| CN103055343A (en) * | 2011-10-19 | 2013-04-24 | 袁暾 | Potato starch-hyaluronic acid composite hemostatic powder and preparation method thereof |
| CN103055343B (en) * | 2011-10-19 | 2014-07-30 | 袁暾 | Potato starch-hyaluronic acid composite hemostatic powder and preparation method thereof |
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Application publication date: 20100728 |