CN101053669A - Water soluble chitosan-based hemostatic wound-healing marine sponge and its preparation method and application - Google Patents
Water soluble chitosan-based hemostatic wound-healing marine sponge and its preparation method and application Download PDFInfo
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- CN101053669A CN101053669A CNA200710015626XA CN200710015626A CN101053669A CN 101053669 A CN101053669 A CN 101053669A CN A200710015626X A CNA200710015626X A CN A200710015626XA CN 200710015626 A CN200710015626 A CN 200710015626A CN 101053669 A CN101053669 A CN 101053669A
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- chitosan
- healing
- water
- water soluble
- wound
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
- C08L5/08—Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
Abstract
A preparation method of water soluble chitosan group stanch wound sponge, which is characterized in dissolving water soluble chitosan derivatives in water, preparing 1%-10% weight percentage concentration of uniform colloid solution; subpackaging the colloid solution in mould, freezing in vacuum freeze drier at -20--60 DEG C, vacuum freeze drying 24-60 hours. The water soluble chitosan group stanch wound sponge of the invention is used for stanching and boosting wound healing of clinical operation, has advantages of convenient using, great mount of absorption solution, firm adhesion, better exerting function locally; selected material absorb water gradually to form gel in physiology pH condition during preparation, products have good local pasting property, exert stanching and boosting wound healing function so much the better; and products without immunogenicity in body, short degradation time, good compatibility with living body, better safety performance of clinic.
Description
Technical field
The present invention relates to a kind of anti hemorrhagic healing traumatic medical material, particularly relate to a kind of water soluble chitosan-based hemostatic wound-healing marine sponge and its production and application.
Background technology
In clinical operation and operation back control over bleeding, hemostasis, promotion wound healing, for shorten operating time, improve surgical effect, to reduce postoperative complication extremely important.Clinical operation operation hemostasis and trauma hemostasis are often used conventional hemostasis methods such as ligation, stitching, electricity coagulate, but these hemostasis methods control over bleeding effectively always not.Therefore according to clinical needs, used multiple local hemostasis material, these hemostatic materials mainly contain products such as gelfoam, collagen protein sponge, Fibrin Glue.Gelfoam is used for many years clinically, but its hydrophilic is relatively poor, and is not good enough for bigger hemorrhage its haemostatic effect.The anthemorrhagic performance of collagen protein sponge is better than gelfoam, and its raw materials for production come from cattle heel string, tendon, therefore has the transmission danger of viral disease too.Fibrin Glue is used comparatively extensive in the clinical operation hemostasis, but because Fibrin Glue becomes to belong to blood products, therefore exists certain antigenicity and viral disease transmission danger, and its application security is subjected to certain query.Above-mentioned gelfoam, collagen protein sponge, Fibrin Glue all belong to heterogenous animal albumen, and the certain immunogenicity and the danger of virus disseminating are all arranged.
Chitosan is a kind of linear polymeric compound of polysaccharide, is the unique positively charged polysaccharide of occurring in nature, and non-immunogenicity is biodegradable, has multiple physiologically active, as has the damage of promotion wound healing, hemostatic analgesia, antibacterial bacteriostatic function.The hemostatic function of chitosan mainly is to come from charge interaction between chitosan and the erythrocyte, and coagulation takes place, thus hemostasis.But chitosan is not dissolved in water, is chitosan powder, chitosan film, chitosan sponge, chitin fiber and the fabric etc. of feedstock production with the chitosan, and degradation in vivo is (needing more than half a year) approximately slowly, can also cause the body inflammatory reaction simultaneously in degradation process.
Application number is to have disclosed carboxymerhyl chitosan sponge and method for making and the purposes with water-swelling property in 200510024503.3 the Chinese invention patent, with the carboxymethyl chitosan is primary raw material, add a small amount of chitosan powder or chitin powder, add ion crosslinking agent, through lyophilization, make carboxymerhyl chitosan sponge with imbibition.This imbibition carboxymerhyl chitosan sponge can absorb the wound transudate preferably.Yet the chitosan powder of adding or chitin powder are because the characteristic of itself has prolonged this carboxymerhyl chitosan sponge degradation time in vivo, so be unsuitable for wound application in the body.
Summary of the invention
The purpose of this invention is to provide a kind of water soluble chitosan-based hemostatic wound-healing marine sponge and its production and application, to overcome the above-mentioned shortcoming of prior art.
A kind of water soluble chitosan-based hemostatic wound-healing marine sponge is characterized in that it is by a kind in the water-solubility chitosan derivative or 2 kinds or 3 kinds cellular sponges of making; Described water-solubility chitosan derivative is carboxymethyl chitin sodium salt or potassium salt, carboxymethyl chitosan sodium salt or potassium salt, Chitofilmer, hydroxypropyl chitosan, ethoxyl chitin, hydroxyethyl chitosan or succinyl-chitosan sodium salt or potassium salt, and their molecular structural formula is:
In the formula, R
1Be H, COCH
3, CH
2COONa, CH
2COOK, CH
2CHOHCH
3, CH
2CH
2OH, COCH
2CH
2COONa or COCH
2CH
2COOK; R
2Be H, CH
2COONa, CH
2COOK, CH
2CHOHCH
3Or CH
2CH
2OH; The substitution value of described carboxymethyl, hydroxypropyl, ethoxy or succinyl group is all greater than 60%.
The preparation method of above-mentioned water soluble chitosan-based hemostatic wound-healing marine sponge is characterized in that being dissolved in water with a kind in the water-solubility chitosan derivative or 2 kinds or 3 kinds, makes concentration expressed in percentage by weight and be 1%～10% even colloid solution; With this colloid solution be sub-packed in put in the mould vacuum freeze drier-20 ℃～-60 ℃ down freezing, vacuum lyophilization 24～60 hours.
Above-mentioned water soluble chitosan-based hemostatic wound-healing marine sponge before the art of clinical operation, in the art, the hemostasis of postoperative and promote application in the wound healing.
The advantage that water-soluble chitosan hemostatic wound-healing marine sponge of the present invention has is easy to use, the absorption liquid scale of construction big, adhere to comparatively firmly, the part can be brought into play product function better; Selected raw material can absorb water gradually to dissolve under the physiological pH condition and form gel during preparation, and the local sticking performance of product is good, the function that can bring into play the product hemostasis better and heal and create; And product is non-immunogenicity in vivo, and degradation time is short, and good with the compatibility of organism, the security performance of clinical use is better.
The specific embodiment
Embodiment 1
Take by weighing carboxymethyl chitosan Icing Sugar 5g, be placed in the beaker of 500ml, after adding 195g distilled water is stirred to dissolving fully, get carboxymethyl chitosan colloid solution.This colloid solution is poured in the stainless steel mould of 50mm * 50mm * 5mm, put into vacuum freeze drier-45 ℃ freezing 2 hours down, open vacuum pump, distillation moisture, vacuum lyophilization 36 hours, making specification is the flake porous sponge of 50mm * 50mm * 5mm, packing
60The Co sterilization is water soluble chitosan-based hemostatic wound-healing marine sponge of the present invention.This sponge quality softness, loose porous, color and luster is a white.
Embodiment 2
Take by weighing carboxymethyl chitin powder 5g, be placed in the beaker of 500ml, after the distilled water that adds 196g is stirred to and dissolves fully, add concentration expressed in percentage by weight and be 5% Fibrinogen aqueous solution 4g as hemorrhage, the part by weight of carboxymethyl chitosan Icing Sugar and hemorrhage is 100: 4, stir, get carboxymethyl chitosan colloid solution.This colloid solution is poured in the stainless steel mould of 50mm * 50mm * 5mm, put into vacuum freeze drier-45 ℃ after freezing 2 hours, open vacuum pump, distillation moisture, vacuum lyophilization 24～36 hours, getting specification is the flake porous shape sponge of 50mm * 50mm * 5mm, and packing is water soluble chitosan-based hemostatic wound-healing marine sponge of the present invention.This sponge quality softness, loose porous, color and luster is an off-white color.
Embodiment 3
Take by weighing hydroxypropyl Icing Sugar 6g, place the beaker of 500ml, after the distilled water that adds 197g is stirred to and dissolves fully, add concentration expressed in percentage by weight and be 1% thrombin aqueous solution 3g as hemorrhage, the part by weight of hydroxypropyl Icing Sugar and hemorrhage is 100: 0.5, stir, get hydroxypropyl chitosan colloid solution.This colloid solution is poured in the stainless steel mould of 50mm * 50mm * 5mm, put into vacuum freeze drier-45 ℃ after freezing 2 hours, open vacuum pump, distillation moisture, vacuum lyophilization 36～48 hours, getting specification is the flake porous shape sponge of 50mm * 50mm * 5mm, and packing is water soluble chitosan-based hemostatic wound-healing marine sponge of the present invention.This sponge quality softness, loose porous, color and luster is an off-white color.
In the above-described embodiments, described carboxymethyl chitosan, carboxymethyl chitin, hydroxypropyl chitosan all can be described as water-solubility chitosan derivative; The concentration expressed in percentage by weight of the water-solubility chitosan derivative of described colloid solution can be 1%～10%, and preferred concentration expressed in percentage by weight is 2%～5%; Described water-solubility chitosan derivative can be a kind or 2 kinds or 3 kinds in the following water-solubility chitosan derivative: carboxymethyl chitin sodium salt or potassium salt, carboxymethyl chitosan sodium salt or potassium salt, Chitofilmer, hydroxypropyl chitosan, ethoxyl chitin, hydroxyethyl chitosan or succinyl-chitosan sodium salt or potassium salt all can reach same effect; The molecular structural formula of described water-solubility chitosan derivative is:
In the formula, R
1Be H, COCH
3, CH
2COONa, CH
2COOK, CH
2CHOHCH
3, CH
2CH
2OH, COCH
2CH
2COONa or COCH
2CH
2COOK; R
2Be H, CH
2COONa, CH
2COOK, CH
2CHOHCH
3Or CH
2CH
2OH; The substitution value size of described carboxymethyl, hydroxypropyl, ethoxy or succinyl group influences its water-soluble, and carboxymethyl, hydroxypropyl, ethoxy or succinyl group substitution value are all greater than 60% in the present invention.
In embodiment 2 and embodiment 3, after the water-solubility chitosan derivative dissolving, add hemorrhage in proportion, can strengthen the hemostatic function of hemostatic wound-healing marine sponge.Described hemorrhage is a kind or 2 kinds or 3 kinds in the following hemorrhage: thrombin, thrombinogen, Fibrinogen, the X/Xa factor, the VII/VIIa factor, the IX/IXa factor, the XI/XIa factor, Ca
2+The preferred hemorrhage of the present invention is thrombin, Fibrinogen, Ca
2+The part by weight of described water-solubility chitosan derivative and hemorrhage is: the part by weight of water-solubility chitosan derivative and thrombin is 100: 0.001～1, water-solubility chitosan derivative and fibrinogenic part by weight are 100: 0.01～10, the part by weight of the water-solubility chitosan derivative and the X/Xa factor or the VII/VIIa factor or the IX/IXa factor or the XI/XIa factor is 100: 0.001～1, water-solubility chitosan derivative and Ca
2+Weight ratio be 100: 0.01～1.
In embodiment 1～embodiment 3, described cryodesiccated temperature can be-20 ℃～-60 ℃; Described sublimation drying can be 24～60 hours.Described flake porous sponge can be made lamellar, bulk, strip or column mandruka according to clinical needs.
Embodiment 4
The anthemorrhagic performance evaluation test of water soluble chitosan-based hemostatic wound-healing marine sponge: with the rat is experimental animal, make the damaged model of hepatic tissue, estimate relatively gelfoam (Jinting Pharmaceutical Co., Ltd.'s product), water soluble chitosan-based hemostatic wound-healing marine sponge 1 (embodiment 1 preparation), water soluble chitosan-based hemostatic wound-healing marine sponge 2 (embodiment 2 preparations) the anti hemorrhagic healing traumatic effect damaged respectively hepatic tissue.Under aseptic condition, respectively each test material is cut into the lamellar of 1cm * 1cm before the test, standby.Selecting body weight is 36 of the Wistar rat of 250 ± 20g, and male and female half and half are divided into 3 groups at random, 12 every group, and male and female half and half.3 groups are respectively: gelfoam matched group (is hemostatic material with the gelfoam), water soluble chitosan-based hemostatic wound-healing marine sponge 1 group of (water soluble chitosan-based hemostatic wound-healing marine sponge with embodiment 1 preparation is a hemostatic material), 2 groups of water soluble chitosan-based hemostatic wound-healing marine sponges (water soluble chitosan-based hemostatic wound-healing marine sponge with embodiment 2 preparations is a hemostatic material).All animals all adopts the pentobarbital sodium intraperitoneal injection of anesthesia, and dosage is 30mg/Kg.Cut the otch that is about 3cm in the epigastrium center, open the abdominal cavity, aseptic condition is down with the blunt nosed tweezers liver lobus sinister that dissociates, take off the hepatic tissue of 5mm * 5mm * 2mm at the liver middle part with tissue forceps, cause the hepatic injury wound surface, use hemostatic material slightly to push 20 seconds of wound surface rapidly, observe 40 seconds of hemorrhage situation, repeat 2 times, amount to 3 minutes.Record gelfoam matched group and hemostatic wound-healing marine sponge rats in test groups hepatic injury haemostatic effect, the edge of a knife is sewed up and is closed abdomen after 3 minutes, iodophor disinfection, grouping is raised, and respectively at respectively putting to death 6 rats in 1 week, 2 weeks, observes animal liver damage wound healing situation.
Result of the test sees Table 1 and table 2, the result shows that water soluble chitosan-based hemostatic wound-healing marine sponge and gelfoam relatively have better haemostatic effect, can shorten bleeding stopping period, water soluble chitosan-based hemostatic wound-healing marine sponge has significant promotion wound healing effect simultaneously.
Table 1. water soluble chitosan-based hemostatic wound-healing marine sponge anthemorrhagic performance evaluation test result
| Group | Size of animal (only) | Bleeding stopping period (second) |
| Gelfoam matched group water soluble chitosan-based hemostatic wound-healing marine sponge is tested 1 group of water soluble chitosan-based hemostatic wound-healing marine sponge and is tested 2 groups | 12 12 12 | 90～120 ≤60 ≤40 |
Table 2. water soluble chitosan-based hemostatic wound-healing marine sponge is to rats'liver damage wound healing effect result of the test
| Group | Hepatic injury wound healing situation | |
| The 7th day (6 animals) | The 14th day (6 animals) | |
| Gelfoam matched group water soluble chitosan-based hemostatic wound-healing marine sponge is tested 1 group of water soluble chitosan-based hemostatic wound-healing marine sponge and is tested 2 groups | Sponge does not have obvious degradation and absorbs, wound healing 15-30% sponge is degraded and absorbed, wound healing 50-60% sponge is degraded and absorbed, wound healing 50-60% | Sponge is partly degraded, wound healing 50-60% sponge is degraded and absorbed, wound healing 90% above sponge is degraded and absorbed, wound healing 90% |
Water soluble chitosan-based hemostatic wound-healing marine sponge of the present invention can be applied to wound hemostasis, clinical abdominal operation, thoracic surgery, bone surgery, gynecilogical operation, microsurgery, Department of B urn operation, plastic surgery operations etc., with postoperative water soluble chitosan-based hemostatic wound-healing marine sponge is placed on the bleeding part in the Rhizoma Atractylodis Macrocephalae, slightly push, can effectively bring into play anastalsis, after the water soluble chitosan-based hemostatic wound-healing marine sponge absorb body fluids dissolving simultaneously, can also promote the healing of wound surface.
Above embodiment shows, water soluble chitosan-based hemostatic wound-healing marine sponge of the present invention has preferably the effect of stopping blooding, promote wound healing, develops as a kind of hemostatic material in medical use, and market prospect is wide.
Claims (7)
1, a kind of water soluble chitosan-based hemostatic wound-healing marine sponge is characterized in that it is by a kind in the water-solubility chitosan derivative or 2 kinds or 3 kinds cellular sponges of making; Described water-solubility chitosan derivative is carboxymethyl chitin sodium salt or potassium salt, carboxymethyl chitosan sodium salt or potassium salt, Chitofilmer, hydroxypropyl chitosan, ethoxyl chitin, hydroxyethyl chitosan or succinyl-chitosan sodium salt or potassium salt, and their molecular structural formula is:
In the formula, R
1Be H, COCH
3, CH
2COONa, CH
2COOK, CH
2CHOHCH
3, CH
2CH
2OH, COCH
2CH
2COONa or COCH
2CH
2COOK; R
2Be H, CH
2COONa, CH
2COOK, CH
2CHOHCH
3Or CH
2CH
2OH; The substitution value of described carboxymethyl, hydroxypropyl, ethoxy or succinyl group is all greater than 60%.
2, the preparation method of the described water soluble chitosan-based hemostatic wound-healing marine sponge of claim 1 is characterized in that being dissolved in water with a kind in the water-solubility chitosan derivative or 2 kinds or 3 kinds, makes concentration expressed in percentage by weight and be 1%～10% even colloid solution; With this colloid solution be sub-packed in put in the mould vacuum freeze drier-20 ℃～-60 ℃ down freezing, vacuum lyophilization 24～60 hours.
3, the described water soluble chitosan-based hemostatic wound-healing marine sponge of claim 1 before the art of clinical operation, in the art, the hemostasis of postoperative and promote application in the wound healing.
4, water soluble chitosan-based hemostatic wound-healing marine sponge as claimed in claim 1 is characterized in that described water soluble chitosan-based hemostatic wound-healing marine sponge is the mandruka of lamellar, bulk, strip or column.
5, the preparation method of water soluble chitosan-based hemostatic wound-healing marine sponge as claimed in claim 2, the preferred concentration that it is characterized in that the concentration expressed in percentage by weight of water-solubility chitosan derivative in the described colloid solution is 2%～5%.
6, the preparation method of water soluble chitosan-based hemostatic wound-healing marine sponge as claimed in claim 2, it is characterized in that described water-solubility chitosan derivative is dissolved in water after, add hemorrhage, make even colloid solution; Described hemorrhage is thrombin, thrombinogen, the X/Xa factor, the VII/VIIa factor, the IX/IXa factor, the XI/XIa factor or Ca
2+In a kind or 2 kinds or 3 kinds.
7, the preparation method of water soluble chitosan-based hemostatic wound-healing marine sponge as claimed in claim 6, the part by weight that it is characterized in that described water-solubility chitosan derivative and hemorrhage is: the part by weight of water-solubility chitosan derivative and thrombin is 100: 0.001～1, water-solubility chitosan derivative and fibrinogenic part by weight are 100: 0.01～10, the part by weight of the water-solubility chitosan derivative and the X/Xa factor or the VII/VIIa factor or the IX/IXa factor or the XI/XIa factor is 100: 0.001～1, water-solubility chitosan derivative and Ca
2+Weight ratio be 100: 0.01～1.
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