CN105363075A - Haemostatic and anti-adhesion absorbable medical material and preparation method thereof - Google Patents
Haemostatic and anti-adhesion absorbable medical material 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/041—Mixtures of macromolecular compounds
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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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Abstract
The invention provides a haemostatic and anti-adhesion absorbable medical material and a preparation method thereof. The medical material consists of the following raw material components in terms of 100 parts by weight: 50-90 parts of natural polymer polysaccharide or derivatives thereof containing hydroxyl and carboxyl, and 10-50 parts of water-soluble alkaline polysaccharide. A preparation method comprises the following steps: (1) dissolving the natural polymer polysaccharide or derivatives thereof containing the hydroxyl and the carboxyl in water according to a formulated amount, so that a solution with concentration being 0.02-2.5% is prepared, standing by and swelling so as to obtain a solution A; (2) dissolving the water-soluble alkaline polysaccharide according to a formulated amount in water, so that a solution with concentration being 0.02-2.5% is prepared, standing by and swelling so as to obtain a solution B; (3) uniformly mixing the solution A and the solution B, standing by and swelling; and (4) drying and sterilizing a mixed solution, so that the absorbable medical material is obtained. The medical material disclosed by the invention is good in effect, simple in preparation process, energy-saving and environment-friendly, and the medical material is applicable to industrialized production; the massive use of an organic solvent and the like is avoided; and higher biological safety is guaranteed.
Description
Technical field
The present invention relates to medical material tech field, being specifically related to a kind of for stopping blooding and the absorbent medical material and preparation method thereof of anti.
Background technology
In the emergency treatment and various surgical operation of sudden accident, fast and effeciently Bleeding control, obviously can reduce because of the hemorrhage death caused, have important impact to patient.At present, conventional biodegradable hemostatic material mainly contains Fibrin Glue, oxidized cellulose and oxidized regenerated cellulose, a-cyanoacrylate class loading glue, natural macromolecular material, gelfoam etc.Adhesion is the surgical operation particularly ubiquitous problem of abdominal postoperative.Tissue adhesion can cause serious complication, and such as, in abdominal operation, adhesion may cause the diseases such as intestinal obstruction, infertility and chronic pelvic pain.At present, conventional adherence preventing material mainly contains polylactic acid, natural macromolecular material, collagen protein etc.
Although also have some at present on the market for the material of clinical treatment wound hemostasis, they have certain drawback or limitation mostly.
Such as Chinese patent CN03121886.5 (publication number CN1538006A) discloses a kind of for the local hemostasis of clinical operation, wound and the biochargeable paper of anti.Its main component is macromolecular compound containing carboxyl and containing amino polymer substance.In preparation process, first carboxyl macromolecular compound and amino macromolecular compound are made certain density solution, and add activator in amino-compound solution, make it produce cross-linking reaction.Then amino-compound is added in the solution of carboxyl macromolecular compound, place certain hour, form hydrogel.Dissolve unreacted amino-compound with dilute hydrochloric acid, then rinse with large water gaging, remove unreacted activator and byproduct of reaction.Freeze-30 DEG C of refrigerator and cooled, then adopt freezer dryer drying to obtain biochargeable paper in 24 hours-48 hours.The biochargeable paper obtained by said method can clinically for hemostasis and Film with Preventing Adhesion.Although this biochargeable paper possesses the effect of hemostasis and anti, in preparation process, with the addition of crosslinker component, and need to use hydrochloric acid and a large amount of water to clean.The interpolation of cross-linking agent can increase the harm of risk biochargeable paper produces to(for) human body, and hydrochloric acid cleaning adds the complexity of production technology, thus the large-scale production of biochargeable paper is not easily realized, the use of large water gaging adds production cost, and easily impacts environment.
And for example Chinese patent CN201410150503.7 (publication number CN103920182A) discloses a kind of biological absorbable haemostatic membrane.This absorbable hemostatic film is cross-linked hyaluronate sodium and cellulose derivative, then mix with the cross-linking products of hyaluronate sodium or sodium alginate, is then prepared from by dry pressurization.This haemostatic membrane haemostatic effect is good, and degradation rate is moderate, and the homogeneous softness of quality also has certain mechanical strength.But in order to make cross-linking reaction complete in its preparation process, need to regulate the pH value of solution system, the use of cross-linking agent not only increases production cost in addition, too increase the harm of risk product produces to(for) human body.
Therefore, hemostasis higher for safety and preventing adhesiving effect is better and cry that the is medical material of the simple environmental protection of preparation technology is very high clinically at present.
Summary of the invention
The object of the invention is to overcome above-mentioned various defect of the prior art, and provide a kind of for stopping blooding and the absorbent medical material and preparation method thereof of anti.The effect of medical material hemostasis of the present invention and anti is very good, and preparation technology is simple, and energy-conserving and environment-protective, are suitable for suitability for industrialized production, because avoiding a large amount of uses of organic solvent etc., therefore have higher biological safety.
One of technical scheme provided by the invention is: a kind of for stopping blooding and the absorbent medical material of anti, it comprises following raw material components: with parts by weight, contains natural macromolecule amylose or derivatives thereof 50-90 part of tool hydroxyl and carboxyl, water-soluble alkaline polysaccharide 10-50 part in every 100 parts;
Its preparation method comprises the steps:
(1) the tool hydroxyl of formula ratio and the natural macromolecule amylose or derivatives thereof of carboxyl are dissolved in water and are mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution A;
(2) the water-soluble alkaline polysaccharide of formula ratio is dissolved in water and is mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution B;
(3) swelling by leaving standstill after solution A and solution B mix homogeneously;
(4) mixed solution drying step (3) obtained and sterilization treatment, to obtain final product.
Preferably, described for stop blooding and the absorbent medical material of anti comprises following raw material components: with parts by weight, the natural macromolecule amylose or derivatives thereof 60-80 part containing tool hydroxyl and carboxyl in every 100 parts, water-soluble alkaline polysaccharide 20-40 part.The medical material obtained with this preferred formula has good hydrophilic and the water absorption of excellence, can absorb the moisture of at least own wt 10 times fast, and formation hydrogel sticks to wound surface surface after absorbing water.
More preferably, described for stop blooding and the absorbent medical material of anti comprises following raw material components: with parts by weight, natural macromolecule amylose or derivatives thereof 75 parts, water-soluble alkaline polysaccharide 25 parts containing tool hydroxyl and carboxyl in every 100 parts.The medical material obtained with the formula of this best has good hydrophilic and the water absorbing properties of excellence, can absorb the moisture of own wt 15 times fast, and formation hydrogel sticks to wound surface surface after absorbing water.
Described weight portion can be the known unit of weights of field of medicaments such as μ g, mg, g, kg, also can be its multiple, as 1/10,1/100,10 times, 100 times etc.
The natural macromolecule amylose or derivatives thereof of described tool hydroxyl and carboxyl can be natural macromolecule amylose and the derivant thereof of all kinds of tool hydroxyl described in the routine of this area and carboxyl, as hyaluronic acid and derivant, alginic acid and derivant thereof etc., preferably clear matter acid sodium.Described hyaluronate sodium does not have particular/special requirement to molecular weight, and the hyaluronate sodium in common molecular weight range is all applicable to the present invention.
Described water-soluble alkaline polysaccharide can be all kinds of water-soluble alkaline polysaccharide described in the routine of this area, as water-soluble chitosan, carboxymethyl cellulose and carboxymethyl starch etc., and preferred water soluble chitosan.Described water-soluble chitosan does not have particular/special requirement to molecular weight, and the water-soluble chitosan in common molecular weight range is all applicable to the present invention.
Two of technical scheme provided by the invention is: aforementioned for stopping blooding and the preparation method of absorbent medical material of anti, it comprises the steps:
(1) the tool hydroxyl of formula ratio and the natural macromolecule amylose or derivatives thereof of carboxyl are dissolved in water and are mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution A;
(2) the water-soluble alkaline polysaccharide of formula ratio is dissolved in water and is mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution B;
(3) swelling by leaving standstill after solution A and solution B mix homogeneously;
(4) mixed solution drying step (3) obtained and sterilization treatment, to obtain final product.
Wherein, in step (1) and step (2), described water is that this area is conventional, preferred purified water; The implication of described percentage ratio is the implication of this area routine, and for example, namely 1% refer to concentration 1g solute being dissolved in the formation of 100mL water.
In step (1), when the tool hydroxyl of formula ratio and the natural macromolecule amylose or derivatives thereof of carboxyl are dissolved in water, be preferably mixed with the solution that concentration is 0.5 ~ 1.5%; Preferably 1 ~ 2 hour described swelling time.
In step (2), when the water-soluble alkaline polysaccharide of formula ratio is dissolved in water, be preferably mixed with the solution that concentration is 0.5 ~ 1.5%; Preferably 1 ~ 2 hour described swelling time.
In step (3), preferably 1 ~ 2 hour described swelling time.
In step (4), described dry preferably freeze drying, described cryodesiccated condition is: freezing 1 ~ 5h under-30 DEG C ~-10 DEG C conditions, then in 5 DEG C ~ 30 DEG C drying 15 ~ 24h; As preferred further, in dry run, the temperature of system rises at 5 DEG C ~ 30 DEG C scope inside gradients.Described sterilizing can use the sterilizing methods of conventional medical material, preferred irradiation sterilization or electron beam sterilization.
On the basis meeting this area general knowledge, above-mentioned each optimum condition, can combination in any, obtains the preferred embodiments of the invention.
Agents useful for same of the present invention and raw material are all commercially.
Positive progressive effect of the present invention is:
Medical material of the present invention has extraordinary hemostasis and preventing adhesiving effect, and does not use cross-linking agent and collagen protein constituents, greatly reduces chemical toxicity and the immunotoxicity of product.According to GB/T16886 " BiologicalEvaluationofMedicalDevice " series standard, medical material cytotoxicity of the present invention is 1 grade, stimulates, hereditary-less toxicity without sensitization and Intradermal, and good with blood compatibility, and its every physical and chemical index is as shown in table 1.Preclinical animal studies shows, medical material of the present invention can complete hemostasis in 2 minutes, and obviously reduced bleeding amount of wound.In addition, in rabbit digital flexor tendon injury repairing process, continue to form peplos in tendon week, hinder exogenous tissue, as close in the granulation tissue such as new capillary vessel, fibroblast or tendon injury place of growing into, reduces Adhesion formation, and promotes healing process of tendons.Medical material preparation method of the present invention is simple, and energy-conserving and environment-protective, are suitable for suitability for industrialized production.
Table 1
| Project | Technical requirement |
| PH value | The pH value of the solution of 1% is 6.0 ~ 8.0 |
| Protein content | ≤ 0.1% (mass fraction) |
| Content of beary metal | ≤10μg/g |
| Residual ethanol | ≤400μg/g |
| Bacterial endotoxin is limited the quantity | ≤0.5EU/mg |
| Aseptic | Should be aseptic |
Accompanying drawing explanation
Fig. 1 is the electron microscope picture of the medical material that embodiment 1 obtains, and shows its macromolecule network structure in figure.
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.In following each embodiment, unless otherwise noted, being conventional commercial can obtain for the various kinds of equipment used, reagent and material.
Embodiment 1 is for stopping blooding and the preparation process of absorbent medical material of anti
The medical material of the present embodiment comprises following raw material components: with parts by weight, and molecular weight is 1,000,000 daltonian hyaluronate sodiums 90 parts, water-soluble chitosan 10 parts.
The preparation process of described medical material comprises the following steps:
(1) hyaluronate sodium is dissolved in purified water, is prepared into the solution that concentration is 0.5%.Stirring makes hyaluronate sodium fully dissolve, and then leaves standstill swelling 1h.
(2) water-soluble chitosan is mixed with the solution of 0.5% concentration, and uses agitator stirring to make it fully dissolve.Then swelling 1h is left standstill.
(3) the two kinds of solution mixing (1), (2) step obtained, stir and make its mix homogeneously.Leave standstill swelling 2h.
(4) solution after mixing is poured in mould, after using the abundant freezing 5h of freezer dryer-30 DEG C, dry 15h is carried out with the thermograde of 10 DEG C, 20 DEG C, 30 DEG C, and irradiation sterilization, obtain macromolecule netted for stopping blooding and the absorbent medical material of anti, its electron microscope picture is as shown in Figure 1.
Embodiment 2 is for stopping blooding and the preparation process of absorbent medical material of anti
The medical material of the present embodiment comprises following raw material components: with parts by weight, and molecular weight is 1,000,000 daltonian hyaluronate sodiums 80 parts, carboxymethyl cellulose 20 parts.
The preparation process of described medical material comprises the following steps:
(1) hyaluronate sodium is dissolved in purified water, is prepared into the solution that concentration is 2%, stir and hyaluronate sodium is fully dissolved, then leave standstill swelling 2h.
(2) carboxymethyl cellulose is mixed with the solution of 0.8% concentration, and uses agitator stirring to make it fully dissolve, then leave standstill swelling 1h.
(3) the two kinds of solution mixing (1), (2) step obtained, stir and make its mix homogeneously, leave standstill swelling 2h.
(4) solution after mixing is poured in mould, after using the abundant freezing 5h of freezer dryer-30 DEG C, carry out dry 24h with the thermograde of 10 DEG C, 20 DEG C, 30 DEG C, and irradiation sterilization, obtain macromolecule netted for stopping blooding and the absorbent medical material of anti.
Embodiment 3 is for stopping blooding and the preparation process of absorbent medical material of anti
The medical material of the present embodiment comprises following raw material components: with parts by weight, sodium alginate 60 parts, carboxymethyl starch 40 parts.
The preparation process of described medical material comprises the following steps:
(1) sodium alginate is dissolved in purified water, is prepared into the solution that concentration is 1.5%, stir and hyaluronate sodium is fully dissolved, then leave standstill swelling 2h.
(2) carboxymethyl starch is mixed with the solution of 1.5% concentration, and uses agitator stirring to make it fully dissolve, then leave standstill swelling 2h.
(3) the two kinds of solution mixing (1), (2) step obtained, stir and make its mix homogeneously, leave standstill swelling 1h.
(4) solution after mixing is poured in mould, after using the abundant freezing 1h of freezer dryer-10 DEG C, carry out dry 24h with the thermograde of 5 DEG C, 20 DEG C, 30 DEG C, and irradiation sterilization, obtain macromolecule netted for stopping blooding and the absorbent medical material of anti.
Embodiment 4 is for stopping blooding and the preparation process of absorbent medical material of anti
The medical material of the present embodiment comprises following raw material components: with parts by weight, and molecular weight is 1,000,000 daltonian hyaluronate sodiums 50 parts, water-soluble chitosan 50 parts.
The preparation process of described medical material comprises the following steps:
(1) hyaluronate sodium is dissolved in purified water, is prepared into the solution that concentration is 0.02%, stir and hyaluronate sodium is fully dissolved, then leave standstill swelling 2h.
(2) water-soluble chitosan is mixed with the solution of 0.02% concentration, and uses agitator stirring to make it fully dissolve, then leave standstill swelling 2h.
(3) the two kinds of solution mixing (1), (2) step obtained, stir and make its mix homogeneously, leave standstill swelling 1h.
(4) solution after mixing is poured in mould, after using the abundant freezing 1h of freezer dryer-10 DEG C, carry out dry 24h with the thermograde of 5 DEG C, 20 DEG C, 30 DEG C, and use electron beam sterilization, obtain macromolecule netted for stopping blooding and the absorbent medical material of anti.
Embodiment 5 is for stopping blooding and the preparation process of absorbent medical material of anti
The medical material of the present embodiment comprises following raw material components: with parts by weight, sodium alginate 75 parts, water-soluble chitosan 25 parts.
The preparation process of described medical material comprises the following steps:
(1) sodium alginate is dissolved in purified water, is prepared into the solution that concentration is 2.5%, stir and hyaluronate sodium is fully dissolved, then leave standstill swelling 2h.
(2) water-soluble chitosan is mixed with the solution of 2.5% concentration, and uses agitator stirring to make it fully dissolve, then leave standstill swelling 2h.
(3) the two kinds of solution mixing (1), (2) step obtained, stir and make its mix homogeneously, leave standstill swelling 1h.
(4) solution after mixing is poured in mould, after using the abundant freezing 1h of freezer dryer-10 DEG C, carry out dry 24h with the thermograde of 5 DEG C, 20 DEG C, 30 DEG C, and irradiation sterilization, obtain macromolecule netted for stopping blooding and the absorbent medical material of anti.
Experimental example 1 physicochemical property detects
1, detect the compositions that embodiment 1 ~ 5 provides, concrete detection method is:
PH value: the method specified according to the Pharmacopoeia of the People's Republic of China two annex VI H measures.
Protein content: adopt Ku Masi light blue method to measure.
Content of beary metal: measure according to the Pharmacopoeia of the People's Republic of China two annex VIII H first methods.
Residual ethanol: adopt headspace gas chromatography that ethanol is separated with other components, with flame ionization ditector detection, and compared with the chromatographic peak ethanol chromatographic peak obtained and embodiment 1-5 obtained, calculates Residual ethanol.
Bacterial endotoxin is limited the quantity: measure according to the Pharmacopoeia of the People's Republic of China (version in 2010) two methods that annex XIE specifies.
Aseptic: to measure according to the Pharmacopoeia of the People's Republic of China (version in 2010) two methods that annex XIH specifies.
2, testing result: in table 2
Table 2 embodiment 1 ~ 5 testing result
Table 2 result shows, and embodiment 1 ~ 5 has good physicochemical property.Specifically, neutral pH value and lower albumen, heavy metal and Residual ethanol, demonstrate material prepared by embodiment and cause the probability of immunologic rejection or stimulation lower, be applicable to human body and use.In addition, aseptic and lower Bacterial endotoxin limit, demonstrate medical material prepared by embodiment and can not cause in application process and infect phenomenon and heat source response.
The hemostatic effect evaluation of experimental example 2 pairs of hepatorrhagia models
1, laboratory animal: new zealand rabbit
2, experiment grouping: 50 new zealand rabbits are divided into 5 groups at random, are respectively contrast 1 group, contrast 2 groups, embodiment 1 group, embodiment 2 groups and embodiment 5 groups.
Contrast 1 group: give normal saline;
Contrast 2 groups: prepare biochargeable paper with reference to patent CN03121886.5 (publication number CN1538006A) embodiment;
Embodiment 1,2,5 groups: the absorbent medical material giving embodiment 1,2,5 respectively.
3, experimental technique:
Fixing after new zealand rabbit anesthesia, along left side rib along lower 5cm otch, cut off skin, peritoneum and successively open abdomen and enter abdominal cavity.Use scalpel to draw the wound of long 1cm, dark 0.5cm on liver verso surface.Place in the most obvious hemorrhage position and often organize corresponding hemostatic material (contrast 1 group and only use normal saline flushing), observe the bleeding time, and absorb with the dry gauze of consistent weight the blood reserved, calculate blood volume.
4, experimental result: in table 3
Table 3 zoopery respectively organize bleeding time, amount of bleeding
| Experiment group | Bleeding time (s) | Amount of bleeding (g) |
| Contrast 1 group | 205.8±9.20 | 1.53±0.12 |
| Contrast 2 groups | 83±10.6 | 0.84±0.12 |
| Embodiment 1 group | 68.3±3.2 | 0.15±0.06 |
| Embodiment 2 groups | 62.9±4.9 | 0.12±0.04 |
| Embodiment 5 groups | 60.2±2.5 | 0.08±0.01 |
Table 3 result shows: the amount of bleeding of embodiment 1,2,5 is shorter than the bleeding time of contrast 1,2 groups, and amount of bleeding is few, and has significant difference (p<0.05).Illustrate that absorbent medical material prepared by embodiment is obvious at haemostatic effect, anthemorrhagic performance is better than the biochargeable paper of contrast 2 groups.
Experimental example 3 prevents the animal experiment study of adhesion of tendon
1, laboratory animal: Japan large ear rabbit
2, experiment grouping: 50 large ear rabbits are divided into 5 groups at random, are respectively contrast 1 group, contrast 2 groups, embodiment 1 group, embodiment 2 groups and embodiment 5 groups.
Contrast 1 group: give normal saline;
Contrast 2 groups: prepare biochargeable paper with reference to patent CN03121886.5 (publication number CN1538006A) embodiment;
Embodiment 1,2,5 groups: the absorbent medical material giving embodiment 1,2,5 respectively.
3, experimental technique:
After large ear rabbit anesthesia, expose metapedes sole of the foot face the 2nd, both sides digital flexor tendon surface, the long stndon sheath of 1cm between excision the 1st, 2 ring-type coasters, with clamp flexor digitorum profundus muscle tendon 10 times, then with sharp knife, longitudinally running through tendon cuts 3 cuttves, makes extruding and frustrates and split incision model.After hemostasis, contrast 1 group and use normal saline flushing, contrast 2 groups and use biochargeable paper circular muscle tendons to wrap up for one week, the medical material that embodiment 1,2,5 groups uses embodiment 1,2,5 method to prepare respectively was around tendon one week.Sew up wound.Sterile dressing, the fixing two lower limb knee sprung 150 degree of plaster cast, ankle joint plantar flexion 15 degree, toes nature position.Single cage is raised.Within postoperative 4 weeks, observe measurement range of motion and evaluate adhesion of tendon situation, range of motion low explanation adhesion of tendon is serious.In addition histological observation is carried out to peri-musculotendinous.
4, experimental result: in table 4
The range of motion that table 4 zoopery is respectively organized
| Experiment group | Range of motion (°) |
| Contrast 1 group | 16.33±3.20 |
| Contrast 2 groups | 20.83±2.99 |
| Embodiment 1 group | 26.33.3±4.32 |
| Embodiment 2 groups | 27.50±3.08 |
| Embodiment 5 groups | 30.25±2.09 |
Table 4 result shows: the range of motion of embodiment 1,2,5 is maximum, illustrates that adhesion degree is minimum.To compare with 2 with matched group 1 and all have significant difference (p<0.05).Illustrate that the preventing adhesiving effect of absorbent medical material prepared by embodiment is obvious, anti performance is better than the biochargeable paper of contrast 2 groups.Histological section's observed result finds that embodiment 1,2,5 groups of tendon week thin layer isolation strip continuation are thinning or disappear, and tendon smooth surface, tendon Zhou Kejian thin layer loose connective tissue, inflammatory reaction is light, and collagen fiber propagation in tendon, seriality is good, close to normal muscle-tendon structure.Contrast 1 group of side and still have a small amount of chronic inflammatory cell infiltration, the granulation tissue of the composition such as tendon Zhou great Liang fibroblast, newborn blood capillary is grown into, and tendon surface texture is disorderly, and adhesion is serious.Contrast and 2 groups of tendon weeks have a large amount of fibroblast and granulation tissue to grow into, have obvious adhesion.
Although above with general explanation, detailed description of the invention and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (10)
1. one kind for stopping blooding and the absorbent medical material of anti, it is characterized in that, it comprises following raw material components: with parts by weight, contains natural macromolecule amylose or derivatives thereof 50-90 part of tool hydroxyl and carboxyl, water-soluble alkaline polysaccharide 10-50 part in every 100 parts;
Its preparation method comprises the steps:
(1) the tool hydroxyl of formula ratio and the natural macromolecule amylose or derivatives thereof of carboxyl are dissolved in water and are mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution A;
(2) the water-soluble alkaline polysaccharide of formula ratio is dissolved in water and is mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution B;
(3) swelling by leaving standstill after solution A and solution B mix homogeneously;
(4) mixed solution drying step (3) obtained and sterilization treatment, to obtain final product.
2. according to claim 1 for stopping blooding and the absorbent medical material of anti, it is characterized in that, it comprises following raw material components: with parts by weight, contains natural macromolecule amylose or derivatives thereof 60-80 part of tool hydroxyl and carboxyl, water-soluble alkaline polysaccharide 20-40 part in every 100 parts.
3. according to claim 1 for stopping blooding and the absorbent medical material of anti, it is characterized in that, it comprises following raw material components: with parts by weight, contains natural macromolecule amylose or derivatives thereof 75 parts, the water-soluble alkaline polysaccharide 25 parts of tool hydroxyl and carboxyl in every 100 parts.
4. according to claim 1 for stopping blooding and the absorbent medical material of anti, it is characterized in that, the natural macromolecule amylose or derivatives thereof of described tool hydroxyl and carboxyl is hyaluronic acid and derivant thereof or alginic acid and derivant thereof, preferably clear matter acid sodium; And/or,
Described water-soluble alkaline polysaccharide is water-soluble chitosan, carboxymethyl cellulose or carboxymethyl starch, preferred water soluble chitosan.
5. described in any one of Claims 1 to 4 for stopping blooding and the preparation method of absorbent medical material of anti, it is characterized in that, it comprises the steps:
(1) the tool hydroxyl of formula ratio and the natural macromolecule amylose or derivatives thereof of carboxyl are dissolved in water and are mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution A;
(2) the water-soluble alkaline polysaccharide of formula ratio is dissolved in water and is mixed with the solution that concentration is 0.02 ~ 2.5%, leave standstill swelling, obtain solution B;
(3) swelling by leaving standstill after solution A and solution B mix homogeneously;
(4) mixed solution drying step (3) obtained and sterilization treatment, to obtain final product.
6. preparation method according to claim 5, is characterized in that, in step (1), when the tool hydroxyl of formula ratio and the natural macromolecule amylose or derivatives thereof of carboxyl are dissolved in water, is mixed with the solution that concentration is 0.5 ~ 1.5%; The described swelling time is 1 ~ 2 hour.
7. preparation method according to claim 5, is characterized in that, in step (2), when the water-soluble alkaline polysaccharide of formula ratio is dissolved in water, is mixed with the solution that concentration is 0.5 ~ 1.5%; The described swelling time is 1 ~ 2 hour.
8. preparation method according to claim 5, is characterized in that, in step (3), and described 1 ~ 2 hour swelling time.
9. preparation method according to claim 5, it is characterized in that, in step (4), described dried is lyophilization process, the condition of described lyophilization process is: freezing 1 ~ 5h under-30 DEG C ~-10 DEG C conditions, then in 5 DEG C ~ 30 DEG C drying 15 ~ 24h; And/or,
Described sterilizing is irradiation sterilization or electron beam sterilization.
10. preparation method according to claim 9, is characterized in that, in dry run, the temperature of system rises at 5 DEG C ~ 30 DEG C scope inside gradients.
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| CN201510763334.9A Pending CN105363075A (en) | 2015-11-10 | 2015-11-10 | Haemostatic and anti-adhesion absorbable medical material and preparation method thereof |
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