CN101537205A - Degradable medical hemostatic non-viscous material and preparation method thereof - Google Patents
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Abstract
The invention discloses a degradable medical hemostatic adhesion-resistant material and a preparation method thereof. The invention uses chitosan or derivatives thereof and transparent sodium hyaluronate as main raw materials, adopts methods, such as spray drying, self lamination assembly, and the like to prepare microspheric and gel-type hemostatic adhesion-resistant materials, and medicines and activated substances capable of stimulating hemostasis and antiphlogosis can be compounded and added in the preparation process. The material has high water absorption rate, can rapidly arrest bleeding to form an aquagel protective layer on a wound surface, has favorable tissue adhesiveness, adhesion resistance and bacterinertness, can suit a wound in an irregular shape, truly fully covers the wound surface to fully take the aims of arrest bleeding, resisting adhesion and stimulating wound surface healing, has remarkable postoperative hemostatic adhesion-resistant effects while being used for ear-nose-throat department operations, is convenient to use and brings little pain to patients.
Description
Technical field
The present invention relates to medical technical field, specifically is a kind of degradable medical hemostatic non-viscous material and preparation method thereof.
Background technology
The emergency treatment of daily life sudden accident, hospital to the wound hemostasis in patient's operation process, war in injured soldier's the rescue, it is very important being stopped blooding fast and effectively in the patient part.The tissue adhesion often betides after abdominal cavity, gynecological, orthopaedics, cardiothoracic surgery and the orthopaedic surgery, can cause serious clinical complication, as intestinal obstruction, abdominal cavity and pelvic pain, infertility etc., has increased the difficulty of operation once more.Normally by thromboembolism, contraction small artery and blood capillary, enhancing platelet function accelerate blood process of setting, the local hemostasis material of Shi Yonging mainly contains present hemostatic material clinically: Fibrin Glue, gelfoam, cellulose soluble stanching gauze etc.At present these materials still exist and may bring human body or animal blood borne disease to infect, use complicated, shortcoming such as anthemorrhagic speed is slow, haemostatic effect is not good enough when the general coagulation disorders is arranged, and more existing anti products do not possess the effect of hemostasis and repair in trauma on the market.Therefore to have the medical material of hemostasis, preventing adhesiving effect simultaneously be the problem always explored of people in recent years in exploitation.Comprehensive existing hemostasis, the present situation of adherence preventing material and the requirement of clinical use, ideal medical hemostatic non-viscous material should satisfy following characteristics: (1) is simple and practical, no obvious toxicity; (2) hemostasis rapidly, haemostatic effect is definite, to being in the function that patient under the anticoagulation therapy state still has certain promotion blood coagulation; (3) can adapt to the irregularly shaped and space of wound surface, real flap coverage fully; (4) have favorable tissue adhesion, difficult drop-off; (5) prevent the adhesion of art chamber, mucosa injury is light, does not produce because mucosa, the tissue necrosis due to the local compression can promote the rapid epithelization of wound surface; (6) have controlled degradation rate, make material and wound healing synchronous.
Summary of the invention
The present invention is directed to the deficiencies in the prior art a kind of anthemorrhagic performance and all good degradable medical hemostatic non-viscous material of anti performance are provided.
The present invention also provides the preparation method of above-mentioned degradable medical hemostatic non-viscous material.
A kind of degradable medical hemostatic non-viscous material, mainly make by the component of following mass parts is compound:
100 parts of chitosan or derivatives thereofs;
20～100 parts of hyaluronate sodiums;
0～10 part of cross-linking agent;
0～10000 part in water.
Further, described cross-linking agent is sodium polyphosphate, genipin or bis-epoxy class cross-linking agent.
Further, described degradable medical hemostatic non-viscous material is the compound system of microspheric, gel-type or two types.
A kind of preparation method of degradable medical hemostatic non-viscous material comprises the steps:
1) with chitosan or derivatives thereof and hyaluronate sodium, the compound preparation chitosan of cross-linking agent-hyaluronic acid complex;
2) utilize spray drying to prepare the microspheric bleeding stopping and adherence preventing material;
In the above-mentioned preparation process, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium and cross-linking agent is 100: 20～100: 0～10.
A kind of preparation method of degradable medical hemostatic non-viscous material comprises the steps:
1) adopts electromagnetism, high pressure or air stream drives that the aqueous solution of chitosan or derivatives thereof is added dropwise in the aqueous solution that contains hyaluronate sodium and cross-linking agent, form gel micro-ball;
2) at a plurality of polyelectrolyte layers of gel micro-ball surface-assembled;
3) lyophilization obtains the microspheric bleeding stopping and adherence preventing material;
In the above-mentioned preparation process, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium and cross-linking agent is 100: 20～100: 0～10.
A kind of preparation method of degradable medical hemostatic non-viscous material comprises the steps:
1) with chitosan or derivatives thereof aqueous solution freezing below 0 ℃;
2) add the aqueous solution that contains hyaluronate sodium and cross-linking agent, the bleeding stopping and adherence preventing material of preparation aquogel type;
In the above-mentioned preparation process, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium, cross-linking agent and water is 100: 20～100: 0～10: 1000～10000.
A kind of preparation method of degradable medical hemostatic non-viscous material comprises the steps:
1) preparation microspheric bleeding stopping and adherence preventing material; In the microspheric bleeding stopping and adherence preventing material, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium and cross-linking agent is 100: 20～100: 0～10;
2) in chitosan or derivatives thereof aqueous solution, add the microspheric bleeding stopping and adherence preventing material, freezing below 0 ℃;
3) add the aqueous solution that contains hyaluronate sodium and cross-linking agent, preparation microspheric and the compound bleeding stopping and adherence preventing material of gel-type;
In step 2) and step 3) in, chitosan or derivatives thereof aqueous solution and contain hyaluronate sodium and the aqueous solution of cross-linking agent, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium, cross-linking agent and water is 100: 20～100: 0～10: 1000～10000.
In order further to improve the performance of degradable medical hemostatic non-viscous material, combination drug and active substance (as vitamin K1, Menaquinone K6, vitamin K3, norfloxacin, thrombin, somatomedin etc.) are to improve the bleeding stopping and adherence preventing effect of material therein among the present invention.
Beneficial effect of the present invention is:
The present invention is directed to the hemostasis of using clinically at present, the defective of adherence preventing material, the anthemorrhagic performance and the ideal anti characteristic of hyaluronic acid of comprehensive utilization chitosan and derivant excellence thereof are developed a kind of more effectively bleeding stopping and adherence preventing material.That chitosan has is nontoxic, no antigen and excellent blood coagulation characteristic, stick platelet by protein mediation on the one hand, the complex that forms quickens the polymerization and the common grumeleuse that forms of fibrin monomer, induce erythrocyte aggregation on the other hand, stimulate vasoconstriction, final thrombosis, the involution wound of forming.Its anastalsis does not rely on normal blood coagulation system and platelet, existing result of study shows that chitosan is a kind of than collagen protein, oxidation regeneration fiber and fibrin hemostatic material more efficiently, and chitosan and derivant thereof also have the effect that promotes wound healing, suppresses growth of microorganism simultaneously.Hyaluronic acid has good lubricity, viscoelasticity and non-immunogenic, and participation various kinds of cell activity and physiological process, as migration and differentiation, the wound healing of cell, influence the effect of somatomedin etc., so hyaluronic acid has possessed all characteristics of desirable adherence preventing material substantially.
Degradable medical hemostatic non-viscous material among the present invention has high water absorbing capacity; can quick-acting haemostatic powder and form the hydrogel protective layer in wound surface; have favorable tissue adhesiveness, adhesion inhibiting properties and antibiotic property; simultaneously can adapt to the irregularly shaped of wound site; real flap coverage fully fully plays bleeding stopping and adherence preventing and promotes the purpose of wound healing, and the bleeding stopping and adherence preventing effect that is used for behind common wound and surgery, the ent surgery is remarkable; easy to use, the patient suffering is little.。When this material is applied to wound site, can directly overlays the bleeding part or after it covers the bleeding part, adopt the mode of pushing to strengthen its haemostatic effect and be fixed in the bleeding part.The microspheric bleeding stopping and adherence preventing material can be sprayed directly on the bleeding part or cover gauze thereon pushes hemostasis.The gel-type bleeding stopping and adherence preventing material can directly apply or be pasted on bleeding part and wound surface, also can with microspheric and the gel-type material is compound one be used from the bleeding part again.
Description of drawings
Fig. 1 is the SEM photo of the degradable medical hemostatic non-viscous material of embodiment 1.
Fig. 2 is for using 3 days concha nasalis tissue slices of high expanded tampon sponge hemostasis postoperative photo.
Fig. 3 is for using 3 days concha nasalis tissue slices of bleeding stopping and adherence preventing material postoperative photo of embodiment 1.
Fig. 4 is for using 3 days concha nasalis SEM of bleeding stopping and adherence preventing material postoperative photo of embodiment 3.
Fig. 5 is for using 12 days concha nasalis SEM of bleeding stopping and adherence preventing material postoperative photo of embodiment 5.。
The specific embodiment
Below the present invention will be further described with drawings and Examples.
The preparation of embodiment 1 microspheric bleeding stopping and adherence preventing material
The 1g chitosan is dissolved in 10mL, in the aqueous hydrochloric acid solution of 10wt%, adds 40mLNH
4HCO
3Aqueous solution (contains NH
4HCO
39.6g), 20 ℃ left standstill 3 days, 12,000 leave the heart, abandon supernatant, add the dilution of 200mL water in the precipitate, high-speed stirred 30s adds 100ml aqueous solution of sodium hyaluronate (containing hyaluronate sodium 0.2g), stirs and obtains chitosan-hyaluronic acid complex solution, 150 ℃ of spray dryinges of complex solution are obtained the microspheric bleeding stopping and adherence preventing material, and scanning electron microscope (PhilipsESEM-30) the results are shown in Figure 1.
To causing epistaxis after the New Zealand white rabbit row jaw concha nasalis part enucleation, the microspheric bleeding stopping and adherence preventing material that this embodiment of 1g is prepared sprays on wound surface, and matched group adopts high expanded tampon sponge hemostasis.Use that epistaxis appears in none example in the new zealand white rabbit 24 hours of bleeding stopping and adherence preventing material of the present invention, haemostatic effect is good.Postoperative was cut the rabbit jawbone in 3 days open fully exposes concha nasalis, use high expanded tampon sponge hemostatic concha nasalis position than using bleeding stopping and adherence preventing material hemostatic concha nasalis of the present invention position that tangible suppuration phenomenon is arranged, tissue slice result (Fig. 2, Fig. 3) shows that the tissue repair situation of use bleeding stopping and adherence preventing material of the present invention is better than high expanded tampon sponge.
The preparation of embodiment 2 microspheric bleeding stopping and adherence preventing materials
The 1g phosphonized chitosan is dissolved in the 50mL water, dropwise add 100mL aqueous solution of sodium hyaluronate (containing hyaluronate sodium 0.5g), stirring obtains chitosan-hyaluronic acid complex solution, and 150 ℃ of spray dryinges of complex solution are obtained the microspheric bleeding stopping and adherence preventing material.
Do the hemorrhage wound surface of about 1cm * 0.5cm size on new zealand rabbit kidney surface, microspheric bleeding stopping and adherence preventing material hemostasis with this embodiment preparation of 1g, the result shows that this bleeding stopping and adherence preventing material can play haemostatic effect preferably, bleeding stopping period is 75 ± 12s, amount of bleeding is 0.8 ± 0.1mL, and the adhesion of no art chamber takes place in 30 days.
The preparation of embodiment 3 microspheric bleeding stopping and adherence preventing materials
The 1g chitosan is dissolved in the 50mL acetic acid aqueous solution and (contains acetic acid 0.5g), adopt the static drop generating device that chitosan solution is added drop-wise in the 100mL aqueous solution of sodium hyaluronate and (contain hyaluronate sodium 1g), centrifugalize obtains chitosan-hyaluronic acid derivatives microsphere, immerse successively in chitosan and the aqueous solution of sodium hyaluronate and assemble 6 strata dielectric films at microsphere surface, the centrifugalize postlyophilization gets the microspheric bleeding stopping and adherence preventing material.
To causing epistaxis after the New Zealand white rabbit row jaw concha nasalis part enucleation, the microspheric bleeding stopping and adherence preventing material of this embodiment preparation of 1g is sprayed on wound surface, bleeding stopping period is 160 ± 10s, none routine epistaxis occurs in 24 hours, haemostatic effect is good, 3 days nasal mucosas of postoperative and cilium are repaired all right (Fig. 4), and nasal cavity does not have adhesion to be taken place.
The preparation of embodiment 4 microspheric bleeding stopping and adherence preventing materials
The 1g chitosan is dissolved in 10mL, in the aqueous hydrochloric acid solution of 10wt%, adds 40mL NH
4HCO
3Aqueous solution (contains NH
4HCO
39.6g), 20 ℃ left standstill 3 days, 12,000 leave the heart, abandon supernatant, add the dilution of 200mL water in the precipitate, high-speed stirred 30s adds the aqueous solution (containing hyaluronate sodium 1g, genipin 0.001g) that 100ml contains hyaluronate sodium and cross-linking agent, stirring obtains chitosan-hyaluronic acid complex solution, and 150 ℃ of spray dryinges of complex solution are obtained the microspheric bleeding stopping and adherence preventing material.
Do the hemorrhage wound surface of about 1cm * 0.5cm size on new zealand rabbit kidney surface, microspheric bleeding stopping and adherence preventing material hemostasis with this embodiment preparation of 1g, the result shows that this bleeding stopping and adherence preventing material can play haemostatic effect preferably, bleeding stopping period is 80 ± 10s, amount of bleeding is 0.85 ± 0.12mL, and the serious adhesion in no art chamber takes place in 30 days.
The preparation of embodiment 5 microspheric bleeding stopping and adherence preventing materials
The 1g carboxymethyl chitosan is dissolved in the 50mL water, dropwise add the aqueous solution that 100mL contains hyaluronate sodium and cross-linking agent and (contain hyaluronate sodium 0.4g, sodium polyphosphate 0.05g), stirring obtains chitosan-hyaluronic acid complex solution, and 150 ℃ of spray dryinges of complex solution are obtained the microspheric bleeding stopping and adherence preventing material.
To causing epistaxis after the New Zealand white rabbit row jaw concha nasalis part enucleation, the microspheric bleeding stopping and adherence preventing material of this embodiment preparation of 1g is sprayed on wound surface, bleeding stopping period is 185 ± 10s, there is not epistaxis in 24 hours, haemostatic effect is good, 12 days nasal cavities of postoperative do not have adhesion to be taken place, and nasal mucosa and cilium are repaired all right (Fig. 5).
The preparation of embodiment 6 microspheric bleeding stopping and adherence preventing materials
The 1g phosphonized chitosan is dissolved in the 50mL water, adopt the static drop generating device that chitosan solution is added drop-wise in the aqueous solution that 50mL contains hyaluronate sodium and cross-linking agent and (contain hyaluronate sodium 0.2g, sodium polyphosphate 0.1g), centrifugalize obtains chitosan-hyaluronic acid derivatives microsphere, immerse successively in the aqueous solution of chitosan, hyaluronate sodium and cross-linking agent and assemble 6 strata dielectric films at microsphere surface, the centrifugalize postlyophilization gets the microspheric bleeding stopping and adherence preventing material.
SD rat, pentobarbital sodium are anaesthetized, lie on the back fixing, and rat tails is sterilized, afterbody is sawed-off at the most advanced and sophisticated 5cm of afterbody place with blade, and the bleeding stopping and adherence preventing material of this embodiment of 1g preparation is sprinkling upon rapidly on the afterbody section, investigate the material anthemorrhagic performance, matched group adopts common gauze hemostasis.Bleeding stopping and adherence preventing material of the present invention is compared with common gauze, and anastalsis is rapid-action, haemostatic effect is definite, can significantly reduce blood loss, obviously shortens the bleeding time.
The preparation of embodiment 7 gel-type bleeding stopping and adherence preventing materials
The 1g hydroxyethyl chitosan is dissolved in the 50mL water, place-4 ℃ freezing 12 hours, add 4 ℃ of 50mL aqueous solution of sodium hyaluronate (containing hyaluronate sodium 1g, sodium polyphosphate 0.03g) and preserved 24 hours in 4 ℃, obtain the gel-type bleeding stopping and adherence preventing material.
Do the hemorrhage wound surface of about 1cm * 1cm size at rat back, use the gel-type bleeding stopping and adherence preventing material of this embodiment to paint a wound, bleeding stopping period is all less than 3 minutes, wherein in 2 minutes produce effects reach 97.8%, this material can promote wound healing simultaneously, reduces cicatrization.
The preparation of embodiment 8 gel-type bleeding stopping and adherence preventing materials
The 1g chitosan is dissolved in the 25mL acetic acid aqueous solution and (contains acetic acid 0.5g), place-4 ℃ freezing 12 hours, add 4 ℃ of 25mL aqueous solution of sodium hyaluronate (containing hyaluronate sodium 0.5g, genipin 0.002g) and, obtain the gel-type bleeding stopping and adherence preventing material in 4 ℃ of preservations 24 hours.
Do the hemorrhage wound surface of about 1cm * 1cm size at rat back, use the gel-type bleeding stopping and adherence preventing material of this embodiment to paint a wound, bleeding stopping period is all less than 3 minutes, wherein in 2 minutes produce effects reach 98.2%, this material can promote wound healing simultaneously, reduces cicatrization.
The preparation of embodiment 9 microspheres-compound bleeding stopping and adherence preventing material of gel
The microspheric bleeding stopping and adherence preventing material 1g that gets embodiment 1 preparation adds 10mL carboxymethyl chitosan sugar aqueous solution (containing carboxymethyl chitosan 0.2g), ultra-sonic dispersion is even, place-4 ℃ freezing 12 hours, add 4 ℃ of 2mL polyphosphoric acids sodium water solutions (containing sodium polyphosphate 0.02g) and, obtain the compound bleeding stopping and adherence preventing material of microsphere-gel in 4 ℃ of preservations 24 hours.
Do the hemorrhage wound surface of about 1cm * 1cm size at rat back, use the gel-type bleeding stopping and adherence preventing material of this embodiment to paint a wound, bleeding stopping period is all less than 3 minutes, wherein in 1.5 minutes produce effects reach 98%, this material can promote wound healing simultaneously, reduces cicatrization.
Claims (7)
1, a kind of degradable medical hemostatic non-viscous material is characterized in that mainly making by the component of following mass parts is compound:
100 parts of chitosan or derivatives thereofs;
20～100 parts of hyaluronate sodiums;
0～10 part of cross-linking agent;
0～10000 part in water.
2, degradable medical hemostatic non-viscous material according to claim 1 is characterized in that described cross-linking agent is sodium polyphosphate, genipin or bis-epoxy class cross-linking agent.
3, degradable medical hemostatic non-viscous material according to claim 1 is characterized in that: described degradable medical hemostatic non-viscous material is the compound system of microspheric, gel-type or two types.
4, a kind of preparation method of degradable medical hemostatic non-viscous material is characterized in that comprising the steps:
1) with chitosan or derivatives thereof and hyaluronate sodium, the compound preparation chitosan of cross-linking agent-hyaluronic acid complex;
2) utilize spray drying to prepare the microspheric bleeding stopping and adherence preventing material;
In the above-mentioned preparation process, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium and cross-linking agent is 100: 20～100: 0～10.
5, a kind of preparation method of degradable medical hemostatic non-viscous material is characterized in that comprising the steps:
1) adopts electromagnetism, high pressure or air stream drives that the aqueous solution of chitosan or derivatives thereof is added dropwise in the aqueous solution that contains hyaluronate sodium and cross-linking agent, form gel micro-ball;
2) at a plurality of polyelectrolyte layers of gel micro-ball surface-assembled;
3) lyophilization obtains the microspheric bleeding stopping and adherence preventing material;
In the above-mentioned preparation process, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium and cross-linking agent is 100: 20～100: 0～10.
6, a kind of preparation method of degradable medical hemostatic non-viscous material is characterized in that comprising the steps:
1) with chitosan or derivatives thereof aqueous solution freezing below 0 ℃;
2) add the aqueous solution that contains hyaluronate sodium and cross-linking agent, the bleeding stopping and adherence preventing material of preparation aquogel type;
In the above-mentioned preparation process, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium, cross-linking agent and water is 100: 20～100: 0～10: 1000～10000.
7, a kind of preparation method of degradable medical hemostatic non-viscous material is characterized in that comprising the steps:
1) preparation microspheric bleeding stopping and adherence preventing material; In the microspheric bleeding stopping and adherence preventing material, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium and cross-linking agent is 100: 20～100: 0～10;
2) in chitosan or derivatives thereof aqueous solution, add the microspheric bleeding stopping and adherence preventing material, freezing below 0 ℃;
3) add the aqueous solution that contains hyaluronate sodium and cross-linking agent, preparation microspheric and the compound bleeding stopping and adherence preventing material of gel-type;
In step 2) and step 3) in, chitosan or derivatives thereof aqueous solution and contain hyaluronate sodium and the aqueous solution of cross-linking agent, the mass ratio of chitosan or derivatives thereof, hyaluronate sodium, cross-linking agent and water is 100: 20～100: 0～10: 1000～10000.
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| CN101816627B (en) * | 2010-04-16 | 2012-03-07 | 浙江大学 | Synergistic treatment type multi-material sustained-release eye drop and preparation method |
| CN101816627A (en) * | 2010-04-16 | 2010-09-01 | 浙江大学 | Synergistic treatment type multi-material sustained-release eye drop and preparation method |
| CN101837143A (en) * | 2010-04-22 | 2010-09-22 | 胡堃 | Medicinal sustained-release and hemostatic composition and preparation method thereof |
| CN102258813A (en) * | 2010-05-31 | 2011-11-30 | 中国科学院化学研究所 | Medical anti-adhesion material and preparation method thereof |
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| CN102309776A (en) * | 2011-09-05 | 2012-01-11 | 北京博恩康生物科技有限公司 | A kind of powdery absorbable hemostatics and preparation method thereof |
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