JPH11276571A - Material for medical care and its manufacturing method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method and material for medical care that is excellent in safety, close adhesiveness water absorbency, water-retentivity, durability, organism adaptability, managing convenience, preservability, ability to shut bacteria, easiness to suture and to be peeled from the surface of a affected part, strength, softness and permeability. SOLUTION: This material for medical care consists of a sponge layer composed of crosslinking material of N-succinyl chitosan and gelatin and a reinforcing layer made of non-woven cloth. The sponge layer is exposed to radioactive rays, and it may contains an anti-bacterial agent. Also, at least one sort of anti-bacterial agent should be selected as the antibacterial agent among sulfa drag, aminoglycoside, penicillin and inorganic anti-bacterial agent. The manufacturing method for this medical material is as follows; an aqueous solution which contains N-succinyl chitosan, gelatin and crosslinking agent and the non-woven cloth is made to be contacted, frozen and dried.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical material excellent in biocompatibility in which a sponge layer composed of N-succinyl chitosan and gelatin is reinforced with a nonwoven fabric, and a method for producing the medical material. The present invention relates to a medical material applicable to a material and a method for producing the medical material.

[0002]

2. Description of the Related Art As a medical material excellent in biocompatibility, a wound dressing material having a sponge layer composed of a chitosan derivative and collagen and a film layer formed of a specific polyurethane resin has been known. (Japanese Unexamined Patent Publication
No. 289961). Such a wound dressing has a specific polyurethane resin film as a reinforcing material,
Since the flexibility is not sufficient, the adhesiveness is poor when applied to a curved portion or the like. In particular, in order to promote healing of deep wounds such as pressure ulcers, the adhesion of the wound dressing is required, and therefore the wound dressing is required to have high flexibility.

Further, since the polyurethane resin film is inferior in moisture permeability, the exudate is stored under the wound dressing, and the wound portion is likely to be in a wet state. In the case of a wound with a large amount of exudate, the polyurethane resin film sufficiently functions as a wound dressing. There is a problem that can not be. In particular, deep wounds such as pressure ulcers often generate exudate, and an efficient drainage function, that is, moisture permeability, is required to prevent the accumulation of exudate. A method of mechanically drilling a drainage hole in a coating material to increase moisture permeability is known, but no remarkable improvement has been found. Further, collagen has a high raw material price, so that the product price of a medical material manufactured using the same is very high.

[0004] On the other hand, in order to impart antibacterial properties to the wound dressing, the wound dressing may contain an antibacterial agent. In this case, it is required that the antibacterial agent is efficiently eluted in order to exhibit antibacterial properties. It is described that the wound dressing described in JP-A-3-289961 may also contain an antimicrobial agent, but in the wound dressing, the antimicrobial agent is firmly held in the polyurethane resin film. Therefore, the dissolution rate is low and its antibacterial activity cannot be expected to be high. In addition, a wound dressing material in which a polyamino acid is impregnated with an antibacterial agent is known (Japanese Patent Application Laid-Open No. 63-115566). Therefore, the dissolution of the antibacterial agent was inferior and the antibacterial activity during the clinical stage could not be expected.

[0005] Further, the wound dressing described in JP-A-3-289961 described above comprises a freeze-drying step of a chitosan derivative and a collagen solution, a crosslinking step of a sponge obtained by the freeze-drying step, a washing step, It is produced by a plurality of bonding steps of a crosslinked sponge obtained from the crosslinking step and a specific polyurethane resin film. Therefore, the operation steps are complicated, and a large amount of organic solvent is required for the production. Therefore, this production method requires improvement in production efficiency and cost.

JP-A-8-196613 discloses a medical material having a sponge layer containing N-succinyl chitosan cross-linked with an epoxy-based cross-linking agent and a reinforcing material layer made of a nonwoven fabric. Since this medical material has the inherent strength of chitosan, it is difficult to apply the medical material to curved parts requiring flexibility and pocket-shaped wounds such as pressure ulcers. Upon use, residual material was noted. In addition, it was suggested that an uncleaved terminal of the cross-linking agent may remain because an epoxy compound is used as the cross-linking agent.

[0007]

DISCLOSURE OF THE INVENTION The present invention relates to safety, adhesion, water absorption, water retention, durability, biocompatibility, easy handling, preservation, bacterial barrier, suture, and wound surface. An object of the present invention is to provide a medical material having excellent peelability, strength, flexibility and moisture permeability, and a method for producing the medical material.
That is, the present invention has high flexibility without causing any harm to a living body, has close adherence even when applied to a pocket-shaped wound surface such as a pressure ulcer or a curved portion, and retains bodily fluids by moderate moisture permeability. The present invention provides a medical material which exhibits excellent antibacterial properties by preventing the occurrence of antibacterial agents, dissolution of an appropriate antibacterial agent, and is free from breakage, melting or peeling during peeling, and excellent in strength and ease of handling, and a method for producing the medical material. The purpose is to do. Moreover,
An object of the present invention is to provide an inexpensive medical material having high production efficiency, excellent environmental hygiene, and low production cost, and a method for producing the medical material.

[0008]

Means for Solving the Problems The inventors of the present invention have conducted intensive studies in order to solve the above-mentioned problems, and as a result, a medical material in which a sponge made of a cross-linked product of N-succinyl chitosan and gelatin is reinforced with a nonwoven fabric. Safety, adhesion, water absorption, water retention, durability, biocompatibility, easy handling, storage,
Bacterial barrier, suture, exfoliation from wound surface, strength, flexibility and moisture permeability are excellent, and by irradiating radiation to completely eliminate unreacted crosslinker terminals, safety, strength,
It has been found that it is a medical material with excellent handling convenience.

That is, the present invention is a medical material having a sponge layer made of a cross-linked product of N-succinyl chitosan and gelatin and a reinforcing material layer made of a nonwoven fabric. Here, the sponge layer may be irradiated, and may further contain at least one antibacterial agent selected from the group consisting of sulfa antibacterial agents, aminoglycoside antibacterial agents, penicillin antibacterial agents and inorganic antibacterial agents. . The cross-linking may be performed by a compound having at least two epoxy groups. Further, the nonwoven fabric may be made of natural fibers or synthetic fibers.

Further, the present invention is a method for producing a medical material, comprising contacting an aqueous solution containing N-succinylchitosan, gelatin and a crosslinking agent with a nonwoven fabric and freeze-drying the same. Further, the present invention is a method for producing a medical material, comprising contacting an aqueous solution containing N-succinylchitosan, gelatin, a crosslinking agent and an antibacterial agent with a nonwoven fabric and freeze-drying the same.

Further, the present invention is characterized in that an aqueous solution containing N-succinylchitosan, gelatin and a crosslinking agent is brought into contact with a nonwoven fabric and freeze-dried, and the resulting freeze-dried product is further irradiated with radiation. This is a method for producing a medical material. Furthermore, the present invention is characterized in that an aqueous solution containing N-succinyl chitosan, gelatin, a crosslinking agent and an antibacterial agent is brought into contact with a nonwoven fabric and freeze-dried, and the resulting freeze-dried product is further irradiated with radiation. This is a method for producing a medical material. Hereinafter, the present invention will be described in detail.

[0012]

BEST MODE FOR CARRYING OUT THE INVENTION The medical material of the present invention has a sponge layer and a reinforcing material layer made of a nonwoven fabric, wherein the sponge layer has a crosslinked product of N-succinylchitosan and gelatin. Things. By using a sponge layer containing a crosslinked product of N-succinyl chitosan and gelatin, the strength, water absorption and texture of the medical material are improved. In the present invention, the cross-linked sponge or medical material can be sterilized by irradiating the cross-linked sponge or medical material, and
The crosslinking agent remaining in the medical material can be inactivated.

N-succinyl chitosan is obtained by deacetylating a part or all of the N-acetyl group of chitin, in which the amino group (-NH ₂ ) of chitosan is succinylated. Chitin is obtained, for example, by subjecting crusts such as crabs and shrimps to decalcium carbonate treatment with dilute hydrochloric acid and then deproteinizing with dilute sodium hydroxide solution. The obtained crude chitin may be used as it is or may be used after purification treatment. Deacetylation of chitin can be performed by treating chitin with a concentrated alkali such as a concentrated sodium hydroxide solution. The obtained chitosan can be used as long as it dissolves in an acid, but it is preferable to use those having a degree of deacetylation of 65% or more, and more preferably 85% or more. Are preferred. Succinylation of the amino group of chitosan is performed using succinic anhydride. Any water-soluble N-succinyl chitosan can be used, but the succinyl group after succinylation relative to the amount (mol) of amino group (-NH ₂ ) of chitosan before succinylation is used. Quantity (m
ol) (succinylation degree) is preferably 40% or more.

As the gelatin, there can be used, for example, ordinary commercially available gelatin obtained from cattle bone, cow skin or pig skin by an alkali method or an acid method, or gelatin prepared by heat denaturing collagen. Among them, gelatin specified in the Japanese Pharmacopoeia or purified gelatin,
Alternatively, gelatin satisfying the same standard as these is preferable.

In the present invention, a crosslinked sponge of N-succinylchitosan and gelatin is used. Also, N-
The degree of crosslinking between the succinyl chitosan and the gelatin sponge is usually from 0.01 to 100%, preferably from 0.1 to 30%. Here, the degree of crosslinking of N- succinyl chitosan and gelatin sponge, amino (-NH ₂₎ and a carboxyl group contained in the N- succinyl chitosan and gelatin before crosslinking (-C
OOH) relative to the total amount (mol) of the crosslinked group after crosslinking. If the degree of cross-linking is too high, the flexibility is reduced, and if the ratio of cross-linking is too low, when a medical material is formed, elution of N-succinylchitosan or gelatin may occur. As the cross-linking agent used for cross-linking N-succinyl chitosan and gelatin sponge, any compound that reacts with N-succinyl chitosan and gelatin can be used, and specifically, 4,4 methylene -
Bis- (2-chloroaniline), compounds having an amino group such as hydroxypropylated ethylenediamine, compounds having an aldehyde group such as glutaraldehyde, isocyanates such as hexamethylene diisocyanate, glycerin-1,3-diamine Examples thereof include compounds having at least two epoxy groups such as glycidyl ether and 1,6 hexanediol diglycidyl ether, and acid anhydrides such as acetic anhydride and succinic anhydride. These may be used alone or in combination of two or more. It can be used in combination. Preferred among these are compounds having at least two epoxy groups as reactive groups.

Further, the medical material of the present invention has a reinforcing material layer made of a nonwoven fabric in order to improve its strength.
Natural fibers or synthetic fibers are used as the nonwoven fabric. As the natural fiber, specifically, cellulosic fiber, protein fiber and the like are exemplified, and as the synthetic fiber,
Specifically, polyamide fiber, polyester fiber, polyurethane fiber, polyurea fiber, polyolefin fiber, polystyrene fiber, polyvinyl chloride fiber, polyvinylidene chloride fiber, polyfluoroethylene fiber, polyacrylonitrile fiber Examples thereof include fibers, polyvinyl alcohol-based fibers, and polyvinylidene cyanide-based fibers. Among these, cellulosic fibers are preferred.

Further, the medical material of the present invention can be sterilized by irradiation with radiation, and can inactivate unreacted crosslinking agent residues. Irradiation can be performed using either continuous irradiation or batch irradiation of gamma rays, electron beams or X-rays using cobalt 60 or cesium 137. The irradiation dose is usually 1 kGy to 50 kGy, preferably 5 kGy to 25 kGy. If the irradiation dose is too high, it may cause decomposition of the raw material, while if the irradiation dose is too low, the crosslinker residue is not sufficiently inactivated.

In the medical material of the present invention, in consideration of flexibility, the thickness of the sponge layer is preferably in the range of 1 to 20 mm, and the thickness of the reinforcing nonwoven fabric layer is more preferably in the range of 0.1 to 1 mm. preferable. In the medical material of the present invention, an antibacterial agent can be contained in the sponge layer. As the antibacterial agent, a conventionally known antibacterial agent can be used without particular limitation. For example, sulfadiamine antibacterial agents such as silver sulfadiazine, zinc sulfadiazine and cerium sulfadiazine; aminoglycoside antibacterial agents such as gentamicin sulfate, streptomycin sulfate and fradiomycin sulfate; penicillin antibacterial agents such as ampicillin and sodium methicillin; inorganic antibacterial agents such as silver nitrate Agents and the like, which can be used alone or in combination of two or more. Among them, those containing at least a sulfa drug-based antibacterial agent are preferable in that the antibacterial property and suppression of resistant bacteria are effectively performed.

The medical material of the present invention can be manufactured as follows. That is, an aqueous solution containing N-succinylchitosan, gelatin and a cross-linking agent is brought into contact with a nonwoven fabric, layered thereon, and freeze-dried. Lyophilization is
It is carried out by a commonly used method, for example, by freezing an aqueous solution and a nonwoven fabric dispensed in a tray at -40 ° C, and then drying them under vacuum or reduced pressure. The freeze-dried product may be irradiated with radiation. In this way, it is possible to easily produce a double-layered medical material in which one surface is composed of a cross-linked sponge layer of N-succinylchitosan and gelatin and the other surface is a reinforcing material layer composed of a nonwoven fabric.

Here, the concentration of N-succinyl chitosan and gelatin in the aqueous solution is not particularly limited, but considering the improvement of the flexibility and strength of the sponge layer obtained,
The range is preferably from 0.1 to 4.0% w / v, more preferably from 1.0 to 2.0% w / v. Also, the ratio of N-succinyl chitosan and gelatin is usually 1: 9 to 9: 1, preferably 4: 6 to 7: 3
It is. The amount of the crosslinking agent to be added may be such that the degree of crosslinking between N-succinyl chitosan and gelatin falls within the above range.Specifically, the amount of the crosslinking agent is 0.01 to 0.01 mol per mol of amino group and carboxyl group. It is preferably added in the range of 1 mol, and more preferably in the range of 0.01 to 0.3 mol. Whether or not N-succinylchitosan and gelatin have been crosslinked can be confirmed by the degree of insolubilization of the sponge layer. As a confirmation method, for example, measurement of potassium permanganate consumption of the sponge eluate,
Measurement of glucosamine or hydroxyproline and the like.

The nonwoven fabric may be, for example, placed in an aqueous solution containing the above-mentioned N-succinylchitosan and gelatin in a container, and may be layered in such a manner as to cover the surface of the aqueous solution.
Radiation may be directly applied to the obtained freeze-dried sponge. Further, by contacting an aqueous solution containing N-succinyl chitosan, gelatin and a crosslinking agent and an antibacterial agent with the nonwoven fabric, freeze-drying, and further irradiating radiation,
The medical material of the present invention, which exhibits antibacterial properties, has a double structure in which one side is a crosslinked sponge layer containing N-succinylchitosan, gelatin and an antibacterial agent, and the other side is a reinforcing layer made of a nonwoven fabric. Can be manufactured. The amount of the antibacterial agent to be added varies depending on the antibacterial activity of the antibacterial agent used, but is preferably from 0.1 to 500 μg, more preferably from 0.1 to 10 μg, per cm ^{2 of the} obtained sponge layer. When the medical material of the present invention is used as a wound dressing, the antibacterial agent is slowly released to the affected area, and the growth of bacteria existing on the wound surface can be effectively prevented. Can be prevented.

[0022]

EXAMPLES Examples of the present invention will be described below in detail, but the present invention is not limited to these examples. Reference Example 1 Preparation of Chitosan 400 g of crushed red snow crab shell was placed in 4 L of 5% hydrochloric acid.
After stirring at room temperature for 5 hours, the solution was filtered and the remaining solid was washed with water. The solid was placed in 4 L of a 5% aqueous sodium hydroxide solution, heated at 90 ° C. for 2.5 hours, filtered, and the remaining solid was washed with water to obtain chitin.
4% of 50% aqueous sodium hydroxide solution of chitin obtained here
And heated with stirring to 90 ° C. for 2.5 hours, then the solution was filtered, the solid which had settled out was thoroughly washed with water, and heated to 95 ° C.
And 82 g of chitosan having a degree of deacetylation of 99% was obtained.

Preparation of N-Succinyl Chitosan 50 g of the above chitosan was dispersed in 2.4 L of deionized water, and then 50 g of acetic acid was added.
And dissolved. 2.5 L of methanol was gradually added to this solution, and the mixture was stirred well.
0 ml (59.0 g / 400 ml) was added and stirred overnight. After the reaction, the precipitate was separated, and 2.5 L of demineralized water and 800 ml of 5 mol / L sodium hydroxide were added thereto, and the mixture was stirred and dissolved overnight. After dialysis, the solution was concentrated to obtain 4.5 L of a 1.5% N-succinyl chitosan solution. The degree of succinylation of N-succinyl chitosan is 50%
Met.

Production Example 1 Production of Medical Material I 100 g of 1.5% N-succinyl chitosan solution prepared in Reference Example 1
Glycerin-1,3-diglycidyl ether as a crosslinking agent was added so as to be 0.1 mol (0.18 g) with respect to 1 mol of amino groups and carboxyl groups of N-succinylchitosan. After sufficiently stirring the obtained mixed solution, 11 cm × 10
22 g of the solution was dispensed into a cm square container. Next, a 0.3 mm-thick cellulose-based nonwoven fabric was layered on the surface of the mixed solution in the container, and then rapidly frozen in a methanol bath, followed by vacuum freeze-drying for 24 hours. Thus, a medical material X composed of the sponge layer and the reinforcing material layer made of the nonwoven fabric was obtained.

Production of Medical Material II 1.5 g of gelatin (ES-290 manufactured by Miyagi Chemical Co., Ltd.) was added to 10 g of distilled water.
After 0 g was added and left at room temperature for 4 hours, the mixture was heated to 40 ° C. and dissolved by stirring to prepare a 1.5% gelatin solution. To this, 0.18 g of glycerin-1,3-diglycidyl ether was added as a crosslinking agent. In the subsequent treatment, a medical material II was obtained in the same manner as in the method for producing the medical material I.

Production of Medical Material III 10 g of 1.5% gelatin solution and 1.5% N-succinyl chitosan solution 9
And glycerin-1,3 as a crosslinking agent.
-Diglycidyl ether is used in an amount of 0.1 mole (0.1 mole) to 1 mole of amino group and carboxyl group of N-succinylchitosan.
16 g) was added. In the subsequent treatment, a medical material III was obtained in the same manner as in the method for producing the medical material I.

Preparation of medical material IV 50% 1.5% gelatin solution and 1.5% N-succinyl chitosan solution 5
And glycerin-1,3 as a crosslinking agent.
-Diglycidyl ether is used in an amount of 0.1 mole (0.1 mole) to 1 mole of amino group and carboxyl group of N-succinylchitosan.
09g). In the subsequent treatment, a medical material IV was obtained in the same manner as in the method for producing the medical material I.

Preparation of Medical Material V 90% of 1.5% gelatin solution
10 g of a 1.5% N-succinyl chitosan solution was mixed well, and glycerin-1,3-diglycidyl ether as a cross-linking agent was added thereto in an amount of 0.1 mol (0.02 mol) relative to 1 mol of amino groups and carboxyl groups of N-succinyl chitosan. g). In the subsequent processing, the medical material V was obtained in the same manner as the method for manufacturing the medical material V.

Example 1 The obtained medical materials I to V were compared and observed for moldability and flexibility. Table 1 shows the results. Medical materials I and III were excellent in moldability but lacked in flexibility, and a little stiffness was recognized. Further, the medical materials II and V were somewhat inferior in moldability and were somewhat insufficient to obtain as products. On the other hand, the medical material IV had a shape sufficient to be applied to the wound surface, and became a flexible sheet that was resistant to bending and pulling.

[0030]

[Table 1]

Production Example 2 Production of Medical Material VI 50 g of 1.5% gelatin solution and 1.5% N-succinyl chitosan solution 5
And glycerin-1,3 as a crosslinking agent.
-Diglycidyl ether is used in an amount of 0.5 mol (0.1 mol) to 1 mol of amino group and carboxyl group of N-succinylchitosan.
45 g). In the subsequent treatment, a medical material VI was obtained in the same manner as in the method for producing the medical material I.

Preparation of Medical Material VII 50 g of 1.5% gelatin solution and 1.5% N-succinyl chitosan solution 5
And glycerin-1,3 as a crosslinking agent.
-Diglycidyl ether is used in an amount of 0.05 mol per 1 mol of amino group and carboxyl group of N-succinyl chitosan.
(0.05 g). In the subsequent processing, a medical material VII was obtained in the same manner as in the method for producing the medical material I.

Preparation of Medical Material VIII 50 g of 1.5% gelatin solution and 1.5% N-succinyl chitosan solution 5
And glycerin-1,3 as a crosslinking agent.
-Diglycidyl ether is used in an amount of 0.01 mol per 1 mol of amino group and carboxyl group of N-succinyl chitosan.
(0.01 g). In the subsequent treatment, a medical material VIII was obtained in the same manner as in the method for producing the medical material I.

Example 2 As a result of comparative observation of the medical material IV and the obtained medical materials VI to VIII, the sponge layer of the medical material VI was rigid and inferior in flexibility.
The sponge layers I and VIII were soft, did not break even when bent, and had good water absorption. Further, for the purpose of measuring the degree of insolubilization of the sponge layer, the elution amount of the base material from each medical material was measured. First, the medical material is immersed in demineralized water for a certain period of time, the base material eluted in the immersion liquid is oxidized by potassium permanganate, and the base material from each medical material is used as an index based on the potassium permanganate consumption. Was shown. Specifically, 1 g of the medical materials IV, VI to VIII was added to 10 ml of deionized water.
0 ml, and extracted by shaking at 37 ° C for 24 hours.
In accordance with the rubber stopper test method for infusion (3) eluate test (V) potassium permanganate reducing substance measurement method (13th revision, Japanese Pharmacopoeia, 176-177, 1996), 0.002mol / Oxidized with potassium permanganate and the amount of consumed potassium permanganate was quantified by back titration with a 0.01 mol / l sodium thiosulfate solution. Separately, the same operation was performed using 100 ml of deionized water for a blank test. Table 2 shows medical materials I
V, VI-VIII potassium permanganate consumption was shown.

[0035]

[Table 2]

Although the amount of the eluate of the medical materials IV and VI was small, the consumption value of VII and VIII increased with the decrease in the amount of glycerin-1,3-diglycidyl ether, and it became easy to dissolve. confirmed.

Example 3 A defect layer (3 cm × 2.5 cm) was surgically formed on one side of the back of two rats aged 6 to 8 weeks, and the medical material I obtained in Production Example 1 was used. , Medical Materials IV
After the sutures were sutured, they were bandaged with an elastic band. Two weeks later, when the medical material was peeled from the wound surface of the rat, the wound surface obtained with the medical material I was inferior in granulation formation and the wound surface contracted little. On the other hand, the wound surface obtained with Medical Material IV
It was found that the IV was soft and adhered to the wound surface, formed good granulation, showed sufficient shrinkage, and had a healing promoting effect.

Production Example 3 Production of Medical Material IX Gamma rays using cobalt 60 as a radiation source were further added to medical material IV.
Irradiation at 1 kGy yielded medical material IX. Manufacture of medical material X Further gamma rays using cobalt 60 as a source were added to medical material IV.
Irradiation at 5 kGy gave medical material X.

Production of Medical Material XI Further gamma rays using cobalt 60 as a radiation source were added to medical material IV.
Irradiation at 10 kGy yielded medical material XI. Manufacture of medical material XII Further gamma rays using cobalt 60 as a source were added to medical material IV.
Irradiation at 20 kGy yielded medical material XII. Manufacture of medical material XIII In addition to medical material IV, gamma rays using cobalt 60 as a radiation source
Irradiation at 100 kGy yielded medical material XIII.

Example 4 Medical material produced in Production Example 3
IX to XIII were homogenized with 100 ml of pure water, and the amount of epoxy contained in the clarified solution was measured by the following method. That is, 0.15 ml of the reagent and 0.6 ml of the reagent were added to 0.3 ml of the clear solution,
Heated at 80 ° C. for 10 minutes. After cooling to room temperature, 0.5 ml of the reagent was added and immediately measured at 600 nm. Table 3 shows the results.

[0041]

[Table 3]

Although a small amount of epoxy was confirmed in the medical material IX, no epoxy residue was observed in the medical materials X, XI, XII and XIII. The medical material XIII showed a sense of rigidity, but the medical materials IX, X, XI, and XII, like the sponge after freeze-drying, were soft, did not break even when bent, and had good water absorption.

Production Example 4 Production of Medical Material XIV 1.5 g of gelatin (ES-290 manufactured by Miyagi Chemical Co., Ltd.) was added to 10 g of distilled water.
After 0 g was added and left at room temperature for 4 hours, the mixture was heated to 40 ° C., stirred and dissolved. 100 g of the 1.5% N-succinyl chitosan solution prepared in Production Example 1 and a gelatin solution were mixed well, and glycerin-1,3-diglycidyl ether was added as a cross-linking agent to the amino group and carboxyl group of N-succinyl chitosan. It was added so as to be 0.1 mol (0.18 g) with respect to mol, and further 200 μg of silver sulfadiazine was added and mixed. The subsequent treatment was performed by freeze-drying in the same manner as in the method for producing the medical material I, and then irradiating with 10 kGy of gamma rays using cobalt 60 as a radiation source to obtain a medical material XIV.

Example 5 Agar Medium (Nutrient agar Eiken)
(35 g / 1000 ml), and a medical material X produced in Production Example 3 containing physiological saline and a medical material XIV5 cm produced in Production Example 4
A gauze 5 cm × 5c containing 2 × 5 cm of sterile physiological saline containing 1 × 10 ⁴ cells / cm ² of Pseudomonas aeruginosa
m for 3 days at 37 ° C. 1cm agar under medical materials
× 1 cm was cut out, and the agar was placed in 10 ml of sterilized water and treated with an ultrasonic cleaner (38 kHz) for 30 seconds to shake off bacteria on the agar surface to prepare a mother liquor. This mother liquor was diluted with sterile water to prepare a diluted solution having a concentration of 1/10 to 1/10 ⁶ times. 0.1 ml of these dilutions were inoculated on an agar medium and cultured at 30 ° C. for 1 day, and the number of colonies formed was measured to determine the number of bacteria existing on the agar under the covering material. Table 4 shows the results.

[0045]

[Table 4]

In the case of the medical material X, Pseudomonas aeruginosa permeated the agar under the medical material, but in the case of the medical material XIV, no Pseudomonas aeruginosa was found in the agar under the medical material, and the invasion of bacteria from the outside was prevented. It was confirmed that.

[0047]

According to the present invention, there is provided a medical material having a sponge layer composed of a crosslinked product of N-succinyl chitosan and gelatin and a reinforcing material layer composed of a nonwoven fabric, and a method for producing the medical material. The medical material of the present invention has safety, adhesion, water absorption, water retention, durability, biocompatibility, easy handling, preservability, bacterial barrier, suture, releasability from the wound surface, etc. Has high strength, excellent flexibility,
Excellent moisture permeability. Therefore, the medical material of the present invention is suitable as a medical material such as a wound dressing.
Further, according to the method for producing a medical material of the present invention, the steps are simplified, the process is efficient, and the production cost can be reduced. Further, since an organic solvent is not used, a safer medical material can be manufactured.

Claims (10)

[Claims] 1. A medical material having a sponge layer composed of a crosslinked product of N-succinylchitosan and gelatin and a reinforcing material layer composed of a nonwoven fabric. 2. The medical material according to claim 1, wherein the sponge layer has been irradiated. 3. The medical material according to claim 1, wherein the crosslinking is performed by a compound having at least two epoxy groups. 4. The medical material according to claim 1, wherein the nonwoven fabric is made of a natural fiber or a synthetic fiber. 5. The medical material according to claim 1, wherein the sponge layer contains an antibacterial agent. 6. The medical material according to claim 5, wherein the antimicrobial agent is at least one selected from the group consisting of a sulfa antimicrobial agent, an aminoglycoside antimicrobial agent, a penicillin antimicrobial agent, and an inorganic antimicrobial agent. 7. A method for producing a medical material, comprising bringing an aqueous solution containing N-succinylchitosan, gelatin and a crosslinking agent into contact with a nonwoven fabric and freeze-drying the same. 8. A method for producing a medical material, comprising bringing an aqueous solution containing N-succinylchitosan, gelatin, a crosslinking agent and an antibacterial agent into contact with a nonwoven fabric and freeze-drying the same. 9. A method for producing a medical material, comprising contacting an aqueous solution containing N-succinylchitosan, gelatin and a cross-linking agent with a nonwoven fabric, freeze-drying the resulting solution, and further irradiating the resulting freeze-dried product with radiation. Method. 10. A medical product comprising contacting an aqueous solution containing N-succinylchitosan, gelatin, a cross-linking agent and an antibacterial agent with a nonwoven fabric and freeze-drying the resultant, and further irradiating the resulting freeze-dried product with radiation. Material manufacturing method.