Summary of the invention
In order to solve the deficiencies in the prior art, the invention provides a kind of safe and reliable, absorbability medical dressing that humid stability is good and preparation method thereof.
The technical solution adopted for the present invention to solve the technical problems is:
A kind of absorbability medical dressing, comprise and there is elastic backing and be arranged on the polymer matrix layer on backing, described backing is by polyurethane, hyaluronic acid, hyaluronate, at least one composition in absorbability aliphatic polyester or poly butyric, polymer matrix layer is by polyacrylic acid, alginic acid, chitosan, water soluble polyamide, chitosan derivatives, at least one composition in polylysine or cellulose derivative, in polymer matrix layer, be provided with medicine layer, described medicine layer is by collagen protein, Fibrinogen, at least one composition in somatomedin or antibiotic.
As such scheme preferably, described backing is poly butyric material, poly butyric material has good thermoplasticity, and can be degradable be in vivo carbon dioxide.
Described polymer matrix layer is comprised of chitosan, and chitosan has the biologic activity such as hemostatic bacteriostatic, and is Biodegradable material, can be degradable in vivo.
A preparation method for absorbability medical dressing as above, comprises the following steps:
(1) produce polymeric matrix aqueous solution: choose polymeric matrix, polymeric matrix is polyacrylic acid, alginic acid, chitosan, water soluble polyamide, chitosan derivatives, at least one in polylysine or cellulose derivative, the polymeric matrix that utilization is chosen is prepared polymeric matrix aqueous solution, in polymeric matrix aqueous solution, add acidic materials and medicine, in the polymeric matrix aqueous solution making, the concentration of polymeric matrix is 0.1%~2.5%, the concentration of acidic materials is 0.5%~5%, acidic materials are glutamic acid, lactic acid, hydrochloric acid, any one in acetic acid or glycolic, the mass ratio of medicine and polymeric matrix is 1:1000~1:10000,
(2) prepared polymeric matrix aqueous solution is injected to mould: the length for the mould of polymeric matrix aqueous solution injection molding is 60~70cm, width is 9~21cm, described mould has 3 chambers, and the height of chamber is 0.05~0.2cm, and width is 2~6cm;
(3) to the polymeric matrix aqueous solution in mould, carry out freezing: the mould that polymeric matrix aqueous solution is housed is inserted to freeze dryer cryodesiccation chamber, described refrigerating process includes four steps, the first step is hygral equilibrium process, in hygral equilibrium process, temperature is 20~25 ℃, and equilibration time is 2~5h; Second step is temperature-fall period, is cooled to 2~10 ℃, and keeps the temperature 20~60min of 2~10 ℃ with the rate of temperature fall of 0.3~1.0 ℃/min; The 3rd step is cooling deferring procedure, and the rate of temperature fall continuation cooling with 0.3~1.0 ℃/min, when cooling temperature reaches-5 ℃, need to keep the of short duration stage of rising again, and the temperature of rising again is-3~0 ℃, and the retention time is 3~5min; The 4th step is for continuing temperature-fall period, with the rate of temperature fall of 0.3~1.0 ℃/min, continues to be cooled to-40 ℃, and at-40 ℃ of freezing 30~60min.After freezing completing, obtain refrigeration material;
(4) refrigeration material is carried out to lyophilizing: negative pressure be in the environment of-80~-20KPa to refrigeration material lyophilizing, lyophilizing includes four steps, the first step is the stage of being rapidly heated, temperature is rapidly heated to 0 ℃ by cryogenic temperature, the heating-up time is 20~50min; Second step is delayed phase, and temperature remains on 0 ℃, and be 400~600min time delay; The 3rd step is for continuing the stage of being rapidly heated, and temperature is rapidly heated to 35~40 ℃ by 0 ℃, and the heating-up time is 20~50min; The 4th step is for continuing delayed phase, and temperature remains on 35~40 ℃ of intensification temperature, and be 1000~2000min time delay; After lyophilizing completes, obtain polymeric matrix sponge;
(5) polymeric matrix sponge is carried out to post processing, make absorbability medical dressing: described post processing comprises three steps, the first step is the densification stage, utilize hot melt by polymeric matrix sponge and backing laminating, then take hot plate compression method, make polymeric matrix sponge and backing bonding, the temperature that hot plate compression method is selected is 75~85 ℃, moulding pressure is 0.5~0.6MPa, and the thickness of resulting polymers substrate sponge is 0.6~10mm, and density is 0.1~0.5g/m
3; Second step is pretreatment stage, and by polymeric matrix sponge and backing baking, bake out temperature is 75~80 ℃, and drying time is 0.25~0.5h.The processing stage that the 3rd step being softening, adopt softening machine that polymeric matrix sponge and backing are softened, make absorbability medical dressing, the Gurley hardness number of resulting polymers substrate sponge is 2000~10000.
As such scheme preferably, described polymeric matrix is that molecular weight is the chitosan of 150~300Qian Dao Er, the deacetylation of chitosan is 80%~95%.
In step (1), need polymeric matrix aqueous solution to carry out vacuum deaerator in the preparation process of polymeric matrix aqueous solution, the pressure of vacuum deaerator is-8 * 10
5~-3 * 10
5pa, the deaeration time is 5~30min.
The beneficial effect that the present invention has than prior art is: absorbability medical dressing provided by the invention and preparation method thereof, adopt polymeric matrix that absorbability is good as polymer matrix layer, and in polymer matrix layer, be provided with carrier layer, carrier layer is the ingredients with healing property, safety and the curative effect of dressing have been improved, and by techniques such as freezing, lyophilizing, densification, pretreatment and softening processing, change the hardness of dressing, improved the humid stability of dressing.
The specific embodiment
Below in conjunction with embodiment, the invention will be further described.
In the present embodiment 1, first produce polymeric matrix aqueous solution: the chitosan 455g that chooses molecular weight Wei300 thousand Dao Er, the deacetylation of chitosan is 95%, the chitosan that utilization is chosen is prepared chitosan aqueous solution, in chitosan aqueous solution, add acetic acid and 0.4g collagen protein, in the chitosan aqueous solution making, the concentration of chitosan is 2.3%, and the concentration of acetic acid is 4%, in chitosan aqueous solution preparation process, need chitosan aqueous solution to carry out vacuum deaerator, deaeration pressure is-3 * 10
5pa, the deaeration time is 5min;
Secondly prepared polymeric matrix aqueous solution is injected to mould: the length for the mould of polymeric matrix aqueous solution injection molding is 60~70cm, width is 9~21cm, described mould has 3 chambers, and the height of chamber is 0.05~0.2cm, and width is 2~6cm;
Then the chitosan aqueous solution in mould is carried out freezing: the mould that chitosan aqueous solution is housed is inserted to freeze dryer cryodesiccation chamber, described refrigerating process includes four steps, the first step is hygral equilibrium process, and in hygral equilibrium process, temperature is preferably 25 ℃, and equilibration time is preferably 5h; Second step is temperature-fall period, is cooled to 2 ℃, and keeps the temperature 60min of 2 ℃ with the rate of temperature fall of 0.5 ℃/min; The 3rd step is cooling deferring procedure, and the rate of temperature fall continuation cooling with 0.5 ℃/min, when cooling temperature reaches-5 ℃, need to keep the of short duration stage of rising again, and the temperature of rising again is-3 ℃, and the retention time is 5min; The 4th step is for continuing temperature-fall period, with the rate of temperature fall of 0.5 ℃/min, continues to be cooled to-40 ℃, and at-40 ℃ of freezing 30min.After freezing completing, obtain refrigeration material;
Then refrigeration material is carried out to lyophilizing: in the environment that is-80KPa in negative pressure,, to refrigeration material lyophilizing, lyophilizing includes four steps, and the first step is the stage of being rapidly heated, and temperature is rapidly heated to 0 ℃ by cryogenic temperature, and the heating-up time is 50min; Second step is delayed phase, and temperature remains on 0 ℃, and be 600min time delay; The 3rd step is for continuing the stage of being rapidly heated, and temperature is rapidly heated to 40 ℃ by 0 ℃, and the heating-up time is 40min; The 4th step is for continuing delayed phase, and temperature remains on 40 ℃ of intensification temperature, and be 2000min time delay; After lyophilizing completes, obtain chitosan sponge;
Next step carries out post processing by chitosan sponge: described post processing comprises three steps, the first step is the densification stage, utilize hot melt by chitosan sponge and backing laminating, take again hot plate compression method, make polymeric matrix sponge and backing bonding, the temperature that hot plate compression method is selected is 80 ℃, and moulding pressure is 0.5MPa, the thickness of gained chitosan sponge is 10mm, and density is 0.1g/m
3; Second step is pretreatment stage, takes baking, and bake out temperature is 80 ℃, and drying time is 0.5h.The processing stage that the 3rd step being softening, adopt softening machine that polymeric matrix sponge and backing are softened, make absorbability medical dressing, the Gurley hardness number of gained chitosan sponge is 4000.
Then the dressing assembling is cut, encapsulate and use the sterilizing of 19kGy gamma ray.
In the present embodiment 2, first produce polymeric matrix aqueous solution: the chitosan 455g that chooses molecular weight Wei150 thousand Dao Er, the deacetylation of chitosan is 85%, the chitosan that utilization is chosen is prepared chitosan aqueous solution, in chitosan aqueous solution, add acetic acid and 0.4g somatomedin, in the chitosan aqueous solution making, the concentration of chitosan is 0.1%, and the concentration of acetic acid is 0.8%, in chitosan aqueous solution preparation process, need chitosan aqueous solution to carry out vacuum deaerator, deaeration pressure is-8 * 10
5pa, the deaeration time is 30min;
Secondly prepared polymeric matrix aqueous solution is injected to mould: the length for the mould of polymeric matrix aqueous solution injection molding is 60~70cm, width is 9~21cm, described mould has 3 chambers, and the height of chamber is 0.05~0.2cm, and width is 2~6cm;
Then the chitosan aqueous solution in mould is carried out freezing: the mould that chitosan aqueous solution is housed is inserted to freeze dryer cryodesiccation chamber, described refrigerating process includes four steps, the first step is hygral equilibrium process, and in hygral equilibrium process, temperature is preferably 20 ℃, and equilibration time is preferably 2h; Second step is temperature-fall period, is cooled to 10 ℃, and keeps the temperature 20min of 10 ℃ with the rate of temperature fall of 0.3 ℃/min; The 3rd step is cooling deferring procedure, and the rate of temperature fall continuation cooling with 0.3 ℃/min, when cooling temperature reaches-5 ℃, need to keep the of short duration stage of rising again, and the temperature of rising again is 0 ℃, and the retention time is 3min; The 4th step is for continuing temperature-fall period, with the rate of temperature fall of 0.3 ℃/min, continues to be cooled to-40 ℃, and at-40 ℃ of freezing 50min.After freezing completing, obtain refrigeration material;
Then refrigeration material is carried out to lyophilizing: in the environment that is-20KPa in negative pressure,, to refrigeration material lyophilizing, lyophilizing includes four steps, and the first step is the stage of being rapidly heated, and temperature is rapidly heated to 0 ℃ by cryogenic temperature, and the heating-up time is 20min; Second step is delayed phase, and temperature remains on 0 ℃, and be 400min time delay; The 3rd step is for continuing the stage of being rapidly heated, and temperature is rapidly heated to 40 ℃ by 0 ℃, and the heating-up time is 20min; The 4th step is for continuing delayed phase, and temperature remains on 40 ℃ of intensification temperature, and be 1300min time delay; After lyophilizing completes, obtain chitosan sponge;
Next step carries out post processing by chitosan sponge: described post processing comprises three steps, described post processing comprises three steps, the first step is the densification stage, utilize hot melt by polymeric matrix sponge and backing laminating, then take hot plate compression method, make polymeric matrix sponge and backing bonding, the temperature that hot plate compression method is selected is 75 ℃, moulding pressure is 0.6MPa, and the thickness of gained chitosan sponge is 0.6mm, and density is 0.3g/m
3; Second step is pretreatment stage, takes baking, and bake out temperature is 75 ℃, and drying time is 0.25h.The processing stage that the 3rd step being softening, adopt softening machine that polymeric matrix sponge and backing are softened, make absorbability medical dressing, the Gurley hardness number of gained chitosan sponge is 2000.
Then the dressing assembling is cut, encapsulate and use the sterilizing of 15kGy gamma ray.
In the present embodiment 3, first produce polymeric matrix aqueous solution: the chitosan 455g that chooses molecular weight Wei200 thousand Dao Er, the deacetylation of chitosan is 90%, the chitosan that utilization is chosen is prepared chitosan aqueous solution, in chitosan aqueous solution, add acetic acid and 0.04g Fibrinogen, in the chitosan aqueous solution making, the concentration of chitosan is 1%, and the concentration of acetic acid is 2%, in chitosan aqueous solution preparation process, need chitosan aqueous solution to carry out vacuum deaerator, deaeration pressure is-5 * 10
5pa, the deaeration time is 20min;
Secondly prepared polymeric matrix aqueous solution is injected to mould: the length for the mould of polymeric matrix aqueous solution injection molding is 60~70cm, width is 9~21cm, described mould has 3 chambers, and the height of chamber is 0.05~0.2cm, and width is 2~6cm;
Then the chitosan aqueous solution in mould is carried out freezing: the mould that chitosan aqueous solution is housed is inserted to freeze dryer cryodesiccation chamber, described refrigerating process includes four steps, the first step is hygral equilibrium process, and in hygral equilibrium process, temperature is preferably 22 ℃, and equilibration time is preferably 3h; Second step is temperature-fall period, is cooled to 5 ℃, and keeps the temperature 40min of 5 ℃ with the rate of temperature fall of 0.4 ℃/min; The 3rd step is cooling deferring procedure, and the rate of temperature fall continuation cooling with 0.4 ℃/min, when cooling temperature reaches-5 ℃, need to keep the of short duration stage of rising again, and the temperature of rising again is-2 ℃, and the retention time is 4min; The 4th step is for continuing temperature-fall period, with the rate of temperature fall of 0.4 ℃/min, continues to be cooled to-40 ℃, and at-40 ℃ of freezing 60min.After freezing completing, obtain refrigeration material;
Then refrigeration material is carried out to lyophilizing: in the environment that is-50KPa in negative pressure,, to refrigeration material lyophilizing, lyophilizing includes four steps, and the first step is the stage of being rapidly heated, and temperature is rapidly heated to 0 ℃ by cryogenic temperature, and the heating-up time is 30min; Second step is delayed phase, and temperature remains on 0 ℃, and be 500min time delay; The 3rd step is for continuing the stage of being rapidly heated, and temperature is rapidly heated to 40 ℃ by 0 ℃, and the heating-up time is 30min; The 4th step is for continuing delayed phase, and temperature remains on 40 ℃ of intensification temperature, and be 1600min time delay; After lyophilizing completes, obtain chitosan sponge;
Next step carries out post processing by chitosan sponge: described post processing comprises three steps, described post processing comprises three steps, the first step is the densification stage, utilize hot melt by polymeric matrix sponge and backing laminating, then take hot plate compression method, make polymeric matrix sponge and backing bonding, the temperature that hot plate compression method is selected is 85 ℃, moulding pressure is 0.6MPa, and the thickness of gained chitosan sponge is 0.8mm, and density is 0.2g/m
3; Second step is pretreatment stage, takes baking, and bake out temperature is 78 ℃, and drying time is 0.4h.The processing stage that the 3rd step being softening, adopt softening machine that polymeric matrix sponge and backing are softened, make absorbability medical dressing, the Gurley hardness number of gained chitosan sponge is 3000.
Then the dressing assembling is cut, encapsulate and use the sterilizing of 17kGy gamma ray.