Disclosure of Invention
The invention aims to provide a fetal bovine dermal matrix dressing and a preparation method thereof. The technical effects that can be produced by the preferred technical scheme in the technical schemes provided by the invention are described in detail in the following.
In order to achieve the purpose, the invention provides the following technical scheme:
the invention provides a preparation method of a fetal bovine dermal matrix dressing, which comprises the following steps:
(1) preparing raw materials: weighing a certain amount of purified fetal bovine dermis;
(2) soaking: placing the weighed purified fetal bovine dermis in an ultrasonic rotary drum, adding ultrapure water, rotating, soaking for 60-180 minutes, rotating, and draining;
(3) crosslinking modification: adding ultrapure water into the ultrasonic rotary drum, adjusting the temperature in the rotary drum to 25-40 ℃, adding 1-8% of oxidized chitosan quaternary ammonium salt, rotating for 60-180 minutes, and discharging liquid when the shrinkage temperature of the skin sheet reaches above 70 ℃;
(4) cleaning: adding ultrapure water into the ultrasonic rotary drum in the step (3), rotating, and draining;
(5) and (3) antibacterial modification: adding 50% of phosphate buffer solution with the pH value of 7.4 and 10-80% of dialdehyde-beta-cyclodextrin into the ultrasonic rotary drum in the step (4), rotating, adding 10-25% of tea tree oil dissolved by absolute ethyl alcohol, and rotating for 60-180 minutes; heating to enable the temperature in the rotary drum to reach 35-42 ℃, rotating for 10-20 hours, standing overnight, then rotating for 2-6 hours the next day, adding 3-7% of ammonium chloride, and discharging liquid after rotating;
(6) and sequentially cleaning, centrifugally dewatering, freeze-drying, molding, packaging and irradiating to obtain a finished product.
According to a preferred embodiment, in step (2), the method further comprises: placing 100 parts by weight of purified fetal bovine dermis in an ultrasonic rotary drum, adding ultrapure water with the weight of 200% of the weight of the fetal bovine dermis, rotating for 5 minutes, soaking for 60-180 minutes, rotating for 30 minutes, and draining.
According to a preferred embodiment, in step (4), the method further comprises: and (4) adding 200% of ultrapure water into the ultrasonic rotary drum in the step (3), rotating for 10 minutes, and draining.
According to a preferred embodiment, the washing process in step (6) comprises:
adding 200% of ultrapure water into the ultrasonic rotary drum in the step (5), and rotating for 10 minutes; and adding 200% of ultrapure water, rotating for 10 minutes, repeating the steps for 2-4 times, draining water, and taking out of the drum.
According to a preferred embodiment, the centrifugal dewatering process in step (6) comprises:
and (4) centrifugally dewatering the repeatedly cleaned semi-finished product on a centrifugal machine to ensure that the water content is 40-50%.
According to a preferred embodiment, the freeze-drying process in step (6) comprises:
placing the semi-finished product after centrifugal dehydration in a freeze dryer for freeze drying;
the forming process in the step (6) comprises the following steps:
cutting the freeze-dried skin sheets on a superclean workbench of a hundred-grade workshop by using a small shearing machine according to the specification requirement;
the packaging process in the step (6) comprises the following steps:
on the superclean bench of hundred grades of workshops, cut out fashioned skin piece and pack as required, the packing divide into inner packing and extranal packing: the inner package is divided into an inner layer and an outer layer, the inner layer is a plastic film, and the outer layer is a tin foil bag; the external package is a hard paper bag.
According to a preferred embodiment, the irradiation process in step (6) comprises:
sterilizing with gamma ray of 10.0-30.0KGy/h60Co to obtain the final product.
The invention also provides the fetal bovine dermal matrix dressing which is prepared according to the preparation method.
The fetal bovine dermal matrix dressing made in accordance with the above invention should meet the key performance requirements in table 1 below:
TABLE 1 Key Properties of fetal bovine dermal matrix dressings
Based on the technical scheme, the fetal bovine dermal matrix dressing and the preparation method thereof at least have the following technical effects:
the invention takes purified fetal bovine dermis as a raw material, the purified fetal bovine dermis is firstly placed into a rotary drum under the condition of ultrasonic waves, after being soaked, the purified fetal bovine dermis is subjected to cross-linking modification by using oxidized chitosan quaternary ammonium salt, not only is good physical and mechanical properties and degradation stability endowed to the purified fetal bovine dermis, but also good lasting antibacterial property is endowed to the purified fetal bovine dermis, and dialdehyde-beta-cyclodextrin and tea tree oil are added for carrying out antibacterial modification. And finally, repeatedly cleaning, centrifugally dewatering, freeze-drying, forming, packaging and irradiating to obtain the fetal bovine dermal matrix dressing with the lasting antibacterial and bacteriostatic functions. The dressing has the characteristics of good biocompatibility, excellent physical and mechanical properties and durable antibacterial and bacteriostatic properties, has the function of promoting healing, and is an ideal high-end dressing.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the examples given herein without any inventive step, are within the scope of the present invention.
Example 1
This example 1 provides a method for preparing a fetal bovine dermal matrix dressing, including the following steps:
(1) preparing raw materials: and (3) taking the purified fetal bovine dermis, accurately weighing the fetal bovine dermis, and taking the fetal bovine dermis as a material counting basis in the following steps.
(2) Soaking: in an ultrasonic rotating drum. Firstly, 100 parts by weight of purified fetal bovine dermis is placed in an ultrasonic rotary drum, ultrapure water with the weight of 200% of the weight of the fetal bovine dermis is added, the fetal bovine dermis is rotated for 5 minutes, soaked for 60 minutes, rotated for 30 minutes, and drained.
(3) Crosslinking modification: adding 80% of ultrapure water into the ultrasonic rotary drum, adjusting the temperature in the rotary drum to 25 ℃, adding 4% of oxidized chitosan quaternary ammonium salt, rotating for 60 minutes, detecting the shrinkage temperature of the skin piece, requiring the shrinkage temperature to reach more than 70 ℃, and discharging liquid after the shrinkage temperature of the skin piece meets the requirement.
(4) Cleaning: 200% ultrapure water was added thereto, and the mixture was rotated for 10 minutes and then drained.
(5) And (3) antibacterial modification: adding 50% phosphate buffer solution with pH of 7.4, adding 10% dialdehyde-beta-cyclodextrin, rotating for 10 min, adding 10% tea tree oil dissolved completely with anhydrous ethanol, rotating for 120 min, heating to 35 deg.C, rotating for 10 hr, and standing overnight. The next day, rotate for 2 hours, add 3% ammonium chloride, rotate for 10 minutes, drain.
(6) Cleaning: adding 200% ultrapure water, rotating for 10 min, repeating the steps for 2 times, draining, and taking out of the drum.
(7) And (3) centrifugal dehydration: centrifuging and dewatering in a centrifuge with water content of 40-50%.
(8) And (3) freeze drying: and (4) placing the semi-finished product subjected to centrifugal dehydration in a freeze dryer for freeze drying.
(9) Molding: and (4) cutting the freeze-dried skin sheets on a superclean workbench of a hundred-grade workshop by using a small shearing machine according to the specification requirement for molding.
(10) Packaging: and packaging the cut and formed leather sheets on a superclean workbench of a hundred-grade workshop according to requirements. The package is divided into an inner package and an outer package: the inner package is divided into an inner layer and an outer layer, the inner layer is a plastic film, and the outer layer is a tin foil bag; the external package is a hard paper bag.
(11) Irradiation: sterilizing with gamma ray of 10KGy/h60Co to obtain the final product.
Example 2
This example 2 provides a method for preparing a fetal bovine dermal matrix dressing, including the following steps:
(1) preparing raw materials: and (3) taking the purified fetal bovine dermis, accurately weighing the fetal bovine dermis, and taking the fetal bovine dermis as a material counting basis in the following steps.
(2) Soaking: in an ultrasonic rotating drum. Firstly, 100 parts by weight of purified fetal bovine dermis is placed in an ultrasonic rotary drum, ultrapure water with the weight of 200% of the weight of the fetal bovine dermis is added, the fetal bovine dermis is rotated for 5 minutes, soaked for 120 minutes, rotated for 30 minutes, and drained.
(3) Crosslinking modification: adding 140% of ultrapure water into the ultrasonic rotary drum, adjusting the temperature in the rotary drum to 33 ℃, adding 6% of oxidized chitosan quaternary ammonium salt, rotating for 120 minutes, detecting the shrinkage temperature of the skin piece, and requiring the shrinkage temperature to reach more than 70 ℃. And discharging liquid after the shrinkage temperature meets the requirement.
(4) Cleaning: 200% ultrapure water was added thereto, and the mixture was rotated for 10 minutes and then drained.
(5) And (3) antibacterial modification: adding 50% phosphate buffer solution with pH 7.4, adding 45% dialdehyde-beta-cyclodextrin, rotating for 10 min, adding 18% tea tree oil dissolved completely with anhydrous ethanol, rotating for 120 min, heating to 39 deg.C, rotating for 15 hr, standing overnight, rotating for 4 hr the next day, adding 5% ammonium chloride, and rotating for 10 min. And (6) draining.
(6) Cleaning: adding 200% ultrapure water, rotating for 10 min, repeating the steps for 3 times, draining, and taking out of the drum.
(7) And (3) centrifugal dehydration: centrifuging and dewatering in a centrifuge with water content of 40-50%.
(8) And (3) freeze drying: and (4) placing the semi-finished product subjected to centrifugal dehydration in a freeze dryer for freeze drying.
(9) Molding: and (4) cutting the freeze-dried skin sheets on a superclean workbench of a hundred-grade workshop by using a small shearing machine according to the specification requirement for molding.
(10) Packaging: and packaging the cut and formed leather sheets on a superclean workbench of a hundred-grade workshop according to requirements. The package is divided into an inner package and an outer package: the inner package is divided into an inner layer and an outer layer, the inner layer is a plastic film, and the outer layer is a tin foil bag; the external package is a hard paper bag.
(11) Irradiation: sterilizing with gamma ray of 20KGy/h60Co to obtain the final product.
Example 3
This example 3 provides a method for preparing a fetal bovine dermal matrix dressing, including the following steps:
(1) preparing raw materials: and (3) taking the purified fetal bovine dermis, accurately weighing the fetal bovine dermis, and taking the fetal bovine dermis as a material counting basis in the following steps.
(2) Soaking: in an ultrasonic rotating drum. Firstly, 100 parts by weight of purified fetal bovine dermis is placed in an ultrasonic rotary drum, ultrapure water with the weight of 200% of the weight of the fetal bovine dermis is added, the fetal bovine dermis is rotated for 5 minutes, soaked for 180 minutes, rotated for 30 minutes, and drained.
(3) Crosslinking modification: adding 200% of ultrapure water into the ultrasonic rotary drum, adding 8% of oxidized chitosan quaternary ammonium salt when the temperature in the rotary drum reaches 40 ℃, rotating for 180 minutes, detecting the shrinkage temperature of the skin piece, requiring the shrinkage temperature to reach more than 70 ℃, and discharging liquid after the shrinkage temperature meets the requirement.
(4) Cleaning: 200% ultrapure water was added thereto, and the mixture was rotated for 10 minutes and then drained.
(5) And (3) antibacterial modification: adding 50% phosphate buffer solution with pH 7.4, adding 80% dialdehyde-beta-cyclodextrin, rotating for 10 min, adding 25% tea tree oil dissolved completely with anhydrous ethanol, rotating for 180 min, heating to 42 deg.C, rotating for 20 hr, standing overnight, rotating for 6 hr the next day, adding 7% ammonium chloride, rotating for 10 min, and discharging.
(6) Cleaning: adding 200% ultrapure water, rotating for 10 min, repeating the steps for 4 times, draining, and taking out of the drum.
(7) And (3) centrifugal dehydration: centrifuging and dewatering in a centrifuge with water content of 40-50%.
(8) And (3) freeze drying: and (4) placing the semi-finished product subjected to centrifugal dehydration in a freeze dryer for freeze drying.
(9) Molding: and (4) cutting the freeze-dried skin sheets on a superclean workbench of a hundred-grade workshop by using a small shearing machine according to the specification requirement for molding.
(10) Packaging: and packaging the cut and formed leather sheets on a superclean workbench of a hundred-grade workshop according to requirements. The package is divided into an inner package and an outer package: the inner package is divided into an inner layer and an outer layer, the inner layer is a plastic film, and the outer layer is a tin foil bag; the external package is a hard paper bag.
(11) Irradiation: sterilizing with gamma ray of 30.0KGy/h60Co to obtain the final product.
The results of testing the key performance indicators of the fetal bovine dermal matrix dressings prepared in examples 1 to 3 are shown in table 2 below:
TABLE 2 Key Performance index test results
The purified fetal bovine dermis adopted by the preparation method has rich raw material sources, low price, easy obtainment and reliable quality, and the durable antibacterial fetal bovine dermis matrix dressing prepared by the method not only endows the target material with good physical and mechanical properties and degradation stability, but also endows the target material with good durable antibacterial performance because the purified fetal bovine dermis is subjected to crosslinking modification by adopting the oxidized chitosan quaternary ammonium salt. Particularly, the purified fetal bovine dermis is modified by dialdehyde with both crosslinking function and inclusion capacity, so that the durable antibacterial fetal bovine dermis matrix dressing with good biocompatibility, degradation stability, physical and mechanical properties and excellent temperature-sensitive slow-release antibacterial property is prepared. In addition, the raw materials, equipment and key materials used by the invention are all made from China.
The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.