CN111714688A - Bone hemostatic material and preparation method thereof - Google Patents
Bone hemostatic material and preparation method thereof Download PDFInfo
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- CN111714688A CN111714688A CN201910208653.1A CN201910208653A CN111714688A CN 111714688 A CN111714688 A CN 111714688A CN 201910208653 A CN201910208653 A CN 201910208653A CN 111714688 A CN111714688 A CN 111714688A
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- hemostatic material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/08—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0042—Materials resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/046—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
Abstract
The invention provides a bone hemostatic material, which comprises the following components: tween 80, vitamin E ester, carboxymethyl chitosan and fatty acid salt. The bone hemostatic material has good hemostatic performance, adhesion performance and performance of promoting healing of bone injury parts, is degradable and absorbable in vivo, has no immunogenicity and high safety, and is suitable for hemostasis and repair of different bone injury wound surfaces.
Description
Technical Field
The invention belongs to the field of biomedical materials, and particularly relates to a bone hemostatic material for craniocerebral surgery, orthopaedics and orthopedic surgery and a preparation method thereof.
Background
The bleeding of the cancellous wound surface in the orthopedic operation is not only stopped or the complete hemostasis is difficult, which is a troublesome problem often encountered by craniocerebral surgery, orthopedics and orthopedic surgeons. Cancellous bone is loose in structure and rich in blood circulation, and the wound surface is mostly caused by sharp instrument cutting and violent striking, the bleeding is mostly oozing blood, different from bleeding of other tissues, the self hemostasis by vasoconstriction is difficult, and the complete hemostasis is also difficult to be realized by conventional methods such as electric coagulation, clamping, hemostatic gauze and collagen sponge filling in the operation. An ideal cancellous bone wound hemostat should meet the following requirements: filling cracks and blood sinuses with different wound surface forms; ② the adhesive has the function of adhering to the wound surface; the platelet adheres and gathers to form the thrombus function; fourthly, promoting the wound repair function; fifthly, the product is absorbable and nontoxic. At present, the cancellous bone wound surface hemostasis is carried out on the bone wax which is commonly used clinically, the main components of the cancellous bone wound surface hemostasis are beeswax, sesame oil and the like, the biocompatibility is poor, the cancellous bone wound surface hemostasis is difficult to degrade and absorb by organisms, residues are locally and greatly hindered to bone healing, and the formation of original callus is not facilitated, so that bone non-healing is caused. Therefore, scholars at home and abroad have already carried out research work on bone wax replacement of absorbable bone hemostatic material products from artificially synthesized polymer materials, biological agents and the like.
Patent application No. 200910076033.3 discloses a degradable hemostatic material in bone cavity system, which is composed of sodium alginate solution and medical starch, and can be degraded and absorbed in vivo, and does not cause inflammatory reaction, and has good ductility and mechanical strength. However, the material has poor adhesion on the surface of the bone injury and degrades quickly.
Patent application No. 201210067344.5 discloses a medical absorbable bone wound hemostasis and healing promotion material and a preparation method thereof, the material is prepared by adopting matrix materials such as oligosaccharide and polysaccharide, and auxiliary materials such as hydroxyl alcohol, vegetable oil and emulsifier through a blending method and a latex blending method, and the material can be degraded in vivo and does not influence the healing of injured parts. However, this material only serves to physically plug hemostasis and has no utility in promoting bone healing.
Patent application No. 201610364917.9 discloses an absorbable bone wax and a preparation method thereof, which is obtained by mainly blending polyoxypropylene polyoxyethylene front-segment copolymer (PEG-PPG-PEG), polyoxypropylene polyoxyethylene random copolymer (PEG-PPG) and carboxymethyl chitosan, can promote blood coagulation, can be left in vivo for a long enough time (about 72 hours) to realize bone interface hemostasis, but cannot play a role in repairing damaged parts of bones.
Patent application No. 201810634183.0 discloses a rapidly absorbable hemostatic bone wax for promoting bone hemostasis for spinal facets in spinal surgery, comprising: 60-75% of poloxamer mixture; 20-30% of carboxymethyl chitosan by weight; and 5-20% of sodium hyaluronate by weight portion. The product can be used for treating bone bleeding, but its adhesiveness to bone is still required to be improved.
In conclusion, the bone wax which is a bone wound hemostatic material and is used more at present in China limits clinical application due to non-absorbability, and increases foreign body reaction to influence the repair of the bone wound. Although researches on absorbable bone wound hemostatic materials exist at present, the absorbable bone wound hemostatic materials still have unsolved practical problems of poor adhesiveness, incapability of promoting bone wound healing, rapid degradation in vivo and the like. Therefore, in order to meet the clinical convenience, the performance of the existing absorbable bone hemostatic material still needs to be improved.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a degradable absorbable bone hemostatic material which has good adhesion and strong hemostatic property and can promote the healing of a bone wound surface and a preparation method thereof.
To achieve the object of the present invention, the present invention provides a bone hemostatic material comprising the following components: tween 80, vitamin E ester, carboxymethyl chitosan and fatty acid salt.
Further, the bone hemostatic material comprises the following components in parts by weight: 10-45 parts of tween 80, 10-45 parts of vitamin E ester, 15-50 parts of carboxymethyl chitosan and 5-35 parts of fatty acid salt.
Preferably, the bone hemostatic material comprises the following components in parts by weight: 20-45 parts of tween 80, 20-45 parts of vitamin E ester, 20-50 parts of carboxymethyl chitosan and 10-35 parts of fatty acid salt.
More preferably, the bone hemostatic material comprises the following components in parts by weight: 25-45 parts of tween 80, 25-45 parts of vitamin E ester, 25-50 parts of carboxymethyl chitosan and 20-30 parts of fatty acid salt.
More preferably, the bone hemostatic material comprises the following components in parts by weight: 25-35 parts of tween 80, 25-35 parts of vitamin E ester, 25-50 parts of carboxymethyl chitosan and 20-25 parts of fatty acid salt.
Most preferably, the bone hemostatic material comprises the following components in parts by weight: 25 parts of tween 80, 30 parts of vitamin E ester, 40 parts of carboxymethyl chitosan and 15 parts of fatty acid salt.
Preferably, the fatty acid salt is selected from one or more of magnesium laurate, calcium palmitate, zinc palmitate, magnesium stearate, calcium stearate, zinc stearate, magnesium myristate or calcium myristate.
Preferably, the fatty acid salt is selected from calcium stearate.
In another aspect, the present invention further provides a method for preparing a bone hemostatic material, comprising the following steps:
1) uniformly mixing 10-45 parts of tween 80 and 10-45 parts of vitamin E ester, and then carrying out hot melting at 50-100 ℃ to obtain a completely dissolved blending solution;
2) taking 15-50 parts of carboxymethyl chitosan with the particle size of 50-200 mu m and 5-35 parts of fatty acid salt, mixing the carboxymethyl chitosan with the blending liquid in a mechanical stirring manner, and standing and cooling for 0.5-2 hours at room temperature after molding to obtain a wax/paste material;
3) packaging the waxy/pasty material, and sterilizing with high pressure steam or60Sterilizing with Co ray to obtain absorbable bone hemostatic material, and sealing and storing at room temperature.
As a preferred embodiment, the present invention provides a method for preparing a bone hemostatic material, comprising the following steps:
1) uniformly mixing 20-45 parts of tween 80 and 20-45 parts of vitamin E ester, and thermally melting at 100 ℃ to obtain a completely dissolved blend solution;
2) taking 30-50 parts of carboxymethyl chitosan with the particle size of 50-200 mu m and 10-35 parts of fatty acid salt, mixing the carboxymethyl chitosan with the blending solution in a mechanical stirring manner, and standing and cooling for 1.4 hours at room temperature after molding to obtain a wax/paste material;
3) packaging the waxy/pasty material, and sterilizing with high pressure steam or60Sterilizing with Co ray to obtain absorbable bone hemostatic material, and sealing and storing at room temperature.
More preferably, the weight portion of tween 80 of the invention is 25, 30, 35, 40 or 45; the vitamin E ester is 25 parts, 30 parts, 35 parts, 40 parts or 45 parts by weight; the carboxymethyl chitosan is 25 parts, 30 parts, 35 parts, 40 parts, 45 parts or 50 parts by weight; the fatty acid salt is 10 parts, 15 parts, 20 parts, 25 parts, 30 parts or 35 parts by weight.
Preferably, the fatty acid salt is selected from calcium stearate.
Compared with the prior art, the invention has the beneficial effects that:
carboxymethyl chitosan belongs to absorbable polymer material, and the addition of carboxymethyl chitosan can effectively adsorb redundant water in blood to inhibit the mobility of blood, can excite a physiological hemostasis mechanism, and plays roles in physical hemostasis and physiological hemostasis, so that the addition of carboxymethyl chitosan can effectively improve the hemostasis performance of the bone hemostasis material.
The tween 80 is added to form a wax-like or paste-like material with the carboxymethyl chitosan, and simultaneously, paste-like materials with different viscosities can be obtained by controlling the dosage of the tween 80, so that the paste-like material is convenient for molding and clinical use.
The invention takes carboxymethyl chitosan and Tween 80 as the basis, and adds fatty acid salt, thereby having good hemostatic performance and adhesiveness.
The addition of the fatty acid salt can not only improve the strength of the bone hemostatic material, but also enhance the ductility and the adhesiveness of the product after being blended with the Tween 80 and the carboxymethyl chitosan, thereby being convenient for clinical use.
The invention prepares the water-soluble bone hemostatic material with different hydrophilic properties by adopting the combination of various dispersion systems, improves the degradation period of the material in vivo and is convenient for hemostasis and repair of different bone injury wounds.
The absorbable bone hemostatic material prepared by the invention can be degraded and absorbed in vivo, has no immunogenicity and high safety, can be selected according to the repair time of a bone injury part in clinical use, and improves the use convenience of doctors.
Drawings
Fig. 1A to fig. 1B are views illustrating the hemostatic effect of a rabbit femur defect model, wherein fig. 1A illustrates the effect of bone wax hemostasis; FIG. 1B shows the hemostatic effect of the hemostatic material of absorbable bone of the present invention.
Fig. 2C to 2D show X-ray results of the rabbit femur defect model 12w after material selection, wherein fig. 2C shows X-ray results of bone wax after material selection; FIG. 2D is the X-ray result of the absorbable bone hemostatic material of the present invention after being taken.
Detailed Description
The present invention will be described in further detail with reference to examples, but the embodiments of the present invention are not limited thereto.
First, an embodiment
The present embodiment provides a bone hemostatic material comprising the following components: tween 80, vitamin E ester, carboxymethyl chitosan and fatty acid salt.
On the other hand, the embodiment also provides a preparation method of the bone hemostatic material, which comprises the following steps:
1) uniformly mixing Tween 80 and vitamin E ester to obtain a uniform solid dispersion system;
2) carrying out hot melting on the solid dispersion system obtained in the step 1) at 100 ℃ to obtain a completely dissolved blending solution;
3) selecting carboxymethyl chitosan with the particle size of 200 mu m and calcium stearate, mixing the carboxymethyl chitosan with the dispersion system in the step 2) by adopting a mechanical stirring method, shaping, standing at room temperature, and cooling for 1.4 hours to obtain a waxy material;
4) after the wax-like material in the step 3) is packaged, the wax-like material is adopted60Sterilizing with Co ray to obtain absorbable bone hemostatic material, and sealing and storing at room temperature.
As a preferred embodiment, the weight part of tween 80 in this example is 25 parts, 30 parts, 35 parts, 40 parts or 45 parts; the vitamin E ester in the embodiment is 25 parts, 30 parts, 35 parts, 40 parts or 45 parts by weight; the carboxymethyl chitosan in this example is 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts, 55 parts, 60 parts or 65 parts by weight; the weight portion of the calcium cinnamate described in this embodiment is 10, 15, 20, 25, 30 or 35.
Second, effect verification
The absorbable bone hemostatic prepared by the embodiment of the invention is used for rabbit femoral defect tests, and the specific operation process is as follows:
12 New Zealand rabbits are used as experimental animals, and are averagely divided into two groups, wherein the absorbable bone hemostatic material is used as a test group, and the bone wax is used as a control group. A defect model is manufactured at the femur of a new Zealand rabbit, namely a tunnel with the diameter of 5mm and the depth of 10mm is drilled at the inner malleolus of the right femur along the vertical position of the femur. Filling the corresponding materials into the bone tunnel, performing electrotome hemostasis on peripheral soft tissue bleeding points, and observing whether the hole bleeds blood after 5 min. Meanwhile, 12w is used for observing the defect size of the damaged part.
And (3) test results:
1) general observation:
animals in the test group and the control group are not oozed blood within 5min, and fig. 1A and 1B are respectively a state diagram after hemostasis of the test group and the control group.
2) Observation of material drawing
When 12w is used for taking materials, no obvious postoperative adverse reaction occurs in all the test animals. FIGS. 2C and 2D are X-ray views of defect parts of the test group and the control group after material drawing, wherein the size of the bone defect is not changed in the X-ray result of bone wax of the control group, and the bone defect is still completely covered by the bone wax during material drawing; the absorbable bone hemostatic material can grow new bone at the bone defect position 12 weeks after the operation, the defect size is reduced (5 mm → 1 mm), and the material of the injury part can not be observed by naked eyes when the material is taken.
And (4) analyzing results: according to the observation after hemostasis and the X-ray result after material drawing of the rabbit femoral defect test, the absorbable bone hemostatic material can effectively stop bleeding at the damaged part, promote bone growth after operation and effectively reduce the defect size.
The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.
Claims (8)
1. A bone hemostatic material, comprising the following components: tween 80, vitamin E ester, carboxymethyl chitosan and fatty acid salt.
2. The bone hemostatic material of claim 1, wherein the bone hemostatic material comprises, in parts by weight: 10-45 parts of tween 80, 10-45 parts of vitamin E ester, 15-50 parts of carboxymethyl chitosan and 5-35 parts of fatty acid salt.
3. The bone hemostatic material of claim 1, wherein the bone hemostatic material comprises, in parts by weight: 20-45 parts of tween 80, 20-45 parts of vitamin E ester, 30-50 parts of carboxymethyl chitosan and 10-35 parts of fatty acid salt.
4. Bone haemostatic material according to claim 1, wherein the fatty acid salt is selected from one or more of magnesium laurate, calcium palmitate, zinc palmitate, magnesium stearate, calcium stearate, zinc stearate, magnesium myristate or calcium myristate.
5. Bone haemostatic material according to claim 1, characterised in that the fatty acid salt is selected from calcium stearate.
6. The method for preparing a bone hemostatic material according to claim 1, comprising the steps of:
1) uniformly mixing 10-45 parts of tween 80 and 10-45 parts of vitamin E ester, and then carrying out hot melting at 50-100 ℃ to obtain a completely dissolved blending solution;
2) taking 15-50 parts of carboxymethyl chitosan with the particle size of 50-200 mu m and 5-35 parts of fatty acid salt, mixing the carboxymethyl chitosan with the blending liquid in a mechanical stirring manner, and standing and cooling for 0.5-2 hours at room temperature after molding to obtain a wax/paste material;
3) packaging the waxy/pasty material, and sterilizing with high pressure steam or60Sterilizing with Co ray to obtain absorbable bone hemostatic material, and sealing and storing at room temperature.
7. The method for preparing a bone hemostatic material according to claim 6, comprising the steps of:
1) uniformly mixing 20-45 parts of tween 80 and 20-45 parts of vitamin E ester, and thermally melting at 100 ℃ to obtain a completely dissolved blend solution;
2) taking 30-50 parts of carboxymethyl chitosan with the particle size of 50-200 mu m and 10-35 parts of fatty acid salt, mixing the carboxymethyl chitosan with the blending solution in a mechanical stirring manner, and standing and cooling for 1.4 hours at room temperature after molding to obtain a wax/paste material;
3) packaging the waxy/pasty material, and sterilizing with high pressure steam or60Sterilizing with Co ray to obtain absorbable bone hemostatic material, and sealing and storing at room temperature.
8. The method for preparing a bone hemostatic material according to claim 7, wherein the fatty acid salt is selected from calcium stearate.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910208653.1A CN111714688A (en) | 2019-03-19 | 2019-03-19 | Bone hemostatic material and preparation method thereof |
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| CN201910208653.1A CN111714688A (en) | 2019-03-19 | 2019-03-19 | Bone hemostatic material and preparation method thereof |
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| CN111714688A true CN111714688A (en) | 2020-09-29 |
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| CN201910208653.1A Withdrawn CN111714688A (en) | 2019-03-19 | 2019-03-19 | Bone hemostatic material and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11739166B2 (en) | 2020-07-02 | 2023-08-29 | Davol Inc. | Reactive polysaccharide-based hemostatic agent |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101052360A (en) * | 2003-09-23 | 2007-10-10 | 奥斯治疗有限公司 | Absorbable implants and methods for their use in hemostasis and in the treatment of osseous defects |
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2019
- 2019-03-19 CN CN201910208653.1A patent/CN111714688A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101052360A (en) * | 2003-09-23 | 2007-10-10 | 奥斯治疗有限公司 | Absorbable implants and methods for their use in hemostasis and in the treatment of osseous defects |
| CN102579162A (en) * | 2003-09-23 | 2012-07-18 | 奥索康公司 | Absorbable implants and methods for their use in hemostasis and in the treatment of osseous defects |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11739166B2 (en) | 2020-07-02 | 2023-08-29 | Davol Inc. | Reactive polysaccharide-based hemostatic agent |
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Effective date of registration: 20210428 Address after: 710024 B1 building, standard factory building, textile industry zone, Baqiao District, Xi'an, Shaanxi Applicant after: SHAANXI BIO REGENERATIVE MEDICINE Co.,Ltd. Address before: Taiwan high tech park of Songshan Lake high tech Industrial Development Zone of Dongguan City, Guangdong province 523808 Taoyuan Road No. 1, Dongguan Taiwan Biological Technology Cooperation Center 1 Building 1 room 05 Applicant before: GUANGDONG BO YU REGENERATIVE MEDICINE Co.,Ltd. |
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Application publication date: 20200929 |