CN109200332A - A kind of biodegradable hemostasis bone wax and preparation method thereof - Google Patents

A kind of biodegradable hemostasis bone wax and preparation method thereof Download PDF

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Publication number
CN109200332A
CN109200332A CN201811418783.XA CN201811418783A CN109200332A CN 109200332 A CN109200332 A CN 109200332A CN 201811418783 A CN201811418783 A CN 201811418783A CN 109200332 A CN109200332 A CN 109200332A
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CN
China
Prior art keywords
bone wax
biodegradable
hemostasis
gelatin
preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201811418783.XA
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Chinese (zh)
Inventor
曾晨光
王栋
许羽冬
刘云奇
唐婷
李少军
杨习锋
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guangzhou Sun Shing Biotech Co ltd
Original Assignee
Guangzhou Sun Shing Biotech Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Guangzhou Sun Shing Biotech Co ltd filed Critical Guangzhou Sun Shing Biotech Co ltd
Priority to CN201811418783.XA priority Critical patent/CN109200332A/en
Publication of CN109200332A publication Critical patent/CN109200332A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/043Mixtures of macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001Use of materials characterised by their function or physical properties
    • A61L24/0042Materials resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

The present invention provides a kind of biodegradable hemostasis bone wax, prepared composition is made of C2-C3 polyalkylene glycol, glutamine transaminage and gelatin, preparation method is that C2-C3 polyalkylene glycol is first added in glutamine transaminage aqueous solution under magnetic agitation effect, add the aqueous gelatin solution sufficiently dissolved, it is reacted under water bath chader, then the middle reaction 5-10min under 80-100 DEG C of water bath condition, it is cooled to room temperature while stirring, hemostasis bone wax of the invention has degradability, excellent sealing characteristics and quick-acting haemostatic powder performance.

Description

A kind of biodegradable hemostasis bone wax and preparation method thereof
Technical field
The present invention relates to hemostatic material technical fields, relate more specifically to a kind of hemostasis bone wax and its system that can give birth to solution degradation Preparation Method.
Background technique
Bone wax is a kind of material that marrow portion capillary oozing of blood is blocked by physical method, can effectively block cancellous bone Bleeding, the hemostasis that can be used for when various first-aid patients bone oozings of blood.The specific mechanism of action of bone wax is: one side bone wax is stopping blooding There is very high absorption to liquid in the process, by absorbing the moisture in blood rapidly in the bleeding surface of a wound to promote blood platelet Concentration, to enhance the agglutination speed and agglutinability of blood platelet;On the other hand, it is gluey that water-setting is formed after bone wax water suction, it can It blocks in wound surface, increases the effect of hemostasis.In addition, can be formed to peripheral vessels has centainly after bone wax water swelling The contention effect of pressure further promotes hemostasis.
Clinically present used bone wax, is mostly 70% beeswax and the mixture of 30% vaseline, has good Softening performance, energy plastotype, nontoxic after rubbing softening with hand rubbing, but can not be degraded and absorb by body.Since beeswax and vaseline are mixed The bone wax material for closing object preparation is unable to organism absorption, leaves the probability that will increase infection as foreign matter in vivo.Simultaneously as point Sub- gap is too small, bone tissue can not by bone wax material, can hindering bone growth, it is postoperative will appear that wound do not recover for a long time ask Topic, needs to carry out postoperative debridement when necessary.Treatment time is not only extended in this way, also increases the pain of patient.
Therefore it develops that a kind of haemostatic effect is good and the bone wax material of degradable absorption, while bone wax being made to can satisfy clinic The mechanical property requirements used have great importance and are worth.
Summary of the invention
The purpose of the present invention is being absorbed for bone wax non-degradable in the prior art, leaves and be unfavorable for wound healing in vivo The defects of, a kind of biodegradable hemostasis bone wax is provided.The present invention turns amine by C2-C3 polyalkylene glycol, glutamine Not only there is excellent physics to block, clog performance for the effect of the coordinated of enzyme and gelatin three, the bone wax product being prepared And haemostatic effect, and fully biodegradable absorbs, while product has excellent mechanical performance.
In order to solve the above technical problems, the technical scheme adopted by the invention is that:
A kind of biodegradable hemostasis bone wax, prepared composition is by C2-C3 polyalkylene glycol, glutamine transaminage It is formed with gelatin, the mass ratio of the C2-C3 polyalkylene glycol, glutamine transaminage and gelatin are as follows: 1:2-4:8-10.
In mentioned component, C2-C3 polyalkylene glycol, glutamine transaminage and gelatin mutual cooperation can generate it is excellent Different closure haemostatic effect, three are indispensable.
In above-mentioned mass ratio, if glutamine transaminage, less than 2, gelatin cannot be fully modified, if paddy ammonia Amide transaminase is greater than 4, then the sealing characteristics of bone wax is poor.
It is unfavorable if gelatin is greater than 10 if gelatin less than 8, cannot generate good plugging effect in above-mentioned mass ratio In the growth of newborn bony structures.
Effective plugging material when bone wax is for cancellous bone bleeding, traditional material are the mixture of paraffin and beeswax, body Interior non-degradable, therefore will limit the growth of newborn bony structures.Hemostasis bone wax of the invention is logical to use C2-C3 polyalkylene Glycol, glutamine transaminage and gelatin are made, and block with excellent physics, clog performance and haemostatic effect, and can be complete Complete biodegradable absorbs, and without limitation on the growth of newborn bony structures, while product has excellent mechanical performance.
The present invention also provides a kind of preparation methods of biodegradable hemostasis bone wax comprising following steps:
S1. glutamine transaminage aqueous solution is prepared;
S2. C2-C3 polyalkylene glycol is first added in glutamine transaminage aqueous solution under magnetic agitation effect, then The aqueous gelatin solution sufficiently dissolved is added, reacts 20-30min under 30-50 DEG C of water bath chader;
S3. the middle reaction 5-10min under 80-100 DEG C of water bath condition, is cooled to room temperature while stirring.
Compared with prior art, the beneficial effects of the present invention are:
The present invention provides a kind of biodegradable hemostasis bone wax and preparation method thereof, the prepared composition of the bone wax that stops blooding by C2-C3 polyalkylene glycol, glutamine transaminage and gelatin composition have the function of that degradability and excellent physical block and fastly Fast anthemorrhagic performance.The preparation method of hemostasis bone wax provided by the invention is water-soluble in glutamine transaminage under magnetic agitation effect C2-C3 polyalkylene glycol is first added in liquid, adds the aqueous gelatin solution sufficiently dissolved, is reacted under water bath chader, Then the middle reaction 5-10min under 80-100 DEG C of water bath condition, is cooled to room temperature while stirring.Hemostasis bone wax of the invention Ingredient is simple, and preparation process is simple, and the hemostasis bone wax of preparation has suitable volume sweell(ing) rate and saturated water absorption, bone wax Degradation time is 5-10 weeks, and burst pressure is not less than 120mmHg, has good plugging effect, can be widely applied to orthopaedics and stop Blood field.
Specific embodiment
The present invention is further illustrated With reference to embodiment, but embodiment the present invention is not done it is any The restriction of form.
Embodiment 1
A kind of biodegradable hemostasis bone wax, prepared composition is by C2-C3 polyalkylene glycol, glutamine transaminage It is formed with gelatin, the mass ratio of the C2-C3 polyalkylene glycol, glutamine transaminage and gelatin are as follows: 1:2:8.It is described to stop The preparation method of blood bone wax the following steps are included:
S1. glutamine transaminage aqueous solution is prepared;
S2. C2-C3 polyalkylene glycol is first added in glutamine transaminage aqueous solution under magnetic agitation effect, then The aqueous gelatin solution sufficiently dissolved is added, reacts 30min under 30 DEG C of water bath chader;
S3. the middle reaction 10min under 80 DEG C of water bath conditions, is cooled to room temperature while stirring.
Embodiment 2
A kind of biodegradable hemostasis bone wax, prepared composition is by C2-C3 polyalkylene glycol, glutamine transaminage It is formed with gelatin, the mass ratio of the C2-C3 polyalkylene glycol, glutamine transaminage and gelatin are as follows: 1:4:8.It is described to stop The preparation method of blood bone wax the following steps are included:
S1. glutamine transaminage aqueous solution is prepared;
S2. C2-C3 polyalkylene glycol is first added in glutamine transaminage aqueous solution under magnetic agitation effect, then The aqueous gelatin solution sufficiently dissolved is added, reacts 20min under 50 DEG C of water bath chader;
S3. the middle reaction 8min under 90 DEG C of water bath conditions, is cooled to room temperature while stirring.
Embodiment 3
A kind of biodegradable hemostasis bone wax, prepared composition is by C2-C3 polyalkylene glycol, glutamine transaminage It is formed with gelatin, the mass ratio of the C2-C3 polyalkylene glycol, glutamine transaminage and gelatin are as follows: 1:2:10.It is described to stop The preparation method of blood bone wax the following steps are included:
S1. glutamine transaminage aqueous solution is prepared;
S2. C2-C3 polyalkylene glycol is first added in glutamine transaminage aqueous solution under magnetic agitation effect, then The aqueous gelatin solution sufficiently dissolved is added, reacts 30min under 30 DEG C of water bath chader;
S3. the middle reaction 5min under 100 DEG C of water bath conditions, is cooled to room temperature while stirring.
Embodiment 4
A kind of biodegradable hemostasis bone wax, prepared composition is by C2-C3 polyalkylene glycol, glutamine transaminage It is formed with gelatin, the mass ratio of the C2-C3 polyalkylene glycol, glutamine transaminage and gelatin are as follows: 1:4:10.It is described to stop The preparation method of blood bone wax the following steps are included:
S1. glutamine transaminage aqueous solution is prepared;
S2. C2-C3 polyalkylene glycol is first added in glutamine transaminage aqueous solution under magnetic agitation effect, then The aqueous gelatin solution sufficiently dissolved is added, reacts 25min under 40 DEG C of water bath chader;
S3. the middle reaction 7min under 95 DEG C of water bath conditions, is cooled to room temperature while stirring.
Comparative example 1
A kind of biodegradable hemostasis bone wax, component are made of glutamine transaminage and gelatin, remaining is the same as implementation Example 1.
Comparative example 2
A kind of biodegradable hemostasis bone wax, the matter of C2-C3 polyalkylene glycol, glutamine transaminage and gelatin Measure ratio are as follows: 1:1:8, remaining is the same as embodiment 1.
Comparative example 3
A kind of biodegradable hemostasis bone wax, the matter of C2-C3 polyalkylene glycol, glutamine transaminage and gelatin Measure ratio are as follows: 1:4:12, remaining is the same as embodiment 1.
Performance test
(1) resistance to compression explosion bulge test
External resistance to compression explosion bulge test experimental method: pressure test method is used, the thickness with multi-pore structure is specifically prepared Degree is the acrylic plectane of 1cm, and plectane closed can be fixed on pressure tester port, and pressure tester is that there are plectane interfaces Acrylic box, the opposite connection pressure-detecting device and device for exerting of plectane interface, after closed acrylic box connects plectane, Hemostasis bone wax material of the invention is smeared in plectane aperture position, material will fill up entire hole, and plectane direction is downward, in box Water is filled with, press and detects leakage numerical value.
External resistance to compression explosion bulge test, embodiment 1-4 are carried out to the hemostasis bone wax that embodiment 1-4 and comparative example 1-3 is obtained The burst pressure of acquisition is not less than 120mmHg, and comparative example 1-3 is then lower than 120mmHg.
(2) cellulotoxic experiment
Culture cell is contacted by leaching liquor, using L929 as experimental cell, embodiment 1-4 is evaluated in cell proliferation observation Toxic effect of the prepared bone wax to cell in vitro.The experimental results showed that hemostasis bone wax of the invention has good safety Property, it has no toxic side effect to cell growth.
(3) validity experiment is blocked
By embodiment 1-4 resulting materials by external resistance to compression explosion bulge test experiments have shown that it blocks validity, specific experiment Method is: preparing the acrylic plectane with a thickness of 1cm with multi-pore structure, plectane closed can be fixed on pressure tester end Mouthful, pressure tester is that there are the acrylic box of plectane interface, the opposite connection pressure-detecting devices and pressure of plectane interface Device smears this material in plectane aperture position after closed acrylic box connects plectane, and material will fill up entire hole, circle Plate direction is downward, and water is filled in box, presses and detects leakage numerical value.The experimental results showed that the equal energy of embodiment 1-4 resulting materials It is enough effectively blocked, the sealing characteristics of comparative example 2-3 is secondly, the sealing characteristics of comparative example 1 is worst.
(4) hemostasis validity experiment
After experimental dog is anaesthetized, using normal sterile surgical procedure, dog hind leg skin is cut, manufactures bone defect bleeding.It is real It tests a group hemostasis bone wax of use embodiment 1-3 to stop blooding, as a result can effectively stop blooding in 15 seconds, and existing without oozing of blood As haemostatic effect is significant.And comparative example 1 needs 40 seconds, comparative example 2 needs 30 seconds, and comparative example 3 needs 20 seconds.
The above embodiment is a preferred embodiment of the present invention, but embodiments of the present invention are not by above-described embodiment Limitation, other any changes, modifications, substitutions, combinations, simplifications made without departing from the spirit and principles of the present invention, It should be equivalent substitute mode, be included within the scope of the present invention.

Claims (6)

1. a kind of biodegradable hemostasis bone wax, which is characterized in that its prepared composition includes C2-C3 polyalkylene glycol, paddy Glutamine transaminase and gelatin.
2. the biodegradable hemostasis bone wax of one kind according to claim 1, which is characterized in that its prepared composition is by C2- C3 polyalkylene glycol, glutamine transaminage and gelatin composition.
3. the biodegradable hemostasis bone wax of one kind according to claim 2, which is characterized in that the poly- alkylene of C2-C3 The mass ratio of base glycol, glutamine transaminage and gelatin are as follows: 1:2-4:8-10.
4. the preparation method of biodegradable hemostasis bone wax according to claim 1 to 3, which is characterized in that including as follows Step:
S1. glutamine transaminage aqueous solution is prepared;
S2. C2-C3 polyalkylene glycol is first added in glutamine transaminage aqueous solution under magnetic agitation effect, adds The aqueous gelatin solution sufficiently dissolved, reacts 20-30min under 30-50 DEG C of water bath chader;
S3. the middle reaction 5-10min under 80-100 DEG C of water bath condition, is cooled to room temperature while stirring.
5. the preparation method of biodegradable hemostasis bone wax according to claim 4, which is characterized in that further include step S4 carries out irradiation sterilization to obtained hemostasis bone wax.
6. the preparation method of biodegradable hemostasis bone wax according to claim 4, which is characterized in that described sufficiently molten The preparation method of the aqueous gelatin solution solved is crosslinking agent to be added in aqueous gelatin solution to carry out crosslinking Treatment, then be placed in water Sufficiently it is swollen.
CN201811418783.XA 2018-11-26 2018-11-26 A kind of biodegradable hemostasis bone wax and preparation method thereof Pending CN109200332A (en)

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Application Number Priority Date Filing Date Title
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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101816801A (en) * 2003-01-09 2010-09-01 聚合物器官股份有限公司 Biomedical foams
CN101854960A (en) * 2006-12-15 2010-10-06 生命连结有限公司 Gelatin-transglutaminase hemostatic dressings and sealants
US20120253298A1 (en) * 2010-09-30 2012-10-04 Ethicon Endo-Surgery, Inc. Layered tissue thickness compensator
CN102719411A (en) * 2012-06-18 2012-10-10 华东师范大学 Microbial transglutaminase and application thereof
CN103816562A (en) * 2013-12-02 2014-05-28 华东师范大学 Rapid hemostatic product for war wounds and preparation method thereof
CN108187128A (en) * 2018-02-07 2018-06-22 广州迈普再生医学科技有限公司 A kind of absorbable hemostasis bone wax and preparation method thereof
CN108187129A (en) * 2018-02-07 2018-06-22 广州迈普再生医学科技有限公司 A kind of absorbable gelatin styptic powder and preparation method thereof

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101816801A (en) * 2003-01-09 2010-09-01 聚合物器官股份有限公司 Biomedical foams
CN101854960A (en) * 2006-12-15 2010-10-06 生命连结有限公司 Gelatin-transglutaminase hemostatic dressings and sealants
US20120253298A1 (en) * 2010-09-30 2012-10-04 Ethicon Endo-Surgery, Inc. Layered tissue thickness compensator
CN102719411A (en) * 2012-06-18 2012-10-10 华东师范大学 Microbial transglutaminase and application thereof
CN103816562A (en) * 2013-12-02 2014-05-28 华东师范大学 Rapid hemostatic product for war wounds and preparation method thereof
CN108187128A (en) * 2018-02-07 2018-06-22 广州迈普再生医学科技有限公司 A kind of absorbable hemostasis bone wax and preparation method thereof
CN108187129A (en) * 2018-02-07 2018-06-22 广州迈普再生医学科技有限公司 A kind of absorbable gelatin styptic powder and preparation method thereof

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Application publication date: 20190115