CN106075608A - A kind of fibrin ferment sustained release medicine equipment and preparation method - Google Patents

A kind of fibrin ferment sustained release medicine equipment and preparation method Download PDF

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Publication number
CN106075608A
CN106075608A CN201610395324.9A CN201610395324A CN106075608A CN 106075608 A CN106075608 A CN 106075608A CN 201610395324 A CN201610395324 A CN 201610395324A CN 106075608 A CN106075608 A CN 106075608A
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CN
China
Prior art keywords
preparation
fibrin ferment
medicine equipment
described step
sustained release
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Pending
Application number
CN201610395324.9A
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Chinese (zh)
Inventor
高峰
高奇辉
李磊
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Tai'an City Yuxiang Medical Technology Co Ltd
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Tai'an City Yuxiang Medical Technology Co Ltd
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Priority to CN201610395324.9A priority Critical patent/CN106075608A/en
Publication of CN106075608A publication Critical patent/CN106075608A/en
Priority to PCT/CN2016/109991 priority patent/WO2017206478A1/en
Pending legal-status Critical Current

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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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/086—Phosphorus-containing materials, e.g. apatite
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254—Enzymes, proenzymes
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents

Abstract

The invention provides the preparation method of a kind of fibrin ferment sustained release medicine equipment, comprise the steps: that (1) is soaked in 1-hydroxy ethylidene-1,1-diphosphonic acid solution after being dried medicine equipment deionized water supersound washing, take out and carry out washing after redrying；(2) medicine equipment after processing step (1) is soaked in hydroxyapatite suspension, takes out and is dried；(3) medicine equipment after processing step (2) is soaked in thrombin solution taking-up and obtains fibrin ferment sustained release medicine equipment.The present invention can realize that fibrin ferment etc. is only capable of the target slow-release of the medicine of topical application, and " feature " medicine that can be used for preparing is combined apparatus can be placed directly in human body target organ and operation target site.

Description

A kind of fibrin ferment sustained release medicine equipment and preparation method
Technical field
The present invention relates to medicine equipment and preparation field thereof, particularly relate to a kind of fibrin ferment sustained release medicine equipment and system thereof Preparation Method.
Background technology
At present, developing rapidly and innovating with medical technology, the doctor of the diagnosis and treatment unifications such as various endoscopic technics, minimal invasive techniques The section of learning to do progressively becomes main flow medical technology constantly to be occurred, but scope and mis instruments also bring one.UGB is normal The disease of digestive tract seen, is also postoperative complication common in Endoscopic Treatment simultaneously.For in the tradition of UGB Section's treatment means mainly have localized pulverization or injection hemostasis, intravenous applications haemostatic medicament etc., and current Hemostasis through endoscopy is extensively applied Targeted drug fibrin ferment acts locally on focus surface, and blood quickly forms stable sludged blood.But targeting exists solidifying after spraying Hemase, by the problem of tissue fluid rapid dilution, makes drug effect reduce.After the development of apparatus and improvement under scope, be used for office The various anastomosis clamps of portion's hemostasis and closing perforation start appearance.Titanium presss from both sides one of important apparatus as Endoscopic Treatment, at present only Undertake physical containment therapeutic action to local damage.A lot of scholars attempt target slow-release fibrin ferment, mesh on medical metal base material The research of front all of sustained release is all based on bio-inert material surface, not only biologically active difference, and heavy metal ion toxicity can be made Fibrin ferment is become to lose efficacy.(hydroxyapatite, is abbreviated as HA or HAP to hydroxyapatite, and molecular formula is Ca10(OH)2(PO4)6) be Main (inorganic) composition of tooth and bone, medically also serves as the optimal components of artifical bone ahead of the curve.Hydroxylapatite biology Compatibility is good, is to stimulate or induce bone growth and can form synosteotic natural ceramic material with bone tissue, raw Thing compatibility and biologically active are superior to tricalcium phosphate and other phosphorus calcium ceramic materials.The use of hydroxyapatite, contributes to thin The adhesion of born of the same parents, propagation and Function, on the basis of directly as the replacement such as bone, tooth or impairment renovation material, still unexcellent Different bone tissue engineer carrier material, it is possible to as the carrier material of other medical science functional materials or medicine.
Content of the invention
Present invention aim to address subproblem present in existing fibrin ferment sustained release medical device technology, provide and (send out Bright title).
It is an object of the invention to be achieved through the following technical solutions:
The preparation method of a kind of fibrin ferment sustained release medicine equipment, comprises the steps:
(1) be soaked in 1-hydroxy ethylidene-1,1-diphosphonic acid solution after metallic plate deionized water supersound washing being dried, take out into Wash after row redrying；
(2) metallic plate after processing step (1) is soaked in hydroxyapatite suspension, takes out and is dried；
(3) metallic plate after processing step (2) is soaked in thrombin solution and takes out and get final product；
Described metallic plate is the medicine equipment of metal matrix.
Preferably, the drying in described step (1) and step (2) be in drying box 50-70 DEG C of dry 5-10 minute or 20-30 DEG C of air drying 1-2 hour.
Preferably, the soaking temperature in described step (1) is 20-30 DEG C, and the time is 1-2 minute.
Preferably, the 1-hydroxy ethylidene-1,1-diphosphonic acid solution concentration in described step (1) is 3-5mol/l.
Preferably, the 1-hydroxy ethylidene-1,1-diphosphonic acid solution concentration in described step (1) is 4-5mol/l.
Preferably, the redrying in described step (1) is 50-70 DEG C of dry 10-20 minute or 20-30 DEG C in drying box Air drying 2-4 hour.
Preferably, the wash time in described step (1) is 2-3 minute.
Preferably, the hydroxyapatite turbid liquid concentration in described step (2) is 5-50g/l, and soaking temperature is 20-30 DEG C, the time is 5-10 minute.
Preferably, the hydroxyapatite turbid liquid concentration in described step (2) is 20-30g/l.
Preferably, in the thrombin solution in described step (3), concentration of thrombin is 4000-8000U/l, is frozen by fibrin ferment Prepared by dry powder and 0.9% physiological saline.
Preferably, in the thrombin solution in described step (3), concentration of thrombin is 4500-5500U/l.
Preferably, the soaking temperature in described step (3) is 20-30 DEG C, and the time is 1-2 hour.
Another aspect of the present invention, a kind of fibrin ferment sustained release medicine equipment, it is prepared by any of the above-described described method.
Beneficial effects of the present invention:
1. prepared by the fibrin ferment controlled-release coating of the bioactivity surface that present invention achieves medicine equipment Metal Substrate, can realize It is combined the upgrading of apparatus from simple " naked " apparatus to " feature " medicine.
2. the present invention can realize that fibrin ferment etc. is only capable of the target slow-release of the medicine of topical application, can be used for " the function of preparation Property " medicine be combined apparatus can be placed directly in human body target organ and operation target site.
3. the present invention can realize stable sustained-release on metal based coating systems for the medicines such as fibrin ferment, and medicine may be implemented in finger Determine position sustained release thus sustainable increase surrounding tissue concentration, solve the medicine of localized pulverization by tissue fluid rapid dilution shadow The problem ringing drug effect.
Brief description
Fig. 1 is the product diagram of the application fibrin ferment sustained release metal medical appliance；
Fig. 2 is the stable hydroxyapatite nano/sub-micron coating prepared；
Fig. 3 is the thrombin layer of hydroxyapatite nano/sub-micron coating surface；
Fig. 4 is photoelectron spectroscopy (XPS) curve of hydroxyapatite layer；
Fig. 5 is photoelectron spectroscopy (XPS) curve of thrombin layer；
Fig. 6 is fibrin ferment mean concentration curve map under different time；
Fig. 7 is the post figure of different time sections dynamic blood coagulation enzyme sustained concentration.
Detailed description of the invention
In order to the present invention is better described, below in conjunction with the accompanying drawing in the embodiment of the present invention, in the embodiment of the present invention Technical scheme is clearly and completely described.
Specific embodiment 1: fibrin ferment controlled-release coating is prepared in laboratory
1.SUS304 austenite stainless steel sample spends ionized water supersound washing 2 minutes, removes greasy dirt or the corrosion on surface. It after surface is clean, is positioned in drying box 70 DEG C of dryings 5 minutes, is qualified with surface noresidue water droplet.
2. it is soaked in 25 DEG C, in the 1-hydroxy ethylidene-1,1-diphosphonic acid solution of 5mol/l 2 minutes, carry out 1-hydroxy ethylidene-1,1-diphosphonic acid surface Chemistry dress changes the preparation of film.
3. it after taking out after redundant solution flows down, is positioned in drying box 70 DEG C of dryings 10 minutes, make the film of preparation do Dry.
4. treat sample surfaces without obvious liquid or colloid, with deionized water lavage specimens product surface 3 minutes, it was unnecessary to rinse out 1-hydroxy ethylidene-1,1-diphosphonic acid crystallization residual, the remaining 1-hydroxy ethylidene-1,1-diphosphonic acid metal surface chemical conversion film being difficult to be rinsed.Put Being placed in hydroxyapatite (HA) suspension that 20g/l is constantly stirred, 25 DEG C are soaked 5 minutes.Complete 1-hydroxy ethylene-1,1-diphosphonic Prepared by the self assembly of the hydroxyapatite coating layer on acid surfaces chemical conversion film.Retain a part of sample and carry out hydroxyapatite The photoelectron spectroscopy (XPS) of coating characterizes with AFM (AFM), sees accompanying drawing 2-5.
5. take out the product for preparing of step 4 and put in drying box 70 DEG C of dryings 10 minutes, after surface noresidue water droplet. Putting into fibrin ferment freeze-dried powder and 0.9% physiological saline being prepared in 5000U/l thrombin solution, 25 DEG C are soaked 2 hours.
6. take out 30 DEG C of air dryings 2 hours, carry out photoelectron spectroscopy (XPS) and AFM (AFM) table Levy.AFM characterization test result is shown in accompanying drawing 2-3, from AFM comparison diagram it can be seen that preparation front and rear surfaces occurs substantially Change, light areas is prothrombin molecule.Photoelectron spectroscopy characterization test result is shown in accompanying drawing 4-5, can see through XPS contrast Going out, (1) prothrombin molecule successful application is in hydroxyapatite surface, and has certain thickness；(2) from the point of view of high-resolution XPS spectrum unscrambling, Not having new chemical bond and generation, slow release product is fibrin ferment.Before and after the above results explanation fibrin ferment coating, composition produces with pattern Having given birth to obvious change, having defined stable coating, coating is thrombin layer；Do not have new chemical bonds to produce, illustrate solidifying Hemase produces without other pollutants.
Specific embodiment 2: factory floor prepares fibrin ferment controlled-release coating
1.SUS304 austenite stainless steel sample surface cleaning liquid soaks 2 minutes, removes the greasy dirt on surface, spends subsequently Ionized water cleans twice, 2 minutes every time.It after range estimation surface is clean, is positioned in 20 DEG C of air of relative humidity 55% temperature dry Dry 2 hours, be qualified with surface without obvious residual water droplet.
2. take out step 1 sample and be soaked in 20 DEG C, in the 1-hydroxy ethylidene-1,1-diphosphonic acid solution of 5mol/l 5 minutes, carry out hydroxyl Ethylene-diphosphonic acid surface chemistry dress changes the preparation of film.
3. step 2 sample take out after be positioned over 20 DEG C of air dryings of relative humidity 55% temperature 2 hours, allow preparation thin Film is dried.
4. treat that step 3 sample surfaces, without obvious liquid or colloid, is positioned over the hydroxyapatite that 20g/l is constantly stirred (HA), in suspension, 25 DEG C are soaked 10 minutes.Unnecessary 1-hydroxy ethylidene-1,1-diphosphonic acid crystallization residual can be dissolved in water, simultaneously complete Prepared by the self assembly becoming 1-hydroxy ethylidene-1,1-diphosphonic acid surface chemistry dress to change the hydroxyapatite coating layer on film.
5. take out step 4 sample and be positioned over 20 DEG C of air dryings of relative humidity 55% temperature 2 hours, treat surface without substantially After residual water droplet.Putting into fibrin ferment freeze-dried powder and 0.9% physiological saline being prepared in 5000U/l thrombin solution, 25 DEG C of immersions 1 are little When.
6. taking out step 5 sample 30 DEG C of air dryings 2 hours, often group takes 6 pieces of samples, utilizes ELIASA at 450nm Measure the absorbance of variable concentrations standard items under wavelength respectively, draw standard according to various criterion product concentration and corresponding absorbance Curve.The average concentration of thrombin going out calculating under different time on this basis as shown in Figure 6, understands at 0-from accompanying drawing 6 Within 60 minutes, intravascular coagulation enzyme r e lease is rapid, very slowly but still can maintain certain concentration from the release of 60-180 minute fibrin ferment.
It is soaked in the metallic plate (totally 6 pieces) being coated with fibrin ferment in the beaker filling 200ml physiological saline respectively, respectively at 0h, 1h, 2h, 3h, 4h, 5h sample this liquid 100ul and are placed in the EP pipe having marked, and discard original physiological saline after every sub-sampling, ELIASA is utilized to measure the absorbance of six groups of solution under different time and calculate mean value.Discard soaking solution under different time to survey Absorbance application t check and compare P value two-by-two between group and be all higher than 0.05, no significant difference, discarded leaching every 1 hour The absorbance of the solution recording before bubble solution is without significant difference, and in one can consider that same time period, medication coat metallic plate can Stablize sustained release fibrin ferment.Concrete outcome is as shown in Figure 7.
The above results explanation fibrin ferment as a child reached stable sustained-release value 1, and can be steady in the solution persistently changing Fixed sustained release fibrin ferment.
The fibrin ferment sustained release metallic plate prepared by said method, when described metallic plate is the medicine equipment of metal matrix, The 13rd, this fibrin ferment sustained release medicine equipment as it is shown in figure 1, include metallic substrates the 12nd, metal surface the 15th, the phosphate layer of medicine equipment Phosphoric acid chemical conversion film the 14th, hydroxyapatite layer and 16 and thrombin layer 17.
Above-mentioned experimental study shows " fibrin ferment-hydroxyapatite-non-oxidation nitride layer-metal " steel plate in normal saline solution In sustainable stably discharge fibrin ferment, thus ensure the concentration of fibrin ferment in solution, there is fibrin ferment slow release effect, i.e. as The fibrin ferment sustained release metal matrix medicine equipment that this prepares also has good fibrin ferment slow release effect.
The above, the only present invention preferably detailed description of the invention, but protection scope of the present invention is not limited thereto, Any those familiar with the art in the technical scope of present disclosure, the change that can readily occur in or replacement, All should cover within protection scope of the present invention.Therefore, protection scope of the present invention should be with the protection of claims Scope is as the criterion.

Claims (10)

1. the preparation method of a fibrin ferment sustained release medicine equipment, it is characterised in that comprise the steps:
(1) it is soaked in after metallic plate deionized water supersound washing being dried in 1-hydroxy ethylidene-1,1-diphosphonic acid solution, take out and carry out two Wash after secondary drying；
(2) metallic plate after processing step (1) is soaked in hydroxyapatite suspension, takes out and is dried；
(3) metallic plate after processing step (2) is soaked in thrombin solution taking-up, obtains fibrin ferment sustained release medicine equipment.
2. preparation method according to claim 1, it is characterised in that the drying in described step (1) and step (2) be 50-70 DEG C of dry 5-10 minute or 20-30 DEG C of air drying 1-2 hour in drying box.
3. preparation method according to claim 1, it is characterised in that the soaking temperature in described step (1) is 20-30 DEG C, the time is 1-2 minute.
4. preparation method according to claim 1, it is characterised in that the 1-hydroxy ethylidene-1,1-diphosphonic acid in described step (1) is molten Liquid concentration is 3-5mol/l.
5. preparation method according to claim 1, it is characterised in that the redrying in described step (1) is drying box Middle 50-70 DEG C of dry 10-20 minute or 20-30 DEG C of air drying 2-4 hour.
6. preparation method according to claim 1, it is characterised in that the wash time in described step (1) is that 2-3 divides Clock.
7. preparation method according to claim 1, it is characterised in that the hydroxyapatite suspension in described step (2) Concentration is 5-50g/l, and soaking temperature is 20-30 DEG C, and the time is 5-10 minute.
8. preparation method according to claim 1, it is characterised in that blood coagulation in the thrombin solution in described step (3) Enzyme concentration is 4000U/l-8000U/l, is prepared by fibrin ferment freeze-dried powder and 0.9% physiological saline.
9. preparation method according to claim 1, it is characterised in that the soaking temperature in described step (3) is 20-30 DEG C, the time is 1-2 hour.
10. a fibrin ferment sustained release medicine equipment, it is characterised in that be prepared by the arbitrary described method of claim 1-9.
CN201610395324.9A 2016-06-03 2016-06-03 A kind of fibrin ferment sustained release medicine equipment and preparation method Pending CN106075608A (en)

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CN201610395324.9A CN106075608A (en) 2016-06-03 2016-06-03 A kind of fibrin ferment sustained release medicine equipment and preparation method
PCT/CN2016/109991 WO2017206478A1 (en) 2016-06-03 2016-12-15 Medical device with extended thrombin release and manufacturing method

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106086842A (en) * 2016-08-25 2016-11-09 济南御麟化工科技有限公司 A kind of metal surface high biological compatibility coating and preparation method
CN106835095A (en) * 2017-01-17 2017-06-13 李乃义 Tooth-implanting surface biological compatibility coating and preparation method

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US20120288705A1 (en) * 2010-11-08 2012-11-15 The Board Of Regents For Oklahoma State University Hydroxyapatite coated metal surface and method for producing
CN103732155A (en) * 2011-08-10 2014-04-16 伊西康内外科公司 Surgical staple with localized adjunct coating
CN104606722A (en) * 2013-11-01 2015-05-13 上海交通大学医学院附属第九人民医院 Degradable gasket with anti-bacterial anti-adhesion performance

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CA2702183A1 (en) * 2007-10-10 2009-04-16 Miv Therapeutics Inc. Lipid coatings for implantable medical devices
JP2009201639A (en) * 2008-02-27 2009-09-10 Univ Kinki Implant

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Publication number Priority date Publication date Assignee Title
US20120288705A1 (en) * 2010-11-08 2012-11-15 The Board Of Regents For Oklahoma State University Hydroxyapatite coated metal surface and method for producing
CN103732155A (en) * 2011-08-10 2014-04-16 伊西康内外科公司 Surgical staple with localized adjunct coating
CN104606722A (en) * 2013-11-01 2015-05-13 上海交通大学医学院附属第九人民医院 Degradable gasket with anti-bacterial anti-adhesion performance

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106086842A (en) * 2016-08-25 2016-11-09 济南御麟化工科技有限公司 A kind of metal surface high biological compatibility coating and preparation method
CN106835095A (en) * 2017-01-17 2017-06-13 李乃义 Tooth-implanting surface biological compatibility coating and preparation method

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Application publication date: 20161109