CN115300676A - Medicine-carrying medical instrument and preparation method thereof - Google Patents

Medicine-carrying medical instrument and preparation method thereof Download PDF

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Publication number
CN115300676A
CN115300676A CN202210943572.8A CN202210943572A CN115300676A CN 115300676 A CN115300676 A CN 115300676A CN 202210943572 A CN202210943572 A CN 202210943572A CN 115300676 A CN115300676 A CN 115300676A
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magnesium alloy
parts
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李双
符劲飞
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Xiangya Hospital of Central South University
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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
    • A61L31/14—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
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C1/00—Making non-ferrous alloys
    • C22C1/02—Making non-ferrous alloys by melting
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C23/00—Alloys based on magnesium
    • C22C23/06—Alloys based on magnesium with a rare earth metal as the next major constituent
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/02—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working in inert or controlled atmosphere or vacuum
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/06—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of magnesium or alloys based thereon
    • 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
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Metallurgy (AREA)
  • Mechanical Engineering (AREA)
  • Materials Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A medicine-carrying medical device and a preparation method thereof. In order to prolong the service life of the medicine-carrying medical instrument, the invention adds rare earth elements of lanthanum and cerium into the traditional medical magnesium alloy material. Research shows that the doping of the rare earth elements La and Ce is helpful for improving the corrosion resistance of the medical Mg-2Gd-0.5Zr alloy, and when the same amount is used, the effect of using two metals simultaneously is more remarkable than the effect of using a single metal. In addition, the use amount of the rare earth with a proper amount has a positive effect on the biocompatibility of the magnesium alloy while improving the corrosion resistance of the magnesium alloy, but when the rare earth is used excessively, the biocompatibility is deteriorated, so that the magnesium alloy material cannot be used as a medical material.

Description

Medicine-carrying medical instrument and preparation method thereof
Technical Field
The invention relates to the field of medical instruments, in particular to a drug-loaded medical instrument and a preparation method thereof.
Background
Drug-loaded medical devices, such as medical stent materials, are widely used in clinical medical practice, and magnesium alloys are largely used for preparing medical devices due to their excellent properties. However, the weak corrosion resistance is a problem that medical magnesium alloy has not been solved, and the method for improving the corrosion resistance of magnesium alloy in industry generally causes the biocompatibility of magnesium alloy to be reduced, so that the magnesium alloy cannot be applied to the medical field. Aiming at the problems in the prior art, in order to prolong the service life of a medicine-carrying medical instrument, a magnesium alloy medicine-carrying medical material which has excellent corrosion resistance and biocompatibility and meets the medical requirement needs is necessary to be designed.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide a drug-loaded medical device and a preparation method thereof.
The invention provides a preparation method of a medicine-carrying medical instrument, which comprises the following steps:
coating a medicine on the surface of a medical appliance, wherein the medicine comprises one or more of dexamethasone, paclitaxel, rapamycin or derivatives thereof, and the medical appliance is processed from Mg-Ce-La-Gd-Zr magnesium alloy.
Preferably, the magnesium alloy is processed into a rod-like, wire-like, net-like, spherical or porous structure.
Preferably, the medical device is a medical stent material.
Preferably, the Mg-Ce-La-Gd-Zr magnesium alloy is prepared by the following method: weighing 97.5-99 parts of magnesium, 2-3 parts of gadolinium, 0.5-1 part of zirconium, 2-6.2 parts of lanthanum and 2-6.2 parts of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, then preserving heat for 60-90min, and stirring at the speed of 300-500r/min in the heat preservation process to uniformly distribute all the components; then casting to obtain Mg-Ce-La-Gd-Zr magnesium alloy, putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box type resistance furnace, carrying out solution treatment for 12-15h at 430-450 ℃, taking out and cooling under protective gas.
Preferably, the composition of the raw material is 97.5 parts by weight of magnesium, 2 parts by weight of gadolinium, 0.5 parts by weight of zirconium, 3 parts by weight of lanthanum and 3.2 parts by weight of cerium.
Further, the invention also provides a medicine-carrying medical device, which is prepared by the preparation method.
In order to prolong the service life of the medicine-carrying medical instrument, the invention adds rare earth elements of lanthanum and cerium into the traditional medical magnesium alloy material. Research shows that the doping of the rare earth elements La and Ce is helpful for improving the corrosion resistance of the medical Mg-2Gd-0.5Zr alloy, and when the same amount is used, the effect of using two metals simultaneously is more remarkable than the effect of using a single metal. In addition, the use amount of the rare earth with a proper amount has a positive effect on the biocompatibility of the magnesium alloy while improving the corrosion resistance of the magnesium alloy, but when the rare earth is used excessively, the biocompatibility is deteriorated, so that the magnesium alloy material cannot be used as a medical material.
Detailed Description
The technical effects of the present invention are demonstrated below by specific examples, but the embodiments of the present invention are not limited thereto.
Example 1
The preparation method of the medical magnesium alloy comprises the following steps: weighing 97.5g of magnesium, 2g of gadolinium, 0.5g of zirconium, 3g of lanthanum and 3.2g of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, and then preserving heat for 60min, wherein the stirring is carried out at the speed of 300r/min in the heat preservation process, so that the components are uniformly distributed. Then casting is carried out to obtain the Mg-Ce-La-Gd-Zr magnesium alloy. Putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box-type resistance furnace, carrying out solution treatment for 12h at 430 ℃, taking out and cooling under protective gas.
Example 2
The preparation method of the medical magnesium alloy comprises the following steps: weighing 97.5g of magnesium, 2g of gadolinium, 0.5g of zirconium and 6.2g of lanthanum as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, and then preserving heat for 60min, wherein the stirring is carried out at the speed of 300r/min in the heat preservation process, so that the components are uniformly distributed. Then casting is carried out to obtain the Mg-Ce-La-Gd-Zr magnesium alloy. Putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box-type resistance furnace, carrying out solution treatment for 12h at 430 ℃, taking out and cooling under protective gas.
Example 3
The preparation method of the medical magnesium alloy comprises the following steps: weighing 97.5g of magnesium, 2g of gadolinium, 0.5g of zirconium and 6.2g of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, and then preserving heat for 60min, wherein the stirring is carried out at the speed of 300r/min in the heat preservation process, so that the components are uniformly distributed. Then casting is carried out to obtain the Mg-Ce-La-Gd-Zr magnesium alloy. Putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box-type resistance furnace, carrying out solution treatment for 12h at 430 ℃, taking out and cooling under protective gas.
Example 4
The preparation method of the medical magnesium alloy comprises the following steps: weighing 97.5g of magnesium, 2g of gadolinium, 0.5g of zirconium, 2g of lanthanum and 2g of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, and then preserving heat for 60min, wherein the stirring is carried out at the speed of 300r/min in the heat preservation process, so that the components are uniformly distributed. Then casting is carried out to obtain the Mg-Ce-La-Gd-Zr magnesium alloy. Putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box-type resistance furnace, carrying out solution treatment for 12h at 430 ℃, taking out and cooling under protective gas.
Example 5
The preparation method of the medical magnesium alloy comprises the following steps: weighing 97.5g of magnesium, 2g of gadolinium, 0.5g of zirconium, 6g of lanthanum and 6g of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, keeping the temperature for 60min, and stirring at the speed of 300r/min in the heat preservation process to uniformly distribute all the components. Then casting is carried out to obtain the Mg-Ce-La-Gd-Zr magnesium alloy. Putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box-type resistance furnace, carrying out solution treatment for 12h at 430 ℃, taking out and cooling under protective gas.
Comparative example 1
The preparation method of the medical magnesium alloy comprises the following steps: weighing 97.5g of magnesium, 2g of gadolinium, 0.5g of zirconium, 1g of lanthanum and 1g of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, and then preserving heat for 60min, wherein the stirring is carried out at the speed of 300r/min in the heat preservation process, so that the components are uniformly distributed. Then casting is carried out to obtain the Mg-Ce-La-Gd-Zr magnesium alloy. Putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box-type resistance furnace, carrying out solution treatment for 12h at 430 ℃, taking out and cooling under protective gas.
Comparative example 2
The preparation method of the medical magnesium alloy comprises the following steps: weighing 97.5g of magnesium, 2g of gadolinium, 0.5g of zirconium, 10g of lanthanum and 10g of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, and then preserving heat for 60min, wherein the stirring is carried out at the speed of 300r/min in the heat preservation process, so that the components are uniformly distributed. Then casting is carried out to obtain the Mg-Ce-La-Gd-Zr magnesium alloy. Putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box-type resistance furnace, carrying out solution treatment for 12h at 430 ℃, taking out and cooling under protective gas.
Comparative example 3
The medical Mg alloy Mg-2Gd-0.5Zr which is sold in the market is selected as a reference.
Next, we evaluated the corrosion resistance and biocompatibility of the magnesium alloys of examples 1 to 5 and comparative examples 1 to 3 by the following specific methods:
corrosion resistance: an electrochemical workstation is adopted to carry out electrochemical test on each sample in simulated body fluid PBS, and the specific test method can refer to the research on the mechanical property and the corrosion property of Mg-Gd series alloy for the esophageal stent material in the prior art;
biocompatibility: the hemocompatibility of each sample was evaluated by a hemolysis test, which is based on the following principle: the sample is directly contacted with blood, and the amount of hemoglobin released after rupture of the erythrocyte membrane is measured to detect the degree of hemolysis of each sample in vitro. The absorption wavelength of hemoglobin is 545nm, and its concentration can be detected by a spectrophotometer. The specific operation steps are as follows:
(1) Blood is collected from the heart of a healthy rabbit by 100mL, and 2% potassium oxalate by 5mL is added to prepare fresh anticoagulation blood. And taking 40mL of anticoagulation blood, and adding 50mL of 0.9% sodium chloride injection for dilution.
(2) Taking 3 silicified test tubes, loading a test sample and 10mL of sodium chloride injection into one test tube, taking a blank of one test tube as a negative control group, adding 10mL of sodium chloride normal saline, and taking a blank of the other test tube as a positive control group, and respectively adding 10mL of distilled water.
(3) All the test tubes are kept constant in a water bath at 37 ℃ for 30min, 5mL of anticoagulated rabbit blood is added respectively, and the temperature is kept at 37 ℃ for 60min.
(4) The supernatant of the test tube was collected and the absorbance was measured at 545 nm. Three replicates of each sample were run and averaged.
The hemolysis rate is calculated as follows:
hemolysis rate (%) = (sample average absorbance-absorbance in negative group)/(absorbance in positive group-absorbance in negative group) × 100.
The results of the experiment are shown in table 1.
TABLE 1
Figure BDA0003786768890000041
As can be seen from Table 1, the incorporation of rare earth elements La and Ce contributes to the improvement of the corrosion resistance of the Mg-2Gd-0.5Zr medical magnesium alloy, and when the same amount is used, the effect of using two metals simultaneously is more remarkable than the effect of using a single metal. In addition, the use amount of the rare earth with a proper amount has a positive effect on the biocompatibility of the magnesium alloy while improving the corrosion resistance of the magnesium alloy, but when the rare earth is used excessively, the biocompatibility is deteriorated, so that the magnesium alloy material cannot be used as a medical material.
Further, the Mg-Ce-La-Gd-Zr magnesium alloy can be processed into a proper shape by a person skilled in the art, such as a rod-shaped, a wire-shaped, a net-shaped, a ball-shaped or a porous structure, so as to meet the use requirement of clinical medicine. And, drugs including but not limited to dexamethasone, paclitaxel, rapamycin or derivatives thereof, etc. can be loaded on the surface of the medical magnesium alloy by the method known in the prior art.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and variations can be made without departing from the technical principle of the present invention, and these modifications and variations should also be regarded as the protection scope of the present invention.

Claims (6)

1. A preparation method of a drug-loaded medical device is characterized by comprising the following steps:
coating a medicine on the surface of a medical appliance, wherein the medicine comprises one or more of dexamethasone, paclitaxel, rapamycin or derivatives thereof, and the medical appliance is processed from Mg-Ce-La-Gd-Zr magnesium alloy.
2. A method according to claim 1, wherein the magnesium alloy is processed into a rod-like, wire-like, net-like, spherical or porous structure.
3. The method of claim 1, wherein the medical device is a medical stent material.
4. The preparation method according to claim 1, wherein the Mg-Ce-La-Gd-Zr magnesium alloy is prepared by the following method: weighing 97.5-99 parts of magnesium, 2-3 parts of gadolinium, 0.5-1 part of zirconium, 2-6.2 parts of lanthanum and 2-6.2 parts of cerium as raw materials, putting the raw materials into a resistance furnace, heating and melting the raw materials, then preserving heat for 60-90min, and stirring at the speed of 300-500r/min in the heat preservation process to uniformly distribute all the components; then casting to obtain Mg-Ce-La-Gd-Zr magnesium alloy, putting the Mg-Ce-La-Gd-Zr magnesium alloy into a box type resistance furnace, carrying out solution treatment for 12-15h at 430-450 ℃, taking out and cooling under protective gas.
5. The method of claim 1, wherein the raw material comprises 97.5 parts by weight of magnesium, 2 parts by weight of gadolinium, 0.5 parts by weight of zirconium, 3 parts by weight of lanthanum, and 3.2 parts by weight of cerium.
6. A drug-loaded medical device, wherein the drug-loaded medical device is prepared by the preparation method of any one of claims 1 to 5.
CN202210943572.8A 2022-08-08 2022-08-08 Medicine-carrying medical instrument and preparation method thereof Pending CN115300676A (en)

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