AU2020101744A4

AU2020101744A4 - A Zn-Ga series alloy and its preparation method and application

Info

Publication number: AU2020101744A4
Application number: AU2020101744A
Authority: AU
Inventors: Huafang LI; Luning WANG; Yixing Zheng
Original assignee: University of Science and Technology Beijing USTB
Current assignee: University of Science and Technology Beijing USTB
Priority date: 2020-08-10
Filing date: 2020-08-10
Publication date: 2020-09-17
Anticipated expiration: 2028-08-10

Abstract

The invention discloses a Zn-Ga series alloy and a preparation method and application thereof, belonging to the technical field of medical alloys. The Zn-Ga series alloy includes Zn and Ga, and Ga accounts for 0-30wt% but not including 0. The preparation method is to mix Zn and Ga or Zn, Ga and trace elements, then to obtain a Zn-Ga series alloy by coating paint after smelting or sintering. The mechanical properties of the prepared Zn-Ga series alloy meet the requirements of the strength and toughness of medical implant materials, and it can be degraded in vivo. It has the dual characteristics of biological corrosion degradation and suitable corrosion rate to provide long-term effective mechanical support. -1/1 4 Figure

Description

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Figure

AUSTRALIA

PATENTS ACT 1990

PATENT SPECIFICATION FOR THE INVENTION ENTITLED:

A Zn-Ga series alloy and its preparation method and application

The invention is described in the following statement:-

A Zn-Ga series alloy and its preparation method and application

TECHNICAL FIELD

The invention relates to the technical field of medical alloys, in particular to a Zn-Ga

series alloy and a preparation method and application thereof.

BACKGROUND

The biomedical materials currently used in clinics mainly include biomedical metal

materials, inorganic materials, polymer materials, composite materials and bionic

materials. Compared with polymer materials and ceramic materials, medical metal

materials have higher strength, toughness and processing properties, so they are the most

widely used, such as 316L, 317L, 304V stainless steel, Co-Cr-Mo alloy, pure titanium,

Ti-6Al-4V, TiNi alloy, and so on. These materials are non-degradable in the human body

and are permanently implanted. After the service period of the implant in the human body

expires, it must be removed through a second operation, which brings unnecessary

physical pain and economic burden to the patient.

With the development of medicine and material science, for some materials that require

temporary service, such as sutures, fracture fixation plates, vascular stents, biliary stents,

etc., people hope that the material implanted in the body will only serve as a temporary

replacement, and will gradually degrade and absorb with the regeneration of tissues or

organs, so as to minimize the long-term impact of the material on the body. Because

biodegradable materials are easy to interact with body fluids and other media in the body and gradually degrade, their decomposition products can be metabolized and eventually excreted from the body without the need for a second operation to remove them.

Therefore, people pay more and more attention on it and it has become the current

frontier and research hotspot in the field of international biomaterials.

The biodegradable materials commonly used in clinical practice are mainly

biodegradable polymer materials and biodegradable ceramics. Although biodegradable

polymer materials can be completely absorbed by the human body, their strength is low

and it is difficult to provide structural support. The disadvantage of biodegradable

ceramics is poor toughness and inability to coordinate deformation.

In recent years, biodegradable biomedical magnesium alloy materials have become one

of the research hotspots. A series of biomedical biodegradable magnesium alloys have

been developed, such as AZ31, WE43, Mg-Ca, etc.. Although magnesium alloys have

attractive application prospects as biomaterials, studies have found that magnesium alloys

corrode too fast, and implants will quickly lose their mechanical integrity before tissues

and organs are fully healed. Therefore, it is necessary to develop new degradable alloys

to meet clinical needs.

Like magnesium and magnesium alloys, metallic zinc and its alloys are often used as

anode materials sacrificed in corrosion protection due to their active chemical properties

and easy corrosion. However, compared with magnesium, metallic zinc and its alloys

have a higher corrosion potential. Therefore, compared with magnesium alloy, the

corrosion rate of zinc and its alloy is slower, which is more in line with clinical needs, and is expected to be developed into new biomedical biodegradable implant materials and devices.

The normal zinc content in the human body is 2-3 grams. Zinc is the main component of

dozens of enzymes in the body. Zinc is distributed in most organs and tissues, among

which the content is higher in liver, muscle and bone. Although zinc is a trace element in

the human body, it has a great effect. Known as the "spark plug of life". (1) Zinc is

related to various bone matrix synthase, and it can participate in bone formation and bone

reconstruction. When zinc is deficient, the activity of a variety of zinc-containing

enzymes in bone decreases, and bone growth is inhibited. (2) Zinc is a key component of

biofilm, which plays an important role in maintaining the structure and function of more

than 2,000 transcription factors and more than 300 enzymes. (3) Zinc can quickly enter

endothelial cells and maintain the integrity of endothelial cells, reduce the susceptibility

of blood vessels to atherosclerosis. (4) Zinc can protect cardiomyocytes from acute

oxidative stress and inflammatory reactions caused by myocardial injury. (5) Zinc can

actively participate in nucleic acid protein synthesis and accelerate wound healing; (6) In

addition, zinc is also closely related to the metabolism of various cells in the body, such

as sugar metabolism, lipid metabolism and anti-aging. Zinc deficiency can lead to

arteriosclerosis, arrhythmia and failure, brain abnormalities, weakened immunity,

diarrhea, loss of appetite, slowed growth, hair loss, night blindness, enlarged prostate,

decreased male reproductive function, anemia, etc. Adults need to supplement 15-25mg

zinc daily.

Gallium (Ga) is a strong bone-fixing calcium agent for human body, which can be used to

treat cancer-related hypercalcemia and osteitis deformans. Gallium has a strong bactericidal effect because it can bind to bacterial proteins. Gallium and its compounds have anti-inflammatory and anti-osteoporosis effects. Gallium can inhibit the resorption of osteoclasts, inhibit osteolysis, prevent the release of bone calcium, change the gene expression of type I collagen and fibrin in bone, can be beneficial to the formation of new bone, and can also increase the content of calcium and phosphorus in bone. It acts directly on the formation of human bones.

At present, there are no documents and patents at home and abroad that report the

synthesis and performance of Zn-Ga series alloys, and no relevant documents and patents

propose the use of Zn-Ga series alloys as degradable biomedical materials.

SUMMARY

The purpose of the present invention is to provide a Zn-Ga series zinc alloy and a

preparation method and application thereof, in particular to a Zn-Ga series zinc alloy, a

preparation method thereof, and application in the preparation of a body fluid-degradable

medical implant. The zinc alloy prepared by the invention has excellent mechanical

properties, can provide long-term effective support in the body, has excellent cell

compatibility, blood compatibility, and tissue and organ compatibility, and can be used as

biomedical implant materials.

In order to achieve the above objectives, the present invention provides the following

solutions:

The present invention provides a Zn-Ga series alloy, including Zn and Ga, in which Ga

accounts for 0-30 wt%, but not including 0.

As a further improvement of the present invention, the Zn-Ga series alloy also includes

trace elements, which are magnesium, calcium, strontium, manganese, titanium,

zirconium, germanium, copper, silicon, phosphorus, lithium, silver, tin and at least one of

the rare earth elements. Wherein the trace element accounts for 0-1Owt%.

As a further improvement of the present invention, the surface of the Zn-Ga series alloy

is further coated with a degradable high polymer coating, a degradable ceramic coating or

a degradable drug coating.

As a further improvement of the present invention, the thickness of the degradable

polymer coating, the degradable ceramic coating and the degradable drug coating are all

0.001 to 5 mm.

As a further improvement of the present invention, the preparation material of the

degradable polymer coating is at least one of the following 1) and 2).

1) Any one of polycaprolactone, polylactic acid, polyglycolic acid, L-polylactic acid,

polycyanoacrylate, polyanhydride, polyphosphazene, polydioxanone,

polyhydroxybutyrate and polyhydroxyvalerates;

2) A copolymer of any two or more of polylactic acid, polycaprolactone, polyglycolic

acid, L-polylactic acid, polycyanoacrylate, and polydioxanone;

The preparation material of the degradable ceramic coating is at least one of

hydroxyapatite, tricalcium phosphate or tetracalcium oxyphosphate;

The degradable drug coating is at least one of rapamycin and its derivatives coating,

paclitaxel coating, everolimus coating, sirolimus coating, mitomycin coating and

antibacterial coating One kind.

As a further improvement of the present invention, the Zn-Ga series zinc alloy is

specifically any one of the following 1)-4), in a mass percentage,

1) composed of 95~99% Zn and 1%~5% Ga;

2) composed of 99% Zn and 1% Ga;

3) composed of 98% Zn and 2% Ga;

4) composed of 98.5% Zn, 1% Ga and 0.5% Y.

The Zn-Ga series zinc alloy prepared by the invention has a dense structure or a porous

structure, has good tissue compatibility, and is a reliable biomedical implant material.

The present invention also provides a method for preparing the Zn-Ga series alloy, which

includes the following steps:

Mix Zn, Ga and the trace elements according to any one of the following methods 1) and

2) to obtain a mixture.

1) Zn and Ga;

2) Zn, Ga and trace elements;

The zinc alloy can be obtained according to the following steps a) or b).

a) Under the protection of C02 and SF6 atmosphere, the mixture is smelted or sintered,

and the zinc alloy is obtained after cooling; b) Under the protectionof C02and SF6atmosphere, the mixture is smelted or sintered, and the degradable polymer coating, the degradable ceramic coating or the degradable drug coating is coated after cooling to obtain the zinc alloy. The method of preparing the zinc alloy also includes the step of applying a coating is to meet different clinical needs.

As a further improvement of the present invention, the melting temperature in the

preparation method is 500 to 700°C.

As a further improvement of the present invention, the preparation method further

includes machining steps of zinc alloy

As a further improvement of the present invention, the mechanical processing is at least

one of rolling, forging, rapid solidification and extrusion.

As a further improvement of the present invention, repeated rolling is performed in a

back rolling mill, the hot rolling temperature is 250°C, and finally in a finishing rolling

mill, it is rolled to a thickness of 1.5 mm at 250°C.

As a further improvement of the present invention, the forging includes the steps of heat

retaining the Zn-Ga series alloy at a temperature of 150-200°C and forging at a

temperature of 200-300°C, and the heat-retaining time is 3 -50h, the forging speed rate is

not less than 350mm/s.

As a further improvement of the present invention, the extrusion temperature is 150

250°C, specifically 200-220°C; and the extrusion ratio is 10-70, specifically 20-25.

As a further improvement of the present invention, the rapid solidification includes the

following steps- under the protection of Ar gas, a high vacuum rapid quenching system is used to prepare a rapid solidification thin strip, and then the thin strip is crushed into powder. Then under the condition of 200-350'C, carry out vacuum hot pressing for 1-24h.

As a further improvement of the present invention, the settings of the high-vacuum rapid

quenching system are as follows:

the feeding amount is 2-8g, the induction heating power is 3-7kW, the distance between

the nozzle and the roller is 0.80mm, the spray pressure is 0.05-0.2MPa, and the roller

speed is 500-3000r/min and the nozzle slit size is lfilmx8mmx6mm.

As a further improvement of the present invention, the sintering is any one of the

following methods- element powder mixed sintering method, pre-alloyed powder

sintering method, and self-propagating high-temperature synthesis method.

As a further improvement of the present invention, the element powder mixing and

sintering method is to uniformly mix the raw materials for preparing the porous structure

Zn-Ga series alloy, press it into a green body, and then in a vacuum sintering furnace,

slowly heat up to 100-200°C at 2-4°C/min, then quickly heat up to 200-300°C at

°C/min for sintering, then lower the temperature to obtain a porous structure of Zn-Ga

series alloy.

As a further improvement of the present invention, the pre-alloyed powder sintering

method is to mix the raw materials for preparing the porous structure Zn-Ga series alloy

and then perform high-energy ball milling, then press molding, and perform heat

treatment at 250-350°C for 10-20 hours to obtain a porous structure of Zn-Ga series

alloy;

As a further improvement of the present invention, the self-propagating high-temperature

synthesis method is to mix the raw materials for preparing porous structure Zn-Ga series

alloys and press them into billets, under the protection of inert gas, with the pressure

1x103~Ix105 Pa and temperature 250-35 0 °C. Then the Zn-Ga series alloy blank is

ignited for self-propagating high-temperature synthesis to obtain a Zn-Ga series alloy

with porous structure.

As a further improvement of the present invention, the method for coating the

biodegradable polymer coating is to take the zinc alloy for acid pickling. Then it is

immersed in the preparation material of the biodegradable polymer coating in a colloid

prepared by trichloroethane for 10 to 30 minutes, and then pulling out at a uniform speed

for centrifugal treatment to obtain a zinc alloy with biodegradable polymer coating.

As a further improvement of the present invention, the method for applying the

degradable ceramic coating can be any one of plasma spraying, electrophoretic

deposition, anodizing and hydrothermal synthesis;

As a further improvement of the present invention, the main plasma gas used in plasma

spraying is Ar, the flow rate is 30-100 scfi, the secondary plasma gas is H2, the flow rate

is 5-20 scfh, and the spraying current is 400-800A. The spraying voltage is 4080V, and

the spraying distance is 100500mm.

As a further improvement of the present invention, the method for electrodeposition of

the degradable ceramic coating is to use a zinc alloy as a cathode in an electrolyte

containing calcium and phosphorus salts with a current density of 2-10mA/cm 2 , and after

treatment for 10-60min, washing and drying to obtain the surface modified zinc alloy;

As a further improvement of the present invention, the method of combining anodization

and hydrothermal synthesis is to oxidize the zinc alloy in an electrolyte containing 0.01 to

0.5 mol/Lj-glycerophosphate sodium and 0.1 to 2 mol/L calcium acetate, at 200-5OOV

for 10-30min, and then treat the zincalloy at 200~400°C for 1~4h.

As a further improvement of the present invention, the method for applying the

degradable drug coating is a physical and chemical method;

The physical method coating process mainly uses immersion and spraying methods; the

chemical method mainly uses electrochemical principles for electroplating;

The soaking method is to prepare a solution of the active drug and a controlled release

carrier (or a separate active drug), and the specific concentration may vary due to the

viscosity of the solution and the required drug dosage. Then, the medical implant is

immersed in the solution, and then undergoes necessary post-treatment processes, such as

cross-linking, drying, curing, etc., to form a drug coating;

The spraying method is to prepare a solution of the active drug and a controlled release

carrier (or a separate active drug), and then uniformly coat the solution on the surface of

the medical implant through a spraying tool or a special spraying device, After drying,

curing and other post-processing steps, the drug coating is made;

The chemical method uses active drugs and (or) a controlled release carrier to generate an

electrical oxidation-reduction reaction on the electrode made by the medical implant, so

that the medical implant surface forms a stable drug coating connected by chemical

bonds.

According to the characteristics of Zn and Zn alloy easy to corrode, the invention selects

Zn-Ga alloy as degradable material for medical implants. The mechanical properties of

the Zn-Ga series alloy of the present invention meet the requirements of the strength and

toughness of medical implant materials, and at the same time it can be degraded in vivo,

that is, it can overcome the low strength of medical polymer materials and the

indegradability of traditional medical metal materials such as 316L stainless steel,

titanium and titanium alloys. It can also overcome the defect that the excessive

degradation rate of magnesium and magnesium alloy leads to the loss of mechanical

properties of the implant. It has the dual characteristics of "bio-corrosive degradation

characteristics" and "appropriate corrosion rate to ensure long-term effective mechanical

support".

The present invention also provides the application of the Zn-Ga series alloy, which is

used to prepare a body fluid-degradable medical implant which includes a therapeutic

implanted stent, a bone repair instrument, and a cranio-maxillofacial repair instrument.

As a further improvement of the present invention, the therapeutic implantable stent may

be a blood vessel stent, an esophageal stent, an intestinal stent, a tracheal stent, a biliary

stent or a urethral stent.

The bone repair instrument can be a bone tissue repair bracket, a bone connector, a

fixation wire, a fixation screw, a fixation rivet, a fixation pin, a bone splint, an

intramedullary nail or a bone sleeve.

The cranio-maxillofacial repair instrument can be a cranial bone repair net, a

maxillofacial bone defect repair bracket, etc.

The present invention discloses the following technical effects:

(1) The mechanical properties of the Zn-Ga series alloy prepared by the present invention

meet the requirements of the strength and toughness of medical implant materials, and at

the same time it is degradable in vivo. It has the dual characteristics of "bio-corrosive

degradation characteristics" and " appropriate corrosion rate to ensure long-term effective

mechanical support".

(2) When the Zn-Ga series alloy of the present invention is used in a degradable medical

implant, it can not only exert the high strength characteristics of its metal material within

a period of implantation to complete the function of the implant (such as inducing the

formation of new bone tissue or supporting narrow blood vessels), and it can be gradually

corroded and degraded by the human body as a "foreign body" while the diseased part of

the human body repairs itself. The quantity and volume are gradually reduced, and the

dissolved metal ions can be absorbed and utilized by the organism to promote bone

growth or metabolism to be eliminated from the body, and finally the metal material

implant completely degrades and disappears when the body finishes its self-repair.

(3) The body fluid-degradable medical implant provided by the present invention is non

toxic and has good tissue compatibility and blood compatibility.

BRIEF DESCRIPTION OF THE FIGURES

In order to explain the embodiments of the present invention or the technical solutions in

the prior art more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative labor.

Figure 1 shows the cell compatibility test results of Zn-Ga alloy.

DESCRIPTION OF THE INVENTION

Various exemplary embodiments of the present invention will now be described in detail.

The detailed description should not be considered as a limitation to the present invention,

but should be understood as a more detailed description of certain aspects, characteristics,

and embodiments of the present invention.

It should be understood that the terms described in the present invention are only used to

describe specific embodiments and are not used to limit the present invention. In addition,

for the numerical range in the present invention, it should be understood that each

intermediate value between the upper limit and the lower limit of the range is also

specifically disclosed. Each smaller range between any stated value or intermediate value

within the stated range and any other stated value or intermediate value within the stated

range is also included in the present invention. The upper and lower limits of these

smaller ranges can be independently included or excluded from the range.

Unless otherwise specified, all technical and scientific terms used herein have the same

meaning as commonly understood by those skilled in the art in the field of the present

invention. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe methods and/or materials related to the documents. In the event of conflict with any incorporated document, the content of this manual shall prevail.

Without departing from the scope or spirit of the present invention, various improvements

and changes can be made to the specific embodiments of the present specification, which

is obvious to those skilled in the art. Other embodiments derived from the description of

the present invention will also be obvious to the skilled person. The specification and

examples of this application are only exemplary.

As used herein, "including", "included", "having", "containing", etc., are all open terms,

which means including but not limited to.

The percentages used in the following examples are all mass percentages unless

otherwise specified.

Example 1. Preparation of as-cast Zn-Ga series alloy

Using pure Zn (99.99 wt.%) and pure Ga (99.95 wt.%) (purchased from Beijing Cuibailin

Nonferrous Metal Technology Development Center) as raw materials. Mixing according

to different mass ratios- the mass ratio of Zn to Ga and other trace elements Y(Gd, Nd) is

99:1, 98.5: 1.5, 98: 2, 97: 3, 95: 5) and smelting at 550°C under the protection of

C02+SF6atmosphere. After the raw materials are fully melted, holding for 10 minutes,

then using circulating water to cool quickly and the Zn-Ga alloy ingot was prepared.

Example 2. Preparation of rolled Zn-Ga series alloy

First, prepare as-cast Zn-Ga alloy ingots according to the steps in Example 1. Then, the

obtained Zn-Ga alloy ingots were hot rolled, and the ingots were preheated at 250 C.

Then, it is rolled repeatedly in a reciprocating mill by hot rolling at a warm rolling

temperature of 250 °C and finally rolled to a thickness of 1.5 mm in a finishing mill at

250 C.

Example 3. Preparation of extruded Zn-Ga series alloy

Follow the steps in 1) or 2) below to prepare.

1) First, prepare as-cast Zn-Ga series alloy ingots according to the steps in Example 1 and

prepare Zn-Ga series alloy bars by extrusion. Using radial extrusion with an extrusion

temperature 200°C. The extrusion ratio is 20. Then a Zn-Ga series alloy bar with a

diameter of 10 mm was prepared.

2) First, prepare as-cast Zn-Ga series alloy ingots according to the steps in Example 1,

and use high vacuum rapid quenching system to prepare rapidly solidified Zn-Ga series

alloy thin strips. The specific method is that the raw materials are mixed according to the

stated ratio and then a high vacuum rapid quenching system is used to prepare a rapidly

solidified Zn-Ga ribbon (temperature 550°C, no hot pressing time). The parameters are

feeding amount 2-8g, induction heating power 3-7kW, nozzle and roller distance

0.80mm, spray pressure 0.1MPa, roller speed 2000r/min and nozzle slit size

lfilmx8mmx6mm. Then the thin strip is crushed and pressed into a billet. The Zn-Ga

series alloy bar is prepared by extrusion. Using radial extrusion with an extrusion temperature 200°C and an extrusion ratio 20, and then the Zn-Ga series alloy bars with a diameter of 10mm is prepared.

Example 4. Zn-Ga series alloy mechanical properties

The Zn-Ga series alloys, prepared according to the methods of Examples 1-3, were

respectively prepared into tensile samples according to ASTM-E8-04 tensile test

standard, and then polished by 400#, 800#, 1200# and 2000# SiC sandpaper series. After

ultrasonic cleaning in acetone, absolute ethanol and deionized water for 15 minutes, a

universal material mechanics testing machine was used to perform a tensile test at room

temperature, and the tensile speed was 1 mm/min.

The tensile properties at room temperature of each sample of the Zn-Ga series alloy are

shown in Table 1. From Table 1, it can be seen that the yield strength and tensile strength

of the rolled alloy and the extruded alloy are obviously improved compared to the as-cast

alloy. At the same time, the elongation has been greatly increased, indicating that the

mechanical properties of the material have been further optimized after the deformation

process.

Table 1. Zn-Ga alloy tensile mechanical properties data

Tensile Yield Sample No Elongation/% strength/MPa strength/MPa

Pure zinc ingot 22.32 13.53 0.25

Zn-5Ga ingot 103.38 78.06 1.15

Zn-1Ga-0.5Y rolled 269.21 210.05 26.91 plate

Zn-1Ga-0.5Y bar 290.39 243.60 18.05

Zn-1Ga-0.5Y casting 183.39 135.26 2.57 ingot

Example 5. Zn-Ga alloy blood compatibility

The rolled Zn-Ga alloy of Example 2 was prepared into a lOx1Ox1.5 mm Zn-Ga alloy

sample piece by wire cutting, which was polished by 400#, 800#, 1200# and 2000# SiC

sandpaper series. After ultrasonic cleaning for 15 minutes in acetone, absolute ethanol

and deionized water, they were dried at 25°C. Fresh blood from healthy volunteers was

collected and stored in an anticoagulant tube containing 3.8wt% sodium citrate as an

anticoagulant. Dilute with 0.9% normal saline at a ratio of 4:5 to prepare a diluted blood

sample. Soak the sample in 10 mL of normal saline, keep it at 37±0.5°C for 30 min, add

0.2 mL of diluted blood sample, and keep it at 37±0.5°C for 60 min. 10 mL of normal saline was used as the negative control group, and 10 mL of deionized water was used as the positive control group. After centrifugation at 3000 rpm for 5 minutes, the supernatant was taken to measure the absorbance OD value with an Unic-7200 UV-Vis spectrophotometer at 545nm, and three sets of parallel samples were set for statistical analysis.

Use the following formula to calculate the hemolysis rate:

Hemolysis rate = (experimental group OD value-negative group OD value) / (positive

group OD value-negative group OD value) x 100%.

The experimental results show that the hemolysis rate of Zn-Ga alloy is between 0.2%

and 0.5%, which is far less than the safety threshold of 5% required for clinical use, and

shows good compatibility of red blood cells and hemoglobin.

Example 7. Preparation of body fluid degradable medical Zn-Ga implant and its cell

compatibility experiment

The Zn-Ga alloy was prepared according to the method of Examples 1-3. The 6 Zn-Ga

alloy blocks prepared above with length, width, and thickness of 10mm, 10mm, and 1.5

mm respectively were sterilized by y-ray and placed in a sterile culture flask. Add MEM

cell culture medium at the ratio of sample surface area to MEM cell culture medium

volume of 1.25 cm2 /mL, and place it in an incubator at 37°C, 95% relative humidity, and

%CO2for 72 hours to obtain Zn-Ga alloy extraction liquid stock solution. Seal it and

keep it in refrigerator at 4C for later use.

Extraction and cell inoculation culture and observation result. MG63 cells (purchased

from Guangzhou Genio Biotechnology Co., Ltd.) were resuscitated and passaged,

suspended in MEM cell culture medium, and inoculated on 96-well culture plates. The

negative control group was added with MEM cell culture medium, and the Zn-Ga alloy

extract group was added with the 4-fold diluted Zn-Ga alloy extract obtained above, so

that the final cell concentration was 5x10 4 /mL. Culture in a 37°C, 5%CO2 incubator.

After 5 days, take out the culture plate and observe the morphology of living cells under

an inverted phase contrast microscope (as shown in Figure 1). The results showed that the

cell morphology showed healthy and stretched spindle-shaped convergent growth,

indicating that Zn-Ga alloy has excellent cell compatibility.

The above-mentioned embodiments only describe the preferred modes of the present

invention, and do not limit the scope of the present invention. Without departing from the

design spirit of the present invention, various modifications and improvements made by

those of ordinary skill in the art to the technical solution of the present invention shall fall

within the protection scope determined by the claims of the present invention.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. A Zn-Ga series alloy is characterized in that it comprises Zn and Ga, and Ga accounts

for 0-30 wt%, but not including 0.

2. The Zn-Ga series alloy according to claim 1 is characterized in that the Zn-Ga series

alloy further includes trace elements, which is at least one of magnesium, calcium,

strontium, manganese, titanium, zirconium, germanium, copper, silicon, phosphorus,

lithium, silver, tin and rare earth elements.

3. The Zn-Ga series alloy according to claim 2 is characterized in that the trace element

accounts for 0-10 wt%.

4. The Zn-Ga series alloy according to claim 1 is characterized in that the surface of the

Zn-Ga series alloy is further coated with a degradable polymer coating, a degradable

ceramic coating or a degradable drug coating.

5. The Zn-Ga series alloy according to claim 1 is characterized in that the preparation

material of the degradable polymer coating is at least one of the following 1) and 2):

polycyanoacrylate, polyanhydride, polyphosphazene, polydioxanone,

polyhydroxybutyrate and polyhydroxyvalerates;

acid, L-polylactic acid, polycyanoacrylate, and polydioxanone;

The preparation material of the ceramic coating is at least one of hydroxyapatite,

tricalcium phosphate or tetracalcium oxyphosphate;

The drug coating is at least one of rapamycin and its derivative coatings, paclitaxel

coatings, everolimus coatings, sirolimus coatings, mitomycin coatings and antibacterial

coatings.

6. A method for preparing a Zn-Ga series alloy according to any one of claims 1 to 5 is

characterized in that it comprises the following steps:

2) to obtain a mixture.

1) Zn and Ga;

2) Zn, Ga and trace elements;

The zinc alloy can be obtained according to the following steps a) or b).

and the zinc alloy is obtained after cooling;

b) Under the protection of C02 and SF6 atmosphere, the mixture is smelted or sintered,

and the degradable polymer coating, the degradable ceramic coating or the degradable

drug coating is coated after cooling to obtain the Zn-Ga series alloy.

7. The method for preparing the Zn-Ga series alloy according to claim 6 is characterized

in that it further comprises a step of machining the Zn GA series alloy.

8. The method for preparing a Zn-Ga series alloy according to claim 7 is characterized in

that the mechanical processing is at least one of rolling, forging, rapid solidification and

extrusion.

9. The method for preparing a Zn-Ga series alloy according to claim 6 is characterized in

that the sintering is any one of the following methods- element powder mixed sintering

method, pre-alloyed powder sintering method, and self-propagating high-temperature

synthesis method.

10. An application of the Zn-Ga series alloy according to any one of claims 1 to 5 is

characterized in that the Zn-Ga series alloy is used in preparing a body fluid-degradable

medical implant.

-1/1-

Figure 1