CN103372234A - Drug eluting stent and preparation method thereof - Google Patents
Drug eluting stent and preparation method thereof Download PDFInfo
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- CN103372234A CN103372234A CN2012101279484A CN201210127948A CN103372234A CN 103372234 A CN103372234 A CN 103372234A CN 2012101279484 A CN2012101279484 A CN 2012101279484A CN 201210127948 A CN201210127948 A CN 201210127948A CN 103372234 A CN103372234 A CN 103372234A
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Abstract
The invention provides a drug eluting stent which comprises a stent and a drug coating covering the surface of the stent. The drug coating comprises a drug and a drug carrier, wherein the drug is astragalus polysaccharide, astragaloside and bilobalide in weight ratio of (1-2):1:(1-2). The invention further provides a preparation method of the drug eluting stent. The drug coating of the drug eluting stent provided by the invention is uniform in thickness, smooth in surface, free from cracks and falling. In vitro degradation experiment shows that the drug stent coating material is corroded and degraded on the surface to release the drug without falling. The drug in the drug coating of the drug eluting stent provided by the invention is slowly released and has the effect of inhibiting intimal hyperplasia, so that occurrence of restenosis is reduced.
Description
Technical field
The invention belongs to medical instruments field, relate in particular to a kind of bracket for eluting medicament and preparation method thereof.
Background technology
Atherosclerosis is the important diseases that affects human health, and wherein the pathological changes of heart coronary artery is called coronary heart disease, and coronary heart disease has become the No.1 killer of human health.In recent years, along with the coronary artery balloon expandable forms applying of art (PTCA), intravascular stent develops rapidly.By supporting at the coronary artery placing rack, thereby dredging vascellum is received good therapeutic effect.But support expansion is brought out vascellum endometrial hyperplasia after causing the tunica intima damage, causes easily the restenosis behind the stenting.
Summary of the invention
The present invention provides a kind of bracket for eluting medicament that reduces restenosis and preparation method thereof for solving the restenosis problem of existing bracket for eluting medicament.
The invention provides a kind of bracket for eluting medicament, this bracket for eluting medicament comprises support and covers the medication coat of rack surface; Described medication coat comprises medicine and pharmaceutical carrier, and described medicine is astragalus polysaccharides, astragaloside and bilobalide; The weight ratio of described astragalus polysaccharides, astragaloside and bilobalide is 1-2:1:1-2.
The present invention also provides a kind of preparation method of bracket for eluting medicament of the present invention, and the method may further comprise the steps:
S1 dissolves medicine and pharmaceutical carrier in proportion in solvent, obtain medication coat solution;
S2 is coated to rack surface with medication coat solution;
S3 solidifies the support vacuum drying of coating, namely obtains bracket for eluting medicament.
Bracket for eluting medicament of the present invention is coated on rack surface with astragalus polysaccharides, astragaloside and bilobalide, behind the implant frame, and sustained release, performance suppresses the effect of neointimal hyperplasia, thereby reduces the generation of restenosis.
The specific embodiment
In order to make technical problem solved by the invention, technical scheme and beneficial effect clearer, below in conjunction with embodiment, the present invention is further elaborated.Should be appreciated that specific embodiment described herein only in order to explain the present invention, is not intended to limit the present invention.
The invention provides a kind of bracket for eluting medicament, this bracket for eluting medicament comprises support and covers the medication coat of rack surface; Described medication coat comprises medicine and pharmaceutical carrier, and described medicine is astragalus polysaccharides, astragaloside and bilobalide; The weight ratio of described astragalus polysaccharides, astragaloside and bilobalide is 1-2:1:1-2.The weight ratio of described astragalus polysaccharides, astragaloside and bilobalide is the cardiovascular that medicine that 1-2:1:1-2 mixes in this ratio can be protected the diabetes patient better.
Insulin resistant (insulin resistance, IR), type 2 diabetes mellitus (2-diabetes mellitus, one of important pathogenesis 2-DM), its main manifestations is that peripheral tissues's (mainly comprising skeletal muscle, fatty tissue) of insulin stimulating reduces the picked-up utilization of glucose, causes pathoglycemia.Studies confirm that in a large number, the expression of GLUT4 (GLUT4) and transposition play critical effect to the picked-up utilization of glucose, GLUT4 is the factor of mediation glucose uptake, the glucose transport of its mediation is the rate-limiting step of peripheral tissues's glucose utilization, and this process generation obstacle then causes IR, hyperglycemia and obesity.Therefore significant for prevention and treatment type 2 diabetes mellitus for the research of GLUT4.
Astragalus polysaccharides (APS) is one of main active of the Radix Astragali, and the activity of Cellular Immunity, humoral immunization, nonspecific immunity and cytokine is all had regulating action, has the effect of two-ways regulation blood glucose.Insulin receptor INSR InsR during its mechanism may be organized with the raising diabetes patient, IRS 1 (IRS-1), phospholipid phthalein inositol 3 kinases PI3K levels increase tissue to the sensitivity of insulin, and it is relevant to improve the insulin signaling transduction.Have research to find that APS can increase the GLUT4 protein expression by improving Insulin receptor INSR and receptor metasomite signal transduction, improve the type 2 diabetes mellitus people insulin-resistant states, reduce type 2 diabetes mellitus people's blood sugar level.
The diabetic cardiomyopathy change shows as myocardial cell hypertrophy, hypertrophy and interstitial collagen deposition, and its myocardial fibrosis is that diabetic cardiomyopathy becomes the characteristic change.The activation of its cardiac Local Angiotensin II (Angiotensin II, Ang II) has important function in generation that diabetic cardiomyopathy becomes, development, the abnormal activation of Ang II has the effect that promotes that collagen is synthetic and make myocardial fibrosis.APS can regulate the gene expression of relevant helper T lymphocyte subgroup 1 with the type 1 diabetes autoimmune response (Thelper Cell, Th1)/Th2 cytokines; Simultaneously APS treatment can also obviously improve the collagen deposition of DM hamster cardiac muscle; there is certain protective effect APS treatment can also obviously improve type 1 diabetes (diabetes mellitus to the DM cardiomyopathy; DM) collagen deposition of cardiac muscle; significantly reduce the cease to be faithful Ang II level of flesh part of diabetes; suppress the excessive generation of diabetes regional myocardial Ang II, the DM cardiomyopathy is had certain protective effect.
There are some researches show that astragaloside has significant anti-apoptosis effect, indirectly delay or reverse myocardial fibrosis, suppress apoptosis of cardiac muscle.Astragaloside can reduce the propagation of the vascular smooth muscle cell that high sugar induces, and the proliferation index of bleeding of eye pipe smooth muscle cell also is lowered, and is dose dependent.But astragaloside induction of vascular Vascular Smooth Muscle Cell Apoptosis under the state of high sugar, thereby suppress the cell proliferation that high sugar is induced.Also point out astragaloside can suppress the pathological process of diabetics blood vessel.
Bilobalide is the diterpenic lactone that extracts by in Semen Ginkgo or the Folium Ginkgo, has the effect of antagonism platelet activating factor.Platelet activating factor (platelet activing factor, PAF) be a kind of endogenous phospholipid that platelet and inflammation cell produce and secrete, it also is the most effective platelet aggregation of finding up to now, have widely physiologically active, with increase vascular permeability, thrombosis shape atherogenesis is relevant.
According to bracket for eluting medicament provided by the present invention, in order better to control drug release cycle and local drug concentration, preferably, the weight ratio of described medicine and pharmaceutical carrier is 1:5-200.1:20-50 more preferably.
According to bracket for eluting medicament provided by the present invention, selected support refers to can be used for the vasodilation support of interventional therapy cardiovascular and peripheral blood vessel obstruction, comprises the porous support of various materials.Described support is the hollow out arbitrary shape, can be that cut, welding or braiding form.Preferably, described support is a kind of in rustless steel, cochrome, magnesium alloy, Nitinol, the biopolymer degradation material.
According to bracket for eluting medicament provided by the present invention, the pharmaceutical carrier of selecting is the good degradation material of biocompatibility.Preferably, described pharmaceutical carrier be that polylactic acid, Polyethylene Glycol, phosphocholine, glutin, polysiloxanes, positive polyester, polyethers are cruel, at least a in polyesteramide, poly phosphate, polyurethane, silicones, polysiloxanes and the micropore ceramics.
According to bracket for eluting medicament provided by the present invention, preferably, the thickness of described medication coat is the 1-100 micron.The thickness of coating directly affects the wall thickness of support, and the support wall thickness can cause local vascular inflammation, causes hyperplasia, causes a series of complication.The medication coat THICKNESS CONTROL satisfies the requirement of local drug concentration as far as possible when not increasing the support wall thickness.
The present invention also provides a kind of preparation method of bracket for eluting medicament of the present invention, and the method may further comprise the steps:
S1 dissolves medicine and pharmaceutical carrier in proportion in solvent, obtain medication coat solution;
S2 is coated to rack surface with medication coat solution;
S3 is placed on dry solidification in the vacuum drying oven with propping up of coating, namely obtains bracket for eluting medicament.
According to preparation method provided by the present invention, preferably, described solvent is at least a in acetone, methanol, ethanol, acetonitrile, N monomethyl pyrroles, dimethyl sulfoxide, toluene, dichloromethane, chloroform, ethyl acetate, oxolane, dimethyl formamide and the dimethyl acetylamide.
According to preparation method provided by the present invention, preferably, the method for described coating is spraying or dipping.
According to preparation method provided by the present invention, preferably, the temperature of described dry solidification is 0.5-100 ℃, and the time is 0.5-72h.More preferably, temperature is 30-80 ℃, and the time is 2-24h.
For the thickness that makes coating reaches requirement, can repeating step S2 and S3.
Below by embodiment the present invention is further described in detail.
Embodiment 1
Medicine is astragalus polysaccharides, astragaloside and bilobalide, and weight ratio is 2:1:2, and pharmaceutical carrier is PLA, and the weight ratio of medicine and carrier is 1:20.Medicine and pharmaceutical carrier ultrasonic dissolution in oxolane is even, make solution, on stainless steel stent, 40 ℃ of vacuum dryings solidify 20h again with accurate spray gun spraying, and medication coat thickness is 70 microns, obtains bracket for eluting medicament A1.
Embodiment 2
Medicine is astragalus polysaccharides, astragaloside and bilobalide, and weight ratio is 1:1:2, and pharmaceutical carrier is glutin, and the weight ratio of medicine and carrier is 1:10.Medicine and carrier ultrasonic dissolution in acetone is even, make medication coat solution, be coated on the magnesium alloy bracket surface, 30 ℃ of vacuum drying 24h again, the thickness of medication coat is 55 microns, obtains bracket for eluting medicament A2.
Embodiment 3
Medicine is astragalus polysaccharides, astragaloside and bilobalide, and weight ratio is 1:1:1, and pharmaceutical carrier is polyesteramide, and the weight ratio of medicine and carrier is 1:100.Medicine and carrier ultrasonic dissolution in dimethyl sulfoxide is even, make medication coat solution.The nick-eltitanium alloy stent surface at first sprays one deck parylene polymer film, behind the dry solidification, this support is dipped in the medication coat solution again, takes out rear 80 ℃ of vacuum drying 2h, and the thickness of medication coat is 80 microns, obtains bracket for eluting medicament A3.
Embodiment 4
Medicine is astragalus polysaccharides, astragaloside and bilobalide, and weight ratio is 1:1:1, and pharmaceutical carrier is Polyethylene Glycol, and the weight ratio of medicine and carrier is 1:50.Medicine and carrier ultrasonic dissolution in toluene is even, make medication coat solution.The cochrome rack surface at first sprays one deck parylene polymer film, behind the dry solidification, this support is dipped in the medication coat solution again, takes out rear 100 ℃ of vacuum drying 0.5h, and the thickness of medication coat is 75 microns, obtains bracket for eluting medicament A4.
Embodiment 5
Medicine is astragalus polysaccharides, astragaloside and bilobalide, and weight ratio is 1:1:1, and pharmaceutical carrier is polysiloxanes, and the weight ratio of medicine and carrier is 1:200.Medicine and carrier ultrasonic dissolution in dichloromethane is even, make medication coat solution.The stainless steel stent surface at first sprays one deck parylene polymer film, behind the dry solidification, this support is dipped in the medication coat solution again, takes out rear 40 ℃ of vacuum drying 20h, and the thickness of medication coat is 100 microns, obtains bracket for eluting medicament A5.
Embodiment 6
Medicine is astragalus polysaccharides, astragaloside and bilobalide, and weight ratio is 1:1:1, and pharmaceutical carrier is polyurethane, and the weight ratio of medicine and carrier is 1:5.Medicine and carrier ultrasonic dissolution in dimethyl formamide is even, make medication coat solution.The intravascular stent surface at first sprays one deck parylene polymer film, behind the dry solidification, this support is dipped in the medication coat solution again, takes out rear 40 ℃ of vacuum drying 20h, and the thickness of medication coat is 40 microns, obtains bracket for eluting medicament A6.
Method of testing and test result
1, outward appearance
Under scanning electron microscope, observe the outward appearance of A1-A6, the results are shown in Table 1.
,The external degradation experiment
External degradation experiment is to be 7.4 at pH, and temperature is to carry out in 37 ℃ the phosphate buffer, observes under scanning electron microscope after 5 days.The results are shown in Table 1.
3, cell culture experiments in vitro
Mouse endothelial cells places 37 degrees centigrade with DMEM low sugar culture medium culturing, cultivates in the 5%CO2 incubator, treats the most cells adherent growth, be linked to be netted after, use 0.25% trypsinization, be used for testing.
Normal model group culture medium: cultivate with the low sugar culture-medium (5.6mmol/L) of DMEM.
Add D-Glucose in the low sugar culture-medium of high sugared model group culture medium: DMEM, making its ultimate density is 20mmol/L.
The mouse endothelial cells of getting the equivalent normal growth is inoculated in respectively in A, B, four culture bottles of C, D, DMEM low sugar culture medium culturing, when treating adherent growth to 60%, the DMEM culture medium of changing different disposal continues to cultivate a week, with inverted microscope observation of cell growing state.Different processing means and observed results see Table 2.
Table 1
| Outward appearance | The external degradation experiment | |
| A1 | The medication coat even thickness, the smooth surface flawless is without coming off | The drug stent coating material is in the surface erosion degraded, discharges medicine, without coming off generation |
| A2 | The medication coat even thickness, the smooth surface flawless is without coming off. | The drug stent coating material is in the surface erosion degraded, discharges medicine, without coming off generation. |
| A3 | The medication coat even thickness, the smooth surface flawless is without coming off | The drug stent coating material is in the surface erosion degraded, discharges medicine, without coming off generation. |
| A4 | The medication coat even thickness, the smooth surface flawless is without coming off. | The drug stent coating material is in the surface erosion degraded, discharges medicine, without coming off generation. |
| A5 | The medication coat even thickness, the smooth surface flawless is without coming off. | The drug stent coating material is in the surface erosion degraded, discharges medicine, without coming off generation. |
| A6 | The medication coat even thickness, the smooth surface flawless is without coming off. | The drug stent coating material is in the surface erosion degraded, discharges medicine, without coming off generation. |
Table 2
| ? | The A group | The B group | The C group | The D group |
| The processing means | Low sugar DMEM(5.6mmol/L) | DMEM in high glucose (20mmol/L)+paclitaxel (1 μ mol/L) | Astragaloside, astragalus polysaccharides, the bilobalide of DMEM in high glucose (20mmol/L)+admixing medical solutions 10 μ g/mL(1:1:1) | DMEM in high glucose (20mmol/L) |
| 2d | The most of adherent growth of cell connects into netted | The most of adherent growth of cell connects into netted | The most of adherent growth of cell connects into netted | Cellular morphology is slightly irregular, the part adherent growth |
| 4d | Cell attachment is good, and growth is fine and close | The most of adherent growth of cell connects into netted | Cell attachment is good, and growth is fine and close | Cellular morphology is irregular, has floating on a small quantity |
| 6d | The endotheliocyte island occurs, and density increases, well-grown | Cell attachment is good, and growth is fine and close | Growth of Cells is good, has part floating | Cellular morphology is irregular, and is floating many |
Bracket for eluting medicament medication coat even thickness of the present invention as can be seen from Table 1, the smooth surface flawless is without coming off.And through the external degradation experiment, the drug stent coating material is in the surface erosion degraded, discharges medicine, without coming off generation.Sustained release in the bracket for eluting medicament medication coat of the present invention is described, can brings into play the effect that suppresses neointimal hyperplasia, thereby reduce the generation of restenosis.
Can find out to a certain extent inhibition of endothelial cell proliferation of B group solution from the experimental result of table 2, C group Growth of Cells is hyper-proliferative well and not, shows to a certain extent inducing endothelial cell apoptosis of this hybrid medicine.The D group shows cell ill degeneration growth under high sugar juice.This experiment shows that intravascular stent that pharmaceutical formulation of the present invention is made can reduce the generation of the again stopping state after diabetics is implanted.
The above only is preferred embodiment of the present invention, not in order to limiting the present invention, all any modifications of doing within the spirit and principles in the present invention, is equal to and replaces and improvement etc., all should be included within protection scope of the present invention.
Claims (10)
1. a bracket for eluting medicament is characterized in that, this bracket for eluting medicament comprises support and covers the medication coat of rack surface; Described medication coat comprises medicine and pharmaceutical carrier, and described medicine is astragalus polysaccharides, astragaloside and bilobalide; The weight ratio of described astragalus polysaccharides, astragaloside and bilobalide is 1-2:1:1-2.
2. bracket for eluting medicament according to claim 1 is characterized in that, the weight ratio of described medicine and pharmaceutical carrier is 1:5-200.
3. bracket for eluting medicament according to claim 1 is characterized in that, the material of described support is a kind of in rustless steel, cochrome, magnesium alloy, Nitinol and the biopolymer degradation material.
4. bracket for eluting medicament according to claim 1, it is characterized in that described pharmaceutical carrier is at least a in polylactic acid, Polyethylene Glycol, phosphocholine, glutin, polysiloxanes, positive polyester, polyether ester, polyesteramide, poly phosphate, polyurethane, silicones, polysiloxanes and the micropore ceramics.
5. bracket for eluting medicament according to claim 1 is characterized in that, the thickness of described medication coat is the 1-100 micron.
6. the preparation method of a bracket for eluting medicament claimed in claim 1 is characterized in that, the method may further comprise the steps:
S1: medicine and pharmaceutical carrier are dissolved in solvent in proportion, obtain medication coat solution;
S2: medication coat solution is coated to rack surface;
S3: the support vacuum drying of coating is solidified, namely obtain bracket for eluting medicament.
7. preparation method according to claim 6, it is characterized in that described solvent is at least a in acetone, methanol, ethanol, acetonitrile, N-methylpyrrole, dimethyl sulfoxide, toluene, dichloromethane, chloroform, ethyl acetate, oxolane, dimethyl formamide and the dimethyl acetylamide.
8. preparation method according to claim 6 is characterized in that, the method for described coating is spraying or dipping.
9. preparation method according to claim 6 is characterized in that, the temperature that described vacuum drying solidifies is 0.5-100 ℃, and the time is 0.5-72h.
10. preparation method according to claim 6 is characterized in that, repeating step S2 and S3.
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| CN105771005A (en) * | 2016-03-24 | 2016-07-20 | 乐普（北京）医疗器械股份有限公司 | Anti-rheumatic blood vessel stenosis drug-eluting stent and preparation method and application thereof |
| CN115569240A (en) * | 2022-09-15 | 2023-01-06 | 辽宁垠艺生物科技股份有限公司 | Medicine coating plastic capsule and preparation method thereof |
| WO2023178519A1 (en) * | 2022-03-22 | 2023-09-28 | 乐普（北京）医疗器械股份有限公司 | Drug coating, drug balloon, preparation method for drug balloon and use thereof |
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