CN101147813A - Method for preparing medicine coating carrier and medicine coating blood vessel support - Google Patents
Method for preparing medicine coating carrier and medicine coating blood vessel support Download PDFInfo
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- CN101147813A CN101147813A CNA2007101444974A CN200710144497A CN101147813A CN 101147813 A CN101147813 A CN 101147813A CN A2007101444974 A CNA2007101444974 A CN A2007101444974A CN 200710144497 A CN200710144497 A CN 200710144497A CN 101147813 A CN101147813 A CN 101147813A
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Abstract
The present invention relates to a preparation method of medicine coating carrier and medicine coating blood vessel scaffold. The preparation method of said medicine coating carrier includes the following steps: prepolymerization and mixing so as to obtain the medicine coating carrier, and the preparation method of said medicine coating blood vessel scaffold includes the following steps: (a), prepolymerization and mixing; and (b), polycondensation.
Description
Technical field
The present invention relates to the preparation method of a kind of medication coat and drug stent.
Background technology
Medicine coating carrier on the coating stent of medicine of exploitation has polylactic acid, polyglycolic acid, poly-propylene oxide and poe etc. now, its major defect medicine coating carrier needs to add extra catalyst and solvent in building-up process, to having a negative impact of biocompatibility, be easy to generate inflammatory reaction, and medicine coating carrier is coated on the support after synthetic, not strong with the support adhesion, discharge in the medicine process in degraded, medication coat is easy to generate large tracts of land and comes off, particularly, bring danger for patient's life as coronary artery stent.
Summary of the invention
The present invention is easy to generate the problem that degraded comes off for the medicine coating carrier that solves on the existing medicine coating blood vessel support is easy to generate inflammatory reaction in degradation process, and the preparation method of a kind of medicine coating carrier and coating stent of medicine is provided.
Medicine coating carrier of the present invention is prepared by the following method: get the pre-polymerization 6～10 hours under 130～160 ℃ condition of 0.8～1.2 part of degraded 0.2～1 part of instrumentality, 1～2.5 part of decanedioic acid and glycerol by the mole portion rate, 20%～50% the ingredient that adds the gross weight of decanedioic acid and glycerol again, mix homogeneously promptly obtains medicine coating carrier; The degraded instrumentality is hydroxyacetic acid, lactic acid, Acetic acid, hydroxy-, bimol. cyclic ester, lactide, chitin, polyglycolic acid, polylactic acid or chitosan.
Medicine coating blood vessel support of the present invention is prepared according to the following steps: one, get the pre-polymerization 6～10 hours under 130～160 ℃ condition of 0.8～1.2 part of degraded 0.2～1 part of instrumentality, 1～2.5 part of decanedioic acid and glycerol by the mole portion rate, 20%～50% the ingredient that adds the gross weight of decanedioic acid and glycerol again, mix homogeneously promptly obtains medicine coating carrier; Two, with after the medicine coating carrier dip-coating or spraying to rack surface, polycondensation is 6～8 hours under 120～150 ℃ condition; Promptly obtain medicine coating blood vessel support.
In the medicine coating carrier preparation method of the present invention with medicine coating blood vessel support preparation in the ingredient of step 1 be rapamycin or paclitaxel.
The degraded instrumentality of step 1 is hydroxyacetic acid, lactic acid, Acetic acid, hydroxy-, bimol. cyclic ester, lactide, chitin, polyglycolic acid, polylactic acid or chitosan in the medicine coating blood vessel support preparation of the present invention; Adding the degraded instrumentality is in order to regulate the mechanical property and the degradation property of synthetic support.
The decanedioic acid in the medicine coating blood vessel support preparation of the present invention in the step 1 and the degree of functionality of glycerol are respectively 2 and 3.
Support in the medicine coating blood vessel support preparation of the present invention in the step 2 is a bare bracket.
Medicine coating blood vessel support of the present invention can be used for the angiostenosis treatment and reduces the restenosis incidence rate.
Medicine coating carrier of the present invention compared with prior art has the following advantages: poly-decanedioic acid glyceryl alcohol ester elastomer no extra catalyst and solvent in building-up process, thus avoided the negative effect to the material biocompatibility such as extra catalyst and solvent.
Medicine coating blood vessel support of the present invention compared with prior art has the following advantages: (1) carries out polycondensation reaction again because medicine coating blood vessel support of the present invention adopts with the dip-coating of pastille prepolymer or after spraying to rack surface, does not come off so the medicine coating carrier that forms can not produce in degradation process; (2) zoopery shows, poly-decanedioic acid glyceryl alcohol ester elastomer has the favorable tissue reaction, and inflammation and fibrosis are less in the body; There is not tangible swelling phenomenon when (3) degrading; (4) determination of lactate dehydrogenase method and mtt assay are measured no vitro cytotoxicity; (5) degradation process medium-height trestle quality is linear and descends, and its mass loss changes as shown in Figure 1 with degradation time, and the medicine coating carrier that the medicine coating blood vessel support of the present invention's preparation be described is the slow release degraded, does not have the large tracts of land generation that comes off of degrading, and is safe; (6) adhesion of coating and metal rack can reach 3.7～4.5Mpa, and is strong with the support basal body binding force, is suitable for the performance requirement as medicaments coating material, difficult drop-off.
Description of drawings
Fig. 1 is linear change figure for support mass loss of the present invention with degradation time.
The specific embodiment
The specific embodiment one: the medicine coating carrier of present embodiment is prepared by the following method: get the pre-polymerization 6～10 hours under 130～160 ℃ condition of 0.8～1.2 part of degraded 0.2～1 part of instrumentality, 1～2.5 part of decanedioic acid and glycerol by the mole portion rate, 20%～50% the ingredient that adds the gross weight of decanedioic acid and glycerol again, mix homogeneously promptly obtains medicine coating carrier; The degraded instrumentality is hydroxyacetic acid, lactic acid, Acetic acid, hydroxy-, bimol. cyclic ester, lactide, chitin, polyglycolic acid, polylactic acid or chitosan.
The specific embodiment two: the difference of the present embodiment and the specific embodiment one is: get the pre-polymerization 7～9 hours under 140～150 ℃ condition of 0.9～1.1 part of degraded 0.4～0.8 part of instrumentality, 1.4～2 parts of decanedioic acid and glycerol by the mole portion rate.Other step and parameter are identical with the specific embodiment one.
The specific embodiment three: the difference of the present embodiment and the specific embodiment one is: get the pre-polymerization 8 hours under 145 ℃ condition of 1 part of degraded 0.6 part of instrumentality, 1.7 parts of decanedioic acid and glycerol by the mole portion rate.Other step and parameter are identical with the specific embodiment one.
The specific embodiment four: the difference of the present embodiment and the specific embodiment one is: ingredient is rapamycin or paclitaxel.Other step and parameter are identical with the specific embodiment one.
The specific embodiment five: present embodiment and the specific embodiment one or fours' difference is: 25%～45% the rapamycin that adds the gross weight of decanedioic acid and glycerol again.Other step and parameter are identical with the specific embodiment one or four.
The specific embodiment six: present embodiment and the specific embodiment one or fours' difference is: 30%～40% the paclitaxel that adds the gross weight of decanedioic acid and glycerol again.Other step and parameter are identical with the specific embodiment one or four.
The specific embodiment seven: present embodiment and the specific embodiment one or fours' difference is: 35% the paclitaxel that adds the gross weight of decanedioic acid and glycerol again.Other step and parameter are identical with the specific embodiment one or four.
The specific embodiment eight: the medicine coating blood vessel support of present embodiment is prepared according to the following steps: one, get the pre-polymerization 6～10 hours under 130～160 ℃ condition of 0.8～1.2 part of degraded 0.2～1 part of instrumentality, 1～2.5 part of decanedioic acid and glycerol by the mole portion rate, 20%～50% the ingredient that adds the gross weight of decanedioic acid and glycerol again, mix homogeneously obtains medicine coating carrier; Two, with after the medicine coating carrier dip-coating or spraying to rack surface, polycondensation is 6～8 hours under 120～150 ℃ condition; Promptly obtain medicine coating blood vessel support; Degraded instrumentality in the step 1 is hydroxyacetic acid, lactic acid, Acetic acid, hydroxy-, bimol. cyclic ester, lactide, chitin, polyglycolic acid, polylactic acid or chitosan.
The specific embodiment nine: the difference of the present embodiment and the specific embodiment eight is: get the pre-polymerization 7～9 hours under 140～150 ℃ condition of 0.9～1.1 part of degraded 0.4～0.8 part of instrumentality, 1.4～2 parts of decanedioic acid and glycerol by the mole portion rate in the step 1.Other step and parameter are identical with the specific embodiment eight.
The specific embodiment ten: the difference of the present embodiment and the specific embodiment eight is: get the pre-polymerization 8 hours under 145 ℃ condition of 1 part of degraded 0.6 part of instrumentality, 1.7 parts of decanedioic acid and glycerol by the mole portion rate in the step 1.Other step and parameter are identical with the specific embodiment eight.
The specific embodiment 11: the difference of the present embodiment and the specific embodiment eight is: the ingredient in the step 1 in the step 1 is rapamycin or paclitaxel.Other step and parameter are identical with the specific embodiment eight.
The specific embodiment 12: the difference of present embodiment and the specific embodiment eight or 11 is: 25%～45% the rapamycin that adds the gross weight of decanedioic acid and glycerol in the step 1 again.Other step and parameter are identical with the specific embodiment eight or 11.
The specific embodiment 13: the difference of present embodiment and the specific embodiment eight or 11 is: 30%～40% the paclitaxel that adds the gross weight of decanedioic acid and glycerol in the step 1 again.Other step and parameter are identical with the specific embodiment eight or 11.
The specific embodiment 14: the difference of present embodiment and the specific embodiment eight or 11 is: 35% the paclitaxel that adds the gross weight of decanedioic acid and glycerol in the step 1 again.Other step and parameter are identical with the specific embodiment eight or 11.
The specific embodiment 15: the difference of the present embodiment and the specific embodiment eight is: polycondensation 6.5～7.5 hours under 125～145 ℃ condition in the step 2.Other step and parameter are identical with the specific embodiment eight.
The specific embodiment 16: the difference of the present embodiment and the specific embodiment eight is: polycondensation 7 hours under 135 ℃ condition in the step 2.Other step and parameter are identical with the specific embodiment eight.
The specific embodiment 17: the medicine coating blood vessel support of present embodiment is prepared according to the following steps: one, get the pre-polymerization 8 hours under 150 ℃ condition of 1 part of 0.4 part of chitin, 1 part of decanedioic acid and glycerol by the mole portion rate, 30% the rapamycin that adds the gross weight of decanedioic acid and glycerol again, mix homogeneously obtains medicine coating carrier; Two, medicine coating carrier is sprayed to rack surface after, polycondensation is 7 hours under 130 ℃ condition; Promptly obtain medicine coating blood vessel support.
The medicine coating blood vessel support degradation time that present embodiment makes is 60～90 days, support is implanted in the heart coronary artery of pig, support is implanted the no acute complications in back, take out after 30 days, by the face coat micro structure that scanning electron microscope (SEM) is observed support, the no medication coat part that comes off.Take out after 90 days, coating is degraded fully; Detect by the pathology means, no thrombosis forms, the NIP reaction.
Claims (10)
1. the preparation method of a medicine coating carrier, it is characterized in that medicine coating carrier is prepared by the following method: get the pre-polymerization 6～10 hours under 130～160 ℃ condition of 0.8～1.2 part of degraded 0.2～1 part of instrumentality, 1～2.5 part of decanedioic acid and glycerol by the mole portion rate, 20%～50% the ingredient that adds the gross weight of decanedioic acid and glycerol again, mix homogeneously promptly obtains medicine coating carrier; The degraded instrumentality is hydroxyacetic acid, lactic acid, Acetic acid, hydroxy-, bimol. cyclic ester, lactide, chitin, polyglycolic acid, polylactic acid or chitosan.
2. the preparation method of a kind of medicine coating carrier according to claim 1 is characterized in that getting the pre-polymerization 7～9 hours under 140～150 ℃ condition of 0.9～1.1 part of 0.4～0.8 part of instrumentality of degraded, 1.4～2 parts of decanedioic acid and glycerol by the mole portion rate.
3. the preparation method of a kind of medicine coating carrier according to claim 1 is characterized in that getting the pre-polymerization 8 hours under 145 ℃ condition of 1 part of 0.6 part of instrumentality of degraded, 1.7 parts of decanedioic acid and glycerol by the mole portion rate.
4. the preparation method of a kind of medicine coating carrier according to claim 1, the ingredient that it is characterized in that is rapamycin or paclitaxel.
5. according to the preparation method of claim 1 or 4 described a kind of medicine coating carriers, it is characterized in that adding again 25%～45% rapamycin of the gross weight of decanedioic acid and glycerol.
6. according to the preparation method of claim 1 or 4 described a kind of medicine coating carriers, it is characterized in that adding again 30%～40% paclitaxel of the gross weight of decanedioic acid and glycerol.
7. according to claim 1 or 4 described a kind of medicine coating carrier preparation methoies, it is characterized in that adding again 35% paclitaxel of the gross weight of decanedioic acid and glycerol.
8. the preparation method of a medicine coating blood vessel support, it is characterized in that medicine coating blood vessel support is prepared according to the following steps: one, get the pre-polymerization 6～10 hours under 130～160 ℃ condition of 0.8～1.2 part of degraded 0.2～1 part of instrumentality, 1～2.5 part of decanedioic acid and glycerol by the mole portion rate, 20%～50% the ingredient that adds the gross weight of decanedioic acid and glycerol again, mix homogeneously obtains medicine coating carrier; Two, with after the medicine coating carrier dip-coating or spraying to rack surface, polycondensation is 6～8 hours under 120～150 ℃ condition, promptly obtains medicine coating blood vessel support; Degraded instrumentality in the step 1 is hydroxyacetic acid, lactic acid, Acetic acid, hydroxy-, bimol. cyclic ester, lactide, chitin, polyglycolic acid, polylactic acid or chitosan.
9. the preparation method of a kind of medicine coating blood vessel support according to claim 8 is characterized in that in the step 2 under 125～145 ℃ condition polycondensation 6.5～7.5 hours.
10. the preparation method of a kind of medicine coating blood vessel support according to claim 8 is characterized in that in the step 2 under 135 ℃ condition polycondensation 7 hours.
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| CNB2007101444974A CN100566764C (en) | 2007-10-26 | 2007-10-26 | A kind of preparation method that is used for the medicine coating carrier and the medicine coating blood vessel support of medicine coating blood vessel support |
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