CN108853690A - A kind of film envelope drug storage sacculus and preparation method - Google Patents
A kind of film envelope drug storage sacculus and preparation method Download PDFInfo
- Publication number
- CN108853690A CN108853690A CN201810920055.2A CN201810920055A CN108853690A CN 108853690 A CN108853690 A CN 108853690A CN 201810920055 A CN201810920055 A CN 201810920055A CN 108853690 A CN108853690 A CN 108853690A
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- drug
- sacculus
- groove
- film
- pressure
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- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 3
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Classifications
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- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
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- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
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Abstract
The invention discloses a kind of film envelope drug storage sacculus and preparation methods.This method, which holds mold at a certain temperature using sacculus pressure, makes balloon surface extrude groove, is used for storing drugs, and have overlay film, the opening of closed pockets, the Targeting delivery that the rupture of film sealing can be made to realize drug by increasing pressure in outer surface;The groove arrangement mode is spiral, grid type, waveform or the geometry arrangement for being designed as other forms.The release rate of medicine balloon dilating catheter drug under different sacculus filling pressures of the method for the present invention preparation is different;Drug in the overlay film protector on surface can reduce the loss of washing away of drug during reaching lesion by blood, improve drug in the bioavilability of target lesion position.
Description
Technical field
The invention belongs to medical instruments fields, are related to a kind of foley's tube of surface covering drug, and especially one kind has
The foley's tube of groove and outer surface with overlay film for drug storage.
Background technique
Coronary heart disease has become the major disease for threatening human life and health, includes for the treatment means of coronary heart disease at present
Drug therapy, cardiovascular Coronary Artery Bypass(Coronary Artery Bypass Grafting, CABG)Percutaneous coronary is situated between
Enter iatrotechnics(Percutaneous Coronary Intervention, PCI)Deng.Wherein, PCI because its wound it is small, painful
Small, post-operative recovery becomes the primary means for the treatment of fastly.In recent years, China's coronary disease PCI number of cases keeps 20% ~ 30% average annual growth
Rate.Bracket for eluting medicament is the essential therapeutic arsenals in PCI, medicament elution sacculus(Drug Coated Balloon, DCB)It is
Important supplement is mainly used for bifurcated lesions, Small vessel and in-stent restenosis.
The main problem for influencing current DCB clinical effectiveness is that balloon surface drug is washed away by blood vessel by blood, reaches disease
Become position and there was only 5%--15% by passively diffusing into blood vessel, bioavilability harmonic(-)mean.A kind of this film envelope drug storage sacculus
Preparation method, it is desirable to be able to improve DCB drug in the bioavilability of target vessel.
106237485 A of patent document CN discloses a kind of medicine-coated balloon dilating catheter and preparation method thereof.It is described
Medication coat exceptionally layer and internal layer, outer layer are water soluble protective layer, and internal layer is active drug and excipient.
104174073 B of patent document CN is related to a kind of medicine-carrying method of medicine eluting balloon catheter, first carries out sacculus
Then the mixed liquor being made of curative drug, additive and solvent is sprayed on molten by swelling treatment using airless spraying technology
Balloon surface after swollen, natural air drying.The medicinal balloon that this patent is announced balloon surface first extrudes groove, the storage for drug
Hiding, and there is overlay film in outer surface, it is different with two patent drug sacculus coating treatment technologies retrieving.
Summary of the invention
In order to solve the above problem, the present invention provide it is a kind of preferably by drug pack the medicinal balloon of balloon surface system
Preparation Method.
The present invention solve the above problems used by technical solution be:A kind of preparation method of sacculus dilating catheter, including
Sacculus dilating catheter ontology and medication coat.Carry medicine ball utricule and contain drug storage groove, and in the groove part of sacculus outer surface and
Flat coats the medication coat, then by coating one layer of high molecular polymer for drug encapsulation in a groove on surface.
When sacculus fills, film sealing rupture, drug storage groove bulged under the action of internal pressure directly by drug quick release extremely
Lesions position.
The preparation method holds mold using sacculus pressure by raising temperature on sacculus dilating catheter surface and extrudes groove,
Balloon surface is set to form concave-convex nonplanar structure.
The material of the sacculus is nylon (PA) or polyether block amide (PEBAX).
The temperature of the molding is 25 ~ 200oC。
The pressure of the molding is 2-30atm.
The shape of the groove is round, ellipse, square or oval.
The volume of the groove is uniform.Wherein, slot pitch 0.02-0.2mm, groove depth 0.01-2mm, groove width are
0.02-0.2mm。
The groove helically formula, grid type or other forms geometry arrangement.
The semienclosed slot is used for the storage of drug.
The medication coat includes drug-loaded layer and confining bed, and drug-loaded layer includes active medicine and adhesive.
The active medicine can be rapamycin and its derivative tacrolimus, everolimus, Zuo Tamosi,
Mytrolimus etc., taxol and its derivative, dexamethasone, heparin, hirudin, dexamethasone, 17 beta estradiols, Statins
Drug, one of chuanxiong piperazine, rheum emodin, curcumin, triptolide, Puerarin etc. or a variety of mixtures, medicine
The load capacity of object is 1-100 μ g/mm2。
The medicine adhesive is that hydroaropic substance includes natural macromolecular material gelatin, sodium alginate, chitosan, hydroxyl second
The starch derivatives such as starch, carboxymethylstarch, semi-synthetic high molecular material carboxymethyl cellulose salt, cellacefate, ethyl cellulose,
Methylcellulose, hydroxypropyl methylcellulose, the poly- carbon ester of synthesis high molecular material, polyaminoacid, polylactic acid, poly- acetic acid-polyglycolic acid
Copolymer, polylactic acid-polyethylene glycol block copolymer.
The confining bed of the drug is that high molecular polymer includes gelatin, sodium alginate, chitosan, hydroxyl second starch, carboxylic first
The starch derivatives such as starch, carboxymethyl cellulose salt, cellacefate, ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose,
Poly- carbon ester, polyaminoacid, polylactic acid, poly- acetic acid-co-glycolic acid, polylactic acid-polyethylene glycol block copolymer.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of medicinal balloon catheter of the present invention;
Fig. 2 is the enlarged diagram of sacculus vertical section structure in Fig. 1;
Fig. 3 is the schematic diagram of drug release in sacculus when pressurizeing;
Fig. 4 is the release rate schematic diagram of drug at various pressures.
Specific embodiment
Specific embodiments of the present invention are described in detail below, but embodiments of the present invention are not limited thereto.
Embodiment 1:
1, in 3.0*20 model(Diameter 3.0mm length 20mm)Common sacculus molding die inner surface design diameter is 0.1mm, length
The strip protrusion that degree is 18mm, axially extends, is made molding die needed for the present invention;
2, the 12 sacculus former material expects pipe of nylon with a thickness of 0.05mm is chosen, according to conventional steps, sacculus molding is carried out, channel-shaped is made
Sunk structure(Section is in semiclosed circle).It is welded later according to conventional steps, sacculus dilating catheter, such as Fig. 1 is made;
3, sacculus is filled up in 4atm pressure, makes balloon surface sunk structure(Groove)In half expansion state then by taxol second
Alcoholic solution is sprayed on balloon surface;
4, pressure is withdrawn to 2atm, sacculus rebound, taxol drug is wrapped in groove.Polylactic acid is sprayed in balloon surface
(PLA)Acetone soln forms surface coating, such as Fig. 2;
5, routinely step carries out tabletting, roll film to sacculus, and the present invention is made.
Drug storage sacculus is sealed by film made from embodiment 1, the release journey of drug can be can control by adjusting the size of pressure
Degree.Its drug release characteristics such as Fig. 3:When pressure is 3atm, the release rate of drug is 30%;When pressure is 4atm, drug is released
Putting rate is then 50%;When pressure is 6atm, drug release rate 80%;Drug release rate is more than 90% when pressure is 8atm, such as Fig. 4.
, it can be achieved that it is 0 that drug, which washes away loss, during reaching lesion by bloody path.
Embodiment 2:
Common sacculus molding die inner surface design diameter be 0.1mm, the strip protrusion of length 18mm, spiral extension,
The required molding die of the present invention is made.Other conditions are the same as embodiment 1.
Embodiment 3:
The latticed square protrusion for being 0.1mm in common sacculus molding die inner surface design side length, it is required to be made the present invention
Molding die.Other conditions are the same as embodiment 1.
Embodiment 4:
Sacculus former material expects pipe can be polyether block amide (PEBAX).Other conditions are the same as embodiment 1.
Embodiment 5:
The drug wrapped up in sacculus can be rapamycin.Other conditions are the same as embodiment 1.
Claims (13)
1. a kind of film seals drug storage sacculus dilating catheter, it is characterised in that:It is fluted in sacculus dilating catheter balloon portion band(Or it is recessed
Hole), drug can be stored in the groove or pit;Outer surface has surface coating, for closing above-mentioned groove(Or it is recessed
Hole)Opening and control drug and release.
2. film as described in claim 1 seals drug storage foley's tube, it is characterised in that the groove(Or pit)It can be at spiral
Formula, grid type or the geometry arrangement for being designed as other forms.
3. film as described in claim 1 seals drug storage foley's tube, it is characterised in that the groove(Or pit)It is by balloon wall
Be recessed inwardly composition, and cup depth can be 0.01-2mm.
4. surface coating as described in claim 1, it is characterised in that:By high molecular polymer, drug or other can have into
The small molecule of film property is made.
5. the high molecular polymer as described in claim 4, it is characterised in that:It can be gelatin, sodium alginate, chitosan, hydroxyl second
The starch derivatives such as starch, carboxymethylstarch, carboxymethyl cellulose salt, cellacefate, ethyl cellulose, methylcellulose, hydroxypropyl
Methylcellulose, poly- carbon ester, polyaminoacid, polylactic acid, poly- acetic acid-co-glycolic acid, polylactic acid-polyglycol block copolymerization
One of object or several mixing, or other materials are mixed in above-mentioned high molecular polymer(Drug, active factors, metal from
Son etc.).
6. surface coating according to claim 1, it is characterised in that:It can be or certain by some tension
It is ruptured when in the environment such as ion, enzyme, pH, temperature, to open the opening of groove or pit, releases stored drug.
7. film as described in claim 1 seals drug storage sacculus, it is characterised in that:The size of pressure can be filled up by adjusting sacculus
To control rupture and the groove of surface coating(Or pit)Degree of opening, thus realize drug control release.
8. sacculus according to claim 5, is made to be in expansion state then for hydrophilic coating and drug under 6atm pressure
It is sprayed on balloon surface, pressure is withdrawn to after 4atm sacculus rebound hydrophilic coating and drug and then wraps up in a groove, then in table
Face coat one layer of high molecular polymer film, in a groove by drug blockage, increase pressure after sacculus confining bed rupture and incite somebody to action
Drug release is in target position.
9. film according to claims 1-8 seals drug storage sacculus, preparation method is by the sacculus portion of sacculus dilating catheter
Divide and increases temperature when pressure is held and extrude groove(Or pit), there is overlay film for the storage of drug, and in outer surface, for sealing
The opening of groove is closed, and the size that can control slot opening by controlling pressure realizes drug controlled release.
10. preparation method as claimed in claim 9, can be increased by control or reduce pressure realize sacculus fill up or
It shrinks.
11. preparation method as claimed in claim 9, it is characterised in that by holding mold using different pressures when sacculus pressure is held
And extrude spiral, grid type or the groove of other geometric formats.
12. preparation method as claimed in claim 9, it is characterised in that sacculus pressure holds temperature in 35-100oBetween C.
13. as described in claim 1, this sacculus dilating catheter can be applied to coronary artery blood vessel, peripheral blood vessel and intracranial vessel
It intervenes and other needs to load vein, esophagus, tracheae, biliary tract, urethra, fallopian tubal and stomach and intestine of drug etc..
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CN112274745A (en) * | 2020-10-29 | 2021-01-29 | 合肥达米医疗科技有限公司 | Double-layer bag double-cavity bronchial catheter |
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CN111437894A (en) * | 2020-04-09 | 2020-07-24 | 西安交通大学 | Micro-droplet generation system and generation method for accurately wrapping micro-particles |
CN112274745A (en) * | 2020-10-29 | 2021-01-29 | 合肥达米医疗科技有限公司 | Double-layer bag double-cavity bronchial catheter |
CN112402771A (en) * | 2020-11-20 | 2021-02-26 | 东莞天天向上医疗科技有限公司 | Convex-concave expansion balloon and production and use method thereof |
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CN114762640A (en) * | 2021-01-12 | 2022-07-19 | 黑龙江省白金医疗器械科技有限公司 | MAG silver intrauterine contraceptive device |
CN114098899A (en) * | 2021-11-04 | 2022-03-01 | 杭州天路医疗器械有限公司 | Non-closed balloon shock waveguide tube, preparation process thereof and directional drug delivery method |
CN114098899B (en) * | 2021-11-04 | 2023-11-03 | 杭州天路医疗器械有限公司 | Impact waveguide tube of non-closed balloon, preparation process thereof and directional drug delivery method |
CN114699218A (en) * | 2022-06-08 | 2022-07-05 | 北京天星博迈迪医疗器械有限公司 | Self-sealing balloon |
CN114699218B (en) * | 2022-06-08 | 2022-08-16 | 北京天星博迈迪医疗器械有限公司 | Self-sealing balloon |
CN115999024A (en) * | 2023-03-24 | 2023-04-25 | 上海佳沐垚医疗科技有限公司 | Drug release control device |
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