CN104324421A - Method for preparing balloon dilatation catheter medicinal coating for treatment - Google Patents
Method for preparing balloon dilatation catheter medicinal coating for treatment Download PDFInfo
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- CN104324421A CN104324421A CN201410659293.4A CN201410659293A CN104324421A CN 104324421 A CN104324421 A CN 104324421A CN 201410659293 A CN201410659293 A CN 201410659293A CN 104324421 A CN104324421 A CN 104324421A
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- medicine
- dilating catheter
- sacculus dilating
- sacculus
- coating
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
- A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- 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
Abstract
The invention relates to a method for preparing a balloon dilatation catheter medicinal coating for treatment. The method comprises the following steps: adding a diluted solvent into a glass bottle filled with a medicine for treating vascular endothelial re-proliferation, oscillating to completely dissolve the medicine to prepare a medicine solution; mixing the medicine solution and an interference solvent which is incompatible with the medicine, and feeding into a dual-channel ultrasonic nozzle to coat a balloon dilatation catheter; drying, sterilizing and packaging the coated balloon dilatation catheter. According to the method, the medicine solution is mixed with another incompatible interference solvent before ultrasonic coating, so that the shape of the medicine in the solution is changed, and the mixture is fed into the ultrasonic nozzle to perform ultrasonic coating to achieve the aims of controlling the coating granularity, increasing the coating binding force and controlling the releasing rate of the medicine. The medicine coating formed by the method has the characteristics of uniformity, strong binding force with balloon, controllable crystal granularity, durable drug effect and the like.
Description
Technical field
The present invention relates to medical apparatus and instruments preparing technical field, relate to a kind of preparation method for the treatment of with sacculus dilating catheter medication coat particularly.
Background technology
Use and again dredge through percutaneous balloon angioplasty the innovation that narrow lesion vessels is reconstructive vascular operation.But balloon angioplasty defect in Long lesion blood vessel, thin vessels is obvious, and it is again narrow that the blood vessel after dredging is easy to generation.Support in stent procedure is owing to providing certain mechanical support to blood vessel, the retraction of the blood vessel elasticity after simple balloon expandable and later stage negativity vascular remodeling can be eliminated, but it also can cause too much inflammatory reaction, thus cause more neointimal hyperplasia, cause in-stent restenosis (ISR).The main restriction of support is thrombus in stents, needs to control by Antiplatelet therapy.Bracket for eluting medicament (DES) is another breakthrough in support technology, because they can make hyperplasia minimize, makes restenosis rate be reduced to units level.DES Problems existing is the in-stent restenosis in late period.The restriction of DES impels people to constantly bring forth new ideas to provide better solution, and medicament elution sacculus (DEB) is exactly a kind of.
Medicament elution sacculus is drug delivery technologies in the novel vascular that grows up on the interventional technique such as balloon dilatation or Balloon Angioplasty basis, it is by antiproliferative medicine, as paclitaxel, rapamycin etc. coat balloon surface, when sacculus arrive lesion vessels and softened, expansion, contact with blood vessel wall inner membrance time, the medicine fast transfer entrained by it is to blood vessel wall and retain long period of time.Medicine suppresses vascellum endometrial hyperplasia in blood vessel wall, thus prevents postoperative vascular restenosis.
Usually, medicine intravasation tissue has three kinds of approach: 1, inflation medicine discharges from coating surface, makes medicine rapid solution enter in endo cell under the effect of cosolvent; 2, inflation tear portion inner membrance, medicine enters the gap of tearing from balloon surface coating shedding, thus plays long-term slow releasing drug action; 3, medicament contact vascular wall tissue, contacts with the esterophilic site of cell, and sticks on cell wall, and at this moment blood is difficult to medicine to wash away, thus plays the effect of long-term release drug effect.
At present, method prepared by balloon surface medication coat is a lot, such as: on sacculus rough surface, use spraying, dipping, nanometer and embedded technology etc., these Method and Technology are all for solving: discharge to blood vessel wall at balloon expandable time control pharmacy, reduce the drug loss of medicine in course of conveying simultaneously.Wherein reduce drug loss this point ten minutes important.
The coating processes of existing balloon surface medication coat has following two kinds:
1) dip coating
The method is mixed solution apparatus being placed in carrier polymer and medicine, and medicine and polymer support are adsorbed on equipment surfaces.Dip coating processing technology is relatively simple, and process is also convenient to regulate, but easily occurs the phenomenon that material converges or condenses causing coating layer thickness inconsistent, the problems such as drug distribution is uneven for the apparatus that shape and structure is more complicated.Further, coating drug content also depends on the viscosity of drug solution and the power of medicine and equipment surfaces absorption affinity to a great extent.Therefore the method application surface is wideless.
2) spraying process
The method adds suitable retarder thinner again by after appropriate medicine and polymer mixed, and ultrasonic rear dissolving is as drug-carried coat liquid.Drug-carried coat liquid is atomized, is sprayed at equipment surfaces.The coating layer thickness that spraying process makes is homogeneous, effectively can reduce the phenomenon that material converges or condenses, and be conducive to modifying again of coating.But traditional gas atomization method, needs the control of larger air-flow and environment, also larger to inventory charge.And ultrasonic atomizatio method wherein utilizes ultrasonic energy to make liquid form the process of fine mist in the gas phase, namely produce ultrasound wave at the liquid surface of vibration, the peak that shakes be made up of amplitude is separated drop fragmentation from surface.General under hyperacoustic frequency of vibration effect, fine drop can be obtained.After introducing less air-flow again, the stream of liquid droplets of ejection can be made to stable, drop on equipment surfaces uniformly.Therefore be applied in polytype medical apparatus surface coated medicament coating, ultrasonic spraying process is comparatively practical.
And the medicinal balloon of not all has identical curative effect.The factor affecting medicinal balloon curative effect is a lot, such as: medicine is in the Content and distribution of balloon surface, medicine loses in course of conveying, medicine is transferred to blood vessel wall ability, the reserve capability of medicine under blood flow Scouring Condition.These all factors all have in the form of coating surface with medicine and directly contact.Medicine not only affects in the configuration of surface of coating medicine to be transferred to blood vessel wall ability in the loss of course of conveying and medicine, also affects the rate of release of medicine and the retention time at lesion vessels position simultaneously.The form of medicine controlled by its crystal formation.By controlling the solvent composition of medicine, drug level, the temperature of drug crystallization, the time of crystallization, reach the object controlling medicine crystal crystal formation and particle diameter.Crystal morphology rule, the medicine that the medicine that crystallite dimension is suitable can make balloon surface carry to diseased region transfer, also can realize the slow releasing of medicine at diseased region, greatly can improve the therapeutic effect of sacculus rapidly.
Summary of the invention
Technical problem to be solved by this invention is, a kind of preparation method for the treatment of with sacculus dilating catheter medication coat is provided, easy, quick, that dose is controlled coat application process can either be provided, what make medicaments uniformity sticks in balloon surface, reduce the loss of medicine in course of conveying, can improve again the bioavailability behind medicine arrival lesion vessels position, the curative effect of prolong drug, improves the therapeutic effect of medicine balloon dilating catheter.
The present invention is achieved in that provides a kind of preparation method for the treatment of with sacculus dilating catheter medication coat, and it mainly comprises the following steps:
First step, the medicine for the treatment of blood vessel hypertrophy is again being housed---add at least any one the vial in the medicine of paclitaxel and derivant, rapamycin and derivant thereof and anticoagulant in ethanol, methanol, normal hexane, isopropyl alcohol, acetone and dilution in acetonitrile solvent at least after any one, vibration makes described complete drug dissolution make drug solution;
Second step, is connected certain runner in the ultrasonic nozzle of described drug solution and dual channel or multiple flow passages;
Third step, is connected at least one runner in all the other runners of described ultrasonic nozzle with the inconsistent interference solvent of described medicine, described interference solvent be in water, 75% ethanol, water/methanol blend at least any one;
4th step, first mixes described drug solution with interference solvent, sprays, while application sacculus dilating catheter, allow sacculus dilating catheter rotate to the sacculus dilating catheter of the below being arranged on ultrasonic nozzle before entering ultrasonic nozzle;
5th step, taking-up sacculus dilating catheter after application completes, then drying is carried out to the sacculus dilating catheter after application;
6th step, folds the sacculus dilating catheter being attached with medication coat complete for drying, puts into coil pipe, sterilizing, packaging.
Further, in a first step, the weight of medicine and solution: the ratio of volume is: 0.12g ~ 0.50g: 10ml ~ 20ml.
Further, in described 4th step, first described sacculus dilating catheter is forced into complete softened state carries out application again.
Further, in described 4th step, the specification of described sacculus dilating catheter is: external diameter 1.5mm ~ 6.0mm, and length is 15mm ~ 60mm.
Further, in described 4th step, spray parameters mainly comprises: supersonic frequency is 25kHz ~ 60kHz, ultrasonic power is 1w ~ 4w, the flow velocity of drug solution is 0.1ml/min ~ 0.2ml/min, and the flow velocity of interfering solvent is 0.05ml/min ~ 0.2ml/min, and the rotary speed of sacculus dilating catheter is 2r/s ~ 5r/s, spray time is 0.4min ~ 3min, and nebulizer gas pressure is 1psi.
Further, in described 4th step, spraying stroke is consistent with the length of sacculus dilating catheter.
Further, in described 5th step, drying condition parameter mainly comprises: baking temperature 4 DEG C ~ 50 DEG C, and relative humidity is 30% ~ 80%, and drying time is 10min ~ 60min.
Further, in described drug solution and interference solvent, can add pharmaceutical carrier, described pharmaceutical carrier is PEG(Polyethylene Glycol), PVP(polyvinyl pyrrolidone), PVA(polyvinyl alcohol), in nicotiamide and poloxamer at least any one.
Compared with prior art, the preparation method for the treatment of sacculus dilating catheter medication coat of the present invention, drug solution interference solvent inconsistent with another before ultrasonic spraying is allowed to mix, change medicine form in the solution, then enter ultrasonic nozzle and carry out ultrasonic spraying, realize controlling coating granule degree, increase coating binding force, the object of Drug controlled release degree.The medication coat that the present invention also has formation is even, medication coat and sacculus adhesion by force, the features such as crystal size is controlled, lasting medicine.
Accompanying drawing explanation
Fig. 1 is the cross-sectional schematic of the dual channel ultrasonic nozzle that the present invention uses;
Fig. 2 is medicine balloon dilating catheter coating layer thickness SEM observation figure prepared by the embodiment of the present invention 1.
Detailed description of the invention
In order to make technical problem to be solved by this invention, technical scheme and beneficial effect clearly understand, below in conjunction with drawings and Examples, the present invention is further elaborated.Should be appreciated that specific embodiment described herein only in order to explain the present invention, be not intended to limit the present invention.
The conventional method of medicine carrying class medical apparatus and instruments is prepared in ultrasonic spraying.Widely used by production firm in the medication coat preparation of intravascular stent.Ultrasonic flush coater regulates the particle diameter of atomized drop by controlling ultrasonic frequency, control the stability of air-flow and the radius of atomized drop by carrier gas.Utilize ultrasonic spraying can obtain a kind of firmly, evenly, the medication coat of dose controllable precise.But there is not the structure of medicine crystal in the solution that conventional ultrasonic spraying uses, simultaneously because the liquid droplet size after shower nozzle atomization is little, the reason that rate of volatilization is fast, makes the control of its later stage medicine crystal pattern also be difficult to realize.Medicine can be of short duration in suspension its crystal habit of control, but along with time lengthening, the further growth of crystal, the uniformity dyschezia of its crystal size is to control, and the uniformity that medicine distributes in balloon surface can reduce.Crystal size simultaneously in suspension increases to a certain degree, and its mobility can reduce rapidly, and finally lose flowability energy, cannot spray or block ultrasonic nozzle.
A kind of preparation method for the treatment of with sacculus dilating catheter medication coat provided by the invention, can effectively solve the problem.
Ultimate principle of the present invention is, by to retarder thinner with interfere the optimized choice of solvent in conjunction with the design of the ultrasonic nozzle of dual channel or multiple flow passages, can obtain a kind of firmly, evenly, the advantage of the medication coat of dose controllable precise, realize the control to crystal habit and granularity simultaneously.As shown in Figure 1, ultrasonic nozzle mainly comprises runner A, runner B, carrier gas port C, cavity 1, ultrasonic signal interface 2 and jet hole 3.Runner A is communicated with jet hole 3 by internal duct 4 after the ft connection of cavity 1 with runner B again, and carrier gas port C also communicates with jet hole 3, and the gas of carrier gas port C is sprayed from jet hole 3 by the outside of internal duct 4.Ultrasonic signal interface 2 is connected with cavity 1.
First by medicine, as in paclitaxel, rapamycin and derivant thereof etc. at least any one is dissolved in suitable retarder thinner, retarder thinner as in ethanol, methanol, normal hexane, isopropyl alcohol, acetone, acetonitrile etc. at least any one, through vibration or fully stir and be mixed with drug solution.
Secondly, this drug solution is entered in ultrasonic nozzle by runner A.Interference solvent inconsistent with medicine, as in water, 75% ethanol, water/methanol blend etc. at least any one by other runner as runner B also enters in ultrasonic nozzle.Flow to A and runner B just merges together before entering ultrasonic nozzle, then both mixed liquors enter in ultrasonic nozzle again.Simultaneously, can select to dissolve appropriate biocompatible substance in said medicine solution and incompatible interference solvent---pharmaceutical carrier, pharmaceutical carrier be in PEG, PVP, PVA, nicotiamide and poloxamer at least any one, with the release of the form control medicine of medication coat adjuvant.When said medicine solution and after interfering solvent blended, the dissolubility of medicine in mixed solution reduces, and drug molecule is separated out with crystal habit from mixed solution.After this medicine crystal is just sprayed into balloon surface through nozzle atomization.
Again, in sacculus spraying dry run, retarder thinner and interference solvent seasoning volatilization, medicine crystal further growth.Just the control to medicine crystal granularity can be realized by the environment controlling retarder thinner and interference solvent species and drying and volatilizing.
Below in conjunction with specific embodiment, the present invention will be further described.
In the present invention, if not refer in particular to, all parts, percentage ratio are unit of weight, and the equipment adopted and raw material etc. all can be buied from market or this area is conventional.Method in following embodiment, if no special instructions, is the conventional method of this area.
Embodiment 1: taxol drug coating sacculus preparation method:
1st step, paclitaxel solution: the paclitaxel weighing about 0.15g, adds 25ml vial; In vial, add the acetonitrile/acetone 1:1(v/v of 20ml) mixed solution, oscillate to paclitaxel and dissolve completely.
2nd step, the incompatible solution of paclitaxel: the PVP of 0.18g is dissolved in the medical alcohol of 75% of 20ml.
3rd step, spray parameters: the sacculus of 2.0*20mm has been forced under softened state is placed in ultrasonic nozzle, supersonic frequency is 25kHz, arranging ultrasonic power is 1w, and the flow velocity of paclitaxel solution is 0.1ml/min, and the incompatible solution flow rate of paclitaxel is 0.05ml/min, sacculus rotary speed is 3r/s, spraying stroke is 20mm, and spray time is 0.5min, and nebulizer gas pressure is 1psi; After spraying terminates, take out sacculus.
4th step, sacculus under temperature 30 DEG C, relative humidity 60% condition dry 30 minutes.
5th step, folds sacculus, puts into coil pipe, sterilizing, packaging.
Embodiment 2: taxol drug coating sacculus preparation method:
1st step, paclitaxel solution: the paclitaxel weighing about 0.13g, adds 15ml vial; In vial, add the ethanol/normal hexane 3:1(v/v of 10ml) mixed solution, oscillate to paclitaxel and dissolve completely.
2nd step, the incompatible solution of paclitaxel: PEG content is the aqueous solution of 20mg/ml.
3rd step, spray parameters: the sacculus of 3.0*15mm has been forced under softened state is placed in ultrasonic nozzle, supersonic frequency is 60kHz, arranging ultrasonic power is 0.8w, and the flow velocity of paclitaxel solution is 0.15ml/min, and the incompatible solution flow rate of paclitaxel is 0.1ml/min, sacculus rotary speed is 3r/s, spraying stroke is 15mm, spray time 1.1min, and nebulizer gas pressure is 1psi; After spraying terminates, take out sacculus.
4th step, sacculus under temperature 4 DEG C, relative humidity 80% condition dry 60 minutes.
5th step, folds sacculus, puts into coil pipe, sterilizing, packaging.
Embodiment 3: taxol drug coating sacculus preparation method:
1st step, paclitaxel solution: the paclitaxel weighing about 0.13g, adds 15ml vial; In vial, add the methanol/isopropanol 2:1(v/v of 10ml) mixed solution, oscillate to paclitaxel and dissolve completely.
2nd step, the incompatible solution of paclitaxel: PVA content is the 50% water/acetone soln of 10mg/ml.
3rd step, spray parameters: the sacculus of 6.0*40mm has been forced under softened state is placed in ultrasonic nozzle, supersonic frequency is 50kHz, arranging ultrasonic power is 4w, and the flow velocity of paclitaxel solution is 0.2ml/min, and the incompatible solution flow rate of paclitaxel is 0.2ml/min, sacculus rotary speed is 5r/s, spraying stroke is 40mm, spray time 3min, and nebulizer gas pressure is 1psi; After spraying terminates, take out sacculus.
4th step, sacculus under temperature 50 C, relative humidity 30% condition dry 10 minutes.
5th step, folds sacculus, puts into coil pipe, sterilizing, packaging.
Embodiment 4: rapamycin drug coating sacculus preparation method:
1st step, rapamycin solution: the rapamycin weighing about 0.12g, the PVP-I of 0.18g, adds 25ml vial; In vial, add the ethanol of 15ml, oscillate to rapamycin and dissolve completely.
2nd step, the incompatible solution of rapamycin: niacinamide content is the ethanol/water 1:1(v/v of 40mg/ml) solution.
3rd step, spray parameters: the sacculus of 1.5*15mm has been forced under softened state is placed in ultrasonic nozzle, supersonic frequency is 45KHz, power is 3w, and the flow velocity of rapamycin solution is 0.15ml/min, and the incompatible solution flow rate of rapamycin is 0.05ml/min, sacculus rotary speed is 2r/s, spraying stroke is 15mm, spray time 0.4min, and nebulizer gas pressure is 1psi; After spraying terminates, take out sacculus.
4th step, sacculus under temperature 10 DEG C, relative humidity 80% condition dry 60 minutes.
5th step, folds sacculus, puts into coil pipe, sterilizing, packaging.
Embodiment 5: rapamycin drug coating sacculus preparation method:
1st step, rapamycin solution: the rapamycin weighing about 0.25g, the poloxamer of 0.25g, adds 25ml vial; In vial, add the isopropyl alcohol of 20ml, oscillate to rapamycin and dissolve completely.
2nd step, the incompatible solution of rapamycin: the methanol/water of 50%.
3rd step, spray parameters: the sacculus of 4.0*60mm has been forced under softened state is placed in ultrasonic nozzle, supersonic frequency is 45KHz, power is 3w, and the flow velocity of rapamycin solution is 0.15ml/min, and the incompatible solution flow rate of rapamycin is 0.05ml/min, sacculus rotary speed is 2r/s, spraying stroke is 60mm, spray time 1.8min, and nebulizer gas pressure is 1psi; After spraying terminates, take out sacculus.
4th step, sacculus temperature 40 DEG C, under relative humidity 50% condition dry 20 minutes.
5th step, folds sacculus, puts into coil pipe, sterilizing, packaging.
For the medicine balloon dilating catheter actual effect that checking adopts method of the present invention to make, measurement drug release particles degree parameter is adopted to evaluate it.
Aids drug release particles degree method of testing and result as follows:
Medicine balloon dilating catheter the various embodiments described above prepared is placed in the beaker of 100ml respectively.Put into magnetic agitation rotor in beaker, rotating speed is set to 100r/s, uses full device to pressurize and reaches 10atm, is taken out by sacculus after pressurization 3min from beaker.The granularity in this solution is detected with laser particle analyzer.
The drug release particles degree testing result of table 1 medicine balloon dilating catheter
As can be seen from Table 1, in 5 embodiments, the granule of 100 μm of granularities does not all detect.Medicine in medicine balloon dilating catheter coating is because it discharges and the non-water-soluble feature of medicine itself fast, and control medicine granularity is in aqueous a very large challenge.The data of table 1 show method of the present invention has significant effect in the generation of suppression bulky grain.
Please refer to shown in Fig. 2, is the SEM(sweep electron microscope of the medicine balloon dilating catheter coating cross sections of the embodiment of the present invention 1) observe photo.As can be seen from figure we, taxol drug coating is closely attached in balloon surface, and paclitaxel is with the fractions distribution of acicular crystal at coating surface, and the diameter of acicular crystal concentrates on 1 μm, and length concentrates on about 10 μm, and the thickness of coating is about 12 μm.Be dispersed with a large amount of holes between medicine crystal, this hole is conducive to the infiltration of water, is conducive to medicine quick release in vivo.Medicine is adsorbed in blood vessel wall with the form of crystal simultaneously.The medicine of crystal habit has lower dissolution rate relative to unformed medicine, and the character of medicine is also more stable, is conducive to the long-term release of medicine in blood vessel wall.
In sum, the medication coat adopting the preparation method for the treatment of sacculus dilating catheter medication coat of the present invention to prepare is even, good with the affinity of balloon surface, fold or press coating shedding when holding little, large medicine crystal granule is not formed after immersing blood, avoid the situation of thrombosis and blood vessel blockage to occur, the release of medicine is controlled simultaneously.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, all any amendments done within the spirit and principles in the present invention, equivalent replacement and improvement etc., all should be included within protection scope of the present invention.
Claims (8)
1. treat the preparation method with sacculus dilating catheter medication coat, it is characterized in that, it mainly comprises the following steps:
First step, the medicine for the treatment of blood vessel hypertrophy is again being housed---add at least any one the vial in the medicine of paclitaxel and derivant, rapamycin and derivant thereof and anticoagulant in ethanol, methanol, normal hexane, isopropyl alcohol, acetone and dilution in acetonitrile solvent at least after any one, vibration makes described complete drug dissolution make drug solution;
Second step, is connected certain runner in the ultrasonic nozzle of described drug solution and dual channel or multiple flow passages;
Third step, is connected at least one runner in all the other runners of described ultrasonic nozzle with the inconsistent interference solvent of described medicine, described interference solvent be in water, 75% ethanol, water/methanol blend at least any one;
4th step, first mixes described drug solution with interference solvent, sprays, while application sacculus dilating catheter, allow sacculus dilating catheter rotate to the sacculus dilating catheter of the below being arranged on ultrasonic nozzle before entering ultrasonic nozzle;
5th step, taking-up sacculus dilating catheter after application completes, then drying is carried out to the sacculus dilating catheter after application;
6th step, folds the sacculus dilating catheter being attached with medication coat complete for drying, puts into coil pipe, sterilizing, packaging.
2. the treatment preparation method of sacculus dilating catheter medication coat as claimed in claim 1, is characterized in that, in described first step, and the weight of described medicine and solution: the ratio of volume is: 0.12g ~ 0.50g: 10ml ~ 20ml.
3. the treatment preparation method of sacculus dilating catheter medication coat as claimed in claim 1, is characterized in that, in described 4th step, first described sacculus dilating catheter is forced into complete softened state carries out application again.
4. the treatment as claimed in claim 1 preparation method of sacculus dilating catheter medication coat, it is characterized in that, in described 4th step, the specification of described sacculus dilating catheter is: external diameter 1.5mm ~ 6.0mm, and length is 15mm ~ 60mm.
5. the treatment as claimed in claim 1 preparation method of sacculus dilating catheter medication coat, it is characterized in that, in described 4th step, spray parameters mainly comprises: supersonic frequency is 25kHz ~ 60kHz, and ultrasonic power is 1w ~ 4w, and the flow velocity of drug solution is 0.1ml/min ~ 0.2ml/min, the flow velocity of interfering solvent is 0.05ml/min ~ 0.2ml/min, the rotary speed of sacculus dilating catheter is 2r/s ~ 5r/s, and spray time is 0.4min ~ 3min, and nebulizer gas pressure is 1psi.
6. the treatment preparation method of sacculus dilating catheter medication coat as claimed in claim 5, is characterized in that, in described 4th step, spraying stroke is consistent with the length of sacculus dilating catheter.
7. the treatment as claimed in claim 1 preparation method of sacculus dilating catheter medication coat, it is characterized in that, in described 5th step, drying condition parameter mainly comprises: baking temperature 4 DEG C ~ 50 DEG C, relative humidity is 30% ~ 80%, and drying time is 10min ~ 60min.
8. treat the preparation method with sacculus dilating catheter medication coat as claimed in any of claims 1 to 7 in one of claims, it is characterized in that, in described drug solution and interference solvent, can pharmaceutical carrier be added, described pharmaceutical carrier be in PEG, PVP, PVA, nicotiamide and poloxamer at least any one.
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| CN201410659293.4A CN104324421B (en) | 2013-11-27 | 2014-11-19 | Method for preparing balloon dilatation catheter medicinal coating for treatment |
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| CN201410659293.4A Active CN104324421B (en) | 2013-11-27 | 2014-11-19 | Method for preparing balloon dilatation catheter medicinal coating for treatment |
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| CN104174074B (en) | 2016-05-18 |
| CN104324421B (en) | 2017-02-08 |
| CN104174074A (en) | 2014-12-03 |
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Denomination of invention: Preparation method of drug coating for therapeutic balloon dilation catheter Effective date of registration: 20230628 Granted publication date: 20170208 Pledgee: Industrial and Commercial Bank of China Limited Hangzhou Yuhang sub branch Pledgor: Guichuang Tongqiao Medical Technology Co.,Ltd. Registration number: Y2023330001285 |
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