CN117214394A - Device and method for testing firmness of balloon coating and in-vitro release rate of drug - Google Patents
Device and method for testing firmness of balloon coating and in-vitro release rate of drug Download PDFInfo
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- 238000012360 testing method Methods 0.000 title claims abstract description 116
- 239000003814 drug Substances 0.000 title claims abstract description 68
- 229940079593 drug Drugs 0.000 title claims abstract description 57
- 238000000338 in vitro Methods 0.000 title claims abstract description 50
- 239000011248 coating agent Substances 0.000 title claims abstract description 38
- 238000000576 coating method Methods 0.000 title claims abstract description 38
- 238000000034 method Methods 0.000 title claims abstract description 29
- 239000007788 liquid Substances 0.000 claims abstract description 52
- 239000002245 particle Substances 0.000 claims abstract description 40
- 238000004088 simulation Methods 0.000 claims abstract description 36
- 238000011156 evaluation Methods 0.000 claims abstract description 15
- 238000011056 performance test Methods 0.000 claims abstract description 4
- 230000002792 vascular Effects 0.000 claims abstract description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- 210000005077 saccule Anatomy 0.000 claims description 14
- 230000004087 circulation Effects 0.000 claims description 12
- 238000002386 leaching Methods 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 7
- 230000010349 pulsation Effects 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 6
- 239000011148 porous material Substances 0.000 claims description 5
- 230000001105 regulatory effect Effects 0.000 claims description 5
- 238000010008 shearing Methods 0.000 claims description 5
- 238000004140 cleaning Methods 0.000 claims description 4
- 239000011347 resin Substances 0.000 claims description 3
- 229920005989 resin Polymers 0.000 claims description 3
- 210000004204 blood vessel Anatomy 0.000 description 12
- 239000012530 fluid Substances 0.000 description 5
- 230000017531 blood circulation Effects 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 238000013021 overheating Methods 0.000 description 2
- 208000037803 restenosis Diseases 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 229930012538 Paclitaxel Natural products 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 238000013500 data storage Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000010247 heart contraction Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229960001592 paclitaxel Drugs 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 description 1
- 231100000216 vascular lesion Toxicity 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a device and a method for testing the firmness of a balloon coating and the in-vitro release rate of a drug, belonging to the technical field of evaluation of vascular interventional instruments, comprising the following steps: an in vitro release performance testing device; the in vitro release performance test device comprises: the device comprises a medium liquid constant temperature circulating device, a pulse generating device, a flow control unit, a test operation platform and a defoaming and particle capturing unit which are sequentially communicated. The invention realizes the pulse flow environment under physical conditions by adopting the air-driven diaphragm pulse generator and the electric proportional valve adjustment based on the special conditions of the simulation of the test under the physical flow condition of the human body.
Description
Technical Field
The invention discloses a device and a method for testing the firmness of a balloon coating and the in-vitro release rate of a drug, and belongs to the technical field of vascular interventional instrument evaluation.
Background
The medicine coating saccule has wide application in treating intravascular stenosis, small vascular lesion, bifurcation lesion, stent restenosis, etc. and has clinical use rate raised year by year. The medicine in the coating mainly comprises paclitaxel and the lace mould derivatives, and in the using process, the medicine coating saccule can inhibit the growth of a new intima by releasing the medicine, so that the occurrence of restenosis can be effectively reduced.
The coating firmness test and the in-vitro release rate test respectively examine the falling-off condition of the coating and the release condition of the medicine at the lesion part in the simulated use process, which are closely related to the clinical use effect, and at the same time, the falling-off of the particles can cause potential risks. Therefore, the coating firmness and the in-vitro release rate test of the medicine can provide data support for the safety and effectiveness evaluation of the product. At present, no standard method is available for examining the performances of the two aspects, and the simulation of application conditions is insufficient, so that the correlation between in-vitro tests and in-vivo actual conditions is poor.
Chinese patent document CN202111347834.6 discloses an in-vitro transfer efficiency evaluation method of a balloon drug coating, wherein the evaluation method is used for releasing a drug of a drug balloon to be tested according to actual use operation, and then the in-vitro transfer efficiency of the balloon drug coating is obtained by measuring the content of the drug at a target blood vessel and calculating the standard content of the drug balloon to be tested. However, how to use an in-vitro simulation system to track the falling-off condition of the balloon coating and the drug release condition in the using process and establish an in-vitro test evaluation method, so that the detection result provides conditions such as the temperature, the blood flow speed and the condition close to the human body, and further simulates the pulse physiological environment, the pressure and the like of the heart beating, which is a technical problem always focused in the field.
Disclosure of Invention
Aiming at the defects of the prior art, the invention discloses a device for testing the firmness of a balloon coating and the in-vitro release rate of a drug, which provides a temperature, pulse, pressure, blood flow velocity and a blood vessel model which are close to the expected use position and is used for simulating the clinical use condition of the drug coated balloon.
The invention also discloses a method for evaluating the firmness of the balloon coating and the in-vitro release rate of the medicine by using the device, and the method is used for collecting and counting the fallen particles by simulating the conveying process/conveying and expanding process of the balloon; and the residual quantity on the balloon is measured, and the percent and difference calculation is carried out on the residual quantity and the marked content of the drug, so as to evaluate the falling off of the coating and the drug release condition of the drug balloon in the process.
The detailed technical scheme of the invention is as follows:
a device for testing balloon coating firmness and drug release rate in vitro comprising: an in vitro release performance testing device;
the in vitro release performance test device comprises: the medium liquid constant temperature circulating device, the pulse generating device, the flow control unit, the test operation platform and the defoaming and particle capturing unit are sequentially communicated;
the medium liquid constant temperature circulating device comprises: the device comprises a lifting medium tank, a circulating pump and a precision filter which are sequentially connected, wherein a water circulation heater and a temperature sensor are arranged in the lifting medium tank;
the pulse generating device comprises a gas-liquid pulse generator and an electric proportional valve which are connected;
the test operation platform comprises a 3D simulation path and a pore plate for fixing the 3D simulation path, the 3D simulation path is connected with pipelines on two sides of the test operation platform, and a pressure sensor is arranged on the outlet side of the 3D simulation path;
the defoaming and particle capturing unit includes: the air bubble eliminator and the particle catcher are sequentially communicated in the liquid outlet direction of the test operation platform, and a float flowmeter is arranged between the air bubble eliminator and the particle catcher;
the flow control unit comprises a flow control valve arranged at the inlet side of the 3D simulation path;
the particle catcher is communicated with the lifting medium groove through a circulating pipeline, and a first control valve is arranged on the circulating pipeline.
According to a preferred embodiment of the present invention, the test device further comprises a pipeline cleaning device, comprising: the vacuum generation aspirator and the collection tank are respectively connected with the liquid outlets of the float flowmeter and the particle catcher, the float flowmeter is respectively connected with the inlet of the circulating pipeline and the inlet of the particle catcher through the bypass valve, the vacuum generation aspirator is connected with the inlet of the circulating pipeline through the branch pipe, and the branch pipe is provided with the second control valve.
According to the invention, a one-way valve is arranged at the liquid inlet of the 3D simulation path.
According to the invention, the electric proportional valve is also connected with a filter and a mute air compressor.
According to the invention, the lifting medium tank comprises a tank body and a driving motor for driving the tank body to move up and down; the water circulation heater is used for adding the hot liquid medium contained in the tank body. The design is characterized in that the groove body is lifted to enable the groove body and the test operation platform to generate different height differences, so that the pressure of the medium fluid is controlled; the device has the functions of high-temperature protection, low-temperature alarm and low liquid level alarm, adopts coil pipe heat exchange, does not directly electrically heat medium liquid, and avoids local overheating of the medium and salt analysis.
According to the present invention, preferably, the bubble eliminator comprises: the air above the conical resin hose is led out of the hard tube and the exhaust valve to eliminate air bubbles generated in the pipeline, and avoid affecting the normal operation of the particle catcher and the flowmeter.
According to the invention, the gas-liquid pulse generator comprises a gas-driven diaphragm pulse generator, and the simulated pulse physiological environment required by the evaluation test is controlled and regulated through an electric proportion program.
According to the invention, the testing device preferably further comprises a control module, wherein operation software is loaded in the control module, so that a user can set parameters, evaluate operation and store data when performing evaluation tests through the control module.
The method for evaluating the firmness of the balloon coating and the in-vitro release rate of the medicine by using the device comprises the following steps: the evaluation method for the coating firmness is carried out according to the steps S1, S2, S3, S4, S7 and S8,
s1, adding a release medium into a lifting medium groove of the device, starting a water circulation heating device, and setting the temperature of the medium; starting a gas-liquid pulsation generator, and setting pulse flow; then starting the circulating pump, the bubble eliminator and the float flowmeter; opening a particle trap channel; circulating the whole test device to be full of medium and to reach a constant test temperature, preferably 37 ℃;
s2, inserting the guide catheter and the guide wire into the appointed test part of the 3D simulation path, namely the appointed test part of the blood vessel model;
s3, inserting the balloon into the guiding catheter along the guide wire, conveying the balloon to a designated test position of the 3D simulation path, and withdrawing and shearing the balloon after reaching a preset time;
s4, immersing the sheared saccule in a leaching solvent, and measuring the residual drug content on the saccule after leaching is completed; the firmness calculating method comprises the following steps:
firmness= (1-drug content on balloon/nominal drug content) ×100%;
s7, collecting a sample collected at the particle catcher and testing the sample;
and S8, after the test is finished, evacuating the liquid in the testing device.
The method for evaluating the firmness of the balloon coating and the in-vitro release rate of the medicine by using the device comprises the following steps: the method for evaluating the in-vitro release rate of the drug is carried out according to the steps S1, S2, S5, S6, S7 and S8,
s1, adding a release medium into a lifting medium groove of the device, starting a water circulation heating device, and setting the temperature of the medium; starting a gas-liquid pulsation generator, and setting pulse flow; then starting the circulating pump, the bubble eliminator and the float flowmeter; opening a particle trap channel; circulating the whole test device to be full of medium and to reach a constant test temperature, preferably 37 ℃;
s2, inserting the guide catheter and the guide wire into the appointed test part of the 3D simulation path, namely the appointed test part of the blood vessel model;
s5, inserting the balloon into a guide catheter along a guide wire, conveying the balloon to a designated test position of a blood vessel model, slowly pressurizing the balloon to be tested to a nominal pressure by using a pressurizing device, releasing the pressure of the balloon after reaching a preset time, and withdrawing and shearing the balloon;
s6, immersing the sheared saccule into a leaching solvent, measuring the residual drug content on the saccule, and calculating the in-vitro release rate of the drug, wherein the method comprises the following steps:
in vitro release rate = (1-residual drug content on balloon/nominal drug content) ×100%;
s7, collecting a sample collected at the particle catcher and testing the sample;
and S8, after the test is finished, evacuating the liquid in the testing device.
According to the invention, preferably, after the liquid in the testing device is emptied, the lifting medium tank is replaced by pure water, and the circulating pump is started to clean the whole external release performance testing device.
The invention has the technical advantages that:
1. the invention simulates based on human blood flow condition, adopts a gas-driven diaphragm pulse generator, and uses an electric proportional valve to regulate and realize the pulse flow environment under physical condition.
2. The invention adopts the 3D simulation path and the pore plate, is convenient for placing and fixing the simulation blood vessel in the test, and the simulation blood vessel path module can be replaced according to the need, thereby meeting the requirements of the test on different test paths.
3. The system, with the corresponding tubing valve, filter, and specialized bubble removal device, provides a clean fluid environment for testing and avoids the effects of bubbles in the flow path.
4. Parameter setting, test operation and data storage can be conveniently performed through operation software.
5. The invention also fully considers the difficulty of cleaning the pipeline after the evaluation test, and aims at the analysis requirement of the falling particles in the test in the future, the system is provided with the particle catcher, and a special fluid passage is reserved.
Drawings
FIG. 1 is a schematic diagram of the connection of the test device according to the present invention.
Detailed Description
The invention will now be described in more detail with reference to examples and figures of the specification, but is not limited thereto.
Example 1,
A device for testing balloon coating firmness and drug release rate in vitro comprising: an in vitro release performance testing device;
the in vitro release performance test device comprises: the medium liquid constant temperature circulating device, the pulse generating device, the flow control unit, the test operation platform and the defoaming and particle capturing unit are sequentially communicated;
the medium liquid constant temperature circulating device comprises: the device comprises a lifting medium tank and a precision filter which are sequentially connected, wherein a water circulation heater and a temperature sensor are arranged in the lifting medium tank; the liquid medium is used for in-vitro release and firmness test of the holding balloon;
the pulse generating device comprises a gas-liquid pulse generator and an electric proportional valve which are connected; the output power of the circulating pump is regulated, and the float flowmeter is used for regulating and controlling the circulating flow of the medium liquid to be about 80ml/min required by the test;
the test operation platform comprises a 3D simulation path and a pore plate for fixing the 3D simulation path, the 3D simulation path is connected with pipelines on two sides of the test operation platform, and a pressure sensor is arranged on the outlet side of the 3D simulation path; the 3D simulation path is manufactured by simulation according to parameters such as the size, the bending degree, the elasticity, the wall thickness and the like of a blood vessel at a target part, and a silica gel material is adopted to simulate the blood vessel path through which the balloon passes; as shown in FIG. 1, the medium liquid is provided with 4 paths of outlets according to the requirement, the medium liquid is fixed on the pore plate, and each path is provided with a corresponding switch valve, so that the medium liquid can be respectively connected with different tube cavities of the catheter. When different catheter cavities are connected, a clean RHV valve is adopted to prevent the catheter from passing through an analog path, so that liquid cannot flow back and overflow in the back pumping process; the 3D simulation path outlet end is provided with a movable pressure sensor, the fluid pressure at the far end of the path pipe is monitored, the pressure measuring range is 0-10 psi, and the accuracy is high: F.S less than or equal to 1%;
the defoaming and particle capturing unit includes: the air bubble eliminator and the particle catcher are sequentially communicated in the liquid outlet direction of the test operation platform, and a float flowmeter is arranged between the air bubble eliminator and the particle catcher;
the flow control unit comprises a flow control valve arranged at the inlet side of the 3D simulation path;
the particle catcher is communicated with the lifting medium groove through a circulating pipeline, and a first control valve is arranged on the circulating pipeline.
And a one-way valve is arranged at the liquid inlet of the 3D simulation path.
The electric proportional valve is also connected with a filter and a mute air compressor.
The bubble eliminator comprises: the air above the conical resin hose is led out of the hard tube and the exhaust valve to eliminate air bubbles generated in the pipeline, and avoid affecting the normal operation of the particle catcher and the flowmeter.
The gas-liquid pulse generator comprises a gas-driven diaphragm pulse generator, and is controlled and regulated by an electric proportion program to simulate pulse physiological environment, pressure of 80-160mmHg and pulse flow with frequency of 72bpm required by an evaluation test, so that pulse flow impact of an actual working condition on a stent or a medicine balloon can be simulated, and the pulse flow is similar to a sine wave in waveform.
EXAMPLE 2,
A balloon coating firmness and drug release rate test device of embodiment 1, said test device further comprising a tubing washing device comprising: the vacuum generation aspirator and the collection tank are respectively connected with the liquid outlets of the float flowmeter and the particle catcher, the float flowmeter is respectively connected with the inlet of the circulating pipeline and the inlet of the particle catcher through the bypass valve, the vacuum generation aspirator is connected with the inlet of the circulating pipeline through the branch pipe, and the branch pipe is provided with the second control valve.
EXAMPLE 3,
The test device for balloon coating firmness and in-vitro release rate of drugs according to embodiments 1 and 2, wherein the lifting medium tank comprises a tank body and a driving motor for driving the tank body to move up and down; the water circulation heater is used for adding the hot liquid medium contained in the tank body. The design is characterized in that the groove body is lifted to enable the groove body and the test operation platform to generate different height differences, so that the pressure of the medium fluid is controlled; the device has the functions of high-temperature protection, low-temperature alarm and low liquid level alarm, adopts coil pipe heat exchange, does not directly electrically heat medium liquid, and avoids local overheating of the medium and salt analysis. In this example, the medium tank volume was 5L, the temperature was controlled to be within 37.+ -. 1 ℃ and the outlet was equipped with a 0.2 μm precision filter to filter the medium. The design of the medium liquid tank considers that the cleaning convenience adopts a tank body and a metering instrument, a coil pipe is separated, and the medium tank is placed on a platform and can be driven to lift up and down by a small motor.
EXAMPLE 4,
The device for testing firmness of a balloon coating and in-vitro release rate of a drug according to embodiments 1, 2 and 3, wherein the control module is loaded with operation software to enable a user to set parameters, evaluate operation and store data during evaluation test by the control module. The operation software also has abnormality alarming prompt and shutdown setting such as overpressure, overtemperature and the like; the electrical element has the protection functions of electric leakage, overload, overvoltage, undervoltage, phase failure, error and the like; the system has the functions of an emergency stop button, three colors and the like for indicating the working state and the like.
EXAMPLE 5,
The method for evaluating the firmness of the balloon coating and the in-vitro release rate of the drug by using the device is carried out according to the steps S1, S2, S3, S4, S7 and S8,
s1, adding a release medium into a lifting medium groove of the device, starting a water circulation heating device, and setting the temperature of the medium; starting a gas-liquid pulsation generator, and setting pulse flow; then starting the circulating pump, the bubble eliminator and the float flowmeter; opening a particle trap channel; circulating the whole test device to be full of medium and to reach a constant test temperature, preferably 37 ℃;
s2, inserting the guide catheter and the guide wire into the appointed test part of the 3D simulation path, namely the appointed test part of the blood vessel model;
s3, inserting the balloon into the guiding catheter along the guide wire, conveying the balloon to a designated test position of the 3D simulation path, and withdrawing and shearing the balloon after reaching a preset time;
s4, immersing the sheared saccule in a leaching solvent, and measuring the residual drug content on the saccule after leaching is completed; the firmness calculating method comprises the following steps:
firmness= (1-drug content on balloon/nominal drug content) ×100%;
s7, collecting a sample collected at the particle catcher and testing the sample;
and S8, after the test is finished, evacuating the liquid in the testing device.
EXAMPLE 6,
The method for evaluating the firmness of the balloon coating and the in-vitro release rate of the medicine by using the device comprises the following steps: the method for evaluating the in-vitro release rate of the drug is carried out according to the steps S1, S2, S5, S6, S7 and S8,
s1, adding a release medium into a lifting medium groove of the device, starting a water circulation heating device, and setting the temperature of the medium; starting a gas-liquid pulsation generator, and setting pulse flow; then starting the circulating pump, the bubble eliminator and the float flowmeter; opening a particle trap channel; circulating the whole test device to be full of medium and to reach a constant test temperature, preferably 37 ℃;
s2, inserting the guide catheter and the guide wire into the appointed test part of the 3D simulation path, namely the appointed test part of the blood vessel model;
s5, inserting the balloon into a guide catheter along a guide wire, conveying the balloon to a designated test position of a blood vessel model, slowly pressurizing the balloon to be tested to a nominal pressure by using a pressurizing device, releasing the pressure of the balloon after reaching a preset time, and withdrawing and shearing the balloon;
s6, immersing the sheared saccule into a leaching solvent, measuring the residual drug content on the saccule, and calculating the in-vitro release rate of the drug, wherein the method comprises the following steps:
in vitro release rate = (1-residual drug content on balloon/nominal drug content) ×100%;
s7, collecting a sample collected at the particle catcher and testing the sample;
and S8, after the test is finished, evacuating the liquid in the testing device.
According to the invention, preferably, after the liquid in the testing device is emptied, the lifting medium tank is replaced by pure water, and the circulating pump is started to clean the whole external release performance testing device.
EXAMPLE 7,
The method for evaluating the firmness of the balloon coating and the in-vitro release rate of the drug by using the device described in examples 5 and 6 comprises the following steps: after the liquid in the testing device is emptied, the lifting medium tank is replaced by pure water, and the circulating pump is started to clean the whole external release performance testing device.
Claims (10)
1. A device for testing the firmness of a balloon coating and the in vitro release rate of a drug, comprising: an in vitro release performance testing device;
the in vitro release performance test device comprises: the medium liquid constant temperature circulating device, the pulse generating device, the flow control unit, the test operation platform and the defoaming and particle capturing unit are sequentially communicated;
the medium liquid constant temperature circulating device comprises: the device comprises a lifting medium tank, a circulating pump and a precision filter which are sequentially connected, wherein a water circulation heater and a temperature sensor are arranged in the lifting medium tank;
the pulse generating device comprises a gas-liquid pulse generator and an electric proportional valve which are connected;
the test operation platform comprises a 3D simulation path and a pore plate for fixing the 3D simulation path, the 3D simulation path is connected with pipelines on two sides of the test operation platform, and a pressure sensor is arranged on the outlet side of the 3D simulation path;
the defoaming and particle capturing unit includes: the air bubble eliminator and the particle catcher are sequentially communicated in the liquid outlet direction of the test operation platform, and a float flowmeter is arranged between the air bubble eliminator and the particle catcher;
the flow control unit comprises a flow control valve arranged at the inlet side of the 3D simulation path;
the particle catcher is communicated with the lifting medium groove through a circulating pipeline, and a first control valve is arranged on the circulating pipeline.
2. The device for testing the firmness of a balloon coating and the in vitro release rate of a drug according to claim 1, wherein said device further comprises a tube cleaning device comprising: the vacuum generation aspirator and the collection tank are respectively connected with the liquid outlets of the float flowmeter and the particle catcher, the float flowmeter is respectively connected with the inlet of the circulating pipeline and the inlet of the particle catcher through the bypass valve, the vacuum generation aspirator is connected with the inlet of the circulating pipeline through the branch pipe, and the branch pipe is provided with the second control valve.
3. The device for testing the firmness of a balloon coating and the in-vitro release rate of a drug according to claim 1, wherein a one-way valve is arranged at the liquid inlet of the 3D simulation path.
4. The device for testing the firmness of a balloon coating and the in-vitro release rate of a drug according to claim 1, wherein the electric proportional valve is further connected with a filter and a mute air compressor.
5. The device for testing the firmness of a balloon coating and the in-vitro release rate of a drug according to claim 1, wherein the lifting medium tank comprises a tank body and a driving motor for driving the tank body to move up and down; the water circulation heater is used for heating the liquid medium contained in the tank body.
6. The device for testing the firmness of a balloon coating and the in vitro release rate of a drug according to claim 1, wherein said bubble eliminator comprises: the gas above the conical resin hose is led out of the hard tube and the exhaust valve to eliminate bubbles generated in the pipe.
7. The device for testing the firmness of a balloon coating and the in-vitro release rate of a drug according to claim 1, wherein the gas-liquid pulse generator comprises a gas-driven diaphragm pulse generator, and the simulated pulse physiological environment required by the evaluation test is controlled and regulated through an electric proportion program.
8. The device for testing the firmness of a balloon coating and the in-vitro release rate of a drug according to claim 1, further comprising a control module, wherein the control module is loaded with operation software to enable a user to set parameters, evaluate operations and store data during evaluation tests by the control module.
9. A method of evaluating balloon coating firmness and drug release rate in vitro using the device of any one of claims 1-8, comprising: the evaluation method for the coating firmness is carried out according to the steps S1, S2, S3, S4, S7 and S8,
s1, adding a release medium into a lifting medium groove of the device, starting a water circulation heating device, and setting the temperature of the medium; starting a gas-liquid pulsation generator, and setting pulse flow; then starting the circulating pump, the bubble eliminator and the float flowmeter; opening a particle trap channel; the whole testing device is internally circulated and filled with medium and reaches the constant temperature of the test;
s2, inserting the guide catheter and the guide wire into a designated test part of the 3D simulation path in sequence;
s3, inserting the balloon into the guiding catheter along the guide wire, conveying the balloon to a designated test position of the 3D simulation path, and withdrawing and shearing the balloon after reaching a preset time;
s4, immersing the sheared saccule in a leaching solvent, and measuring the residual drug content on the saccule after leaching is completed; the firmness calculating method comprises the following steps:
firmness= (1-drug content on balloon/nominal drug content) ×100%;
s7, collecting a sample collected at the particle catcher and testing the sample;
and S8, after the test is finished, evacuating the liquid in the testing device.
10. A method of evaluating balloon coating firmness and drug release rate in vitro using the device of any one of claims 1-8, comprising: the method for evaluating the in-vitro release rate of the drug is carried out according to the steps S1, S2, S5, S6, S7 and S8,
s1, adding a release medium into a lifting medium groove of the device, starting a water circulation heating device, and setting the temperature of the medium; starting a gas-liquid pulsation generator, and setting pulse flow; then starting the circulating pump, the bubble eliminator and the float flowmeter; opening a particle trap channel; the whole testing device is internally circulated and filled with medium and reaches the constant temperature of the test;
s2, inserting the guide catheter and the guide wire into a designated test part of the 3D simulation path in sequence;
s5, inserting the balloon into the guiding catheter along the guide wire, conveying the balloon to a designated test position of the vascular model, releasing pressure of the balloon after reaching a preset time, and withdrawing and cutting the balloon;
s6, immersing the sheared saccule into a leaching solvent, measuring the residual drug content on the saccule, and calculating the in-vitro release rate of the drug, wherein the method comprises the following steps:
in vitro release rate = (1-residual drug content on balloon/nominal drug content) ×100%;
s7, collecting a sample collected at the particle catcher and testing the sample;
s8, after the test is finished, evacuating the liquid in the test device;
preferably, after the liquid in the testing device is emptied, the lifting medium tank is replaced by pure water, and the circulating pump is started to clean the whole external release performance testing device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311041072.6A CN117214394A (en) | 2023-08-17 | 2023-08-17 | Device and method for testing firmness of balloon coating and in-vitro release rate of drug |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311041072.6A CN117214394A (en) | 2023-08-17 | 2023-08-17 | Device and method for testing firmness of balloon coating and in-vitro release rate of drug |
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| CN117214394A true CN117214394A (en) | 2023-12-12 |
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|---|---|---|---|
| CN202311041072.6A Pending CN117214394A (en) | 2023-08-17 | 2023-08-17 | Device and method for testing firmness of balloon coating and in-vitro release rate of drug |
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| Country | Link |
|---|---|
| CN (1) | CN117214394A (en) |
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2023
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