An automatic drug testing system and test method using a flow cell method

Abstract

A drug automatic testing system and test method by flow-through cell method, comprising a drug circulation system, a solvent heating system, and a sampling system; the drug circulation system includes a machine frame, a frame cover, a support frame, a dry heating block, a heating guide sleeve, a flow-through cell, and a circulation pump; the solvent heating system includes a heating box, a heating wire, a solvent cup holder, and a solvent cup; the sampling system includes a sampling mechanism, a sampling valve, and a sampling pump; the inlet of the flow-through cell is communicated with the outlet of the solvent cup through a pipeline, a circulation pump is communicated on the inlet pipeline of the flow-through cell, and the outlet of the flow-through cell is communicated with the inlet of the solvent cup through a pipeline; the inlet of the sampling mechanism is communicated with the sampling port of the solvent cup through a pipeline. The support frame of the present invention realizes the switching setting of the longitudinal and transverse forms of the flow-through cell; when the flow-through cell is longitudinally arranged, it is suitable for the erosion dissolution and release of traditional tablets and capsules, and when the flow-through cell is horizontally arranged, it is suitable for the osmotic dissolution and release of preparations such as microspheres, suppositories, and suspensions.

Description

Technical Field

[0001] The present invention relates to the technical field of medical experimental equipment applications, and particularly to an automatic drug testing system using the flow-through cell method. Background Art

[0002] With the rapid development of pharmaceutical technology, along with the birth of a large number of new pharmaceutical agents and the current requirements for in vitro-in vivo correlation (IVIVC) of dissolution determination methods, traditional dissolution determination methods (such as paddle method, basket method, etc.) encounter many new problems when evaluating the quality of pharmaceutical preparations, such as the determination of trace drug preparations, the formulation of new pharmaceutical agents such as patches and microspheres, and how to solve the in vitro-in vivo correlation of immediate-release preparations. As a new method for checking dissolution concentration, the flow-through cell method mainly relies on continuously flushing the preparation with a flowing solvent, which can well simulate the in vivo circulation of drugs in the human body. Selecting appropriate cell accessories is applicable to tablets, capsules, patches, microspheres, suppositories, suspensions, stents, implants, liposomes, etc.

[0003] The flow-through cell method can not only be used to determine traditional tablets and capsules, but also be applied to the dissolution measurement of different types of preparations such as suspensions, implants, and microsphere liposomes. However, this process usually requires the use of flow-through cell structures with different structural forms. For the dissolution and release of tablets and capsules, the solvent has a relatively high dissolution and flow rate, which is not suitable for the determination of the dissolution and release concentration of preparations such as microspheres, suppositories, and suspensions. There is a need for a flow-through cell method for a universal testing system for various preparations. Summary of the Invention

[0004] In order to solve the above existing problems, the present invention discloses an automatic drug testing system using the flow-through cell method and a test method, and its specific technical solutions are as follows: An automatic drug testing system using the flow-through cell method includes a drug circulation system, a solvent heating system, and a sampling system;

[0005] The drug circulation system is used to introduce the solvent into the drug circulation system for flow release; it includes a machine frame, a machine frame cover, a support frame, a dry heating block, a heating guide sleeve, a flow-through cell, and a circulation pump; the machine frame cover is arranged on the side of the machine frame; the support frame is arranged on the top surface of the machine frame, and the support frame is rotatably arranged with the machine frame; the dry heating block is fixed inside the support frame; the heating guide sleeve is arranged inside the dry heating block; each flow-through cell is respectively inserted into the heating guide sleeve;

[0006] The solvent heating system is used to receive and store the solvent that has been flow-released through the drug circulation system and perform constant temperature treatment on the solvent; it includes a heating box, a heating wire, a solvent cup rack, and a solvent cup; the heating wire is arranged inside the heating box; the solvent cup rack is fixedly arranged at the top of the heating box, and the solvent cup is inserted and fixed inside the solvent cup rack;

[0007] The sampling system is used to sample the solvent after it is released through the drug circulation system; it includes a sampling mechanism, a sampling valve, and a sampling pump.

[0008] The inlet of the flow cell is connected to the outlet of the solvent cup through a pipeline. A circulation pump is connected to the inlet pipeline of the flow cell. The outlet of the flow cell is connected to the inlet of the solvent cup through a pipeline. The inlet of the sampling mechanism is connected to the sampling port of the solvent cup through a pipeline, and a sampling valve is connected to the inlet pipeline of the sampling mechanism.

[0009] Furthermore, a solvent inlet pipe is provided on the bottom surface of one side of the frame. The solvent inlet pipe corresponds to the bottom end of each flow cell and is connected through a connector plug for pipeline connection. A solvent outlet pipe is provided on one side of the top of the frame. The solvent outlet pipe corresponds to the top end of each flow cell and is connected through a plug for pipeline connection.

[0010] Furthermore, a stepping motor is embedded in the bottom surface of one side of the frame. Each stepping motor is correspondingly arranged at the bottom end of each flow cell. A rotating disk is provided at the end of each stepping motor. The rotating disk rotates coaxially with the stepping motor. Magnetic poles are provided on both sides of the top surface of the rotating disk, and the magnetic poles are fixedly arranged with the rotating disk. A mask is provided on the top surface of the rotating disk, and the mask is fixedly bolted to the bottom surface of the frame.

[0011] Furthermore, the number of dry heating blocks is eight, arranged in a horizontal array; the number of heating guide sleeves is eight; the number of flow cells is eight; the number of solvent inlet pipes is eight; the number of solvent outlet pipes is eight; the number of stepping motors is eight; the number of solvent cups is eight.

[0012] Furthermore, the support frame includes a fixed seat and a movable frame. The fixed seats are arranged on both sides of the top surface of the frame, and each fixed seat is perpendicularly arranged with the frame through bolts. The movable frame is arranged between the two fixed seats, and the bottom ends on both sides of the movable frame are respectively rotatably connected to the fixed seats through rotating shafts.

[0013] Further, a pressing mechanism is also provided on the top surface of the support frame. The pressing mechanism includes an edge plate, a central block, a rotating plate, a threaded cylinder, a star-shaped handle, and a pressing block. The edge plates are arranged on both sides of the top end of the movable frame, and the edge plates are respectively fixedly arranged with the movable frame through bolts. The central block is fixedly arranged at the center of the top side of the movable frame. The cross-section of the central block is in an "I"-shaped structure, and central block card slots are formed on both sides of the central block. The rotating plate is arranged on the top side of the movable frame. One corner of the rotating plate is rotatably arranged with one corner of each edge plate through bolts, and the edge plates are rotatably inserted into the central block card slots. The threaded cylinder is arranged at the bottom end of the rotating plate and is fixedly arranged with the rotating plate. The threaded cylinder penetrates through the rotating plate. The star-shaped handle penetrates through the threaded cylinder and is in threaded connection with the threaded cylinder. The bottom end of the star-shaped handle extends out of the bottom end of the rotating plate. The pressing block is fixedly arranged at the bottom end of the star-shaped handle.

[0014] Further, an upright plugging and locking mechanism is provided on one side of the dry heating block. The upright plugging and locking mechanism includes a plugging and locking block, a plugging and locking rod, a plugging and locking handle, an upper limit block, a lower limit block, and a spring. The plugging and locking block is vertically assembled with one dry heating block through bolts. The plugging and locking rod penetrates through the plugging and locking block, is vertically arranged, and is slidably arranged with the plugging and locking block. The plugging and locking handle is arranged on one side of the top end of the plugging and locking rod. The upper limit block is fixedly arranged on the outer wall of the top end of the plugging and locking rod. The lower limit block is arranged on the outer wall of the bottom end of the plugging and locking rod. The spring is sleeved on the outer wall of the plugging and locking rod, and the top end of the spring abuts against the bottom surface of the plugging and locking block, and the bottom end of the spring abuts against the top surface of the lower limit block. A locking block is also provided on one side of the bottom surface of the frame. The locking block is fixedly assembled with the frame through bolts. A locking hole is provided on the top surface of the locking block. The plugging and locking rod is inserted into the locking hole to fix the upright plugging and locking mechanism to the frame.

[0015] Further, when the frame is in a longitudinal state, a filter layer is sequentially arranged from bottom to top on the upper part of the flow cell, and the number of filter layers is multiple.

[0016] Further, the drug circulation system further includes a control box. The control box is respectively connected to the stepping motor, the dry heating block, the circulation pump, the heating wire, the sampling valve, and the sampling pump through electric wires to realize signal transmission. The control box is a PLC controller, and controls the on / off start of the stepping motor, the circulation pump, and the sampling pump through programming software, controls the switching opening and closing state of the sampling valve, and controls the heating temperature of the dry heating block and the heating wire.

[0017] A test method for a flow cell method drug automatic test system is as follows:

[0018] 1. Place the dissolving drug (such as tablets, capsules) into the flow cell, put a magnetic stir bar into the flow cell, and then fit the heating guide sleeve onto the outer wall of the flow cell; insert the flow cell and the heating guide sleeve together into the dry heating block;

[0019] 2. Rotate the support frame to relatively rotate the movable frame and the fixed seat so that the movable frame is in a vertical state. Adjust the vertical locking mechanism. Pull up the locking rod by hand by pulling the locking handle. The lower limit block abuts against the spring and is in a yielding state. Align the bottom end of the locking rod with the locking hole. After releasing the locking handle, the spring restores its deformation and pushes the locking rod to insert into the locking hole. The bottom surface of the upper limit block fits against the top surface of the locking block, and the support frame is vertically locked with the frame through the vertical locking mechanism;

[0020] 3. Adjust the pressing mechanism. Rotate the rotating plate and insert it into the center block card slot for fixation. Rotate and adjust the star handle to cooperate with the threaded barrel. The star handle drives the pressing block to press down against the top end of the flow cell, and the pressing mechanism presses the flow cell and the dry heating block together for fixation;

[0021] 4. Connect the bottom end of the flow cell to the solvent inlet pipe in an inserted manner, and connect the top end of the flow cell to the solvent outlet pipe in an inserted manner;

[0022] 5. Start the heating wire to heat the water area in the heating box to control the temperature of the solvent in the solvent cup at 37°C;

[0023] 6. Start the circulation pump. The circulation pump circulates the solvent in the solvent cup through the circulation action of the circulation pump, enters the flow cell through the solvent inlet pipe, and after the solvent and the drug are dissolved, they are discharged into the solvent cup through the solvent outlet pipe;

[0024] 7. Start the stepper motor. The stepper motor drives the rotating disk to rotate. The magnetic pole rotates along with the rotating disk, and the magnetic pole drives the magnetic stir bar in the flow cell to rotate, intensifying the disturbance degree of the solvent flowing through the flow cell;

[0025] 8. Start the sampling pump and the sampling valve. The sampling pump pumps the solvent in the solvent cup into the sampling mechanism to achieve the sampling process.

[0026] The beneficial effects of the present invention are:

[0027] In the present invention, a support frame structure is provided in the drug circulation system, and the circulation cell is fixed to the support frame structure by inserting. The support frame enables the circulation cell to be switched between a vertical and a horizontal configuration. When the circulation cell is vertically arranged in cooperation with the support frame, the device meets the requirements of the circulation cell method, and the solvent can flow at a set flow rate, capable of flushing, dissolving, and releasing traditional tablets and capsules. When the circulation cell is replaced and horizontally arranged in cooperation with the support frame, the device is in a permeation and circulation mode, and the solvent can flow at a set flow rate, capable of dissolving and releasing preparations such as microspheres, suppositories, and suspensions. By using the support frame to switch the configuration of the circulation cell between vertical and horizontal, the present device can meet the general dissolution and sampling processes of various preparations such as tablets, capsules, microspheres, suppositories, and suspensions.

[0028] In the present invention, a pressing mechanism is provided on the top side of the support frame structure. By manually adjusting the star-shaped handle, the end of the circulation cell can be pressed and fixed, ensuring that the circulation cell maintains good positioning with the dry heating block in both vertical and horizontal states, and ensuring that the drug dissolution of the circulation cell operates under stable conditions.

[0029] In the present invention, a vertical plug-in locking mechanism is provided on the side wall of the support frame structure. When the support frame is in a vertical state, by aligning and inserting the plug-in locking rod into the locking hole, the support frame can be locked and fixed in the vertical state. The structure design of the vertical plug-in locking mechanism is simple and easy to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is the system flow schematic diagram of the present invention.

[0031] Figure 2 is the overall external structure schematic diagram of the present invention.

[0032] Figure 3 is the overall structure schematic diagram of the present invention in the state of Embodiment 1.

[0033] Figure 4 is the internal structure schematic diagram of the bottom surface of the frame of the present invention.

[0034] Figure 5 is the partial structure schematic diagram of the support frame structure of the present invention.

[0035] Figure 6 is the overall structure schematic diagram of the present invention in the state of Embodiment 1.

[0036] Figure 7 is the cross-sectional structure schematic diagram of the circulation cell when the frame of the present invention is in a vertical state.

[0037] LIST OF REFERENCE NUMERALS:

[0038] Drug circulation system 1;

[0039] Frame 1-1, solvent inlet pipe 1-1-1, solvent outlet pipe 1-1-2, stepper motor 1-1-3, rotating disk 1-1-4, magnetic pole 1-1-5, mask 1-1-6, locking block 1-1-7, locking hole 1-1-7-1;

[0040] Frame cover 1-2;

[0041] Support frame 1-3, fixed seat 1-3-1, movable frame 1-3-2;

[0042] Dry heating block 1-4;

[0043] Heating guide sleeve 1-5;

[0044] Flow cell 1-6;

[0045] Filter screen 1-6-1;

[0046] Circulation pump 1-10;

[0047] Pressing mechanism 1-7, edge plate 1-7-1, center block 1-7-2, center block card slot 1-7-2-1, rotating plate 1-7-3, threaded cylinder 1-7-4, star-shaped handle 1-7-5, pressing block 1-7-6;

[0048] Vertical plug lock mechanism 1-8, plug lock block 1-8-1, plug lock rod 1-8-2, plug lock handle 1-8-3, upper limit block 1-8-4, lower limit block 1-8-5, spring 1-8-6;

[0049] Control box 1-9;

[0050] Solvent heating system 2;

[0051] Heating box 2-1;

[0052] Heating wire 2-2;

[0053] Solvent cup holder 2-3;

[0054] Solvent cup 2-4;

[0055] Sampling system 3;

[0056] Sampling mechanism 3-1;

[0057] Sampling valve 3-2;

[0058] Sampling pump 3-3. Detailed implementation method

[0059] To make the technical solution of the present invention clearer and more explicit, the present invention will be further described below with reference to the accompanying drawings. Any solution obtained by equivalent replacement of the technical features of the technical solution of the present invention and conventional reasoning falls within the protection scope of the present invention. The fixed connection, fixed setting, and fixed structure mentioned in this embodiment are all well-known technologies in the art such as gluing, welding, screw connection, bolt-nut connection, riveting, etc.

[0060] In this embodiment, when the rack is longitudinally arranged, the flow cell adopts a common flow cell method flow cell. Multiple filter layers are sequentially arranged from bottom to top on the upper part of the flow cell. The number of the filter layers is four. The pore diameters of the filter holes of each filter layer are 120um, 80um, 60um, and 20um from bottom to top in sequence.

[0061] When the rack is horizontally arranged, the flow cell used is the flow cell structure with the patent number "20192053381949" and the patent name "Absorption Cell Structure of a Drug Absorption Sampling System".

[0062] Embodiment 1

[0063] As can be seen from the accompanying drawings, an automatic drug testing system using the flow cell method includes a drug circulation system 1, a solvent heating system 2, and a sampling system 3.

[0064] The drug circulation system 1 is used to introduce the solvent into the drug circulation system 1 for flow dilution; it includes a rack 1-1, a rack cover 1-2, a support frame 1-3, a dry heating block 1-4, a heating guide sleeve 1-5, a flow cell 1-6, and a circulation pump 1-10; the rack cover 1-2 is arranged on the side of the rack 1-1; the support frame 1-3 is arranged on the top surface of the rack 1-1, and the support frame 1-3 is rotatably arranged with the rack 1-1; the dry heating block 1-4 is fixed inside the support frame 1-3; the heating guide sleeve 1-5 is arranged inside the dry heating block 1-4; each flow cell 1-6 is respectively inserted into the heating guide sleeve 1-5.

[0065] The solvent heating system 2 is used to receive and store the solvent after being flow-diluted by the drug circulation system 1 and perform constant temperature treatment on the solvent; it includes a heating box 2-1, a heating wire 2-2, a solvent cup rack 2-3, and a solvent cup 2-4; the heating wire 2-2 is arranged inside the heating box 2-1; the solvent cup rack 2-3 is fixedly arranged at the top of the heating box 2-1, and the solvent cup 2-4 is inserted and fixed inside the solvent cup rack 2-3.

[0066] The sampling system 3 is used to sample the solvent after being flow-diluted by the drug circulation system 1; it includes a sampling mechanism 3-1, a sampling valve 3-2, and a sampling pump 3-3.

[0067] The inlet of the flow cell 1-6 is connected to the outlet of the solvent cup 2-4 through a pipeline. A circulation pump 1-10 is connected to the inlet pipeline of the flow cell 1-6. The outlet of the flow cell 1-6 is connected to the inlet of the solvent cup 2-4 through a pipeline. The inlet of the sampling mechanism 3-1 is connected to the sampling port of the solvent cup 2-4 through a pipeline, and a sampling valve 3-2 is connected to the inlet pipeline of the sampling mechanism 3-1.

[0068] Furthermore, a solvent inlet pipe 1-1-1 is provided on the bottom surface of one side of the frame 1-1. The solvent inlet pipe 1-1-1 corresponds to the bottom end of each flow cell 1-6, and the pipeline connection is achieved through socket connection. A solvent outlet pipe 1-1-2 is provided on one side of the top end of the frame 1-1. The solvent outlet pipe 1-1-2 corresponds to the top end of each flow cell 1-6, and the pipeline connection is achieved through plug connection.

[0069] Furthermore, a stepping motor 1-1-3 is embedded in the bottom surface of one side of the frame 1-1. Each stepping motor 1-1-3 is correspondingly arranged at the bottom end of each flow cell 1-6. A rotating disk 1-1-4 is provided at the end of each stepping motor 1-1-3. The rotating disk 1-1-4 rotates coaxially with the stepping motor 1-1-3. Magnetic poles 1-1-5 are provided on both sides of the top surface of the rotating disk 1-1-4, and the magnetic poles 1-1-5 are fixedly arranged with the rotating disk 1-1-4. A mask 1-1-6 is provided on the top surface of the rotating disk 1-1-4, and the mask 1-1-6 is fixedly connected to the bottom surface of the frame 1-1 through bolts.

[0070] Furthermore, the number of dry heating blocks 1-4 is multiple, arranged in a horizontal array. The number of heating guide sleeves 1-5 is multiple. The number of flow cells 1-6 is multiple. The number of solvent inlet pipes 1-1-1 is multiple. The number of solvent outlet pipes 1-1-2 is multiple. The number of stepping motors 1-1-3 is multiple. The number of solvent cups 2-4 is multiple. The number of dry heating blocks 1-4, heating guide sleeves 1-5, flow cells 1-6, solvent inlet pipes 1-1-1, solvent outlet pipes 1-1-2, stepping motors 1-1-3, and solvent cups 2-4 is the same.

[0071] Furthermore, the support frame 1-3 includes a fixed seat 1-3-1 and a movable frame 1-3-2. The fixed seat 1-3-1 is arranged on both sides of the top surface of the frame 1-1, and each fixed seat 1-3-1 is perpendicularly arranged with the frame 1-1 through bolts. The movable frame 1-3-2 is arranged between the two fixed seats 1-3-1, and the bottom ends of both sides of the movable frame 1-3-2 are respectively rotatably connected to the fixed seat 1-3-1 through rotating shafts.

[0072] Further, a pressing mechanism 1-7 is further provided on the top surface of the support frame 1-3. The pressing mechanism 1-7 includes an edge plate 1-7-1, a center block 1-7-2, a rotating plate 1-7-3, a threaded cylinder 1-7-4, a star-shaped handle 1-7-5, and a pressing block 1-7-6. The edge plate 1-7-1 is arranged on both sides of the top end of the movable frame 1-3-2, and the edge plate 1-7-1 is fixedly arranged with the movable frame 1-3-2 through bolts respectively. The center block 1-7-2 is fixedly arranged at the center of the top side of the movable frame 1-3-2. The cross section of the center block 1-7-2 is in an "I" - shaped structure, and center block clamping grooves 1-7-2-1 are formed on both sides of the center block 1-7-2. The rotating plate 1-7-3 is arranged on the top side of the movable frame 1-3-2. One corner of the rotating plate 1-7-3 is rotatably arranged with one corner of each edge plate 1-7-1 through bolts, and the edge plate 1-7-1 is rotatably inserted into the center block clamping groove 1-7-2-1. The threaded cylinder 1-7-4 is arranged at the bottom end of the rotating plate 1-7-3 and is fixedly arranged with the rotating plate 1-7-3. The threaded cylinder 1-7-4 penetrates through the rotating plate 1-7-3. The star-shaped handle 1-7-5 penetrates through the threaded cylinder 1-7-4 and is in threaded connection with the threaded cylinder 1-7-4. The bottom end of the star-shaped handle 1-7-5 extends out of the bottom end of the rotating plate 1-7-3. The pressing block 1-7-6 is fixedly arranged at the bottom end of the star-shaped handle 1-7-5.

[0073] Further, an upright latch mechanism 1-8 is provided on one side of the dry heating block 1-4. The upright latch mechanism 1-8 includes a latch block 1-8-1, a latch rod 1-8-2, a latch handle 1-8-3, an upper limit block 1-8-4, a lower limit block 1-8-5, and a spring 1-8-6. The latch block 1-8-1 is vertically assembled with one of the dry heating blocks 1-4 by bolts. The latch rod 1-8-2 passes through the latch block 1-8-1, is vertically arranged, and is slidably arranged with the latch block 1-8-1. The latch handle 1-8-3 is arranged on one side of the top end of the latch rod 1-8-2. The upper limit block 1-8-4 is fixedly arranged on the outer wall of the top end of the latch rod 1-8-2. The lower limit block 1-8-5 is arranged on the outer wall of the bottom end of the latch rod 1-8-2. The spring 1-8-6 is sleeved on the outer wall of the latch rod 1-8-2, and the top end of the spring 1-8-6 abuts against the bottom surface of the latch block 1-8-1, and the bottom end of the spring 1-8-6 abuts against the top surface of the lower limit block 1-8-5. A locking block 1-1-7 is further provided on one side of the bottom surface of the frame 1-1. The locking block 1-1-7 is fixedly assembled with the frame 1-1 by bolts. A locking hole 1-1-7-1 is provided on the top surface of the locking block 1-1-7. The latch rod 1-8-2 is inserted into the locking hole 1-1-7-1 to fix the upright latch mechanism 1-8 to the frame 1-1.

[0074] Further, when the frame is in a longitudinal state, a filter layer is sequentially arranged from bottom to top on the upper part of the flow cell, and the number of the filter layers is multiple.

[0075] Further, the drug circulation system 1 further includes a control box 1-9. The control box 1-9 is electrically connected to the stepping motor 1-1-3, the dry heating block 1-4, the circulation pump 1-10, the heating wire 2-2, the sampling valve 3-2, and the sampling pump 3-3 through wires to realize signal transmission. The control box 1-9 is a PLC controller, and controls the on / off start of the stepping motor 1-1-3, the circulation pump 1-10, and the sampling pump 3-3 through programming software, controls the switching opening and closing state of the sampling valve 3-2, and controls the heating temperature of the dry heating block 1-4 and the heating wire 2-2.

[0076] A test method for an automatic drug test system using the flow cell method is as follows:

[0077] 1. Put the dissolved drug (such as tablets, capsules) into the flow cell 1-6, put a magnetic stirrer into the flow cell 1-6, and then sleeved the heating guide sleeve 1-5 on the outer wall of the flow cell 1-6. Insert the flow cell 1-6 and the heating guide sleeve 1-5 together into the dry heating block 1-4.

[0078] 2. Rotate the support frame 1-3, rotate the movable frame 1-3-2 and the fixed seat 1-3-1 relatively, so that the movable frame 1-3-2 is in a vertical state, adjust the upright latch mechanism 1-8, and pull the latch handle 1-8-3 by hand to lift the latch rod 1-8-2 upwards, so that the lower limit block 1-8-5 is in a yielded state against the spring 1-8-6, and align the bottom end of the latch rod 1-8-2 with the locking hole 1-1-7-1. After releasing the latch handle 1-8-3, the spring 1-8-6 recovers its deformation, and pushes the latch rod 1-8-2 to be inserted into the locking hole 1-1-7-1. The bottom surface of the upper limit block 1-8-4 is in contact with the top surface of the latch block 1-8-1, and the support frame 1-3 is locked upright with the frame 1-1 through the upright latch mechanism 1-8;

[0079] 3. Adjust the pressing mechanism 1-7, rotate the rotating plate 1-7-3 and insert it into the center block slot 1-7-2-1 to fix it, rotate and adjust the star-shaped handle 1-7-5 to cooperate with the threaded barrel 1-7-4, the star-shaped handle 1-7-5 drives the pressing block 1-7-6 to press down and fit against the top of the circulation pool 1-6, and the pressing mechanism 1-7 fixes the circulation pool 1-6 and the dry heating block 1-4;

[0080] 4. Connect the bottom end of the circulation pool 1-6 to the solvent inlet pipe 1-1-1, and connect the top end of the circulation pool 1-6 to the solvent outlet pipe 1-1-2;

[0081] 5. Start the heating wire 2-2 to heat the water area in the heating box 2-1 to control the temperature of the solvent in the solvent cup 2-4 at 37°C;

[0082] 6. Start the circulation pump 1-10. The circulation pump 1-10 circulates the solvent in the solvent cup 2-4 through the solvent inlet pipe 1-1-1 into the circulation pool 1-6. After the solvent and the drug are dissolved, they are discharged into the solvent cup 2-4 through the solvent outlet pipe 1-1-2.

[0083] 7. Start the stepper motor 1-1-3, the stepper motor 1-1-3 drives the rotating disk 1-1-4 to rotate, the magnetic pole 1-1-5 rotates along with the rotating disk 1-1-4, and the magnetic pole 1-1-5 drives the magnetic stirring bar in the circulation pool 1-6 to rotate, thereby increasing the disturbance degree of the solvent flowing through the circulation pool 1-6;

[0084] 8. Start the sampling pump 3-3 and the sampling valve 3-2. The sampling pump 3-3 draws the solvent in the solvent cup 2-4 into the sampling mechanism 3-1 to realize the sampling process.

[0085] Example 2

[0086] The difference between Example 2 and Example 1 is that:

[0087] A test method for an automatic drug testing system using a flow cell method, the steps are as follows:

[0088] 1. Place the dissolved drugs (such as microspheres, suppositories, suspensions) into the flow cell 1-6, and then fit the heating guide sleeve 1-5 onto the outer wall of the flow cell 1-6; insert the flow cell 1-6 and the heating guide sleeve 1-5 together into the dry heating block 1-4;

[0089] 2. Adjust the pressing mechanism 1-7, rotate the rotating plate 1-7-3 and insert it into the center block card slot 1-7-2-1 for fixation, rotate and adjust the star handle 1-7-5 to cooperate with the threaded cylinder 1-7-4, the star handle 1-7-5 drives the pressing block 1-7-6 to press down and abut against the top of the flow cell 1-6, and the pressing mechanism 1-7 presses and fixes the flow cell 1-6 and the dry heating block 1-4;

[0090] 3. Rotate the support frame 1-3, rotate the movable frame 1-3-2 relative to the fixed seat 1-3-1, so that the movable frame 1-3-2 fits on the top surface of the frame 1-1 and is in a horizontal state;

[0091] 4. Connect the bottom end of the flow cell 1-6 to the solvent inlet pipe 1-1-1 in an inserted manner, and connect the top end of the flow cell 1-6 to the solvent outlet pipe 1-1-2 in an inserted manner;

[0092] 5. Start the heating wire 2-2 to heat the water area in the heating box 2-1 to control the temperature of the solvent in the solvent cup 2-4 at 37°C;

[0093] 6. Start the circulation pump 1-10, and the circulation pump 1-10 circulates the solvent in the solvent cup 2-4 through the circulation of the circulation pump 1-10, enters the flow cell 1-6 through the solvent inlet pipe 1-1-1, and after the solvent and the drug are dissolved, they are discharged through the solvent outlet pipe 1-1-2 into the solvent cup 2-4;

[0094] 7. Start the sampling pump 3-3 and the sampling valve 3-2, and the sampling pump 3-3 pumps the solvent in the solvent cup 2-4 into the sampling mechanism 3-1 to achieve the sampling process.

[0095] The beneficial effects of the present invention are:

[0096] In the present invention, a support frame structure is provided in the drug circulation system, and the circulation cell is fixed to the support frame structure by inserting. The support frame enables the circulation cell to be switched between vertical and horizontal postures. When the circulation cell is vertically arranged in cooperation with the support frame, the device meets the requirements of the circulation cell method, and the solvent is at a relatively high flow rate, which can wash and dissolve and release traditional tablets and capsules. When the circulation cell is replaced and horizontally arranged in cooperation with the support frame, the device is in a permeation circulation mode, and the solvent is at a relatively low flow rate, which can dissolve and release preparations such as microspheres, suppositories, and suspensions. By using the support frame to switch the vertical and horizontal postures of the circulation cell, the present device can meet the general dissolution and sampling processes of various preparations such as tablets, capsules, microspheres, suppositories, and suspensions.

[0097] In the present invention, a pressing mechanism is provided on the top side of the support frame structure. By manually adjusting the star handle, the end of the circulation cell can be pressed and fixed, so as to ensure that the circulation cell maintains good positioning with the dry heating block both in the vertical or horizontal state, and ensure that the drug dissolution of the circulation cell operates under stable conditions.

[0098] In the present invention, a vertical plugging and locking mechanism is provided on the side wall of the support frame structure. When the support frame is in the vertical state, by aligning and inserting the plugging rod into the locking hole, the support frame can be locked and fixed in the vertical state. The structure design of the vertical plugging and locking mechanism is simple and easy to operate.

Claims

1. An automatic drug testing system using the flow cell method, characterized in that, it includes a drug circulation system (1), a solvent heating system (2), and a sampling system (3); The drug circulation system (1) is used to introduce a solvent into the drug circulation system (1) for dilution; it includes a machine frame (1-1), a frame cover (1-2), a support frame (1-3), a dry heating block (1-4), a heating guide sleeve (1-5), a flow cell (1-6), and a circulation pump (1-10); the frame cover (1-2) is arranged on the side of the machine frame (1-1); the support frame (1-3) is arranged on the top surface of the machine frame (1-1), and the support frame (1-3) is rotatably arranged with the machine frame (1-1); the dry heating block (1-4) is fixed inside the support frame (1-3); the heating guide sleeve (1-5) is arranged inside the dry heating block (1-4); each flow cell (1-6) is inserted into the heating guide sleeve (1-5) respectively; The solvent heating system (2) is used to receive and store the solvent diluted by the drug circulation system (1) and perform constant temperature treatment on the solvent; it includes a heating box (2-1), a heating wire (2-2), a solvent cup holder (2-3), and a solvent cup (2-4); the heating wire (2-2) is arranged inside the heating box (2-1); the solvent cup holder (2-3) is fixedly arranged at the top of the heating box (2-1), and the solvent cup (2-4) is inserted and fixed inside the solvent cup holder (2-3); The sampling system (3) is used to sample the solvent diluted by the drug circulation system (1); it includes a sampling mechanism (3-1), a sampling valve (3-2), and a sampling pump (3-3); The inlet of the flow cell (1-6) is connected to the outlet of the solvent cup (2-4) through a pipeline, a circulation pump (1-10) is connected to the inlet pipeline of the flow cell (1-6), and the outlet of the flow cell (1-6) is connected to the inlet of the solvent cup (2-4) through a pipeline; the inlet of the sampling mechanism (3-1) is connected to the sampling port of the solvent cup (2-4) through a pipeline, and a sampling valve (3-2) is connected to the inlet pipeline of the sampling mechanism (3-1); The support frame (1-3) includes a fixed seat (1-3-1) and a movable frame (1-3-2), the fixed seat (1-3-1) is arranged on both sides of the top surface of the machine frame (1-1), and each fixed seat (1-3-1) is vertically arranged with the machine frame (1-1) through bolts; the movable frame (1-3-2) is arranged between the two fixed seats (1-3-1), and the two bottom ends of the movable frame (1-3-2) are respectively rotated with the fixed seat (1-3-1) through a rotating shaft; The top surface of the support frame (1-3) is further provided with a pressing mechanism (1-7). The pressing mechanism (1-7) includes an edge plate (1-7-1), a central block (1-7-2), a rotating plate (1-7-3), a threaded cylinder (1-7-4), a star-shaped handle (1-7-5) and a pressing block (1-7-6). The edge plate (1-7-1) is arranged on both sides of the top end of the movable frame (1-3-2), and the edge plate (1-7-1) is fixedly arranged with the movable frame (1-3-2) through bolts respectively. The central block (1-7-2) is fixedly arranged at the center of the top side of the movable frame (1-3-2). The cross section of the central block (1-7-2) is in an "I" - shaped structure, and two sides of the central block (1-7-2) form central block clamping grooves (1-7-2-1). The rotating plate (1-7-3) is arranged on the top side of the movable frame (1-3-2). One corner of the rotating plate (1-7-3) is rotatably arranged with one corner of each edge plate (1-7-1) through bolts, and the edge plate (1-7-1) is rotatably inserted into the central block clamping groove (1-7-2-1). The threaded cylinder (1-7-4) is arranged at the bottom end of the rotating plate (1-7-3) and is fixedly arranged with the rotating plate (1-7-3). The threaded cylinder (1-7-4) penetrates through the rotating plate (1-7-3). The star-shaped handle (1-7-5) penetrates through the threaded cylinder (1-7-4) and is in threaded connection with the threaded cylinder (1-7-4). The bottom end of the star-shaped handle (1-7-5) extends out of the bottom end of the rotating plate (1-7-3). The pressing block (1-7-6) is fixedly arranged at the bottom end of the star-shaped handle (1-7-5).

2. The automatic drug testing system by flow - through cell method according to claim 1, characterized in that, One side bottom surface of the frame (1-1) is provided with a solvent inlet pipe (1-1-1). The solvent inlet pipe (1-1-1) corresponds to the bottom end of each flow - through cell (1-6), and the pipeline connection is realized through socket connection. One side top end of the frame (1-1) is provided with a solvent outlet pipe (1-1-2). The solvent outlet pipe (1-1-2) corresponds to the top end of each flow - through cell (1-6), and the pipeline connection is realized through plug connection.

3. The automatic drug testing system by flow - through cell method according to claim 2, characterized in that, On one side of the bottom surface of the frame (1-1), a stepping motor (1-1-3) is embedded. Each stepping motor (1-1-3) is correspondingly arranged at the bottom end of each flow cell (1-6). At the end of each stepping motor (1-1-3), there is a rotating disk (1-1-4). The rotating disk (1-1-4) rotates coaxially with the stepping motor (1-1-3). On both sides of the top surface of the rotating disk (1-1-4), there are magnetic poles (1-1-5). The magnetic poles (1-1-5) are fixedly arranged with the rotating disk (1-1-4). On the top surface of the rotating disk (1-1-4), there is a mask (1-1-6). The mask (1-1-6) is fixedly connected to the bottom surface of the frame (1-1) by bolts.

4. A drug automatic testing system by flow cell method according to claim 3, characterized in that The number of the dry heating blocks (1-4) is multiple, and they are arranged in a horizontal array; the number of the heating guide sleeves (1-5) is multiple; the number of the flow cells (1-6) is multiple; the number of the solvent inlet pipes (1-1-1) is multiple; the number of the solvent outlet pipes (1-1-2) is multiple; the number of the stepping motors (1-1-3) is multiple; the number of the solvent cups (2-4) is multiple; the numbers of the dry heating blocks (1-4), heating guide sleeves (1-5), flow cells (1-6), solvent inlet pipes (1-1-1), solvent outlet pipes (1-1-2), stepping motors (1-1-3), and solvent cups (2-4) are the same.

5. A drug automatic testing system by flow cell method according to claim 1, characterized in that One side of the dry heating block (1-4) is provided with a vertical plugging lock mechanism (1-8). The vertical plugging lock mechanism (1-8) includes a plugging lock block (1-8-1), a plugging lock rod (1-8-2), a plugging lock handle (1-8-3), an upper limit block (1-8-4), a lower limit block (1-8-5) and a spring (1-8-6). The plugging lock block (1-8-1) is vertically assembled with one of the dry heating blocks (1-4) through bolts. The plugging lock rod (1-8-2) penetrates through the plugging lock block (1-8-1), is vertically arranged, and is slidably arranged with the plugging lock block (1-8-1). The plugging lock handle (1-8-3) is arranged on one side of the top end of the plugging lock rod (1-8-2). The upper limit block (1-8-4) is fixedly arranged on the outer wall of the top end of the plugging lock rod (1-8-2). The lower limit block (1-8-5) is arranged on the outer wall of the bottom end of the plugging lock rod (1-8-2). The spring (1-8-6) is sleeved on the outer wall of the plugging lock rod (1-8-2), and the top end of the spring (1-8-6) abuts against the bottom surface of the plugging lock block (1-8-1), and the bottom end of the spring (1-8-6) abuts against the top surface of the lower limit block (1-8-5). One side of the bottom surface of the frame (1-1) is further provided with a locking block (1-1-7). The locking block (1-1-7) is fixedly assembled with the frame (1-1) through bolts. The top surface of the locking block (1-1-7) is provided with a locking hole (1-1-7-1). The plugging lock rod (1-8-2) is inserted into the locking hole (1-1-7-1) to fix the vertical plugging lock mechanism (1-8) to the frame (1-1).

6. A drug automatic testing system by flow cell method according to claim 1, characterized in that, when the frame (1-1) is in a vertical state, a filter layer (1-6-1) is sequentially arranged from bottom to top on the upper part of the flow cell (1-6), and the number of the filter layers (1-6-1) is multiple layers.

7. A test method for a drug automatic testing system by flow cell method, the steps are as follows: (1). When the dissolved drug is a tablet or a capsule, put the dissolved drug into the flow cell (1-6), put a magnetic stirrer into the flow cell (1-6), and then sleeved the heating guide sleeve (1-5) on the outer wall of the flow cell (1-6); insert the flow cell (1-6) and the heating guide sleeve (1-5) together into the dry heating block (1-4); (2). Rotate the support frame (1-3), rotate the movable frame (1-3-2) relative to the fixed seat (1-3-1) to make the movable frame (1-3-2) in a vertical state. Adjust the vertical plug lock mechanism (1-8), pull up the plug lock rod (1-8-2) by hand pulling the plug lock handle (1-8-3). The lower limit block (1-8-5) abuts against the spring (1-8-6) and is in a yielding state. Align the bottom end of the plug lock rod (1-8-2) with the locking hole (1-1-7-1). After releasing the plug lock handle (1-8-3), the spring (1-8-6) resumes deformation, pushing the plug lock rod (1-8-2) to insert into the locking hole (1-1-7-1). The bottom surface of the upper limit block (1-8-4) fits against the top surface of the plug lock block (1-8-1), and the support frame (1-3) is vertically locked with the frame (1-1) through the vertical plug lock mechanism (1-8); (3). Adjust the pressing mechanism (1-7), rotate the rotating plate (1-7-3) and insert it into the central block card slot (1-7-2-1) for fixation. Rotate and adjust the star handle (1-7-5) to cooperate with the threaded cylinder (1-7-4). The star handle (1-7-5) drives the pressing block (1-7-6) to press down and abut against the top end of the flow cell (1-6), and the pressing mechanism (1-7) presses and fixes the flow cell (1-6) against the dry heating block (1-4); (4). Insert and connect the bottom end of the flow cell (1-6) with the solvent inlet pipe (1-1-1), and insert and connect the top end of the flow cell (1-6) with the solvent outlet pipe (1-1-2); (5). Start the heating wire (2-2) to heat the water area in the heating box (2-1) to control the temperature of the solvent in the solvent cup (2-4) at 37°C; (6). Start the circulation pump (1-10). The circulation pump (1-10) circulates the solvent in the solvent cup (2-4) through the circulation action of the circulation pump (1-10), enters the flow cell (1-6) through the solvent inlet pipe (1-1-1), and after the solvent and the drug are dissolved, they are discharged into the solvent cup (2-4) through the solvent outlet pipe (1-1-2); (7). Start the stepping motor (1-1-3). The stepping motor (1-1-3) drives the rotating disk (1-1-4) to rotate. The magnetic pole (1-1-5) rotates along with the rotating disk (1-1-4), and the magnetic pole (1-1-5) drives the magnetic stirrer in the flow cell (1-6) to rotate, increasing the disturbance degree of the solvent flowing through the flow cell (1-6); (8). Start the sampling pump (3-3) and the sampling valve (3-2). The sampling pump (3-3) pumps the solvent in the solvent cup (2-4) into the sampling mechanism (3-1) to realize the sampling process.

8. A test method for a flow cell method drug automatic test system is as follows: (1). When the dissolved drug is a microsphere, suppository, or suspension, put the dissolved drug into the flow cell (1-6), and then put the heating guide sleeve (1-5) on the outer wall of the flow cell (1-6). Insert the flow cell (1-6) and the heating guide sleeve (1-5) together into the dry heating block (1-4); (2). Adjust the pressing mechanism (1-7), rotate the rotating plate (1-7-3) and insert it into the central block card slot (1-7-2-1) for fixation. Rotate and adjust the star handle (1-7-5) to cooperate with the threaded cylinder (1-7-4). The star handle (1-7-5) drives the pressing block (1-7-6) to press down and abut against the top end of the flow cell (1-6). The pressing mechanism (1-7) presses and fixes the flow cell (1-6) against the dry heating block (1-4); (3). Rotate the support frame (1-3), rotate the movable frame (1-3-2) relative to the fixed seat (1-3-1), and make the movable frame (1-3-2) fit against the top surface of the frame (1-1) in a horizontal state; (4). Insert and connect the bottom end of the flow cell (1-6) to the solvent inlet pipe (1-1-1), and insert and connect the top end of the flow cell (1-6) to the solvent outlet pipe (1-1-2); (5). Start the heating wire (2-2) to heat the water area in the heating box (2-1) to control the temperature of the solvent in the solvent cup (2-4) at 37°C; (6). Start the circulation pump (1-10). The circulation pump (1-10) circulates the solvent in the solvent cup (2-4) through the circulation of the circulation pump (1-10), enters the flow cell (1-6) through the solvent inlet pipe (1-1-1). After the solvent and the drug are dissolved, they are discharged through the solvent outlet pipe (1-1-2) into the solvent cup (2-4); (7). Start the sampling pump (3-3) and the sampling valve (3-2). The sampling pump (3-3) pumps the solvent in the solvent cup (2-4) into the sampling mechanism (3-1) to achieve the sampling process.

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