A circulation cell method for drug dissolution open-loop sampling system and its use method

Abstract

A circulation pool method drug dissolution open-loop sampling system and use method, the constant temperature water area system includes a constant temperature water tank rack, a constant temperature water tank and a solvent cup rack; the circulation pool system is arranged at the top of the constant temperature water area system, and the circulation pool system includes a circulation pool rack, a circulation pool and a glass tube; the lifting mechanism is arranged on one side of the constant temperature water tank rack; the circulation heating system includes a heating device and a water circulation pump; the solvent monitoring system is arranged at the top of the heating device; the solvent switching system is arranged on one side of the constant temperature water area system; the solvent mixing system includes a solvent mixing seat, a solvent mixer and a solvent suction pump; the solvent circulation system includes a solvent circulation pump and a pulse valve; the sampling system includes a sampling mechanism, a sampling pipeline and a sampling valve. The present invention can perform an open solvent sampling process on the solvent, the solvent heating device is firmly fixed, the heating efficiency is high, the temperature control is precise, the solvent pH can be switched and adjusted, and the real dissolution environment of the human gastrointestinal tract can be simulated.

Description

Technical Field

[0001] The invention relates to the technical field of medical laboratory equipment application, in particular to a circulation pool method drug dissolution open-loop sampling system. Background Art

[0002] The rapid development of pharmaceutical technology, accompanied by the emergence of a large number of new pharmaceutical formulations and the current demand for in vitro-in vivo correlation (IVIVC) of dissolution testing methods, has led to new challenges in evaluating the quality of preparations using traditional dissolution testing methods (such as paddle and basket methods). These challenges include the determination of trace drug preparations, the formulation of new pharmaceutical formulations such as patches and microspheres, and the resolution of in vitro-in vivo correlation for immediate-release preparations. The flow-through cell method, a novel dissolution concentration test method, relies on the continuous flushing of the formulation with a flowing solvent, effectively simulating the drug's circulation in the human body. Appropriate cell accessories are suitable for tablets, capsules, patches, microspheres, suppositories, suspensions, stents, implants, and liposomes.

[0003] For drug dissolution tests with fast dissolution rates, real-time sampling and monitoring of the instantaneous amount of drug dissolved is required, and an open-loop dissolution test using a flow-through cell method is required. In the existing open-loop test process, the solvent enters the system from the solvent bottle and circulates through the system for heating. After the drug is flushed and dissolved in the flow-through cell, the solvent is sampled regularly and quantitatively through a sampling system and directly discharged.

[0004] The existing flow cell method drug dissolution sampling system has the following defects:

[0005] 1. When controlling the temperature of the solvent in the solvent cup, a separate heating water tank is used to heat the water area of the solvent cup. This water area heating system and the dissolution system of the circulation pool use two sets of devices. During the test of the system, the inlet and outlet pipes of the solvent cup need to be plugged and fixed with the inlet and outlet of the dissolution system of the circulation pool. At the same time, the inlet and outlet pipes of the heating system circulating water need to be plugged and fixed with the inlet and outlet pipes of the circulating water of the dissolution system of the circulation pool. The test operation process is very inconvenient; and the overall equipment of this structural form occupies a large area and the structure is not compact enough.

[0006] 2. When heating the water area of the solvent cup, a heating wire is placed directly in the heating water tank of the solvent cup to directly and locally heat the water area in the water tank. The temperature distribution in the water tank is uneven, making it difficult to control the heat exchange temperature between the water area and the solvent in the solvent cup. In addition, during the circulation of the solvent, the solvent cannot be continuously controlled at multiple points to ensure that the solvent and the drug are at the optimal temperature for drug dissolution testing.

[0007] 3. When conducting open-loop dissolution tests on drugs, solvent bottles are used to store the solvent due to the large solvent flow rate. The pH of the solvent stored in the solvent bottle is a fixed value, and it is not convenient to quickly switch the solvent, thereby quickly measuring the dissolution rate of the solvent under different pH values to achieve a drug dissolution effect that simulates the real internal environment of the human body. Summary of the Invention

[0008] In order to solve the above-mentioned problems, the present invention discloses an open-loop sampling system for drug dissolution using a circulation cell method. The specific technical solution is as follows: an open-loop sampling system for drug dissolution using a circulation cell method comprises a constant temperature water system, a circulation cell system, a lifting mechanism, a circulating heating system, a solvent monitoring system, a solvent switching system, a solvent circulation system and a sampling system;

[0009] The constant temperature water system is used to keep the solvent in the solvent cup warm; the constant temperature water system includes a constant temperature water tank rack, a constant temperature water tank and a solvent cup rack, the constant temperature water tank is placed in the constant temperature water tank rack; the solvent cup rack is arranged on the top surface of the constant temperature water tank;

[0010] The circulation cell system is used for the solvent to carry out the dissolution process of the drug; the circulation cell system is arranged at the top of the constant temperature water system, and the circulation cell system includes a circulation cell rack, a circulation cell and a glass tube. The circulation cell rack is arranged on one side of the top surface of the solvent cup rack, and the circulation cell is fixed on the circulation cell rack and arranged in a horizontal array; the glass tube is correspondingly fitted on the outer wall of each of the circulation cells; the solvent cup cover is hoisted with the circulation cell rack through a clamping structure;

[0011] The lifting mechanism is used to lift and lower the circulation pool system as a whole; the lifting mechanism is arranged on one side of the constant temperature water tank frame, the bottom end of the lifting mechanism is fixed to the top surface of the constant temperature water tank frame, and the top side of the lifting mechanism is fixed to the side wall of the circulation pool frame;

[0012] The circulating heating system is used to perform water circulation heat exchange between the solvent in the circulation pool and the solvent flowing through the constant temperature water tank to achieve temperature control; the circulating heating system includes a heating device and a water circulation pump, the heating device is arranged on one side of the top surface of the solvent cup rack and on one side of the circulation pool rack; the constant temperature water tank circulates water between the circulation pool system and the constant temperature water tank through a pipe via the water circulation pump;

[0013] The solvent monitoring system is used to monitor the temperature and pressure of the circulating solvent and switch the flow direction of the solvent; the solvent monitoring system is arranged at the top of the heating device, the circulation inlet end of the solvent monitoring system is connected to the heating device, and the circulation outlet end of the solvent monitoring system is respectively connected to the sampling system and the circulation pool;

[0014] The solvent switching system is used to store the solvent required for the dissolution test and switch and control the amount of the solvent; the solvent switching system is arranged on one side of the constant temperature water system;

[0015] The solvent mixing system is used to extract the solvent in the solvent switching system and mix the solvent before passing it into the circulation pool system; the solvent mixing system includes a solvent mixing seat, a solvent mixer and a solvent suction pump, the solvent mixer is arranged at the top of the solvent mixing seat; the solvent suction pump is arranged in the solvent mixing seat, and the solvent suction pump is connected to the solvent mixer through a pipeline; the input end of the solvent mixer is connected to the output end of the solvent switching system, and the output end of the solvent mixer is connected to the sampling system;

[0016] The solvent circulation system is used to circulate the solvent between the solvent mixing system, the circulating heating system, the circulation cell system and the sampling system; the solvent circulation system includes a solvent circulation pump and a pulse valve, the solvent circulation pump is connected to the solvent mixer through a pipeline, the solvent circulation pump is connected to the pulse valve through a pipeline, and the pulse valve is connected to the circulating heating system, the circulation cell system and the sampling system in sequence through pipelines;

[0017] The sampling system is used to perform time-sharing and quantitative sampling of the circulating solvent; the sampling system includes a sampling mechanism, a sampling pipeline and a sampling valve, one end of the sampling valve is connected to the solvent outlet of the circulation pool through a pipeline, the sampling pipeline is connected to one end of the sampling valve, and the sampling mechanism is connected to the sampling pipeline.

[0018] Furthermore, the constant temperature water tank rack includes a water tank bottom rod, a water tank bottom plate, a water tank side plate, a water tank rack foot and a water tank back frame; the water tank bottom plate is arranged on the top surface of the water tank bottom rod and is arranged on both sides, the water tank bottom plate on one side is folded upward, and the water tank bottom plate on one side is folded downward; the water tank side plates are arranged on both sides of the water tank bottom plate and are fixedly assembled with the water tank bottom plate by fasteners, and the top ends of the water tank side plates on both sides are fixedly assembled with the solvent cup rack by fasteners; the water tank rack foot is arranged at the bottom end of the water tank bottom rod; the water tank back frame is arranged on one side of the water tank side plate.

[0019] Furthermore, the circulation pool rack includes side fixing blocks, a liquid collecting trough, a drain pipe, a pad, a liquid trough top plate, a water area base, a water area cover, a knob, a support rod, a side fixing plate, a mask connecting block, a mask fixing rod, a circulation pool mask and a circulation pool back plate; the side fixing blocks are arranged at both ends of the liquid collecting trough, and the side fixing blocks are assembled with the liquid collecting trough through fasteners; the pad blocks are arranged at the bottom sides of both ends of the liquid collecting trough, and the pad blocks are assembled with the side fixing blocks through fasteners; the side wall of the liquid collecting trough is provided with a liquid collecting trough side hole, and the bottom end of the liquid collecting trough is provided with a liquid collecting trough bottom hole , one end of the drainage pipe is assembled and connected with the bottom hole of the liquid collecting tank, the bottom end of the drainage pipe passes through the solvent cup holder and extends into the constant temperature water tank; the liquid tank top plate is arranged on the top surface of the liquid collecting tank, and the liquid tank top plate is assembled with the liquid collecting tank through fasteners; the water area base is fixed to the top surface of the liquid tank top plate and is arranged in a horizontal array, a solvent inlet is provided at the center of the water area base, one end of the solvent inlet is connected to a solvent inlet joint, a water area water inlet is provided on one side of the water area base, and the water area water inlet is connected to a water area water inlet joint; the water area The upper cover is arranged on the top surface of the water area base, the center of the water area upper cover is provided with an upper cover fixing hole, one side of the water area upper cover is provided with a water area outlet, and the water area outlet is connected to the water area outlet joint; knob fixing cylinders are provided on both sides of the top surface of the water area upper cover, and the knob is plug-connected with the knob fixing cylinder; the support rods are arranged on both sides of the outer wall of the water area base, the bottom end of the support rod is vertically fixed to the liquid tank top plate, and the top end of the support rod is vertically fixed to the bottom surface of the water area upper cover; the side fixing plates are arranged on both sides of the liquid tank top plate, and are symmetrically arranged, each The bottom end of the side fixing plate is fixed to the liquid tank top plate by fasteners; the mask connecting block is arranged on the top side of the side fixing plate on each side, and is assembled with the side fixing plate by fasteners; the two ends of the mask fixing rod are rotatable with the mask connecting blocks on both sides through a rotating shaft; the circulation pool mask is attached to the side wall of the mask connecting block, and the circulation pool mask is assembled with the mask fixing rod by fasteners; the circulation pool back plate is arranged on one side of the circulation pool, and the two sides of the circulation pool back plate are assembled with the side fixing plates on both sides by fasteners.

[0020] Furthermore, the solvent inlet joint is arranged at the center of the top surface of the water area base, and the solvent inlet joint is arranged vertically to the water area base.

[0021] Furthermore, the water area cover is a square structure; the center of the bottom surface of the water area cover is a layered platform structure, forming an upper cover platform, the side wall of the upper cover platform is circumferentially embedded with an upper cover sealing ring, the top end of the glass tube is fitted on the outer wall of the upper cover platform to achieve plug-in fixation, and the glass tube and the water area cover are sealed by the upper cover sealing ring; the water outlet of the water area is connected to the bottom surface of the upper cover platform.

[0022] Furthermore, the solvent inlet connector, the water inlet connector and the water outlet connector all adopt Luer connectors.

[0023] Furthermore, the bottom end of the knob extends into the corresponding knob fixing tube, and the knob is fixed to the knob fixing tube by threads; the side wall of each knob is provided with a knob fixing piece, and the knob fixing piece is arranged perpendicular to the knob.

[0024] Furthermore, the circulating heating system also includes a water tank outlet pipe, a water circulation main pipe, a diversion tee, a diversion pipe, a return branch pipe, a water supply tee, a water supply pipe, a water supply stop valve, a branch tee and a bypass pipe; one end of the water tank outlet pipe is connected to the bottom end of the constant temperature water tank, and one end of the water tank outlet pipe is connected to the suction end of the water circulation pump; one end of the water circulation main pipe is connected to the output end of the water circulation pump, and one end of the water circulation main pipe is connected to the diversion tee; one end of each of the diversion pipes is connected to the diversion tee At one end, the diversion pipe is plugged into each of the water inlet joints of the water area through a manifold; both ends of each of the return branch pipes are connected to a side hole of the sump and a water outlet joint of the water area; the water supply tee is arranged on the water outlet pipe of the water tank, the water supply pipe is connected to one end of the water supply tee, and the water supply stop valve is arranged on the water supply pipe; the side branch tee is arranged on the water circulation main pipe, one end of the bypass pipe is connected to the side branch tee, and one end of the bypass pipe is connected to one side of the constant temperature water tank.

[0025] Furthermore, the heating device includes a heating fixing plate, a heating wire, a connecting head, a direct head, a connecting wire, a solvent inlet pipe, a solvent outlet pipe and a heating shield; the heating fixing plate is embedded in the top surface of the solvent cup holder; the heating wire is arranged in the constant temperature water tank, and one end of each heating wire extends through the heating fixing plate and is plugged and fixed with the connecting head; the connecting wire is arranged on the top surface of the heating fixing plate, and the two ends of the connecting wire are plugged and fixed by the connecting head; the plug connector of the connecting wire and the plug connector of the heating wire are respectively threadedly fixed with the two ends of the direct head, The connecting wire is now connected to the heating wire; the solvent inlet pipe is arranged in the constant temperature water tank, and one end of each solvent inlet pipe extends through the heating fixing plate and is plugged and fixed with the connecting head; the solvent outlet pipe is arranged in the constant temperature water tank, and one end of each solvent outlet pipe extends through the heating fixing plate and is plugged and fixed with the connecting head, and the bottom end of the solvent inlet pipe is connected to the bottom end of the solvent outlet pipe; the heating shield buckle is placed on the top surface of the heating fixing plate, and one end of the heating shield is rotated with the constant temperature water tank frame through a movable hinge.

[0026] Furthermore, the heating wires are arranged in two rows, each row of heating wires is arranged in two layers, and each layer of heating wires is a circular coil structure; the two adjacent heating wires connected by a single connecting wire are arranged obliquely in upper and lower layers.

[0027] Furthermore, the connecting wire is in an inverted "U" shape.

[0028] Furthermore, the solvent inlet pipe is arranged at the center of the top surface of the heating fixed plate and between the heating wires; the solvent outlet pipe is arranged on one side of the top surface of the heating fixed plate.

[0029] Furthermore, the solvent monitoring system includes a detection frame, a three-way valve island, a lubricating valve island, a pressure valve, a photoelectric switch, a flow guide tube and a temperature sensor; the detection frame is arranged on the top surface of the heating shield, and the detection frame and the heating shield are fixed; the three-way valve island is arranged at one end of the interior of the detection frame, and the three-way valve island is supported and fixed by a first bracket; the lubricating valve island is arranged at one end of the interior of the detection frame, and the lubricating valve island is supported and fixed by a second bracket; the pressure valve is arranged at the inner middle end of the detection frame and at one side of the three-way valve island, a pressure valve fixing block is provided on the outside of the pressure valve, the pressure valve is embedded in the pressure valve fixing block, and the pressure valve fixing block is fixedly supported by a third bracket; the photoelectric switch is arranged at one end of the interior of the detection frame and at one side of the pressure valve On the other side, the photoelectric switch is fixed in the detection frame by a pipe clamp; the guide pipe is arranged at the internal top of the detection frame and on one side of the lubricating valve island, and the guide pipe is fixedly supported by a fourth bracket; the temperature sensor is vertically fixed to the bottom end of the guide pipe, and the end of the temperature sensor extends into the interior of the guide pipe; the solvent outlet pipe extends into the detection frame through a pipe and is connected with the inlet end of the corresponding three-way valve island; the side outlet of the three-way valve island is connected with one end of the corresponding pressure valve through a pipe; the other end of the pressure valve is connected with a pipe, and the pipe is embedded in the pipe clamp; the top outlet of the three-way valve island is connected with the bottom end of the corresponding lubricating valve island through a pipe; the outlet of one end of the lubricating valve island is connected to the waste liquid barrel through a pipe, and the outlet of one end of the lubricating valve island is connected with the corresponding guide pipe through a pipe.

[0030] The cam is secured to the chassis at two ends, and the cam is secured to the chassis at two ends, and the cam is secured to the chassis at two ends.

[0031] Furthermore, the three-way valve island is arranged at the top end of the through hole of the rack base plate; the first bracket is arranged on one side of the three-way valve island, the cross-section of the first bracket is an "L"-shaped structure, the bottom surface of the first bracket is fixed to the rack base plate, and the top side surface of the second bracket is fixed to the side surface of the three-way valve island.

[0032] Furthermore, the lubricating valve island is arranged at the top of the three-way valve island; the second bracket is arranged at both ends of the lubricating valve island, the cross-section of the second bracket at each end is an "L"-shaped structure, the bottom surface of the second bracket at each end is fixed to the bottom plate of the rack, and the top side surface of the second bracket at each end is fixed to the end surface of the lubricating valve island, and the lubricating valve island and the three-way valve island are arranged in the same direction.

[0033] Furthermore, the pressure valves are arranged in a horizontal array, and each pressure valve is arranged in opposition to the outlet of the three-way valve island; the third bracket is arranged on the bottom side of the pressure valve, and the third bracket is in a "Z"-shaped structure. The bottom surface of the third bracket is fixed to the bottom plate of the frame, and the top surface of the third bracket is fixed to the pressure valve fixing block.

[0034] Furthermore, the transverse array of pipe clamps is arranged on the top surface of the rack base plate, and the top surface of each pipe clamp is groove-shaped to form a pipe clamp slot, and each pipe clamp slot is arranged in alignment with the pressure valve; the photoelectric switch is arranged on the top surface of the pipe clamp and spans the top surface of the pipe clamp slot.

[0035] Further, the diversion pipes are arranged in a horizontal array, the diversion pipes and the pipe flushing valve island are arranged at the same height, and each diversion pipe is arranged opposite to the outlet of the pipe flushing valve island; the fourth bracket is arranged between the third bracket and the pipe clamp, the cross section of the fourth bracket is in a "U" shape structure, the bottom surface of the fourth bracket is fixed to the machine frame bottom plate, and the diversion pipes are arranged on the top surface of the fourth bracket.

[0036] Further, the solvent switching system includes a solvent bottle rack, a solvent bottle water tank, a solvent bottle limiting plate, a solvent bottle, a support frame, a back connecting piece, a top cross bar, a top connecting piece, an insertion lock block, an insertion lock rod, a fixed support rod, a movable support rod, a locking device and a liquid taking needle; the solvent bottle water tank is placed in the solvent bottle rack; the solvent bottle limiting plate is arranged on the top surface of the solvent bottle rack, the solvent bottle limiting plate is fixedly arranged with the solvent bottle rack through fasteners, and a limiting plate hole is arranged on the surface of the solvent bottle limiting plate; the solvent bottle penetrates through the limiting plate hole and is placed in the solvent bottle water tank; the support frame is arranged on one side of the top surface of the solvent bottle rack and is vertically and fixedly arranged with the solvent bottle rack; the back connecting piece is arranged at the top end of the support frame, and one side of the back connecting piece is fixed to the support frame through fasteners; the top cross bar is horizontally arranged at the top end of the solvent bottle rack, and one side of the top cross bar is fixed to one side of the back connecting piece through fasteners; the top connecting piece is arranged on the top surface of the top cross bar, and the top side of the top connecting piece is fixed to the bottom surface of the top cross bar through fasteners; the insertion lock block is fitted on one side bottom surface of the top connecting piece, and one side of the insertion lock block is fixedly arranged with one side of the top connecting piece; the insertion lock rod penetrates through the insertion lock block and the top connecting piece, and the insertion lock rod is slidably arranged with the insertion lock block; the fixed support rod is arranged on the side wall of the top cross bar, and the fixed support rod is vertically and fixedly arranged with the top cross bar; the movable support rod is arranged at one end of the fixed support rod, and the movable support rod is rotatably arranged with the fixed support rod through a rotating shaft; the locking device is arranged at the end of the movable support rod, and the locking device is fixedly arranged with the movable support rod; the liquid taking needle longitudinally penetrates through the locking device and extends into the solvent bottle, and the liquid taking needle is detachably arranged with the locking device.

[0037] Furthermore, the solvent bottle rack includes a solvent bottle bottom rod, a solvent bottle bottom plate, a solvent bottle side plate, a solvent bottle bottom foot and a solvent bottle back frame. The solvent bottle bottom plate is arranged on the top surface of the solvent bottle bottom rod and is arranged on both sides. The solvent bottle bottom plate on one side is folded upward, and the solvent bottle bottom plate on one side is folded downward; the solvent bottle side plates are arranged on both sides of the solvent bottle bottom plate and are fixedly assembled with the solvent bottle bottom plate by fasteners, and the top ends of the solvent bottle side plates on both sides are fixedly assembled with the solvent bottle limit plates by fasteners; the solvent bottle rack bottom foot is arranged at the bottom end of the solvent bottle bottom rod; the solvent bottle back frame is arranged on one side of the solvent bottle side plate.

[0038] Furthermore, a water circulation pump is provided on one side of the back frame of the solvent bottle, and a water heating pipe is provided on one side of the back frame of the solvent bottle; the suction end of the water circulation pump is connected to the bottom end of the solvent bottle water tank through a pipe, and the output end of the water circulation pump is connected to the inlet end of the water heating pipe through a pipe; the outlet end of the water heating pipe is connected to one side of the solvent bottle water tank through a pipe.

[0039] Furthermore, the number of the limit plate holes is multiple, the number of the solvent bottles is multiple, the number of the locking blocks is multiple, the number of the fixed support rods is multiple, the number of the movable support rods is multiple, and the number of the locks is multiple; the number of the limit plate holes, solvent bottles, locking blocks, fixed support rods, movable support rods and locks remains consistent.

[0040] Furthermore, the pH value of the solvent in each solvent bottle is set to increase, and the pH value of the solvent in the solvent bottle ranges from pH 7.

[0041] Furthermore, the back connecting piece has an "L"-shaped structure.

[0042] Furthermore, the top connecting piece has an inverted "L"-shaped structure.

[0043] Furthermore, there are two locking rods provided on each locking block, which are arranged in parallel on both sides; a rubber sleeve is provided at one end of each locking rod, and the rubber sleeve is wrapped around the end of the locking rod; a cut-off piece is provided at one end of the locking rod, and the cut-off piece is vertically fixed to the end of the locking rod, and the area of the cut-off piece is larger than the cross-sectional area of the locking rod.

[0044] Furthermore, the locking device includes a locking block and a locking rod, the top surface of the locking block is in the shape of a through hole, forming a liquid collection needle socket, a locking hole is provided on one side of the locking block, the locking hole is in the shape of an internal thread, the locking hole and the liquid collection needle socket are vertically arranged, and the locking hole and the liquid collection needle socket are through-arranged; one end of the locking rod extends into the locking hole, and the locking rod is threadedly fixed to the locking block.

[0045] Furthermore, a sensor jack is provided on one side of the top surface of the locking block, and the sensor jack is arranged on one side of the liquid collection needle jack; the sensor wire passes through the sensor jack and can penetrate into the solvent bottle.

[0046] Furthermore, the solvent mixer includes a mixer base, a mixer side frame, a mixer top plate, a mixing barrel and a mixer top plug, the mixer base is fixed to the top surface of the solvent mixing seat; the mixer side frame is arranged on the top surface of the solvent mixing seat and wrapped around the outside of the solvent mixing seat; the mixer top plate is fixed to the top end of the mixer side frame, the mixing barrel is arranged in the mixer side frame, the bottom end of the mixing barrel is sealed and fixed to the mixer base, and the top end of the mixing barrel is sealed and fixed to the mixer top plate; the mixer top plug is embedded in the center of the mixer top plate.

[0047] Furthermore, the solvent circulation system also includes a first solvent tube, a second solvent tube, a third solvent tube, a fourth solvent tube, a fifth solvent tube, a sixth solvent tube and a seventh solvent tube; one end of the first solvent tube is connected to the liquid collection needle and extends into the corresponding solvent bottle, and one end of the first solvent tube is connected to the suction end of the solvent suction pump; one end of the second solvent tube is connected to the output end of the solvent suction pump, and one end of the second solvent tube passes through the mixer top plug and extends into the mixing cylinder; one end of the third solvent tube passes through the mixer top plug and extends into the mixing cylinder, and the One end of the third solvent tube is connected to the suction end of the solvent circulation pump; one end of the fourth solvent tube is connected to the output end of the solvent circulation pump, and one end of the fourth solvent tube is connected to the input end of the pulse valve; one end of the fifth solvent tube is connected to the output end of the pulse valve, and one end of the fifth solvent tube is connected to the solvent inlet pipe; one end of the sixth solvent tube is connected to one end of the guide tube, and one end of the sixth solvent tube is connected to the solvent inlet of the circulation pool; one end of the seventh solvent tube is connected to the top of the circulation pool, and one end of the seventh solvent tube is connected to the sampling valve and connected to the waste liquid barrel.

[0048] Furthermore, the solvent circulation pump adopts a piston injection pump; the number of the solvent circulation pumps is two, one end of the third solvent tube is connected to the suction end of each of the solvent circulation pumps through a manifold, and one end of the third solvent tube is connected to the output end of each of the solvent circulation pumps through a manifold.

[0049] Furthermore, the heating wire, water circulation pump, solvent circulation pump, pulse valve, sampling valve, three-way valve island, lubrication valve island, photoelectric switch, and temperature sensor are electrically connected to an external controller through wires; the controller controls the set temperature value of the heating wire, the controller controls the opening and closing of the water circulation pump, solvent circulation pump, pulse valve, sampling valve, three-way valve island, and lubrication valve island, the photoelectric switch uploads signals to the controller, and the temperature sensor uploads temperature information to the controller.

[0050] A method for using a flow cell method drug dissolution open-loop sampling system, comprising the following steps:

[0051] 1. Secure the drug support structure in the flow cell and insert the flow cell into the fixing hole of the upper cover. Plug and secure the bottom end of the flow cell to the solvent inlet connector. Then, rotate the knob so that the knob fixing piece snaps onto the end of the flow cell. Connect one end of the flow cell to one end of the first solvent tube to connect the flow cell to the solvent circulation system.

[0052] 2. Start the adjustment lifting mechanism and lower it to the lowest point. The lifting mechanism drives the circulation pool system to the lowest point, and the solvent cup cover is pressed down to fit the solvent cup hole;

[0053] 3. Start heating the heating wire, which heats the water in the constant temperature water tank;

[0054] 4. Start the water circulation pump. The water in the constant temperature water tank is sucked into the suction end of the water circulation pump through the water tank outlet pipe. Under the pumping action of the water circulation pump, the water flows into the diversion pipe through the diversion tee, and then enters the glass tube through the water inlet through the manifold. After the glass tube is filled, it is injected into the liquid collection tank from the return branch pipe. The water in the liquid collection tank is re-injected into the constant temperature water tank through the drain pipe;

[0055] 5. Start the solvent suction pump to suck the solvent in the corresponding solvent bottle into the mixing barrel through the first solvent tube and the second solvent tube for mixing, and perform pH value detection through the sensor in the mixing barrel.

[0056] 6. Directly connect one outlet end of the lubrication valve island to the waste liquid barrel through a conduit; start the solvent circulation pump, and the solvent in the mixing cylinder is sucked into the suction end of the solvent circulation pump through the third solvent pipe. Through the pumping action of the solvent circulation pump, the solvent is delivered to the pulse valve through the fourth solvent pipe. The pulse valve performs a pulse delivery effect on the solvent, simulating human blood circulation. The solvent enters the constant temperature water tank through the fifth solvent pipe for heat exchange. The solvent flows through the heating device and the solvent monitoring system, and the solvent is directly discharged into the waste liquid barrel. At the same time, the solvent fills the diversion pipe, and the solvent temperature is monitored;

[0057] 7. When the temperature sensor monitors that the solvent temperature reaches 37°C, the output end of the flow guide tube is connected to the solvent inlet of the circulation pool through the sixth solvent tube. The solvent flowing into the solvent monitoring system passes through the lubrication valve island and flows into the bottom end of the circulation pool through the sixth solvent tube. After the solvent and the drug are flushed, it flows through the seventh solvent tube, through the sampling valve, and is discharged into the waste liquid tank.

[0058] 8. Adjust the sampling valve, the solvent in the seventh solvent tube flows into the sampling pipe through the sampling valve switch, and instantaneous sampling is performed in the sampling mechanism. After the sampling is completed, the solvent continues to be discharged into the waste liquid barrel when the sampling valve is adjusted.

[0059] The beneficial effects of the present invention are:

[0060] 1. The present invention presents an open-loop circulation pool drug dissolution sampling system for drug dissolution design. This system can realize the continuous flushing effect of the solvent on the drug and perform instantaneous sampling of the solvent. The invention arranges the circulation pool system above the constant temperature water system and realizes the longitudinal lifting and lowering between the circulation pool system and the constant temperature water system through a lifting mechanism. The two systems are designed as an integral whole. The drug dissolution of the circulation pool and the circulation and heat preservation function of the water area can be realized through one device. The system functions are integrated and processed. Under the premise of ensuring the functionality of the device, the structure of the device is compact, the overall volume of the device is reduced, and the placement and transportation of the device are convenient.

[0061] 2. This device is integrated with a circulating heating system on one side of the constant temperature water tank system. The circulating heating system heats the water area of the constant temperature water tank. The heating device adopts a heating fixing plate to fix the heating wire. The heating wire array design is arranged in the constant temperature water tank, and multiple groups of heating wires are inserted in the constant temperature water tank to fix the heating wire well. When water circulates in the constant temperature water tank, there is no deviation of the heating wire, which ensures a good heating effect. At the same time, the present invention designs the heating wire as a coil structure, and staggers the upper and lower layers, which greatly compresses the structural size of the heating wire and increases the heat exchange area between the heating wire and the water area. The two adjacent heating wire structures are connected by a connecting wire, and the heating wire is modularized to further improve the heating effect of the heating wire. The heating wire cooperates with the flow of water in the constant temperature water tank, and the temperature in the water area is evenly distributed, which can accurately control the temperature of the water in the solvent cup at 37°C.

[0062] 3. The present invention is provided with a solvent monitoring system at the heating device, and the solvent is circulated and heated between the heating device and the solvent cup before the solvent is heated and controlled to 37°C. When the solvent reaches 37°C, the solvent is flowed through the circulation pool for drug dissolution circulation. By using the lubricating valve island to switch the flow direction of the solvent, the solvent temperature can be accurately controlled, and it is ensured that the solvent is always operated at 37°C, thereby realizing temperature control of the solvent; the solvent monitoring system can also monitor the circulating pressure of the solvent. Through the function of the three-way valve island, it can detect when the circulating pressure of the solvent is greater than 0.1MPa, and an audible and visual alarm can be issued to warn the test personnel, ensuring that the circulating pipeline of the solvent maintains a safe pressure circulation, and the safety performance of the device is high.

[0063] 4. The present invention is designed with a system for centralized storage of multiple solvent bottles. In the system, solvents with different pH values are set in multiple solvent bottles, and the pH values of the solvents in the multiple solvent bottles are linearly measured. By taking liquids of solvents with different pH values and mixing them, multiple groups of solvents with pH values can be obtained, and the pH value is slowly adjusted regularly, and the pH value of the solvent is gradually changed from acidic to alkaline, and the solvent enters the circulation pool system in real time for drug dissolution test, which can truly simulate the dissolution environment of the drug from the stomach to the intestine. The accuracy of the drug dissolution test is higher, the test range of the dissolution test is wider, and the data obtained is more comprehensive; at the same time, the pH adjustment process of the solvent is convenient, and the pH value of the solvent can be quickly switched.

[0064] 5. The present invention provides a solvent bottle water tank structure for multiple solvent bottles, which can insulate the solvent bottles; a movable support rod and a locker are provided at the top of the solvent bottle, which can quickly rotate, insert, assemble and fix the liquid collection needle; a locking rod is provided at the bottle mouth of the solvent bottle to pull and limit the solvent bottle to prevent the solvent bottle from floating; the overall structure of the device is well designed, and the installation and use process is convenient, which can ensure that the solvent bottle is in a stable state for the connection and liquid collection process, and the system has strong operational stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 It is a schematic diagram of the overall equipment structure of the present invention.

[0066] Figure 2 It is a structural schematic diagram of the constant temperature water area system of the present invention.

[0067] Figure 3 It is a schematic diagram of the external structure of the circulation pool system of the present invention.

[0068] Figure 4 It is a schematic diagram of the internal structure of the circulation cell system of the present invention.

[0069] Figure 5 It is a front view of the circulation pool system of the present invention.

[0070] Figure 6 It is a front cross-sectional view of the circulation cell system of the present invention.

[0071] Figure 7 It is a schematic cross-sectional view of the circulation pool of the present invention.

[0072] Figure 8 It is a front view of the heating device and solvent monitoring system of the present invention.

[0073] Figure 9 It is a partial structural diagram of the heating device and the detection frame of the present invention.

[0074] Figure 10 It is a structural schematic diagram of the heating device of the present invention.

[0075] Figure 11 It is a structural schematic diagram of the sampling system of the present invention.

[0076] Figure 12 It is a schematic diagram of the front appearance structure of the solvent switching system of the present invention.

[0077] Figure 13 It is a schematic diagram of the back appearance structure of the solvent switching system of the present invention.

[0078] Figure 14 It is a cross-sectional schematic diagram of the locking device of the present invention.

[0079] Figure 15 It is a structural schematic diagram of the solvent mixing system of the present invention.

[0080] Figure 16 It is a schematic flow chart of the water circulation heating system of the present invention.

[0081] Figure 17 It is a schematic diagram of the solvent sampling process of the present invention.

[0082] List of reference numerals:

[0083] Constant temperature water system 1;

[0084] Constant temperature water tank frame 1-1, water tank bottom rod 1-1-1, water tank bottom plate 1-1-2, water tank side plate 1-1-3, water tank frame foot 1-1-4, water tank back frame 1-1-5, constant temperature water tank 1-2, solvent cup rack 1-3;

[0085] Circulation cell system 2;

[0086] Circulation cell frame 2-1, side fixing block 2-1-1, liquid collecting tank 2-1-2, liquid collecting tank side hole 2-1-2-1, liquid collecting tank bottom hole 2-1-2-2, drain pipe 2-1-3, pad 2-1-4, rubber foot 2-1-4-1, liquid tank top plate 2-1-5, water area base 2-1-6, solvent inlet 2-1-6-1, solvent inlet connector 2-1-6-2, water area inlet 2-1-6-3, water area inlet connector 2-1-6-4, base platform 2-1-6-5, base sealing ring 2-1-6-6, water area cover 2 -1-7, upper cover fixing hole 2-1-7-1, water outlet 2-1-7-2, water outlet connector 2-1-7-3, knob fixing tube 2-1-7-4, upper cover platform 2-1-7-5, upper cover sealing ring 2-1-7-6, knob 2-1-8, knob fixing piece 2-1-8-1, support rod 2-1-9, side fixing plate 2-1-10, mask connecting block 2-1-11, mask fixing rod 2-1-12, flow cell mask 2-1-13, flow cell back plate 2-1-14, flow cell 2-2, glass tube 2-3;

[0087] Lifting mechanism 3;

[0088] Circulation heating system 4;

[0089] Heating device 4-1, heating fixing plate 4-1-1, heating wire 4-1-2, connector 4-1-3, straight connector 4-1-4, connecting wire 4-1-5, solvent inlet pipe 4-1-6, solvent outlet pipe 4-1-7, heating shield 4-1-8, water circulation pump 4-2, water tank outlet pipe 4-3, water circulation main pipe 4-4, diverter tee 4-5, diverter pipe 4-6, return branch pipe 4-7, water supply tee 4-8, water supply pipe 4-9, water supply stop valve 4-10;

[0090] Solvent monitoring system 5;

[0091] Detection rack 5-1, rack bottom plate 5-1-1, rack bottom plate through hole 5-1-1-1, rack side plate 5-1-2, rack back plate 5-1-3, rack cover 5-1-4, rack handle 5-1-5, three-way valve island 5-2, lubrication valve island 5-3, pressure valve 5-4, pressure valve fixing block 5-4-1, photoelectric switch 5-5, flow guide tube 5-6, temperature sensor 5-7, first bracket 5-8, second bracket 5-9, third bracket 5-10, pipe clamp 5-11, pipe clamp slot 5-11-1, fourth bracket 5-12;

[0092] Solvent switching system 6;

[0093] Solvent bottle rack 6-1, solvent bottle bottom bar 6-1-1, solvent bottle bottom plate 6-1-2, solvent bottle side plate 6-1-3, solvent bottle bottom foot 6-1-4, solvent bottle back frame 6-1-5, solvent bottle water tank 6-2, solvent bottle limit plate 6-3, limit plate hole 6-3-1, solvent bottle 6-4, support frame 6-5, back connecting piece 6-6, top cross bar 6-7, top connecting piece 6-8, locking block 6-9, lock Rod 6-10, rubber sleeve 6-10-1, cut-off piece 6-10-2, fixed support rod 6-11, movable support rod 6-12, locker 6-13, locking block 6-13-1, liquid collection needle socket 6-13-1-1, locking hole 6-13-1-2, sensor socket 6-13-1-3, locking rod 6-13-2, liquid collection needle 6-14, water area circulation pump 6-15, water area heating pipe 6-16;

[0094] Solvent mixing system 7;

[0095] Solvent mixing seat 7-1, solvent mixer 7-2, mixer base 7-2-1, mixer side frame 7-2-2, mixer top plate 7-2-3, mixing cylinder 7-2-4, mixer top plug 7-2-5, solvent suction pump 7-3;

[0096] Solvent circulation system 8;

[0097] Solvent circulation pump 8-1, pulse valve 8-2, first solvent tube 8-3, second solvent tube 8-4, third solvent tube 8-5, fourth solvent tube 8-6, fifth solvent tube 8-7, sixth solvent tube 8-8, seventh solvent tube 8-9;

[0098] Sampling system 9;

[0099] Sampling mechanism 9-1, sampling pipeline 9-2, sampling valve 9-3. DETAILED DESCRIPTION

[0100] To make the technical solution of the present invention clearer and more specific, the present invention is further described below with reference to the accompanying drawings. Any equivalent replacement of the technical features of the technical solution of the present invention and any solution derived from conventional reasoning shall fall within the scope of protection of the present invention. The fixed connection, fixed arrangement, and fixed structure mentioned in this embodiment are all well-known technologies known to those skilled in the art, such as gluing, welding, screw connection, bolt and nut connection, and riveting.

[0101] As shown in the accompanying drawings, a flow cell method drug dissolution open-loop sampling system includes a constant temperature water system 1, a flow cell system 2, a lifting mechanism 3, a circulating heating system 4, a solvent monitoring system 5, a solvent switching system 6, a solvent circulation system 8 and a sampling system 9;

[0102] The constant temperature water system 1 is used to keep the solvent in the solvent cup warm; the constant temperature water system 1 includes a constant temperature water tank rack 1-1, a constant temperature water tank 1-2 and a solvent cup rack 1-3, the constant temperature water tank 1-2 is placed in the constant temperature water tank rack 1-1; the solvent cup rack 1-3 is arranged on the top surface of the constant temperature water tank 1-2;

[0103] The circulation cell system 2 is used for the solvent to flush and dissolve the drug; the circulation cell system 2 is arranged at the top of the constant temperature water system 1, and the circulation cell system 2 includes a circulation cell rack 2-1, a circulation cell 2-2 and a glass tube 2-3. The circulation cell rack 2-1 is arranged on one side of the top surface of the solvent cup rack 1-3, and the circulation cell 2-2 is fixed on the circulation cell rack 2-1 and arranged in a horizontal array; the glass tube 2-3 is correspondingly fitted on the outer wall of each of the circulation cells 2-2; the solvent cup cover is hoisted with the circulation cell rack 2-1 through a snap-fit structure;

[0104] The lifting mechanism 3 is used to lift and lower the circulation cell system 2 as a whole; the lifting mechanism 3 is arranged on one side of the constant temperature water tank rack 1-1, the bottom end of the lifting mechanism 3 is fixed to the top surface of the constant temperature water tank rack 1-1, and the top side of the lifting mechanism 3 is fixed to the side wall of the circulation cell rack 2-1;

[0105] The circulating heating system 4 is used to perform water circulation heat exchange between the solvent in the circulation pool 2-2 and the solvent flowing through the constant temperature water tank 1-2 to achieve temperature control; the circulating heating system 4 includes a heating device 4-1 and a water circulation pump 4-2, the heating device 4-1 is arranged on one side of the top surface of the solvent cup rack 1-3 and on one side of the circulation pool rack 2-1; the constant temperature water tank 1-2 circulates water between the circulation pool system 2 and the constant temperature water tank 1-2 through a pipe via the water circulation pump 4-2;

[0106] The solvent monitoring system 5 is used to monitor the temperature and pressure of the circulating solvent and switch the flow direction of the solvent; the solvent monitoring system 5 is arranged at the top of the heating device 4-1, the circulation inlet end of the solvent monitoring system 5 is connected to the heating device 4-1, and the circulation outlet end of the solvent monitoring system 5 is respectively connected to the sampling system 9 and the circulation cell 2-2;

[0107] The solvent switching system 6 is used to store the solvent required for the dissolution test and switch and control the amount of the solvent; the solvent switching system 6 is arranged on one side of the constant temperature water system 1;

[0108] The solvent mixing system 7 is used to extract the solvent in the solvent switching system 6, mix the solvent, and then pass it into the circulation pool system 2; the solvent mixing system 7 includes a solvent mixing seat 7-1, a solvent mixer 7-2 and a solvent suction pump 7-3, and the solvent mixer 7-2 is arranged at the top of the solvent mixing seat 7-1; the solvent suction pump 7-3 is arranged in the solvent mixing seat 7-1, and the solvent suction pump 7-3 is connected to the solvent mixer 7-2 through a pipeline; the input end of the solvent mixer 7-2 is connected to the output end of the solvent switching system 6, and the output end of the solvent mixer 7-2 is connected to the sampling system 9;

[0109] The solvent circulation system is used to circulate the solvent between the solvent mixing system 7, the circulating heating system 4, the circulation cell system 2 and the sampling system 9; the solvent circulation system includes a solvent circulation pump 8-1 and a pulse valve 8-2, the solvent circulation pump 8-1 is connected to the solvent mixer 7-2 through a pipeline, the solvent circulation pump 8-1 is connected to the pulse valve 8-2 through a pipeline, and the pulse valve 8-2 is connected to the circulating heating system 4, the circulation cell system 2 and the sampling system 9 in sequence through pipelines;

[0110] The sampling system 9 is used to perform time-sharing and quantitative sampling of the circulating solvent; the sampling system 9 includes a sampling mechanism 9-1, a sampling pipe 9-2 and a sampling valve 9-3, one end of the sampling valve 9-3 is connected to the solvent outlet of the circulation pool 2-2 through a pipe, the sampling pipe 9-2 is connected to one end of the sampling valve 9-3, and the sampling mechanism 9-1 is connected to the sampling pipe 9-2.

[0111] Furthermore, the constant temperature water tank frame 1-1 includes a water tank bottom rod 1-1-1, a water tank bottom plate 1-1-2, a water tank side plate 1-1-3, a water tank frame foot 1-1-4 and a water tank back frame 1-1-5; the water tank bottom plate 1-1-2 is arranged on the top surface of the water tank bottom rod 1-1-1, and is arranged on both sides, one side of the water tank bottom plate 1-1-2 is folded upward, and the other side of the water tank bottom plate 1-1-2 is folded downward; The water tank side panels 1-1-3 are arranged on both sides of the water tank bottom panel 1-1-2 and are fixedly assembled with the water tank bottom panel 1-1-2 by fasteners. The top ends of the water tank side panels 1-1-3 on both sides are fixedly assembled with the solvent cup rack 1-3 by fasteners; the water tank frame foot 1-1-4 is arranged at the bottom end of the water tank bottom rod 1-1-1; the water tank back frame 1-1-5 is arranged on one side of the water tank side panel 1-1-3.

[0112] Furthermore, the constant temperature water tank 1-2 is placed on the water tank bottom plate 1-1-2, the top side of the constant temperature water tank 1-2 is assembled with the solvent cup rack 1-3 through fasteners, and the side wall of the constant temperature water tank 1-2 is limited by the water tank side plate 1-1-3.

[0113] Furthermore, the circulation pool rack 2-1 includes a side fixing block 2-1-1, a liquid collecting tank 2-1-2, a drain pipe 2-1-3, a pad 2-1-4, a liquid tank top plate 2-1-5, a water area base 2-1-6, a water area cover 2-1-7, a knob 2-1-8, a support rod 2-1-9, a side fixing plate 2-1-10, a mask connecting block 2-1-11, a mask fixing rod 2-1-12, a circulation pool mask 2-1-13 and a circulation pool back plate 2-1-14; the side fixing blocks 2-1-1 are arranged at both ends of the liquid collecting tank 2-1-2, and the side fixing blocks 2-1-1 are assembled with the liquid collecting tank 2-1-2 by fasteners; the pad 2-1-4 is arranged at the liquid collecting tank 2-1-2 On the bottom side of both ends, the pad 2-1-4 is assembled with the side fixing block 2-1-1 by fasteners; the side wall of the liquid collecting tank 2-1-2 is provided with a liquid collecting tank side hole 2-1-2-1, and the bottom end of the liquid collecting tank 2-1-2 is provided with a liquid collecting tank bottom hole 2-1-2-2, one end of the drain pipe 2-1-3 is assembled and connected with the liquid collecting tank bottom hole 2-1-2-2, and the bottom end of the drain pipe 2-1-3 passes through the solvent cup rack 1-3 and extends into the constant temperature water tank 1-2; the liquid tank top plate 2-1-5 is arranged on the top surface of the liquid collecting tank 2-1-2, and the liquid tank top plate 2-1-5 is assembled with the liquid collecting tank 2-1-2 by fasteners; the water area base 2-1-6 is fixed to the top of the liquid tank The top surface of the plate 2-1-5 is arranged in a horizontal array. A solvent inlet 2-1-6-1 is provided in the center of the water area base 2-1-6. One end of the solvent inlet 2-1-6-1 is connected to a solvent inlet connector 2-1-6-2. A water area water inlet 2-1-6-3 is provided on one side of the water area base 2-1-6. The water area water inlet 2-1-6-3 is connected to a water area water inlet connector 2-1-6-4. The water area upper cover 2-1-7 is provided on the top surface of the water area base 2-1-6. A cover fixing hole 2-1-7-1 is provided in the center of the water area upper cover 2-1-7. A water area water outlet 2-1-7-2 is provided on one side of the water area upper cover 2-1-7. The water area water outlet 2-1-7-2 is connected to There is a water outlet joint 2-1-7-3 for the water area; knob fixing cylinders 2-1-7-4 are provided on both sides of the top surface of the water area cover 2-1-7, and the knob 2-1-8 is plugged and connected to the knob fixing cylinder 2-1-7-4; the support rod 2-1-9 is arranged on both sides of the outer wall of the water area base 2-1-6, and the bottom end of the support rod 2-1-9 is vertically fixed to the liquid tank top plate 2-1-5, and the top end of the support rod 2-1-9 is vertically fixed to the bottom surface of the water area cover 2-1-7; the side fixing plates 2-1-10 are arranged on both sides of the liquid tank top plate 2-1-5, and are symmetrically arranged. The bottom end of the side fixing plate 2-1-10 on each side is fixed to the liquid tank top plate 2-1-5 by fasteners;The shield connection block 2-1-11 is arranged on the top side of each side of the side fixing plate 2-1-10 and is assembled with the side fixing plate 2-1-10 via fasteners. The ends of the shield fixing rod 2-1-12 are rotatably arranged with the shield connection blocks 2-1-11 on both sides via a rotating shaft. The flow cell shield 2-1-13 is attached to the side wall of the shield connection block 2-1-11 and is assembled with the shield fixing rod 2-1-12 via fasteners. The flow cell back plate 2-1-14 is arranged on one side of the flow cell 2-2 and is assembled with the side fixing plates 2-1-10 on both sides via fasteners.

[0114] Furthermore, the length of the pad 2-1-4 is longer than the width of the liquid collecting tank 2-1-2, and the two ends of the pad 2-1-4 extend out from both sides of the bottom surface of the liquid collecting tank 2-1-2; the bottom surface of each side of the pad 2-1-4 is provided with a rubber foot 2-1-4-1, and the rubber foot 2-1-4-1 is fixed to the two ends of the bottom surface of each pad 2-1-4 by plugging; the pad 2-1-4 is fitted with the top surface of the solvent cup rack 1-3 through the rubber foot 2-1-4-1.

[0115] Furthermore, the number of the liquid collecting trough bottom holes 2-1-2-2 provided in the liquid collecting trough 2-1-2 is two, and each of the drainage pipes 2-1-3 is arranged in opposition to each of the liquid collecting trough bottom holes 2-1-2-2; the end of the drainage pipe 2-1-3 is flange-shaped, and one end of the drainage pipe 2-1-3 extends into the liquid collecting trough bottom hole 2-1-2-2, and the flange of the drainage pipe 2-1-3 fits into the inner bottom surface of the liquid collecting trough 2-1-2, and the drainage pipe 2-1-3 is matched with the liquid collecting trough 2-1-2 through fasteners to realize the vertical connection between the drainage pipe 2-1-3 and the liquid collecting trough 2-1-2.

[0116] Furthermore, the top surface of the water area base 2-1-6 is in a layered platform structure, forming a base platform 2-1-6-5, and the side wall of the base platform 2-1-6-5 is circumferentially embedded with a base sealing ring 2-1-6-6, and the bottom end of the glass tube 2-3 is fitted on the outer wall of the base platform 2-1-6-5 to achieve plug-in fixation, and the glass tube 2-3 and the water area base 2-1-6 are sealed by the base sealing ring 2-1-6-6; the water inlet 2-1-6-3 of the water area passes through the top surface of the base platform 2-1-6-5.

[0117] Furthermore, the solvent inlet joint 2-1-6-2 is arranged at the center of the top surface of the water area base 2-1-6, and the solvent inlet joint 2-1-6-2 is arranged vertically to the water area base 2-1-6.

[0118] Furthermore, the water area cover 2-1-7 is a square structure; the center of the bottom surface of the water area cover 2-1-7 is a layered platform structure, forming an upper cover platform 2-1-7-5, and the side wall of the upper cover platform 2-1-7-5 is circumferentially embedded with an upper cover sealing ring 2-1-7-6, and the top end of the glass tube 2-3 is fitted on the outer wall of the upper cover platform 2-1-7-5 to achieve plug-in fixation, and the glass tube 2-3 and the water area cover 2-1-7 are sealed by the upper cover sealing ring 2-1-7-6; the water outlet 2-1-7-2 of the water area is connected to the bottom surface of the upper cover platform 2-1-7-5.

[0119] Furthermore, the solvent inlet connector 2-1-6-2, the water inlet connector 2-1-6-4 and the water outlet connector 2-1-7-3 all adopt Luer connectors.

[0120] Furthermore, the bottom end of the knob 2-1-8 extends into the corresponding knob fixing tube 2-1-7-4, and the knob 2-1-8 is threadedly fixed to the knob fixing tube 2-1-7-4; the side wall of each knob 2-1-8 is provided with a knob fixing plate 2-1-8-1, and the knob fixing plate 2-1-8-1 is vertically arranged to the knob 2-1-8.

[0121] Furthermore, the circulating heating system 4 also includes a water tank outlet pipe 4-3, a water circulation main pipe 4-4, a diversion tee 4-5, a diversion pipe 4-6, a return branch pipe 4-7, a water supply tee 4-8, a water supply pipe 4-9, a water supply stop valve 4-10, a branch tee 4-11 and a bypass pipe 4-12; one end of the water tank outlet pipe 4-3 is connected to the bottom end of the constant temperature water tank 1-2, and one end of the water tank outlet pipe 4-3 is connected to the suction end of the water circulation pump 4-2; one end of the water circulation main pipe 4-4 is connected to the output end of the water circulation pump 4-2, and one end of the water circulation main pipe 4-4 is connected to the diversion tee 4-5; one end of each of the diversion pipes 4-6 is connected to one end of the diversion tee 4-5 , the diversion pipe 4-6 is plugged into each of the water inlet joints 2-1-6-4 of the water area through a manifold; both ends of each of the return branch pipes 4-7 are connected to a side hole 2-1-2-1 of the sump and a water outlet joint 2-1-7-3 of the water area; the water supply tee 4-8 is arranged on the water tank outlet pipe 4-3, the water supply pipe 4-9 is connected to one end of the water supply tee 4-8, and the water supply stop valve 4-10 is arranged on the water supply pipe 4-9; the side branch tee 4-11 is arranged on the water circulation main pipe 4-4, one end of the bypass pipe 4-12 is connected to the side branch tee 4-11, and one end of the bypass pipe 4-12 is connected to one side of the constant temperature water tank 1-2.

[0122] Furthermore, the heating device 4-1 includes a heating fixing plate 4-1-1, a heating wire 4-1-2, a connector 4-1-3, a direct connector 4-1-4, a connecting wire 4-1-5, a solvent inlet pipe 4-1-6, a solvent outlet pipe 4-1-7 and a heating shield 4-1-8; the heating fixing plate 4-1-1 is embedded in the top surface of the solvent cup holder 1-3; the heating wire 4-1-2 is arranged in the constant temperature water tank 1-2, and one end of each heating wire 4-1-2 extends through the heating fixing plate 4-1-1 and is plugged and fixed with the connector 4-1-3; the connecting wire 4-1-5 is arranged on the top surface of the heating fixing plate 4-1-1, and the two ends of the connecting wire 4-1-5 are plugged and fixed through the connector 4-1-3; the plug connector of the connecting wire 4-1-5 and the plug connector of the heating wire 4-1-2 are respectively connected to the direct connector The two ends of 4-1-4 are threadedly fixed to connect the connecting wire 4-1-5 with the heating wire 4-1-2; the solvent inlet pipe 4-1-6 is arranged in the constant temperature water tank, and one end of each solvent inlet pipe 4-1-6 extends through the heating fixing plate 4-1-1 and is plugged and fixed with the connecting head 4-1-3; the solvent outlet pipe 4-1-7 is arranged in the constant temperature water tank, and one end of each solvent outlet pipe 4-1-7 extends through the heating fixing plate 4-1-1 and is plugged and fixed with the connecting head 4-1-3, and the bottom end of the solvent inlet pipe 4-1-6 is connected to the bottom end of the solvent outlet pipe 4-1-7; the heating shield 4-1-8 is buckled on the top surface of the heating fixing plate 4-1-1, and one end of the heating shield 4-1-8 is rotated with the constant temperature water tank frame 1-1 through a movable hinge.

[0123] Furthermore, the heating wires 4-1-2 are arranged in two rows, each row of the heating wires 4-1-2 is arranged in two layers, and each layer of the heating wires 4-1-2 has a circular coil structure; the two adjacent heating wires 4-1-2 connected by a single connecting wire 4-1-5 are arranged obliquely in upper and lower layers.

[0124] Furthermore, the connecting wire 4-1-5 is in an inverted "U" shape.

[0125] Furthermore, the solvent inlet pipe 4-1-6 is arranged at the center of the top surface of the heating fixed plate 4-1-1 and between the heating wires 4-1-2; the solvent outlet pipe 4-1-7 is arranged on one side of the top surface of the heating fixed plate 4-1-1.

[0126] Furthermore, the solvent monitoring system 5 includes a detection rack 5-1, a three-way valve island 5-2, a lubricating valve island 5-3, a pressure valve 5-4, a photoelectric switch 5-5, a flow guide tube 5-6 and a temperature sensor 5-7; the detection rack 5-1 is arranged on the top surface of the heating shield 4-1-8, and the detection rack 5-1 and the heating shield 4-1-8 are fixedly arranged; the three-way valve island 5-2 is arranged at one end of the interior of the detection rack 5-1, and the three-way valve island 5-2 is supported and fixed by the first bracket 5-8; the lubricating valve island 5-3 is arranged on At one end of the interior of the detection rack 5-1, the lubricating valve island 5-3 is supported and fixed by a second bracket 5-9; the pressure valve 5-4 is arranged at the middle end of the interior of the detection rack 5-1 and on one side of the three-way valve island 5-2. A pressure valve fixing block 5-4-1 is provided on the outside of the pressure valve 5-4. The pressure valve 5-4 is embedded in the pressure valve fixing block 5-4-1, and the pressure valve fixing block 5-4-1 is fixedly supported by a third bracket 5-10; the photoelectric switch 5-5 is arranged at one end of the interior of the detection rack 5-1. The photoelectric switch 5-5 is fixed to the detection frame 5-1 through a pipe clamp 5-11; the guide pipe 5-6 is arranged at the top of the inner part of the detection frame 5-1 and is arranged on one side of the lubricating valve island 5-3. The guide pipe 5-6 is fixedly supported by a fourth bracket 5-12; the temperature sensor 5-7 is vertically fixed to the bottom end of the guide pipe 5-6, and the end of the temperature sensor 5-7 extends into the interior of the guide pipe 5-6; the solvent outlet pipe 4-1-7 extends into the detection frame 5-1 through a pipe. The detection rack 5-1 is connected with the inlet end of the corresponding three-way valve island 5-2; the side outlet of the three-way valve island 5-2 is connected with one end of the corresponding pressure valve 5-4 through a pipeline; the other end of the pressure valve 5-4 is connected with the pipeline, and the pipeline is embedded in the pipe clamp 5-11; the top outlet of the three-way valve island 5-2 is connected with the bottom end of the corresponding lubricating valve island 5-3 through a pipeline; one end outlet of the lubricating valve island 5-3 is connected to the waste liquid barrel through a pipeline, and one end outlet of the lubricating valve island 5-3 is connected with the corresponding guide pipe 5-6 through a pipeline.

[0127] Further, the detection rack 5-1 includes a rack bottom plate 5-1-1, rack side plates 5-1-2, a rack back plate 5-1-3, a rack cover plate 5-1-4 and a rack handle 5-1-5. The rack side plates 5-1-2 are symmetrically arranged on both sides. The top and bottom edges of each rack side plate 5-1-2 are bent. The bottom sides of the two rack side plates 5-1-2 are fixed to the top surface of the heating mask 4-1-8. The rack bottom plate 5-1-1 is arranged between the bottom sides of the two rack side plates 5-1-2 and is fixed to the two rack side plates 5-1-2. A through hole 5-1-1-1 of the rack bottom plate is provided on one side of the surface of the rack bottom plate 5-1-1. The cross section of the rack back plate 5-1-3 is in a "U" shape. The rack back plate 5-1-3 is arranged at one end of the two rack side plates 5-1-2 and is fixed to the two rack side plates 5-1-2. The rack cover plate 5-1-4 is buckled on the top side of the rack side plates 5-1-2, and both sides of the rack cover plate 5-1-4 are fixed to the top sides of the two rack side plates 5-1-2. The rack handle 5-1-5 is arranged on one side of one rack side plate 5-1-2 and is perpendicularly fixed to the rack side plate 5-1-2.

[0128] Further, the three-way valve island 5-2 is arranged opposite to the top end of the through hole 5-1-1-1 of the rack bottom plate. The first bracket 5-8 is arranged on one side of the three-way valve island 5-2. The cross section of the first bracket 5-8 is in an "L" shape. The bottom surface of the first bracket 5-8 is fixed to the rack bottom plate 5-1-1, and the top side surface of the second bracket 5-9 is fixed to the side surface of the three-way valve island 5-2.

[0129] Further, the pipe flushing valve island 5-3 is arranged opposite to the top end of the three-way valve island 5-2. The second brackets 5-9 are arranged at both ends of the pipe flushing valve island 5-3. The cross section of each second bracket 5-9 is in an "L" shape. The bottom surface of each second bracket 5-9 is fixed to the rack bottom plate 5-1-1, and the top side surface of each second bracket 5-9 is fixed to the end surface of the pipe flushing valve island 5-3. The pipe flushing valve island 5-3 and the three-way valve island 5-2 are arranged in the same direction.

[0130] Further, the pressure valves 5-4 are arranged in a horizontal array, and each pressure valve 5-4 is arranged opposite to the outlet of the three-way valve island 5-2. The third bracket 5-10 is arranged at the bottom side of the pressure valve 5-4. The third bracket 5-10 is in a "Z" shape. The bottom surface of the third bracket 5-10 is fixed to the rack bottom plate 5-1-1, and the top surface of the third bracket 5-10 is fixed to the pressure valve fixing block 5-4-1.

[0131] Further, the pipe clamps 5-11 are arranged in a horizontal array on the top surface of the frame bottom plate 5-1-1. The top surface of each pipe clamp 5-11 is in a groove shape, forming a pipe clamp card slot 5-11-1. Each pipe clamp card slot 5-11-1 is arranged in alignment with the pressure valve 5-4; the photoelectric switch 5-5 is arranged on the top surface of the pipe clamp 5-11 and straddles the top surface of the pipe clamp card slot 5-11-1.

[0132] Further, the diversion pipes 5-6 are arranged in a horizontal array. The diversion pipes 5-6 are arranged at the same height as the pipe flushing valve island 5-3. Each diversion pipe 5-6 is arranged in alignment with the outlet of the pipe flushing valve island 5-3; the fourth bracket 5-12 is arranged between the third bracket 5-10 and the pipe clamp 5-11. The cross-section of the fourth bracket 5-12 is in a "U" shape. The bottom surface of the fourth bracket 5-12 is fixed to the frame bottom plate 5-1-1. The diversion pipe 5-6 is arranged on the top surface of the fourth bracket 5-12.

[0133] Furthermore, the solvent switching system 6 includes a solvent bottle rack 6-1, a solvent bottle water tank 6-2, a solvent bottle limiting plate 6-3, a solvent bottle 6-4, a support frame 6-5, a back connecting piece 6-6, a top cross bar 6-7, a top connecting piece 6-8, a locking block 6-9, a locking rod 6-10, a fixed support rod 6-11, a movable support rod 6-12, a locker 6-13 and a liquid collection needle 6-14; the solvent bottle water tank 6-2 is placed in the solvent bottle rack 6-1; the solvent bottle limiting plate 6-3 is arranged on the top surface of the solvent bottle rack 6-1, and the solvent bottle limiting plate 6-3 is connected to the solvent bottle rack 6-1 by fasteners. 1 is fixedly arranged, a limit plate hole 6-3-1 is provided on the surface of the solvent bottle limit plate 6-3; the solvent bottle 6-4 passes through the limit plate hole 6-3-1 and is placed in the solvent bottle water tank 6-2; the support frame 6-5 is arranged on one side of the top surface of the solvent bottle rack 6-1 and is fixed vertically to the solvent bottle rack 6-1; the back connecting piece 6-6 is arranged on the top of the support frame 6-5, and one side of the back connecting piece 6-6 is fixed to the support frame 6-5 by a fastener; the top cross bar 6-7 is horizontally arranged on the top of the solvent bottle rack 6-1, and one side of the top cross bar 6-7 is passed through The top connecting piece 6-8 is fixed to one side of the back connecting piece 6-6 through a fastener; the top connecting piece 6-8 is arranged on the top surface of the top cross bar 6-7, and the top side of the top connecting piece 6-8 is fixed to the bottom surface of the top cross bar 6-7 through a fastener; the locking block 6-9 is fitted on the bottom surface of one side of the top connecting piece 6-8, and one side of the locking block 6-9 is fixed to one side of the top connecting piece 6-8; the locking rod 6-10 passes through the locking block 6-9 and the top connecting piece 6-8, so that the locking rod 6-10 and the locking block 6-9 are slidable; the fixed support rod 6-11 is arranged on the The side wall of the top cross bar 6-7, the fixed support rod 6-11 and the top cross bar 6-7 are vertically fixed; the movable support rod 6-12 is arranged at one end of the fixed support rod 6-11, and the movable support rod 6-12 and the fixed support rod 6-11 are rotatable through a rotating shaft; the locking device 6-13 is arranged at the end of the movable support rod 6-12, and the locking device 6-13 is fixed to the movable support rod 6-12; the liquid collection needle 6-14 longitudinally penetrates the locking device 6-13 and extends into the solvent bottle 6-4, and the liquid collection needle 6-14 and the locking device 6-13 are detachable.

[0134] Furthermore, the solvent bottle rack 6-1 includes a solvent bottle bottom rod 6-1-1, a solvent bottle 6-4 bottom plate 6-1-2, a solvent bottle 6-4 side plate 6-1-3, a solvent bottle bottom foot 6-1-4 and a solvent bottle back frame 6-1-5, and the solvent bottle 6-4 bottom plate 6-1-2 is arranged on the top surface of the solvent bottle bottom rod 6-1-1 and is arranged on both sides, one side of the solvent bottle 6-4 bottom plate 6-1-2 is folded upward, and the other side of the solvent bottle 6-4 bottom plate 6-1-2 is folded downward; The side panels 6-1-3 of the solvent bottle 6-4 are arranged on both sides of the bottom plate 6-1-2 of the solvent bottle 6-4, and are fixedly assembled with the bottom plate 6-1-2 of the solvent bottle 6-4 by fasteners. The top ends of the side panels 6-1-3 of the solvent bottle 6-4 on both sides are fixedly assembled with the solvent bottle limit plates 6-3 by fasteners; the bottom foot of the solvent bottle rack 6-1 is arranged at the bottom end of the solvent bottle bottom rod 6-1-1; the solvent bottle back frame 6-1-5 is arranged on one side of the side panel 6-1-3 of the solvent bottle 6-4.

[0135] Furthermore, a water circulation pump 6-15 is provided on one side of the solvent bottle back frame 6-1-5, and a water heating pipe 6-16 is provided on one side of the solvent bottle back frame 6-1-5; the suction end of the water circulation pump 6-15 is connected to the bottom end of the solvent bottle water tank 6-2 through a pipeline, and the output end of the water circulation pump 6-15 is connected to the inlet end of the water heating pipe 6-16 through a pipeline; the outlet end of the water heating pipe 6-16 is connected to one side of the solvent bottle water tank 6-2 through a pipeline.

[0136] Furthermore, the number of the limit plate holes 6-3-1 is multiple, the number of the solvent bottles 6-4 is multiple, the number of the locking blocks 6-9 is multiple, the number of the fixed support rods 6-11 is multiple, the number of the movable support rods 6-12 is multiple, and the number of the locks 6-13 is multiple; the number of the limit plate holes 6-3-1, the solvent bottles 6-4, the locking blocks 6-9, the fixed support rods 6-11, the movable support rods 6-12 and the locks 6-13 remain consistent.

[0137] Furthermore, the pH value of the solvent in each solvent bottle 6 - 4 is set to increase, and the pH value of the solvent in the solvent bottle 6 - 4 ranges from pH 1 to pH 7.

[0138] Furthermore, the back connecting piece 6 - 6 has an “L”-shaped structure.

[0139] Furthermore, the top connecting piece 6-8 is an inverted "L"-shaped structure.

[0140] Furthermore, the number of the locking rods 6-10 provided on each of the locking blocks 6-9 is two, which are arranged in parallel on both sides; a rubber sleeve 6-10-1 is provided at one end of each of the locking rods 6-10, and the rubber sleeve 6-10-1 is wrapped around the end of the locking rod 6-10; a cut-off piece 6-10-2 is provided at one end of the locking rod 6-10, and the cut-off piece 6-10-2 is vertically fixed to the end of the locking rod 6-10, and the area of the cut-off piece 6-10-2 is larger than the cross-sectional area of the locking rod 6-10.

[0141] Furthermore, the locking device 6-13 includes a locking block 6-13-1 and a locking rod 6-13-2, the top surface of the locking block 6-13-1 is in the shape of a through hole, forming a liquid collection needle 6-14 insertion hole 6-13-1-1, and a locking hole 6-13-1-2 is provided on one side of the locking block 6-13-1, and the locking hole 6-13-1-2 is in the shape of an internal thread, and the locking hole 6-13-1-2 and the liquid collection needle 6-14 insertion hole 6-13-1-1 are vertically arranged, and the locking hole 6-13-1-2 and the liquid collection needle 6-14 insertion hole 6-13-1-1 are connected; one end of the locking rod 6-13-2 extends into the locking hole 6-13-1-2, and the locking rod 6-13-2 is threadedly fixed to the locking block 6-13-1.

[0142] Furthermore, a sensor socket 6-13-1-3 is provided on one side of the top surface of the locking block 6-13-1, and the sensor socket 6-13-1-3 is arranged on one side of the socket 6-13-1-1 of the liquid collection needle 6-14; the sensor wire passes through the sensor socket 6-13-1-3 and can penetrate into the solvent bottle 6-4.

[0143] Furthermore, the solvent mixer 7-2 includes a mixer base 7-2-1, a mixer side frame 7-2-2, a mixer top plate 7-2-3, a mixing barrel 7-2-4 and a mixer top plug 7-2-5, wherein the mixer base 7-2-1 is fixed to the top surface of the solvent mixing seat 7-1; the mixer side frame 7-2-2 is arranged on the top surface of the solvent mixing seat 7-1 and wrapped around the outer side of the solvent mixing seat 7-1; the mixer top plate 7-2-3 is fixed to the top end of the mixer side frame 7-2-2, the mixing barrel 7-2-4 is arranged in the mixer side frame 7-2-2, the bottom end of the mixing barrel 7-2-4 is sealed and fixed to the mixer base 7-2-1, and the top end of the mixing barrel 7-2-4 is sealed and fixed to the mixer top plate 7-2-3; the mixer top plug 7-2-5 is embedded in the center of the mixer top plate 7-2-3.

[0144] Furthermore, the solvent circulation system also includes a first solvent tube 8-3, a second solvent tube 8-4, a third solvent tube 8-5, a fourth solvent tube 8-6, a fifth solvent tube 8-7, a sixth solvent tube 8-8 and a seventh solvent tube 8-9; one end of the first solvent tube 8-3 is connected to the liquid collection needle 6-14 and extends into the corresponding solvent bottle 6-4, and one end of the first solvent tube 8-3 is connected to the suction end of the solvent suction pump 7-3; one end of the second solvent tube 8-4 is connected to the output end of the solvent suction pump 7-3, and one end of the second solvent tube 8-4 passes through the mixer top plug 7-2-5 and extends into the mixing barrel 7-2-4; one end of the third solvent tube 8-5 passes through the mixer top plug 7-2-5 and extends into the mixing barrel 7-2-4 One end of the third solvent tube 8-5 is connected to the suction end of the solvent circulation pump 8-1; one end of the fourth solvent tube 8-6 is connected to the output end of the solvent circulation pump 8-1, and one end of the fourth solvent tube 8-6 is connected to the input end of the pulse valve 8-2; one end of the fifth solvent tube 8-7 is connected to the output end of the pulse valve 8-2, and one end of the fifth solvent tube 8-7 is connected to the solvent inlet tube 4-1-6; one end of the sixth solvent tube 8-8 is connected to one end of the guide tube 5-6, and one end of the sixth solvent tube 8-8 is connected to the solvent inlet 2-1-6-1 of the circulation pool 2-2; one end of the seventh solvent tube 8-9 is connected to the top of the circulation pool 2-2, and one end of the seventh solvent tube 8-9 is connected to the sampling valve 9-3 and connected to the waste liquid barrel.

[0145] Furthermore, the solvent circulation pump 8-1 adopts a piston injection pump; the number of the solvent circulation pumps 8-1 is two, one end of the third solvent tube 8-5 is connected to the suction end of each of the solvent circulation pumps 8-1 through a manifold, and one end of the third solvent tube is connected to the output end of each of the solvent circulation pumps 8-1 through a manifold.

[0146] Furthermore, the heating wire 4-1-2, the water circulation pump 4-2, the solvent circulation pump 8-1, the pulse valve 8-2, the sampling valve 9-3, the three-way valve island 5-2, the lubricating valve island 5-3, the photoelectric switch 5-5, and the temperature sensor 5-7 are electrically connected to an external controller through wires; the controller controls the set temperature value of the heating wire 4-1-2, the controller controls the opening and closing of the water circulation pump 4-2, the solvent circulation pump 8-1, the pulse valve 8-2, the sampling valve 9-3, the three-way valve island 5-2 and the lubricating valve island 5-3, the photoelectric switch 5-5 uploads a signal to the controller, and the temperature sensor 5-7 uploads temperature information to the controller.

[0147] A method for using a flow cell method drug dissolution open-loop sampling system, comprising the following steps:

[0148] 1. Secure the drug support structure within the circulation cell 2-2 and insert the circulation cell 2-2 into the upper cover fixing hole 2-1-7-1. Plug and secure the bottom end of the circulation cell 2-2 to the solvent inlet connector 2-1-6-2. Rotate the knob 2-1-8 so that the knob fixing piece 2-1-8-1 snaps onto the end of the circulation cell 2-2. Connect one end of the circulation cell 2-2 to one end of the first solvent tube 8-3 to connect the circulation cell 2-2 to the solvent circulation system 8.

[0149] 2. Start the adjustment lifting mechanism 3 and lower it to the lowest point. The lifting mechanism 3 drives the flow cell system 2 to the lowest point, and the solvent cup cover is pressed down to fit the solvent cup hole;

[0150] 3. Start heating the heating wire 4-1-2, and the heating wire 4-1-2 heats the water in the constant temperature water tank 1-2;

[0151] 4. Start the water circulation pump 4-2. The water in the constant temperature water tank 1-2 is sucked into the suction port of the water circulation pump 4-2 through the water tank outlet pipe 4-3. Under the pumping action of the water circulation pump 4-2, the water flows into the diversion pipe 4-6 through the diversion tee 4-5. Then, through the manifold, the water is input into the glass tube 2-3 through the water inlet 2-1-6-3 of the water area. After the glass tube 2-3 is filled, it is injected into the liquid collection tank 2-1-2 through the return branch pipe 4-7. The water in the liquid collection tank 2-1-2 is then injected into the constant temperature water tank 1-2 through the drain pipe 2-1-3.

[0152] 5. Start the solvent suction pump 7-3, suck the solvent in the corresponding solvent bottle 6-4 through the first solvent tube 8-3 and the second solvent tube 8-4 into the mixing cylinder 7-2-4 for mixing, and detect the pH value through the sensor in the mixing cylinder 7-2-4.

[0153] 6. Directly connect one outlet end of the lubrication valve island 5-3 to the waste liquid barrel through a conduit; start the solvent circulation pump 8-1, and the solvent in the mixing cylinder 7-2-4 is sucked into the suction end of the solvent circulation pump 8-1 through the third solvent pipe 8-5. Through the pumping action of the solvent circulation pump 8-1, the solvent is delivered to the pulse valve 8-2 through the fourth solvent pipe 8-6. The pulse valve 8-2 performs a pulse delivery action on the solvent to simulate human blood circulation. The solvent enters the constant temperature water tank 1-2 through the fifth solvent pipe 8-7 for heat exchange. The solvent flows through the heating device 4-1 and the solvent monitoring system 5, and the solvent is directly discharged into the waste liquid barrel; at the same time, the solvent fills the guide pipe 5-6, and the temperature of the solvent is monitored;

[0154] 7. When the solvent temperature monitored by temperature sensor 5-7 reaches 37°C, the output end of flow guide tube 5-6 is connected to solvent inlet 2-1-6-1 of circulation cell 2-2 via sixth solvent tube 8-8. The solvent flowing into solvent monitoring system 5 passes through lubrication valve island 5-3 and sixth solvent tube 8-8 into the bottom end of circulation cell 2-2. After the solvent and the drug are flushed, it flows through seventh solvent tube 8-9, sampling valve 9-3, and is discharged into the waste liquid tank.

[0155] 8. Adjust the sampling valve 9-3, the solvent in the seventh solvent tube 8-9 switches through the sampling valve 9-3 and flows into the sampling pipe 9-2, and performs instantaneous sampling in the sampling mechanism 9-1. After the sampling is completed, adjust the sampling valve 9-3 and the solvent continues to be discharged into the waste liquid barrel.

[0156] The beneficial effects of the present invention are:

[0157] 1. The present invention presents an open-loop circulation pool drug dissolution sampling system for drug dissolution design. This system can realize the continuous flushing effect of the solvent on the drug and perform instantaneous sampling of the solvent. The invention arranges the circulation pool system above the constant temperature water system and realizes the longitudinal lifting and lowering between the circulation pool system and the constant temperature water system through a lifting mechanism. The two systems are designed as an integral whole. The drug dissolution of the circulation pool and the circulation and heat preservation function of the water area can be realized through one device. The system functions are integrated and processed. Under the premise of ensuring the functionality of the device, the structure of the device is compact, the overall volume of the device is reduced, and the placement and transportation of the device are convenient.

[0158] 2. This device is integrated with a circulating heating system on one side of the constant temperature water tank system. The circulating heating system heats the water area of the constant temperature water tank. The heating device adopts a heating fixing plate to fix the heating wire. The heating wire array design is arranged in the constant temperature water tank, and multiple groups of heating wires are inserted in the constant temperature water tank to fix the heating wire well. When water circulates in the constant temperature water tank, there is no deviation of the heating wire, which ensures a good heating effect. At the same time, the present invention designs the heating wire as a coil structure, and staggers the upper and lower layers, which greatly compresses the structural size of the heating wire and increases the heat exchange area between the heating wire and the water area. The two adjacent heating wire structures are connected by a connecting wire, and the heating wire is modularized to further improve the heating effect of the heating wire. The heating wire cooperates with the flow of water in the constant temperature water tank, and the temperature in the water area is evenly distributed, which can accurately control the temperature of the water in the solvent cup at 37°C.

[0159] 3. The present invention is provided with a solvent monitoring system at the heating device, and the solvent is circulated and heated between the heating device and the solvent cup before the solvent is heated and controlled to 37°C. When the solvent reaches 37°C, the solvent is flowed through the circulation pool for drug dissolution circulation. By using the lubricating valve island to switch the flow direction of the solvent, the solvent temperature can be accurately controlled, and it is ensured that the solvent is always operated at 37°C, thereby realizing temperature control of the solvent; the solvent monitoring system can also monitor the circulating pressure of the solvent. Through the function of the three-way valve island, it can detect when the circulating pressure of the solvent is greater than 0.1MPa, and an audible and visual alarm can be issued to warn the test personnel, ensuring that the circulating pipeline of the solvent maintains a safe pressure circulation, and the safety performance of the device is high.

[0160] 4. The present invention is designed with a system for centralized storage of multiple solvent bottles. In the system, solvents with different pH values are set in multiple solvent bottles, and the pH values of the solvents in the multiple solvent bottles are linearly measured. By taking liquids of solvents with different pH values and mixing them, multiple groups of solvents with pH values can be obtained, and the pH value is slowly adjusted regularly, and the pH value of the solvent is gradually changed from acidic to alkaline, and the solvent enters the circulation pool system in real time for drug dissolution test, which can truly simulate the dissolution environment of the drug from the stomach to the intestine. The accuracy of the drug dissolution test is higher, the test range of the dissolution test is wider, and the data obtained is more comprehensive; at the same time, the pH adjustment process of the solvent is convenient, and the pH value of the solvent can be quickly switched.

[0161] 5. The present invention provides a solvent bottle water tank structure for multiple solvent bottles, which can insulate the solvent bottles; a movable support rod and a locker are provided at the top of the solvent bottle, which can quickly rotate, insert, assemble and fix the liquid collection needle; a locking rod is provided at the bottle mouth of the solvent bottle to pull and limit the solvent bottle to prevent the solvent bottle from floating; the overall structure of the device is well designed, and the installation and use process is convenient, which can ensure that the solvent bottle is in a stable state for the connection and liquid collection process, and the system has strong operational stability.

Claims

1. A flow cell method drug dissolution open loop sampling system, characterized in that: It includes a constant temperature water system (1), a circulation pool system (2), a lifting mechanism (3), a circulation heating system (4), a solvent monitoring system (5), a solvent switching system (6), a solvent circulation system (8) and a sampling system (9); The constant temperature water area system (1) is used to keep the solvent in the solvent cup warm; the constant temperature water area system (1) comprises a constant temperature water tank frame (1-1), a constant temperature water tank (1-2) and a solvent cup rack (1-3); the constant temperature water tank (1-2) is placed in the constant temperature water tank frame (1-1); the solvent cup rack (1-3) is arranged on the top surface of the constant temperature water tank (1-2); The circulation cell system (2) is used for the solvent to carry out the flushing and dissolution process of the drug; the circulation cell system (2) is arranged at the top of the constant temperature water area system (1), and the circulation cell system (2) comprises a circulation cell frame (2-1), a circulation cell (2-2) and a glass tube (2-3); the circulation cell frame (2-1) is arranged on one side of the top surface of the solvent cup frame (1-3); the circulation cell (2-2) is fixed on the circulation cell frame (2-1) and arranged in a horizontal array; the glass tube (2-3) is correspondingly fitted on the outer wall of each circulation cell (2-2); the solvent cup cover is hoisted with the circulation cell frame (2-1) through a clamping structure; The lifting mechanism (3) is used to perform overall lifting and lowering of the circulation pool system (2); the lifting mechanism (3) is arranged on one side of the constant temperature water tank frame (1-1), the bottom end of the lifting mechanism (3) is fixed to the top surface of the constant temperature water tank frame (1-1), and the top end of the lifting mechanism (3) is fixed to the side wall of the circulation pool frame (2-1); The circulating heating system (4) is used to perform water circulation heat exchange between the solvent in the circulation pool (2-2) and the solvent flowing through the constant temperature water tank (1-2) to achieve temperature control; the circulating heating system (4) includes a heating device (4-1) and a water circulation pump (4-2); the heating device (4-1) is arranged on one side of the top surface of the solvent cup rack (1-3) and on one side of the circulation pool rack (2-1); the constant temperature water tank (1-2) circulates water between the circulation pool system (2) and the constant temperature water tank (1-2) through a pipeline via the water circulation pump (4-2); The solvent monitoring system (5) is used to monitor the temperature and pressure of the circulating solvent and switch the flow direction of the solvent; the solvent monitoring system (5) is arranged at the top of the heating device (4-1), the circulation inlet end of the solvent monitoring system (5) is connected to the heating device (4-1), and the circulation outlet end of the solvent monitoring system (5) is respectively connected to the sampling system (9) and the circulation pool (2-2); The solvent switching system (6) is used to store the solvent required for the dissolution test and to switch and control the amount of the solvent; the solvent switching system (6) is arranged on one side of the constant temperature water area system (1); The solvent mixing system (7) is used to extract the solvent in the solvent switching system (6), mix the solvent, and then pass it into the circulation pool system (2); the solvent mixing system (7) includes a solvent mixing seat (7-1), a solvent mixer (7-2) and a solvent suction pump (7-3), wherein the solvent mixer (7-2) is arranged at the top of the solvent mixing seat (7-1); the solvent suction pump (7-3) is arranged in the solvent mixing seat (7-1), and the solvent suction pump (7-3) is connected to the solvent mixer (7-2) through a pipeline; the input end of the solvent mixer (7-2) is connected to the output end of the solvent switching system (6), and the output end of the solvent mixer (7-2) is connected to the sampling system (9); The solvent circulation system is used to circulate the solvent between the solvent mixing system (7), the circulating heating system (4), the circulation cell system (2) and the sampling system (9); the solvent circulation system includes a solvent circulation pump (8-1) and a pulse valve (8-2); the solvent circulation pump (8-1) is connected to the solvent mixer (7-2) through a pipeline, the solvent circulation pump (8-1) is connected to the pulse valve (8-2) through a pipeline, and the pulse valve (8-2) is connected to the circulating heating system (4), the circulation cell system (2) and the sampling system (9) in sequence through a pipeline; The sampling system (9) is used for time-sharing and quantitative sampling of the circulating solvent; the sampling system (9) comprises a sampling mechanism (9-1), a sampling pipeline (9-2) and a sampling valve (9-3); one end of the sampling valve (9-3) is connected to the solvent outlet of the circulation pool (2-2) through a pipeline, the sampling pipeline (9-2) is connected to one end of the sampling valve (9-3), and the sampling mechanism (9-1) is connected to the sampling pipeline (9-2).

2. A flow cell method drug dissolution open-loop sampling system according to claim 1, characterized in that: The circulation pool frame (2-1) comprises a side fixing block (2-1-1), a liquid collecting tank (2-1-2), a liquid drain pipe (2-1-3), a pad (2-1-4), a liquid tank top plate (2-1-5), a water area base (2-1-6), a water area upper cover (2-1-7), a knob (2-1-8), a support rod (2-1-9), a side fixing plate (2-1-10), a shield connecting block (2-1-11), a shield fixing rod (2-1-12), a circulation pool shield (2-1-13) and a circulation pool back plate (2-1-14); the side fixing blocks (2-1-1) are arranged at both ends of the liquid collecting tank (2-1-2); the side fixing blocks (2-1-1 ) is assembled with the liquid collecting trough (2-1-2) through fasteners; the pad (2-1-4) is arranged on the bottom sides of both ends of the liquid collecting trough (2-1-2), and the pad (2-1-4) is assembled with the side fixing block (2-1-1) through fasteners; the side wall of the liquid collecting trough (2-1-2) is provided with a liquid collecting trough side hole (2-1-2-1), and the bottom end of the liquid collecting trough (2-1-2) is provided with a liquid collecting trough bottom hole (2-1-2-2), one end of the drain pipe (2-1-3) is assembled and connected with the liquid collecting trough bottom hole (2-1-2-2), and the bottom end of the drain pipe (2-1-3) passes through the solvent cup rack (1-3) and extends into the constant temperature water The liquid tank top plate (2-1-5) is arranged on the top surface of the liquid collecting tank (2-1-2), and the liquid tank top plate (2-1-5) is assembled with the liquid collecting tank (2-1-2) through fasteners; the water area base (2-1-6) is fixed to the top surface of the liquid tank top plate (2-1-5) and is arranged in a horizontal array, a solvent inlet (2-1-6-1) is provided at the center of the water area base (2-1-6), one end of the solvent inlet (2-1-6-1) is connected to a solvent inlet connector (2-1-6-2), a water area water inlet (2-1-6-3) is provided on one side of the water area base (2-1-6), and the water area water inlet ( The water area upper cover (2-1-7) is provided on the top surface of the water area base (2-1-6); a cover fixing hole (2-1-7-1) is provided at the center of the water area upper cover (2-1-7); a water area outlet (2-1-7-2) is provided on one side of the water area upper cover (2-1-7); the water area outlet (2-1-7-2) is connected to the water area outlet connector (2-1-7-3); knob fixing cylinders (2-1-7-4) are provided on both sides of the top surface of the water area upper cover (2-1-7); the knob (2-1-8) is plug-connected to the knob fixing cylinder (2-1-7-4);The support rod (2-1-9) is arranged on both sides of the outer wall of the water area base (2-1-6), the bottom end of the support rod (2-1-9) is vertically fixed to the liquid tank top plate (2-1-5), and the top end of the support rod (2-1-9) is vertically fixed to the bottom surface of the water area cover (2-1-7); the side fixing plates (2-1-10) are arranged on both sides of the liquid tank top plate (2-1-5) in a symmetrical arrangement, and the bottom end of the side fixing plate (2-1-10) on each side is fixed to the liquid tank top plate (2-1-5) by fasteners; the shield connection block (2-1-11) is arranged on the top side of the side fixing plate (2-1-10) on each side, and is connected to the liquid tank top plate (2-1-5) by fasteners. The two ends of the mask fixing rod (2-1-12) are rotatably connected to the mask connecting blocks (2-1-11) on both sides via a rotating shaft; the circulation pool mask (2-1-13) is attached to the side wall of the mask connecting block (2-1-11), and the circulation pool mask (2-1-13) is assembled with the mask fixing rod (2-1-12) via fasteners; the circulation pool back plate (2-1-14) is arranged on one side of the circulation pool (2-2), and the two sides of the circulation pool back plate (2-1-14) are assembled with the two side fixing plates (2-1-10) via fasteners.

3. A flow cell method drug dissolution open-loop sampling system according to claim 2, characterized in that: The circulating heating system (4) further comprises a water tank outlet pipe (4-3), a water circulation main pipe (4-4), a diversion tee (4-5), a diversion pipe (4-6), a return branch pipe (4-7), a water supply tee (4-8), a water supply pipe (4-9), a water supply stop valve (4-10), a side branch tee (4-11) and a bypass pipe (4-12); one end of the water tank outlet pipe (4-3) is connected to the bottom end of the constant temperature water tank (1-2), and one end of the water tank outlet pipe (4-3) is connected to the suction end of the water circulation pump (4-2); one end of the water circulation main pipe (4-4) is connected to the output end of the water circulation pump (4-2), and one end of the water circulation main pipe (4-4) is connected to the diversion tee (4-5); one end of each of the diversion pipes (4-6) is connected to the diversion tee (4-5). One end of the diversion pipe (4-6) is plugged into each of the water inlet joints (2-1-6-4) of the water area through a manifold; both ends of each of the return branch pipes (4-7) are connected to a side hole of the liquid collecting tank (2-1-2-1) and a water outlet joint (2-1-7-3) of the water area; the water supply tee (4-8) is arranged on the water tank outlet pipe (4-3), the water supply pipe (4-9) is connected to one end of the water supply tee (4-8), the water supply stop valve (4-10) is arranged on the water supply pipe (4-9), the side branch tee (4-11) is arranged on the water circulation main pipe (4-4), one end of the bypass pipe (4-12) is connected to the side branch tee (4-11), and one end of the bypass pipe (4-12) is connected to one side of the constant temperature water tank (1-2).

4. The open-loop sampling system for drug dissolution using a flow cell method according to claim 1, characterized in that: The heating device (4-1) comprises a heating fixing plate (4-1-1), a heating wire (4-1-2), a connector (4-1-3), a direct connector (4-1-4), a connecting wire (4-1-5), a solvent inlet pipe (4-1-6), a solvent outlet pipe (4-1-7) and a heating shield (4-1-8); the heating fixing plate (4-1-1) is embedded in the top surface of the solvent cup rack (1-3); the heating wire (4-1-2) is arranged on the constant temperature water tank (1 -2), one end of each heating wire (4-1-2) extends through the heating fixing plate (4-1-1) and is plugged and fixed with the connecting head (4-1-3); the connecting wire (4-1-5) is arranged on the top surface of the heating fixing plate (4-1-1), and the two ends of the connecting wire (4-1-5) are plugged and fixed through the connecting head (4-1-3); the plug connector of the connecting wire (4-1-5) and the plug connector of the heating wire (4-1-2) are respectively connected to the direct connector The two ends of (4-1-4) are threadedly fixed to realize the connection between the connecting wire (4-1-5) and the heating wire (4-1-2); the solvent inlet pipe (4-1-6) is arranged in the constant temperature water tank (1-2), and one end of each solvent inlet pipe (4-1-6) extends through the heating fixing plate (4-1-1) and is plugged and fixed with the connector (4-1-3); the solvent outlet pipe (4-1-7) is arranged in the constant temperature water tank, and each solvent outlet pipe (4-1-8) is connected to the heating fixing plate (4-1-1). One end of the outlet pipe (4-1-7) extends through the heating fixed plate (4-1-1) and is plugged and fixed to the connector (4-1-3); the bottom end of the solvent inlet pipe (4-1-6) is connected to the bottom end of the solvent outlet pipe (4-1-7); the heating shield (4-1-8) is buckled on the top surface of the heating fixed plate (4-1-1), and one end of the heating shield (4-1-8) is rotated with the constant temperature water tank frame (1-1) through a movable hinge.

5. The open-loop sampling system for drug dissolution using a flow cell method according to claim 4, characterized in that: The solvent monitoring system (5) comprises a detection rack (5-1), a three-way valve island (5-2), a lubricating valve island (5-3), a pressure valve (5-4), a photoelectric switch (5-5), a flow guide tube (5-6) and a temperature sensor (5-7); the detection rack (5-1) is arranged on the top surface of the heating shield (4-1-8), and the detection rack (5-1) and the heating shield (4-1-8) are fixedly arranged; the three-way valve island (5-2) is arranged at one end inside the detection rack (5-1), and the three-way valve island (5-2) is supported and fixed by a first bracket (5-8); the lubricating valve island (5-3) is arranged The lubricating valve island (5-3) is placed at one end of the interior of the detection frame (5-1), and is supported and fixed by a second bracket (5-9); the pressure valve (5-4) is arranged at the middle end of the interior of the detection frame (5-1) and is arranged on one side of the three-way valve island (5-2); a pressure valve fixing block (5-4-1) is provided on the outside of the pressure valve (5-4), the pressure valve (5-4) is embedded in the pressure valve fixing block (5-4-1), and the pressure valve fixing block (5-4-1) is fixedly supported by a third bracket (5-10); the photoelectric switch (5-5) is arranged inside the detection frame (5-1). The photoelectric switch (5-5) is fixed to the detection frame (5-1) through a pipe clamp (5-11); the guide pipe (5-6) is arranged at the top end of the detection frame (5-1) and is arranged on one side of the lubricating valve island (5-3); the guide pipe (5-6) is fixedly supported by a fourth bracket (5-12); the temperature sensor (5-7) is vertically fixed to the bottom end of the guide pipe (5-6), and the end of the temperature sensor (5-7) extends into the interior of the guide pipe (5-6); the solvent outlet pipe (4-1-7) is fixed to the detection frame (5-1) through a pipe clamp (5-11); the solvent outlet pipe (5-6) is fixed to the detection frame (5-1) through a pipe clamp (5-11); the photoelectric switch (5-5 ... The pipe extends into the detection frame (5-1) and is connected to the inlet end of the corresponding three-way valve island (5-2); the side outlet of the three-way valve island (5-2) is connected to one end of the corresponding pressure valve (5-4) through a pipe; the other end of the pressure valve (5-4) is connected to the pipe, and the pipe is embedded in the pipe clamp (5-11); the top outlet of the three-way valve island (5-2) is connected to the bottom end of the corresponding lubricating valve island (5-3) through a pipe; one end outlet of the lubricating valve island (5-3) is connected to a waste liquid bucket through a pipe, and one end outlet of the lubricating valve island (5-3) is connected to the corresponding guide pipe (5-6) through a pipe.

6. The open-loop sampling system for drug dissolution using a flow cell method according to claim 5, characterized in that: The detection rack (5-1) includes a rack bottom plate (5-1-1), rack side plates (5-1-2), a rack back plate (5-1-3), a rack cover plate (5-1-4) and a rack handle (5-1-5). The rack side plates (5-1-2) are symmetrically arranged on both sides. The top and bottom edges of each rack side plate (5-1-2) are bent. The bottom sides of the two rack side plates (5-1-2) are fixed to the top surface of the heating mask (4-1-8). The rack bottom plate (5-1-1) is arranged between the bottom sides of the two rack side plates (5-1-2) and is fixed to the two rack side plates (5-1-2). A rack bottom plate through hole (5-1-1-1) is provided on one side of the surface of the rack bottom plate (5-1-1). The cross section of the rack back plate (5-1-3) is in a "C" - shaped structure. The rack back plate (5-1-3) is arranged at one end of the two rack side plates (5-1-2) and is fixed to the two rack side plates (5-1-2). The rack cover plate (5-1-4) is buckled on the top side of the rack side plates (5-1-2), and the two sides of the rack cover plate (5-1-4) are fixed to the top sides of the two rack side plates (5-1-2). The rack handle (5-1-5) is arranged on one side of one rack side plate (5-1-2) and is perpendicularly fixed to the rack side plate (5-1-2).

7. The open-loop sampling system for drug dissolution using a flow cell method according to claim 5, characterized in that: The solvent switching system (6) comprises a solvent bottle rack (6-1), a solvent bottle water tank (6-2), a solvent bottle limiting plate (6-3), a solvent bottle (6-4), a support frame (6-5), a back connecting piece (6-6), a top cross bar (6-7), a top connecting piece (6-8), a locking block (6-9), a locking rod (6-10), a fixed support rod (6-11), a movable support rod (6-12), a locking device (6-13) and a liquid collection needle (6-14); the solvent bottle water tank (6-2) is placed in the solvent bottle rack (6-1); the solvent bottle limiting plate (6-3) is arranged on the top surface of the solvent bottle rack (6-1), and the solvent bottle limiting plate (6-3) is connected to the solvent bottle rack through a fastener. (6-1) is fixedly arranged, and a limiting plate hole (6-3-1) is provided on the surface of the solvent bottle limiting plate (6-3); the solvent bottle (6-4) passes through the limiting plate hole (6-3-1) and is placed in the solvent bottle water tank (6-2); the support frame (6-5) is arranged on one side of the top surface of the solvent bottle rack (6-1) and is fixedly arranged vertically with the solvent bottle rack (6-1); the back connecting piece (6-6) is arranged at the top end of the support frame (6-5), and one side of the back connecting piece (6-6) is fixed to the support frame (6-5) by a fastener; the top cross bar (6-7) is horizontally arranged at the top end of the solvent bottle rack (6-1), and one side of the top cross bar (6-7) is fixed to the support frame (6-5); The side of the back connecting piece (6-6) is fixed to one side of the back connecting piece (6-6) by a fastener; the top connecting piece (6-8) is arranged on the top surface of the top cross bar (6-7), and the top side of the top connecting piece (6-8) is fixed to the bottom surface of the top cross bar (6-7) by a fastener; the locking block (6-9) is fitted on the bottom surface of one side of the top connecting piece (6-8), and one side of the locking block (6-9) is fixed to one side of the top connecting piece (6-8); the locking rod (6-10) passes through the locking block (6-9) and the top connecting piece (6-8), so that the locking rod (6-10) and the locking block (6-9) are slidable; the fixed support rod (6-11) is arranged on the The side wall of the top cross bar (6-7), the fixed support rod (6-11) and the top cross bar (6-7) are vertically fixed; the movable support rod (6-12) is arranged at one end of the fixed support rod (6-11), and the movable support rod (6-12) and the fixed support rod (6-11) are rotatable through a rotating shaft; the locker (6-13) is arranged at the end of the movable support rod (6-12), and the locker (6-13) and the movable support rod (6-12) are fixed; the liquid collection needle (6-14) longitudinally penetrates the locker (6-13) and extends into the solvent bottle (6-4), and the liquid collection needle (6-14) and the locker (6-13) are detachable.

8. The open-loop sampling system for drug dissolution using a flow cell method according to claim 7, characterized in that: The solvent mixer (7-2) comprises a mixer base (7-2-1), a mixer side frame (7-2-2), a mixer top plate (7-2-3), a mixing cylinder (7-2-4) and a mixer top plug (7-2-5), wherein the mixer base (7-2-1) is fixed to the top surface of the solvent mixing seat (7-1); the mixer side frame (7-2-2) is arranged on the top surface of the solvent mixing seat (7-1) and wrapped around the outside of the solvent mixing seat (7-1); the mixer The mixer top plate (7-2-3) is fixedly arranged on the top end of the mixer side frame (7-2-2), the mixing cylinder (7-2-4) is arranged in the mixer side frame (7-2-2), the bottom end of the mixing cylinder (7-2-4) is sealed and fixed to the mixer base (7-2-1), and the top end of the mixing cylinder (7-2-4) is sealed and fixed to the mixer top plate (7-2-3); the mixer top plug (7-2-5) is embedded in the center of the mixer top plate (7-2-3).

9. The open-loop sampling system for drug dissolution using a flow cell method according to claim 8, characterized in that: The solvent circulation system also includes a first solvent tube (8-3), a second solvent tube (8-4), a third solvent tube (8-5), a fourth solvent tube (8-6), a fifth solvent tube (8-7), a sixth solvent tube (8-8) and a seventh solvent tube (8-9); one end of the first solvent tube (8-3) is connected to the liquid collection needle (6-14) and extends into the corresponding solvent bottle (6-4), and one end of the first solvent tube (8-3) is connected to the suction end of the solvent suction pump (7-3); one end of the second solvent tube (8-4) is connected to the output end of the solvent suction pump (7-3), and one end of the second solvent tube (8-4) passes through the mixer top plug (7-2-5) and extends into the mixing barrel (7-2-4); one end of the third solvent tube (8-5) passes through the mixer top plug (7-2-5) and extends into the mixing barrel (7-2-4), One end of the third solvent tube (8-5) is connected to the suction end of the solvent circulation pump (8-1); one end of the fourth solvent tube (8-6) is connected to the output end of the solvent circulation pump (8-1), and one end of the fourth solvent tube (8-6) is connected to the input end of the pulse valve (8-2); one end of the fifth solvent tube (8-7) is connected to the output end of the pulse valve (8-2), and one end of the fifth solvent tube (8-7) is connected to the solvent inlet tube (4-1-6); one end of the sixth solvent tube (8-8) is connected to one end of the guide tube (5-6), and one end of the sixth solvent tube (8-8) is connected to the solvent inlet (2-1-6-1) of the circulation pool (2-2); one end of the seventh solvent tube (8-9) is connected to the top end of the circulation pool (2-2), and one end of the seventh solvent tube (8-9) is connected to the sampling valve (9-3) and connected to the waste liquid barrel.

10. A method for using a flow cell drug dissolution open-loop sampling system according to any one of claims 1 to 9, characterized in that: Here are the steps: (1) Fix the drug support structure in the circulation pool (2-2), insert the circulation pool (2-2) into the upper cover fixing hole (2-1-7-1), plug and fix the bottom end of the circulation pool (2-2) to the solvent inlet connector (2-1-6-2), and then rotate the knob (2-1-8) to buckle the knob fixing piece (2-1-8-1) to the end of the circulation pool (2-2); connect one end of the circulation pool (2-2) to one end of the first solvent tube (8-3), so that the circulation pool (2-2) is connected to the solvent circulation system (8); (2) Start the adjustment lifting mechanism (3), lower the lifting mechanism (3) to the lowest point, the lifting mechanism (3) drives the circulation pool system (2) to the lowest point, and the solvent cup cover is pressed down to fit the solvent cup hole; (3) Start heating the heating wire (4-1-2), and the heating wire (4-1-2) heats the water in the constant temperature water tank (1-2); (4) Start the water circulation pump (4-2), and the water in the constant temperature water tank (1-2) is sucked into the suction end of the water circulation pump (4-2) through the water tank outlet pipe (4-3). Through the pumping action of the water circulation pump (4-2), the water flows into the diversion pipe (4-6) through the diversion tee (4-5), and then enters the glass tube (2-3) through the water inlet (2-1-6-3) of the water area through the manifold. After the glass tube (2-3) is filled, it is injected into the collecting tank (2-1-2) from the reflux branch pipe (4-7). The water in the collecting tank (2-1-2) is re-injected into the constant temperature water tank (1-2) through the drain pipe (2-1-3); (5) Start the solvent suction pump (7-3), suck the solvent in the corresponding solvent bottle (6-4) through the first solvent tube (8-3) and the second solvent tube (8-4) into the mixing cylinder (7-2-4) for mixing, and detect the pH value through the sensor in the mixing cylinder (7-2-4); (6) Connect one outlet end of the lubricating valve island (5-3) directly to the waste liquid barrel through the conduit; start the solvent circulation pump (8-1), and the solvent in the mixing cylinder (7-2-4) is sucked into the suction end of the solvent circulation pump (8-1) through the third solvent pipe (8-5). Through the pumping action of the solvent circulation pump (8-1), the solvent is sent to the pulse valve (8-2) through the fourth solvent pipe (8-6). The pulse valve (8-2) performs a pulse conveying action on the solvent to simulate the blood circulation of the human body. The solvent enters the constant temperature water tank (1-2) through the fifth solvent pipe (8-7) for heat exchange. The solvent flows through the heating device (4-1) and the solvent monitoring system (5), and the solvent is directly discharged into the waste liquid barrel; at the same time, the solvent is filled in the guide pipe (5-6), and the temperature of the solvent is monitored; (7) When the temperature sensor (5-7) monitors that the temperature of the solvent reaches 37°C, the output end of the flow guide tube (5-6) is connected to the solvent inlet (2-1-6-1) of the circulation pool (2-2) through the sixth solvent tube (8-8); the solvent flowing into the solvent monitoring system (5) passes through the lubrication valve island (5-3) and flows into the bottom end of the circulation pool (2-2) through the sixth solvent tube (8-8). After the solvent and the drug are flushed, it flows through the seventh solvent tube (8-9) through the sampling valve (9-3) and is discharged into the waste liquid barrel; (8) Adjust the sampling valve (9-3), the solvent in the seventh solvent tube (8-9) switches through the sampling valve (9-3) and flows into the sampling pipe (9-2), and performs instantaneous sampling in the sampling mechanism (9-1). After the sampling is completed, the solvent continues to be discharged into the waste liquid barrel when the sampling valve (9-3) is adjusted.

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