Microsphere release test system

Abstract

The invention discloses a microsphere release test system, which comprises a microsphere release instrument host, an injection sampling pump, a sample collector and a fluid infusion storage station, the microsphere release instrument host comprises a rack shell, a water tank, a sealed sample tube, a stirring driving device, a temperature control device and a water level control device, and the temperature control device heats water in the water tank; the water level control device is used for supplementing water in the water tank; a tube plate is arranged on the rack shell, a plurality of tube holes used for installing and sealing sample tubes are formed in the tube plate, and an anti-floating device is arranged at the position, located at each tube hole, of the bottom of the tube plate; a stirrer is arranged in the sealed sample tube and is driven by a stirring driving device to rotate; a sealing cover is arranged on the sealing sample tube, an injection hole, a sampling hole, an air inlet hole, a liquid supplementing hole and a temperature probe insertion hole are formed in the sealing cover, a sampling needle and a liquid supplementing needle are embedded into the sampling hole and the liquid supplementing hole respectively, and one end of the sampling needle and one end of the liquid supplementing needle are connected with an injection sampling pump through pipelines respectively; the injection sampling pump is respectively connected with the sample collector and the fluid infusion storage station through pipelines, so that automation and standardization are realized, the requirements of microsphere release degree detection are met, the test sampling efficiency is improved, and the labor cost is reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of drug dissolution testing, and in particular relates to a testing system for microsphere release. Background Art

[0002] Microspheres refer to tiny spherical entities formed by dissolving or dispersing drugs in a polymer matrix, such as risperidone microspheres, leuprorelin acetate microspheres, etc. As long-acting sustained-release preparations, microspheres are administered subcutaneously or intramuscularly to slowly release drugs over a certain period of time, maintain effective blood drug concentrations in the body for a long time, avoid peaks and valleys in blood drug concentrations, reduce toxic side effects, significantly reduce the number of dosing times, and improve patient compliance, thus gradually becoming a hot research topic in modern pharmacy.

[0003] The release rate detection of microspheres is a very important aspect of the entire drug development process and is a key indicator for drug evaluation and quality control. However, due to the lack of standardized in vitro release guidance methods and the lack of mature in vitro and in vivo correlation models, the development of in vitro release methods for microspheres is limited. Researchers generally use self-designed methods to make the in vitro release conditions simulate the in vivo conditions as much as possible to predict the release behavior of microspheres in vivo.

[0004] At present, commonly used methods for in vitro release of microspheres include flow cell method, dialysis method and shake bottle method.

[0005] The flow cell method is included in the USP, EP and JP pharmacopoeias and is a new dissolution method designed for poorly soluble and sustained-release drug preparations. However, due to the high price, low throughput and cumbersome operation of the instrument, the instrument is not widely used in microsphere quality control.

[0006] The dialysis method is to place the drug microspheres into a dialysis bag and place them in the corresponding medium for testing. This method can avoid the loss of microspheres during the sampling process. However, the dialysis membrane may hinder the diffusion of the drug, so that the release of the drug is restricted by the membrane. On the other hand, if the released drug cannot pass through the dialysis bag immediately, there will be a problem that the free drug in the dialysis bag is difficult to meet the leakage conditions, further affecting the release rate of the microspheres.

[0007] The shake bottle method is currently a common method for measuring the in vitro release of microspheres, which involves placing a certain amount of microspheres directly into a certain volume of medium, oscillating at a certain frequency, or leaving it to stand (shaking the solution to make it uniform before sampling), taking samples at regular intervals, and replenishing the corresponding fresh medium at the same time. This method has the advantages of high throughput and low cost. However, due to the lack of standardized equipment, the size or shape of the bottle / centrifuge tube used, the height of the sampling position, etc. may affect the release results. At the same time, due to the long in vitro release time of the microspheres, manual sampling for a long time and at regular intervals is required, which increases labor costs. Summary of the invention

[0008] In view of the above problems, the present invention discloses a microsphere release test system. Based on the existing technical conditions, the present invention designs and manufactures an automated, standardized and universal equipment device according to the detection method of the shake bottle method. Within a controllable temperature range and at a controllable stirring speed, the microsphere product is released and sampled in 24 sealed sample pools, solving the problem that the test system in the prior art cannot be applied to the microsphere release detection.

[0009] The specific technical solutions are as follows: The microsphere release test system comprises a microsphere release instrument host, an injection sampling pump, a sample collector and a rehydration storage station. The microsphere release instrument host comprises a frame shell, a water tank, a sealed sample tube, a stirring drive device, a temperature control device and a water level control device. The water tank is arranged in the middle of the frame shell; the temperature control device is used to heat the water in the water tank; the water level control device is used to rehydration the water in the water tank; a detachable and replaceable tube sheet is horizontally arranged at the upper end of the frame shell, a plurality of tube holes for installing the sealed sample tube are opened on the tube sheet, and an anti-floating device is arranged at each tube hole at the bottom of the tube sheet to prevent the sealed sample tube from floating in the water tank; the lower end of the sealed sample tube is embedded in the tube hole and enters the water tank, and the sealed sample tube is A stirring bar is placed, and the stirring bar in each sealed sample tube is driven to rotate by a stirring driving device arranged at the lower end of the frame shell; a detachable sealing cover is provided at the upper end of the sealed sample tube, and an injection hole, a sampling hole, an air inlet, a refill hole and a temperature probe jack are provided on the sealing cover, and the sampling hole and the refill hole are respectively used to embed a sampling needle and a refill needle, and one end of the sampling needle and the refill needle are respectively connected to an injection sampling pump through pipelines, and the injection sampling pump is respectively connected to a sample collector and a refill storage station through pipelines, and the injection sampling pump takes samples from the sealed sample tube through the sampling needle and transports the samples to the sample collector to achieve sampling; the active injection sampling pump draws refill through the refill storage station and injects it into the sample collector through the refill needle to achieve refill.

[0010] Furthermore, the temperature control device includes an outer shell, a circulation pump, a heating pipe, a temperature measuring probe, a water inlet pipe and a water outlet pipe. The outer shell is arranged at the rear end of the frame shell, and the circulation pump and the heating pipe are arranged in the shell. The water inlet end of the circulation pump is connected to the bottom of the water tank through the water inlet pipe, and the water outlet end of the circulation pump is connected to the heating pipe through a pipeline. One end of the heating pipe is connected to the side wall of the water tank through the water outlet pipe, and a temperature measuring probe is arranged in the heating pipe. The temperature measuring probe is used to monitor and control the temperature of water entering the water bath.

[0011] Furthermore, the water level control device includes a mounting frame, a liquid replenishment tank, a liquid replenishment pipe, and a liquid level sensor. The liquid replenishment tank is arranged above the rear end of the frame shell through the mounting frame. The bottom pipe opening of the liquid replenishment tank is connected to one end of the liquid replenishment pipe through a switch valve. The other end of the liquid replenishment pipe penetrates downward through the tube plate and enters the water tank. A liquid level sensor is arranged on the inner wall of the water tank to detect the water level of the water tank.

[0012] Furthermore, a heat preservation cover is hingedly provided at the upper end of the frame shell, and the heat preservation cover is arranged on the tube plate, so that a closed heat chamber is formed between the inner side of the heat preservation cover and the upper end of the tube plate.

[0013] Furthermore, the anti-floating device includes fasteners and O-rings. The fasteners are in multiple numbers and are evenly distributed on the outside of the tube hole. The O-rings are sleeved on the outside of the multiple fasteners and are polygonal in shape. The sides of the O-rings extend to the bottom of the tube hole and are fitted with the outer wall of the sealed sample tube to achieve positioning.

[0014] Furthermore, the tube sheet is placed on the upper end of the frame shell, handles are provided on both sides of the upper end of the tube sheet, and a plurality of positioning grooves are opened at one end of the tube sheet. The positioning grooves cooperate with the positioning columns provided at one end of the top of the frame shell to realize the horizontal positioning of the tube sheet.

[0015] Furthermore, there are several stirring drive devices, which are respectively arranged on the mounting plate at the bottom end of the frame shell, each stirring drive device corresponds to the position of a sealed sample tube, and the stirring drive device includes a stirring motor, a connecting seat arranged on the output end of the stirring motor, and magnets arranged on both sides of the upper end of the connecting seat. The magnets are arranged close to the bottom of the water tank, and the two magnets are driven to rotate by the stirring motor, thereby driving the stirring bar in the sealed sample tube to rotate.

[0016] Furthermore, a sealing portion for embedding in the upper opening of the sealed sample tube is provided at the bottom of the sealing cover, and a sealing ring is sleeved outside the sealing portion, so that the sealing portion is sealed by pressing and fitting with the inner wall of the sealed sample tube through the sealing ring.

[0017] Furthermore, a control system is integrated in the injection sampling pump, and the control system includes a PLC controller and a touch display screen. The PLC controller is electrically connected to the touch display screen, the stirring drive device, the temperature control device, the water level control device, the injection sampling pump and the temperature probe jack.

[0018] The test method of the microsphere release test system specifically includes the following steps: S1. Preparation. First, heat the water in the water tank to a constant temperature through a temperature control device, then insert the sealed sample tubes into the tube holes of the tube plate one by one, add a solvent medium and a stirrer into each sealed sample tube, weigh a certain amount of microspheres and inject them into the sealed sample tube, then cover the sealing cover and place the sampling needle and the rehydration needle into the sampling hole and the rehydration hole, and finally close the insulation cover; S2, stirring, the test system is controlled by the touch screen, and the stirring drive device drives the stirring bar in each sealed sample tube to rotate and stir; S3, sampling, when the sampling time point is reached, sampling begins after the stirrer stops stirring for a period of time, and the injection sampling pump extracts the mixed solution in the sealed sample tube through the sampling needle and transports it to the sample collector to complete the sampling; S4, after the rehydration and sampling are completed, the syringe sampling pump transports the extracted solvent medium in the rehydration storage station to the sealed sample tube through the pipeline to complete the rehydration, and repeat steps S3 and S4; S5. Cleaning and testing After the test is completed, clean the sealed sample tube, sealing cover and the pipeline of the injection sampling pump.

[0019] The beneficial effects of the present invention are embodied in: During the testing process of the testing system of the present invention, all sealed samples are placed in a temperature-controllable water bath, and sampling is automatically performed at the set time interval and temperature. After the samples are taken out, the culture medium is automatically replaced, thereby realizing automation and standardization, meeting the needs of microsphere release detection, improving the test sampling efficiency, and reducing labor costs.

[0020] The microsphere release instrument of the present invention meets the testing requirements of different types of microsphere products, adopts water circulation online heating to accurately control the water temperature, and is equipped with an automatic water replenishing device to prevent the liquid level in the water tank from decreasing due to evaporation, thereby ensuring the test quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a structural schematic diagram of the present invention.

[0022] Figure 2 This is a three-dimensional diagram of the microsphere releaser host of the present invention after removing the insulation cover.

[0023] Figure 3 This is a top view of the microsphere releaser host of the present invention after removing the insulation cover.

[0024] Figure 4 It is a structural schematic diagram of the tube plate in the present invention.

[0025] Figure 5 It is a schematic structural diagram of the anti-floating device in the present invention.

[0026] Figure 6It is a cross-sectional view between the sealed sample tube and the stirring driving device in the present invention.

[0027] Figure 7 It is a schematic diagram of the structure of the sealing cover in the present invention.

[0028] Figure 8 It is a schematic diagram of the structure of the temperature control device in the present invention.

[0029] Fig. 9 It is a structural schematic diagram of the water level control device in the present invention.

[0030] Description of reference numerals: microsphere release instrument main unit 1, injection sampling pump 2, touch display screen 21, sample collector 3, rack housing 4, heat preservation cover 41; Water tank 5, tube sheet 51, tube hole 52, fastener 53, O-ring 54, handle 55, positioning groove 56; Sealed sample tube 6, sealing cover 61, sealing portion 62, sealing ring 63, injection hole 64, sampling hole 65, air inlet hole 66, liquid replenishment hole 67, temperature probe jack 68; Stirring drive device 7, mounting plate 71, stirring motor 72, connecting seat 73, magnet 74, stirring rod 75; Temperature control device 8, outer shell 81, circulation pump 82, heating tube 83, temperature measuring probe 84, water inlet pipe 85, water outlet pipe 86; Water level control device 9, mounting frame 91, liquid replenishing tank 92, switch valve 93, liquid replenishing pipe 94. DETAILED DESCRIPTION

[0031] In order to make the technical solution of the present invention clearer, the present invention is further described below in conjunction with 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 protection scope of the present invention. The fixed connection and fixed setting mentioned in the present invention are all common connection methods in the mechanical field, including welding, bolt and nut connection, and screw connection.

[0032] In the description of the present invention, it should be understood that the terms "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" etc. indicating directions or positional relationships are based on the directions or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as a limitation on the present invention.

[0033] See also Figure 1-9This embodiment provides a microsphere release test system, which can test the microsphere release while meeting the specifications. The microsphere product is released and sampled in 24 sealed sample tubes 6 at a controllable temperature range and a controllable stirring speed. During the test, all sealed samples are placed in a temperature-controlled water bath, and samples are taken at set time intervals and temperatures. The culture medium is replaced after the samples are taken out, and the system is equipped with an automatic water replenishment device to prevent the liquid level in the water tank 5 from decreasing due to evaporation.

[0034] The test system includes a microsphere releaser main unit 1, an injection sampling pump 2, a sample collector 3 and a rehydration storage station. The microsphere releaser main unit 1 includes a frame shell 4, a water tank 5, a sealed sample tube 6, a stirring drive device 7, a temperature control device 8, and a water level control device 9. The water tank 5 is arranged in the middle of the frame shell 4; the temperature control device 8 is used to heat the water in the water tank; the water level control device 9 is used to rehydration the water in the water tank; a tube plate 51 is horizontally arranged at the upper end of the frame shell 4. In this embodiment, 24 tube holes 52 for installing sealed sample tubes 6 are opened on the tube plate, so that the tube plate 51 can accommodate up to 24 sealed sample tubes 6; an anti-floating device is arranged at the bottom of the tube plate at each tube hole 52, which is used to prevent the sealed sample tube 6 from floating in the water tank and play a positioning role.

[0035] The lower end of the sealed sample tube 6 is embedded in the tube hole 52 and enters the water tank 5, and the bottom end of the sealed sample tube 6 is supported at the bottom end of the water tank 5. Before the sealed sample tube 6 is loaded with the microsphere sample, a stirrer 75 is first loaded into each tube, and the stirrer 75 in each sealed sample tube 6 is driven to rotate by the stirring driving device 7 arranged at the lower end of the frame shell 4. A detachable sealing cover 61 is provided at the upper end of the sealed sample tube 6, and a sealing portion 62 for embedding the upper end opening of the sealed sample tube 6 is provided at the bottom of the sealing cover 61. A sealing ring 63 is sleeved on the outer side of the sealing portion, so that the sealing portion is pressed and matched with the inner wall of the sealed sample tube 6 through the sealing ring 63 to achieve sealing to prevent evaporation. The sealing cover 61 is provided with an injection hole 64, a sampling hole 65, an air inlet hole 66 with a one-way valve, a refill hole 67, and a socket 68 for installing a temperature probe. The sampling hole 65 and the refill hole 67 are respectively used to embed a sampling needle and a refill needle. One end of the sampling needle and the refill needle are respectively connected to the injection sampling pump 2 through pipelines. The injection sampling pump 2 is respectively connected to the sample collector 3 and the refill storage station through pipelines. The injection sampling pump 2 takes samples from the sealed sample tube 6 through the sampling needle and transports the samples to the sample collector 3 to achieve sampling. The sample collector 3 collects samples at each sampling time. The sample delivery head moves the needle to the flushing position to clean the needle, and then moves to the collection position. The sampling pump delivers the sample into the sample bottle. The active injection sampling pump 2 extracts the refill through the refill storage station and injects it into the sample collector 3 through the refill needle to achieve refill.

[0036] In this embodiment, the temperature control device 8 includes an outer shell 81, a circulation pump 82, a heating pipe 83, a temperature measuring probe 84, a water inlet pipe 85 and a water outlet pipe 86. The outer shell 81 is arranged at the rear end of the frame shell 4, and the circulation pump 82 and the heating pipe 83 are arranged in the outer shell. The water inlet end of the circulation pump 82 is connected to the bottom of the water tank 5 through the water inlet pipe 85, and the water outlet end of the circulation pump 82 is connected to the heating pipe 83 through a pipeline. One end of the heating pipe 83 is connected to the side wall of the water tank 5 through the water outlet pipe 86, and a temperature measuring probe 84 is arranged in the heating pipe 83. The temperature measuring probe 84 is used to monitor and control the water temperature entering the water bath. The heating system is water circulation online heating, and the temperature measuring probe 84 is installed in the heating pipe 83 to control the water temperature entering the water bath. This design is different from other designs in which the heater is directly installed in the water bath.

[0037] Since the release cycle of the microspheres is long, the reaction rate can be increased by increasing the temperature during the test. Therefore, the system can operate at room temperature to 70 degrees Celsius. When the temperature is high, water will evaporate. Once the water level of the water tank 5 drops, it is difficult for the medium in the sealed sample tube 6 to maintain the set temperature. In view of this problem, a water level control device 9 for the water tank 5 is designed: an additional liquid replenishment tank 92 is installed above the water tank 5. When the liquid level in the water tank 5 drops, water will be automatically injected into the water tank 5. The water level control device 9 specifically includes a mounting frame 91, a liquid replenishment tank 92, a liquid replenishment tube 94, and a liquid level sensor (not shown in the figure). The liquid replenishment water tank 5 is arranged on the outer shell 81 at the rear end of the frame shell 4 through the mounting frame 91. The bottom pipe opening of the liquid replenishment water tank 5 is connected to one end of the liquid replenishment tube 94 through the switch valve 93. The other end of the liquid replenishment tube 94 penetrates the tube plate 51 downward and enters the water tank. A liquid level sensor is arranged on the inner wall of the water tank to detect the water level of the water tank. When the water level is lower than the set value, the control system controls the switch valve 93 to open and inject water into the water tank 5.

[0038] The upper end of the frame shell 4 is hinged with an insulation cover 41, which is covered on the tube sheet 51, and a closed heat chamber is formed between the inner side of the insulation cover 41 and the upper end of the tube sheet 51. In order to keep the water temperature stable, the heat chamber on the water tank 5 separates the contact between the hot water tank 5 and the air and reduces water evaporation.

[0039] In this embodiment, the anti-floating device includes fasteners 53 and O-rings 54. There are three fasteners 53 and they are evenly distributed on the periphery of the tube hole 52. The O-rings 54 are sleeved on the outer sides of the three fasteners 53. The O-rings 54 are elastic and are equilaterally shaped. The sides of the O-rings 54 extend to the bottom of the tube hole 52 and fit the O-rings 54 against the outer wall of the sealed sample tube 6. The tension of the O-rings 54 is used to achieve positioning to prevent the sealed sample tube 6 from floating in the water tank 5 under the buoyancy of the water.

[0040] Since different types of microsphere products need to be tested in glass tubes of different capacities, the tube sheet 51 is detachable and replaceable, and the sizes of the tube holes 52 on different tube sheets 51 are different, so as to be used with sealed sample tubes 6 of different capacities. The tube sheet 51 is placed on the upper end of the rack housing 4, and can also be fixed to the rack housing 4 by fasteners 53. Handles 55 are provided on both sides of the upper end of the tube sheet 51, and a plurality of positioning grooves 56 are provided at one end of the tube sheet 51. The positioning grooves 56 cooperate with the positioning columns provided at one end of the top of the rack housing 4 to realize the horizontal positioning of the tube sheet 51. During operation, the tube sheet 51 located on the water tank 5 can be conveniently replaced by lifting the two handles 55.

[0041] There are 24 stirring drive devices 7 and they are respectively arranged on the mounting plate 71 at the bottom end of the frame shell 4. Each stirring drive device 7 corresponds to the position of a sealed sample tube 6. The stirring drive device 7 includes a stirring motor 72, a connecting seat 73 arranged on the output end of the stirring motor 72, and magnets 74 arranged on both sides of the upper end of the connecting seat 73. In this embodiment, the stirring motor 72 is a speed-controlled motor with a controllable stirring speed of 0 to 1000 revolutions per minute. The magnet 74 is arranged close to the bottom of the water tank 5, and the two magnets 74 are driven to rotate by the stirring motor 72, thereby driving the stirring rod 75 in the sealed sample tube 6 to rotate for stirring.

[0042] In this embodiment, the injection sampling pump 2 includes 4 injection pumps, each of which has a driving motor, and each motor drives 6 syringes. There are 4 injection pumps in the system, which can drive 24 syringes to inject samples and rehydration into 24 glass tubes. There is a four-way valve under each syringe, one of which is connected to the syringe, and the other three are used to pull in samples, transport samples to the collector, and replace rehydration. According to different needs, 1 to 4 injection pumps can be installed. The specific structure and use method of the injection sampling pump 2 and the sample collector 3 used in the present invention have been disclosed in Patent No.: CN202010907775.2, which is the prior art and will not be repeated here.

[0043] A control system is integrated in the injection sampling pump 2 to control the operation of all equipment. The control system includes a PLC controller and a touch display screen 21. The touch display screen 21 is arranged at the front end of the injection sampling pump 2 and is used to display the control program and the user interface. The PLC controller is electrically connected to the touch display screen 21, the stirring drive device 7, the temperature control device 8, the water level control device 9, the injection sampling pump 2 and the temperature probe jack 68 respectively.

[0044] This embodiment also discloses a test method for a microsphere release test system, which specifically includes the following steps: Preparation: First, heat the water in the water tank 5 to a constant temperature ranging from room temperature to 70°C through the temperature control device 8, then embed the sealed sample tubes 6 into the tube holes 52 of the tube plate 51 one by one, and add the solvent medium and the stirring bar 75 to each sealed sample tube 6, weigh a certain amount of microspheres and inject them into the sealed sample tube 6, then cover the sealing cover 61 and place the sampling needle and the rehydration needle into the sampling hole 65 and the rehydration hole 67, and finally close the insulation cover 41.

[0045] Stirring, the test system is controlled to run by the touch display screen 21, and the stirring driving device 7 drives the stirring rod 75 in each sealed sample tube 6 to rotate and stir.

[0046] Sampling, because the microspheres are very small, once the drug is released from the microspheres, it cannot be observed by the naked eye. In most cases, the drug sample and the microspheres are mixed in a solution. In order to sample from this mixed solution, the program must stop stirring for a period of time before sampling, and then sample; when the sampling time point is reached, sampling begins after the stirrer 75 stops stirring for a period of time, and the injection sampling pump 2 extracts the mixed solution in the sealed sample tube 6 through the sampling needle and transports it to the sample collector 3 to complete the sampling.

[0047] After the rehydration and sampling are completed, the injection sampling pump 2 transports the extracted solvent medium in the rehydration storage station to the sealed sample tube 6 through the pipeline to complete the rehydration, and repeats the stirring and sampling steps at the set time interval and temperature.

[0048] After the cleaning and testing test is completed, the sealed sample tube 6, the sealing cover 61 and the pipeline of the injection sampling pump 2 are cleaned.

[0049] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A microsphere release test system, characterized in that: The invention comprises a microsphere release instrument host (1), an injection sampling pump (2), a sample collector (3) and a rehydration storage station. The microsphere release instrument host (1) comprises a frame shell (4), a water tank (5), a sealed sample tube (6), a stirring drive device (7), a temperature control device (8) and a water level control device (9). The water tank (5) is arranged in the middle of the frame shell; the temperature control device (8) is used to heat the water in the water tank; the water level control device (9) is used to rehydration the water in the water tank; a detachable and replaceable tube sheet (51) is horizontally arranged at the upper end of the frame shell (4); a plurality of tube holes (52) for installing the sealed sample tube are opened on the tube sheet (51); an anti-floating device is arranged at the bottom of each tube hole (52) for preventing the sealed sample tube (6) from floating in the water tank; the lower end of the sealed sample tube (6) is embedded in the tube hole (52) and enters the water tank; a stirring rod (75) is placed in each of the sealed sample tubes (6) ), the stirring rod (75) in each sealed sample tube (6) is driven to rotate by a stirring driving device (7) arranged at the lower end of the frame shell (4); a detachable sealing cover (61) is provided at the upper end of the sealed sample tube (6), and the sealing cover (61) is provided with an injection hole (64), a sampling hole (65), an air inlet hole (66), a liquid replenishing hole (67) and a temperature probe jack (68), and the sampling hole (65) and the liquid replenishing hole (67) are respectively used to insert A sampling needle and a rehydration needle are inserted, one end of each of the sampling needle and the rehydration needle are connected to the injection sampling pump (2) through pipelines, and the injection sampling pump (2) is connected to the sample collector (3) and the rehydration storage station through pipelines. The injection sampling pump (2) takes a sample from the sealed sample tube (6) through the sampling needle and transports the sample to the sample collector (3) to achieve sampling; the movable injection sampling pump (2) extracts the rehydration fluid through the rehydration storage station and injects it into the sample collector (3) through the rehydration needle to achieve rehydration.

2. The microsphere release test system according to claim 1, characterized in that: The temperature control device (8) comprises an outer shell (81), a circulation pump (82), a heating pipe (83), a temperature measuring probe (84), a water inlet pipe (85) and a water outlet pipe (86). The outer shell (81) is arranged at the rear end of the frame shell (4). The circulation pump (82) and the heating pipe (83) are arranged in the outer shell. The water inlet end of the circulation pump (82) is connected to the bottom of the water tank through the water inlet pipe. The water outlet end of the circulation pump (82) is connected to the heating pipe (83) through a pipeline. One end of the heating pipe (83) is connected to the side wall of the water tank (5) through the water outlet pipe (86). The temperature measuring probe (84) is arranged in the heating pipe (83). The temperature measuring probe (84) is used to monitor and control the temperature of water entering the water bath.

3. The microsphere release test system according to claim 1, characterized in that: The water level control device (9) comprises a mounting frame (91), a liquid replenishing tank (92), a liquid replenishing pipe (94), and a liquid level sensor. The liquid replenishing water tank (5) is arranged above the rear end of the frame shell (4) through the mounting frame (91). The bottom pipe opening of the liquid replenishing water tank (5) is connected to one end of the liquid replenishing pipe (94) through a switch valve (93). The other end of the liquid replenishing pipe (94) passes through the tube plate (51) and enters the water tank (5). The liquid level sensor is arranged on the water tank (5) for detecting the water level of the water tank (5).

4. The microsphere release test system according to claim 1, characterized in that: The anti-floating device comprises a fastener (53) and an O-ring (54). The fasteners (53) are in a plurality and are evenly distributed on the outside of the tube hole (52). The O-rings (54) are sleeved on the outside of the plurality of fasteners (53) so that the O-rings (54) are polygonal in shape. The side of the O-ring (54) extends to the bottom of the tube hole (52) so that the O-ring (54) fits with the outer wall of the sealed sample tube (6) to achieve positioning.

5. The microsphere release test system according to claim 1, characterized in that: The tube sheet (51) is placed on the upper end of the frame shell (4), and handles (55) are provided on both sides of the upper end of the tube sheet (51). A plurality of positioning grooves (56) are provided at one end of the tube sheet (51), and the positioning grooves (56) cooperate with positioning columns provided at one end of the top of the frame shell (4) to realize the horizontal positioning of the tube sheet (51).

6. The microsphere release test system according to claim 5, characterized in that: The upper end of the frame shell (4) is hingedly provided with a heat preservation cover (41), and the heat preservation cover (41) is covered on the tube plate (51), so that a closed heat chamber is formed between the inner side of the heat preservation cover (41) and the upper end of the tube plate (51).

7. The microsphere release test system according to claim 1, characterized in that: The stirring driving devices (7) are in a plurality and are respectively arranged on a mounting plate (71) at the bottom end of the frame shell (4). Each stirring driving device (7) corresponds to the position of a sealed sample tube (6). The stirring driving device (7) comprises a stirring motor (72), a connecting seat (73) arranged on the output end of the stirring motor (72), and magnets (74) arranged on both sides of the upper end of the connecting seat (73). The magnets (74) are arranged close to the bottom of the water tank (5), and the two magnets (74) are driven to rotate by the stirring motor (72), thereby driving the stirring rod (75) in the sealed sample tube to rotate.

8. The microsphere release test system according to claim 1, characterized in that: The bottom of the sealing cover (61) is provided with a sealing portion (62) for embedding into the upper opening of the sealed sample tube (6), and a sealing ring (63) is sleeved on the outer side of the sealing portion (62), so that the sealing portion (62) is pressed and matched with the inner wall of the sealed sample tube (6) through the sealing ring (63) to achieve sealing.

9. The microsphere release test system according to claim 1, characterized in that: The injection sampling pump (2) is integrated with a control system, the control system comprising a PLC controller and a touch display screen (21), the PLC controller being electrically connected to the touch display screen (21), the stirring drive device (7), the temperature control device (8), the water level control device (9), the injection sampling pump (2) and the temperature probe jack (68).

10. The test method of the microsphere release test system according to any one of claims 1 to 9, comprising the following steps: S1. Preparation. First, heat the water in the water tank (5) to a constant temperature through the temperature control device (8). Then, insert the sealed sample tubes into the tube holes (52) of the tube plate one by one. Add a solvent medium and a stirrer (75) into each sealed sample tube (6). Weigh a certain amount of microspheres and inject them into the sealed sample tube (6). Then, cover the sealing cover (61) and place the sampling needle and the rehydration needle into the sampling hole (65) and the rehydration hole (67). Finally, close the heat preservation cover (41). S2, stirring, controlling the operation of the test system through the touch display screen (21), and the stirring driving device (7) driving the stirring rod (75) in each sealed sample tube (6) to rotate and stir; S3, sampling, when the sampling time point is reached, sampling begins after the stirrer (75) stops stirring for a period of time, and the injection sampling pump (2) extracts the mixed solution in the sealed sample tube (6) through the sampling needle and transports it to the sample collector (3), completing the sampling; S4, after the rehydration and sampling are completed, the injection sampling pump (2) transports the extracted solvent medium in the rehydration storage station to the sealed sample tube (6) through the pipeline to complete the rehydration, and repeat steps S3 and S4; S5. Cleaning and testing After the test is completed, clean the sealed sample tube (6), the sealing cover (61) and the pipeline of the injection sampling pump (2).

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