Stem cell medicine finished product detection equipment and method thereof
Through the integrated stem cell drug product detection equipment with flexible heating sheets and adjustable centripetal sampling tubes, the problem of step-by-step operation of the detection process in the existing technology is solved, and the full process automation and cell activity are improved.
Patent Information
- Application Number
- CN202510761359.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-09
- Publication Date
- 2025-07-08
- Estimated Expiration
- 2045-06-09
AI Technical Summary
The existing stem cell drug product detection process relies on multiple independent equipment to operate step by step, making it difficult to achieve full process automation, and manual operations are required during centrifugation and washing, which affects detection efficiency and cell activity.
A stem cell drug product detection device is designed, and a flexible heating sheet and an adjustable centripetal sampling tube are integrated. The assembly line operation of thawing, centrifugation, washing and resuspension is achieved through the centrifugal body. The linkage design of the cover body and the sampling sleeve is used to automatically switch the sampling tube state to ensure the cell precipitation aggregation and the precise processing of supernatant.
The full process of stem cell drug product detection has been achieved, reducing the number of sample transfers, improving cell viability and detection efficiency, and reducing the damage to cells caused by sudden temperature changes.
Smart Images

Figure CN120275236A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of cell detection, and specifically provides a finished stem cell drug detection device and method thereof. Background Art
[0002] Stem cell drugs are regenerative medicine products developed using the characteristics of stem cells - self-renewal and multi-directional differentiation ability, aiming to repair or replace damaged tissues or cells. The quality inspection of finished stem cell drugs is the core link to ensure their safety and effectiveness.
[0003] The invention patent with the application number CN202011553545.7 discloses a kit for stem cell detection, including a box body, a sealing door is hinged to the box body, test tubes are detachably connected to the box body through a partition board, the partition board is fixedly connected to the box body through a limit bolt, one end of the test tube is snap-connected to the partition board through a clamping member, the clamping member is slidably connected to the partition board, and the other end of the test tube is movably connected to the bottom plate of the box body through a pressing mechanism. The above invention patent makes the reagent sample temperature remain constant during the stem cell detection process by setting a kit with a temperature control function, effectively reducing the influence of room temperature on stem cell detection, improving the accuracy of stem cell detection results. At the same time, the test tube is fixed to the kit through a pressing mechanism to avoid the offset of the reagent sample during the detection process, reducing the error of manual operation during the detection process, and improving the detection quality and efficiency of stem cells.
[0004] In the prior art, the detection process usually depends on multiple independent devices to complete thawing, centrifugation, and washing step by step; although the above patent optimizes the sample preservation through a temperature control kit, it still relies on manual step-by-step operations and is difficult to achieve a full-process automated closed loop; during centrifugation and washing, it is necessary to continuously open and close the lid for liquid extraction and addition operations. Since the test tube in an inclined state is the best centrifugation state, however, the space between the test tube and the lid body is limited, and it is not convenient for a long tubular pipette to extract liquid one by one. It is necessary to rotate the sampling tube to avoid the lid body shielding area before it is convenient to insert the pipette. Therefore, a new centrifugation structure speeds up the pre-detection processing steps and shortens the exposure of cell fluid to reduce its activity. Summary of the Invention
[0005] In order to overcome the defects in the prior art, the purpose of the present invention is to provide a finished stem cell drug detection device and method thereof to solve the problems raised in the above background art.
[0006] To achieve the above object, on the one hand, the present invention provides a finished product detection device for stem cell drugs, including a centrifuge body and a cover body hinged to the top thereof. A tray and a sampling part are arranged inside the top of the centrifuge body. The tray is sleeved inside the top surface of the centrifuge body, and the sampling part is placed inside the center of the tray and rotates around the central axis. A motor is arranged at the center of the bottom of the tray, and flexible heating sheets are symmetrically arranged on the bottom side wall of the tray. The sampling part includes a plurality of sampling tubes, a plurality of sampling sleeves correspondingly sleeved with the plurality of sampling tubes, and a centrifuge cylinder coaxially connected to the motor. The plurality of sampling sleeves are annularly and equally spaced outside the centrifuge cylinder. The sampling sleeve is rotatably connected to the top of the centrifuge cylinder, and the rotation central axis is horizontally arranged. A pressing block is arranged on one side of the top of the sampling sleeve. The pressing block is inclined upward and extends into the top of the centrifuge cylinder. A pressing pad is fixedly arranged at the center of the bottom surface of the cover body. When the cover body is in a closed state, the pressing pad flattens the plurality of pressing blocks, and thus the plurality of sampling tubes are in a centripetal inclined state.
[0007] The above design thaw, centrifuge, add liquid, and take liquid for the stem cell suspension in a flowing water manner before detection, and the sampling tubes automatically switch and adapt to the state between centrifugation and liquid addition / extraction, ensuring the optimization of the whole process. Closing the cover body can trigger the plurality of sampling tubes to be in a centripetal inclined state, which is beneficial to centrifugation separation. Opening the cover body makes the plurality of sampling tubes return to the upright state for liquid addition and extraction. Closing the cover body switches the plurality of sampling tubes to the inclined centrifugation state, generating a centripetal centrifugal motion, ensuring that the cell precipitate gathers at the bottom of the cylinder, which is beneficial to the subsequent extraction of the supernatant.
[0008] As a further improvement of the technical solution, a rotating block is horizontally extended on one side of the top of the sampling sleeve, the pressing block is embedded on the outer wall of the rotating block, and a plurality of clamping grooves are penetrated through the top side wall of the centrifuge cylinder. The rotating block is rotationally clamped with the clamping grooves.
[0009] As a further improvement of the technical solution, an annular groove is formed on the top surface of the centrifuge cylinder, and the bottom surface of the annular groove is higher than the bottom surface of the clamping groove. Rotating shafts are embedded at both ends of the central axis of the rotating block, and the rotating shafts are rotationally clamped with the annular groove. A sealing ring is tightly clamped inside the top of the annular groove. A plurality of pairs of limiting blocks are annularly and equally spaced on the bottom surface of the sealing ring, and the distance between each pair of limiting blocks is equal to the width of the clamping groove.
[0010] The above setting supports the sampling tubes through the sampling sleeves. As the centrifuge cylinder drives the plurality of sampling sleeves and the plurality of sampling tubes to rotate, a centrifugal motion is performed.
[0011] As a further improvement of the technical solution, a sealing platform is arranged on the inner wall of the centrifuge cylinder at the bottom surface of the clamping groove. A folding elastic sheet is slidably arranged below the pressing block. A sleeve frame is arranged at the bottom surface of the upper end of the pressing block. The upper end of the folding elastic sheet is slidably sleeved with the sleeve frame, and the lower end of the folding elastic sheet is lapped on the top surface of the sealing platform.
[0012] The above settings utilize the automatic rebound of the folding elastic piece to restore the sampling sleeve to an upright state. Since the sampling tube in the inclined state is in the best centrifugal state, however, the space between the sampling tube and the cover body is limited, and it is not convenient for the long tubular pipette to take liquid one by one. It is necessary to rotate the sampling tube to avoid the shielding area of the cover body before it is convenient to insert the pipette. Therefore, the sampling tube in the upright state is convenient for adding and taking liquid midway.
[0013] As a further improvement of this technical solution, a groove in the shape of a hemispherical cavity is provided at the top surface of the upper end of the pressing block. A ball is adaptively placed in the groove, and a limiting ring is sleeved on the outer wall of the ball. A bearing is sleeved inside the bottom of the centrifugal cylinder, and the inner hole of the bearing is sleeved and matched with the output shaft of the motor. The top end of the output shaft of the motor is fixedly connected to the center of the sealing table.
[0014] As a further improvement of this technical solution, a placement opening tightly sleeved with the tray is provided on the top surface of the centrifuge body. A convex platform is provided at the center of the bottom surface of the tray, and the motor is placed inside the convex platform and fixedly connected by bolts.
[0015] The above settings are to ensure that when the pressing pad presses several pressing blocks in a rotating state, the frictional interference is reduced; the bottom surface of the pressing pad rolls and contacts several balls to reduce friction, so that the damage of the pressing pad is minimized and its service life is extended.
[0016] On the other hand, the present invention provides a method for detecting finished stem cell drugs, using the above-mentioned detection equipment for finished stem cell drugs, including the following steps: S1. Quickly take out the sampling tube containing the stem cell suspension from the refrigerator, and sequentially sleeved it into the sampling sleeve, and then cover the cover body; S2. Operate the touch screen of the centrifuge body to start the flexible heating sheet for gradient heating, gradually heating from 4°C to 37°C, and then thawing; S3. Open the cover and add preheated 10% serum medium into the sampling tube, and the volume ratio of it to the stem cell suspension is 1:5 - 1:10; S4. Operate the touch screen of the centrifuge body to start the motor at a speed of 300 - 400g for 5 - 10 minutes, and then centrifuge to separate the supernatant, and use a pipette to suck it out to obtain cell precipitates; during the process of covering the cover body, the pressing pad will press several sampling tubes into a centripetal inclined shape, and then centripetal centrifugal motion will occur; S5. Then take out several centrifuged sampling tubes to make several test specimens, and put them into the cell analysis platform to analyze the cell density and viability respectively.
[0017] As a further improvement of this technical solution, the S4 includes a cell washing step: S41. Add 5 - 10 mL of buffer - saline to the cell pellet after centrifugation, start the centrifugation step at 300 g for 5 minutes, and discard the supernatant. Repeat the washing 2 - 3 times.
[0018] As a further improvement of this technical solution, S4 includes a cell resuspension step: S42. After the cells are washed, add an appropriate amount of buffer, and slowly pipette and disperse the cell clumps in the sampling tube using a 2 - 4 mL pipette tip; S43. Remove the aggregated cell clumps through a 40 - μm cell sieve.
[0019] As a further improvement of this technical solution, before measuring the cell density using a hemocytometer or an automatic cell counter, adjust it to the target concentration by adding buffer.
[0020] Compared with the prior art, the beneficial effects of the present invention are: 1. For the stem cell drug finished - product detection device and its method, through the integration of a flexible heating sheet, an adjustable centripetal sampling tube, and a temperature control module in the centrifuge body, it realizes the pipeline operation of thawing, centrifuging, washing, and resuspending, reducing the number of sample transfers.
[0021] 2. For the stem cell drug finished - product detection device and its method, through the linkage design of the pressure pad on the cover and the sampling sleeve pressing block, when closing the cover, it automatically triggers the centripetal inclination of the sampling tube, improving the aggregation efficiency of the cell pellet after centrifugation; after opening the cover, the folding elastic piece resets the sampling tube to the upright state, facilitating the accurate and rapid aspiration of the supernatant and reducing the cell exposure time.
[0022] 3. For the stem cell drug finished - product detection device and its method, through the programmed gradient heating of the flexible heating sheet, it avoids the rupture of the cell membrane caused by sudden temperature changes and improves the cell viability after thawing. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The drawings described herein are only for explanatory purposes and are not intended to limit the scope of the present invention disclosure in any way. Additionally, the shapes and proportional dimensions of the components in the drawings are only schematic and are used to assist in understanding the present invention, rather than specifically limiting the shapes and proportional dimensions of the components of the present invention. Those skilled in the art, under the teaching of the present invention, can select various possible shapes and proportional dimensions according to specific circumstances to implement the present invention.
[0024] Figure 1 It is a schematic diagram of the overall assembly structure of the present invention; Figure 2 It is a partial exploded view of the present invention; Figure 3 It is a schematic diagram of the assembly structure of the tray and the sampling part of the present invention; Figure 4 It is a schematic diagram of the assembly structure of the sampling part of the present invention; Figure 5 Schematic structural diagram of the rotating state of the sampling part of the present invention; Figure 6 Side view of the rotating state of the sampling part of the present invention; Figure 7 Schematic structural diagram of the assembly of the sampling tube and the sampling sleeve of the present invention; Figure 8 Exploded view of the assembly of the sampling sleeve of the present invention; Figure 9 Exploded view of the centrifuge tube of the present invention; Figure 10 Schematic structural diagram of the assembly of the centrifuge tube from the bottom-up perspective of the present invention; The meanings of the various reference numerals in the figure are as follows: 100, centrifuge body; 101, placement opening; 102, positioning groove; 110, cover body; 120, pressure pad; 130, sealing ring; 140, clamping block; 200, tray; 201, boss; 210, motor; 220, flexible heating sheet; 300, sampling part; 310, sampling tube; 320, sampling sleeve; 321, rotating block; 3211, rotating shaft; 322, pressing block; 3221, sleeve frame; 3222, groove; 323, folding elastic piece; 324, ball; 3241, limiting ring; 325, pre-tightening ring; 330, centrifuge tube; 3301, clamping groove; 3302, annular groove; 3303, sealing platform; 331, sealing ring; 332, limiting block; 333, bearing. Detailed implementation manners
[0025] Combined with the description of the specific implementation manners of the present invention and the accompanying drawings, the details of the present invention can be understood more clearly. However, the specific implementation manners of the present invention described herein are only for the purpose of explaining the present invention and should not be construed in any way as a limitation of the present invention. Under the teaching of the present invention, the concepts of those skilled in the art based on any possible deformations of the present invention should be regarded as belonging to the scope of the present invention. The terms "installation" and "connection" should be understood in a broad sense, which can be directly connected or indirectly connected through an intermediate medium.
[0026] The orientation or positional relationship indicated by the terms "central axis", "vertical", "horizontal", "front", "rear", "upper", "lower", "left", "right", "top", "bottom", "inner", "outer", etc. used herein is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, in the description of the present invention, the meaning of "several" is two or more unless otherwise specifically defined.
[0027] Please refer to Figures 1 - 7 As shown, the present invention provides a finished product detection device for stem cell drugs, including a centrifuge body 100 and a cover 110 hinged to the top thereof. A clamping block 140 is embedded at the front corner of the bottom surface of the cover 110, and a positioning groove 102 is opened at the front corner of the top surface of the centrifuge body 100. The clamping block 140 is correspondingly inserted and matched with the positioning groove 102, so that the cover 110 is tightly closed. Inside the top of the centrifuge body 100, a tray 200 and a sampling part 300 are arranged. The tray 200 is sleeved inside the top surface of the centrifuge body 100, and the sampling part 300 is placed inside the center of the tray 200 and rotates around this central axis. A motor 210 is arranged at the center of the bottom of the tray 200, and flexible heating sheets 220 are symmetrically arranged on the bottom side wall of the tray 200. A temperature control module is installed inside the centrifuge body 100 to control the flexible heating sheets 220 to increase the temperature in a programmed gradient. This is a prior art and will not be elaborated here. The sampling part 300 includes a plurality of sampling tubes 310, a plurality of sampling sleeves 320 correspondingly sleeved on the plurality of sampling tubes 310, and a centrifuge cylinder 330 coaxially connected to the motor 210. The plurality of sampling sleeves 320 are annularly and equidistantly distributed outside the centrifuge cylinder 330. The sampling sleeve 320 is rotatably connected to the top of the centrifuge cylinder 330, and the rotation central axis is horizontally arranged, so that the sampling sleeve 320 drives the centrifuge cylinder 330 to flip up and down, forming a switch between an upright state and an inclined state. A pressing block 322 is arranged on one side of the top of the sampling sleeve 320. The pressing block 322 is inclined upward and extends into the top of the centrifuge cylinder 330. A pressing pad 120 is fixedly arranged at the center of the bottom surface of the cover 110 through bolts. When the cover 110 is in a closed state, the pressing pad 120 flattens the plurality of pressing blocks 322, and then the plurality of sampling tubes 310 are in a centripetal inclined state, so that when the plurality of sampling tubes 310 perform centrifugal motion, they can rotate towards the rotation axis. After the cell suspension in the sampling tubes 310 is centrifuged, the cell precipitate accumulates at the bottom of the tubes. This is the best state for centrifugal separation and is conducive to taking the supernatant later.
[0028] Further, a placement opening 101 tightly sleeved with the tray 200 is opened on the top surface of the centrifuge body 100. A sealing ring 130 is bonded to the central area of the bottom surface of the cover 110 to cover the upper port of the tray 200 and play a sealing role. A boss 201 is arranged at the center of the bottom surface of the tray 200, and the motor 210 is placed inside the boss 201 and fixedly connected through bolts.
[0029] Further, as Figures 8 - 10As shown, a rotating block 321 is horizontally extended on the top side of the sampling sleeve 320. The pressing block 322 is embedded on the outer wall of the rotating block 321 and is made of plastic material and integrally formed; a plurality of clamping grooves 3301 are formed through the top side wall of the centrifugal cylinder 330, and the number of the plurality of clamping grooves 3301 is the same as the number of the plurality of sampling tubes 310; the rotating block 321 is rotationally clamped with the clamping grooves 3301; An annular groove 3302 is formed on the top surface of the centrifugal cylinder 330, and the bottom surface of the annular groove 3302 is higher than the bottom surface of the clamping groove 3301. The two ends of the central axis of the rotating block 321 are embedded with rotating shafts 3211, and the rotating shafts 3211 are rotationally clamped with the annular groove 3302, so that the rotating shafts 3211 are supported and rotated; a sealing ring 331 is tightly clamped inside the top of the annular groove 3302. The bottom surface of the sealing ring 331 is provided with a plurality of pairs of limiting blocks 332 at equal intervals in a ring shape. The limiting blocks 332 are placed on the top of the rotating shafts 3211 for limiting. The distance between each pair of limiting blocks 332 is equal to the width of the clamping groove 3301, so that the rotation of the rotating block 321 is not interfered.
[0030] Furthermore, a sealing platform 3303 is provided on the inner wall of the centrifugal cylinder 330 and at the bottom surface of the clamping groove 3301, and this is an integrally formed structure; a folding elastic sheet 323 is slidably arranged below the pressing block 322 and is made of spring steel to make it elastic; a sleeve frame 3221 is provided at the bottom surface of the upper end of the pressing block 322. The upper end of the folding elastic sheet 323 is slidably sleeved with the sleeve frame 3221, and the lower end of the folding elastic sheet 323 is lapped on the top surface of the sealing platform 3303, so that the folding elastic sheet 323 and the pressing block 322 are connected into a whole. When the pressing block 322 rotates downward, the folding elastic sheet 323 is squeezed to store elastic force. After the cover body 110 is opened and the pressing block 322 loses pressure, the pressing block 322 rotates upward under the action of the return elastic force of the folding elastic sheet 323, so that the sampling sleeve 320 automatically switches from an inclined state to an upright state, which is convenient for liquid taking and liquid adding operations.
[0031] In addition, in order to ensure that when the pressing pad 120 presses a plurality of pressing blocks 322 in a rotating state, the friction interference is reduced. A groove 3222 in the shape of a hemispherical cavity is formed on the top surface of the upper end of the pressing block 322. A ball 324 is adaptively placed in the groove 3222, and a limiting ring 3241 is sleeved on the outer wall of the ball 324 to hoop the ball 324 to rotate in the groove 3222; the bottom surface of the pressing pad 120 is in rolling contact with a plurality of balls 324 to reduce friction, so that the damage of the pressing pad 120 is maximally reduced and its service life is prolonged; a bearing 333 is sleeved inside the bottom of the centrifugal cylinder 330, and the inner hole of the bearing 333 is sleeved and matched with the output shaft of the motor 210. The top end of the output shaft of the motor 210 is fixedly connected with the center of the sealing platform 3303, so that the centrifugal cylinder 330 rotates stably and the centrifugation of a plurality of sampling tubes 310 is ensured to be stable; A plurality of pre-tightening rings 325 are embedded in the inner wall of the sampling sleeve 320. The pre-tightening rings 325 are rubber rings, so that the sampling tubes 310 are tightly sleeved with the sampling sleeve 320, which is beneficial to keeping the centrifugal motion stable.
[0032] The present invention also provides a method for detecting finished stem cell drugs, using the above-mentioned detection equipment for finished stem cell drugs, including the following steps: S1. Quickly take out the sampling tube 310 containing the stem cell suspension from the refrigerator, and sequentially sleeved it into the sampling sleeve 320, and then cover the cover body 110; S2. Operate the touch screen of the centrifuge body 100 to start the flexible heating sheet 220 for gradient temperature rise, gradually rising from 4°C to 37°C to thaw; S3. Open the cover and add preheated 10% serum medium into the sampling tube 310, and the volume ratio of it to the stem cell suspension is 1:5 to 1:10, such as 1 mL cell suspension + 9 mL serum medium; S4. Operate the touch screen of the centrifuge body 100 to start the motor 210 at a rotational speed of 300 - 400 g for 5 - 10 minutes, and centrifuge to separate the supernatant, and use a pipette to aspirate it to obtain cell precipitates; during the process of covering the cover body 110, the pressure pad 120 will press several sampling tubes 310 into a centripetal inclined shape, then centripetal centrifugal motion occurs; Cell washing step: S41. Add 5 - 10 mL of buffer - normal saline to the cell precipitate after centrifugation, start the centrifugation step at 300 g for 5 minutes, and discard the supernatant, repeat the washing 2 - 3 times, initially wash to remove most of the debris, and subsequent washing to remove the residual protective agent to ensure no interference in detection; Cell resuspension step: S42. After cell washing, add an appropriate amount of buffer, and slowly pipette and disperse the cell mass in the sampling tube 310 using a 2 - 4 mL pipette tip to avoid mechanical damage; S43. Remove the aggregated cell mass through a 40μm cell sieve; S5. Then take out several sampling tubes 310 after centrifugation to make several detection specimens, and put them into the cell analysis platform to analyze the cell density and viability respectively; before measuring the cell density using a hemocytometer or an automatic cell counter, adjust to the target concentration by adding buffer, because too high a concentration will cause cell aggregation, hypoxia or accumulation of metabolic waste, affecting viability; too low a concentration will cause functional abnormalities due to lack of intercellular signals, and the target concentration is used to ensure experimental consistency.
[0033] It should be noted that the above - mentioned embodiments are only for explaining the technical concept and characteristics of the present invention, and its purpose is to enable those who are familiar with this technology to understand the content of the present invention and implement it accordingly, and it cannot be used to limit the protection scope of the present invention. All equivalent changes or modifications made according to the spirit of the present invention should be covered within the protection scope of the present invention.
Claims
1. A finished product detection device for stem cell drugs, comprising a centrifuge body and a cover body hinged to the top thereof, characterized in that: Inside the top of the centrifuge body, there is a tray and a sampling part. The tray is sleeved inside the top surface of the centrifuge body, and the sampling part is placed inside the center of the tray and rotates around this central axis. At the center of the bottom of the tray, there is a motor, and flexible heating sheets are symmetrically arranged on the bottom side wall of the tray. The sampling part includes several sampling tubes, several sampling sleeves sleeved corresponding to the several sampling tubes, and a centrifuge tube coaxially connected to the motor. The several sampling sleeves are distributed equidistantly in a ring outside the centrifuge tube. The sampling sleeve is rotationally connected to the top of the centrifuge tube, and this rotation central axis is horizontally arranged. On one side of the top of the sampling sleeve, there is a pressing block, which is inclined upward and extends into the top of the centrifuge tube. At the center of the bottom surface of the cover body, there is a pressing pad. When the cover body is in a closed state, the pressing pad flattens several pressing blocks, and thus several sampling tubes are in a centripetal inclined state.
2. The stem cell drug finished product detection device according to claim 1, characterized in that: On one side of the top of the sampling sleeve, there is a horizontally extending rotating block, and the pressing block is embedded on the outer wall of the rotating block. Several card slots are penetrated through the top side wall of the centrifuge tube, and the rotating block is rotationally connected with the card slots.
3. The stem cell drug finished product detection device according to claim 2, wherein: A ring groove is opened on the top surface of the centrifuge tube, and the bottom surface of the ring groove is higher than the bottom surface of the card slot. Rotating shafts are embedded at both ends of the central axis of the rotating block, and the rotating shafts are rotationally connected with the ring groove. A sealing ring is tightly clamped inside the top of the ring groove. Several pairs of limiting blocks are arranged at equal intervals in a ring on the bottom surface of the sealing ring, and the distance between each pair of limiting blocks is equal to the width of the card slot.
4. The finished product detection device for stem cell drugs according to claim 3, wherein: On the inner wall of the centrifuge tube and at the bottom surface of the card slot, there is a sealing platform. A folding elastic sheet is slidably arranged below the pressing block. A sleeve frame is arranged at the bottom surface of the upper end of the pressing block, and the upper end of the folding elastic sheet is slidably sleeved with the sleeve frame, and the lower end of the folding elastic sheet is lapped on the top surface of the sealing platform.
5. The finished product detection device for stem cell drugs according to claim 4, wherein: At the top surface of the upper end of the pressing block, there is a groove in the shape of a hemispherical cavity. A ball is adaptively placed in the groove, and a limiting ring is sleeved on the outer wall of the ball. A bearing is sleeved inside the bottom of the centrifuge tube, and the inner hole of the bearing is sleeved and matched with the output shaft of the motor. The top end of the output shaft of the motor is fixedly connected to the center of the sealing platform.
6. The finished product detection device for stem cell drugs according to claim 5, wherein: On the top surface of the centrifuge body, there is a placement opening tightly sleeved with the tray. There is a convex platform at the center of the bottom surface of the tray, and the motor is placed inside the convex platform and fixedly connected by bolts.
7. A method for detecting a finished stem cell drug product, using the stem cell drug product detection device according to any one of claims 1-6, characterized in that, It includes the following steps: S1. Quickly take out the sampling tubes filled with stem cell suspension from the refrigerator, and sequentially sleeve them into the sampling sleeves, and then cover the cover body. S2. Operate the touch screen of the centrifuge body to start the flexible heating sheet for gradient heating, gradually heating from 4°C to 37°C, and then thawing. S3. Open the cover and add preheated 10% serum culture medium into the sampling tubes, and the volume ratio of it to the stem cell suspension is 1:5 - 1:
10. S4. Operate the touch screen of the centrifuge body to start the motor at a rotational speed of 300 - 400g for 5 - 10 minutes, and centrifuge to separate out the supernatant, and use a pipette to suck it out, thus obtaining cell precipitates. During the process of covering the cover body, the pressing pad will press several sampling tubes into a centripetal inclined state, and thus centripetal centrifugal motion occurs. S5. Then take out several centrifuged sampling tubes to make several detection specimens, and put them into the cell analysis platform to analyze the cell density and viability respectively.
8. The finished product detection method of the stem cell drug according to claim 7, characterized in that: The S4 includes a cell washing step: S41. Add 5 - 10 mL of buffer - saline to the cell pellet after centrifugation, start the centrifugation step at 300 g for 5 minutes, and discard the supernatant. Repeat the washing 2 - 3 times.
9. The finished product detection method of the stem cell drug according to claim 8, wherein: The said S4 includes a cell resuspension step: S42. After the cells are washed, add an appropriate amount of buffer, and slowly pipette and disperse the cell mass in the sampling tube using a 2 - 4 mL pipette tip; S43. Remove the aggregated cell mass through a 40 - μm cell sieve.
10. The finished product detection method of the stem cell drug according to claim 9, characterized in that: Adjust to the target concentration by adding buffer before measuring the cell density using a hemocytometer or an automatic cell counter.
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