A finished product detection device and method for stem cell drugs

Through the integrated stem cell drug product detection equipment with centrifugal body and flexible heating sheet, the problem of step-by-step relying on manual operation in the existing technology is solved, and the full process automation and cell viability improvement are achieved.

CN120275236BActive Publication Date: 2025-08-01BEIJING HONGKAI BIOTECHNOLOGY CO LTD

Patent Information

Application Number
CN202510761359.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-06-09
Publication Date
2025-08-01
Estimated Expiration
2045-06-09

AI Technical Summary

Technical Problem

The existing stem cell drug product testing process is completed in steps by multiple independent equipment, making it difficult to achieve full process automation, and manual operations are required during centrifugation and washing, which affects detection efficiency and cell activity.

Method used

Design a stem cell drug product detection device, integrate the centrifugal body, flexible heating sheet and adjustable centripetal sampling tube to realize the assembly line operation of thawing, centrifugation, washing and resuspension. Through the linkage design of the cover body and the sampling sleeve, the sampling tube state is automatically switched to ensure the accumulation of cell precipitates and the accurate removal of supernatant.

Benefits of technology

The full process automation of stem cell drug product detection has been achieved, reducing the number of sample transfers, improving cell viability, reducing operational errors, and enhancing detection efficiency and accuracy.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN120275236B_ABST
    Figure CN120275236B_ABST
Patent Text Reader

Abstract

The present invention relates to the technical field of cell detection, and specifically to a finished product detection device and method for stem cell drugs, including a centrifuge body and a cover body hinged to the top thereof. Inside the top of the centrifuge body, there is a tray and a sampling part. The sampling part is placed inside the center of the tray and rotates around this central axis; a motor is provided 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 number of sampling tubes, a number of sampling sleeves correspondingly sleeved with the sampling tubes, and a centrifuge cylinder coaxially connected to the motor. Through the linkage design of the pressing pad on the cover body and the sampling sleeve pressing block in the present invention, when the cover body is closed, the sampling tube is automatically triggered to incline towards the center, and the aggregation efficiency of cell precipitation after centrifugation is improved; after the cover is opened, the folding elastic piece resets the sampling tube to an upright state, which is convenient for accurately and quickly sucking out the supernatant and reducing the cell exposure time.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The present invention relates to the technical field of cell detection, and specifically to a finished product detection device and method for stem cell drugs. 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 a 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 partition plates, the partition plates are fixedly connected to the box body through limit bolts, one end of the test tube is snap-connected to the partition plate through a clamping member, the clamping member is slidably connected to the partition plate, and the other end of the test tube is movably connected to the bottom plate of the box body through a pressing mechanism. By setting a kit with a temperature control function, the above invention patent enables the reagent sample temperature to be constantly maintained during the stem cell detection process, 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 tubes are fixed to the kit through a pressing mechanism, avoiding the deviation 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 relies 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 fully 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 optimal centrifugation state, however, the space between the test tube and the lid body is limited, which 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 the cell solution 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 product detection device and method for stem cell drugs 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 this 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.

[0007] The sampling part includes a plurality of sampling tubes, a plurality of sampling sleeves sleeved corresponding to the plurality of sampling tubes, and a centrifuge cylinder coaxially connected to the motor. The plurality of sampling sleeves are annularly and equidistantly distributed outside the centrifuge cylinder. The sampling sleeve is rotatably connected to the top of the centrifuge cylinder, and this rotation central axis is horizontally arranged. One side of the top of the sampling sleeve is provided with a pressing block, 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 a plurality of pressing blocks, and then a plurality of sampling tubes are in a centripetal inclined state.

[0008] 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 the state between centrifugation and liquid addition and extraction, ensuring the optimization of the whole process. Triggering the cover body can make a plurality of sampling tubes in a centripetal inclined state, which is beneficial to centrifugation separation. Opening the cover body makes a plurality of sampling tubes return to the upright state for liquid addition and extraction, and closing the cover body makes a plurality of sampling tubes switch 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 taking out the supernatant later.

[0009] 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.

[0010] As a further improvement of the technical solution, an annular groove is opened 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. The two ends of the central axis of the rotating block are embedded with rotating shafts, the rotating shafts are rotationally clamped with the annular groove, and a sealing ring is tightly clamped inside the top of the annular groove. The bottom surface of the sealing ring is annularly and equidistantly provided with a plurality of pairs of limiting blocks, and the distance between each pair of limiting blocks is equal to the width of the clamping groove.

[0011] The above setting supports the sampling tubes through the sampling sleeves, and as the centrifuge cylinder drives a plurality of sampling sleeves and a plurality of sampling tubes to rotate, a centrifugal motion is performed.

[0012] As a further improvement of the technical solution, a sealing platform is provided on the inner wall of the centrifugal cylinder and at the bottom surface of the card slot. A folding elastic sheet is slidably arranged below the pressing block. A sleeve frame is provided 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.

[0013] The above setting utilizes the automatic rebound of the folding elastic sheet to restore the sampling sleeve to an upright state. Since the inclined sampling tube 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 upright sampling tube is convenient for adding and taking liquid in the middle.

[0014] As a further improvement of the 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 platform.

[0015] As a further improvement of the 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.

[0016] The above setting is to reduce frictional interference when the pressing pad presses a number of pressing blocks in a rotating state; the bottom surface of the pressing pad rolls and contacts with a number of balls to reduce friction, so that the damage of the pressing pad is minimized and its service life is prolonged.

[0017] On the other hand, the present invention provides a method for detecting a finished stem cell drug product, using the above-mentioned stem cell drug product detection device, including the following steps:

[0018] 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;

[0019] 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 to thaw;

[0020] S3. Open the cover and add preheated 10% serum culture medium into the sampling tube, and the volume ratio of it to the stem cell suspension is 1:5 to 1:10;

[0021] 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 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 a number of sampling tubes into a centripetal inclined shape, and then centripetal centrifugal motion will occur;

[0022] 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.

[0023] As a further improvement of this technical solution, S4 includes a cell washing step:

[0024] S41. Add 5 - 10 mL of buffer - saline to the centrifuged cell pellet, start the centrifugation step at 300 g for 5 minutes, and discard the supernatant. Repeat the washing 2 - 3 times.

[0025] As a further improvement of this technical solution, S4 includes a cell resuspension step:

[0026] S42. After the cells are washed, add an appropriate amount of buffer, and use a 2 - 4 mL pipette tip to slowly pipette and disperse the cell clumps in the sampling tube.

[0027] S43. Remove the aggregated cell clumps through a 40 - μm cell sieve.

[0028] 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.

[0029] Compared with the prior art, the beneficial effects of the present invention are:

[0030] 1. For this 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 on the centrifuge body, it realizes the pipeline operation of thawing, centrifuging, washing and resuspending, reducing the number of sample transfers.

[0031] 2. For this 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 the cover is closed, the sampling tube is automatically triggered to incline centripetally, 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 suction of the supernatant and reducing the cell exposure time.

[0032] 3. For this 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

[0033] The accompanying drawings described herein are for illustrative purposes only 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 figures are only schematic, for assisting in understanding the present invention, and do not specifically define the shapes and proportional dimensions of the components of the present invention. Those skilled in the art, under the teachings of the present invention, can select various possible shapes and proportional dimensions according to specific circumstances to implement the present invention.

[0034] Figure 1 Schematic diagram of the overall assembly structure of the present invention;

[0035] Figure 2 Partial disassembly diagram of the present invention;

[0036] Figure 3 Schematic diagram of the assembly structure of the tray and the sampling part of the present invention;

[0037] Figure 4 Schematic diagram of the assembly structure of the sampling part of the present invention;

[0038] Figure 5 Schematic diagram of the structure of the sampling part in the rotating state of the present invention;

[0039] Figure 6 Side view of the sampling part in the rotating state of the present invention;

[0040] Figure 7 Schematic diagram of the assembly structure of the sampling tube and the sampling sleeve of the present invention;

[0041] <9110009>3>Disassembly diagram of the sampling sleeve assembly of the present invention;

[0042] Figure 9 Disassembly diagram of the centrifuge tube of the present invention;

[0043] Figure 10 Schematic diagram of the assembly structure of the centrifuge tube from the bottom-up perspective of the present invention;

[0044] The meanings of the various reference numerals in the figure are as follows:

[0045] 100, centrifuge body; 101, placement opening; 102, positioning groove; 110, cover body; 120, pressure pad; 130, sealing ring; 140, clamping block;

[0046] 200, tray; 201, boss; 210, motor; 220, flexible heating sheet;

[0047] 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. Limit ring; 325. Pre-tightening ring; 330. Centrifugal cylinder; 3301. Card slot; 3302. Ring groove; 3303. Sealing platform; 331. Sealing ring; 332. Limit block; 333. Bearing. Detailed implementation manner

[0048] Combined with the description of the specific implementation manner of the present invention and the accompanying drawings, the details of the present invention can be more clearly understood. However, the specific implementation manner of the present invention described herein is only for the purpose of explaining the present invention and cannot be understood 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 are based on any possible deformations of the present invention, and these should all 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.

[0049] 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 cannot be understood 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 clearly and specifically defined.

[0050] Please refer to Figures 1 - 7 As shown in the figure, the present invention provides a finished product detection device for stem cell drugs, including a centrifuge body 100 and a cover body 110 hinged to the top thereof. A clamping block 140 is embedded at the front corner of the bottom surface of the cover body 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 inserted and matched with the positioning groove 102 in a corresponding manner, so that the cover body 110 is tightly closed; a tray 200 and a sampling part 300 are arranged inside the top of the centrifuge body 100. 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.

[0051] The sampling part 300 includes a number of sampling tubes 310, a number of sampling sleeves 320 sleeved corresponding to the number of sampling tubes 310, and a centrifugal cylinder 330 coaxially connected to the motor 210; the number of sampling sleeves 320 are annularly and equidistantly distributed outside the centrifugal cylinder 330, the sampling sleeve 320 is rotatably connected to the top of the centrifugal cylinder 330, and the rotation central axis is horizontally arranged, so that the sampling sleeve 320 drives the centrifugal cylinder 330 to turn up and down, forming a switch between an upright state and an inclined state; on one side of the top of the sampling sleeve 320, there is a pressing block 322, the pressing block 322 is inclined upward and extends into the top of the centrifugal cylinder 330, and a pressing pad 120 is fixedly arranged at the center of the bottom surface of the cover body 110 through bolts. When the cover body 110 is in a closed state, the pressing pad 120 flattens a number of pressing blocks 322, and then a number of sampling tubes 310 are in a centripetal inclined state, so that when a number of sampling tubes 310 perform centrifugal motion, they can rotate towards the rotation axis. After the cell suspension in the sampling tube 310 is centrifuged, the cell precipitate gathers at the bottom of the tube, which is the best state for centrifugal separation and is conducive to taking the supernatant later.

[0052] Further, a placement opening 101 tightly sleeved with the tray 200 is opened on the top surface of the centrifuge body 100, and a sealing ring 130 is adhesively bonded to the central area of the bottom surface of the cover body 110 for covering the upper port of the tray 200 to play a sealing role; a boss 201 is provided at the center of the bottom surface of the tray 200, and the motor 210 is placed inside the boss 201 and fixedly connected by bolts.

[0053] Further, as Figures 8 - 10 shown, a rotating block 321 is horizontally extended on one side of the top of the sampling sleeve 320, the pressing block 322 is embedded on the outer wall of the rotating block 321, and is integrally formed with a plastic material; a number of clamping grooves 3301 are penetrated through the top side wall of the centrifugal cylinder 330, and the number of a number of clamping grooves 3301 is the same as the number of a number of sampling tubes 310; the rotating block 321 is rotationally clamped with the clamping groove 3301;

[0054] An annular groove 3302 is opened 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 a rotating shaft 3211, and the rotating shaft 3211 is rotationally clamped with the annular groove 3302, so that the rotating shaft 3211 is supported and rotated; a sealing ring 331 is tightly clamped inside the top of the annular groove 3302, and a number of pairs of limiting blocks 332 are annularly and equidistantly arranged on the bottom surface of the sealing ring 331. The limiting blocks 332 are placed on the top of the rotating shaft 3211 for limiting, and the distance between each pair of limiting blocks 332 is equal to the width of the clamping groove 3 thirty, so that the rotation of the rotating block 321 is not interfered.

[0055] The folding spring 323 is slidingly arranged under 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, and the upper end of the folding spring 323 is slidably sleeved with the sleeve frame 3221, and the lower end of the folding spring 323 is overlapped on the top surface of the sealing platform 3303, so that the folding spring 323 and the pressing block 322 are connected as a whole. When the pressing block 322 rotates downward, the folding spring 323 is squeezed to store elastic force. When the cover body 110 is opened, the pressing block 322 loses pressure and rotates upward under the action of the rebound force of the folding spring 323, so that the sampling sleeve 320 automatically switches from an inclined state to an upright state, which is convenient for liquid collection and addition operations.

[0056] In addition, in order to ensure that friction interference is reduced when the pressure pad 120 applies pressure to the rotating pressure blocks 322, a groove 3222 in the form of a hemispherical cavity is opened on the top surface of the upper end of the pressure block 322, and a ball 324 is adapted to be placed in the groove 3222, and a limit ring 3241 is provided on the outer wall of the ball 324 to clamp the ball 324 and place it in the groove 3222 for rotation; the bottom surface of the pressure pad 120 is in rolling contact with the ball 324 to reduce friction, thereby minimizing damage to the pressure pad 120 and extending its service life; a bearing 333 is provided on the bottom inner sleeve of the centrifugal cylinder 330, and the inner hole of the bearing 333 is sleeved with the output shaft of the motor 210, and the top end of the output shaft of the motor 210 is fixedly connected to the center of the sealing platform 3303, so that the centrifugal cylinder 330 rotates stably, ensuring the centrifugal stability of the sampling tubes 310;

[0057] 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, which enable the sampling tube 310 and the sampling sleeve 320 to be tightly sleeved, thereby facilitating the centrifugal movement to maintain stability.

[0058] The present invention also provides a method for detecting a finished stem cell drug product, using the above-mentioned finished stem cell drug product detection device, comprising the following steps:

[0059] S1. Quickly take out the sampling tubes 310 containing the stem cell suspension from the refrigerator, insert them into the sampling sleeve 320 one by one, and then cover them with the cover 110.

[0060] S2. Control the touch screen of the centrifuge body 100 to start the flexible heating plate 220 to gradually increase the temperature from 4°C to 37°C, thereby thawing;

[0061] S3. Open the cover and add preheated 10% serum medium into the sampling tube 310. The volume ratio of 10% serum medium to the stem cell suspension is 1:5 to 1:10, such as 1 mL cell suspension + 9 mL serum medium.

[0062] S4. Operate the touch screen of the centrifuge body 100 to start the motor 210 at a rotational speed of 300 - 400g for 5 - 10 minutes to centrifuge and separate the supernatant, then 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, thus causing centripetal centrifugal motion;

[0063] Cell washing step:

[0064] S41. Add 5 - 10 mL of buffer - saline to the centrifuged cell precipitate, start the centrifugation step at 300g for 5 minutes, and discard the supernatant. Repeat the washing 2 - 3 times. The initial washing removes most of the debris, and the subsequent washing removes the residual protective agent to ensure no interference in the detection;

[0065] Cell resuspension step:

[0066] S42. After the cells are washed, 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;

[0067] S43. Remove the aggregated cell mass through a 40μm cell sieve;

[0068] S5. Then take out several centrifuged sampling tubes 310 to make several test specimens, and place them on 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 it to the target concentration by adding buffer, because too high a concentration will cause cell aggregation, hypoxia or accumulation of metabolic waste, affecting the viability; too low a concentration will cause functional abnormalities due to the lack of inter - cellular signals, and the target concentration is used to ensure the consistency of the experiment.

[0069] It should be noted that the above - mentioned embodiments are only for explaining the technical concept and characteristics of the present invention. The 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. Any 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 a number of sampling tubes, a number of sampling sleeves sleeved corresponding to the number of sampling tubes, and a centrifuge cylinder coaxially connected to the motor; the number of sampling sleeves are annularly and equidistantly distributed outside the centrifuge cylinder. The sampling sleeve is rotatably connected to the top of the centrifuge cylinder, and this rotation central axis is horizontally arranged. On one side of the top of the sampling sleeve, there is a pressing block, the pressing block is inclined upward and extends into the top of the centrifuge cylinder. At the center of the bottom surface of the cover body, there is a pressing pad fixedly arranged. When the cover body is in a closed state, the pressing pad flattens a number of pressing blocks, and thus a number of sampling tubes are in a centripetal inclined state.

2. The finished product detection device for stem cell drugs according to claim 1, wherein: On one side of the top of the sampling sleeve, there is a horizontally extending rotating block, the pressing block is embedded on the outer wall of the rotating block, and a number of clamping grooves are penetrated and opened on the top side wall of the centrifuge cylinder, and the rotating block is rotationally clamped with the clamping grooves.

3. The stem cell drug finished product detection device according to claim 2, wherein: On the top surface of the centrifuge cylinder, there is an annular groove, and the bottom surface of the annular groove is higher than the bottom surface of the clamping groove. At both ends of the central axis of the rotating block, there are rotating shafts embedded, and the rotating shafts are rotationally clamped with the annular groove. Inside the top of the annular groove, there is a sealing ring tightly clamped, and on the bottom surface of the sealing ring, there are a number of pairs of limiting blocks arranged annularly and equidistantly. The distance between each pair of limiting blocks is equal to the width of the clamping groove.

4. The stem cell drug finished product detection device according to claim 3, characterized in that: On the inner wall of the centrifuge cylinder and at the bottom surface of the clamping groove, there is a sealing platform. Below the pressing block, there is a folding elastic sheet slidably arranged. At the bottom surface of the upper end of the pressing block, there is a sleeve frame, 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: On the top surface of the upper end of the pressing block, there is a groove in the shape of a hemispherical cavity. Inside the groove, there is a ball placed in a fitting manner, and a limiting ring is sleeved on the outer wall of the ball. Inside the bottom of the centrifuge cylinder, there is a bearing sleeved, 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. At the center of the bottom surface of the tray, there is a convex platform, 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, Including 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 temperature increase, gradually increase the temperature from 4°C to 37°C, and thus thaw; 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, and thus obtain cell precipitates; during the process of covering the cover body, the pressing pad will press a number of sampling tubes into a centripetal inclined state, and thus centripetal centrifugal motion occurs; S5. Then take out a number of centrifuged sampling tubes to make a number of test 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, wherein: 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 method for detecting the finished stem cell drug according to claim 8, characterized in that: 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 clumps in the sampling tube using a 2 - 4 mL pipette tip. S43. Remove the aggregated cell clumps through a 40 - μm cell sieve.

10. The stem cell drug finished product detection method 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.

Citation Information

Patent Citations

  • Kit for detecting stem cells

    CN112782397A

  • Blood detection sampling device and sampling method

    CN117433837A

  • Lung cancer detection kit

    CN118146932A

Cited By

  • A physical detection analysis device based on stem cell properties

    CN120665707B