A sample processing device and processing method for rivastigmine test

Abstract

The application discloses a sample processing device for rivastigmine test, which comprises a low-temperature centrifuge and a low-temperature storage box. An assembly groove is formed at the top end of the low-temperature centrifuge, and a rotating centrifugal mechanism is installed in the assembly groove. The low-temperature storage box has a hollow structure, and ice water is injected into the hollow structure. A plurality of groups of jacks are formed at the top end of the low-temperature storage box, and the jacks are used for installing vacuum blood collection tubes. A screw cap is rotatably connected to the low-temperature storage box, and the screw cap is used for sealing the low-temperature storage box. The collected blood samples are stored in the low-temperature storage box through ice bath low-temperature preservation, and low-temperature centrifugation can be directly performed in the low-temperature storage box. The number of blood sample transfer times is greatly reduced. The blood sample can be prevented from deteriorating during the transfer process, the accuracy of test results is improved, the workload of test personnel is reduced, and the test progress is accelerated.

Description

Technical Field

[0001] This invention relates to the field of biological testing technology, and in particular to a sample processing device and method for rivastigmine testing. Background Technology

[0002] This single-center, randomized, open-label, two-period, two-sequence, two-formulation, crossover bioequivalence study of rivastigmine bitartrate capsules in healthy adult subjects, administered orally once in both fasting and postprandial conditions, aimed to evaluate the pharmacokinetic characteristics and bioequivalence of the test and reference formulations, estanol, of rivastigmine bitartrate capsules in healthy adult subjects. Simultaneously, the safety of both rivastigmine bitartrate capsules and estanol in healthy adult subjects was investigated.

[0003] During the experiment, subjects used lancets or indwelling needles to collect blood samples. The collected blood samples needed to undergo centrifugation, separation, and other processing steps before they could be used for pharmacokinetic analysis. Due to the large number of blood samples and the temperature-sensitive nature of their preservation, multiple transfers were required during these processing steps. This not only easily led to blood sample deterioration but was also time-consuming and labor-intensive, increasing the workload of the experimenters. In particular, when centrifuging multiple sets of blood samples using a low-temperature centrifuge, the experimenters had to place each set of blood samples individually inside the centrifuge, and then remove them sequentially after centrifugation. This easily led to blood sample deterioration, affecting the accuracy of the experimental results, and was also time-consuming and labor-intensive, impacting the experimental progress.

[0004] Therefore, in view of the above-mentioned technical problems, it is necessary to provide a sample processing device and method for rivastigmine testing. Summary of the Invention

[0005] The purpose of this invention is to provide a sample processing device and method for rivastigmine testing, which can solve the problems of blood samples needing to be transferred several times, easily becoming deteriorated, and being time-consuming and laborious to operate.

[0006] To achieve the above objectives, embodiments of the present invention provide a sample processing apparatus for rivastigmine testing, comprising: a low-temperature centrifuge and a low-temperature storage box;

[0007] The low-temperature centrifuge has an assembly slot at the top, and a rotary centrifugation mechanism is installed inside the assembly slot.

[0008] The low-temperature storage box has a hollow interior structure, which is filled with ice water. The top of the low-temperature storage box has several sets of insertion holes for installing vacuum blood collection tubes. A screw cap is screwed onto the low-temperature storage box to seal it.

[0009] A locking structure is provided between the low-temperature storage box and the rotary centrifuge mechanism. The low-temperature storage box can be assembled onto the rotary centrifuge mechanism through the locking structure, thereby allowing the blood samples from several sets of vacuum blood collection tubes to be centrifuged directly inside the low-temperature storage box.

[0010] In one or more embodiments of the present invention, the rotary centrifugal mechanism includes an electric turntable rotatably connected to the bottom of the assembly slot, the electric turntable being driven to rotate by a motor.

[0011] In one or more embodiments of the present invention, the locking structure includes a clamping component, a fixing post, and a central hole. The central hole is opened on the central axis of the screw cap and the low-temperature storage box. The fixing post is fixedly connected to the central axis of the electric turntable and can pass through the central hole. The clamping component is mounted on the fixing post.

[0012] In one or more embodiments of the present invention, the clamping assembly includes a clamping plate and a hexagonal nut, the hexagonal nut being fixedly connected to the clamping plate, and the fixing post being provided with threads that match the hexagonal nut.

[0013] In one or more embodiments of the present invention, a threaded interface is fixedly connected to the low-temperature storage box, and the screw cap is matched with the threaded interface.

[0014] In one or more embodiments of the present invention, a vacuum chamber is provided on the outer wall of the socket.

[0015] In one or more embodiments of the present invention, an inner liner is fixedly connected inside the insertion hole, and the inner liner can be interference-fitted with the vacuum blood collection tube.

[0016] Embodiments of the present invention also provide a sample processing method for rivastigmine testing, comprising the following steps:

[0017] S1, Blood sample collection: Take 4 mL of blood sample and place it in a vacuum blood collection tube containing K2EDTA anticoagulant that has been labeled and pre-cooled. After mixing by inverting, insert the tube into the insertion hole so that the vacuum blood collection tube is immersed in ice water inside the hollow structure.

[0018] S2, Centrifugation: The low-temperature storage box filled with vacuum blood collection tubes is fixed to the electric turntable by a locking structure. The electric turntable drives the low-temperature storage box to rotate at high speed, so that the blood sample inside the vacuum blood collection tube is centrifuged at low temperature inside the low-temperature storage box, and then the plasma sample is separated.

[0019] S3, quantitative aliquoting: The separated plasma sample is divided into two portions. Take 0.8-1.5 mL of plasma sample and add it to the test cryovial. Put the remaining plasma sample into the backup cryovial.

[0020] S4, cryopreservation: The test cryopreservation tubes and backup cryopreservation tubes obtained in S3 are temporarily stored in a -20℃ freezer for 0-2 hours. Then, within 0-24 hours after blood sample collection, they are transferred to an ultra-low temperature freezer at -60℃ or below for cryopreservation. Alternatively, within 0-2 hours after the blood sample centrifugation is completed, the test cryopreservation tubes and backup cryopreservation tubes obtained in S3 are directly transferred to an ultra-low temperature freezer at -60℃ or below for cryopreservation.

[0021] S5, pharmacokinetic analysis.

[0022] In one or more embodiments of the present invention, in step S1, the temperature of the ice water is 2 to 8°C.

[0023] In one or more embodiments of the present invention, in step S1, the low-temperature centrifugation time is 5 to 10 minutes.

[0024] Compared with the prior art, the embodiments of the present invention have the following technical effects:

[0025] This invention preserves collected blood samples in a low-temperature storage box using an ice bath, and allows for direct low-temperature centrifugation within the storage box. This significantly reduces the number of times blood samples need to be transferred, preventing sample deterioration during transfer, improving the accuracy of test results, reducing workload for researchers, and accelerating the testing process. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of a sample processing device for a rivastigmine test according to an embodiment of the present invention;

[0027] Figure 2 This is an exploded view of a sample processing apparatus for a rivastigmine test according to an embodiment of the present invention;

[0028] Figure 3 This is a top view of a low-temperature centrifuge for a sample processing apparatus for a rivastigmine test according to an embodiment of the present invention;

[0029] Figure 4 This is a front view cross-sectional structural diagram of a sample processing device for rivastigmine testing according to an embodiment of the present invention;

[0030] Figure 5 This is a schematic diagram of the clamping component structure of a sample processing device for rivastigmine testing according to an embodiment of the present invention;

[0031] Figure 6 is a flow chart of a rivastigmine test sample processing method according to an embodiment of the present invention.

[0032] Description of main reference numerals:

[0033] 1. Low-temperature centrifuge; 2. Touch screen; 3. Assembly groove; 4. Screw cap; 401. Handle; 5. Compression assembly; 501. Compression plate; 502. Hexagonal nut; 503. Rotating handle; 6. Flip cover; 7. Fixing post; 8. Low-temperature storage box; 801. Insertion hole; 8011. Inner liner sleeve; 802. Central hole; 803. Vacuum chamber; 804. Positioning block; 9. Threaded interface; 10. Electric turntable; 1001. Positioning hole. Detailed Description of the Embodiments

[0034] Specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings, but it should be understood that the protection scope of the present invention is not limited by the specific embodiments.

[0035] Unless otherwise expressly stated otherwise, throughout the specification and claims, the term "comprises" or variations thereof such as "comprises" or "including" will be understood to include the stated elements or components, but not exclude other elements or other components.

[0036] As shown in Figures 1 to 5 , a rivastigmine test sample processing device according to a preferred embodiment of the present invention includes a low-temperature centrifuge 1 and a low-temperature storage box 8. A touch screen 2 is installed on the low-temperature centrifuge 1, and the touch screen 2 facilitates controlling the operation of the low-temperature centrifuge 1 and displaying various parameters.

[0037] Referring to Figures 1-3 , the top of the low-temperature centrifuge 1 is provided with an assembly groove 3, and a rotary centrifugal mechanism is installed inside the assembly groove 3. Wherein, the rotary centrifugal mechanism includes an electric turntable 10 rotatably connected to the bottom of the assembly groove 3, and the electric turntable 10 is driven to rotate by a motor.

[0038] A flip cover 6 is rotatably connected to the low-temperature centrifuge 1, and the flip cover 6 can be flipped to cover the upper part of the assembly groove 3 to close the assembly groove 3, ensuring the safety during the operation of the low-temperature centrifuge 1.

[0039] Referring to Figure 2 and Figure 4 , the interior of the low-temperature storage box 8 is a hollow structure, and ice water is injected into the hollow structure, and the ice water is used for ice-bath storage of blood samples. A plurality of groups of insertion holes 801 are opened at the top end of the low-temperature storage box 8, and the plurality of groups of insertion holes 801 are used for installing vacuum blood collection tubes. The insertion holes 801 communicate with the hollow structure, and the vacuum blood collection tubes can pass through the insertion holes 801 and be inserted into the hollow structure, so that the tubes are immersed in the ice water, realizing ice-bath storage of blood samples.

[0040] Wherein, an inner liner 8011 is fixedly connected inside the insertion hole 801, and the inner liner 8011 can form an interference fit with the vacuum blood collection tube. The interference fit between the vacuum blood collection tube and the inner liner 8011 can not only realize the insertion and fixation of the vacuum blood collection tube, but also ensure the sealing performance between the vacuum blood collection tube and the inner liner 8011 to prevent ice water from leaking.

[0041] Preferably, the inner liner 8011 is made of rubber or silica gel, the inner wall of the inner liner 8011 can closely fit the outer wall of the vacuum blood collection tube, and the vacuum blood collection tube is fixed by friction.

[0042] Specifically, an appropriate amount of ice water is injected into the hollow structure in advance. After a blood sample is collected by the vacuum blood collection tube, the vacuum blood collection tube is directly inserted and fixed inside the insertion hole 801. At this time, the lower half part of the vacuum blood collection tube is immersed in ice water, so that the collected blood sample can be preserved in an ice bath to prevent deterioration.

[0043] It is worth noting that a vacuum chamber 803 is provided on the outer wall of the insertion hole 801. The vacuum chamber 803 enables the low-temperature storage box 8 to have a good heat preservation effect, so that the ice water inside the hollow structure can maintain a stable low temperature for a long time, which allows the blood samples to be stably preserved in an ice bath and is not prone to deterioration.

[0044] Referring Figure 1 , Figure 2 and Figure 4 , a screw cap 4 is screwed onto the low-temperature storage box 8, and the screw cap 4 is used to seal the low-temperature storage box 8. Wherein, a threaded interface 9 is fixedly connected to the low-temperature storage box 8, the inner wall of the screw cap 4 is provided with threads that cooperate with the threaded interface 9, and the screw cap 4 can be screwed and fixed on the low-temperature storage box 8 through the threaded interface 9.

[0045] Specifically, after the screw cap 4 is screwed and fixed onto the low-temperature storage box 8, the screw cap 4 and the low-temperature storage box 8 are combined into a sealed box body, which allows multiple vacuum blood collection tubes to be stably stored at low temperature in the sealed box body, making the use of the low-temperature storage box 8 safer and more reliable.

[0046] Wherein, two sets of handles 401 are fixedly connected to the screw cap 4. The handles 401 can not only facilitate the disassembly and assembly of the screw cap 4 on the low-temperature storage box 8, but also facilitate the carrying of the low-temperature storage box 8 and subsequent operations.

[0047] Referring Figure 1 and Figure 2 , a locking structure is provided between the low-temperature storage box 8 and the rotary centrifugal mechanism, and the low-temperature storage box 8 can be assembled on the electric rotary disc 10 through the locking structure, so that centrifugation can be directly performed on blood samples in several sets of vacuum blood collection tubes inside the low-temperature storage box 8.

[0048] Refer to Figure 2 As shown in the figure, the locking structure comprises a pressing assembly 5, a fixing column 7 and a central hole 802. The central hole 802 is opened on the central axis of the screw cap 4 and the low-temperature storage box 8, and the fixing column 7 is fixedly connected to the central axis of the electric turntable 10. The cross-sectional diameter of the fixing column 7 is smaller than that of the central hole 802, and the fixing column 7 can pass through the central hole 802.

[0049] Refer to Figure 4 As shown in the figure, an annular protrusion is arranged below the central hole 802 on the screw cap 4, and the annular protrusion can be tightly attached to the upper end surface of the low-temperature storage box 8 after the screw cap 4 is screwed onto the low-temperature storage box 8, ensuring that the box body formed by the screw cap 4 and the low-temperature storage box 8 has good sealing performance, and the sealing performance will not be affected by the central hole 802 on the screw cap 4.

[0050] The pressing assembly 5 is installed on the fixing column 7. After the fixing column 7 passes through the central hole 802 and the low-temperature storage box 8 is placed on the electric turntable 10, the pressing and fixing of the low-temperature storage box 8 can be realized by the pressing assembly 5, so that the low-temperature storage box 8 is assembled on the electric turntable 10, and centrifugal treatment is performed on blood samples in a plurality of vacuum blood collection tubes inside the low-temperature storage box 8.

[0051] Refer to Figure 3 and Figure 4 As shown in the figure, at least three groups of positioning blocks 804 are welded and fixed at the bottom of the low-temperature storage box 8, and positioning holes 1001 corresponding to the positioning blocks 804 in number are formed on the electric turntable 10. When the low-temperature storage box 8 is placed on the electric turntable 10, the positioning blocks 804 are inserted into the positioning holes 1001, which can position the low-temperature storage box 8 and improve the stability of the low-temperature storage box 8 on the electric turntable 10, so as to ensure that the low-temperature storage box 8 can rotate stably along with the electric turntable 10 on the electric turntable 10 and guarantee the centrifugal effect of blood samples.

[0052] Refer to Figure 5 As shown in the figure, the pressing assembly 5 comprises a pressing plate 501 and a hexagon nut 502. The hexagon nut 502 is welded and fixed on the pressing plate 501, and the electric turntable 10 is provided with threads matching the hexagon nut 502. The hexagon nut 502 can rotate and lift on the fixing column 7 through threads, so as to realize the pressing and fixing of the low-temperature storage box 8.

[0053] Wherein, a pair of rotating handles 503 is also welded and fixed on the hexagon nut 502, which facilitates manual rotation of the hexagon nut 502 through the rotating handles 503, making the operation more convenient.

[0054] Specifically, the fixing post 7 passes through the central hole 802 on the cap 4 and the low-temperature storage box 8. The low-temperature storage box 8 is placed on the electric turntable 10. Then, the hexagonal nut 502 is manually rotated by the rotating handle 503, causing the hexagonal nut 502 to drive the clamping plate 501 to rotate and descend until the clamping plate 501 is pressed tightly against the cap 4. This fixes the low-temperature storage box 8 on the electric turntable 10, thereby transferring the array of vacuum centrifuge tubes into the low-temperature centrifuge 1. At this time, the flip cover 6 is closed, and the electric turntable 10 is driven by the motor to rotate at high speed, which drives the low-temperature storage box 8 to rotate at high speed, thereby centrifuging the blood sample in the array of vacuum centrifuge tubes inside the low-temperature storage box 8.

[0055] This eliminates the need to transfer each array of vacuum centrifuge tubes individually into the cryogenic centrifuge 1, effectively preventing blood sample deterioration caused by repeated transfers and ensuring the accuracy of test results. It also reduces the workload for laboratory personnel and accelerates the experimental process.

[0056] It is worth noting that the low-temperature centrifugation process is carried out under the ice bath conditions inside the low-temperature storage box 8, so that the low-temperature centrifuge 1 no longer needs to be pre-cooled or connected to an external refrigeration system, saving unnecessary operations and reducing test costs.

[0057] In use, after collecting blood samples using an array of vacuum blood collection tubes, the array of vacuum blood collection tubes are sequentially inserted and fixed inside the low-temperature storage box 8 until all the sockets 801 on the low-temperature storage box 8 are filled with a set of vacuum blood collection tubes. Of course, the vacuum blood collection tubes can be used even if blood samples have been collected. In actual use, it is only necessary to ensure that all the sockets 801 on the low-temperature storage box 8 are filled with a set of vacuum blood collection tubes before proceeding to the next centrifugation operation, to ensure that the ice water inside the hollow structure cannot be ejected through the sockets 801 during centrifugation.

[0058] Next, screw the cap 4 onto the low-temperature storage box 8, then position the low-temperature storage box 8 on the electric turntable 10 and lock it in place using the clamping assembly 5. Close the flip cover 6 and start the motor drive for centrifugation. After centrifugation, open the flip cover 6, remove the clamping assembly 5, and use the handle 401 to pull the low-temperature storage box 8 out of the assembly slot 3.

[0059] like Figure 6 As shown, a sample processing method for a rivastigmine test according to a preferred embodiment of the present invention includes the following steps:

[0060] S1, Blood sample collection: Take 4 mL of blood sample and place it in a vacuum blood collection tube containing K2EDTA anticoagulant that has been labeled and pre-cooled. After mixing by inverting, insert the tube into the socket 801 so that the vacuum blood collection tube is immersed in ice water inside the hollow structure.

[0061] S2, centrifugal separation: The low-temperature storage box 8 filled with vacuum blood collection tubes is fixed to the electric turntable 10 by a locking structure. The electric turntable 10 drives the low-temperature storage box 8 to rotate at high speed, so that the blood sample inside the vacuum blood collection tube is centrifuged at low temperature inside the low-temperature storage box 8, and then the plasma sample is separated.

[0062] S3, quantitative aliquoting: The separated plasma sample is divided into two portions. Take 0.8-1.5 mL of plasma sample and add it to the test cryovial. Put the remaining plasma sample into the backup cryovial.

[0063] S4, cryopreservation: The test cryopreservation tubes and backup cryopreservation tubes obtained in S3 are temporarily stored in a -20℃ freezer for 0-2 hours. Then, within 0-24 hours after blood sample collection, they are transferred to an ultra-low temperature freezer at -60℃ or below for cryopreservation. Alternatively, within 0-2 hours after the blood sample centrifugation is completed, the test cryopreservation tubes and backup cryopreservation tubes obtained in S3 are directly transferred to an ultra-low temperature freezer at -60℃ or below for cryopreservation.

[0064] S5, pharmacokinetic analysis.

[0065] Preferably, in S1, the temperature of the ice water is 2-4℃.

[0066] Preferably, in S1, the low-temperature centrifugation time is 10 min.

[0067] This invention preserves the collected blood samples in a low-temperature storage box 8 using an ice bath, and allows for direct low-temperature centrifugation within the storage box 8. This significantly reduces the number of times the blood samples need to be transferred, not only preventing the blood samples from deteriorating during transfer and improving the accuracy of the test results, but also reducing the workload of the test personnel and accelerating the test progress.

[0068] The foregoing description of specific exemplary embodiments of the invention is for illustrative and explanatory purposes. These descriptions are not intended to limit the invention to the precise forms disclosed, and it will be apparent that many changes and variations can be made in accordance with the foregoing teachings. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application, thereby enabling those skilled in the art to implement and utilize various different exemplary embodiments of the invention, as well as various different choices and variations. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A sample processing device for the rivastigmine test, characterized in that, include: A low-temperature centrifuge has an assembly slot at the top, and a rotary centrifugation mechanism is installed inside the assembly slot. The low-temperature storage box has a hollow internal structure, which is filled with ice water. The top of the low-temperature storage box has several sets of insertion holes for installing vacuum blood collection tubes. A screw cap is screwed onto the low-temperature storage box to seal it. A locking structure is provided between the low-temperature storage box and the rotary centrifuge mechanism. The low-temperature storage box can be assembled onto the rotary centrifuge mechanism through the locking structure, thereby allowing the blood samples from several sets of vacuum blood collection tubes to be centrifuged directly inside the low-temperature storage box.

2. The sample processing device for the rivastigmine test as described in claim 1, characterized in that, The rotary centrifugal mechanism includes an electric turntable rotatably connected to the bottom of the assembly slot, which is driven to rotate by a motor.

3. The sample processing device for the rivastigmine test as described in claim 2, characterized in that, The locking structure includes a clamping component, a fixing post, and a central hole. The central hole is located on the central axis of the cap and the low-temperature storage box. The fixing post is fixedly connected to the central axis of the electric turntable and can pass through the central hole. The clamping component is mounted on the fixing post.

4. The sample processing device for the rivastigmine test as described in claim 3, characterized in that, The clamping assembly includes a clamping plate and a hexagonal nut, the hexagonal nut being fixedly connected to the clamping plate, and the fixing post having threads that match the hexagonal nut.

5. The sample processing device for the rivastigmine test as described in claim 1, characterized in that, The low-temperature storage box is fixedly connected to a threaded interface, and the screw cap is matched with the threaded interface.

6. The sample processing device for the rivastigmine test as described in claim 5, characterized in that, A vacuum chamber is provided on the outer wall of the socket.

7. The sample processing device for the rivastigmine test as described in claim 1, characterized in that, An inner liner is fixedly connected inside the insertion hole, and the inner liner can be interference-fitted with the vacuum blood collection tube.

8. A sample preparation method for a rivastigmine test, comprising a sample preparation apparatus for a rivastigmine test as described in any one of claims 1 to 7, characterized in that, Includes the following steps: S1, Blood sample collection: Take 4 mL of blood sample and place it in a vacuum blood collection tube containing K2EDTA anticoagulant that has been labeled and pre-cooled. After mixing by inverting, insert the tube into the insertion hole so that the vacuum blood collection tube is immersed in ice water inside the hollow structure. S2, Centrifugation: The low-temperature storage box filled with vacuum blood collection tubes is fixed to the electric turntable by a locking structure. The electric turntable drives the low-temperature storage box to rotate at high speed, so that the blood sample inside the vacuum blood collection tube is centrifuged at low temperature inside the low-temperature storage box, and then the plasma sample is separated. S3, quantitative aliquoting: The separated plasma sample is divided into two portions. Take 0.8-1.5 mL of plasma sample and add it to the test cryovial. Put the remaining plasma sample into the backup cryovial. S4, cryopreservation: The test cryopreservation tubes and backup cryopreservation tubes obtained in S3 are temporarily stored in a -20℃ freezer for 0-2 hours. Then, within 0-24 hours after blood sample collection, they are transferred to an ultra-low temperature freezer at -60℃ or below for cryopreservation. Alternatively, within 0-2 hours after the blood sample centrifugation is completed, the test cryopreservation tubes and backup cryopreservation tubes obtained in S3 are directly transferred to an ultra-low temperature freezer at -60℃ or below for cryopreservation. S5, pharmacokinetic analysis.

9. A sample preparation method for rivastigmine testing as described in claim 8, characterized in that, In step S1, the temperature of the ice water is 2–8°C.

10. The sample processing method for the rivastigmine test as described in claim 8, characterized in that, In S1, the low-temperature centrifugation time is 5 to 10 minutes.

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