Automatic solution extraction and replenishment device for drug detection

Abstract

The utility model discloses a kind of solution automatic extraction replenishing device for drug detection, it relates to drug detection equipment technical field.It includes cup cover and solution displacer;Solution displacer includes driving part, shell and piston, shell is divided into bearing part and replacement part along axial direction, bearing part is separated with replacement part by partition;Driving part is fixedly installed on bearing part, its output end is downward and penetrates partition and extends into replacement part;Piston is arranged on the output end of driving part;The bottom of replacement part is equipped with the extraction port of solution, and the upper end of replacement part is equipped with liquid supplementing hole.The utility model has beneficial effect for integrating two steps of "extracting solution" and "replenishing new liquid" in one equipment, and automatically completing by driving part, realizes the automation of "extraction" and "replenishment", completely eliminates the huge workload and physical fatigue brought by frequent manual sampling, liquid supplementing of experimental personnel, and experimental personnel need not interrupt other work in fixed time point, can carry out on duty or multitask operation.

Description

Technical Field

[0001] This utility model relates to the field of pharmaceutical testing equipment technology, specifically to an automatic solution extraction and replenishment device for pharmaceutical testing. Background Technology

[0002] In the field of pharmaceutical quality control and research and development, drug dissolution testing is a crucial testing procedure. This test assesses the in vitro dissolution rate and extent of solid drug formulations (such as tablets and capsules) by simulating the dissolution behavior of drugs in the human gastrointestinal environment. It plays an irreplaceable role in ensuring the bioequivalence, batch-to-batch consistency, and product quality stability of drugs.

[0003] When conducting drug dissolution experiments, especially for formulations with special release behaviors such as sustained-release tablets, controlled-release tablets, and enteric-coated tablets, the dissolution profile is a key indicator for evaluating drug performance. To plot a complete dissolution profile, experimental procedures require precisely extracting a specific volume of sample solution from the dissolution vessel at different time points and immediately replenishing it with the same volume of blank dissolution medium at the same temperature.

[0004] Currently, most laboratory procedures rely on manual operation. Researchers need to manually insert a pipette or syringe into the dissolution vessel at predetermined time points to extract the solution, and then use another tool to measure and inject an equal volume of blank dissolution medium.

[0005] The experimenters need to frequently interrupt other work at different times to perform repetitive sampling and fluid replenishment operations, which is a huge workload and can easily cause fatigue. Summary of the Invention

[0006] The purpose of this invention is to address the problem in the prior art where laboratory personnel need to repeatedly perform sampling and replenishment operations at different time points, by providing an automatic solution extraction and replenishment device for drug testing.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: an automatic solution extraction and replenishment device for pharmaceutical testing, comprising... Dissolution tester; The reaction vessel is located within the working area of ​​the dissolution tester; A lid that detachably fits over the opening of the reaction vessel; A solution displacement device is vertically inserted through and fixedly mounted on the cup lid, with its lower part extending into the interior of the reaction vessel; The solution displacement device includes a drive unit, a housing, and at least one piston. The housing is divided axially into an upper support section and a lower displacement section, and the support section and the displacement section are separated by a horizontal partition. The driving component is fixedly installed on the bearing part, and its output end passes downward through the partition and extends into the replacement part. The pistons are equidistantly arranged on the output end of the drive member, and reciprocate along the axial direction of the replacement part under the drive of the drive member; The bottom of the replacement section is provided with an extraction port for extracting or discharging the solution, and the upper end of the replacement section is provided with a replenishment hole that communicates with the outside.

[0008] Furthermore, the replacement part includes a connecting end and a sleeve arranged sequentially from top to bottom. The upper part of the connecting end and the bearing part are integrally formed, and the lower part of the connecting end and the sleeve are detachably connected by threads.

[0009] Furthermore, the cup lid is provided with a sampling hole, a temperature measuring hole, and a stirring paddle hole for the stirring paddle of the dissolution tester to pass through; the outer wall of the bearing part is provided with an external thread, which is detachably fixed to the cup lid by thread engagement with the corresponding sampling hole on the cup lid.

[0010] Furthermore, the output end of the driving component is driven to connect to a piston rod, and a plurality of pistons are spaced apart on the piston rod along the extension direction of the piston rod; each piston has a sealing element on its outer peripheral surface, and the sealing element is used to form a sealing fit with the sleeve.

[0011] After adopting the above technical solution, the beneficial effects of this utility model are as follows: the device integrates the two steps of "extracting solution" and "replenishing new solution" into the solution replacement device, and completes them automatically through the driving component, realizing the automation of the two key steps of "extraction" and "replenishment", completely eliminating the huge workload and physical fatigue caused by frequent manual sampling and replenishment by experimental personnel. Experimental personnel do not need to interrupt other work at fixed time points and can perform on-duty or multi-tasking operations. Attached Figure Description

[0012] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0013] Figure 1 This is a schematic diagram of the structure of this utility model.

[0014] Figure 2 This is a schematic diagram showing the connection of the reaction vessel, cup lid, and solution displacement device in this utility model.

[0015] Figure 3 This is a schematic diagram of the cup lid structure in this utility model.

[0016] Figure 4 This is a schematic diagram of the solution displacement device in this utility model.

[0017] Figure 5 yes Figure 4 A sectional view.

[0018] Figure 6 yes Figure 5 The exploded diagram.

[0019] Explanation of reference numerals in the attached drawings: 1. Dissolution tester; 2. Reaction vessel; 3. Cup lid; 3. Sampling hole; 31. Temperature measuring hole; 32. Stirring paddle hole; 33. Solution displacement device; 4. Drive component; 41. Piston rod; 411. Housing; 42. Supporting part; 421. External thread; 4211. Displacement part; 422. Connecting end; 4221. Sleeve; 4222. Extraction port; 4223. Liquid replenishment hole; 4224. Partition plate; 423. Piston; 43. Seal; 431. Detailed Implementation

[0020] See Figure 1-6 As shown, the technical solution adopted in this specific embodiment is: an automatic extraction and replenishment device for drug testing solution. This device mainly includes a dissolution tester 1, a reaction container 2, a cup lid 3, and a solution replacement device 4.

[0021] The reaction vessel 2, such as a dissolution cup, is positioned within the designated working area of ​​the dissolution testing apparatus 1. A lid 3 is detachably fitted over the opening of the reaction vessel 2 to seal the vessel and support other components.

[0022] The cup lid 3 has multiple functional holes, including but not limited to: a sampling hole 31 for inserting a traditional sampling needle or installing a solution displacement device 4; a temperature measuring hole 32 for installing a temperature sensor; and a stirring paddle hole 33 for the stirring paddle of the dissolution tester 1 to extend downward into the reaction vessel 2 for stirring.

[0023] Solution Displacer 4 The solution displacement device 4 is the core component of this invention, vertically penetrating and fixedly mounted on the cup lid 3. Specifically, the outer wall of the supporting part 421 of the solution displacement device 4 is provided with external threads 4211, which engage with the sampling hole 31 pre-set on the cup lid 3 to achieve detachable fixed installation. This design allows the device to utilize the interfaces of existing equipment and facilitates disassembly, cleaning, and maintenance. After installation, the lower displacement part 422 of the solution displacement device 4 extends below the internal liquid level of the reaction vessel 2.

[0024] The solution displacement device 4 mainly consists of a drive element 41, a housing 42, and at least one piston 43.

[0025] The housing 42 is axially divided into an upper support portion 421 and a lower replacement portion 422. The support portion 421 and the replacement portion 422 are separated by a horizontal partition 423. The replacement portion 422 further includes a connecting end 4221 and a sleeve 4222 arranged sequentially from top to bottom. The upper part of the connecting end 4221 and the support portion 421 are preferably integral structures to ensure overall strength. The lower part of the connecting end 4221 is detachably connected to the sleeve 4222 by threads. This design greatly facilitates the installation and replacement of the piston 43 inside the sleeve 4222 and the cleaning of the inner wall of the sleeve 4222.

[0026] A drive element 41, such as a stepper motor or a precision linear motor, is fixedly mounted on the upper part of the support portion 421. Its output end extends downward through the partition 423 and into the sleeve 4222 of the replacement portion 422. The output end of the drive element 41 is driven to connect a piston rod 411. At least one piston 43 (multiple pistons are shown in the figure) is fixedly disposed on the piston rod 411 at equal intervals along the extension direction of the piston rod 411. Each piston 43 has a sealing element 431, such as an O-ring, on its outer peripheral surface. This sealing element 431 forms a dynamic sealing fit with the inner wall of the sleeve 4222 to ensure the sealing performance of the piston 43 during sliding.

[0027] At the bottom of the replacement section 422, i.e., at the bottom end of the sleeve 4222, an extraction port 4223 is provided for extracting solution when the piston 43 moves. At the upper end of the replacement section 422, i.e., near the connection end 4221, a replenishment hole 4224 is provided.

[0028] The working principle of this utility model: Prerequisites: Assume that the experimental procedure requires 10 mL of solution to be drawn for analysis at regular intervals or at specific time points (e.g., every 30 minutes).

[0029] Phase 1: Preparation Phase (Before Sampling) 1. Initial position adjustment of piston 43 and pre-filling with electrolyte: The drive unit 41 (a lifting motor with timing and displacement control) is activated, adjusting the position of the piston rod 411 so that the first piston 43 at the uppermost end of the piston rod 411 moves to close the opening of the housing 42. At this time, a pre-filled cavity is formed inside the replacement part 422 above the first piston 43.

[0030] Blank dissolution medium (replenishment liquid) is injected into and fills the pre-filled cavity through the replenishment hole 4224 at the upper end of the replacement section 422.

[0031] At this point: the first piston 43 seals the upper end of the displacement section 422, and its lower part is connected to the solution in the reaction vessel 2; the pre-filling chamber above it is already filled with replenishing liquid.

[0032] 2. Device in place: Add the specified volume of dissolution medium to reaction vessel 2. Securely screw the assembled solution displacement device 4 into the sampling hole 31 of the cup lid 3 via the external thread 4211 of its support part 421. Place the cup lid 3, with the solution displacement device 4, temperature probe, etc., already installed, onto reaction vessel 2, ensuring a tight seal to maintain a sealed system.

[0033] Phase Two: Synchronous Sampling and Fluid Replacement Phase The device simultaneously performs two actions—sampling from below and discharging replenishing fluid from above—during the single upward movement of piston 43. At a preset time point (e.g., 30 minutes), the drive unit 41 receives an "execute" command, driving piston rod 411 to synchronously slide all pistons 43 upwards.

[0034] 1. Lower cavity: Sampling process Creating negative pressure: When the piston rod 411 moves upward, the first piston 43 will create a negative pressure (vacuum) region in the displacement part 422 below it.

[0035] Liquid aspiration: Under negative pressure, the test solution in reaction vessel 2 is aspirated into its internal cavity through the extraction port 4223 at the lower end of the displacement section 422.

[0036] Precise sampling: The drive unit 41 controls the piston 43 to move upward by a fixed stroke, and the volume corresponding to this stroke is the volume of the sample to be extracted (e.g., 10 mL).

[0037] 2. Upper cavity: Fluid resuscitation process Synchronous discharge: At the same moment that piston rod 411 moves upward, the first piston 43 also moves upward. Its movement causes the volume of the pre-filled chamber above it to decrease.

[0038] Pressure-driven: The reduction in the volume of the prefill chamber will generate pressure on the prefilled replenishment fluid inside the chamber.

[0039] Replenishment injection: Driven by this pressure, the replenishment liquid in the pre-filled chamber is squeezed out of the replacement part 422 through the replenishment hole 4224 and injected into the reaction vessel 2 immediately.

[0040] 3. Completion of action and sealing: When the upward sliding stroke ends, the second piston 43 moves exactly to the position of the first piston 43, closing the extraction port 4223 of the replacement section 422, sealing the 10mL sample liquid that was just drawn in within the cavity between it and the first piston 43, isolating it from the pre-filling cavity above and the reaction container 2 below.

[0041] At this point, one cycle ends: 10 mL of the test solution has been removed from reaction vessel 2 and immediately and synchronously injected with 10 mL of blank replenishment solution, keeping the total volume unchanged.

[0042] 4. Multiple sampling and fluid replacement At the next time point (e.g., 45 minutes, 60 minutes), the device will repeat the process of Phase 2, automatically completing a new round of sampling and liquid replenishment. Finally, the housing 42 will be divided into multiple chambers by the piston 43 to store sample liquids from different time periods.

[0043] Phase 3: Equipment cleaning after the test is completed 1. Disassembly: Unscrew the solution displacement device 4 from the sampling hole 31 of the cup lid 3.

[0044] Unscrew the threads of the sleeve 4222 and the connecting end 4221 to separate the sleeve 4222 from the bearing part 421.

[0045] Carefully remove the piston rod 411 assembly (with piston 43) from the sleeve 4222.

[0046] 2. Cleaning: Thoroughly clean the inside of sleeve 4222, piston 43, and piston rod 411 using the prescribed cleaning agent (such as purified water, diluted soap solution, or a suitable solvent).

[0047] 3. Drying and Inspection: Wipe all cleaned parts dry with a lint-free cloth or let them air dry.

[0048] Inspect seal 431 for wear, deformation or cracks, and replace it immediately if necessary.

[0049] The above description is only used to illustrate the technical solution of this utility model and is not intended to limit it. Any other modifications or equivalent substitutions made by those skilled in the art to the technical solution of this utility model, as long as they do not depart from the spirit and scope of the technical solution of this utility model, should be covered within the scope of the claims of this utility model.

Claims

1. An automatic solution extraction and replenishment device for pharmaceutical testing, characterized in that: include Dissolution tester (1); The reaction vessel (2) is located within the working area of ​​the dissolution tester (1); The cup lid (3) is detachably fitted onto the opening of the reaction vessel (2); The solution displacement device (4) is vertically inserted through and fixedly installed on the cup lid (3), and its lower part extends into the interior of the reaction vessel (2); The solution displacement device (4) includes a drive (41), a housing (42) and at least one piston (43). The housing (42) is divided axially into an upper support part (421) and a lower displacement part (422). The support part (421) and the displacement part (422) are separated by a horizontal partition (423). The driving component (41) is fixedly installed on the bearing part (421), and its output end passes through the partition (423) downward and extends into the replacement part (422); The pistons (43) are equidistantly arranged on the output end of the drive member (41), and reciprocate along the axial direction of the replacement part (422) under the drive of the drive member (41). The bottom of the replacement part (422) is provided with an extraction port (4223) for extracting or discharging solution, and the upper end of the replacement part (422) is provided with a replenishment hole (4224) communicating with the outside.

2. The automatic solution extraction and replenishment device for pharmaceutical testing according to claim 1, characterized in that: The replacement part (422) includes a connecting end (4221) and a sleeve (4222) arranged sequentially from top to bottom. The upper part of the connecting end (4221) and the bearing part (421) are integrally formed, and the lower part of the connecting end (4221) and the sleeve (4222) are detachably connected by threads.

3. The automatic solution extraction and replenishment device for pharmaceutical testing according to claim 1, characterized in that: The cup lid (3) is provided with a sampling hole (31), a temperature measuring hole (32), and a stirring paddle hole (33) for the stirring paddle of the dissolution tester (1) to pass through; the outer wall of the bearing part (421) is provided with an external thread (4211), which is detachably fixed to the cup lid (3) by threading with the corresponding sampling hole (31) on the cup lid (3).

4. The automatic solution extraction and replenishment device for pharmaceutical testing according to claim 1, characterized in that: The output end of the drive member (41) is driven to connect to the piston rod (411), and a plurality of pistons (43) are spaced apart on the piston rod (411) along the extension direction of the piston rod (411); each piston (43) is provided with a sealing member (431) on its outer peripheral surface, and the sealing member (431) is used to form a sealing fit with the sleeve (4222).

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