A multi-module collaborative drug content uniformity detection pretreatment system and method

Abstract

The application discloses a multi-module cooperative medicine content uniformity detection pretreatment system and method, and belongs to the technical field of medicine detection. The system comprises a container processing module, a fluid processing module, a constant volume module, a mixing module, a transfer module and a control system. The container processing module realizes automatic cap pulling and cap pressing of non-standard capacity bottles; the fluid processing module realizes liquid injection and pipetting; the constant volume module realizes automatic constant volume through visual identification; the mixing module realizes automatic liquid mixing; the transfer module automatically transfers containers between modules; the control system determines the operation sequence, controls the transfer module to sequentially transfer the containers and triggers each module to perform operations, and simultaneously receives state feedback. Through multi-module cooperative linkage, the application realizes full-process automation of plaster medicine detection pretreatment without manual intervention, significantly improves processing efficiency, precision and consistency, and has state monitoring and data tracing functions.

Description

Technical Field

[0001] This invention belongs to the field of drug detection technology, specifically relating to a multi-module collaborative drug content uniformity detection pretreatment system and method, so as to realize the automation, standardization and intelligentization of pretreatment for drug content uniformity detection in plasters. Background Technology

[0002] Drug content uniformity is one of the core indicators for evaluating the quality of pharmaceutical preparations, and it is directly related to the safety and efficacy of clinical medication. All pharmaceutical preparations must undergo content uniformity testing to verify product quality consistency before being marketed and during production. Among these, pretreatment, as a crucial preliminary step in content uniformity analysis, directly determines the reliability of subsequent test results through its standardized operation, accuracy, and efficiency.

[0003] Due to the unique dosage form of plaster-type drugs (usually composed of a backing layer, a drug matrix layer, and a capping layer), the pretreatment process for detecting the uniformity of drug content is distinctive. The drug components in the plaster must first be extracted into a solvent before being analyzed by subsequent testing instruments. This pretreatment process involves multiple consecutive steps, including removing the cap, injecting the solution, ultrasonic extraction, cooling in water, making up to volume, mixing, and transferring the solution, and requires the use of non-standard glass volumetric flasks as the core container.

[0004] Currently, there is no mature, fully automated solution for the pretreatment of plaster drugs for testing. The industry still generally relies on manual labor or semi-automated equipment, which has the following technical shortcomings: Low detection accuracy and poor consistency: Volume determination requires manual observation of the scale lines, which is affected by visual errors, operating rhythm and individual experience differences; some of the liquids used in the rapid liquid injection process are harmful to the human body, and there is a risk of liquid contact or inhalation of volatilization during manual operation; the pipetting process requires extremely high precision, and manual operation is limited by hand stability; the mixing process relies on manual shaking, and it is difficult to unify the force and frequency, resulting in distorted test data.

[0005] Independent and decentralized modules lead to process interruptions and low efficiency: existing injection, ultrasound, cooling, and pipetting are mostly independent modules with no collaborative linkage mechanism between modules. Manual transfer of volumetric flasks is required to complete the connection between each step, which not only increases the cost of manual intervention but also causes process interruptions and makes it impossible to achieve continuous processing.

[0006] Insufficient adaptability: Existing automated capping and pressing modules are mostly designed for standard volumetric bottles and cannot be adapted to non-standard specifications. They also require manual and repeated parameter adjustments, lack stall protection, and are prone to component damage.

[0007] Therefore, providing a drug content uniformity detection pretreatment system and method that can automate the entire pretreatment process, enable multi-module collaborative linkage, and adapt to non-standard containers is a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0008] To address the aforementioned technical problems, this invention provides a multi-module collaborative drug content uniformity detection pretreatment system and method to overcome the technical defects of existing technologies, such as low detection accuracy, poor consistency, independent and dispersed modules, and insufficient adaptability.

[0009] This invention achieves efficient, accurate, and safe pre-processing for detection by constructing a dual-core system architecture consisting of "multiple operational modules" and "control system".

[0010] The system adopts a modular architecture, consisting of a container processing module, a fluid processing module, a volume control module, a mixing module, a transfer module, and a control system. These modules work together to form a complete closed-loop system. Preferably, the system further includes at least one of an ultrasonic processing module and a cooling processing module.

[0011] Specifically, this invention automatically transfers containers between various operating modules via a transfer module. The control system determines the required operations and corresponding operating modules, controls the transfer module to sequentially transfer containers to the designated operating modules, and controls the operating module to perform the corresponding operation upon arrival, while receiving status feedback. The container handling module achieves automated and precise capping and capping of non-standard volumetric flasks through precise force and angle control of the grippers. It uses an EEPROM storage chip to pre-store multiple specification parameters and is equipped with a current detection chip for stall protection. The fluid handling module uses a combination of closed-loop stepper motor and peristaltic pump control to achieve precise and rapid liquid injection into the container. The volume adjustment module uses an industrial camera vision recognition, backlight illumination, and dual-pump collaboration to achieve automatic volume adjustment. The mixing module uses a servo motor with precise speed control and a double-fixed anti-shake design to achieve automatic mixing of liquids within the container. The pipetting unit uses pressure monitoring to achieve precise pipetting from large bottles to small bottles. Each module has a built-in storage unit and status detection unit to achieve parameter pre-storage, automatic adaptation, and anomaly protection.

[0012] Thus, this invention achieves a complete closed loop from container handling to mixing and then to pipetting, significantly improving the efficiency, accuracy and automation level of pretreatment before detection.

[0013] According to one aspect of the present invention, a multi-module collaborative pretreatment system for detecting drug content uniformity is provided, comprising: The system comprises multiple operating modules, including a container processing module, a fluid processing module, a volume-fixing module, and a mixing module; preferably, the multiple operating modules further include at least one of an ultrasonic processing module and a cooling processing module; wherein, the container processing module is used to perform opening and / or sealing operations on the container; the fluid processing module is used to inject and / or remove liquid from the container; the volume-fixing module is used to adjust the liquid level in the container to a target scale; and the mixing module is used to mix the liquid in the container. A transfer module is used to automatically transfer the container between the plurality of operating modules; The control system is communicatively connected to the transfer module and the multiple operation modules. The control system is used to determine at least one operation to be performed and the corresponding work module, control the transfer module to transfer the container to the determined work module in sequence, control the arrived work module to perform the corresponding operation after the container arrives at each work module, and receive status feedback after each work module performs the operation.

[0014] In another aspect, the present invention provides a pretreatment method for detecting drug content uniformity based on the multi-module collaboration of the above-mentioned system, which includes the following steps: The control system determines at least one operation to be performed and the corresponding work module; The control system controls the transfer module to sequentially transfer the containers to the designated operation modules; After the container arrives at each of the work modules, the control system controls the arriving work modules to perform the corresponding operations; The control system receives status feedback from each of the operation modules after they have performed their operations.

[0015] Compared with the prior art, the present invention has the following beneficial effects: Multi-module collaboration automates the entire pre-treatment process for plaster application. Key pre-treatment modules, such as non-standard volumetric flask processing, large-bottle volume adjustment, mixing, and pipetting, are interconnected with a host computer via a 485 bus. Combined with a robotic arm for full-stroke transport, this achieves fully automated execution of the pre-treatment process, including cap removal, liquid injection, ultrasonication, cooling, volume adjustment, mixing, and pipetting, without human intervention. This addresses the core pain points of existing technologies, such as manual connection of scattered equipment, high dependence, and low efficiency.

[0016] High-precision volume control and pipetting are both guaranteed. The volumetric flask volume control module adopts an industrial camera vision recognition, backlight illumination, and dual-pump collaboration solution, while the pipetting unit adopts a pressure monitoring solution, accurately ensuring the consistency and reliability of automated processing results and laying the foundation for the accuracy of subsequent test results.

[0017] A closed-loop system for end-to-end status monitoring and data traceability. The host computer collects key parameters from each collaborative module in real time, forming a closed-loop control system encompassing operation, monitoring, alarm, and recording; data is stored in real time, improving the automation system. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application 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 recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the overall architecture of the multi-module collaborative drug content uniformity detection pretreatment system provided in this embodiment of the invention. Figure 2 This is a schematic diagram of the control system workflow provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the working process of the pipetting unit provided in the embodiment of the present invention.

[0020] Terminology Explanation To facilitate understanding of the technical solution of this invention, some technical terms appearing in the specification are explained as follows: Non-standard volumetric flasks: These are glass volumetric flasks with non-standard dimensions, typically with a mouth diameter of 15 to 30 mm and a height of 80 to 150 mm. These containers are commonly used in the pretreatment of plaster-type medications. This system can flexibly adapt to different sizes of non-standard volumetric flasks by changing specialized clamps or bases.

[0021] Cap removal / cap pressing: refers to the operation of opening and closing the cap of a volumetric flask. Cap removal involves releasing the seal between the cap and the flask body by clamping the cap with the jaws, rotating it 180 degrees to break the seal, and then pulling it upwards to completely separate the cap from the flask body. Cap pressing involves pressing the cap down until it is completely sealed to the flask body.

[0022] Volumetric grading: This refers to the operation of adding liquid to a container to precisely reach a predetermined graduation mark on the container. This invention uses an industrial camera to capture images of the container, and the control system identifies the liquid level from the image, compares it with the target graduation mark, and then controls the liquid replenishment unit to add liquid.

[0023] Closed-loop stepper motor: This refers to a stepper motor with a built-in encoder that can provide real-time feedback on position and speed information. Combined with a closed-loop stepper motor driver, it enables precise position and speed control. In this invention, it is used to drive the precise movement of bottle pressing modules, cap removing modules, etc.

[0024] Peristaltic pump: A pump that delivers liquid by squeezing a tubing, characterized by liquid not contacting the pump body, no pollution, and high precision, suitable for liquid injection operations. In this invention, it is used for rapid liquid injection and rapid liquid replenishment.

[0025] Injection pump: A pump that achieves high-precision micro-volume liquid delivery through the propulsion of a syringe piston. It is suitable for micro-volume replenishment and pipetting operations at the end of a constant volume, enabling liquid delivery control with precision down to the micro-level.

[0026] EEPROM: Electrically Erasable Programmable Read-Only Memory, used to retain stored parameter data even after power loss. In this invention, it is used to pre-store the core parameters for cap removal and cap pressing corresponding to different specifications of non-standard capacity bottles, including the gripper stroke, the stroke of the upper and lower cap gripping module, and the stroke of the bottle pressing module. Each specification corresponds to a unique set of parameters, eliminating the need for repeated adjustments during subsequent use.

[0027] Current detection chip: The present invention uses the INA2266 chip to collect the working current of the closed-loop stepper motor in real time. The sampling frequency is 10 Hz. When the current is detected to rise abnormally and exceed the preset threshold, it is determined that the motor is in a stall state and the protection mechanism is triggered.

[0028] The RS-485 bus is a commonly used serial communication bus standard in industrial settings, characterized by strong anti-interference capabilities and support for multi-point communication. In this invention, it is used for bidirectional communication between the host computer and the control boards of each module.

[0029] Industrial camera: A high-resolution camera used to capture images of containers. It is fixed on the modular frame with an adjustable precision bracket and can be driven by a stepper motor to achieve smooth up and down movement with a displacement accuracy of ±0.01 mm. It is suitable for volumetric flasks of different heights, ranging from 20 ml to 250 ml.

[0030] Backlight: A high-brightness LED surface light source is used, installed on the opposite side of the industrial camera and coaxially aligned with the camera lens. The brightness is adjusted through a dimming module to enhance the contrast between the volumetric flask graduation lines and the sample liquid surface.

[0031] Robotic arm: A programmable, multi-degree-of-freedom automated gripping and handling device for transferring containers between modules. In this invention, it is used to grip volumetric flasks from a material pallet, transfer them between work modules, and return the processed containers to the pallet.

[0032] Host computer: refers to a computer device used for human-computer interaction and system monitoring. It is usually equipped with an operating interface for parameter setting, status monitoring, and data recording. In this invention, operators can independently configure the operating parameters of each functional module through the host computer. All configuration parameters can be saved and reused after being set once.

[0033] Dual-pump collaboration: The specified volume module uses an injection pump and a peristaltic pump connected in parallel to the injection pipeline. The control system performs differentiated replenishment control based on the difference between the liquid level and the target scale: when the difference between the liquid level and the target scale is large, the peristaltic pump is controlled to replenish the liquid quickly; when the liquid level is close to the scale line, that is, when the difference is less than the preset threshold, the injection pump is switched to replenish the liquid in small amounts.

[0034] Pressure sensor: Used to monitor the pressure of the pipetting line in real time. When an abnormal pressure is detected, it is determined that the pipetting is abnormal and feedback is sent to the control board. The control board suspends the pipetting operation and sends an alarm message to the host computer.

[0035] Pipetting unit: refers to the sub-unit in the fluid handling module used to remove liquid from one container to another, including the pipetting power unit, the pipetting execution unit, and the pressure sensor.

[0036] Control board: refers to the local control unit set in each functional module. It has a built-in control chip and communicates with the host computer via the 485 bus. It is used to receive instructions from the host computer, drive the execution components (including motors, pumps, etc.), collect sensor data and provide feedback on the status.

[0037] Development board: refers to the parameter writing tool used during the equipment debugging phase. It is used to write the debugged and calibrated operating parameters into the EEPROM storage chip, which is different from the control board during operation. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] The embodiments of this invention are written in a progressive manner.

[0040] Example 1: System Architecture like Figure 1 As shown, this invention provides a multi-module collaborative pretreatment system for detecting drug content uniformity. Its core lies in the automatic transfer of containers between various operational modules via a transport module, and the unified scheduling of the collaborative work of each module by the control system. The system adopts a modular architecture, consisting of multiple operational modules, a transport module, and a control system, working collaboratively to achieve a complete closed loop from container processing to mixing and then pipetting.

[0041] Specifically, the system includes the following functional modules: I. Container Processing Module The container processing module is used to perform opening and / or sealing operations on containers, realizing fully automated cap removal and cap pressing without manual intervention, solving the problems of cumbersome parameter debugging, lack of stall protection, and poor adaptability in existing technologies.

[0042] The module includes a first storage unit, a container fixing unit, a cover operation unit, and a first status detection unit.

[0043] The first storage unit uses an EEPROM storage chip to pre-store container operation parameters and a first state threshold for at least one specification of the container. During the debugging phase, the core parameters for cap removal and cap pressing corresponding to different specifications of non-standard volumetric bottles are calibrated. The diameter range of different specifications of non-standard volumetric bottles is 15 to 30 mm, and the height range is 80 to 150 mm. The core parameters include the gripper stroke, the stroke of the upper and lower cap gripping module, and the stroke of the bottle pressing module. After calibration, the parameters are written into the EEPROM storage chip via the development board. Each specification corresponds to a unique parameter set, and no repeated debugging is required during subsequent use. The preset clamping force for standard specification non-standard volumetric bottles is 5 to 8 Newtons, which can be flexibly adjusted according to the cap material. The cap removal rotation angle is uniformly 180 degrees.

[0044] The container fixing unit is used to fix the container based on the container operating parameters. After the robotic arm accurately transfers the non-standard volumetric bottle to be processed to the positioning position of this module's workbench, the host computer sends a cap removal command. After receiving the command, the control board retrieves the cap removal parameters matching the specification and sends a control signal to the closed-loop stepper motor driver to drive the bottle pressing module to move downwards until the bottle pressing claws are in contact with the top of the volumetric bottle, thus fixing the volumetric bottle and preventing the bottle from shaking when removing the cap.

[0045] The cap-operating unit is used to grasp and rotate the bottle cap of the container based on the container operation parameters to open or close the cap. When removing the cap, the cap-removing module moves downwards under the drive of a stepper motor until the servo gripper aligns with the cap. The control board then controls the servo gripper to clamp the cap with a preset clamping force. After clamping, the gripper rotates 180 degrees to break the seal between the cap and the bottle. After rotation, the cap-removing module pulls upwards at a preset speed until the cap is completely separated from the bottle, completing the cap removal action. When pressing the cap, the control board retrieves the pressing parameters corresponding to the bottle's capacity, controls the servo gripper to clamp the cap, drives the cap-removing module downwards to precisely align the cap with the bottle opening, and presses it down with a preset pressing pressure until the cap and bottle are completely fitted and sealed.

[0046] The first state detection unit uses a current detection chip to detect the first actual state parameter of the container processing module, which includes the operating current of the closed-loop stepper motor. The first state detection unit compares the first actual state parameter with the first state threshold in the first storage unit. When the first actual state parameter exceeds the first state threshold, protection is triggered. The sampling frequency is 10 Hz. The control board analyzes the current data in real time. When an abnormal increase in current exceeding a preset threshold is detected, it is determined to be a motor stall state, such as a stuck bottle cap or module jamming. The control board immediately triggers the protection mechanism, quickly cutting off the motor drive signal, stopping the module and gripper movement to prevent motor burnout, damage to the volumetric bottle or bottle cap, etc., and simultaneously sending a stall alarm message to the host computer via the 485 bus.

[0047] II. Fluid Processing Module The fluid handling module is used to inject and / or remove liquid from the container, enabling automated and precise injection of extractant and precise transfer from large bottles to small bottles, all without human intervention, effectively avoiding the risk of contact with harmful liquids.

[0048] The module includes a second storage unit, a second status detection unit, a liquid injection unit, and a liquid pipetting unit.

[0049] The second storage unit is used to pre-store fluid operation parameters and a second state threshold for at least one specification of the container. The fluid operation parameters include injection volume, injection rate, rinsing volume, pipetting volume, number of rinsing cycles, and number of cleaning cycles. The injection volume can be flexibly set within the range of 5 to 2000 ml according to actual needs.

[0050] The second state detection unit is used to detect a second actual state parameter of the fluid processing module. This second actual state parameter includes peristaltic pump operating parameters, stepper motor speed, syringe pump operating parameters, and pipetting line pressure. The second state detection unit compares the second actual state parameter with the second state threshold in the second storage unit. When the second actual state parameter exceeds the second state threshold, protection is triggered.

[0051] The injection unit includes an injection power unit and an injection output unit.

[0052] The liquid injection power unit is used to provide liquid delivery power based on the fluid operating parameters. The liquid injection power unit adopts a combination of a closed-loop stepper motor and a closed-loop stepper motor driver. After receiving the instructions from the host computer, the control board sends a control signal to the closed-loop stepper motor driver, driving the stepper motor to run at a preset speed. The stepper motor drives the peristaltic pump to run synchronously.

[0053] The liquid injection output unit is used to inject liquid into the container based on the liquid delivery power. The inlet of the peristaltic pump is connected to the outlet of the extract storage tank through a corrosion-resistant liquid pipeline, and the outlet of the peristaltic pump is fixedly connected to the injection needle tube through a liquid pipeline of the same specification. The height of the injection needle tube can be flexibly adjusted according to the non-standard volume bottle diameter to ensure that the needle tube is aligned with the bottle mouth during liquid injection and to avoid liquid spillage.

[0054] During operation, the control board collects the operating parameters of the peristaltic pump in real time and calculates the real-time injection volume by combining the stepper motor speed. When the injection volume is detected to have reached the preset value of the host computer, a stop command is immediately sent. The closed-loop stepper motor driver cuts off the motor power, the peristaltic pump stops running, and the rapid injection action is completed.

[0055] The pipetting unit includes a pipetting power unit, a pipetting execution unit, and a pressure sensor.

[0056] The pipetting power unit uses a high-precision syringe pump to provide pipetting power.

[0057] The pipetting unit includes a pipette and X-axis and Z-axis modules for driving the pipette to move, and is used to insert the pipette into a container to draw or inject liquid.

[0058] The pressure sensor is used to monitor the pressure of the pipetting line in real time. When an abnormal pressure is detected, it determines that the pipetting is abnormal, sends feedback to the control board, and the control board suspends the pipetting operation and sends an alarm message to the host computer.

[0059] III. Volume Control Module The volumetric flask adjustment module is used to adjust the liquid level in the container to the target mark. Through a closed-loop process of positioning, identification, replenishment, and termination, it realizes automated and accurate volumetric flask adjustment, effectively replacing manual operation.

[0060] This module includes a third storage unit, an imaging unit, a liquid replenishment unit, a third state detection unit, and volume control logic in the control system.

[0061] The third storage unit is used to pre-store the volume-fixing parameters and a third state threshold for at least one type of container. The volume-fixing parameters include the container size and target graduation position, with the container size ranging from 20 ml to 250 ml.

[0062] The imaging unit is used to acquire images of the container, which are then used to identify the liquid level within the container. The imaging unit employs an industrial camera, fixed to the module frame via an adjustable precision bracket. The camera lens is precisely aligned with the volumetric flask's graduation lines to ensure distortion-free imaging. The imaging unit can move smoothly up and down via a stepper motor, with a displacement accuracy of ±0.01 mm, adaptable to volumetric flasks of varying heights. The imaging unit is also equipped with a backlight, using a high-brightness LED surface light source, mounted opposite the industrial camera and coaxially aligned with the camera lens. Brightness is adjusted via a dimming module, enhancing the contrast between the volumetric flask's graduation lines and the sample liquid surface, thus resolving the graduation identification errors caused by insufficient light and shadow interference in existing technologies.

[0063] The replenishment unit is used to replenish liquid into the container. The replenishment unit includes an injection pump and a peristaltic pump, which are connected in parallel to the liquid injection line, which is made of corrosion-resistant material.

[0064] The third state detection unit is used to detect the third actual state parameter of the capacity-limiting module and compare the third actual state parameter with the third state threshold in the third storage unit. When the third actual state parameter exceeds the third state threshold, protection is triggered.

[0065] The control system is also used to determine the liquid level in the container based on the image, compare the liquid level with the target scale, and control the replenishment unit to replenish liquid into the container according to the comparison result and the volume control parameters. Specifically, the control system calculates the required replenishment volume based on the difference between the identified scale reference position and the preset target liquid level using a built-in algorithm, and performs differentiated replenishment control: when the difference between the liquid level and the scale line is large, the peristaltic pump is controlled to perform rapid replenishment; when the liquid level and the scale line are close, i.e., the difference is less than the preset threshold, the injection pump is switched to perform micro-replenishment. An industrial camera acquires liquid level images in real time, and the liquid level position is identified in real time through an intelligent vision algorithm. When the liquid level is detected to have reached the preset scale line, the liquid injection is immediately stopped, completing the entire volume control process and forming a closed-loop control.

[0066] IV. Mixing Module The mixing module is used to mix the liquid in the container. Through a closed-loop process of positioning, fixing, mixing, and resetting, it realizes the automated and uniform mixing of the liquid in the volumetric flask.

[0067] The module includes a fourth storage unit, a clamping unit, a mixing power unit, a transmission mechanism, a fixture base, and a fourth state detection unit.

[0068] The fourth storage unit is used to pre-store mixing parameters and a fourth state threshold for at least one specification of the container. The mixing parameters include mixing speed and mixing time, with the mixing speed ranging from 500 to 2000 revolutions per minute and the mixing time ranging from 1 to 10 minutes.

[0069] The clamping unit is used to clamp or loosen the container based on the mixing parameters. The clamping unit is fixed to the stepper motor drive via a rigid connector. The stepper motor can precisely control the lifting stroke of the clamping unit, with a stroke accuracy of ±0.05 mm. The clamping unit adopts a rigid clamping design, combined with a flexible clamping head, to avoid damaging the bottle body. It can automatically adjust the clamping force according to the height of the volumetric flask. The host computer sends a mixing command to the control board via a 485 bus. After receiving the command, the control board drives the stepper motor to rotate, causing the clamping unit to slowly move downwards until the flexible clamping head is tightly fitted against the bottle neck. The clamping force is automatically adjusted based on the current value fed back from a preset current sampling, thus clamping the volumetric flask. After mixing is complete, the control board drives the stepper motor to reverse, causing the clamping unit to rise upwards and disengage from the bottle neck.

[0070] The mixing power unit provides mixing power based on the mixing parameters. The mixing power unit uses a servo motor, which is bolted to a preset mounting position on the module frame. The motor output shaft is directly connected to the crank mechanism via a belt connection, enabling precise power output. The servo motor features adjustable speed and rapid response, allowing for flexible adjustment of operating parameters according to the mixing requirements of different samples.

[0071] The transmission mechanism is connected to the mixing power unit and is used to drive the container to reciprocate based on the mixing power. The transmission mechanism adopts a crank mechanism, and the output shaft of the servo motor drives the crank mechanism to reciprocate, thereby driving the clamp base and the volumetric flask to move synchronously, so as to achieve uniform mixing of the liquid in the volumetric flask.

[0072] The clamp base is used to support the container and is connected to the transmission mechanism. The clamp base is a replaceable design to accommodate bottles of different sizes, especially suitable for the mixing requirements of extraction containers of different sizes in the pretreatment of plaster-type drugs.

[0073] The fourth state detection unit is used to detect the fourth actual state parameter of the mixing module, which includes the servo motor speed, the position of the clamping unit, etc. The fourth state detection unit compares the fourth actual state parameter with the fourth state threshold in the fourth storage unit. When the fourth actual state parameter exceeds the fourth state threshold, protection is triggered. During operation, the control board monitors the speed in real time through the encoder built into the servo motor. If the speed deviates from the preset value by more than ±50 revolutions per minute, the drive current parameter is automatically adjusted immediately to ensure stable speed.

[0074] V. Transfer Module The transfer module is used to automatically transfer the container between the plurality of operation modules. Preferably, the transfer module includes a robotic arm for grasping the container and transferring it between the plurality of operation modules.

[0075] VI. Control System It should be noted that the control system of the present invention includes a host computer and control boards installed in each functional module. The control boards are connected to the host computer via a 485 bus and are used to receive commands from the host computer, drive the execution components, and provide feedback on the status.

[0076] The control system is communicatively connected to the transfer module and the multiple operating modules. Preferably, the control system is communicatively connected to the transfer module and the multiple operating modules via a 485 bus. The control board has a built-in dedicated control chip that establishes bidirectional communication with the host computer via the 485 bus. On the one hand, it receives control commands sent by the host computer, and on the other hand, it provides real-time feedback on the operating status of each component, including equipment status and liquid level detection results.

[0077] The control system is used to determine at least one operation to be performed and the corresponding work module; control the transfer module to sequentially transfer the container to the determined work module; after the container arrives at each work module, control the arrived work module to perform the corresponding operation; and receive status feedback after each work module performs the operation.

[0078] The control system is also used to record and store the operating status and operating parameters of each of the operation modules in real time, forming a traceable data record.

[0079] The control system is also used to suspend subsequent operations and issue an alarm signal when the received status feedback is an abnormal signal.

[0080] VII. Extended Modules Preferably, the plurality of operating modules further includes at least one of an ultrasonic processing module and a cooling processing module. The ultrasonic processing module is used to perform ultrasonic extraction on the sealed volumetric flask; the ultrasonic time and frequency can be set via a host computer. The cooling processing module is used to cool the ultrasonically extracted volumetric flask at a constant temperature; the cooling time and temperature can be set via a host computer. The transfer module is used to transfer the container to at least one of the ultrasonic processing module and the cooling processing module.

[0081] Example 2: Control System Workflow like Figure 2 As shown, the control system is the decision-making core of the entire system, and its workflow is as follows: S1. Parameter Configuration and Storage Operators can access the equipment's host computer interface to independently configure the operating parameters of each functional module, including rapid liquid injection volume, volume determination module specifications, ultrasonic treatment duration, cooling and temperature control duration, mixing speed and number of mixing cycles, transfer volume, and rinsing / washing cycles. After setting the parameters, clicking the start button will allow the equipment to run fully automatically and continuously; all configuration parameters can be saved and reused after a single setting.

[0082] S2. Determine the operation and corresponding module The control system determines at least one operation and its corresponding work module to be executed based on a preset process. For example, for the pretreatment process of plaster drugs, the determined operation sequence is: removing the cap, injecting liquid, sealing, ultrasonication, cooling, opening the cap, adjusting the volume, sealing, mixing, opening the cap, transferring liquid, and sealing.

[0083] S3. Control the transfer module to transfer containers. The control system controls the transfer module, i.e., the robotic arm, to sequentially transfer containers to designated work modules. The robotic arm picks up a 250 ml volumetric flask from the material tray and transfers it to the container processing module for automatic cap removal. The capped volumetric flask is then transferred to the dispensing unit of the fluid processing module for dispensing. After dispensing, it is returned to the container processing module for capping and sealing. The sealed volumetric flask is then transferred to the ultrasonic processing module for ultrasonic treatment. After ultrasonic treatment, it is transferred to the cooling processing module for constant temperature cooling. Once the cooling reaches the target temperature, it is transferred back to the container processing module to remove the cap. The capped volumetric flask is then transferred to the volume adjustment module for precise volume adjustment. After volume adjustment, it is capped again and transferred to the mixing module. After mixing, it is transferred to the container processing module for cap removal. The capped large bottle is transferred to the large bottle station of the pipetting unit in the fluid processing module, while the robotic arm simultaneously removes a small bottle from the small bottle material tray and transfers it to the small bottle station of the pipetting unit. After pipetting, the large volumetric flask is transported to the container processing module for capping and sealing, and then returned to the tray. The pipetting small bottles are also returned to the tray.

[0084] S4. Control the execution of operations by the job module. After the container arrives at each work module, the control system controls the arriving work module to perform the corresponding operation. The specific execution process of each module is as described in Example 1.

[0085] S5. Receive status feedback The control system receives status feedback from each operational module after it has performed its operation. Status feedback includes two types: completion signals and abnormal signals. When a completion signal is received, the control system continues to execute the next operation according to a preset sequence; when an abnormal signal is received, the control system suspends subsequent operations and issues an alarm signal.

[0086] S6. Data Recording and Traceability The control system records and stores the operating status and parameters of each work module in real time, forming a traceable data record. All configuration parameters can be saved and reused after being set once. The host computer collects key parameters of each collaborative module in real time, forming a closed-loop control system encompassing operation, monitoring, alarm, and recording.

[0087] Example 3: Complete Application Process of Plaster Drug Pretreatment Taking the pretreatment for detecting the uniformity of drug content in a plaster as an example, the specific application process of the system of this invention is described in detail. It should be noted that the system can operate in parallel; the following only describes the complete process executed on one bottle.

[0088] Sample preparation: The operator places the cut plaster sample into a 250 ml non-standard volumetric flask and tightens the seal; the material trays filled with 12 250 ml volumetric flasks and the material trays filled with 12 20 ml vials are placed in sequence at the designated workstations on the equipment platform.

[0089] Parameter Configuration: Operators access the equipment's host computer interface and configure the operating parameters for each functional module. Example parameters are as follows: Injection unit: 200 ml injection volume; Ultrasonic oscillation duration: 30 minutes, frequency: 100 kHz; Cooling duration: 15 minutes, temperature: 15 degrees Celsius; Large bottle volume adjustment: 250 ml; Mixing speed: 45 times per minute, duration: 300 seconds; Pipette unit settings: 3 rinses, 3000 μL rinse volume, 3000 μL pipetting volume, 1 wash, 5 ml wash volume. All configuration parameters can be saved and reused after a single setting.

[0090] Capping: After the equipment starts, the robotic arm automatically picks up a 250 ml volumetric flask from the material tray and transfers it to the container processing module for automatic capping. The control system retrieves the container operation parameters matching the volumetric flask specification from the first storage unit, including a clamping force of 5 to 8 Newtons and a capping rotation angle of 180 degrees. The control container fixing unit fixes the flask body, and the capping operation unit picks up the cap, rotates it 180 degrees, and then pulls it up to remove the cap. During capping, the current detection chip collects the operating current of the closed-loop stepper motor in real time at a sampling frequency of 10 Hz. When an abnormal increase in current exceeding a preset threshold is detected, a protection mechanism is triggered, cutting off the motor drive signal and sending a stall alarm message to the host computer.

[0091] Liquid Injection: After the volumetric flask is opened, it is transferred by a robotic arm to the liquid injection unit of the fluid processing module. The control system controls the liquid injection power unit to provide liquid delivery power according to the preset liquid injection parameters of 200 ml, and accurately injects liquid into the volumetric flask through the liquid injection output unit. During the liquid injection process, the control board collects the peristaltic pump operating parameters in real time, and calculates the real-time liquid injection volume by combining it with the stepper motor speed. When the liquid injection volume is detected to have reached the preset value, it stops immediately.

[0092] Sealing and ultrasonic treatment: After the liquid injection is completed, the robotic arm returns the volumetric flask to the container processing module for capping and sealing. After sealing, it is transferred to the ultrasonic treatment module for 30 minutes of ultrasonic treatment at a frequency of 100 kHz.

[0093] Cooling: After the ultrasonic process is completed, the robotic arm transfers the volumetric flask to the cooling module, where it is cooled to a constant temperature of 25 degrees Celsius.

[0094] Secondary opening and volume adjustment: After cooling to the target temperature, the robotic arm transfers the volumetric flask back to the container handling module to remove the cap, and then moves it to the volume adjustment module. The imaging unit uses an industrial camera and backlight to capture images of the container. The control system determines the liquid level in the container based on the images, compares the liquid level with the target mark of 250 ml, and controls the replenishment unit to add liquid to the container based on the comparison result and volume adjustment parameters. The replenishment unit includes a syringe pump and a peristaltic pump. The control system controls the peristaltic pump to replenish liquid based on the difference between the liquid level and the target mark, and switches to the syringe pump to replenish liquid when the difference is less than a preset threshold, achieving precise volume adjustment. During the volume adjustment process, the industrial camera captures liquid level images in real time, and immediately stops liquid injection when the liquid level reaches the preset mark, forming a closed-loop control.

[0095] Mixing: After volume determination, the robotic arm seals the volumetric flask and transfers it to the mixing module. The clamping unit clamps and secures the container based on the mixing parameters, while the mixing power unit provides the mixing power. The transmission mechanism drives the container in reciprocating motion based on this mixing power, achieving fully automatic mixing at a speed of 45 times per minute for 300 seconds. During mixing, the control board monitors the rotational speed in real time via a servo motor encoder. If the speed deviates from the preset value by more than ±50 revolutions per minute, the drive current parameters are immediately and automatically adjusted.

[0096] Pipetting: After mixing, the robotic arm transfers the volumetric flask to the container handling module for opening, and then to the large bottle station of the pipetting unit in the fluid handling module. Simultaneously, the robotic arm picks up a 20 ml vial from the material tray and transfers it to the vial station of the pipetting unit. The pipetting unit performs pipetting operations according to preset parameters: First, it initializes the equipment and pre-cleans the tubing, completing full-axis zero-point positioning, and the syringe pump draws 10 ml of cleaning solution to flush the tubing; then, it performs automatic rinsing, performing 3 rinsing cycles with a rinsing volume of 3000 μL, while the pressure sensor monitors the tubing pressure in real time; next, it performs precise pipetting, with the syringe pump drawing 3000 μL of sample solution and injecting it into the 20 ml vial; finally, it performs a final tubing cleaning, performing one cleaning cycle with a cleaning volume of 5 ml. During pipetting, the pressure sensor monitors the tubing pressure in real time. If an abnormal pressure is detected, a pipetting abnormality is determined, and feedback is immediately sent to the control board. The control board pauses the pipetting operation and sends an alarm message to the host computer.

[0097] Sealing and Collection: After pipetting, the robotic arm transfers the 250 ml volumetric flask to the container handling module, seals it, and returns it to the tray. It then returns the 20 ml vial from the pipetting vial station to the tray. This completes the entire automated process, processing 12 bottles per group.

[0098] Data Logging: The control system communicates with each module via a 485 bus, recording and storing the operating status and parameters of each module in real time, forming a traceable data log. Upon receiving an abnormal status feedback signal, the control system suspends subsequent operations and issues an alarm signal. Throughout the entire operation of the equipment, the real-time operating status of the pipetting unit is uploaded to the central control system via 485 communication, enabling real-time status monitoring and data traceability.

[0099] Example 4: Detailed workflow of the pipetting unit like Figure 3 As shown, the pipetting unit of the fluid processing module is an important component of this invention, and its detailed working process is as follows: Equipment Initialization: The entire equipment is powered on, and the pipetting unit synchronously completes its power-on initialization. The host computer supports custom configuration of the pipetting unit's operating parameters, with configurable items including rinsing volume, washing volume, pipetting volume, number of rinsing cycles, and number of washing cycles.

[0100] A1. Equipment initialization and pipeline pre-cleaning After the pipetting unit is powered on, the Z-axis carrying the pipette automatically returns to its origin. Then, the X-axis starts and zeros, moving to the designated position in the cleaning tank. The Z-axis descends, inserting the pipette into the cleaning tank, while the syringe module descends to complete zeroing calibration, achieving full-axis zero-point positioning. The cleaning tank replenishment motor automatically replenishes the tank to full capacity, and the syringe pump draws out the cleaning solution. Subsequently, the Z-axis rises and removes the unit from the tank, and the pump discharges the liquid from its chamber, completing the overall flushing of the tubing and ensuring the pipetting tubing is clean and residue-free. After cleaning, the X-axis and Z-axis modules reset to zero, and the drain motor discharges the waste liquid from the cleaning tank into the waste tank, awaiting standby commands.

[0101] A2. Automatic Rinse-Off Process After the user issues the start command, the X-axis module, carrying the Z-axis module, moves to directly above the mouth of the large-capacity bottle. The Z-axis then descends, smoothly inserting the pipette into the bottle. The syringe pump draws a quantitative amount of stock solution according to preset parameters. After aspiration, the Z-axis slowly rises and returns to its original position. The X-axis automatically moves above the cleaning tank, and the Z-axis descends to insert into the tank and drain any residual liquid, repeating the user-set number of rinse cycles. Throughout the Z-axis descent phase, a pressure sensor monitors the pipeline pressure in real time. If an abnormal pressure is detected, a pipetting malfunction is identified, the equipment immediately stops, and a fault code is reported to ensure operational safety.

[0102] A3. Precise pipetting and delivery After the rinsing process is completed, the X-axis is repositioned above the large-volume bottle, and the Z-axis descends to insert into the bottle; the syringe pump accurately draws the sample solution according to the set volume. After the required volume is drawn, the Z-axis is raised and reset, and the X-axis is transferred to the vial opening position; once in position, the Z-axis drives the pipette downward to insert into the vial, smoothly injecting the measured amount of liquid into the vial, completing the precise dispensing and pipetting.

[0103] A4. Final cleaning and resetting of pipelines After a single pipetting operation is completed, the Z-axis returns to zero, and the X-axis moves the pipette above the cleaning tank. The Z-axis then descends into the tank, and the cleaning pump quickly fills the tank with liquid. The syringe pump draws out the cleaning solution and then lifts it to discharge the solution. This process is repeated according to the number of cleaning cycles set by the user. After a single cleaning cycle is completed, the waste pump starts to empty the waste liquid from the cleaning tank, and all motion axis modules return to their original positions for standby.

[0104] A5. Data Communication During the entire operation of the equipment, the real-time working status of the pipetting unit is uploaded to the central control system of the whole machine via 485 communication, so as to realize real-time status monitoring and data traceability.

[0105] Example 5: Parameter Configuration Instructions The following is a complete example of the operating parameter settings for the plaster detection module.

[0106] The dispensing unit's dispensing volume is set to 200 ml. The ultrasonic treatment module's ultrasonic duration is set to 30 minutes, and the frequency to 100 kHz. The cooling treatment module's cooling duration is set to 15 minutes, and the temperature to 15 degrees Celsius. The large-bottle volume adjustment module's volume adjustment specification is set to 250 ml. The mixing module's mixing speed is set to 45 times per minute, and the mixing time is set to 300 seconds. The pipetting unit's rinsing frequency is set to 3 times, the rinsing volume to 3000 μL, the pipetting volume to 3000 μL, the washing frequency to 1 time, and the washing volume to 5 ml.

[0107] The parameters above are examples only; users can adjust them flexibly according to their actual needs. All configuration parameters can be saved and reused after being set once.

[0108] This invention is not only applicable to the pretreatment of plaster-type drugs for content uniformity detection, but also applicable to the pretreatment of other dosage forms such as tablets, capsules, and ointments, and has broad application prospects.

[0109] The foregoing has provided a detailed description of a multi-module collaborative drug content uniformity detection pretreatment system and method provided by the present invention. The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A multi-module collaborative pretreatment system for detecting drug content uniformity, characterized in that, include: Multiple operating modules, including a container processing module, a fluid processing module, a volume-fixing module, and a mixing module; wherein, the container processing module is used to perform opening and / or sealing operations on the container; The fluid handling module is used to inject liquid into and / or remove liquid from the container; The volume control module is used to adjust the liquid level in the container to the target scale. The mixing module is used to mix the liquid in the container; A transfer module is used to automatically transfer the container between the plurality of operating modules; The control system is communicatively connected to the transfer module and the multiple operation modules. The control system is configured to determine at least one operation to be performed and the corresponding work module; control the transfer module to sequentially transfer the container to the determined work module; control the arriving work module to perform the corresponding operation after the container arrives at each work module; and receive status feedback after each work module performs the operation.

2. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 1, characterized in that, The container processing module includes: The first storage unit is used to pre-store container operation parameters and a first state threshold of at least one specification of the container; A container fixing unit is used to fix the container based on the container operating parameters; A cap operation unit is used to grasp the cap of the container based on the container operation parameters and rotate it to open or close the cap. The first state detection unit is used to detect the first actual state parameter of the container processing module and compare the first actual state parameter with the first state threshold. When the first actual state parameter exceeds the first state threshold, protection is triggered.

3. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 1, characterized in that, The fluid processing module includes: The second storage unit is used to pre-store fluid operation parameters and a second state threshold of at least one specification of the container; The liquid injection unit is used to inject liquid into the container based on the fluid operation parameters; A pipetting unit for removing liquid from the container to a target container based on the fluid operating parameters; The second state detection unit is used to detect the second actual state parameter of the fluid processing module and compare the second actual state parameter with the second state threshold. When the second actual state parameter exceeds the second state threshold, protection is triggered.

4. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 1, characterized in that, The volume-regulating module includes: The third storage unit is used to pre-store the volume parameters and third state threshold of at least one specification of the container; An imaging unit is used to acquire images of the container, and the images are used to identify the liquid level inside the container; A liquid replenishment unit is used to replenish liquid into the container; The third state detection unit is used to detect the third actual state parameter of the capacity stabilization module and compare the third actual state parameter with the third state threshold. When the third actual state parameter exceeds the third state threshold, protection is triggered.

5. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 4, characterized in that, The fluid replenishment unit includes an injection pump and a peristaltic pump; The control system is used to determine the liquid level in the container based on the image, compare the liquid level with the target scale, and control the replenishment unit to replenish liquid into the container based on the comparison result and the volume control parameter. The control system controls the peristaltic pump to replenish the liquid based on the difference between the liquid level and the target scale, and switches to the injection pump to replenish the liquid when the difference is less than a preset threshold.

6. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 1, characterized in that, The mixing module includes: The fourth storage unit is used to pre-store the mixing parameters and the fourth state threshold of at least one specification of the container; A clamping unit is used to clamp or loosen the container based on the mixing parameters; A power unit is used to provide mixing power based on the mixing parameters; A transmission mechanism, connected to the power unit, is used to drive the container to reciprocate based on the mixing power; A clamp base for supporting the container and connecting to the transmission mechanism; The fourth state detection unit is used to detect the fourth actual state parameter of the mixing module and compare the fourth actual state parameter with the fourth state threshold. When the fourth actual state parameter exceeds the fourth state threshold, protection is triggered.

7. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 1, characterized in that, The control system is also configured to suspend subsequent operations and issue an alarm signal when the received status feedback is an abnormal signal.

8. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 1, characterized in that, The transfer module includes a robotic arm for gripping the container and transferring it between the plurality of working modules.

9. The multi-module collaborative drug content uniformity detection pretreatment system according to claim 1, characterized in that, The control system is communicatively connected to the transfer module and the multiple operation modules via a 485 bus. The control system is also used to record and store the operating status and operating parameters of each of the operation modules in real time, forming a traceable data record.

10. A pretreatment method for detecting drug content uniformity based on the multi-module collaborative system of claim 1, characterized in that, Includes the following steps: The control system determines at least one operation to be performed and the corresponding work module; The control system controls the transfer module to sequentially transfer the containers to the designated operation modules; After the container arrives at each of the work modules, the control system controls the arriving work modules to perform the corresponding operations; The control system receives status feedback from each of the operation modules after they have performed their operations.

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