A semi-automatic judgment and dispensing method and system for radiopharmaceuticals

Abstract

The application is suitable for the technical field of medicine dispensing, and provides a semi-automatic judgment and dispensing method and system for radiopharmaceuticals, acquires stock solution information and bar code information; judges actual number of branches according to total activity of the stock solution and target activity, compares required number of branches with the actual number of branches, outputs a dilution scheme according to a diluent volume, sends the dilution scheme to a terminal, and recompares the required number of branches with the actual number of branches; after the recomparison, records a judgment result and an operator ID, calculates required activity at the time of dispensing according to a decay value, recommends an extracted volume according to real-time stock solution concentration, and compares the recommended extracted volume with a safety threshold; acquires real-time actual activity after dispensing, compares a deviation percentage with an acceptable threshold, and uploads to a database; while retaining the advantages of machine automatic calculation and safety check, the judgment right of a manual key node is integrated into a dispensing decision chain to improve dispensing accuracy and whole-process traceability, and operation safety and clinical flexibility are taken into account.

Description

Technical Field

[0001] This invention belongs to the field of drug packaging technology, and particularly relates to a semi-automatic judgment and packaging method and system for radiopharmaceuticals. Background Technology

[0002] Before radiopharmaceuticals are used in PET / CT imaging, SPECT imaging, or radionuclide therapy, the original solution needs to be repackaged into single-dose injectable or oral formulations for different patients.

[0003] However, the dispensing process of radiopharmaceuticals has long faced two major challenges: First, the half-lives of the radionuclides used are generally short, and the process from the arrival of the original solution to dispensing and administration must be completed in a very short time, which places extremely high demands on the timeliness and accuracy of dispensing; second, the drugs are radioactive, and strict protection must be taken during the operation to reduce the radiation exposure of the operators.

[0004] Balancing operational efficiency, safety precautions, and the flexibility of human judgment while ensuring accurate dispensing has become a prominent issue that nuclear medicine urgently needs to address. Summary of the Invention

[0005] The purpose of this invention is to provide a semi-automatic method for judging and dispensing radiopharmaceuticals, which aims to solve the problems raised in the third part of the background art.

[0006] The present invention is implemented as follows: a semi-automatic method for judging and dispensing radiopharmaceuticals, the method comprising: Obtain stock solution information, including real-time concentration and total activity; obtain barcode information, including stock solution batch number, nuclide type and reference time point. The actual number of vials is determined based on the total activity of the original solution and the target activity. The required number of vials is compared with the actual number of vials. The dilution plan is output based on the volume of the diluent and sent to the terminal. The required number of vials is compared with the actual number of vials again. After the comparison is passed again, record the judgment result and operator ID, obtain the task table, calculate the activity required for dispensing based on the attenuation value, recommend the extraction volume based on the real-time stock solution concentration, and compare the recommended extraction volume with the safety threshold. The system acquires the actual activity level after dispensing in real time, compares the percentage deviation with the acceptable threshold, obtains terminal processing information, and uploads it to the database.

[0007] Preferably, the steps of determining the actual number of vials based on the total activity and target activity of the original solution, comparing the required number of vials with the actual number of vials, outputting a dilution plan based on the volume of diluent, sending the dilution plan to the terminal, and re-comparing the required number of vials with the actual number of vials specifically include: Obtain the task table, which includes prescription information for all patients to be dispensed, and obtain the target activity, upper volume limit, and dosing time based on the prescription information; The actual number of vials is determined based on the total activity of the stock solution and the target activity. The required number of vials is compared with the actual number of vials. If the actual number of vials is greater than the required number of vials, it is determined that the stock solution meets the requirements. If it is determined that the requirements are not met, the required volume of diluent is obtained. Output the dilution plan based on the volume of diluent, send the dilution plan to the terminal, obtain terminal confirmation information, perform online dilution based on the confirmation information, and re-compare the required number of vials with the actual number of vials.

[0008] Preferably, after the second comparison passes, the judgment result and operator ID are recorded, the task table is obtained, the activity required for dispensing is calculated based on the attenuation value, the extraction volume is recommended based on the real-time stock solution concentration, and the recommended extraction volume is compared with the safety threshold. Specifically, this includes the following steps: After the comparison is successful again, record the judgment result and operator ID, and obtain the drug decay value from the current time to the dosing period; The required activity for dispensing is calculated based on the attenuation value, and the extraction volume is recommended based on the real-time stock solution concentration. The safe extraction volume threshold is obtained, which is 0.2ml-5ml. The recommended extraction volume is compared with the safe threshold. If the judgment is satisfactory, a confirmation message is sent to the terminal. If the judgment is unsatisfactory, the process is paused and a manual decision is obtained. The manual decision includes enabling dilution, dispensing in multiple batches, and confirming that the volume should still be used.

[0009] Preferably, the step of acquiring the actual activity after dispensing in real time, comparing the deviation percentage with an acceptable threshold, acquiring terminal processing information, and uploading it to the database specifically includes: Obtain dispensing information, including operator ID, confirmation method, target activity, and final selected volume, and obtain the actual activity after dispensing in real time; Obtain the percentage deviation between the target activity and the actual activity, obtain the acceptable threshold, compare the percentage deviation with the acceptable threshold, and if the deviation does not exceed the threshold, it is considered qualified; If the deviation exceeds the threshold, an audible and visual alarm will be triggered, and specific information will be sent to the terminal. The specific information includes the specific deviation value, cause prompts, and handling measures. The terminal's handling information will be obtained and uploaded to the database.

[0010] Preferably, the actual number of vials = total activity of the original solution / target activity.

[0011] Another objective of this invention is to provide a semi-automatic judgment and dispensing system for radiopharmaceuticals, the system comprising: The information acquisition module acquires the original solution information, including real-time concentration and total activity, and acquires barcode information, including the original solution batch number, nuclide type, and reference time point. The activity determination module determines the actual number of vials based on the total activity of the original solution and the target activity, compares the required number of vials with the actual number of vials, outputs the dilution plan based on the volume of the diluent, sends the dilution plan to the terminal, and re-compares the required number of vials with the actual number of vials. The volume determination module records the determination result and operator ID after the comparison is passed again, obtains the task table, calculates the activity required for dispensing based on the attenuation value, recommends the extraction volume based on the real-time original solution concentration, and compares the recommended extraction volume with the safety threshold. The activity determination module obtains the actual activity after dispensing in real time, compares the deviation percentage with the acceptable threshold, obtains terminal disposal information, and uploads it to the database.

[0012] Preferably, the activity determination module includes: The task table unit retrieves the task table, which includes prescription information for all patients to be dispensed. Based on the prescription information, the target activity, upper volume limit, and dosing time are obtained. The unit that determines the number of vials determines the actual number of vials based on the total activity of the original solution and the target activity. It compares the required number of vials with the actual number of vials. If the actual number of vials is greater than the required number of vials, it is determined that the original solution meets the requirements. If it is determined that the requirements are not met, the required volume of diluent is obtained. The dilution scheme unit outputs a dilution scheme based on the volume of the diluent, sends the dilution scheme to the terminal, obtains confirmation information from the terminal, performs online dilution based on the confirmation information, and re-compares the required number of vials with the actual number of vials.

[0013] Preferably, the volume determination module includes: After the attenuation value acquisition unit passes the comparison again, it records the judgment result and operator ID, and obtains the attenuation value of the drug from the current time to the dosing period. Extraction volume unit, calculate the activity required for dispensing based on the attenuation value, recommend extraction volume based on real-time stock solution concentration, obtain extraction volume safety threshold, the safety threshold is 0.2ml-5ml, compare the recommended extraction volume with the safety threshold; If the volume judgment unit is qualified, it sends a confirmation message to the terminal; if it is unqualified, it pauses the process and obtains a human decision. The human decision includes enabling dilution, dispensing in multiple batches, and confirming that the volume should still be executed.

[0014] Preferably, the activity determination module includes: The actual activity unit acquires dispensing information, including operator ID, confirmation method, target activity, and final selected volume, and acquires the actual activity after dispensing in real time. The activity determination unit obtains the percentage deviation between the target activity and the actual activity, obtains the acceptable threshold, compares the percentage deviation with the acceptable threshold, and if the deviation does not exceed the threshold, it is deemed qualified. If the deviation exceeds the threshold, the information recording unit will trigger an audible and visual alarm and send specific information to the terminal. The specific information includes the specific deviation value, cause prompts, and handling measures. The unit will also obtain the terminal's handling information and upload it to the database.

[0015] Preferably, the actual number of vials = total activity of the original solution / target activity.

[0016] This invention provides a semi-automatic judgment and dispensing method for radiopharmaceuticals. This method employs a three-tiered sequential mechanism: original solution compatibility judgment, single-vial dosage rationality judgment, and dispensing result conformity judgment. It organically combines machine intelligent calculation with manual confirmation of key nodes, effectively avoiding batch misjudgments caused by algorithm drift or sensor errors in fully automated systems, and overcoming calculation errors and operational oversights prone to occur in purely manual dispensing. The second tier introduces manual volume fine-tuning, and the third tier allows for manual handling of deviated products. This ensures dosage accuracy while preventing unqualified products from entering clinical settings, significantly improving dispensing accuracy and medication safety.

[0017] This system allows operators to manually adjust the extraction volume within safe thresholds based on the patient's specific condition, and provides multiple manual decision-making options such as dilution and fractional dispensing. Compared to the rigid execution logic of fully automated systems, it is more flexible in adapting to complex clinical needs, truly achieving human-machine collaboration. Simultaneously, from reading the original solution information, processing judgments at all levels, recording manual confirmation, to handling deviations, all data is uploaded in real-time to an immutable database and linked to the operator ID and timestamp. This meets the stringent requirements of GMP, GCP, and 21 CFR Part 11 for electronic records and audit trails in radiopharmaceuticals, improving the traceability and compliance of the entire process.

[0018] Through automated activity reading, volume calculation, online dilution, and result verification, operators only need to intervene briefly at critical points, and the entire process is completed within a shielded heated room. Combined with audible and visual alarms and terminal guidance, it effectively reduces repetitive manual operations and radiation exposure time. The first level automatically determines the required concentrate and intelligently recommends dilution or replenishment strategies; the second level automatically calculates the decay compensation volume; and the third level quickly compares deviations and provides cause prompts and suggested measures, assisting operators in quickly locating problems and making decisions. This reduces unnecessary waiting and repeated dispensing, shortens the overall dispensing cycle, and improves the utilization rate of radiopharmaceuticals. It combines the advantages of intelligent assistance and human decision-making, and has extremely high clinical application and industrial promotion value. Attached Figure Description

[0019] Figure 1A flowchart illustrating a semi-automatic judgment and dispensing method for radiopharmaceuticals provided in an embodiment of the present invention; Figure 2 The flowchart illustrates the steps of comparing the required number of tubes with the actual number of tubes, outputting a dilution plan based on the volume of diluent, and re-comparing the required number of tubes with the actual number of tubes, as provided in this embodiment of the invention. Figure 3 The flowchart of the steps provided in this embodiment of the invention is as follows: calculating the activity required for dispensing based on the attenuation value, recommending the extraction volume based on the real-time stock solution concentration, and comparing the recommended extraction volume with the safety threshold. Figure 4 The flowchart illustrates the steps of obtaining the actual activity after dispensing in real time, comparing the deviation percentage with an acceptable threshold, obtaining terminal processing information, and uploading it to the database, as provided in this embodiment of the invention. Figure 5 This is an architecture diagram of a semi-automatic judgment and dispensing system for radiopharmaceuticals provided in an embodiment of the present invention; Figure 6 This is an architecture diagram of the activity determination module provided in an embodiment of the present invention; Figure 7 This is an architecture diagram of the volume determination module provided in an embodiment of the present invention; Figure 8 This is an architecture diagram of the activity determination module provided in an embodiment of the present invention. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0021] It is understood that the terms "first," "second," etc., used in this application may be used herein to describe various elements, but unless otherwise specified, these elements are not limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of this application, a first script may be referred to as a second script, and similarly, a second script may be referred to as a first script.

[0022] like Figure 1 As shown, this is a semi-automatic method for judging and dispensing radiopharmaceuticals provided by an embodiment of the present invention. The method includes: S100, acquire stock solution information, including real-time concentration and total activity, acquire barcode information, including stock solution batch number, nuclide type and reference time point.

[0023] In this step, the raw material information is obtained, starting with the raw material information and barcode information. The operator places the radioactive raw material container into the activity meter's measuring chamber, and the activity meter automatically reads the real-time activity concentration and total activity. Simultaneously, by scanning the barcode on the container surface (or manually entering it), the raw material batch number, nuclide type, and reference time point are obtained. The real-time activity data is correlated with the static information of the barcode, and the nuclide matching and the rationality of the reference time point are verified to form a complete raw material data record for use in the first-level compatibility assessment.

[0024] If the total activity of the stock solution is insufficient, a prompt for replenishment or dilution of the mother liquor will automatically appear. After manual confirmation, the first-level judgment will be re-performed. In this way, by collecting information through both the activity meter and barcode, the accuracy and traceability of the stock solution data are ensured, laying the foundation for subsequent stratified verification.

[0025] S200 determines the actual number of vials based on the total activity of the original solution and the target activity, compares the required number of vials with the actual number of vials, outputs the dilution plan based on the volume of the diluent, sends the dilution plan to the terminal, and re-compares the required number of vials with the actual number of vials.

[0026] In this step, the actual number of vials is determined based on the total activity and target activity of the stock solution. The actual number of vials that the current stock solution can support is calculated based on the total activity of the stock solution and the target activity required by each patient's prescription. The actual number of vials is compared with the required number in the task schedule: if the actual number of vials is greater than or equal to the required number, the stock solution is considered to meet the requirements; if the actual number of vials is insufficient, a dilution strategy is triggered. Based on the current activity concentration of the stock solution and the preset target concentration, the required volume of diluent is calculated, a dilution plan is generated, and sent to the operating terminal. After operator confirmation, online dilution is performed. After dilution, the stock solution activity is remeasured, and the actual number of vials is compared with the required number again until the requirements are met.

[0027] If the dilution is still insufficient, the system will prompt again to add more stock solution or reduce the number of vials to be dispensed. This process will continue after manual confirmation. Through this comparison of the number of vials and dynamic adjustment of the dilution plan, it is ensured that even when the stock solution has insufficient activity, it can still meet the dispensing requirements through dilution, thus avoiding dispensing interruptions due to insufficient activity.

[0028] After the S300 comparison passes again, record the judgment result and operator ID, obtain the task table, calculate the activity required for dispensing based on the attenuation value, recommend the extraction volume based on the real-time stock solution concentration, and compare the recommended extraction volume with the safety threshold.

[0029] In this step, after passing the comparison again and passing the first-level judgment, record the judgment result and the operator ID, and call the sub-packaging task list. According to the time difference between the current moment and the patient's drug administration moment, combined with the decay characteristics of the radionuclide, calculate the decay amount of the drug from the current to the administration period, and then determine the activity required at the time of sub-packaging. Then, based on the real-time activity concentration of the stock solution, calculate the theoretically recommended extraction volume. Compare this recommended volume with the preset safety thresholds (such as the minimum extraction volume and the maximum container capacity): if it is within the threshold range, proceed to the next step; if it exceeds the range, prompt the operator to adjust the prescription or enable the dilution strategy.

[0030] Record the operator ID (such as "ZHS001") and the judgment result ("volume qualified"), generate the second-level verification code, and then enter the subsequent manual confirmation and execution link. If the recommended volume still cannot fall within the safety threshold, suspend the process and prompt for manual intervention. Through the above decay calculation and volume threshold comparison, ensure that the extraction volume of each sub-packaged product is within the reasonable range allowed by the equipment accuracy and the container, and avoid sub-packaging failure caused by too small or too large volume.

[0031] S400, obtain the actual activity after sub-packaging in real time, compare the deviation percentage with the acceptable threshold, obtain the terminal disposal information, and upload it to the database.

[0032] In this step, obtain the actual activity after sub-packaging in real time. After each single sub-packaging is completed, obtain the actual activity of the product in the syringe in real time. Compare this actual activity with the target activity, calculate the deviation percentage, and compare it with the preset acceptable threshold (such as ±5% or ±10%). If the deviation does not exceed the threshold, it is judged as qualified and the qualified information is recorded; if it exceeds the threshold, trigger the manual disposal process, display the deviation value, possible reasons and recommended measures through the terminal (touch screen), and the operator selects to discard and redo, downgrade or suspend the batch according to the prompt. Whether it is qualified or not, all data (actual activity, deviation value, disposal decision, operator ID, etc.) are uploaded to the tamper-proof database in real time for subsequent traceability and quality audit.

[0033] As Figure 2 shown, as a preferred embodiment of the present invention, the step of judging the actual number of branches according to the total activity of the stock solution and the target activity, comparing the required number of branches with the actual number of branches, outputting the dilution plan according to the dilution liquid volume, sending the dilution plan to the terminal, and re-comparing the required number of branches with the actual number of branches specifically includes: S201, obtain the task list, where the task list includes the prescription information of all patients to be sub-packaged, and obtain the target activity, volume upper limit and administration time according to the prescription information.

[0034] In this step, the task table is obtained. First, the task table for this batch of dispensing is retrieved, which contains prescription information for all patients to be dispensed in this batch. Key parameters for each patient are extracted from the task table: target activity, upper volume limit, and administration time. This information serves as the basis for subsequent decay correction calculations, volume rationality assessments, and dispensing sequence arrangements.

[0035] For example, a dispensing task schedule might register three patients: Patient A, target activity 15 mCi, maximum volume 1 ml, administration time 10:00; Patient B, target activity 20 mCi, maximum volume 2 ml, administration time 10:15; and Patient C, target activity 18 mCi, maximum volume 0.5 ml, administration time 10:30. After calling this task schedule, the required attenuation compensation activity is calculated based on the time difference between each administration time and the current dispensing time. Simultaneously, the maximum volume is used as a constraint in subsequent recommended volume calculations: if the recommended volume calculated based on the original solution concentration exceeds the maximum volume, a dilution or multiple dispensing prompt is triggered.

[0036] S202: Determine the actual number of vials based on the total activity of the stock solution and the target activity. Compare the required number of vials with the actual number of vials. If the actual number of vials is greater than the required number of vials, it is determined that the stock solution meets the requirements. If it is determined that the requirements are not met, obtain the required volume of diluent.

[0037] In this step, the actual number of vials is determined based on the total activity and target activity of the stock solution. The actual number of vials that the current stock solution can support is calculated based on the total activity of the stock solution and the target activity required for each formulation in the task schedule. This actual number of vials is compared with the required number of vials in the task schedule: if the actual number of vials is greater than or equal to the required number, it is determined that "the stock solution meets the requirements," and the process can proceed directly to the next level of judgment; if the actual number of vials is less than the required number, it is determined that the requirements are not met. In this case, the required volume of diluent is obtained, a dilution plan is generated, and after confirmation by the operator, online dilution is performed. After dilution, the stock solution activity is remeasured, and the number of vials is compared again.

[0038] For example, a batch of packaging tasks requires packaging for 4 patients. 18 The required total activity for F-FDG is 240 mCi. The actual measured total activity of the stock solution is 180 mCi. Based on a maximum allowable activity of 60 mCi per vial, this actually supports 3 vials, less than the required 4. Therefore, it is deemed insufficient. The system automatically calculates the required diluent volume: if the activity per vial drops to 45 mCi after dilution, then 180 mCi can support 4 vials. The stock solution concentration needs to be diluted from the current value to the target concentration, calculating the required diluent volume as X ml. The dilution plan is sent to the touchscreen. After operator confirmation, the dilution is executed. The stock solution activity concentration and total activity are remeasured, and the actual number of vials is compared with the required number. If the requirement is met, the process proceeds to the next stage.

[0039] S203: Output the dilution plan based on the volume of the diluent, send the dilution plan to the terminal, obtain the terminal confirmation information, perform online dilution based on the confirmation information, and re-compare the required number of vials with the actual number of vials.

[0040] In this step, a dilution plan is generated based on the volume of the diluent. The plan is automatically generated based on the calculated volume and sent to the operating terminal. After reviewing the plan, the operator confirms the information via the terminal (e.g., clicking the confirmation button, entering an authorization password, or scanning a fingerprint). Based on the confirmation, the actuator automatically measures the diluent according to the plan and injects it into the stock solution container for online dilution. After dilution, the activity concentration and total activity of the stock solution are remeasured, and the required number of vials is compared with the actual number until the requirements are met.

[0041] If the actual number of vials after dilution reaches or exceeds the required number, the concentrate is deemed to meet the requirements. The dilution operation and confirmation information are recorded, and the process proceeds to the next stage. By comparing the online dilution and the number of vials again, automated and flexible handling of insufficient concentrate activity is achieved, reducing errors from manual calculation and operation.

[0042] like Figure 3 As shown, in a preferred embodiment of the present invention, after the second comparison is passed, the judgment result and operator ID are recorded, the task table is obtained, the activity required for dispensing is calculated based on the attenuation value, the extraction volume is recommended based on the real-time stock solution concentration, and the recommended extraction volume is compared with the safety threshold. Specifically, this includes the following steps: S301, after the comparison is successful again, record the judgment result and operator ID, and obtain the drug decay value from the current time to the dosing period.

[0043] In this step, after a second successful comparison, the first-level judgment result and the current operator ID are recorded and stored in the local cache. Subsequently, the time difference between each patient's dosing time and the current dispensing time is obtained. Combined with the half-life of the radionuclide used, the drug decay value that will occur from the current time until dosing is calculated. This decay value is used to reverse-calculate the activity required during dispensing to ensure that patients receive the accurate prescribed dose at the time of dosing.

[0044] For example, a patient's prescription requests an injection of 15 mCi activity at 10:30 AM, while the current dispensing time is 9:30 AM, a time difference of 1 hour. The radionuclide used is... 18F has a half-life of approximately 110 minutes, and calculations show that the drug decays by about 32% within 1 hour. This means that from dispensing to injection, the activity will decrease to approximately 68% of its original value. Therefore, the required activity during dispensing should be approximately 22 mCi (15 ÷ 0.68). The decay value (32%) and the required activity for dispensing (22 mCi) are automatically recorded and associated with the operator ID "ZHS002" and the judgment result "Level 1 Pass" in the database.

[0045] S302, calculate the required activity for dispensing based on the attenuation value, recommend the extraction volume based on the real-time stock solution concentration, obtain the extraction volume safety threshold, the safety threshold is 0.2ml-5ml, and compare the recommended extraction volume with the safety threshold.

[0046] In this step, the required activity for dispensing is calculated based on the attenuation value, and the required activity for dispensing is calculated in reverse based on the attenuation value obtained in the previous step. Combined with the current real-time concentration of the stock solution, the theoretically recommended extraction volume is calculated. A preset safe extraction volume threshold is obtained, which is typically set between 0.2 ml and 5 ml depending on the syringe precision and container capacity. The recommended extraction volume is compared with this safe threshold: if it is within the threshold range, proceed to the next step; if it is below the lower limit or above the upper limit, a prompt is triggered and manual intervention is required.

[0047] For example, if a patient requires an activity of 22 mCi for dispensing, and the current concentration of the stock solution is 200 mCi / ml, then the recommended extraction volume is 0.11 ml. The safety threshold is 0.2 ml to 5 ml; 0.11 ml is below the lower limit. The touchscreen will display a prompt: "The recommended volume of 0.11 ml is too small, below the safety lower limit of 0.2 ml. Please dilute the stock solution or adjust the prescription." The operator selects to enable the dilution function, reduces the stock solution concentration to 100 mCi / ml, recalculates the recommended volume to 0.22 ml, which falls within the safety threshold, and the comparison is successful.

[0048] S303: If the judgment is qualified, a confirmation message is sent to the terminal; if the judgment is unqualified, the process is paused and a manual decision is obtained. The manual decision includes enabling dilution, dispensing in multiple batches, and confirming that the volume is still executed.

[0049] In this step, if the sample size is deemed acceptable, the recommended extraction volume is compared with the safety threshold. If the result is also acceptable, a confirmation message is generated and sent to the operating terminal for final confirmation by the operator. If the result is deemed unacceptable, the dispensing process is paused, and a manual decision-making interface pops up on the terminal for the operator to choose a handling method. The manual decision-making includes three options: enable dilution, dispense in stages, and confirm to continue with the original volume.

[0050] For example, the recommended extraction volume is 0.11 ml, which is lower than the lower limit of 0.2 ml. It is judged as unqualified and the process is suspended. The terminal displays: "The volume of 0.11 ml is too small. Please select: 1. Enable dilution; 2. Sub - pack in portions; 3. Execute according to this volume anyway." After the operator's evaluation, it is considered that the dilution operation takes time and 0.11 ml is acceptable under the current high - precision syringe (the minimum scale is 0.01 ml). Therefore, the operator selects "Execute according to this volume anyway", enters the authorization password and the reviewer's fingerprint. The process continues and the sub - packing is executed according to 0.11 ml.

[0051] As Figure 4 shown, as a preferred embodiment of the present invention, the step of obtaining the actual activity after sub - packing in real time, comparing the deviation percentage with the acceptable threshold, obtaining the terminal disposal information, and uploading it to the database specifically includes: S401, obtain the sub - packing information, where the sub - packing information includes the operator ID, confirmation method, target activity, and the finally selected volume, and obtain the actual activity after sub - packing in real time.

[0052] In this step, obtain the sub - packing information. Before the sub - packing is executed, obtain the complete sub - packing information, including the operator ID, confirmation method (such as barcode scanning, inputting the authorization password, fingerprint verification, or double - person review), target activity, and the finally selected extraction volume. During the sub - packing execution process, obtain the actual activity of the product in the syringe after sub - packing in real time, which is used for subsequent deviation comparison and disposal judgment. The operator selects barcode scanning for confirmation, the target activity is 15 mCi, and the volume is manually adjusted to 0.18 ml due to clinical needs. The actual activity read after sub - packing is 14.2 mCi. All information (including the fine - tuning record) is completely saved, providing a basis for subsequent deviation comparison and manual disposal. By obtaining the sub - packing information and the actual activity in real time, it is ensured that the whole process of each product from decision - making to execution is traceable and reviewable.

[0053] S402, obtain the target activity and the deviation percentage of the actual activity, obtain the acceptable threshold, compare the deviation percentage with the acceptable threshold, and if the deviation does not exceed the threshold, it is judged as qualified.

[0054] In this step, obtain the target activity and the deviation percentage of the actual activity, obtain the target activity of the sub - packed product and the actual activity obtained by actual measurement, and calculate the deviation percentage between the two. At the same time, obtain the preset acceptable threshold (such as ±5% or ±10%, which can be configured according to different radionuclides and clinical requirements). Compare the deviation percentage with this threshold: if the deviation does not exceed the threshold, it is judged that this product is qualified, record the qualified status and release the product; if the deviation exceeds the threshold, enter the manual disposal process.

[0055] For example, the target activity of a certain vialed product is 20 mCi, the actually measured activity is 19.3 mCi, and the percentage deviation is 3.5%. The preset acceptable threshold is ±5%, and 3.5% does not exceed 5%, so it is judged as qualified. The touch screen displays "qualified", records the actual activity, deviation value and qualified status, and the operator takes out the product and pastes the label.

[0056] S403, if the deviation exceeds the threshold, give an audible and visual alarm, and send specific information to the terminal. The specific information includes the specific deviation value, cause prompt and disposal measure, obtain the terminal disposal information, and upload it to the database.

[0057] In this step, if the deviation exceeds the threshold, if the percentage deviation exceeds the acceptable threshold, trigger an audible and visual alarm, and at the same time send the specific information to the operation terminal. The specific information includes: the specific deviation value, possible cause prompts, such as "non-uniform stock solution", "activity meter drift", "pipeline bubbles", etc. And recommended disposal measures, such as "redo after mixing the stock solution", "calibrate the activity meter", "check the pipeline". The operator makes a manual decision based on the information displayed on the terminal. The terminal obtains the disposal information, such as discard and redo, downgrade use or suspend the batch, and uploads the disposal information together with the deviation data, operator ID, etc. to the tamper-proof database for quality traceability and auditing.

[0058] As Figure 5 shown, a semi-automatic judgment and vialing system for radioactive drugs provided by an embodiment of the present invention, the system includes: An information acquisition module 100, configured to acquire stock solution information, the stock solution information includes real-time concentration and total activity, acquire barcode information, the barcode information includes stock solution batch number, radionuclide type and reference time point.

[0059] In this system, the information acquisition module 100 acquires stock solution information, and first acquires stock solution information and barcode information. The operator places the radioactive stock solution container in the measurement cavity of the activity meter, and the activity meter automatically reads the real-time activity concentration and total activity; at the same time, by scanning the barcode on the surface of the container (or manually inputting), the stock solution batch number, radionuclide type and reference time point are acquired. The real-time activity data is associated with the static barcode information, and the radionuclide matching and the rationality of the reference time point are verified to form a complete stock solution data record for the first-level adaptability judgment.

[0060] An activity determination module 200, configured to judge the actual number of vials according to the total activity of the stock solution and the target activity, compare the required number of vials with the actual number of vials, output a dilution plan according to the volume of the diluent, send the dilution plan to the terminal, and re-compare the required number of vials with the actual number of vials.

[0061] In this system, the activity determination module 200 determines the actual number of vials based on the total activity of the stock solution and the target activity. It calculates the actual number of vials that the current stock solution can support based on the total activity of the stock solution and the target activity required by each patient's prescription. The actual number of vials is compared with the required number in the task table: if the actual number of vials is greater than or equal to the required number, the stock solution is deemed to meet the requirements; if the actual number of vials is insufficient, a dilution strategy is triggered. Based on the current activity concentration of the stock solution and the preset target concentration, the required volume of diluent is calculated, a dilution plan is generated, and sent to the operating terminal. After operator confirmation, online dilution is performed. After dilution, the stock solution activity is remeasured, and the actual number of vials is compared with the required number again until the requirements are met.

[0062] If the dilution is still insufficient, the system will prompt again to add more stock solution or reduce the number of vials to be dispensed. This process will continue after manual confirmation. Through this comparison of the number of vials and dynamic adjustment of the dilution plan, it is ensured that even when the stock solution has insufficient activity, it can still meet the dispensing requirements through dilution, thus avoiding dispensing interruptions due to insufficient activity.

[0063] The volume determination module 300 is used to record the determination result and operator ID after the comparison is passed again, obtain the task table, calculate the activity required for dispensing based on the attenuation value, recommend the extraction volume based on the real-time original solution concentration, and compare the recommended extraction volume with the safety threshold.

[0064] In this system, the volume determination module 300, after passing the second comparison and the first-level judgment, records the judgment result and operator ID, and calls the dispensing task table. Based on the time difference between the current time and the patient's drug administration time, combined with the decay characteristics of the radionuclide, the amount of drug decay from the current time to the drug administration period is calculated, thereby determining the activity required for dispensing. Then, based on the real-time activity concentration of the original solution, the theoretically recommended extraction volume is calculated. This recommended volume is compared with preset safety thresholds (such as minimum extraction volume and maximum container capacity): if it is within the threshold range, the next step is initiated; if it exceeds the range, the operator is prompted to adjust the prescription or activate a dilution strategy.

[0065] Record the operator ID (e.g., "ZHS001") and the judgment result ("volume qualified"), generate a second-level verification code, and then proceed to the subsequent manual confirmation and execution stage. If the recommended volume consistently fails to fall within the safety threshold, pause the process and prompt for manual intervention. By comparing the above attenuation calculation with the volume threshold, ensure that the extraction volume of each repackaged product is within a reasonable range allowed by the equipment accuracy and container, avoiding repackaging failure due to volume being too small or too large.

[0066] The activity determination module 400 is used to obtain the actual activity after dispensing in real time, compare the deviation percentage with the acceptable threshold, obtain terminal disposal information, and upload it to the database.

[0067] In this system, the activity determination module 400 obtains the actual activity after sub-packaging in real time. After each single-dose sub-packaging is completed, it obtains the actual activity of the product in the syringe in real time. It compares this actual activity with the target activity, calculates the percentage deviation, and compares it with a preset acceptable threshold (such as ±5% or ±10%). If the deviation does not exceed the threshold, it is determined to be qualified and the qualified information is recorded. If the deviation exceeds the threshold, it triggers an artificial disposal process, and displays the deviation value, possible reasons, and recommended measures through a terminal (touch screen). The operator can select to discard and redo, downgrade for use, or suspend the batch according to the prompt. Whether it is qualified or not, all data (actual activity, deviation value, disposal decision, operator ID, etc.) are uploaded to an immutable database in real time for subsequent traceability and quality auditing.

[0068] As Figure 6 shown, as a preferred embodiment of the present invention, the activity determination module 200 includes: A task list unit 201 for obtaining a task list, where the task list includes the prescription information of all patients to be sub-packaged, and obtains the target activity, volume upper limit, and administration time according to the prescription information.

[0069] In this module, the task list unit 201 obtains the task list. First, it obtains the task list for the current sub-packaging, which contains the prescription information of all patients to be sub-packaged in this batch. It extracts the key parameters of each patient one by one from the task list: the target activity, volume upper limit, and administration time. The above information serves as the basis for subsequent decay correction calculation, volume rationality judgment, and sub-packaging order arrangement.

[0070] For example, a certain sub-packaging task list registers 3 patients: Patient A, with a target activity of 15 mCi, a volume upper limit of 1 ml, and an administration time of 10:00; Patient B, with a target activity of 20 mCi, a volume upper limit of 2 ml, and an administration time of 10:15; Patient C, with a target activity of 18 mCi, a volume upper limit of 0.5 ml, and an administration time of 10:30. After calling this task list, according to the time difference between each administration time and the current sub-packaging moment, the required decay compensation activity is calculated respectively. At the same time, when calculating the recommended volume later, the volume upper limit is used as a constraint condition: if the recommended volume calculated according to the stock solution concentration exceeds the upper limit, a dilution or sub-packaging in multiple doses prompt is triggered.

[0071] A vial number determination unit 202 for judging the actual number of vials according to the total activity of the stock solution and the target activity, comparing the required number of vials with the actual number of vials. If the actual number of vials is greater than the required number of vials, it is determined that the stock solution meets the requirements. If it is determined that the requirements are not met, the required dilution volume is obtained.

[0072] In this module, the count determination unit 202 determines the actual number of vials based on the total activity and target activity of the stock solution. It calculates the actual number of vials that the current stock solution can support based on the total activity of the stock solution and the target activity required for each formulation in the task schedule. This actual number of vials is then compared with the required number of vials in the task schedule: if the actual number of vials is greater than or equal to the required number, it is determined that "the stock solution meets the requirements," and the process can proceed directly to the next level of judgment; if the actual number of vials is less than the required number, it is determined that the requirements are not met. In this case, the required volume of diluent is obtained, a dilution plan is generated, and after confirmation by the operator, online dilution is performed. After dilution, the stock solution activity is remeasured, and the number of vials is compared again.

[0073] For example, a batch of packaging tasks requires packaging for 4 patients. 18 The required total activity for F-FDG is 240 mCi. The actual measured total activity of the stock solution is 180 mCi. Based on a maximum allowable activity of 60 mCi per vial, this actually supports 3 vials, less than the required 4. Therefore, it is deemed insufficient. The system automatically calculates the required diluent volume: if the activity per vial drops to 45 mCi after dilution, then 180 mCi can support 4 vials. The stock solution concentration needs to be diluted from the current value to the target concentration, calculating the required diluent volume as X ml. The dilution plan is sent to the touchscreen. After operator confirmation, the dilution is executed. The stock solution activity concentration and total activity are remeasured, and the actual number of vials is compared with the required number. If the requirement is met, the process proceeds to the next stage.

[0074] The dilution scheme unit 203 is used to output a dilution scheme based on the volume of the diluent, send the dilution scheme to the terminal, obtain terminal confirmation information, perform online dilution based on the confirmation information, and re-compare the required number of vials with the actual number of vials.

[0075] In this module, the dilution scheme unit 203 outputs a dilution scheme based on the volume of the diluent. It automatically generates a dilution scheme based on the calculated volume and sends it to the operating terminal. After reviewing the scheme, the operator enters confirmation information through the terminal (e.g., clicking the confirmation button, entering an authorization password, or scanning a fingerprint). Based on the confirmation information, the actuator automatically measures the diluent according to the scheme and injects it into the stock solution container for online dilution. After dilution, the activity concentration and total activity of the stock solution are remeasured, and the required number of vials is compared with the actual number until the requirements are met.

[0076] If the actual number of vials after dilution reaches or exceeds the required number, the concentrate is deemed to meet the requirements. The dilution operation and confirmation information are recorded, and the process proceeds to the next stage. By comparing the online dilution and the number of vials again, automated and flexible handling of insufficient concentrate activity is achieved, reducing errors from manual calculation and operation.

[0077] like Figure 7 As shown, in a preferred embodiment of the present invention, the volume determination module 300 includes: The attenuation value acquisition unit 301 is used to record the judgment result and operator ID after the comparison is passed again, and to obtain the attenuation value of the drug from the current time to the drug administration period.

[0078] In this module, the attenuation value acquisition unit 301, after a second successful comparison, records the first-level judgment result and the current operator ID, and stores them in the local cache. Subsequently, it acquires the time difference between each patient's dosing time and the current dispensing time, and, combined with the half-life of the radionuclide used, calculates the attenuation value of the drug from the current time until dosing. This attenuation value is used to reverse-calculate the activity required during dispensing to ensure that patients receive the accurate prescribed dose at the time of dosing.

[0079] For example, a patient's prescription requests an injection of 15 mCi activity at 10:30 AM, while the current dispensing time is 9:30 AM, a time difference of 1 hour. The radionuclide used is... 18 F has a half-life of approximately 110 minutes, and calculations show that the drug decays by about 32% within 1 hour. This means that from dispensing to injection, the activity will decrease to approximately 68% of its original value. Therefore, the required activity during dispensing should be approximately 22 mCi (15 ÷ 0.68). The decay value (32%) and the required activity for dispensing (22 mCi) are automatically recorded and associated with the operator ID "ZHS002" and the judgment result "Level 1 Pass" in the database.

[0080] The extraction volume unit 302 is used to calculate the activity required for dispensing based on the attenuation value, recommend the extraction volume based on the real-time stock solution concentration, obtain the extraction volume safety threshold, which is 0.2ml-5ml, and compare the recommended extraction volume with the safety threshold.

[0081] In this module, extraction volume unit 302 calculates the required activity for dispensing based on the attenuation value, and then calculates the required activity for dispensing based on the attenuation value obtained in the previous step. Combined with the current real-time concentration of the stock solution, the theoretically recommended extraction volume is calculated. A preset extraction volume safety threshold is obtained, which is typically set between 0.2 ml and 5 ml depending on the syringe precision and container capacity. The recommended extraction volume is compared with this safety threshold: if it is within the threshold range, the next operation is performed; if it is below the lower limit or above the upper limit, a prompt is triggered and manual intervention is required.

[0082] For example, if a patient requires an activity of 22 mCi for dispensing, and the current concentration of the stock solution is 200 mCi / ml, then the recommended extraction volume is 0.11 ml. The safety threshold is 0.2 ml to 5 ml; 0.11 ml is below the lower limit. The touchscreen will display a prompt: "The recommended volume of 0.11 ml is too small, below the safety lower limit of 0.2 ml. Please dilute the stock solution or adjust the prescription." The operator selects to enable the dilution function, reduces the stock solution concentration to 100 mCi / ml, recalculates the recommended volume to 0.22 ml, which falls within the safety threshold, and the comparison is successful.

[0083] The volume judgment unit 303 is used to send confirmation information to the terminal if the judgment is qualified, and to suspend the process and obtain human decision if the judgment is unqualified. The human decision includes enabling dilution, dispensing in batches, and confirming that the volume is still executed.

[0084] In this module, the volume judgment unit 303, if the judgment is qualified, compares the recommended extraction volume with the safety threshold. If the judgment is qualified, it generates confirmation information and sends it to the operation terminal, awaiting final confirmation from the operator. If the judgment is unqualified, the dispensing process is paused, and a manual decision-making interface pops up on the terminal for the operator to choose a handling method. The manual decision-making includes three options: enable dilution, dispensing in stages, and confirm to still execute according to this volume.

[0085] For example, the recommended extraction volume is 0.11 ml. Volume below the 0.2 ml limit is considered unacceptable, and the process is paused. The terminal displays: "Volume of 0.11 ml is too small. Please select: 1. Enable dilution 2. Dispense in fractions 3. Continue with this volume." After assessment, the operator deems the dilution operation time-consuming and 0.11 ml acceptable with the current high-precision syringe (minimum graduation 0.01 ml), so they select "Continue with this volume" and enter the authorization password and the reviewer's fingerprint. The process continues, dispensing in 0.11 ml increments.

[0086] like Figure 8 As shown, in a preferred embodiment of the present invention, the activity determination module 400 includes: The actual activity unit 401 is used to acquire dispensing information, which includes operator ID, confirmation method, target activity and final selected volume, and to acquire the actual activity after dispensing in real time.

[0087] In this module, the actual activity unit 401 acquires dispensing information. Before dispensing, it obtains complete dispensing information, including operator ID, confirmation method (such as scanning a barcode, entering an authorization password, fingerprint verification, or dual verification), target activity, and the final selected extraction volume. During the dispensing process, it acquires the actual activity of the product in the syringe after dispensing in real time for subsequent deviation comparison and handling judgment. The operator selects barcode scanning for confirmation. The target activity is 15 mCi. Manually fine-tune the volume to 0.18 ml as required clinically. After dispensing, the actual activity read is 14.2 mCi. All information (including fine-tuning records) is completely saved to provide a basis for subsequent deviation comparison and manual handling. By obtaining the dispensing information and actual activity in real time, ensure that the whole process of each product from decision-making to execution is traceable and can be rechecked.

[0088] The activity determination unit 402 is used to obtain the target activity and the percentage deviation of the actual activity, obtain the acceptable threshold, compare the percentage deviation with the acceptable threshold, and if the deviation does not exceed the threshold, determine it as qualified.

[0089] In this module, the activity determination unit 402 obtains the target activity and the percentage deviation of the actual activity, obtains the target activity of the dispensed product and the actual activity obtained by actual measurement, and calculates the percentage deviation between the two. At the same time, obtain the preset acceptable threshold (such as ±5% or ±10%, which can be configured according to different radionuclides and clinical requirements). Compare the percentage deviation with this threshold: if the deviation does not exceed the threshold, determine that this product is qualified, record the qualified status and release the product; if the deviation exceeds the threshold, enter the manual handling process.

[0090] For example, the target activity of a dispensed product is 20 mCi, the actual measured activity is 19.3 mCi, and the percentage deviation is 3.5%. The preset acceptable threshold is ±5%, and 3.5% does not exceed 5%, so it is determined as qualified. The touch screen displays "qualified", records the actual activity, deviation value and qualified status, and the operator takes out the product and pastes the label.

[0091] The information recording unit 403 is used to give an audible and visual alarm if the deviation exceeds the threshold, and send specific information to the terminal. The specific information includes the specific deviation value, cause prompt and handling measures, obtain the terminal handling information, and upload it to the database.

[0092] In this module, the information recording unit 403, if the deviation exceeds the threshold, if the percentage deviation exceeds the acceptable threshold, triggers an audible and visual alarm, and at the same time sends the specific information to the operation terminal. The specific information includes: the specific deviation value, possible cause prompts, such as "non-uniform stock solution", "activity meter drift", "pipeline bubbles", etc. And recommended handling measures, such as "redo after mixing the stock solution", "calibrate the activity meter", "check the pipeline". The operator makes a manual decision according to the information displayed on the terminal. The terminal obtains the handling information, such as discard and redo, downgrade use or suspend the batch, and uploads the handling information together with the deviation data, operator ID, etc. to the tamper-proof database for quality traceability and auditing.

[0093] In one embodiment, a computer device is provided, the computer device including a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor, when executing the computer program, performs the following steps: Obtain stock solution information, including real-time concentration and total activity; obtain barcode information, including stock solution batch number, nuclide type and reference time point. The actual number of vials is determined based on the total activity of the original solution and the target activity. The required number of vials is compared with the actual number of vials. The dilution plan is output based on the volume of the diluent and sent to the terminal. The required number of vials is compared with the actual number of vials again. After the comparison is passed again, record the judgment result and operator ID, obtain the task table, calculate the activity required for dispensing based on the attenuation value, recommend the extraction volume based on the real-time stock solution concentration, and compare the recommended extraction volume with the safety threshold. The system acquires the actual activity level after dispensing in real time, compares the percentage deviation with the acceptable threshold, obtains terminal processing information, and uploads it to the database.

[0094] In one embodiment, a computer-readable storage medium is provided, on which a computer program is stored, which, when executed by a processor, causes the processor to perform the following steps: Obtain stock solution information, including real-time concentration and total activity; obtain barcode information, including stock solution batch number, nuclide type and reference time point. The actual number of vials is determined based on the total activity of the original solution and the target activity. The required number of vials is compared with the actual number of vials. The dilution plan is output based on the volume of the diluent and sent to the terminal. The required number of vials is compared with the actual number of vials again. After the comparison is passed again, record the judgment result and operator ID, obtain the task table, calculate the activity required for dispensing based on the attenuation value, recommend the extraction volume based on the real-time stock solution concentration, and compare the recommended extraction volume with the safety threshold. The system acquires the actual activity level after dispensing in real time, compares the percentage deviation with the acceptable threshold, obtains terminal processing information, and uploads it to the database.

[0095] It should be understood that although the steps in the flowcharts of the various embodiments of the present invention are shown sequentially according to the arrows, these steps are not necessarily executed in the order indicated by the arrows. Unless explicitly stated herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least some steps in the various embodiments may include multiple sub-steps or multiple stages. These sub-steps or stages are not necessarily completed at the same time, but can be executed at different times. The execution order of these sub-steps or stages is not necessarily sequential, but can be performed alternately or in turn with other steps or at least a portion of the sub-steps or stages of other steps. Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. The program can be stored in a non-volatile computer-readable storage medium, and when executed, it can include the processes of the embodiments of the above methods. Any references to memory, storage, databases, or other media used in the embodiments provided in this application can include non-volatile and / or volatile memory. Non-volatile memory can include read-only memory (ROM), programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or flash memory. Volatile memory can include random access memory (RAM) or external cache memory. By way of illustration and not limitation, RAM is available in various forms, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), dual data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous link DRAM (SLDRAM), Rambus direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM), etc.

[0096] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0097] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

[0098] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A semi-automatic method for judging and dispensing radiopharmaceuticals, characterized in that, The method includes: Obtain stock solution information, including real-time concentration and total activity; obtain barcode information, including stock solution batch number, nuclide type and reference time point. The actual number of vials is determined based on the total activity of the original solution and the target activity. The required number of vials is compared with the actual number of vials. The dilution plan is output based on the volume of the diluent and sent to the terminal. The required number of vials is compared with the actual number of vials again. After the comparison is passed again, record the judgment result and operator ID, obtain the task table, calculate the activity required for dispensing based on the attenuation value, recommend the extraction volume based on the real-time stock solution concentration, and compare the recommended extraction volume with the safety threshold. The system acquires the actual activity level after dispensing in real time, compares the percentage deviation with the acceptable threshold, obtains terminal processing information, and uploads it to the database.

2. The semi-automatic judgment and dispensing method for radiopharmaceuticals according to claim 1, characterized in that, The steps of determining the actual number of vials based on the total activity and target activity of the original solution, comparing the required number of vials with the actual number of vials, outputting a dilution plan based on the volume of diluent, sending the dilution plan to the terminal, and re-comparing the required number of vials with the actual number of vials specifically include: Obtain the task table, which includes prescription information for all patients to be dispensed, and obtain the target activity, upper volume limit, and dosing time based on the prescription information; The actual number of vials is determined based on the total activity of the stock solution and the target activity. The required number of vials is compared with the actual number of vials. If the actual number of vials is greater than the required number of vials, it is determined that the stock solution meets the requirements. If it is determined that the requirements are not met, the required volume of diluent is obtained. Output the dilution plan based on the volume of diluent, send the dilution plan to the terminal, obtain terminal confirmation information, perform online dilution based on the confirmation information, and re-compare the required number of vials with the actual number of vials.

3. The semi-automatic judgment and dispensing method for radiopharmaceuticals according to claim 1, characterized in that, After the second comparison is passed, the judgment result and operator ID are recorded, the task table is obtained, the activity required for dispensing is calculated based on the attenuation value, the extraction volume is recommended based on the real-time stock solution concentration, and the recommended extraction volume is compared with the safety threshold. The specific steps include: After the comparison is successful again, record the judgment result and operator ID, and obtain the drug decay value from the current time to the dosing period; The required activity for dispensing is calculated based on the attenuation value, and the extraction volume is recommended based on the real-time stock solution concentration. The safe extraction volume threshold is obtained, which is 0.2ml-5ml. The recommended extraction volume is compared with the safe threshold. If the judgment is satisfactory, a confirmation message is sent to the terminal. If the judgment is unsatisfactory, the process is paused and a manual decision is obtained. The manual decision includes enabling dilution, dispensing in multiple batches, and confirming that the volume should still be used.

4. The semi-automatic judgment and dispensing method for radiopharmaceuticals according to claim 1, characterized in that, The steps of acquiring the actual activity after dispensing in real time, comparing the deviation percentage with an acceptable threshold, obtaining terminal processing information, and uploading it to the database specifically include: Obtain dispensing information, including operator ID, confirmation method, target activity, and final selected volume, and obtain the actual activity after dispensing in real time; Obtain the percentage deviation between the target activity and the actual activity, obtain the acceptable threshold, compare the percentage deviation with the acceptable threshold, and if the deviation does not exceed the threshold, it is considered qualified; If the deviation exceeds the threshold, an audible and visual alarm will be triggered, and specific information will be sent to the terminal. The specific information includes the specific deviation value, cause prompts, and handling measures. The terminal's handling information will be obtained and uploaded to the database.

5. A semi-automatic method for judging and dispensing radiopharmaceuticals according to claim 2, characterized in that, The actual number of vials = total activity of the original solution / target activity.

6. A semi-automatic judgment and dispensing system for radiopharmaceuticals, characterized in that, The system includes: The information acquisition module acquires the original solution information, including real-time concentration and total activity, and acquires barcode information, including the original solution batch number, nuclide type, and reference time point. The activity determination module determines the actual number of vials based on the total activity of the original solution and the target activity, compares the required number of vials with the actual number of vials, outputs the dilution plan based on the volume of the diluent, sends the dilution plan to the terminal, and re-compares the required number of vials with the actual number of vials. The volume determination module records the determination result and operator ID after the comparison is passed again, obtains the task table, calculates the activity required for dispensing based on the attenuation value, recommends the extraction volume based on the real-time original solution concentration, and compares the recommended extraction volume with the safety threshold. The activity determination module obtains the actual activity after dispensing in real time, compares the deviation percentage with the acceptable threshold, obtains terminal disposal information, and uploads it to the database.

7. A semi-automatic judgment and dispensing system for radiopharmaceuticals according to claim 6, characterized in that, The activity determination module includes: The task table unit retrieves the task table, which includes prescription information for all patients to be dispensed. Based on the prescription information, the target activity, upper volume limit, and dosing time are obtained. The unit that determines the number of vials determines the actual number of vials based on the total activity of the original solution and the target activity. It compares the required number of vials with the actual number of vials. If the actual number of vials is greater than the required number of vials, it is determined that the original solution meets the requirements. If it is determined that the requirements are not met, the required volume of diluent is obtained. The dilution scheme unit outputs a dilution scheme based on the volume of the diluent, sends the dilution scheme to the terminal, obtains confirmation information from the terminal, performs online dilution based on the confirmation information, and re-compares the required number of vials with the actual number of vials.

8. A semi-automatic judgment and dispensing system for radiopharmaceuticals according to claim 7, characterized in that, The volume determination module includes: After the attenuation value acquisition unit passes the comparison again, it records the judgment result and operator ID, and obtains the attenuation value of the drug from the current time to the dosing period. Extraction volume unit, calculate the activity required for dispensing based on the attenuation value, recommend extraction volume based on real-time stock solution concentration, obtain extraction volume safety threshold, the safety threshold is 0.2ml-5ml, compare the recommended extraction volume with the safety threshold; If the volume judgment unit is qualified, it sends a confirmation message to the terminal; if it is unqualified, it pauses the process and obtains a human decision. The human decision includes enabling dilution, dispensing in multiple batches, and confirming that the volume should still be executed.

9. A semi-automatic judgment and dispensing system for radiopharmaceuticals according to claim 8, characterized in that, The activity determination module includes: The actual activity unit acquires dispensing information, including operator ID, confirmation method, target activity, and final selected volume, and acquires the actual activity after dispensing in real time. The activity determination unit obtains the percentage deviation between the target activity and the actual activity, obtains the acceptable threshold, compares the percentage deviation with the acceptable threshold, and if the deviation does not exceed the threshold, it is deemed qualified. If the deviation exceeds the threshold, the information recording unit will trigger an audible and visual alarm and send specific information to the terminal. The specific information includes the specific deviation value, cause prompts, and handling measures. The unit will also obtain the terminal's handling information and upload it to the database.

10. A semi-automatic judgment and dispensing system for radiopharmaceuticals according to claim 9, characterized in that, The actual number of vials = total activity of the original solution / target activity.

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