Radiopharmaceutical sub-packaging control system and sub-packaging control method

Abstract

The invention discloses a radiopharmaceutical sub-packaging control system and a sub-packaging control method, belongs to the field of radiopharmaceutical sub-packaging, and aims to solve the problem that the existing radiopharmaceutical sub-packaging efficiency is low. The method comprises the following steps of: 1, filling in an order form, confirming order activity A0 and calibration time T0, transmitting the order form to a PLC (Programmable Logic Controller), and automatically forming a production queue; 2, determining formula parameters according to the order form; step 3, calculating the sub-packaging quantity of each member in the production queue; 4, diluting and uniformly mixing according to the formula; and step 5, filling according to a production queue. According to the radiopharmaceutical sub-packaging control method disclosed by the invention, the orders are queued, automatic sub-packaging is controlled through the target activity and the calibration time of the orders, decay correction is carried out on each member in the queue according to the stock solution activity, the sub-packaging time is determined, and the new sub-packaging time theoretical raw material activity is updated. And the sub-packaging control volume of each member in the queue is calculated, so that continuous and efficient automatic queue sub-packaging is realized.

Description

Technical Field

[0001] This invention belongs to the field of radiopharmaceutical repackaging, specifically a radiopharmaceutical repackaging control system and repackaging control method. Background Technology

[0002] Radiopharmaceuticals are special preparations containing radioactive isotopes used for medical diagnosis or treatment, and are a component of nuclear medicine. Radiopharmaceuticals are characterized by radioactivity and instability; that is, their radioactivity decreases over time.

[0003] my country's nuclear medicine industry has developed rapidly. With the widespread use of radiopharmaceuticals and the innovative research and development of new drugs, the types and quantities of radiopharmaceuticals available are also increasing. Because patients undergo different examinations, have different weights and ages, the required amounts of radiopharmaceuticals also vary. Therefore, radiopharmaceuticals need to be labeled beforehand, that is, the activity measurement time, activity, and volume of the drug are marked on accompanying documents or labels. Based on the specific radioactivity dosage for each patient, the drugs are then dispensed to the required activity level for each individual patient. Finally, they are applied to the corresponding patients or examinees.

[0004] Currently, the production and packaging of radiopharmaceuticals mostly rely on pre-calculation, manual packaging, and single-bottle packaging, which has the following drawbacks:

[0005] Firstly, the activity of radiopharmaceuticals decays over time, and existing manual dispensing methods cannot compensate for the decay effect.

[0006] Secondly, it relies on manual calculation and single-bottle dispensing, resulting in low dispensing efficiency and large errors in dispensing volume calculation. Summary of the Invention

[0007] The purpose of this invention is to provide a radiopharmaceutical dispensing control system and dispensing control method to solve the problem of low dispensing efficiency of existing radiopharmaceuticals.

[0008] The technical solution adopted in this invention is: a radiopharmaceutical dispensing control system, comprising:

[0009] The order management module imports order data and performs initial sorting of orders to generate a production queue. The order data includes order activity A0, calibration time T0, order volume V0, and nuclide type.

[0010] A formula database stores formula parameters for nuclides, including the half-life T. 1 / 2 The target concentration C1 and the dispensing mode identifier, wherein the dispensing mode identifier includes mode 1, mode 2 and mode 3;

[0011] The activity dynamic calculation engine queries the formula database based on the nuclide type of the order to obtain the corresponding formula parameters, selects the corresponding dispensing algorithm according to the dispensing mode identifier, and calculates the decay compensation activity based on the dispensing algorithm. The amount to be packaged is then used to generate a packaged instruction queue.

[0012] The PLC execution unit receives the dispensing instruction queue from the activity dynamic calculation engine and controls the filling mechanism to execute any of the following matching dispensing modes according to the instructions in the dispensing instruction queue:

[0013] Mode 1: Single-needle fixed-dispensing diluent, the dispensing volume of the diluent is V3, and the calculation is V3 = A2 / C. X C X For dilution concentration C 1+ Or, the concentration C was measured during the first bottle refilling. T The diluted solution is prepared by mixing V1 volume of the original solution with V2 volume of the diluted solution.

[0014] Mode 2: Double-needle fixed-concentration dispensing of stock solution and diluent, with the dispensing volume of stock solution being V4 and the dispensing volume of diluent being V5. The calculation is as follows: V4 = V1A2 / A1; V5 = A2 / C1-V4.

[0015] Mode 3: Dual-needle fixed-volume dispensing of the stock solution and diluent. The dispensing volume of the stock solution is V4, and the dispensing volume of the diluent is V5. The calculation method is V4 = A2 / C. Y V5 = V0 - V4; C Y The target concentration C1 preset for the formula or the actual concentration C measured in the first bottle is specified. T ;

[0016] The dispensing time T1 is the actual dispensing time obtained by the PLC in real time.

[0017] Furthermore, the packaging mode identifier includes identifier 1, identifier 2 and identifier 3; identifier 1 triggers mode 1 and algorithm; identifier 2 triggers mode 2 and algorithm; identifier 3 triggers mode 3 and algorithm.

[0018] Furthermore, the activity dynamic calculation engine also includes:

[0019] The first-bottle feedback module, in modes 1 and 3, measures the actual concentration C of the first bottle after dispensing. T Dynamically update subsequent packaging parameters;

[0020] In the quality inspection module, under mode 2, the actual concentration C of the first bottle was measured during dispensing. T When the concentration of C1 deviates from the target concentration by more than the threshold, an alarm is triggered and dispensing is suspended.

[0021] Furthermore, the order management module sorts orders in ascending order according to the calibrated time T0.

[0022] The method for controlling the repackaging of radiopharmaceuticals includes the following steps:

[0023] Step 1: Import orders. Each order specifies the order activity A0, calibration time T0, order volume V0, and nuclide type. The imported orders are then dynamically sorted according to their calibration time T0 to form an order queue.

[0024] Step 2: The activity dynamic calculation engine automatically matches formula parameters for each order in the order queue based on the nuclide type. These formula parameters include the nuclide half-life T. 1 / 2 The target concentration C1 and the dispensing mode identifier are selected; the dispensing algorithm is selected based on the dispensing mode identifier to calculate the dispensing amount; and a dispensing instruction queue is generated.

[0025] The packaging mode identifiers include mode 1, mode 2, and mode 3;

[0026] The packaging algorithm is as follows:

[0027] Mode 1: Single-needle fixed-dispensing diluent, the dispensing volume of the diluent is V3, and the calculation is V3 = A2 / C. X C X For dilution concentration C 1+ Or, the concentration C was measured during the first bottle refilling. T ;

[0028] Mode 2: Double-needle fixed-concentration dispensing of stock solution and diluent, with the dispensing volume of stock solution being V4 and the dispensing volume of diluent being V5. The calculation is as follows: V4 = V1A2 / A1; V5 = A2 / C1-V4.

[0029] Mode 3: Dual-needle fixed-volume dispensing of the stock solution and diluent. The dispensing volume of the stock solution is V4, and the dispensing volume of the diluent is V5. The calculation method is V4 = A2 / C. Y V5 = V0 - V4; C Y The target concentration C1 preset for the formula or the actual concentration C measured in the first bottle is specified. T ;

[0030] in, λ=LN(2) / T 1 / 2 ;T 1 / 2 It is the half-life.

[0031] The dispensing time T1 is the actual dispensing time obtained by the PLC in real time;

[0032] Step 3: The dispensing instruction queue is transmitted to the PLC. The PLC controls the filling mechanism to perform the dispensing operation according to the selected dispensing mode.

[0033] Furthermore, the filling mechanism includes a concentrate bag, a diluent bag, a medicine bag, a concentrate dispensing needle, a diluent dispensing needle, and a medicine dispensing needle;

[0034] The original solution bag is connected to the original solution dispensing needle via an original solution dispensing pipeline, and an original solution dispensing pump is installed on the original solution dispensing pipeline; the original solution bag is connected to the medicine bag via an original solution supply pipeline, and an original solution supply pump is installed on the original solution supply pipeline.

[0035] The diluent bag is connected to the diluent dispensing needle via a diluent dispensing pipeline, and a diluent dispensing pump is installed on the diluent dispensing pipeline; the diluent bag is connected to the diluent bag via a diluent supply pipeline, and a diluent supply pump is installed on the diluent supply pipeline.

[0036] The medicine bag is connected to the medicine dispensing needle through a medicine dispensing pipeline, and a medicine dispensing pump is installed on the medicine dispensing pipeline;

[0037] The original liquid dispensing pump, original liquid supply pump, diluent dispensing pump, diluent supply pump, and drug dispensing pump are all controlled by a PLC execution unit.

[0038] In Mode 1, the PLC execution unit first starts the stock solution supply pump to draw V1 volume of stock solution from the stock solution bag into the medicine bag, and the diluent supply pump draws V2 volume of diluent from the diluent bag into the medicine bag. The stock solution V1 volume and the diluent V2 volume are then mixed evenly in the medicine bag to obtain a diluted solution. Then, the medicine dispensing pump is started, and a medicine dispensing needle is used to draw V3 volume of diluted solution from the medicine bag for filling.

[0039] In modes 2 and 3, the PLC execution unit starts the raw liquid dispensing pump, which uses the raw liquid dispensing needle to draw V4 volume of raw liquid from the raw liquid bag for filling; and starts the diluent dispensing pump, which uses the diluent dispensing needle to draw V5 volume of diluent from the diluent bag for filling.

[0040] Furthermore, the measured concentration C of the first bottle was obtained after the first bottle was dispensed. T The concentration C was measured using the first bottle dispensing method under both Mode 1 and Mode 3. T Update the subsequent packaging volume.

[0041] Furthermore, in Mode 3, if the calculated volume of the original solution, V4, before the first bottle is dispensed is greater than V0, then the first bottle will be forcibly dispensed at V4 = V0 and an alarm will sound; after the first bottle, V4 = A2 / C T .

[0042] The beneficial effects of this invention are as follows: The radiopharmaceutical dispensing control system and dispensing method disclosed in this invention incorporate the order calibration time T0, dispensing time T1 and half-life into a unified calculation model, dynamically compensate for decay effects, ensure that the activity at calibration time T0 is equal to the order activity A0, solve the error caused by radionuclide activity decay, greatly reduce dispensing activity error, and improve dispensing accuracy.

[0043] Customer demands are queued, the amount to be dispensed for each member in the queue is calculated, and automatic dispensing is performed according to the queue, realizing automated queue dispensing. Actual calculations show that the dispensing speed is as high as 20 bottles / minute, which greatly improves dispensing efficiency.

[0044] It supports three dispensing modes, covering production needs such as fixed volume, fixed concentration, and pre-mixing, resulting in better production adaptability. The activity dynamic calculation engine drives the PLC to adaptively switch physical actions through dispensing mode identifiers, supporting mixed queue production.

[0045] In both Mode 1 and Mode 3, the concentration C was measured by dispensing the first bottle. T Dynamically adjust subsequent dispensing amounts to reduce dispensing errors. Attached Figure Description

[0046] Figure 1 This is a schematic diagram of a radiopharmaceutical dispensing control system.

[0047] Figure 2 This is a schematic diagram of the filling mechanism.

[0048] In the diagram, the components are: order management module 100, formula database 200, activity dynamic calculation engine 300, PLC execution unit 400, filling mechanism 500, concentrate bag 501, diluent bag 502, medicine bag 503, concentrate dispensing needle 504, diluent dispensing needle 505, medicine dispensing needle 506, concentrate dispensing pump 507, concentrate supply pump 508, diluent dispensing pump 509, diluent supply pump 510, medicine dispensing pump 511, and HMI system 600. Detailed Implementation

[0049] The present invention will be further described below with reference to the accompanying drawings and embodiments:

[0050] A radiopharmaceutical dispensing control system, including:

[0051] The order management module 100 imports order data and performs initial sorting of orders to generate a production queue. The order data includes order activity A0, calibration time T0, order volume V0, and nuclide type.

[0052] Formula database 200 stores formula parameters for nuclides, including nuclide name and half-life T. 1 / 2The target concentration C1 and the dispensing mode identifier, wherein the dispensing mode identifier includes mode 1, mode 2 and mode 3;

[0053] The activity dynamic calculation engine 300 queries the formula database based on the nuclide type in the order, obtains the corresponding formula parameters, selects the corresponding dispensing algorithm according to the dispensing mode identifier, and calculates the decay compensation activity based on the dispensing algorithm. The amount to be packaged is then used to generate a packaged instruction queue.

[0054] The PLC execution unit 400 receives the dispensing instruction queue from the activity dynamic calculation engine 300, and controls the filling mechanism to execute any of the following matching dispensing modes according to the instructions in the dispensing instruction queue:

[0055] Mode 1: Single-needle fixed-dispensing diluent, the dispensing volume of the diluent is V3, and the calculation is V3 = A2 / C. X C X For dilution concentration C 1+ Or, the concentration C was measured during the first bottle refilling. T The diluted solution is prepared by mixing V1 volume of the original solution with V2 volume of the diluted solution.

[0056] Mode 2: Double-needle fixed-concentration dispensing of stock solution and diluent, with the dispensing volume of stock solution being V4 and the dispensing volume of diluent being V5. The calculation is as follows: V4 = V1A2 / A1; V5 = A2 / C1-V4.

[0057] Mode 3: Dual-needle fixed-volume dispensing of the stock solution and diluent. The dispensing volume of the stock solution is V4, and the dispensing volume of the diluent is V5. The calculation method is V4 = A2 / C. Y V5 = V0 - V4; C Y The target concentration C1 preset for the formula or the actual concentration C measured in the first bottle is specified. T ;

[0058] The dispensing time T1 is the actual dispensing time obtained in real time by the PLC execution unit 400.

[0059] The radiopharmaceutical dispensing control system disclosed in this invention incorporates the order calibration time T0, dispensing time T1, and half-life into a unified calculation model, dynamically compensates for decay effects, and ensures that the activity at calibration time T0 is equal to the order activity A0. This solves the error caused by radionuclide activity decay, greatly reduces dispensing activity error, and improves dispensing accuracy.

[0060] It supports three dispensing modes, covering production needs such as fixed volume, fixed concentration, and pre-mixing, resulting in better production adaptability. The activity dynamic calculation engine drives the PLC to adaptively switch physical actions through dispensing mode identifiers, supporting mixed queue production.

[0061] In both Mode 1 and Mode 3, the concentration C was measured by dispensing the first bottle. T Dynamically adjust subsequent dispensing amounts to reduce dispensing errors.

[0062] By using automated queues for packaging, the packaging speed and efficiency are improved.

[0063] It also includes the HMI system 600, which serves as a visual operating interface to display order lists, formula parameters, etc., allowing operators to monitor order status and formula parameters. It is also used to receive manual input, such as manually triggering calculations, alarm confirmations, and manually entering parameters. It can also send operation instructions to the activity dynamic calculation engine 300, such as starting production scheduling.

[0064] The dispensing mode identifiers include identifier 1, identifier 2, and identifier 3; identifier 1 triggers mode 1 and its algorithm; identifier 2 triggers mode 2 and its algorithm; and identifier 3 triggers mode 3 and its algorithm. The radiopharmaceutical dispensing control system disclosed in this invention does not rigidly use a single dispensing mode, but automatically switches algorithms and executes dispensing based on preset parameters in the formula. Specifically, the formula database 200 stores the half-lives T of multiple nuclides. 1 / 2 When matching orders, the packaging mode identifier of the nuclide is automatically read.

[0065] For example, if the nuclide packaging mode in an order is identified as Identifier 1, the activity dynamic calculation engine 300 will call the algorithm for Mode 1, which is V3 = A2 / C. X The PLC execution unit 400 controls the filling mechanism to perform dispensing in mode 1, that is, starting the single needle to extract the original liquid volume V3 and fill it into the medicine bottle.

[0066] The nuclide in a certain order is labeled as label 2. The activity dynamic calculation engine 300 then calls the algorithm of mode 2: V4 = V1A2 / A1; V5 = A2 / C1-V4. The PLC execution unit 400 controls the filling mechanism to perform filling according to mode 2, that is, it starts the stock solution needle to draw V4 volume of stock solution and fills it into the medicine bottle, and starts the diluent needle to draw V5 volume of diluent and fill it into the medicine bottle.

[0067] The nuclide in a certain order is labeled with label 3 for the packaging mode. The activity dynamic calculation engine 300 then calls the algorithm for mode 3: V4 = A2 / C Y V5 = V0 - V4. The PLC execution unit 400 controls the filling mechanism to perform dispensing in mode 3, that is, starting the concentrate needle to draw V4 volume of concentrate and fill it into the medicine bottle, and starting the diluent needle to draw V5 volume of diluent and fill it into the medicine bottle.

[0068] Mode 1 involves mixing before filling, ensuring uniform concentration; Mode 2 involves filling and mixing at a fixed concentration, prioritizing activity accuracy; Mode 3 involves filling and mixing at a fixed volume, strictly locking the order volume V0. This invention automatically matches and switches between these three filling modes to meet complex production needs.

[0069] Preferably, the activity dynamic calculation engine 300 further includes:

[0070] The first-bottle feedback module, in modes 1 and 3, measures the actual concentration C of the first bottle after dispensing. T Dynamically update subsequent packaging parameters.

[0071] After the first bottle is dispensed, an activity meter can be used for online detection to obtain the measured concentration C of the first bottle. T and the measured concentration C T The data is passed to the PLC execution unit 400, which then passes it to the activity dynamic calculation engine 300. The activity dynamic calculation engine 300 uses the measured concentration C from the first bottle dispensed. T Update subsequent packaging parameters. For example: in mode 1, let Cx = C T Calculate the original liquid volume V3. In Mode 3, let C... Y =C T First, calculate the original liquid volume V4, then calculate the diluent volume V5. The first bottle data of this invention (actual concentration C measured during the first bottle dispensing) T It provides real-time feedback to correct subsequent queues without interrupting production, thereby improving continuous packaging capabilities.

[0072] Mode 2 involves simultaneous dispensing and mixing at a fixed concentration using a dual-needle filling system. The bulk solution syringe draws V4 volumes of bulk solution, while the diluent syringe draws V5 volumes of diluent. These are then mixed after being dispensed into vials. Before dispensing, the bulk solution activity A1 and volume V1 are already determined. For example, if the synthesis lab provides the bulk solution activity A1 and weighs it to obtain the volume V1, in Mode 2, C1 is the pre-set target concentration in the formulation, unaffected by mixing uniformity and irrelevant to the current dispensing process. C1 is only used to calculate the diluent volume V5, and the final concentration is guaranteed by A2 / (V4+V5). Therefore, in this invention, in Mode 2, the measured concentration C of the first bottle dispensed is... T It serves a quality control function; specifically, in Mode 2, if the measured concentration of the first bottle deviates from the target concentration C1 by more than a threshold, an alarm is triggered and dispensing is suspended. Manual verification of the accuracy of A1 or V1 can be requested. The first-bottle feedback module and the quality control module fully demonstrate the system's flexibility.

[0073] The order management module 100 is a pure data module, responsible only for importing, storing, and sorting order data, and outputting the production queue. The formula database 200 statically stores nuclide parameters and passively responds to query requests. The activity dynamic calculation engine 300, as the core control, actively calls the formula database 200 to match parameters to orders, production packaging algorithms, and parameters. By having the order management module 100 focus on data scheduling, the formula database 200 on parameter storage, and the activity dynamic calculation engine 300 on decision-making, the system's scalability is improved.

[0074] The order management module 100 sorts orders in ascending order according to the specified time T0. The order management module 100 only performs a preliminary sorting of orders according to the timeline, providing a basis for subsequent queue optimization and prioritizing urgent orders to avoid manual scheduling. That is, the production queue is a queue formed by arranging orders in ascending order according to the specified time T0, as shown in Table 1 below:

[0075] Table 1 Production Queue

[0076] Order ID Nuclide type Packaging mode Calibration time …… #101 <![CDATA[ 177 Monday]]> Mode 1 09：00 …… #102 <![CDATA[ 177 Monday]]> Mode 2 09：05 …… #103 <![CDATA[ 177 Monday]]> Mode 1 10：30 …… #104 <![CDATA[ 177 Monday]]> Mode 2 10：40 …… #105 <![CDATA[ 177 Monday]]> Mode 1 11：00 …… #106 <![CDATA[ 177 Monday]]> Mode 2 11：20 ……

[0077] Methods for controlling the repackaging of radiopharmaceuticals

[0078] Step 1: Import orders into the order management module 100. Each order contains the order activity A0, calibration time T0, order volume V0, and nuclide type. The imported orders are dynamically sorted according to the order of calibration time T0 to form an order queue.

[0079] Step 2: The activity dynamic calculation engine 300 automatically matches formula parameters for each order in the order queue based on the nuclide type. The formula parameters include the nuclide half-life T. 1 / 2 The target concentration C1 and the dispensing mode identifier are selected; the dispensing algorithm is selected based on the dispensing mode identifier to calculate the dispensing amount; and a dispensing instruction queue is generated.

[0080] The packaging mode identifiers include mode 1, mode 2, and mode 3;

[0081] The packaging algorithm is as follows:

[0082] Mode 1 involves mixing first and then dispensing. Calculate the dispensing volume V3, where V3 = A2 / C. X C X For dilution concentration C 1+ Or, the concentration C was measured during the first bottle refilling. T ;

[0083] Mode 2 involves dispensing and mixing at a constant concentration. Calculate the dispensing volume V4 of the stock solution and the dispensing volume V5 of the diluent: V4 = V1A2 / A1; V5 = A2 / C1-V4.

[0084] Mode 3 involves dispensing and mixing at the same time with a fixed volume. The dispensing volume V4 of the original solution and the dispensing volume V5 of the diluent are calculated using the formula: V4 = A2 / C. Y V5 = V0 - V4; C Y The target concentration C1 preset in the formula before the first bottle or the actual concentration C measured during the first bottle dispensing. T ;

[0085] in, λ=LN(2) / T 1 / 2 T 1 / 2 The half-life is given, and the dispensing time T1 is the actual dispensing time obtained by the PLC in real time.

[0086] Step 3: The dispensing instruction queue is transmitted to the PLC. The PLC controls the filling system to execute the dispensing operation according to the selected dispensing mode based on the dispensing queue.

[0087] The HMI system serves as a visual operating interface to display order lists, formula parameters, etc., allowing operators to monitor order status and formula parameters. It is also used to receive manual input, such as manually triggering calculations, confirming alarms, and manually entering parameters. Furthermore, it can send operation commands, such as starting production scheduling, to the activity dynamic calculation engine 300.

[0088] This control method, through real-time activity calculation, avoids the impact of nuclide decay, ensuring that the activity of orders meets requirements. The recipe identifier drives the PLC to adaptively switch physical actions, supporting mixed queue production of different nuclides and adapting to various packaging needs, thus offering better adaptability. Furthermore, the generated packaging queue is designed for efficient packaging, significantly improving efficiency.

[0089] Preferably, mode 1 corresponds to single-needle fixed-volume dispensing, and the PLC starts a single pump to extract the dispensing volume V3 of the original liquid according to the selected mode 1;

[0090] Mode 2 corresponds to dual-needle synchronous fixed-concentration dispensing. The PLC synchronously starts dual pumps according to the selected mode 2 to extract the original solution dispensing volume V4 and the diluent dispensing volume V5 respectively.

[0091] Mode 3 corresponds to dual-needle step-by-step fixed-volume dispensing. The PLC starts the raw liquid pump to extract the raw liquid dispensing volume V4 according to the selected mode 3, and then starts the diluent pump to extract the diluent dispensing volume V5.

[0092] The concentration C of the first bottle was obtained after the first bottle was dispensed. T The concentration C was measured using the first bottle dispensing method under both Mode 1 and Mode 3. T Update subsequent dispensing quantities. In Modes 1 and 3, closed-loop control of the first bottle is used to reduce dispensing errors.

[0093] In Mode 3, if the calculated volume of the original solution, V4, before the first bottle is dispensed is greater than V0, then the first bottle will be forcibly dispensed at V4 = V0 and an alarm will sound; after the first bottle, V4 = A2 / C T .

[0094] The filling mechanism includes a concentrate bag 501, a diluent bag 502, a medicine bag 503, a concentrate dispensing needle 504, a diluent dispensing needle 505, and a medicine dispensing needle 506.

[0095] The original liquid bag 501 is connected to the original liquid dispensing needle 504 through the original liquid dispensing pipeline, and the original liquid dispensing pump 507 is provided on the original liquid dispensing pipeline; the original liquid bag 501 is connected to the medicine bag 503 through the original liquid supply pipeline, and the original liquid supply pump 508 is provided on the original liquid supply pipeline.

[0096] The diluent bag 502 is connected to the diluent dispensing needle 505 through a diluent dispensing pipeline, and a diluent dispensing pump 509 is provided on the diluent dispensing pipeline; the diluent bag 502 is connected to the diluent bag 502 through a diluent supply pipeline, and a diluent supply pump 510 is provided on the diluent supply pipeline.

[0097] The medicine bag 503 is connected to the medicine dispensing needle 506 through the medicine dispensing pipeline, and a medicine dispensing pump 511 is installed on the medicine dispensing pipeline;

[0098] The original liquid dispensing pump 507, the original liquid supply pump 508, the diluent dispensing pump 509, the diluent supply pump 510, and the medicine dispensing pump 511 are all controlled by the PLC execution unit 400.

[0099] In Mode 1, the PLC execution unit 400 first starts the stock solution supply pump 508 to draw V1 volume of stock solution from the stock solution bag 501 into the drug solution bag 503, and the diluent supply pump 510 draws V2 volume of diluent from the diluent bag 502 into the drug solution bag 503. The V1 volume of stock solution and the V2 volume of diluent are then mixed evenly in the drug solution bag 503 to obtain a diluted solution. Then, the drug solution dispensing pump 511 is started, and the drug solution dispensing needle 506 draws V3 volume of diluted solution from the drug solution bag 503 for filling.

[0100] In modes 2 and 3, the PLC execution unit 400 starts the raw liquid dispensing pump 507, which uses the raw liquid dispensing needle 504 to draw V4 volume of raw liquid from the raw liquid bag 501 for filling; and starts the diluent dispensing pump 509, which uses the diluent dispensing needle 505 to draw V5 volume of diluent from the diluent bag 502 for filling.

[0101] In this way, a single filling mechanism can execute multiple filling modes through a PLC execution unit 400, which is more integrated than the traditional single mechanism that executes only one filling mode.

[0102] Example 1:

[0103] A pharmaceutical factory repackages radioactive drugs for treatment. 177 Lu, the customer's requirements are as follows:

[0104] 1) Order activity A0 = 200 MBq; Calibration time T0 = 2023-05-01 10:00:00.

[0105] Dispensing is performed according to Mode 1, which involves first mixing the raw material solution and diluent, and then dispensing the solution by single-syllable volume. The dispensing process is as follows:

[0106] I. Parameter Preparation

[0107]

[0108]

[0109] 2. Mix the diluted solution thoroughly:

[0110] 1) Calculate the volume of the diluent:

[0111]

[0112] 2) Mixing procedure: Inject 50ml of diluent into the stock solution bag containing V1 volume of stock solution and mix thoroughly. At this point, the actual concentration of the diluted solution, C, is measured. 1+ =19.8 MBq / ml (due to mixing deviation being lower than the target of 20 MBq / ml).

[0113] III. Calculation of repackaging quantity:

[0114] 1) Decay compensation calculation (packaging time T1 = 2023-05-01 08:00:00, two hours in advance):

[0115] λ=ln2 / T1 / 2=0.693 / 160.8≈0.0043 / hour

[0116]

[0117] 2) Calculation of repackaging volume:

[0118] First bottle (diluted to a concentration of C1 = 19.8 MBq / ml): V3 = A2 / C1 = 201.72 / 19.8 ≈ 10.19 ml;

[0119] After the first bottle (using the first bottle to dispense the measured concentration C) T =19.7MBq / ml):V3=A2 / C T =201.72 / 19.7≈10.24ml;

[0120] IV. PLC Control Execution Subassembly:

[0121]

[0122] The actual concentration C of the first bottle was measured after dispensing. T =19.7MBq / ml is lower than the dilute concentration C1 =19.8MBq / ml. The activity of subsequent vials is ensured to be accurate by updating V3.

[0123] If the actual concentration C of the first bottle is measured... T If the deviation from the target concentration exceeds the set deviation threshold, the system will record the deviation without interrupting production. If the dispensing volume V3 is greater than the bottle capacity, the PLC will trigger an "over-volume alarm" and suspend dispensing.

[0124] Verification of dispensing results:

[0125]

[0126] The fifth bottle was dispensed at 08:08:00. Due to the decay of A2, it dropped to 201.58 MBq, and the system automatically recalculated and compensated.

[0127] As can be seen from the above, the activity error during dispensing is controlled within 0.5%, which greatly reduces the dispensing error.

[0128] A2 is calculated for each bottle based on the actual dispensing time T1 to address the activity decay issue caused by dispensing delays.

[0129] The dilution concentration deviation was dynamically corrected (from 19.8 MBq / ml to 19.7 MBq / ml), further reducing the error.

[0130] It can achieve efficient and continuous production.

[0131] Example 2: A pharmaceutical factory repackages radioactive drugs for therapeutic use. 99m Tc, the customer's requirements are as follows:

[0132] 1) Order activity A0 = 150 MBq; Calibration time T0 = 2023-06-01 09:00:00.

[0133] Dispense according to Mode 2, which is a fixed-concentration dual-dose dispensing method. The dispensing process is as follows:

[0134] I. Parameter Preparation

[0135] parameter source value Nuclide type Order entry <![CDATA[ 99m Tc]]> <![CDATA[Order Activity A0]]> Order entry 150MBq <![CDATA[Calibration time T0]]> Order entry 2023-06-01 09:00:00 <![CDATA[Half-life T 1 / 2 > Matching from recipe database 6 hours <![CDATA[Target concentration C1]]> Matching from recipe database 10MBq / ml Packaging mode Matching from recipe database Mode 2 <![CDATA[Original solution activity A1]]> Synthesis Chamber Measurement Input 5000MBq <![CDATA[Original solution volume V1]]> Weighing the medicine bag 200ml

[0136] III. Calculation of repackaging quantity:

[0137] 3) Decay compensation calculation (packaging time T1 = 2023-06-01 07:00:00, two hours in advance):

[0138] λ=ln2 / T 1 / 2 =0.693 / 6≈0.1155 / hour

[0139]

[0140] 4) Calculation of repackaging volume:

[0141] V4=V1A2 / A1=200*188.98 / 5000≈7.56ml; V5=A2 / C1-V4=188.98 / 10-7.56≈11.34ml;

[0142] IV. PLC control for dispensing: The concentrate syringe draws 7.56 ml of concentrate into the vial, and the diluent syringe draws 11.34 ml of diluent into the vial.

[0143] Verification of dispensing results:

[0144]

[0145] The fifth bottle was dispensed at time T1 = 07:08:00. Due to the decay of A2, it dropped to 186.09 MBq, and the system automatically recalculated and compensated.

[0146] Example 3: A pharmaceutical factory repackages radioactive drugs for therapeutic use. 177 L U The customer's requirements are as follows:

[0147] 1) Order activity A0 = 250 MBq; Calibration time T0 = 2023-05-01 16:00:00; Order volume V0 = 10 ml (fixed volume canning).

[0148] Dispensing is performed according to Mode 3, while Mode 2 is a fixed-volume dual-needle dispensing. The dispensing process is as follows:

[0149] I. Parameter Preparation

[0150] parameter source value Nuclide type Order entry <![CDATA[ 177 L U ]]> <![CDATA[Order activity A0]]> Order entry 250MBq <![CDATA[Calibration time T0]]> Order entry 2025-05-01 16:00:00 <![CDATA[Order volume V0]]> Order entry 10ml <![CDATA[Half-life T 1 / 2 > Matching from recipe database 6.7 days (160.8 hours) <![CDATA[Target concentration C1]]> Matching from recipe database 25MBq / ml Packaging mode Matching from recipe database Mode 3

[0151] III. Calculation of repackaging quantity:

[0152] 1) Decay compensation calculation (packaging time T1 = 2025-05-01 14:00:00, two hours in advance):

[0153] λ=ln2 / T 1 / 2 =0.693 / 160.8≈0.0043 / hour

[0154]

[0155] 5) Calculation of repackaging volume:

[0156] Calculate the dispensing volume V4 of the original solution:

[0157] First bottle: V4 = A2 / C1 = 252.16 / 25 ≈ 10.09ml;

[0158] Since V4 = 10.09 ml > V0 = 10 ml, there is a contradiction that needs to be addressed. The solution is as follows:

[0159] If V4 > V0, force V4 = V0, but this will result in excessive concentration, requiring manual confirmation of the order's validity.

[0160] If V4 < V0, then it is a reasonable case.

[0161] After the first bottle: Dispense the first bottle to measure the concentration C. T Correction (C) T After the first bottle is dispensed and sent to an activity meter for testing, feedback is received via PLC. T =26.2 MBq / ml):

[0162] V4 = A2 / C T =252.16 / 26.2≈9.62ml; 9.62ml is less than 10ml, which is reasonable.

[0163] Calculate the volume of the diluent V5:

[0164] First bottle: V5 = V0 - V4 = 10 – 10.09 = –0.09 ml, abnormal;

[0165] After the first bottle: V5 = V0 - V4 = 10 – 9.62 = 0.38 ml.

[0166] IV. PLC Control Execution Subassembly:

[0167] For the first bottle, draw 10ml of the original solution from the concentrate syringe into the vial; do not draw from the diluent syringe.

[0168] After the first vial, draw 9.62 ml of the stock solution from the stock solution syringe into the vial, and draw 0.38 ml of the diluent from the diluent syringe into the vial. If V4 > V0, pause dispensing and trigger an over-volume alarm for the stock solution.

[0169] After the measured concentration of the first bottle is returned to the system, the system immediately recalculates the volume of the original solution for subsequent bottles and starts using the new dispensing volume from the second bottle onwards.

Claims

1. A radiopharmaceutical dispensing control system, characterized in that: include: The order management module (100) imports order data and performs a preliminary sorting of the orders to generate a production queue. The order data includes order activity A0, calibration time T0, order volume V0, and nuclide type. A formula database (200) stores formula parameters for nuclides, including the nuclide name and half-life T. 1 / 2 The target concentration C1 and the dispensing mode identifier, wherein the dispensing mode identifier includes mode 1, mode 2 and mode 3; The activity dynamic calculation engine (300) queries the formula database based on the nuclide type of the order, obtains the corresponding formula parameters, selects the corresponding dispensing algorithm according to the dispensing mode identifier, and calculates the decay compensation activity based on the dispensing algorithm. The amount to be packaged is then used to generate a packaged instruction queue. The PLC execution unit (400) receives the dispensing instruction queue from the activity dynamic calculation engine (300) and controls the filling mechanism (500) to execute any of the following matching dispensing modes according to the instructions in the dispensing instruction queue: Mode 1: Single-needle fixed-dispensing diluent, the dispensing volume of the diluent is V3, and the calculation is V3 = A2 / C. X , C X For dilution concentration C 1+ Or, the concentration C was measured during the first bottle repackaging. T The diluted solution is prepared by mixing V1 volume of the original solution with V2 volume of the diluted solution. Mode 2: Double-needle fixed-concentration dispensing of stock solution and diluent, with the dispensing volume of stock solution being V4 and the dispensing volume of diluent being V5. The calculation is as follows: V4 = V1A2 / A1; V5 = A2 / C1-V4. Mode 3: Dual-needle fixed-volume dispensing of the stock solution and diluent. The dispensing volume of the stock solution is V4, and the dispensing volume of the diluent is V5. The calculation method is V4 = A2 / C. Y V5 = V0 - V4; C Y The target concentration C1 preset for the formula or the actual concentration C measured in the first bottle is specified. T ; The dispensing time T1 is the actual dispensing time obtained by the PLC in real time.

2. The radiopharmaceutical dispensing control system as described in claim 1, characterized in that: The packaging mode identifiers include identifier 1, identifier 2, and identifier 3; identifier 1 triggers mode 1 and its algorithm; identifier 2 triggers mode 2 and its algorithm; identifier 3 triggers mode 3 and its algorithm.

3. The radiopharmaceutical dispensing control system as described in claim 1, characterized in that: The activity dynamic calculation engine (300) also includes: The first-bottle feedback module, in modes 1 and 3, measures the actual concentration C of the first bottle after dispensing. T Dynamically update subsequent packaging parameters; In the quality inspection module, under mode 2, the actual concentration C of the first bottle was measured during dispensing. T When the concentration of C1 deviates from the target concentration by more than the threshold, an alarm is triggered and dispensing is suspended.

4. The radiopharmaceutical dispensing control system as described in claim 1, characterized in that: The order management module (100) sorts the orders in ascending order according to the calibrated time T0.

5. A method for controlling the repackaging of radiopharmaceuticals, characterized in that: Step 1: Import orders. Each order specifies the order activity A0, calibration time T0, order volume V0, and nuclide type. The imported orders are then dynamically sorted according to their calibration time T0 to form an order queue. Step 2: The activity dynamic calculation engine (300) automatically matches the formula parameters for each order in the order queue based on the nuclide type. The formula parameters include the nuclide half-life T. 1 / 2 The target concentration C1 and the dispensing mode identifier are selected; the dispensing algorithm is selected based on the dispensing mode identifier to calculate the dispensing amount; and a dispensing instruction queue is generated. The packaging mode identifiers include mode 1, mode 2, and mode 3; The packaging algorithm is as follows: Mode 1: Single-needle fixed-dispensing diluent, the dispensing volume of the diluent is V3, and the calculation is V3 = A2 / C. X , C X For dilution concentration C 1+ Or, the concentration C was measured during the first bottle repackaging. T ; Mode 2: Double-needle fixed-concentration dispensing of stock solution and diluent, with the dispensing volume of stock solution being V4 and the dispensing volume of diluent being V5. The calculation is as follows: V4 = V1A2 / A1; V5 = A2 / C1-V4. Mode 3: Dual-needle fixed-volume dispensing of the stock solution and diluent. The dispensing volume of the stock solution is V4, and the dispensing volume of the diluent is V5. The calculation method is V4 = A2 / C. Y V5 = V0 - V4; C Y The target concentration C1 preset for the formula or the actual concentration C measured in the first bottle is specified. T ; in, λ=LN(2) / T 1 / 2 ;t 1 / 2 It is the half-life. The dispensing time T1 is the actual dispensing time obtained by the PLC in real time; Step 3: The dispensing instruction queue is transmitted to the PLC. The PLC controls the filling mechanism to perform the dispensing operation according to the selected dispensing mode.

6. The method for controlling the dispensing of radiopharmaceuticals as described in claim 5, characterized in that: The filling mechanism includes a concentrate bag (501), a diluent bag (502), a medicine bag (503), a concentrate dispensing needle (504), a diluent dispensing needle (505), and a medicine dispensing needle (506); The original liquid bag (501) is connected to the original liquid dispensing needle (504) through the original liquid dispensing pipeline, and an original liquid dispensing pump (507) is provided on the original liquid dispensing pipeline; the original liquid bag (501) is connected to the medicine bag (503) through the original liquid supply pipeline, and an original liquid supply pump (508) is provided on the original liquid supply pipeline. The diluent bag (502) is connected to the diluent dispensing needle (505) through a diluent dispensing pipeline, and a diluent dispensing pump (509) is provided on the diluent dispensing pipeline; the diluent bag (502) is connected to the diluent bag (502) through a diluent supply pipeline, and a diluent supply pump (510) is provided on the diluent supply pipeline. The medicine bag (503) is connected to the medicine dispensing needle (506) through the medicine dispensing pipeline, and a medicine dispensing pump (511) is installed on the medicine dispensing pipeline; The original liquid dispensing pump (507), the original liquid supply pump (508), the diluent dispensing pump (509), the diluent supply pump (510), and the medicine dispensing pump (511) are all controlled by the PLC execution unit (400); In mode 1, the PLC execution unit (400) first starts the stock solution supply pump (508) to draw V1 volume of stock solution from the stock solution bag (501) into the drug solution bag (503), and the diluent supply pump (510) draws V2 volume of diluent from the diluent bag (502) into the drug solution bag (503). The V1 volume of stock solution and the V2 volume of diluent are mixed evenly in the drug solution bag (503) to obtain a diluted solution. Then, the drug solution dispensing pump (511) is started, and the drug solution dispensing needle (506) draws V3 volume of diluted solution from the drug solution bag (503) for filling. In modes 2 and 3, the PLC execution unit (400) starts the raw liquid dispensing pump (507) and uses the raw liquid dispensing needle (504) to extract V4 volume of raw liquid from the raw liquid bag (501) for filling. Start the diluent dispensing pump (509) and use the diluent dispensing needle (505) to draw V5 volume of diluent from the diluent bag (502) for dispensing.

7. The method for controlling the dispensing of radiopharmaceuticals as described in claim 5, characterized in that: After the first bottle is dispensed, the measured concentration C of the first bottle is obtained. T The concentration C was measured using the first bottle dispensing method under both Mode 1 and Mode 3. T Update the subsequent packaging volume.

8. The method for controlling the dispensing of radiopharmaceuticals as described in claim 7, characterized in that: In Mode 3, if the calculated volume of the original solution, V4, before the first bottle is dispensed is greater than V0, then the first bottle will be forcibly dispensed at V4 = V0 and an alarm will sound; after the first bottle, V4 = A2 / C T .

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