Method, device and equipment for controlling overshoot of pH of ginseng-radix aconiti carmichaeli injection alcohol solution and storage medium

Abstract

The invention provides a Shenfu injection alcohol solution pH overshoot control method, device and equipment and a storage medium, and relates to the technical field of traditional Chinese medicine pharmaceutical engineering. The control method comprises the following steps: acquiring an initial volume of a to-be-adjusted liquid medicine and calculating a predicted total alkali amount; adding first-stage alkali liquor until a preset inflection point proportion is reached; adding of the alkali liquor is stopped, and the real-time pH value is measured; if the real-time pH value is within the inflection point pH range, marking the current accumulated alkali adding amount as the actual inflection point alkali adding amount, and calculating the residual required alkali adding amount; and adding the residual required alkali into the to-be-adjusted liquid medicine. According to the invention, model prediction is combined with segmented control, and intermittent cleaning measurement is utilized to thoroughly solve the problem of detection misalignment caused by precipitation interference on the electrode. Meanwhile, based on a dynamic calibration mechanism of inflection point actual measurement data, control deviation of a nonlinear system is effectively overcome, accurate locking of a pH end point is achieved, effective components are prevented from being decomposed due to overshoot, and production efficiency and medicine quality are remarkably improved.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical engineering technology of traditional Chinese medicine, and in particular to a method, apparatus, equipment and storage medium for pH over-adjustment control of alcoholic solution of Ginseng and Aconite Root Injection. Background Technology

[0002] In the production of traditional Chinese medicine (TCM) injections, precise adjustment of the pH value of intermediate solutions is crucial for ensuring product quality and safety. Especially in the preparation of complex TCM systems such as Shenfu injection, it is often necessary to add an alkaline solution to a high-concentration ethanol environment to adjust the solution from strongly acidic to weakly alkaline, utilizing the principle of "alkali precipitation" to remove impurities such as tannins and resins. This process not only affects the efficiency of impurity removal but also directly impacts the retention rate of active ingredients (such as alkaloids) in the solution. Therefore, achieving precise pH control in complex TCM solution systems with high alcohol content and high ionic strength has always been a key focus in the field of pharmaceutical engineering.

[0003] Existing pH adjustment processes primarily rely on manual operation or conventional online monitoring equipment. In actual production, operators typically add high-concentration alkali solution in stages based on experience, frequently taking samples for offline testing, or directly using online pH meters for real-time monitoring. However, for special systems like secondary alcohol solutions containing pharmaceutical tablets, the ethanol concentration can reach approximately 85%, and a large amount of adhesive, gelatinous precipitate is generated during the adjustment process. When using conventional online pH meters for monitoring, these gelatinous precipitates easily coat the electrode's sensitive membrane, causing the sensor to respond slowly, readings to drift, or even malfunction completely, failing to accurately reflect the current pH state of the solution.

[0004] Furthermore, the physicochemical properties of this system are extremely complex, making traditional linear acid-base neutralization calculation models inapplicable. Actual production data shows a significant non-linear relationship between the pH value of the solution and the amount of alkali added, especially near the endpoint (pH 8.3-8.5), where the pH is extremely sensitive to changes in alkali dosage; even a small amount of alkali can cause drastic pH fluctuations. Due to the lack of effective online detection methods and accurate control models, existing adjustment processes often face significant overshoot risks. Once the pH exceeds the process limit, the key alkaloid components in the solution undergo irreversible hydrolysis, leading to a significant decrease in content, and in severe cases, even rendering the entire batch of solution unusable. Meanwhile, to prevent overshoot, current methods rely mainly on tedious manual cycles of "alkali addition-sampling-washing-measurement," which are not only time-consuming and inefficient but also difficult to guarantee batch-to-batch consistency.

[0005] In summary, existing pH adjustment processes for ginseng and aconite injection alcohol solutions present technical challenges such as distorted detection signals, control model failure, and a high risk of overshoot leading to loss of active ingredients. Due to the interference of precipitates on sensors and the nonlinear characteristics of the system itself, conventional automated control methods are difficult to implement. Therefore, there is an urgent need for a technical solution that can overcome precipitation interference, adapt to nonlinear changes, and accurately control the endpoint to improve production efficiency and ensure drug quality. Summary of the Invention

[0006] In a first aspect, the present invention provides a method for pH over-adjustment control of an alcoholic solution of ginseng and aconite injection, comprising: Obtain the initial volume of the drug solution to be adjusted, and use a preset volume-alkali linear model to calculate the predicted total alkali content for the drug solution to be adjusted. The alkali addition device is controlled to add the first stage alkali solution to the drug solution to be adjusted until the cumulative alkali addition reaches the preset inflection point percentage of the predicted total alkali amount. Stop adding alkali solution, control the cleaning device to clean the pH electrode, and after cleaning, control the pH electrode to measure the real-time pH value of the solution to be adjusted. If the measured real-time pH value is within the preset inflection point pH range, the current cumulative amount of alkali added is marked as the actual inflection point amount of alkali added, and the remaining amount of alkali to be added is calculated based on the preset inflection point percentage and the actual inflection point amount of alkali added. The alkali addition device is controlled to add the remaining amount of alkali to the solution to be adjusted.

[0007] In an optional implementation, the remaining amount of alkali to be added is calculated using the following formula: ; Where X is the remaining amount of alkali to be added; A is the actual amount of alkali to be added at the inflection point; and R is the ratio value corresponding to the preset inflection point percentage.

[0008] In an optional implementation, the expression for the preset volume-alkali linear model is: ; Where Q is the predicted total alkali content; V is the initial volume; k is the slope coefficient; and b is the intercept coefficient.

[0009] In an optional embodiment, controlling the alkali-adding device to add the remaining amount of alkali to the solution to be adjusted includes: The remaining amount of alkali to be added is controlled to be added at a rate lower than that of adding the first stage alkali solution; After the addition is complete, continue stirring for the preset time and monitor the pH value of the solution until the pH value stabilizes within the target range of 8.3 to 8.5.

[0010] In an optional implementation, monitoring the pH value of the drug solution until the pH value stabilizes within the target range of 8.3 to 8.5 includes: The target pH value for stopping alkali addition is set as a first value, which is lower than the lower limit of the process target pH range for the final product. During the preset time period of stopping alkali addition and continuous stirring, the pH value of the solution automatically rises from the first value to the target pH range of the process, utilizing the ion release equilibrium characteristics of the solution; and / or, The rate at which the first-stage alkali solution is added is 450 mL / min to 550 mL / min; and / or, The rate at which the remaining amount of alkali to be added is 200 mL / min to 300 mL / min.

[0011] In an optional implementation, the preset inflection point accounts for 89% to 93%; and / or, The preset inflection point pH range is 4.8 to 5.2.

[0012] In an optional implementation, the preset volume-alkali linear model includes model parameters; the pH over-adjustment control method for the precipitated injection alcohol solution further includes: After the alkali addition device is used to add the remaining amount of alkali to the solution to be adjusted, the total amount of alkali actually consumed in the final adjustment is recorded. Using the initial volume and the final actual total amount of alkali consumed, the model parameters for the volume-alkali linearity are updated and calibrated; and / or, The control cleaning device cleans the pH electrode, and after cleaning, controls the pH electrode to measure the real-time pH value of the solution to be adjusted, including: The robotic arm carrying the pH electrode is controlled to move the pH electrode from the cleaning position above the liquid surface to the detection position below the liquid surface, so that the pH electrode is immersed in the solution to be adjusted. After collecting the real-time pH value, the robotic arm is controlled to move the pH electrode back to the cleaning position, and the spray head located at the cleaning position is activated to spray and clean the pH electrode; and / or, The pH overshoot control method for the ginseng and aconite injection alcohol solution also includes an abnormal handling step: if the measured real-time pH value deviates from the preset inflection point pH range, an alarm signal is issued, and the alkali addition device and pH electrode are controlled to switch to continuous measurement mode.

[0013] Secondly, the present invention provides a pH over-adjustment control device for an alcoholic solution of ginseng and astragalus injection, comprising: The calculation module is used to obtain the initial volume of the drug solution to be adjusted, and to calculate the predicted total alkali content of the drug solution to be adjusted using a preset volume-alkali linear model. The alkali addition module is used to control the alkali addition device to add the first stage alkali solution to the drug solution to be adjusted until the cumulative alkali addition reaches the preset inflection point percentage of the predicted total alkali amount; The cleaning module is used to pause the addition of alkali solution, control the cleaning device to clean the pH electrode, and control the pH electrode to measure the real-time pH value of the solution to be adjusted after cleaning. The calculation module is further configured to mark the current cumulative amount of alkali added as the actual amount of alkali added if the measured real-time pH value is within the preset inflection point pH range, and to calculate the remaining amount of alkali to be added based on the preset inflection point ratio and the actual inflection point amount of alkali added. The alkali addition module is also used to control the alkali addition device to add the remaining amount of alkali to the liquid to be adjusted.

[0014] Thirdly, the present invention provides a computer device, the computer device including a processor and a memory, the memory storing a computer program, and the processor executing the computer program to implement the pH over-adjustment control method for the ginseng-attached injection alcohol solution as described in any of the foregoing embodiments.

[0015] Fourthly, the present invention provides a computer storage medium storing a computer program, which, when executed on a processor, implements the pH over-adjustment control method for the ginseng-attached injection alcohol solution according to any one of the foregoing embodiments.

[0016] The embodiments of this application have the following beneficial effects: The method provided by this invention achieves rapid "blind addition" control in the initial adjustment stage by obtaining the initial volume and calculating and predicting the total alkali amount using a preset linear model. This effectively overcomes the problems of the inapplicability of traditional acid-base neutralization formulas and the lag in initial detection. By controlling the proportion of alkali added to the preset inflection point in the first stage, both adjustment efficiency and a safe buffer space are reserved for subsequent accurate calibration, avoiding excessive alkali addition due to model deviation. More importantly, this method innovatively introduces an intermittent detection mechanism of "pause-cleaning-measurement." By cleaning the pH electrode at key points before measurement, it completely solves the industry problem of detection signal distortion or even failure caused by colloidal substances encapsulating the electrode in high-alcohol precipitation systems, ensuring the authenticity and accuracy of the feedback data.

[0017] Furthermore, this invention utilizes the comparison between the measured real-time pH value and a preset inflection point range to capture the actual state of the reaction process in real time. Once a specific inflection point is confirmed, the remaining amount of alkali to be added is calculated by using the actual amount of alkali added and the preset ratio. This dynamic calibration strategy based on measured data effectively eliminates model errors caused by batch-to-batch raw material differences, achieving precise control of the nonlinear reaction system. Ultimately, through precise, staged addition, the pH value is successfully locked within a narrow target window, significantly reducing the risk of hydrolysis of key alkaloid components due to pH overtuning. This greatly improves production efficiency while effectively ensuring product quality consistency and safety. Attached Figure Description

[0018] To more clearly illustrate the technical solutions of this application, the accompanying drawings used in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of this application and therefore should not be considered as a limitation on the scope of protection of this application. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the hardware operating environment involved in an embodiment of the pH over-adjustment control method for the alcoholic solution of the attached injectable drug of the present invention. Figure 2 This is a schematic flowchart of Example 1 of the method for pH over-adjustment control of the alcohol solution of the ginseng injection of the present invention; Figure 3 This is a detailed flowchart of step S500 in Example 3 of the pH over-adjustment control method for the alcohol solution of the ginseng and ginseng injection of the present invention. Figure 4 This is a detailed flowchart of step S520 in Example 3 of the pH over-adjustment control method for the alcohol solution of the ginseng and aconite injection of the present invention. Figure 5 This is a flowchart illustrating the supplementary steps (S600~S700) in Example 4 of the pH over-adjustment control method for the alcoholic solution of the ginseng injection of the present invention. Figure 6 This is a detailed flowchart of step S300 in Example 4 of the pH over-adjustment control method for the alcohol solution of the ginseng and aconite injection of the present invention. Figure 7 This is a schematic diagram showing the relationship between the pH inflection point of the secondary alcohol solution containing the attached tablets and the proportion of alkali added, as determined in Experimental Example 1 of this invention. Figure 8 This is a schematic diagram illustrating the linear regression relationship between the volume of different batches of drug solution and the total amount of alkali used, as determined in Experimental Example 2 of this invention. Figure 9 This is a schematic diagram illustrating the drift characteristics of the initial pH value of the drug solution and the pH value after continuous stirring, as verified in Experimental Example 2 of this invention. Figure 10This is a schematic diagram showing the trend of the amount of alkali added and the corresponding pH measurement value in the prior art during the artificial pH adjustment process, as illustrated in Experimental Example 3 of the present invention. Figure 11 This is a schematic diagram showing the relationship between the pH value of the drug solution and the content of the key component benzoylneoprothiolane, as measured in Experimental Example 4 of this invention. Figure 12 This is a schematic diagram of the module connection of the pH over-adjustment control device for the attached injectable alcohol solution of the present invention. Detailed Implementation

[0020] The technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments.

[0021] The components of the embodiments of this application described and illustrated in the accompanying drawings can be arranged and designed in a variety of different configurations. Therefore, the following detailed description of the embodiments of this application provided in the drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0022] In the following, the terms “comprising,” “having,” and their cognates, which may be used in various embodiments of this application, are intended only to indicate a particular feature, number, step, operation, element, component, or combination thereof, and should not be construed as excluding, firstly, the presence of one or more other features, numbers, steps, operations, elements, components, or combinations thereof, or adding the possibility of one or more features, numbers, steps, operations, elements, components, or combinations thereof.

[0023] Furthermore, the terms "first," "second," and "third" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0024] Unless otherwise specified, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which the various embodiments of this application pertain. Terms (such as those defined in commonly used dictionaries) shall be interpreted as having the same meaning as in their contextual meaning in the relevant technical field and shall not be construed as having an idealized or overly formal meaning, unless clearly defined in the various embodiments of this application.

[0025] The following detailed description of some embodiments of this application is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0026] like Figure 1 The diagram shown is a structural schematic of the hardware operating environment of the terminal involved in an embodiment of the present invention.

[0027] This invention relates to an injectable alcohol solution pH over-adjustment control system (device), which can be a PC, or a mobile terminal device such as a smartphone, tablet, or laptop. The injectable alcohol solution pH over-adjustment control system may include: a processor 1001, such as a CPU; a network interface 1004; a user interface 1003; a memory 1005; and a communication bus 1002. The communication bus 1002 is used to establish communication between these components. The user interface 1003 may include a display screen, an input unit such as a keyboard, or a remote control; optionally, the user interface 1003 may also include a standard wired interface or a wireless interface. The network interface 1004 may optionally include a standard wired interface or a wireless interface (such as a Wi-Fi interface). The memory 1005 may be a high-speed RAM memory or a stable memory, such as a disk storage device. Optionally, the memory 1005 may also be a storage device independent of the aforementioned processor 1001. Optionally, the injectable alcohol solution pH over-adjustment control system may also include RF (Radio Frequency) circuitry, audio circuitry, a Wi-Fi module, etc. In addition, the pH overtuning control system of the ginseng and aconite injection can also be equipped with other sensors such as gyroscopes, barometers, hygrometers, thermometers, and infrared sensors, which will not be elaborated here.

[0028] Those skilled in the art will understand that Figure 1 The system (device) shown is not intended to limit it and may include more or fewer components than shown, or combine certain components, or have different component arrangements. Figure 1 As shown, the memory 1005, which is a computer-readable storage medium, may include an operating system, a data interface control program, a network connection program, and a pH over-adjustment control program for the attached injectable alcohol solution.

[0029] In summary, the method provided by this invention achieves efficient and precise pH adjustment of complex alcohol systems through pre-set model prediction and staged alkali addition control. Its core lies in introducing a "pause-clean-measure" mechanism, effectively eliminating the interference of colloidal precipitation on the electrodes and ensuring the authenticity and reliability of the detection data. Simultaneously, it cleverly solves the control challenges caused by nonlinear systems and batch-to-batch differences by dynamically inferring the remaining alkali amount using inflection point measured data. This method not only significantly shortens the operation time but also fundamentally avoids the loss of effective components due to pH overtuning, significantly improving product quality and production stability.

[0030] Example 1 Reference Figure 2This embodiment provides a method for pH over-adjustment control of ginseng and aconite injection alcohol solution, including: Step S100: Obtain the initial volume of the drug solution to be adjusted, and use a preset volume-alkali linear model to calculate the predicted total alkali amount for the drug solution to be adjusted.

[0031] This step refers to obtaining the total volume data of the current batch of drug solution (ethanol solution of ginseng and aspirin injection) before pH adjustment, using a flow meter, level gauge, or manual reading. Then, using a pre-established "volume-alkali linear model," this volume value is input to calculate the theoretically required total mass or volume of alkali solution (e.g., 40% sodium hydroxide solution) to adjust the drug solution to the target pH endpoint (e.g., 8.3-8.5).

[0032] The principle is based on the stoichiometry of chemical reactions. Under the premise of relatively stable raw material sources and extraction processes, the amount of alkali consumed is usually directly proportional to the volume of the drug solution to be treated. This step uses a linear relationship fitted from historical production data to establish a macroscopic predictive model between volume and alkali consumption.

[0033] The specific processing procedure involves the system reading data from the volume sensor, retrieving the slope and intercept parameters from memory, performing multiplication and addition operations, and outputting a predicted value. This yields a "predicted total alkali content," which, while containing errors, is of reference value. Its advantage lies in providing a quantitative basis for subsequent "blind addition" operations, enabling the system to start quickly and approach the endpoint significantly without relying on heavily interfered real-time pH monitoring from the outset, thus significantly improving adjustment efficiency.

[0034] This can be achieved, for example, by using a PLC or industrial computer to read the 4-20mA signal from the tank's level sensor and convert it into volume. A linear model can be obtained through regression analysis of multiple batches of historical data. In terms of extensions, the model can be a simple proportional gain model (intercept of 0) or a piecewise linear model to accommodate different volume ranges.

[0035] Step S200: Control the alkali addition device to add the first stage alkali solution to the drug solution to be adjusted until the cumulative amount of alkali added reaches the preset inflection point percentage of the predicted total alkali amount.

[0036] In this step, based on the "predicted total alkali amount" calculated in step S100, and combined with a pre-set proportional coefficient (i.e., "preset inflection point ratio"), the alkali addition pump is turned on to continuously add alkali solution to the chemical solution. When the added amount reaches this proportion of the predicted total amount, the alkali addition is stopped.

[0037] Based on the statistical regularity of the reaction process, the pH value of most batches of the solution will reach a specific "inflection point" before entering the region of drastic change when about 90% of the predicted alkali amount has been consumed. At this point, although the endpoint has not been reached, most of the neutralization task has been completed.

[0038] The process can be as follows: the control system monitors the cumulative flow of the metering pump, and when the cumulative value is ≥ Q × percentage, it sends a pump stop command.

[0039] This step can complete most (e.g., over 90%) of the alkali addition task. Its advantage lies in the use of open-loop control (or feedforward control), which completely eliminates the need for a pH electrode at this stage. This avoids the problem of the electrode being continuously coated and damaged or having incorrect readings when a large amount of precipitation occurs in the early stages of the reaction, while also enabling rapid adjustment.

[0040] In addition, the preset inflection point percentage is usually determined based on the statistical distribution of historical data (e.g., taking the mean or lower limit) to ensure that the pH value is absolutely safe (without overshooting) at this percentage.

[0041] Step S300: Pause the addition of alkali solution, control the cleaning device to clean the pH electrode, and after cleaning, control the pH electrode to measure the real-time pH value of the solution to be adjusted.

[0042] After the first stage of alkali addition is completed, the alkali addition process is paused. At this time, a specialized cleaning device is activated to physically clean the pH electrode (such as by spraying, ultrasonication, or mechanical scraping) to remove any adhering substances. After cleaning, the electrode is then brought into contact with the solution to read the current real-time pH value.

[0043] The principle behind this step is that, given the physical characteristics of high-alcohol-content precipitation systems, the precipitate exhibits adhesiveness. A "pause" is used to ensure uniform mixing; "washing" restores the ion exchange capacity of the electrode's sensitive membrane; and "post-measurement" ensures that the reading represents the true H+ concentration of the fresh drug solution.

[0044] The aforementioned suspension of liquid addition provides a stable time window for cleaning, which in turn ensures the accuracy of measurements. The synergy of these three factors ensures the authenticity of the feedback data.

[0045] The specific processing steps may include: the robotic arm moves the electrode to the cleaning position → spraying water to rinse → the robotic arm moves the electrode underwater → waiting for the reading to stabilize → reading the data.

[0046] This step yields accurate, interference-free intermediate pH values. Its advantage lies in completely resolving the core problem of "inaccurate detection," transforming unreliable continuous monitoring into reliable point measurement, thus providing solid data support for subsequent precise calibration.

[0047] The cleaning medium mentioned above can be purified water or ethanol; the measurement method can be immersion or flow-through sampling.

[0048] Step S400: If the measured real-time pH value is within the preset inflection point pH range, then the current cumulative amount of alkali added is marked as the actual inflection point amount of alkali added, and the remaining amount of alkali to be added is calculated based on the preset inflection point percentage and the actual inflection point amount of alkali added.

[0049] In this step, the system determines whether the measured real-time pH value falls within the preset "inflection point pH range". If so, the current alkali addition status is considered to conform to the expected model. At this point, instead of relying on the total predicted amount from the first step, the system uses the actual amount of alkali already added (actual inflection point alkali addition amount) as a benchmark and the "preset inflection point percentage" ratio to calculate how much alkali still needs to be added.

[0050] This step utilizes the relatively stable characteristic of the "proportional relationship between the part and the whole". Even if the total acidity of different batches of the solution fluctuates (leading to changes in the total alkali content), the proportion of consumed alkali to the total alkali content is often constant when a specific pH value (inflection point) is reached.

[0051] Compare pH real Is it ∈ [min, max]? If true, calculate the remaining amount of alkali to be added. This calculates an accurate remaining amount of alkali to be added after "calibration with measured data". The advantage lies in its adaptive capability, which eliminates model bias caused by batch-to-batch raw material differences (i.e., corrects the prediction error in step one), achieving linearized piecewise control of the nonlinear system and greatly improving the accuracy of endpoint control.

[0052] Furthermore, if the pH is outside the range, an abnormal handling procedure (such as an alarm) can be initiated. The calculation formula can also be transformed into X = (A / R) - A.

[0053] Step S500: Control the alkali addition device to add the remaining amount of alkali to the solution to be adjusted.

[0054] In this step, the alkali addition device is controlled to accurately add the "remaining amount of alkali required" calculated in the previous step to the chemical solution. This is based on corrected quantitative control. Since the remaining amount is usually small and has been precisely calculated, this addition will directly bring the chemical solution into the target pH endpoint range.

[0055] The specific process can be as follows: Set the target flow rate of the metering pump to X, start the pump, and stop the pump after the flow rate is exhausted. This completes the entire pH adjustment process. The advantage is that it avoids the repeated oscillations and overshoot near the endpoint of traditional PID control, accurately reaching the endpoint in one go, effectively preventing pH overshoot, and protecting the active ingredients in the drug solution from being destroyed.

[0056] In addition, this step can use a lower flow rate (slow injection) to cooperate with stirring and ensure that the local concentration is not too high; after injection, a final retest can be performed to confirm the endpoint.

[0057] Example 2 This embodiment provides a method for controlling pH over-adjustment of ginseng and aconite injection alcohol solution. Based on the aforementioned embodiment, the calculation of the remaining amount of alkali to be added is performed using the following formula (Formula 1): ; Where X is the remaining amount of alkali to be added; A is the actual amount of alkali to be added at the inflection point; and R is the ratio value corresponding to the preset inflection point percentage.

[0058] Formula 1 above is a mathematical model used to accurately calculate how much alkali solution needs to be added after the inflection point. Here, X represents the remaining amount of alkali needed to reach the final target pH value; A represents the cumulative amount of alkali actually consumed when the system detects that the pH value is at a specific inflection point (e.g., around pH 5.0); and R represents a preset inflection point percentage (e.g., 0.91), which is theoretically the proportion of alkali already added to the total required alkali when the pH reaches this inflection point.

[0059] This formula is based on the mechanism that "the ratio of a portion to the total amount is relatively constant" in the process of a chemical reaction. In the process of adjusting the alcohol solution of Shenfu injection, although the total acidity of different batches of drug solution may fluctuate due to differences in raw materials (leading to different total alkali amounts at the endpoint), the reaction process (i.e., the percentage of alkali added to the total alkali amount) often has statistical stability when a specific pH inflection point is reached.

[0060] The derivation process can be summarized as follows: Let the total amount of alkali be Q. total Let A be the amount added at the inflection point, and R be the progress ratio at this point. Then A = Q. total ×R, i.e., Q total =A / R. Remaining amount to be added: X = Q total -A=(A / R)-A=A×(1 / R-1).

[0061] Based on Formula 1, the control system reads the current actual amount of alkali added, A (e.g., 12000 mL), calls the preset proportioning parameter R (e.g., 0.91), substitutes it into Formula 1 for calculation, and directly obtains the remaining amount, X (approximately 1186 mL). This processing result corrects the deviation of the initial model prediction.

[0062] Formula 1 transforms the complex nonlinear endpoint control problem into a simple linear proportional calculation. It replaces the predicted value with the measured value A, which can adaptively eliminate the error caused by volume or concentration fluctuations between batches, significantly improve the accuracy of endpoint control, and prevent overshoot.

[0063] Furthermore, the parameter R can be determined and dynamically updated through statistical analysis of multiple batches of historical data (such as taking the average or a specific confidence interval of a normal distribution).

[0064] In some embodiments, the expression (Formula 2) for the preset volume-alkali linear model is: ; Where Q is the predicted total alkali content; V is the initial volume; k is the slope coefficient; and b is the intercept coefficient.

[0065] Formula 2 above is a linear regression model used to predict the total amount of alkali needed based on the volume of the drug solution before adjustment begins. Here, Q is the predicted total amount of alkali required to reach the endpoint; V is the initial volume of the drug solution to be adjusted; k is the slope coefficient, representing the rate at which alkali is consumed per unit volume of drug solution (i.e., the consumption coefficient); and b is the intercept coefficient, representing the basic consumption or system deviation correction amount independent of volume.

[0066] Formula 2 is based on the law of large numbers and the principle of conservation of mass. Under relatively stable process conditions (such as raw material origin, extraction process, alcohol precipitation concentration, etc.), the total amount of acidic substances in the drug solution is usually linearly positively correlated with the volume of the drug solution. This linear law can be found by fitting a large amount of historical batch data.

[0067] Specifically, before the adjustment is initiated, the measured volume V is input, and the system calculates Q using the stored k and b values. This result provides the necessary quantitative target for the first stage of "blind" control.

[0068] This calculation method provides a fast and simple basis for feedforward control. In situations where pH detection is unreliable in the early stages of the reaction, this model allows the system to add most of the alkali solution at a relatively high rate without relying on real-time feedback, thus significantly shortening the process time. Simultaneously, introducing the intercept b can correct for system errors caused by dead volume in the equipment piping or consumption of fixed substrate.

[0069] Furthermore, the values ​​of k and b can be obtained through regression analysis of historical production data (volume vs. total alkali content) using the least squares method. As the number of production batches increases, the system can continuously update k and b using newly generated data points (e.g., using recursive least squares), making the model increasingly accurate in adapting to the current raw material characteristics.

[0070] Example 3 refer to Figure 3 This embodiment provides a method for pH over-adjustment control of ginseng and aconite injection alcohol solution. Based on the aforementioned embodiment, step S500, which controls the alkali addition device to add the remaining amount of alkali to be added to the drug solution to be adjusted, includes: Step S510: Control the alkali addition device to add the remaining amount of alkali to be added at a rate lower than that of adding the first stage alkali solution.

[0071] In this step, when adding the calculated remaining alkali solution in the final stage (i.e. after the inflection point), the flow rate of the alkali addition device (such as a peristaltic pump) is controlled to be significantly lower than the flow rate during the "blind addition" in the first stage.

[0072] This step is based on considerations of reaction kinetics and mixing efficiency. Near the endpoint, the pH value is extremely sensitive to changes in alkali content (buffering capacity decreases), and the high viscosity of the solution leads to localized uneven mixing. Reducing the flow rate allows the system more sufficient mixing time, prevents localized over-alkaliness, and avoids physical inertia over-rush caused by excessively rapid addition.

[0073] Specifically, the system can issue a deceleration command, reducing the pump's speed. As a result, the remaining alkali solution enters the reaction vessel smoothly and evenly. This improves the precision and safety of endpoint control, effectively preventing momentary overshoot caused by excessively rapid operation.

[0074] In step S520, after the addition is complete, continue stirring for a preset time and monitor the pH value of the solution until the pH value stabilizes within the target range of 8.3 to 8.5.

[0075] In this step, after the alkali addition stops, the process is not ended immediately. Instead, the agitator is kept running for a period of time (preset time), during which the pH value is continuously read until the reading no longer fluctuates and is between 8.3 and 8.5.

[0076] The principle is based on the mass transfer hysteresis effect of high-viscosity alcohol precipitation systems. After the alkali solution is added, it takes a certain amount of time for it to completely diffuse and fully react with the acidic substance. In addition, the release of ions from the precipitate also requires an equilibrium time.

[0077] Specifically, a countdown can be started, stirring can be maintained, and pH data can be continuously collected. The result is a true endpoint pH value after thorough equilibration. This eliminates the "false endpoint" phenomenon, ensuring the authenticity of the final product quality and batch-to-batch consistency.

[0078] refer to Figure 4 In some embodiments, step S520, monitoring the pH value of the drug solution until the pH value stabilizes within the target range of 8.3 to 8.5, includes: Step S521: Set the target pH value for stopping alkali addition to a first value, which is lower than the lower limit of the process target pH range for the final product.

[0079] In the system control logic of this step, the target pH value (first value, such as 8.3) that triggers the "stop adding alkali" action is set to be lower than the center value or upper limit of the final qualified range required by the process (such as 8.3-8.5), or even just touching the lower limit.

[0080] This step is based on the system's "self-equilibrium" or "drift" characteristics. In an alcohol precipitation system, as stirring proceeds, the alkaline substances trapped in the precipitate will be slowly released, or the rearrangement of ions within the system will cause the pH value to rise naturally after the addition of alkali is stopped.

[0081] Specifically, a target value can be set as a first value (e.g., 8.3). When the pH reaches 8.3, alkali addition is completely stopped. By utilizing the strategy of "reserving drift allowance," the system's own chemical properties are cleverly used to achieve the final target, fundamentally eliminating the risk of exceeding the upper limit (>8.5) due to human error or mechanical inertia.

[0082] Step S522: During the preset time of stopping alkali addition and continuous stirring, the pH value of the drug solution is automatically shifted from the first value to the process target pH range by utilizing the ion release balance characteristics of the drug solution.

[0083] This step describes the mechanism of the above strategy. During the preset stirring time, no chemical addition is performed; chemical equilibrium is promoted solely through physical stirring, allowing the pH value to automatically and slowly rise from a first value (e.g., 8.3) to the final target (e.g., 8.4 or 8.5). This "soft landing" method is much safer than correcting the pH by adding acid, as adding acid in sensitive areas can easily cause oscillations.

[0084] In some embodiments, the rate at which the first-stage alkali solution is added is 450 mL / min to 550 mL / min.

[0085] This range represents a balance between efficiency and safety. Too slow a speed results in low production efficiency, while too fast a speed may lead to excessively high local concentrations, causing abnormal precipitation or splashing. For example, speeds of 450 mL / min, 460 mL / min, 475 mL / min, 490 mL / min, 500 mL / min, 515 mL / min, 525 mL / min, 540 mL / min, 550 mL / min, etc., are possible.

[0086] In some embodiments, the rate at which the remaining amount of alkali to be added is 200 mL / min to 300 mL / min.

[0087] This flow rate is significantly lower than that in the first stage, ensuring metering accuracy and mixing uniformity when adding trace amounts. Combined with the stirring speed, it effectively avoids localized over-alkaliness. For example, flow rates can be 200 mL / min, 210 mL / min, 225 mL / min, 240 mL / min, 250 mL / min, 260 mL / min, 275 mL / min, 285 mL / min, 290 mL / min, 300 mL / min, etc.

[0088] Furthermore, in some implementations, the preset inflection point percentage is 89% to 93%. For example, it can be 89%, 89.5%, 90%, 90.5%, 91%, 91.5%, 92%, 92.5%, 93%, etc.

[0089] This parameter refers to the threshold ratio set to stop adding alkali in the first stage of "blind addition" control. That is, when the actual amount of alkali added reaches between 89% and 93% of the total alkali used as predicted by the model, the system determines that the first stage task is completed and enters the pause and detection phase.

[0090] This parameter is based on statistical analysis of the neutralization reaction curve of the alcohol solution of Shenfu injection. Within this ratio range, the reaction system is usually at the end of a flat zone with a large buffer capacity, and has not yet entered the endpoint abrupt change zone where the pH value changes drastically.

[0091] Specifically, the system stores this percentage parameter in the control logic for real-time calculation of the target cutoff amount for the first stage. The result is that approximately 90% of the refueling tasks can be completed quickly.

[0092] Choosing the specific range of 89% to 93% achieves an optimal balance between efficiency and safety. Below 89%, the remaining amount needs to be increased excessively, leading to longer fine-tuning times; above 93%, it approaches the reaction endpoint, significantly increasing the risk of overshoot (i.e., accidentally exceeding the endpoint) due to prediction model errors. This range ensures that in the vast majority of batches, the reaction can safely stop before the endpoint, leaving sufficient margin for calibration.

[0093] In some implementations, the preset inflection point pH range is 4.8 to 5.2. For example, it can be 4.8, 4.85, 4.9, 4.95, 5.0, 5.05, 5.1, 5.15, 5.2, etc.

[0094] This parameter refers to the parameter used by the system during the "pause-clean-measure" step to verify whether the current reaction process meets the expected target pH range. Only when the measured pH value falls within this range does the system consider the current amount of alkali added to match the preset percentage (e.g., 91%), and then initiate the calculation of the remaining amount.

[0095] This parameter is a unique chemical fingerprint characteristic of this specific drug solution system (high alcohol content, containing alkaloids). Experiments show that when the system consumes approximately 90% of the alkali, its pH value remains stable between 4.8 and 5.2. This range is a key indicator for distinguishing between the "mid-stage" and "final stage" of the reaction.

[0096] Specifically, the system compares the measured real-time pH value with this range. If it is within the range, the model is confirmed to be effective; if it deviates, anomaly handling is triggered.

[0097] This pH range serves as an "anchor point," providing a reliable linearization calibration benchmark for nonlinear control processes. It avoids the highly acidic region at the beginning (pH<2) and the highly sensitive region at the end (pH>8), placing it within a region where measurements are relatively stable and have the strongest correlation with endpoint prediction, thus ensuring the accuracy of the residual amount calculation formula.

[0098] Example 4 refer to Figure 4 This embodiment provides a method for pH over-adjustment control of ginseng-based injection alcohol solution, wherein the preset volume-alkali linear model includes model parameters; the method for pH over-adjustment control of ginseng-based injection alcohol solution further includes: Step S600: After controlling the alkali addition device to add the remaining amount of alkali to the solution to be adjusted, record the total amount of alkali actually consumed in this adjustment.

[0099] Step S700: Update and calibrate the model parameters of the volume-alkali linearity using the initial volume and the final actual total amount of alkali consumed.

[0100] This step involves updating and calibrating the model parameters. This feature belongs to the "self-learning" or "adaptive" phase of the control method. After each pH adjustment task is fully completed, the system collects the actual operating data for that batch, specifically the "initial volume" of the solution measured at the start of the adjustment and the "final actual total amount of alkali consumed" at the end of the adjustment. Using these two sets of real data, the parameters (such as the slope coefficient k and intercept coefficient b) within the system's preset "volume-alkali linear model" are recalculated or fine-tuned.

[0101] This step is based on the principle of iterative learning. Considering that the acidity characteristics of the solution may slowly drift due to differences in raw material origin, extraction efficiency, or ambient temperature between different batches, fixed model parameters may deviate over time. By incorporating real data from the latest batch, the current process status can be reflected.

[0102] Specifically, new data points (V) can be... new Q realAdd the data to the historical database and rerun the linear regression algorithm, or update the parameters using a weighted average method. The result is a set of k' and b' values ​​that better reflect current production realities.

[0103] This step endows the system with the ability to evolve over time, automatically adapting to long-term changes in raw materials and the environment, ensuring that the prediction model always maintains high accuracy, and reducing reliance on human experience.

[0104] refer to Figure 6 In some embodiments, step S300, which involves controlling the cleaning device to clean the pH electrode, and then controlling the pH electrode to measure the real-time pH value of the solution to be adjusted after cleaning, includes: Step S310: Control the robotic arm carrying the pH electrode to move the pH electrode from the cleaning position above the liquid surface to the detection position below the liquid surface, so that the pH electrode is immersed in the solution to be adjusted.

[0105] Step S320: After collecting the real-time pH value, control the robotic arm to move the pH electrode back to the cleaning position, and start the spray head set at the cleaning position to spray and clean the pH electrode.

[0106] This step provides the hardware action flow for implementing the core strategy of "pause-clean-measure". Specifically, it may include: (1) Downward movement: Control the robotic arm to drive the pH electrode to descend or swing from the "cleaning position" in the air until the electrode probe is completely submerged in the "detection position" below the liquid surface.

[0107] (2) Upward movement: After completing the data acquisition, the robotic arm immediately lifts up, takes the electrode away from the liquid environment, and returns to its original position.

[0108] (3) Cleaning action: After the electrode returns to the cleaning position, start the spray head aligned with the position and spray cleaning liquid to remove the deposits on the electrode surface.

[0109] This step is based on the principles of physical isolation and timely cleaning. Through the displacement of the robotic arm, the electrode only comes into contact with the highly contaminated liquid for the necessary measurement moments, while the rest of the time (including the liquid addition reaction period) is in a safe and clean environment.

[0110] For example, the PLC sends pulse commands to drive the motor to perform position switching and controls the solenoid valve to switch on and off to spray water. As a result, the electrodes are always kept in a "fresh and clean" state for measurement.

[0111] This step completely resolves the sensor poisoning and response lag issues caused by prolonged electrode coating with deposits. Compared to traditional in-situ cleaning (CIP), off-situ cleaning is more thorough and avoids contaminating the reagents in the reaction vessel with the cleaning water.

[0112] The robotic arm can be implemented using cylinder lifting, lead screw modules, or rotary servo motors.

[0113] In some embodiments, the pH overshoot control method for the ginseng and aconite injection alcohol solution further includes step S800, an abnormal handling step: if the measured real-time pH value deviates from the preset inflection point pH range, an alarm signal is issued, and the alkali addition device and pH electrode are controlled to switch to continuous measurement mode.

[0114] This step serves as a safety fallback mechanism for the system. If, during the critical inflection point detection phase, the measured real-time pH value significantly exceeds the expected "preset inflection point pH range" (e.g., 4.8-5.2), the system determines that the current prediction model has failed or that a significant deviation has occurred in the production process. At this point, an audible and visual alarm is immediately triggered to prompt manual intervention, and the control mode is forcibly switched, no longer relying on model predictions, but instead switching to "continuous measurement mode" (i.e., the electrode remains immersed in the liquid for real-time monitoring).

[0115] This step is based on the anomaly detection logic of Statistical Process Control (SPC). If the measured value deviates from the preset range, it indicates that the acid-base characteristics of this batch of medicine solution are significantly different from the historical model (out-of-distribution sample). In this case, continuing to use the original proportional formula to calculate the remaining amount will lead to serious errors.

[0116] Specifically, you can compare | pH real - pH target |>Threshold. If true, output an alarm signal and lock the automatic liquid dispensing program.

[0117] This step greatly improves the robustness and safety of the system, preventing serious quality accidents (such as excessive alkali addition leading to scrap) caused by the system blindly executing automatic programs in the event of abnormal raw material conditions (such as excessively high or low acidity). Although continuous mode carries the risk of electrode contamination, it can provide real-time reference for manual remediation in emergency situations.

[0118] The present invention will be further illustrated below with specific experimental examples. However, it should be understood that these experimental examples are only for more detailed illustration and should not be construed as limiting the present invention in any way.

[0119] Experimental Example 1: Determination of Key Process Parameters (Inflection Points) and Establishment of a Model In order to determine the critical switching point (inflection point) in the automatic control strategy, four batches (batch numbers T-220115 to T-220118) of secondary alcohol solutions with attached tablets were selected for full-process titration analysis in this experiment.

[0120] like Figure 7 As shown in Table 1, the pH value was recorded as a function of the amount of alkali added, and the stable inflection point of pH value before the sudden change was statistically analyzed. Specific data are shown in Table 1.

[0121] Table 1. Statistics on pH inflection point and alkali usage.

[0122] Results analysis: Statistical results show that the average pH inflection point of the four batches of drug solution was about 5.06 (range 4.89-5.23), and the average proportion of alkali consumed at this time was about 91.5% (range 90.4%-92.4%).

[0123] Based on this experimental data, the core control parameters were determined in this experimental example: the preset inflection point pH range is 4.8~5.2, and the preset inflection point percentage is 89%~93%. This confirms the existence of a stable proportional relationship in the nonlinear system and supports the scientific validity of Formula 1 for calculating the remaining amount in the embodiment.

[0124] Experiment Example 2: Validation of Large-Scale Production Application of Automated Control Model This experimental example verifies the feasibility, control accuracy, and efficiency of the "model prediction + segmented control" method described in this invention in a real-world large-scale production environment.

[0125] 2. Experimental subjects: Three batches of large-scale production liquid (batch numbers T230801A, T230802A, and T230803A) were selected to verify the control accuracy of the method of the present invention.

[0126] 3. Experimental methods and results: (1) Establishment and prediction of the initial model (verification in step S100): Take samples of three batches of drug solution respectively, and determine the relationship between their volume and the amount of alkali used, such as Figure 8 As shown, the two exhibit a good linear relationship. The specific linear function and prediction results are shown in Table 2.

[0127] Table 2. Predicted Alkali Consumption and Linear Relationship for Large-Scale Chemical Solution Production

[0128] (2) First stage blind addition and inflection point verification (steps S200-S400 verification): Set the preset inflection point percentage to 91%, and turn on the peristaltic pump to add alkali at a rate of 500 mL / min. When 91% of the predicted volume is reached, pause, clean the electrode, and then measure the pH value. The data are shown in Table 3.

[0129] Table 3. pH values ​​and inflection point verification data at 91% alkali dosage.

[0130] (3) Calculation of remaining amount and endpoint control (verification of step S500): Based on the measured data of the inflection point, the remaining amount of alkali was calculated using the formula, added at a rate of 250 mL / min, and stirred continuously for 10 minutes. The final results are shown in Table 4.

[0131] Table 4. Final pH Adjustment Results and Quality Inspection Data

[0132] Conclusion: Actual production verification shows that the actual amount of alkali used in the three batches of the solution was on average about 1.6% higher than the predicted value. However, through the inflection point calibration mechanism of this invention, the final pH value was accurately locked within the target range, and the batch-to-batch fluctuation of key components was minimal (RSD<5%).

[0133] (4) Supplementary verification of the endpoint control strategy (drift characteristics): In the aforementioned large-scale production verification process, this invention specifically adopted a strategy of "setting a lower target value (e.g., 8.3) and continuous stirring." Figure 9 As shown, historical data from manual operations in large-scale production revealed that if stirring is not continued after adjusting to the initial pH value (i.e., just reaching the lower limit of the process), the pH value will automatically rise as ions in the precipitate are released (the figure shows the rise from the initial point to a higher point).

[0134] This phenomenon confirms the "ion release equilibrium characteristic" mentioned in the claims of this invention. This invention utilizes this characteristic, setting the target value for stopping alkali addition as a first value (e.g., 8.3), reserving a drift space of approximately 0.1, thereby utilizing the system's self-equilibrium to naturally reach a final stable value of around 8.4, effectively avoiding the risk of overshoot caused by directly adding to 8.5.

[0135] Experiment Example 3: Validation of the effectiveness of intermittent cleaning and online detection 1. Experimental objective: To verify whether the "intermittent cleaning-measurement" mechanism adopted in this invention can effectively solve the problem of detection inaccuracy caused by electrode encapsulation in high alcohol content precipitation systems.

[0136] 2. Experimental methods: (1) Initial calibration: Select an industrial online pH electrode and perform two-point calibration using standard buffer solutions of pH 4.00 and pH 9.18 to confirm that the electrode is in normal condition.

[0137] (2) Simulated pollution (control group): The electrode was directly immersed in the secondary alcohol solution of the attached sheet which was undergoing alkaline precipitation reaction (containing a large amount of colloidal precipitate).

[0138] (3) Record the changes in electrode readings at the initial stage of alkali addition. If the pH reading does not change for a long time (e.g., it remains at a certain value), it is determined that the electrode has been damaged by coating.

[0139] (4) Cleaning and recovery (experimental group): The electrodes that had been damaged by precipitation were removed, and the cleaning process of the present invention was simulated: the electrode probe was rinsed with purified water at about 35°C and then dried. The cleaned electrodes were then placed in standard buffer solutions of pH 4.00 and pH 9.18 for retesting, and the reading deviation was recorded.

[0140] 3. Experimental Results: (1) Contamination stage (control group): After the electrode was inserted into the drug solution, the reading initially changed as alkali was added, but quickly stopped changing at pH 1.81 ("deadlock" phenomenon); even if alkali was added again, the electrode reading still did not change. Upon observation, the surface of the electrode sensitive membrane was tightly wrapped with a thick layer of colloidal precipitate.

[0141] (2) Retesting after cleaning (experimental group): After being cleaned by spraying purified water at 35℃, the retesting data of this electrode in standard buffer solution are as follows: Reading in pH 4.00 buffer: 4.01; Reading in pH 9.18 buffer: 9.19; Deviation: within ±0.02 pH units.

[0142] 4. Results Analysis: Experiments have shown that during the alkaline precipitation process of the attached alcohol solution, the precipitate coating does indeed cause the pH electrode to rapidly fail (resulting in inaccurate detection). The cleaning device (35°C purified water spray) used in this invention can thoroughly remove the attached colloidal precipitate, allowing the electrode to quickly return to a high-precision measurement state. This strongly supports the necessity and effectiveness of the "cleaning device" and "intermittent measurement" steps in the claims.

[0143] 5. To verify the necessity of cleaning, a comparative experiment was conducted: Electrode readings were recorded without cleaning the electrodes (simulating conventional online monitoring). Results showed: Initial stage: pH 1.47.

[0144] First measurement: The electrode was inserted into the drug solution. When the reading showed pH 1.81, the value no longer changed. Upon inspection, it was found that the electrode was covered by a gelatinous precipitate.

[0145] Second measurement: After a simple rinse, the measurement was continued. When the reading showed pH 3.32, it stopped changing again, and the electrode failed again.

[0146] Combination Figure 10 As can be seen, due to precipitation interference and nonlinear characteristics, the pH reading and the amount of alkali added exhibit a complex nonlinear relationship, and the change is extremely rapid near the endpoint, making it impossible to rely solely on the reading to guide production. However, after adopting the cleaning method of this invention, the electrode's backtesting deviation in the standard solution is less than 0.02, proving that the device has solved the problem of detection inaccuracy.

[0147] Experiment Example 4: Effect of pH endpoint overtuning on alkaloid content 1. Experimental objective: To verify why the pH endpoint must be strictly controlled below 8.5, and the specific harm of overtuning to drug quality.

[0148] 2. Experimental methods: Take the secondary alcohol solution of the same batch of aconite slices and divide it into four equal portions.

[0149] Under the same conditions, different amounts of sodium hydroxide solution were added to adjust the pH values ​​of the four solutions to 8.3, 8.5, 8.7, and 9.0, respectively.

[0150] After adjusting the endpoint, keep each portion of the medicine solution standing for the same amount of time.

[0151] The residual content of "benzoyl neoaconitine" in each sample of the drug solution was determined by high performance liquid chromatography (HPLC).

[0152] 3. Experimental Results: (1) pH 8.3 group: The alkaloid content is in a high and stable state (benchmark value).

[0153] (2) pH 8.5 group: The alkaloid content decreased slightly, but was still within the acceptable range.

[0154] (3) pH8.7 group: The alkaloid content decreased significantly (about 15% lower than pH8.3 group).

[0155] (4) pH9.0 group: The alkaloid content dropped sharply (more than 40% lower than pH8.3 group).

[0156] 4. Results Analysis: Experimental data (reference) Figure 11 This indicates that benzoylneoprothiolane, the active ingredient in Shenfu injection, is extremely sensitive to alkaline environments. When the pH exceeds the critical point of 8.5, this ingredient undergoes a violent hydrolysis reaction. This fully explains why this invention went to great lengths to design a complex control strategy of "model prediction + inflection point calibration"—precisely controlling the endpoint is not only to meet process parameters, but also to preserve the "effectiveness" of the drug. This experimental example provides a solid biochemical basis for this invention to solve the technical problem of "product quality risk."

[0157] Experimental Example 5: Comparison of the present invention with traditional manual operation Comparing production data of the automated method of this invention with that of traditional manual operation: Traditional manual method: Due to the need to prevent overshoot, a "small amount, multiple times" approach is used, requiring the machine to be stopped, sampled, and measured offline after each addition of approximately 1000ml of alkali solution. A single batch operation is repeated more than 10 times, accumulating a total time of 2.4 to 4 hours. Furthermore, due to human error, the endpoint pH fluctuates significantly between batches.

[0158] The invention group adopts a fully automatic operation of "model prediction + inflection point calibration", with the adjustment time for a single batch stabilizing at around 30 minutes, improving efficiency by more than 5 times, and achieving full traceability of data.

[0159] refer to Figure 12 This application also provides a pH over-adjustment control device for ginseng injection alcohol solution, comprising: The calculation module 10 is used to obtain the initial volume of the drug solution to be adjusted, and to calculate the predicted total alkali content of the drug solution to be adjusted using a preset volume-alkali linear model. Alkali addition module 20 is used to control the alkali addition device to add first-stage alkali solution to the drug solution to be adjusted until the cumulative amount of alkali added reaches the preset inflection point percentage of the predicted total alkali amount; The cleaning module 30 is used to pause the addition of alkali solution, control the cleaning device to clean the pH electrode, and control the pH electrode to measure the real-time pH value of the solution to be adjusted after cleaning. The calculation module 10 is further configured to mark the current cumulative amount of alkali added as the actual amount of alkali added if the measured real-time pH value is within the preset inflection point pH range, and to calculate the remaining amount of alkali to be added based on the preset inflection point ratio and the actual inflection point amount of alkali added. The alkali addition module 20 is also used to control the alkali addition device to add the remaining amount of alkali to be added to the liquid to be adjusted.

[0160] It is understood that the device in this embodiment corresponds to the pH over-adjustment control method of the ginseng injection alcohol solution in the above embodiment. The options in the above embodiment are also applicable to this embodiment, so they will not be described again here.

[0161] This application also provides a computer device, which includes a processor and a memory. The memory stores a computer program, and the processor is used to execute the computer program to implement the pH over-adjustment control method for the ginseng and ginseng injection alcohol solution as described in any of the foregoing embodiments.

[0162] The processor can be an integrated circuit chip with signal processing capabilities. The processor can be a general-purpose processor, including at least one of a Central Processing Unit (CPU), Graphics Processing Unit (GPU), Network Processor (NP), Digital Signal Processor (DSP), Application-Specific Integrated Circuit (ASIC), Field-Programmable Gate Array (FPGA), or other programmable logic devices, discrete gate or transistor logic devices, or discrete hardware components. The general-purpose processor can be a microprocessor or any conventional processor, capable of implementing or executing the methods, steps, and logic block diagrams disclosed in the embodiments of this application.

[0163] The memory can be, but is not limited to, Random Access Memory (RAM), Read Only Memory (ROM), Programmable Read-Only Memory (PROM), Erasable Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM), etc. The memory is used to store computer programs, and the processor can execute the computer programs accordingly after receiving execution instructions.

[0164] This application also provides a computer storage medium storing a computer program, which, when executed on a processor, implements the pH over-adjustment control method for the ginseng and ginseng injection alcohol solution according to any one of the foregoing embodiments.

[0165] The computer storage medium can be a readable storage medium, a non-volatile storage medium, or a volatile storage medium. For example, the computer storage medium may include, but is not limited to, various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0166] In the several embodiments provided in this application, it should be understood that the disclosed apparatus and methods can also be implemented in other ways. The apparatus embodiments described above are merely illustrative. For example, the flowcharts and block diagrams in the accompanying drawings show the architecture, functionality, and operation of possible implementations of apparatus, methods, and computer program products according to various embodiments of this application. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that, in alternative implementations, the functions marked in the blocks may occur in a different order than those marked in the drawings. For example, two consecutive blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in the block diagram and / or flowchart, and combinations of blocks in the block diagram and / or flowchart, can be implemented using a dedicated hardware-based system that performs the specified function or action, or using a combination of dedicated hardware and computer instructions.

[0167] In addition, the functional modules or units in the various embodiments of this application can be integrated together to form an independent part, or each module can exist independently, or two or more modules can be integrated to form an independent part.

[0168] If the aforementioned functions are implemented as software functional modules and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or a part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a smartphone, personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application.

[0169] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application.

Claims

1. A method for pH over-adjustment control of an alcoholic solution of ginseng and aconite injection, characterized in that, include: Obtain the initial volume of the drug solution to be adjusted, and use a preset volume-alkali linear model to calculate the predicted total alkali content for the drug solution to be adjusted. The alkali addition device is controlled to add the first stage alkali solution to the drug solution to be adjusted until the cumulative alkali addition reaches the preset inflection point percentage of the predicted total alkali amount. Stop adding alkali solution, control the cleaning device to clean the pH electrode, and after cleaning, control the pH electrode to measure the real-time pH value of the solution to be adjusted. If the measured real-time pH value is within the preset inflection point pH range, the current cumulative amount of alkali added is marked as the actual inflection point amount of alkali added, and the remaining amount of alkali to be added is calculated based on the preset inflection point percentage and the actual inflection point amount of alkali added. The alkali addition device is controlled to add the remaining amount of alkali to the solution to be adjusted.

2. The method for pH over-adjustment control of the alcoholic solution of ginseng and aconite injection as described in claim 1, characterized in that, The remaining amount of alkali to be added is calculated using the following formula: ； Where X is the remaining amount of alkali to be added; A is the actual amount of alkali to be added at the inflection point; and R is the ratio value corresponding to the preset inflection point percentage.

3. The method for pH over-adjustment control of the alcoholic solution of ginseng and aconite injection as described in claim 1, characterized in that, The expression for the preset volume-alkali linear model is: ； Where Q is the predicted total alkali content; V is the initial volume; k is the slope coefficient; and b is the intercept coefficient.

4. The method for pH over-adjustment control of the alcoholic solution of ginseng and aconite injection as described in claim 1, characterized in that, The control of the alkali addition device to add the remaining amount of alkali to the solution to be adjusted includes: The remaining amount of alkali to be added is controlled to be added at a rate lower than that of adding the first stage alkali solution; After the addition is complete, continue stirring for the preset time and monitor the pH value of the solution until the pH value stabilizes within the target range of 8.3 to 8.

5.

5. The method for pH over-adjustment control of the alcoholic solution of ginseng and aconite injection as described in claim 4, characterized in that, The monitoring of the pH value of the drug solution until the pH value stabilizes within the target range of 8.3 to 8.5 includes: The target pH value for stopping alkali addition is set as a first value, which is lower than the lower limit of the process target pH range for the final product. During the preset time period of stopping alkali addition and continuous stirring, the pH value of the solution automatically rises from the first value to the target pH range of the process, utilizing the ion release equilibrium characteristics of the solution; and / or, The rate at which the first-stage alkali solution is added is 450 mL / min to 550 mL / min; and / or, The rate at which the remaining amount of alkali to be added is 200 mL / min to 300 mL / min.

6. The method for pH over-adjustment control of the alcoholic solution of ginseng and aconite injection as described in claim 1, characterized in that, The preset inflection point percentage is 89%–93%; and / or, The preset inflection point pH range is 4.8 to 5.

2.

7. The method for pH over-adjustment control of the alcoholic solution of ginseng and aconite injection as described in claim 1, characterized in that, The preset volume-alkali linear model includes model parameters; the pH over-adjustment control method for the alcohol solution of the adjuvant injection also includes: After the alkali addition device is used to add the remaining amount of alkali to the solution to be adjusted, the total amount of alkali actually consumed in the final adjustment is recorded. Using the initial volume and the final actual total amount of alkali consumed, the model parameters for the volume-alkali linearity are updated and calibrated; and / or, The control cleaning device cleans the pH electrode, and after cleaning, controls the pH electrode to measure the real-time pH value of the solution to be adjusted, including: The robotic arm carrying the pH electrode is controlled to move the pH electrode from the cleaning position above the liquid surface to the detection position below the liquid surface, so that the pH electrode is immersed in the solution to be adjusted. After collecting the real-time pH value, the robotic arm is controlled to move the pH electrode back to the cleaning position, and the spray head located at the cleaning position is activated to spray and clean the pH electrode; and / or, The pH overshoot control method for the ginseng and aconite injection alcohol solution also includes an abnormal handling step: if the measured real-time pH value deviates from the preset inflection point pH range, an alarm signal is issued, and the alkali addition device and pH electrode are controlled to switch to continuous measurement mode.

8. A pH over-adjustment control device for an alcoholic solution of ginseng and astragalus injection, characterized in that, include: The calculation module is used to obtain the initial volume of the drug solution to be adjusted, and to calculate the predicted total alkali content of the drug solution to be adjusted using a preset volume-alkali linear model. The alkali addition module is used to control the alkali addition device to add the first stage alkali solution to the drug solution to be adjusted until the cumulative alkali addition reaches the preset inflection point percentage of the predicted total alkali amount; The cleaning module is used to pause the addition of alkali solution, control the cleaning device to clean the pH electrode, and control the pH electrode to measure the real-time pH value of the solution to be adjusted after cleaning. The calculation module is further configured to mark the current cumulative amount of alkali added as the actual amount of alkali added if the measured real-time pH value is within the preset inflection point pH range, and to calculate the remaining amount of alkali to be added based on the preset inflection point ratio and the actual inflection point amount of alkali added. The alkali addition module is also used to control the alkali addition device to add the remaining amount of alkali to the liquid to be adjusted.

9. A computer device, characterized in that, The computer device includes a processor and a memory, the memory storing a computer program, and the processor executing the computer program to implement the pH over-adjustment control method for the ginseng and ginseng injection alcohol solution according to any one of claims 1-7.

10. A computer storage medium, characterized in that, It stores a computer program, which, when executed on a processor, implements the pH over-adjustment control method for the alcoholic solution of the ginseng and ginseng injection according to any one of claims 1-7.

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