CN-121995981-A - Method, device, equipment and storage medium for controlling pH overshoot of ginseng and aconite injection alcohol solution

CN121995981ACN 121995981 ACN121995981 ACN 121995981ACN-121995981-A

Abstract

The application provides a method, a device, equipment and a storage medium for controlling pH overshoot of an alcohol solution of a ginseng and aconite injection, and relates to the technical field of traditional Chinese medicine pharmaceutical engineering. The control method comprises the steps of obtaining the initial volume of liquid medicine to be regulated, calculating the predicted total alkali amount, adding alkali liquor in the first stage until the preset inflection point proportion is reached, suspending the alkali liquor, measuring the real-time pH value, marking the current accumulated alkali adding amount as the actual inflection point alkali adding amount if the real-time pH value is within the inflection point pH range, calculating the residual alkali adding amount, and adding the residual alkali adding amount into the liquid medicine to be regulated. The application thoroughly solves the problem of detection misalignment caused by precipitation of the interference electrode by combining model prediction with sectional control and utilizing intermittent cleaning measurement. Meanwhile, based on a dynamic calibration mechanism of inflection point measured data, the control deviation of a nonlinear system is effectively overcome, the accurate locking of a pH end point is realized, the decomposition of active ingredients due to overshoot is prevented, and the production efficiency and the medicine quality are obviously improved.

Inventors

HOU XINLIAN
LI RUIYU
WAN RONG
ZHANG YU
HU MIN
REN XUEFANG

Assignees

华润三九（雅安）药业有限公司

Dates

Publication Date: 20260508
Application Date: 20260213

Claims (10)

1. The method for controlling the pH overshoot of the ginseng-aconite injection alcohol solution is characterized by comprising the following steps of: acquiring the initial volume of the liquid medicine to be regulated, and calculating the predicted total alkali quantity aiming at the liquid medicine to be regulated by utilizing a preset volume-alkali quantity linear model; Controlling an alkali adding device to add first-stage alkali liquor into the liquid medicine to be regulated until the accumulated alkali adding amount reaches the preset inflection point duty ratio of the predicted total alkali amount; Suspending adding alkali liquor, controlling a cleaning device to clean a pH electrode, and controlling the pH electrode to measure the real-time pH value of the liquid medicine to be regulated after the cleaning is finished; If the measured real-time pH value is in the preset inflection point pH range, marking the current accumulated alkali adding amount as an actual inflection point alkali adding amount, and calculating the residual alkali adding amount based on the preset inflection point duty ratio and the actual inflection point alkali adding amount; And controlling the alkali adding device to add the residual alkali adding amount to the liquid medicine to be regulated.
2. The method for controlling the pH overshoot of an alcohol solution of a ginseng and aconite injection according to claim 1, wherein the calculated residual alkali addition amount adopts the following formula: ; Wherein X is the residual alkali adding amount required, A is the actual inflection point alkali adding amount, and R is the ratio value corresponding to the preset inflection point duty ratio.
3. The method for controlling the pH overshoot of an alcohol solution of a ginseng and aconite injection according to claim 1, wherein the expression of the preset volume-alkali linear model is: ; wherein Q is the predicted total alkali amount, V is the initial volume, k is the slope coefficient, and b is the intercept coefficient.
4. The method for controlling pH overshoot of an alcohol solution of a ginseng and aconite injection according to claim 1, wherein the controlling the alkali adding device to add the remaining alkali amount to the liquid medicine to be adjusted includes: controlling the alkali adding device to add the residual alkali required to be added at a rate lower than the rate of adding the alkali liquor in the first stage; And after the addition is completed, stirring for a preset time continuously, and monitoring the pH value of the liquid medicine until the pH value is stabilized within a target range of 8.3-8.5.
5. The method for controlling pH overshoot of an alcohol solution of a ginseng and aconite injection according to claim 4, wherein the monitoring the pH value of the liquid medicine until the pH value is stabilized within a target range of 8.3 to 8.5 comprises: Setting the target pH value at which the alkali addition is stopped to be a first value which is lower than the lower limit of the process target pH range of the final product; automatically increasing the pH value of the liquid medicine from the first numerical value drift to the process target pH range by utilizing the ion release balance characteristic of the liquid medicine within the preset time of stopping adding alkali and continuously stirring, and/or, The speed of adding the alkali liquor in the first stage is 450 mL/min-550 mL/min, and/or, The rate of adding the residual alkali required amount is 200 mL/min-300 mL/min.
6. The method for controlling pH overshoot of an alcohol solution of a ginseng and aconite injection according to claim 1, wherein the preset inflection point accounts for 89% -93% and/or, The pH range of the preset inflection point is 4.8-5.2.
7. The method for controlling pH overshoot of an alcohol solution of a ginseng and aconite injection according to claim 1, wherein the predetermined volume-alkali linear model comprises model parameters, and the method for controlling pH overshoot of an alcohol solution of a ginseng and aconite injection further comprises: after the alkali adding device is controlled to add the residual alkali amount to the liquid medicine to be regulated, recording the total alkali amount actually consumed in the current regulation; Updating and calibrating model parameters of the volume-alkali linearity by utilizing the initial volume and the final actual consumption total alkali, and/or, The control cleaning device cleans the pH electrode, controls the pH electrode to measure the real-time pH value of the liquid medicine to be regulated after the cleaning is finished, and comprises the following steps: controlling a mechanical arm carrying the pH electrode, and moving the pH electrode from a cleaning position above the liquid level to a detection position below the liquid level, so that the pH electrode is immersed in the liquid medicine to be regulated; after the real-time pH value is collected, the mechanical arm is controlled to move the pH electrode back to the cleaning position, a spray head arranged at the cleaning position is started to spray and clean the pH electrode, and/or, The control method for the pH overshoot of the ginseng and aconite injection alcohol solution further comprises an abnormality processing step, wherein if the measured real-time pH value deviates from the preset inflection point pH range, an alarm signal is sent out, and the alkali adding device and the pH electrode are controlled to be switched to a continuous measurement mode.
8. The utility model provides a ginseng-attached injection alcohol liquor pH overshoot controlling means which characterized in that includes: The calculation module is used for obtaining the initial volume of the liquid medicine to be regulated, and calculating the predicted total alkali amount of the liquid medicine to be regulated by utilizing a preset volume-alkali amount linear model; The alkali adding module is used for controlling an alkali adding device to add first-stage alkali liquor into the liquid medicine to be regulated until the accumulated alkali adding amount reaches the preset inflection point duty ratio of the predicted total alkali amount; The cleaning module is used for suspending the addition of alkali liquor, controlling the cleaning device to clean the pH electrode, and controlling the pH electrode to measure the real-time pH value of the liquid medicine to be regulated after the cleaning is finished; The calculation module is further configured to mark a current accumulated alkali adding amount as an actual inflection point alkali adding amount if the measured real-time pH value is within a preset inflection point pH range, and calculate a remaining alkali adding amount required based on the preset inflection point duty ratio and the actual inflection point alkali adding amount; The alkali adding module is also used for controlling the alkali adding device to add the residual alkali adding amount into the liquid medicine to be regulated.
9. A computer device, characterized in that it comprises a processor and a memory, said memory storing a computer program, said processor being adapted to execute said computer program to implement the method for controlling pH overshoot of an alcohol solution of a ginseng-aconite injection according to any one of claims 1-7.
10. Computer storage medium, characterized in that it stores a computer program which, when executed on a processor, implements the method for controlling pH overshoot of an alcohol solution of a reference injection according to any one of claims 1-7.

Description

Method, device, equipment and storage medium for controlling pH overshoot of ginseng and aconite injection alcohol solution Technical Field The application relates to the technical field of traditional Chinese medicine pharmaceutical engineering, in particular to a method, a device, equipment and a storage medium for controlling pH overshoot of an alcohol solution of a ginseng-aconite injection. Background In the production process of the traditional Chinese medicine injection, the accurate adjustment of the pH value (pH value) of the intermediate liquid medicine is a key link for guaranteeing the quality and the safety of the product. Especially when preparing complex traditional Chinese medicine systems such as Ginseng radix and aconiti injection, alkali liquor is usually added in high concentration ethanol environment, and the liquor is regulated from strong acidity to weak alkalinity, so as to remove impurities such as tannins, resins and the like by utilizing the alkali precipitation principle. The process not only relates to the impurity removal efficiency, but also directly influences the retention rate of active ingredients (such as alkaloids) in the liquid medicine. Therefore, how to realize the accurate control of the pH value in a complex liquid medicine system with high alcohol degree and high ionic strength is always an important point of attention in the field of pharmaceutical engineering. The existing pH adjusting process mainly depends on manual operation or conventional on-line monitoring equipment. In actual production, operators usually add high-concentration alkali liquor in batches according to experience, and frequently sample the alkali liquor for offline detection, or directly use an online pH meter for real-time monitoring. However, for special systems such as the secondary alcohol solution of aconite, the ethanol concentration is up to about 85%, and a large amount of colloid-like precipitation with adhesiveness is generated during the adjustment process. When the conventional online pH meter is used for monitoring, the colloid precipitates are very easy to wrap the electrode sensitive film, so that the sensor is slow in response, drifts in readings and even completely fails, and the current pH state of the liquid medicine cannot be truly reflected. In addition, the physical and chemical characteristics of the system are extremely complex, and a traditional linear acid-base neutralization calculation model is difficult to apply. Actual production data show that the pH value of the liquid medicine and the alkali adding amount show obvious nonlinear relation, especially when the pH value is close to an end point (pH value is 8.3-8.5), the pH value is extremely sensitive to the change of the alkali amount, and the addition of a small amount of alkali liquid can cause the sharp fluctuation of the pH value. Due to the lack of effective on-line detection means and accurate control models, existing regulation processes often face a significant risk of overshoot. Once the pH exceeds the upper limit of the process, the key alkaloid components in the liquid medicine undergo irreversible hydrolysis reaction, which results in significant reduction of the content and even rejection of the whole batch of liquid medicine when serious. Meanwhile, in order to prevent overshoot, the complicated cyclic operation of adding alkali, sampling, cleaning and measuring is mainly carried out manually at present, so that the time consumption is long, the efficiency is low, and the consistency among batches is difficult to ensure. In summary, the existing ginseng and aconite injection alcohol solution pH adjusting process has the technical problems of detecting signal distortion, control model failure, active ingredient loss caused by extremely easy overshoot, and the like. Due to the interference of the sediment to the sensor and the nonlinear characteristics of the system, the conventional automatic control means are difficult to implement, and a technical scheme which can overcome the sediment interference, adapt to nonlinear changes and accurately control the end point is needed so as to improve the production efficiency and ensure the medicine quality. Disclosure of Invention In a first aspect, the invention provides a method for controlling pH overshoot of an alcohol solution of a ginseng and aconite injection, comprising the following steps: acquiring the initial volume of the liquid medicine to be regulated, and calculating the predicted total alkali quantity aiming at the liquid medicine to be regulated by utilizing a preset volume-alkali quantity linear model; Controlling an alkali adding device to add first-stage alkali liquor into the liquid medicine to be regulated until the accumulated alkali adding amount reaches the preset inflection point duty ratio of the predicted total alkali amount; Suspending adding alkali liquor, controlling a cleaning device to clean a pH electrode, and controlling the