Method for evaluating quality of Tianyuantong granules by combining thin-layer chromatography identification and specific chromatogram

Abstract

The invention discloses a Tianyuantong particle quality evaluation method combining thin-layer chromatography identification and a specific chromatogram, which comprises the following steps: before continuous quality evaluation of Tianyuantong particles, constructing a constant temperature and humidity control area around a mobile phase system, integrally sealing a liquid storage bottle, a sample introduction pipeline and a pump head in a temperature and humidity balance space, the steady state of the detection environment is maintained by dynamically adjusting the temperature difference and the humidity difference; a charge neutralization device is arranged on a mobile phase input path in a constant-temperature and constant-humidity control area, electrostatic accumulation energy is released through a high-impedance grounding guide path, and potential balance of a liquid storage bottle and a sample introduction path is kept. The stability of the mobile phase is controlled through constant temperature and humidity, charge neutralization and ion capture, and peak position drift caused by metal ion disturbance is avoided; chromatographic balance is maintained through micro-flow velocity pulsation and peak position dynamic compensation, peak position stability and component recognition consistency in continuous detection are achieved, and the accuracy and reliability of quality evaluation of Tianyuantong particles are improved.

Description

Technical Field

[0001] This invention relates to the field of mineral screening technology, specifically to a method for evaluating the quality of Tianyuan Zhitong granules by combining thin-layer chromatography identification and characteristic chromatograms. Background Technology

[0002] Tianyuan Zhitong is a compound formula composed of ten traditional Chinese medicines, including Gastrodia elata, Ligusticum chuanxiong, Angelica dahurica, Corydalis yanhusuo (processed with vinegar), Cynanchum paniculatum, Ziziphus jujuba var. spinosa, Angelica sinensis, Vitex trifolia, Morinda officinalis (processed), and Pinellia ternata (processed). It has the effects of dispelling wind and relieving pain, calming the liver and suppressing yang, and soothing the mind and improving intelligence. It is mainly used to treat tension headaches and accompanying symptoms such as anxiety and insomnia. The quality evaluation of its granules is based on thin-layer chromatography and characteristic chromatographic methods: Thin-layer chromatography is used for qualitative identification of the main medicinal ingredients in the prescription, such as Ligusticum chuanxiong, Angelica sinensis, Corydalis yanhusuo (processed with vinegar), Cynanchum paniculatum, and Ziziphus jujuba var. spinosa, confirming the authenticity and integrity of the medicinal components through the clarity and specificity of characteristic spots; the characteristic chromatographic method uses high-performance liquid chromatography to analyze the overall chemical composition of the sample, extracting nine common peaks and identifying key components such as ferulic acid, paeonol, and ligustilide to reflect the chemical composition characteristics and batch-to-batch consistency of the preparation. The combination of these two aspects forms a systematic quality control system that verifies the source of medicinal materials and ensures the stability and reproducibility of Tianyuan Zhitong granules, providing a scientific basis for its industrial production and clinical application.

[0003] The existing technology has the following shortcomings: During the continuous quality evaluation of Tianyuan Zhitong granules, the mobile phase system is easily affected by changes in temperature and humidity in the experimental environment or static electricity buildup in the storage bottle during long-term operation, leading to a sudden increase in trace metal ions in a short period of time. When the concentration of metal ions accumulates to the critical threshold in the detection pathway, it will undergo a transient complexation reaction with the stationary phase of the chromatographic column, causing a synchronous shift in the overall retention time of the chromatographic peaks, resulting in uneven peak position drift or overall misalignment. Such drift is usually difficult to identify in real time through conventional baseline correction and is easily misjudged by the system as the complete "missing detection" of the main components of the medicinal material or an abnormal decrease in content, which in turn leads to serious deviations in the batch quality evaluation results and even causes incorrect judgments on the stability of the formulation and the consistency of the process.

[0004] The information disclosed in the background section is only intended to enhance the understanding of the background of this disclosure, and therefore may include information that does not constitute prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to provide a method for evaluating the quality of Tianyuan Zhitong granules by combining thin-layer chromatography identification and characteristic chromatograms, so as to solve the problems in the background art mentioned above.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms, comprising the following steps: Step 1: Before continuously evaluating the quality of Tianyuan Zhitong granules, a constant temperature and humidity control area is constructed around the mobile phase system. The storage bottle, injection pipeline and pump head are completely enclosed in a temperature and humidity equilibrium space. The detection environment is kept stable by dynamically adjusting the temperature difference and humidity difference to stabilize the concentration of metal ions in the mobile phase. Step 2: Set up a charge neutralization device in the mobile phase input path within the constant temperature and humidity control area. Release the energy accumulated by static electricity through a high-impedance grounding guide path to maintain the potential balance between the liquid storage bottle and the sample injection path, and suppress the transient increase in metal ion concentration caused by potential change. Step 3: Under the condition of potential equilibrium, a dynamic ion capture device is set at the inlet of the mobile phase. A high specific surface area inert adsorption matrix is ​​used to adsorb transient free ions, and the ion adsorption behavior is stabilized by relying on the aforementioned potential equilibrium environment, thereby reducing the fluctuation of the concentration of metal ions in the mobile phase. Step 4: Under stable ion concentration conditions, micro-flow rate pulsation control is implemented on the mobile phase delivery process. Periodic micro-amplitude flow rate adjustment is applied to the output liquid flow of the mobile phase to maintain the time equilibrium of the adsorption kinetics of the chromatographic stationary phase and reduce the transient complexation reaction caused by local ion accumulation. Step 5: After the mobile phase delivery is stable, a peak position dynamic tracking and compensation mechanism is established. An offset reference interval is generated based on the retention time distribution of the previous detection cycle, and the retention time of the current detection cycle is synchronously fine-tuned to maintain the real-time stability of the chromatographic peak position and the consistency of component identification in continuous detection.

[0007] Preferably, before conducting continuous quality testing and evaluation of Tianyuan Zhitong granules, the steps for constructing a constant temperature and humidity control zone around the mobile phase system include: Before continuous testing, the storage bottle, sample inlet line and pump head are sealed in a closed temperature and humidity balanced space. The space is made of double-layer corrosion-resistant insulating material and has an annular airflow channel inside. The temperature and humidity regulated air is delivered by an external air circulation device to form a continuous thin airflow on the surface of the storage bottle, sample inlet line and pump head. After the enclosed space is established, the temperature and humidity inside the space are dynamically balanced and regulated by an external constant temperature circulation device and a humidity control chamber to control the uniform distribution of gas and ensure that the temperature and humidity of the mobile phase liquid remain stable throughout the storage, transportation and pumping process. Under stable temperature and humidity equilibrium conditions, an isothermal connection pipeline is installed between the outlet of the storage bottle and the inlet of the sample tube. The pipeline includes a polytetrafluoroethylene inner layer and a high thermal conductivity metal outer layer. The temperature of the outer layer and the air is kept in equilibrium through thermal convection to maintain the thermal and humidity consistency of the liquid transport path. Under the condition of establishing a temperature and humidity equilibrium environment, the steady state of the closed space is maintained by adjusting the air flow rate and controlling the heat exchange rate. The liquid storage bottle, sample injection pipeline and pump head are kept under the same temperature and humidity conditions to keep the concentration of metal ions in the mobile phase in equilibrium and prevent transient increases.

[0008] Preferably, the step of setting up a charge neutralization device in the mobile phase input path within the constant temperature and humidity control area includes: A charge guiding layer is set outside the mobile phase input path in the constant temperature and humidity control area. The charge guiding layer is made of a composite conductive material with high dielectric strength and stable surface resistance. It continuously covers the outer wall of the mobile phase input path and penetrates the outlet of the storage bottle, the sample inlet tube connection and the pump head inlet. A high-impedance grounding guide path is set on the extension path of the charge guiding layer. The guide path is made of a polymer conductive composite material and contains conductive particles to control the resistance range. Its two ends are connected to the end of the guiding layer and the external ground potential layer respectively to release the electrostatic energy. Multiple pressure equalization contact points are arranged in the constant temperature and humidity control area. An equipotential surface is formed between the pressure equalization contact points and the charge conduction layer. A continuous potential conduction network is constructed between the liquid storage bottle, the sample injection line and the pump head to maintain potential balance. Under the condition of potential equilibrium, charge diffusion is achieved through the antistatic coating on the surface of the guiding layer. The retained charge moves along the surface of the guiding layer into the high-impedance guiding path to maintain the state of zero electrostatic accumulation in the constant temperature and humidity environment and stabilize the concentration of metal ions in the mobile phase.

[0009] Preferably, the step of installing a dynamic ion trapping device at the mobile phase inlet under potential equilibrium conditions includes: In a constant temperature, humidity and potential equilibrium environment, a high specific surface area inert adsorption matrix structure for ion adsorption is established at the inlet of the mobile phase. The adsorption matrix is ​​made of inert inorganic material with a three-dimensional porous framework. The surface is treated with plasma to remove active functional groups and encapsulated in a shell with fluid distribution channels. A temperature conduction layer is set outside the high specific surface area inert adsorption matrix. The temperature of the adsorption area is kept constant by constant temperature liquid circulation. A low-speed micro-circulation fluid channel is set around the adsorption matrix to achieve self-cleaning and regeneration of adsorption sites and maintain the adsorption and desorption balance of transient free ions. A fluid guiding layer composed of porous flow dividers is set in the adsorption device. The flow dividers are installed at the upper and lower ends of the adsorption substrate and are combined with the adsorption substrate by a flexible pressing method to form a uniform flow field and maintain the continuity of electric potential. Under stable adsorption conditions, the flow rate distribution is controlled by adjusting the inlet pressure and outlet back pressure of the mobile phase. Combined with a constant temperature and humidity environment, the steady state of the adsorption zone is maintained, so that the adsorption and release of metal ions by the adsorption matrix reaches a dynamic equilibrium to stabilize the concentration of metal ions in the mobile phase.

[0010] Preferably, the pore distribution density of the three-dimensional porous framework of the high specific surface area inert adsorption matrix is ​​controlled in the range of micrometers to nanometers. A heat-conducting ring is provided on the outside of the temperature conduction layer to uniformly distribute the heat of the constant temperature liquid circulation layer. The upper flow divider of the fluid guide layer has a larger pore diameter than the lower flow divider. The adsorption matrix is ​​connected to the potential balance network to maintain the stability of the surface potential of the matrix and prevent charge accumulation from interfering with the adsorption performance.

[0011] Preferably, the step of implementing microflow rate pulsation control of the mobile phase transport process under stable ion concentration conditions includes: A liquid delivery structure capable of micro-amplitude flow rate adjustment is established under stable ion concentration conditions. The liquid delivery structure consists of a high-precision drive device and a controllable elastic liquid storage chamber. The elastic liquid storage chamber is covered with a temperature control layer and the temperature is kept constant through constant temperature liquid circulation to form a periodic micro pressure difference. Under the condition of establishing a micro-flow velocity controllable structure, a multi-stage pressure buffer unit is set in the mobile phase passage. The pressure buffer unit is composed of a fine spiral liquid channel to diffuse flow velocity fluctuations and form uniform and coordinated micro-pulsation characteristics. Under stable flow rate pulsation waveform conditions, the shear rate of the stationary phase surface is adjusted by periodic flow rate fluctuations and the boundary layer thickness is controlled to maintain the time equilibrium of the adsorption and desorption processes and suppress transient complexation reactions. Under the condition of establishing adsorption kinetic equilibrium, the pulsation stability is maintained by synchronously adjusting the mobile phase pumping frequency and the elastic recovery rate of the reservoir, and the flow rate period is kept consistent under constant temperature and humidity conditions to ensure stable chromatographic peak retention time.

[0012] Preferably, during the microfluidic pulsation control process, the temperature control layer covering the outside of the elastic reservoir is made of a metal film with high thermal conductivity, and when the reservoir outlet is connected to the main delivery pipeline, the fluid forms a micro-amplitude flow velocity fluctuation when passing through the reservoir and acts on the output liquid flow of the mobile phase to maintain the time equilibrium of the adsorption kinetics of the chromatographic stationary phase.

[0013] Preferably, during the microfluidic pulsation control process, the temperature control layer covering the outside of the elastic reservoir is made of a metal film with high thermal conductivity, and when the reservoir outlet is connected to the main delivery pipeline, the fluid forms a micro-amplitude flow velocity fluctuation when passing through the reservoir and acts on the output liquid flow of the mobile phase to maintain the time equilibrium of the adsorption kinetics of the chromatographic stationary phase.

[0014] Preferably, the steps for establishing a dynamic peak position tracking and compensation mechanism after the mobile phase transport has stabilized include: After the mobile phase is stably delivered, the retention time distribution of the chromatogram from the previous detection cycle is analyzed to determine the peak position reference for the current cycle, and reference data is determined based on the peak shape distribution range, peak area and signal intensity. After the retention time baseline distribution map is established, an offset reference interval is generated based on the time interval and peak shape characteristics of each chromatographic peak. The interval is summarized based on the relative change trend of the retention time of each peak in the previous period, and the stability of the mobile phase delivery path, column temperature difference and microflow rate pulsation waveform change are taken into account. After the offset reference interval is established, the chromatographic retention time of the current detection cycle is adjusted in real time. The synchronous fine adjustment is achieved by adjusting the small-amplitude pulsation period of the mobile phase delivery rate to correct the peak position time. After the peak position synchronization fine-tuning is completed, the peak position dynamic tracking compensation mechanism is continuously maintained to automatically compare the peak position time data of the current cycle with the reference interval, update the offset reference interval boundary of the next detection cycle, and ensure the peak position stability in continuous detection.

[0015] Preferably, when the peak position dynamic tracking compensation mechanism is running in a continuous detection cycle, the offset reference interval is updated based on the retention time distribution of the previous detection cycle. Under the premise that the constant temperature and humidity control area, potential equilibrium conditions and microflow rate pulsation control state remain unchanged, the retention time of the chromatographic peak in the current detection cycle is synchronously fine-tuned to maintain the temporal consistency of the chromatographic peak position and the stability of component identification in continuous detection.

[0016] The technical effects and advantages provided by the present invention in the above technical solution are as follows: This invention establishes a constant temperature and humidity control zone and incorporates charge neutralization and dynamic ion capture devices during continuous quality detection, ensuring the mobile phase system maintains stable temperature, humidity, potential, and ion concentration during long-term operation. This structure effectively prevents transient concentration surges of metal ions caused by environmental disturbances or electrostatic accumulation, suppressing transient complexation reactions between the stationary phase and metal ions at the source. This achieves continuous stability of the mobile phase composition in the detection pathway, ensuring consistent peak retention times, resolving qualitative deviations caused by batch-to-batch drift, and improving the stability and reliability of the quality evaluation results for Tianyuan Zhitong granules.

[0017] This invention introduces microflow rate pulsation control and a dynamic peak position tracking compensation mechanism during mobile phase transport, enabling the chromatographic system to maintain a dynamic balance between adsorption kinetics and retention time during long-term operation. This mechanism can correct peak position shifts in real time during the detection cycle, ensuring the synchronous stability of peak positions of each component during continuous detection, thereby maintaining the temporal consistency of characteristic spectra. This improves the accuracy and reproducibility of component identification, ensures the comparability and consistency of quality evaluation data in continuous monitoring, and provides reliable technical support for the industrial-scale quality control of Tianyuan Zhitong granules. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0019] Figure 1 This is a flowchart of the method for evaluating the quality of Tianyuan Zhitong granules, which combines thin-layer chromatography identification and characteristic chromatograms according to the present invention. Detailed Implementation

[0020] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the examples set forth herein; rather, they are provided so that the description of this disclosure will be more complete and fully convey the concept of the exemplary embodiments to those skilled in the art.

[0021] This invention provides, for example Figure 1 The method for quality evaluation of Tianyuan Zhitong granules, which combines thin-layer chromatography identification and characteristic chromatograms, includes the following steps: Step 1: Before continuously evaluating the quality of Tianyuan Zhitong granules, a constant temperature and humidity control area is constructed around the mobile phase system. The storage bottle, injection pipeline and pump head are completely enclosed in a temperature and humidity equilibrium space. The detection environment is kept stable by dynamically adjusting the temperature difference and humidity difference to stabilize the concentration of metal ions in the mobile phase. The specific implementation method for this step is as follows: Before continuous monitoring, the reservoir bottle for storing the mobile phase solution, the inlet tubing for delivering the solution, and the pump head for providing the liquid flow are all enclosed in a sealed, temperature- and humidity-balanced space. This space is constructed with a double-layered, corrosion-resistant insulating material: an outer heat-reflective layer and an inner thermally conductive layer, with microporous insulating material filling the space to prevent the transfer of external temperature differences. An annular airflow channel is installed inside the space, with multiple evenly distributed microporous air outlets. Temperature- and humidity-controlled air is uniformly introduced into the chamber at a low speed through an external air circulation device, ensuring a continuous, thin-layered airflow over the reservoir bottle, inlet tubing, and pump head. The reservoir bottle is made of borosilicate glass resistant to high-purity solvents, and its opening is connected to the inlet tubing via a sealing gasket to prevent direct contact between external gases and the liquid surface. The inlet tubing is made of polytetrafluoroethylene (PTFE) with a thermally conductive film coating to ensure that the tubing temperature remains consistent with the air temperature inside the chamber. The pump head is fixed at the center of the bottom of the chamber, and a thermally conductive contact pad is placed between the pump head housing and the bottom plate of the chamber to ensure uniform temperature between the pump body and the chamber. This fully enclosed structure keeps the liquid storage bottle, injection tubing, and pump head in a uniform temperature and humidity state within the same microenvironment, structurally eliminating the direct impact of external environmental fluctuations on the mobile phase system.

[0022] After the aforementioned enclosed space is constructed, a temperature and humidity control system is used to dynamically balance and regulate its interior. The temperature control system delivers a constant-temperature fluid to the heat conduction pipes on the inner wall of the cavity via an external constant-temperature circulation device, ensuring the cavity temperature remains stable within the set range. Temperature sensing units are distributed around the storage bottle, at the sample inlet, and on the pump head surface, achieving uniform temperature distribution within the cavity through multi-point detection. The humidity control system adjusts the partial pressure of water vapor in the air entering the cavity. Before entering, the air passes through a humidity control chamber where trace amounts of water vapor are introduced into the gas via ultrasonic atomization to maintain a stable relative humidity within a fixed range. The regulated air circulates slowly within the cavity, ensuring uniform humidity distribution. To prevent uneven temperature and humidity in localized areas, a temperature and humidity mixing channel is installed at the bottom of the storage bottle and around the pump head inlet. Gas flows into and converges from two directions within this channel to balance local humidity differences. By coordinating the regulation of temperature and humidity, the internal environment of the chamber is kept stable over a long period of time, so that the temperature change of the mobile phase liquid is kept within an extremely low range and the humidity change rate is close to zero throughout the storage, transportation and pumping process, thus preventing the metal ions in the mobile phase from changing their dissolution state due to temperature and humidity fluctuations.

[0023] After the temperature and humidity equilibrium space stabilizes, synchronous environmental control is implemented in the fluid connection area between the storage bottle and the injection line to ensure that the mobile phase liquid maintains thermal and humidity consistency throughout its path from the storage bottle to the pump head. Specifically, an isothermal connection line is installed between the storage bottle outlet and the injection line inlet. This connection line consists of a double-layer structure: an inner layer of PTFE tubing resistant to high-purity solvents, and an outer layer covered with a thin metal layer with high thermal conductivity. The outer metal layer achieves rapid temperature equilibrium with the air in the temperature and humidity equilibrium space through thermal convection, ensuring that the mobile phase maintains the same temperature and humidity conditions as the storage bottle before entering the injection line. A temperature sensing strip is wrapped around the outside of the connection line to detect changes in the tube wall temperature. The flow rate of the fluid in the heat conduction path is adjusted based on the feedback signal to ensure a constant tube wall temperature. The injection line inlet uses a sealed conical interface structure, with the outer wall of the interface maintaining the same temperature as the gas inside the cavity, thus preventing the formation of air bubbles due to localized temperature differences when the liquid enters the injection line. The pump head inlet is covered with a flexible, heat-conducting shield to ensure that the temperature of the mobile phase liquid drawn into the pump head is completely consistent with that of the previous stage. This simultaneous temperature and humidity control measure balances the heat and humidity transfer of the mobile phase throughout the entire transport path, preventing local solubility differences caused by temperature or humidity gradients and thus suppressing changes in metal ion concentration.

[0024] After establishing a temperature and humidity equilibrium environment, the entire enclosed space is maintained in a long-term steady-state state to ensure the consistency of environmental parameters during continuous monitoring. Steady-state maintenance is achieved through airflow rate regulation and heat exchange rate control. Airflow enters through a buffer zone at the top of the cavity, which contains an adjustable airflow distribution plate. The airflow direction and flow rate are changed to redistribute the airflow within the cavity. The heat exchange rate is controlled by the fluid flow rate of the external circulation device. The external fluid flows through the temperature conduction pipe along the inner wall of the cavity, keeping the temperature difference between different locations within the cavity within a minimal range. Humidity maintenance is achieved by real-time monitoring of the dew point temperature of the cavity air and adjusting the water vapor input rate, ensuring that the water vapor content in the cavity air fluctuates within a stable range. The temperature and humidity of the vapor phase space above the liquid storage bottle are kept consistent with the temperature and humidity of the air in the middle of the cavity to prevent periodic changes in the liquid surface evaporation rate. The airflow velocity around the pump head is slightly higher than the average airflow velocity within the cavity to ensure uniform heat dissipation during pump operation, thereby maintaining a constant pump head surface temperature. A return channel is provided at the bottom of the cavity to guide air back to the temperature and humidity regulating device, achieving continuous circulation. The entire steady-state maintenance process ensures that the storage bottle, injection line, and pump head are always under the same temperature and humidity conditions. This maintains a balance between the dissolution rate, diffusion rate, and migration rate of metal ions in the mobile phase, preventing a rapid increase in concentration. By maintaining this constant microenvironment, the accumulation of metal ions in the detection pathway to a critical concentration, which would then temporarily complex with the stationary phase of the chromatographic column, is prevented. This fundamentally eliminates the overall retention time shift of the chromatographic peak, ensuring a stable retention time distribution during detection and guaranteeing consistent and reliable results for Tianyuan Zhitong granules in continuous quality evaluation.

[0025] Step 2: Set up a charge neutralization device in the mobile phase input path within the constant temperature and humidity control area. Release the energy accumulated by static electricity through a high-impedance grounding guide path to maintain the potential balance between the liquid storage bottle and the sample injection path, and suppress the transient increase in metal ion concentration caused by potential change. The specific implementation method for this step is as follows: A charge guiding layer is installed outside the mobile phase input path within the constant temperature and humidity control area. This guiding layer is made of a composite conductive material with high dielectric strength and stable surface resistance, continuously covering the outer wall of the mobile phase input path and penetrating the outlet of the storage bottle, the sample inlet tube connection, and the pump head inlet. The thickness of the guiding layer is controlled within a certain range to maintain structural flexibility while possessing sufficient charge conduction capacity. The outer surface of the guiding layer is spaced from the sealed shell within the constant temperature and humidity control area, with the gap filled with dry insulating gas to prevent charge accumulation on the outer shell. A conductive connecting ring is provided at the mouth of the storage bottle, forming a stable electrical contact with the guiding layer. The mechanical fixation and electrical connection are integrated through a threaded crimping structure. The inner surface of the conductive connecting ring maintains an inductive coupling state with the gas phase space above the liquid surface inside the storage bottle, allowing the weak static electricity generated by the gas inside the storage bottle due to liquid surface disturbance to be evenly distributed on the surface of the guiding layer, thereby achieving initial discharge of charge inside the storage bottle. During this process, the outer surface of the liquid storage bottle and the sample injection passage forms the prototype of the charge conduction path, providing a continuous electrical connection basis for the subsequent high-impedance grounding guide path.

[0026] After forming the charge guiding layer, a high-impedance grounding guiding path is set along its extension path to achieve stable release of electrostatic energy. The high-impedance grounding guiding path is made of a high-polymer conductive composite material, filled with trace amounts of conductive particles to control the resistance range. This allows for both charge conduction and limitation of instantaneous current flow rate, preventing sudden energy release. The two ends of the guiding path are connected to the end of the guiding layer and an external grounding terminal, respectively. The grounding terminal is in contact with the ground potential layer outside the constant temperature and humidity control area via a flexible connecting strip. The ground potential layer, made of pure copper plate, is buried beneath the insulation layer at the bottom of the detection equipment to provide a stable ground potential reference surface. To ensure the continuity of charge transmission in the high-impedance guiding path, multiple potential balancing nodes are set inside the guiding path. Each node is connected by a thin wire to form a multi-stage slow-release structure. The charge is transferred step-by-step along the path direction and finally released to the ground potential layer, thus achieving the gradual dissipation of electrostatic energy. During this process, the outer wall of the mobile phase input path in the constant temperature and humidity control area is always in a controlled potential state, and the potential difference between the liquid storage bottle and the sample injection path gradually decreases, avoiding the situation where the local electric field intensity suddenly increases due to charge discharge.

[0027] After establishing a high-impedance grounding guide path, a stable potential equilibrium environment is formed within the constant temperature and humidity control zone to achieve potential balance between the storage bottle and the sample injection path. To this end, multiple pressure-equalizing contact points are arranged on the outer wall of the storage bottle, the sample injection line connection section, and the surface of the pump head inlet shell. Each pressure-equalizing contact point forms an equipotential surface with the charge-conducting layer, thus creating a continuous potential conduction network among the three. The pressure-equalizing contact points are made of solvent-resistant conductive fibers, ensuring stable electrical contact while maintaining mechanical flexibility. The potential between the top of the storage bottle and the bottom of the sample injection line is adjusted in real time through this network, making the potential of the gas phase space above the liquid surface in the storage bottle and the gas inside the sample injection path tend to be consistent. This potential balance structure eliminates the micro-discharge phenomenon caused by the gas-liquid interface potential difference during pumping, fundamentally preventing the short-term increase in the concentration of metal ions in the mobile phase caused by sudden potential changes. Under potential equilibrium, metal ions in the mobile phase are in stable dissolution equilibrium, and metal ions no longer migrate and concentrate due to charge adsorption or interface discharge.

[0028] After establishing a potential equilibrium environment, the charge neutralization structure within the constant temperature and humidity control area is continuously maintained in a steady state to ensure the continuous release of electrostatically accumulated energy during continuous detection. This steady-state maintenance is achieved through an automatic charge diffusion mechanism. This mechanism relies on the interaction between the micro-airflow within the constant temperature and humidity control area and the potential gradient on the surface of the charge guiding layer, causing a small amount of residual charge to slowly move along the surface of the guiding layer and eventually enter the high-impedance grounding path. To prevent the re-accumulation of charge on the guiding layer surface, a polymer antistatic coating is applied. This coating contains charge neutralizing groups in its molecular chain structure, enabling a balance between charge capture and release under the influence of a local electric field. Through this structure, the entire constant temperature and humidity control area forms an adaptive charge dissipation environment, ensuring that the potential of the storage bottle, sample inlet tubing, and pump head remains in equilibrium during the detection process. The mobile phase is unaffected by potential fluctuations during pumping, transfer, and injection, ensuring a stable distribution of metal ions in the solution and preventing short-term concentration increases due to potential abrupt changes. This effectively prevents temporary complexation reactions between the stationary phase and metal ions, avoiding overall peak retention time shifts. Through continuous charge neutralization and potential equilibrium, the entire detection system maintains a state of zero electrostatic accumulation in a constant temperature and humidity environment, providing stable mobile phase conditions for continuous quality evaluation of Tianyuan Zhitong granules, ensuring accurate and consistent component identification and long-term reproducibility of results during detection.

[0029] Step 3: Under the condition of potential equilibrium, a dynamic ion capture device is set at the inlet of the mobile phase. A high specific surface area inert adsorption matrix is ​​used to adsorb transient free ions, and the ion adsorption behavior is stabilized by relying on the aforementioned potential equilibrium environment, thereby reducing the fluctuation of the concentration of metal ions in the mobile phase. The specific implementation method for this step is as follows: In a constant temperature, humidity, and potential equilibrium environment, a high specific surface area inert adsorption matrix structure for ion adsorption is established at the mobile phase inlet. This structure uses an inert inorganic material with a three-dimensional porous framework as its core. The surface is plasma-treated to remove active functional groups, resulting in a low-polarity, low-reactivity matrix that ensures it will not participate in chemical reactions or leach impurities during long-term contact with the mobile phase solution. The pore size distribution density of the matrix is ​​controlled within the micrometer to nanometer range to create a large specific surface area, increasing the physical adsorption capacity for metal ions. The adsorption matrix is ​​encapsulated in a shell with fluid distribution channels. This shell is tightly connected to the mobile phase inlet via a conical sealing structure, ensuring that the mobile phase liquid completely passes through the adsorption matrix region before entering the detection pipeline. The inner wall of the shell has a microporous flow-guiding structure to create a uniform flow field of the mobile phase on the adsorption matrix surface, preventing uneven ion capture caused by excessively high local flow velocities. With this structural design, the mobile phase first passes through a high specific surface area inert adsorption matrix for filtration and ion capture before entering the detection system, thereby forming a preliminary ion stabilization layer, providing a basic environment for subsequent dynamic capture and equilibrium reaction.

[0030] After establishing a high specific surface area inert adsorption matrix, its adsorption behavior is dynamically adjusted to maintain the adsorption and desorption equilibrium of transient free ions. Specifically, a temperature-conducting layer is placed outside the adsorption matrix. This layer maintains a constant temperature in the adsorption region through a constant-temperature liquid circulation system, keeping the molecular motion rate on the matrix surface stable and thus achieving equilibrium between physical adsorption forces and diffusion rates. As the mobile phase liquid passes through the adsorption region, metal ions are adsorbed on the matrix surface through reversible van der Waals forces and charge-induced forces. When the ion concentration in the mobile phase increases, adsorption sites rapidly occupy metal ions; when the concentration decreases, ions are released through a dynamic equilibrium process, maintaining the metal ion concentration in the solution within a constant range. To prevent passivation of adsorption sites during long-term use, a low-speed micro-circulation fluid channel is set around the adsorption matrix. The fluid contains a solvent with the same composition as the mobile phase. This channel is connected in parallel with the main flow path. Once the main flow ion concentration stabilizes, a portion of the solution slowly circulates around the adsorption region, achieving self-cleaning and regeneration of local adsorption sites and ensuring long-term stable adsorption performance. Through this dynamic adjustment method, the adsorption matrix can continuously maintain its transient response to metal ions and achieve balanced adsorption of ions in the mobile phase under the condition of potential equilibrium.

[0031] After dynamic adsorption equilibrium is established, a fluid guiding layer is incorporated into the adsorption device structure to further improve adsorption uniformity and reduce local concentration gradients. This guiding layer consists of porous flow dividers installed at both ends of the adsorption substrate. The pore size of the upper guiding plate is slightly larger than that of the lower guiding plate. After flowing through the upper guiding plate, the liquid disperses into the pores of the adsorption substrate, undergoes sufficient adsorption, and then collects through the lower guiding plate. The guiding plate is made of the same inert material as the adsorption substrate to maintain potential continuity and thermal conductivity consistency, thereby avoiding local potential fluctuations caused by material differences. The guiding plate and the substrate are joined using a flexible press-fit method, maintaining structural stability in a constant temperature and humidity environment. When the fluid flows in this path, a multi-point potential coupling state is formed between the adsorption substrate and the fluid interface. The migration rate of metal ions tends to be constant due to potential equilibrium, thus preventing local supersaturation or over-adsorption during the adsorption process. This structure achieves spatial homogenization of metal ions in the mobile phase, maintaining stable overall conductivity of the mobile phase and providing homogeneous sample introduction conditions for the detection system.

[0032] After the adsorption behavior stabilizes, continuous steady-state control is implemented in the adsorption region to maintain long-term ion concentration stability, ensuring the dynamic ion capture process remains consistent across multiple detection cycles. Steady-state control is achieved by adjusting the residence time and flow rate distribution of the mobile phase within the adsorption device. By adjusting the inlet pressure and outlet back pressure of the mobile phase, the flow rate of the liquid within the adsorption region is maintained within a controllable range, ensuring that each unit volume of mobile phase receives sufficient contact time with the substrate surface. Simultaneously, the temperature and humidity conditions within the constant temperature and humidity control zone continue to affect the adsorption region, preventing external environmental changes from impacting adsorption performance. A heat-conducting ring is installed around the adsorption region to evenly distribute the heat from the constant-temperature liquid circulation layer throughout the entire adsorption device, keeping the temperature gradient close to zero. A potential balance network is connected to the outer surface of the adsorption substrate, continuously releasing surface micro-charges to ensure a stable surface potential and prevent charge accumulation from interfering with adsorption capacity. Under steady-state operating conditions, the adsorption and release of metal ions by the adsorption substrate reach a dynamic equilibrium, maintaining a constant metal ion concentration in the mobile phase with significantly reduced concentration fluctuations. The entire process achieves dynamic capture and concentration control of transient free ions at the mobile phase inlet under potential equilibrium conditions, enabling the mobile phase to reach a chemically stable state before entering the chromatographic system. This fundamentally reduces the problem of chromatographic peak drift caused by fluctuations in metal ion concentration, ensuring the stability and repeatability of Tianyuan Zhitong granules in continuous quality evaluation.

[0033] Step 4: Under stable ion concentration conditions, micro-flow rate pulsation control is implemented on the mobile phase delivery process. Periodic micro-amplitude flow rate adjustment is applied to the output liquid flow of the mobile phase to maintain the time equilibrium of the adsorption kinetics of the chromatographic stationary phase and reduce the transient complexation reaction caused by local ion accumulation. The specific implementation method for this step is as follows: Under stable ion concentration mobile phase conditions, a liquid delivery structure with micro-amplitude flow rate regulation was established. This structure consists of a high-precision drive unit and a controllable elastic reservoir. The elastic reservoir is located at the front end of the mobile phase delivery pipeline and connected to the mobile phase pump outlet via a pressure-resistant flexible connecting pipe. The elastic reservoir is externally covered with a temperature-controlled layer made of a thin metal film with high thermal conductivity. This layer maintains a constant temperature through constant-temperature liquid circulation, preventing volume expansion or contraction of the liquid due to temperature differences, thus ensuring that flow rate changes originate solely from mechanical regulation. The drive unit precisely regulates the internal pressure of the elastic reservoir with high resolution, enabling minute volume changes of the mobile phase liquid within the chamber over a constant period. The reservoir outlet is connected to the main delivery pipeline. Fluid passing through this area experiences periodic micro-pressure differences, creating micro-amplitude pulsating flow rate fluctuations. This structure, while maintaining a constant overall average flow rate, allows for controllable changes in the mobile phase flow rate on a microsecond to second timescale, providing a fundamental condition for maintaining the time equilibrium of the chromatographic stationary phase adsorption kinetics.

[0034] After establishing a micro-amplitude controllable flow structure, a dynamic pressure homogenization mechanism within the mobile phase pathway ensures that the flow velocity pulsation is evenly distributed throughout the entire detection pipeline. To achieve this, multiple pressure buffer units are installed in the middle section of the mobile phase delivery path. Each pressure buffer unit consists of a fine spiral liquid channel. As the liquid passes through this spiral channel, a pressure drop occurs along the path, gradually diffusing the flow velocity fluctuations from the preceding section as they propagate along the line. The radius of curvature of the spiral channel is precisely calculated to ensure that the liquid remains in a laminar state during flow, preventing bubble formation caused by turbulence. Multiple pressure buffer units are arranged in series, causing the pressure waves of the pulsating flow to exhibit continuous attenuation and overlap effects in the transmission path, thus forming a uniform and coordinated micro-amplitude pulsation characteristic in the entire mobile phase output flow. Through this distributed pressure homogenization method, the pulsation waveform of the mobile phase reaches the column inlet with stable, consistent period, and constant amplitude, providing periodic stimulation for the adsorption kinetics of the chromatographic stationary phase surface and promoting a dynamic equilibrium between the active sites of the stationary phase and the ions in the mobile phase.

[0035] Based on the stabilization of the flow rate pulsation waveform, the adsorption kinetics of the chromatographic stationary phase are balanced over time. Specifically, under the influence of periodic flow rate fluctuations, the shear rate of the liquid flowing over the surface of the stationary phase particles undergoes slight changes, thereby causing periodic adjustments to the contact time between the stationary and mobile phases. When the flow rate increases, the thickness of the boundary layer formed on the stationary phase surface decreases, and the diffusion rate of solute molecules in this layer increases; when the flow rate decreases, the boundary layer thickness increases, and the diffusion rate decreases. Through this micro-periodic alternation, the adsorption and desorption processes of the chromatographic stationary phase tend to reach equilibrium on a time scale, avoiding temporary enrichment of metal ions on the stationary phase surface in a certain area due to continuous constant flow. Under constant temperature, humidity, and potential equilibrium, the migration behavior and adsorption kinetics of metal ions in the mobile phase are coordinated, ensuring that the dynamic distribution of metal ions remains consistent, thereby effectively suppressing the occurrence of transient complexation reactions and ensuring the long-term stability of the chemical environment within the chromatographic column.

[0036] After the adsorption kinetics of the chromatographic stationary phase are established over time, the entire microflow rate pulsation control process is maintained in a steady state to ensure the repeatability and consistency of the pulsating flow throughout the continuous detection cycle. Steady-state maintenance is achieved by synchronously adjusting the mobile phase pumping frequency and the elastic recovery rate of the reservoir. The liquid pumping frequency is provided constantly by an external drive control mechanism, and the elastic recovery rate of the reservoir is kept periodically constant by the rebound characteristics of the internal elastomer, thus ensuring the consistency of the flow rate pulsation time period. During this process, the temperature and pressure conditions of the mobile phase delivery channel are kept consistent with the isothermal and humidity control zone to prevent pulsation characteristic drift caused by changes in external conditions. After the fluid passes through the entire delivery path, a balanced output is achieved, the amplitude of the flow rate pulsation fluctuation remains stable, and the periodic changes are continuous and smooth. At this point, the flow trajectory of the mobile phase within the chromatographic stationary phase is stable and uniform, local pressure differences are effectively alleviated, and metal ions maintain a dynamic exchange state between the stationary phase surface and the mobile phase bulk, avoiding the formation of transient complexation reactions. The entire microflow rate pulsation control process achieves dynamic equilibrium at the time level while maintaining a constant system flow rate, ensuring that the chromatographic column maintains stable adsorption kinetics during long-term operation and guaranteeing the consistency of chromatographic peak retention time. This fundamentally reduces the peak position drift problem caused by local ion accumulation, providing highly stable operating conditions and a precise quantitative basis for the continuous quality evaluation of Tianyuan Zhitong granules.

[0037] Step 5: After the mobile phase delivery is stable, a peak position dynamic tracking compensation mechanism is established. Based on the retention time distribution of the previous detection cycle, an offset reference interval is generated, and the retention time of the current detection cycle is synchronously fine-tuned to maintain the real-time stability of the chromatographic peak position and the consistency of component identification in continuous detection. The specific implementation method for this step is as follows: After the mobile phase is stably delivered, retention time distribution analysis is performed on the chromatograms formed in the previous detection cycle to determine the peak position reference for the current cycle. During the operation, the chromatographic detector continuously records the signals of each component of the mobile phase passing through the column throughout the detection time, obtaining a complete chromatographic curve. This curve is acquired in a constant temperature and humidity environment, resulting in low signal noise and clear peak shapes. The retention time data is processed by the detection system's internal time series analysis to obtain a time distribution sequence of multiple peak positions. At this point, the system determines the retention time interval of each peak as reference data based on the peak shape distribution range, peak area, and signal intensity. To eliminate the random influence of environmental disturbances on a single measurement, the system automatically verifies the stability of the column outlet temperature, mobile phase pressure, and ambient humidity after the previous detection cycle, ensuring that the establishment of subsequent reference intervals is based on the same steady-state conditions. The result of this step is the acquisition of a complete retention time reference distribution map, providing fundamental data for the generation of subsequent offset reference intervals.

[0038] After establishing the retention time baseline distribution map, an offset reference interval is generated based on the time interval and peak shape characteristics of each chromatographic peak. This interval is set considering factors such as the stability of the mobile phase delivery path, slight differences in column temperature, and microflow rate pulsation waveform changes. By summarizing the relative trends in the retention times of each peak in the previous detection cycle, interval data including time range and offset tolerance is formed. The offset reference interval is set according to the relative proportional relationship between peak positions, so that when the retention time of one peak changes slightly, other related peaks can be synchronously corrected according to the trend. To make the offset interval more closely reflect actual operating conditions, the combined influence of ion migration rate under potential equilibrium and the stability of temperature and humidity environment on mobile phase viscosity is considered when setting the interval, giving the offset interval environmental adaptability. In this way, the offset reference interval not only reflects the dynamic characteristics of the detection system but also records the microscopic state of chromatographic operation in the previous cycle. At this point, the offset reference interval serves as the core basis of the dynamic compensation mechanism, providing a time-domain reference framework for synchronous fine-tuning of peak positions in the current detection cycle.

[0039] After establishing the offset reference interval, the chromatographic retention time of the current detection cycle is fine-tuned in real time. Specifically, as the mobile phase passes through the column, the system compares the peak position signal detected in the current cycle with the offset reference interval established in the previous cycle. When the detector output signal shows an upward trend in peak shape, it is matched with the time point of the corresponding peak in the reference interval. If the current signal time point deviates from the center value of the reference interval, time synchronization is achieved by adjusting the micro-pulsation period of the mobile phase delivery rate, gradually bringing the detection time of the current peak closer to the center of the reference interval. Under constant temperature, humidity, and potential equilibrium conditions, this fine-tuning does not affect the overall flow rate of the mobile phase; instead, peak position time correction is achieved through extremely small periodic flow rate compensation. Simultaneously, the adsorption kinetics of the stationary phase in the column remain stable under micro-flow rate pulsation control, avoiding peak distortion or signal broadening. Through this synchronous fine-tuning process, the retention times of all peaks gradually align with the center point of the offset reference interval, forming a dynamic, real-time peak position stability state.

[0040] After peak position synchronization fine-tuning is completed, the peak position dynamic tracking compensation mechanism for the entire detection process is maintained in a steady state. This maintenance process runs automatically in continuous detection cycles to ensure that the retention time before the start of each detection cycle is accurately continued from the previous cycle. To this end, after each detection cycle, the system automatically compares the peak position time data of the current cycle with the reference interval and updates the offset reference interval boundary for the next detection cycle, making the peak position compensation process an adaptive dynamic cycle. To ensure that this mechanism maintains high precision and stability in long-term operation, the temperature control, mobile phase potential balance, and microflow rate pulsation state of the entire chromatographic pathway remain consistent. The charge neutralization device maintains the potential balance of the injection path to prevent time shifts caused by electrostatic interference; the constant temperature and humidity control area maintains the stability of the gas-liquid interface to prevent fluid density fluctuations; and the microflow rate pulsation device maintains a constant mobile phase output rhythm, providing a time reference for peak position synchronization. Under this multi-condition stability support, the peak position dynamic tracking compensation mechanism realizes real-time correction and synchronous adjustment of retention time, ensuring that the relative relationship between chromatographic peak positions remains stable in continuous detection. Through this mechanism, the chromatographic peaks of the main components in the continuous quality evaluation process of Tianyuan Zhitong granules remain highly consistent, the peak position drift is controlled within an extremely low range, and the detection results still have high repeatability and comparability in long-term operation, providing precise technical assurance for the quality consistency between batches of the preparation.

[0041] This invention establishes a constant temperature and humidity control zone and incorporates charge neutralization and dynamic ion capture devices during continuous quality detection, ensuring the mobile phase system maintains stable temperature, humidity, potential, and ion concentration during long-term operation. This structure effectively prevents transient concentration surges of metal ions caused by environmental disturbances or electrostatic accumulation, suppressing transient complexation reactions between the stationary phase and metal ions at the source. This achieves continuous stability of the mobile phase composition in the detection pathway, ensuring consistent peak retention times, resolving qualitative deviations caused by batch-to-batch drift, and improving the stability and reliability of the quality evaluation results for Tianyuan Zhitong granules.

[0042] This invention introduces microflow rate pulsation control and a dynamic peak position tracking compensation mechanism during mobile phase transport, enabling the chromatographic system to maintain a dynamic balance between adsorption kinetics and retention time during long-term operation. This mechanism can correct peak position shifts in real time during the detection cycle, ensuring the synchronous stability of peak positions of each component during continuous detection, thereby maintaining the temporal consistency of characteristic spectra. This improves the accuracy and reproducibility of component identification, ensures the comparability and consistency of quality evaluation data in continuous monitoring, and provides reliable technical support for the industrial-scale quality control of Tianyuan Zhitong granules.

[0043] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms, characterized in that, Includes the following steps: Step 1: Before conducting continuous quality evaluation of Tianyuan Zhitong granules, a constant temperature and humidity control area is constructed around the mobile phase system. The storage bottle, sample injection pipeline and pump head are completely enclosed in a temperature and humidity balance space. The detection environment is kept stable by dynamically adjusting the temperature difference and humidity difference. Step 2: Set up a charge neutralization device in the mobile phase input path within the constant temperature and humidity control area. Release the accumulated electrostatic energy through a high-impedance grounding guide path to maintain the potential balance between the storage bottle and the sample injection path. Step 3: Under the condition of potential equilibrium, a dynamic ion capture device is set at the inlet of the mobile phase. A high specific surface area inert adsorption matrix is ​​used to adsorb transient free ions, and the ion adsorption behavior is stabilized by relying on the aforementioned potential equilibrium environment. Step 4: Under stable ion concentration conditions, micro-flow rate pulsation control is implemented on the mobile phase delivery process. Periodic micro-amplitude flow rate adjustment is applied to the output liquid flow of the mobile phase to maintain the time equilibrium of the adsorption kinetics of the chromatographic stationary phase. Step 5: After the mobile phase transport is stabilized, a peak position dynamic tracking and compensation mechanism is established. An offset reference interval is generated based on the retention time distribution of the previous detection cycle, and the retention time of the current detection cycle is synchronously fine-tuned.

2. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 1, characterized in that, Before conducting continuous quality testing and evaluation of Tianyuan Zhitong granules, the steps for constructing a constant temperature and humidity control region around the mobile phase system include: Before continuous testing, the storage bottle, sample inlet line and pump head are sealed in a closed temperature and humidity balanced space. The space is made of double-layer corrosion-resistant insulating material and has an annular airflow channel inside. The temperature and humidity regulated air is delivered by an external air circulation device to form a continuous thin airflow on the surface of the storage bottle, sample inlet line and pump head. After the enclosed space is established, the temperature and humidity inside the space are dynamically balanced and regulated by an external constant temperature circulation device and a humidity control chamber to ensure uniform gas distribution. Under stable temperature and humidity equilibrium conditions, an isothermal connection pipeline is installed between the outlet of the storage bottle and the inlet of the sample tube. The pipeline includes a polytetrafluoroethylene inner layer and a high thermal conductivity metal outer layer. The temperature of the outer layer and the air is kept in equilibrium through thermal convection. Under the condition of establishing a temperature and humidity equilibrium environment, the steady state of the closed space is maintained by adjusting the air flow rate and controlling the heat exchange rate, so that the liquid storage bottle, sample inlet pipeline and pump head are kept under the same temperature and humidity conditions.

3. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 2, characterized in that, The steps for setting up a charge neutralization device in the mobile phase input path within a constant temperature and humidity control area include: A charge guiding layer is set outside the mobile phase input path in the constant temperature and humidity control area. The charge guiding layer is made of a composite conductive material with high dielectric strength and stable surface resistance. It continuously covers the outer wall of the mobile phase input path and penetrates the outlet of the storage bottle, the sample inlet tube connection and the pump head inlet. A high-impedance grounding guide path is set on the extension path of the charge guiding layer. The guide path is made of a polymer conductive composite material, containing conductive particles to control the resistance range. Its two ends are connected to the end of the guiding layer and the external ground potential layer, respectively. Multiple pressure equalization contact points are arranged in the constant temperature and humidity control area. An equipotential surface is formed between the pressure equalization contact points and the charge guiding layer, and a continuous potential conduction network is constructed between the liquid storage bottle, the sample injection line and the pump head. Under the condition of potential equilibrium, charge diffusion is achieved through the antistatic coating on the surface of the guiding layer. The retained charge moves along the surface of the guiding layer into the high-impedance guiding path, maintaining the state of zero electrostatic accumulation in the constant temperature and humidity environment and stabilizing the concentration of metal ions in the mobile phase.

4. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 3, characterized in that, The steps for setting up a dynamic ion trapping device at the inlet of the mobile phase under conditions of potential equilibrium include: In a constant temperature, humidity and potential equilibrium environment, a high specific surface area inert adsorption matrix structure for ion adsorption is established at the inlet of the mobile phase. The adsorption matrix is ​​made of inert inorganic material with a three-dimensional porous framework. The surface is treated with plasma to remove active functional groups and encapsulated in a shell with fluid distribution channels. A temperature conduction layer is set outside the high specific surface area inert adsorption matrix, and the temperature of the adsorption area is kept constant by constant temperature liquid circulation. A low-speed micro-circulation fluid channel is set around the adsorption matrix. A fluid guiding layer composed of porous flow dividers is set in the adsorption device. The flow dividers are installed at the upper and lower ends of the adsorption substrate and are combined with the adsorption substrate by a flexible pressing method. Under stable adsorption conditions, the flow rate distribution is controlled by adjusting the inlet pressure and outlet back pressure of the mobile phase, and the steady state of the adsorption region is maintained in conjunction with a constant temperature and humidity environment, so that the adsorption and release of metal ions by the adsorption matrix reaches a dynamic equilibrium.

5. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 4, characterized in that, The pore distribution density of the three-dimensional porous framework of the high specific surface area inert adsorption matrix is ​​controlled in the range of micrometers to nanometers. A heat-conducting ring is provided on the outside of the temperature conduction layer to uniformly distribute the heat of the constant temperature liquid circulation layer. The upper flow divider of the fluid guide layer has a larger pore diameter than the lower flow divider. The adsorption matrix is ​​connected to the potential balance network.

6. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 4, characterized in that, The steps for implementing microflow rate pulsation control in the mobile phase transport process under stable ion concentration conditions include: A liquid delivery structure capable of micro-amplitude flow rate adjustment is established under stable ion concentration conditions. The liquid delivery structure consists of a high-precision drive device and a controllable elastic liquid storage chamber. The elastic liquid storage chamber is covered with a temperature control layer and the temperature is kept constant through constant temperature liquid circulation. Under the condition of establishing a micro-flow velocity controllable structure, a multi-stage pressure buffer unit is set in the mobile phase passage. The pressure buffer unit is composed of a fine spiral liquid channel to diffuse flow velocity fluctuations and form uniform and coordinated micro-pulsation characteristics. Under stable flow rate pulsation waveform conditions, the shear rate of the stationary phase surface is adjusted by periodic flow rate fluctuations and the boundary layer thickness is controlled to maintain the time equilibrium of the adsorption and desorption processes and suppress transient complexation reactions. Under the condition of establishing adsorption kinetic equilibrium, the pulsation stability is maintained by synchronously adjusting the pumping frequency of the mobile phase and the elastic recovery rate of the storage chamber, and the flow rate period is kept consistent under constant temperature and humidity conditions.

7. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 6, characterized in that, During the micro-flow rate pulsation control process, the temperature control layer covering the outside of the elastic liquid storage chamber is made of a metal thin film with high thermal conductivity. When the outlet of the liquid storage chamber is connected to the main delivery pipeline, the fluid forms a micro-amplitude flow rate fluctuation when passing through the liquid storage chamber and acts on the output liquid flow of the mobile phase.

8. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 7, characterized in that, During the micro-flow rate pulsation control process, the temperature control layer covering the outside of the elastic liquid storage chamber is made of a metal thin film with high thermal conductivity. When the outlet of the liquid storage chamber is connected to the main delivery pipeline, the fluid forms a micro-amplitude flow rate fluctuation when passing through the liquid storage chamber and acts on the output liquid flow of the mobile phase.

9. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 7, characterized in that, The steps for establishing a dynamic peak position tracking and compensation mechanism after the mobile phase transport has stabilized include: After the mobile phase is stably delivered, the retention time distribution of the chromatogram from the previous detection cycle is analyzed to determine the peak position reference for the current cycle, and reference data is determined based on the peak shape distribution range, peak area and signal intensity. After the retention time baseline distribution map is established, an offset reference interval is generated based on the time interval and peak shape characteristics of each chromatographic peak. The interval is summarized based on the relative change trend of the retention time of each peak in the previous period, and the stability of the mobile phase delivery path, column temperature difference and microflow rate pulsation waveform change are taken into account. After the offset reference interval is established, the chromatographic retention time of the current detection cycle is adjusted in real time. The synchronous fine adjustment is achieved by adjusting the small-amplitude pulsation period of the mobile phase delivery rate to correct the peak position time. After the peak position synchronization fine-tuning is completed, the peak position dynamic tracking compensation mechanism is continuously maintained to automatically compare the peak position time data of the current period with the reference interval and update the offset reference interval boundary of the next detection period.

10. The method for quality evaluation of Tianyuan Zhitong granules combining thin-layer chromatography identification and characteristic chromatograms according to claim 9, characterized in that, When the peak position dynamic tracking compensation mechanism is running in a continuous detection cycle, the offset reference interval is updated based on the retention time distribution of the previous detection cycle. Under the premise that the constant temperature and humidity control area, potential equilibrium conditions and microflow rate pulsation control state remain unchanged, the chromatographic peak retention time of the current detection cycle is synchronously fine-tuned.

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