Bacterial liquid preparation system and bacterial liquid preparation method

Abstract

The invention discloses a bacterial liquid preparation system and a bacterial liquid preparation method, and relates to the technical field of bacterial liquid preparation, the bacterial liquid preparation system comprises a treatment chamber, a control module, and a robot operation module, a preparation module and a temperature control module which are arranged in the treatment chamber, the treatment chamber can provide an oxygen-free environment, the temperature control module can adjust the temperature in the treatment chamber, and the robot operation module can operate the preparation module under the control of the control module and enables the preparation module to prepare bacterial liquid. According to the invention, full-process automation and standardized bacterial liquid preparation can be realized, required conditions can be provided for bacterial liquid preparation, and clinical and industrial high-standard requirements are met.

Description

Technical Field

[0001] The present invention relates to the technical field of bacterial liquid preparation, and in particular to a bacterial liquid preparation system and a bacterial liquid preparation method. Background Art

[0002] Fecal microbiota transplantation (FMT), a novel microecological therapy for restoring the intestinal flora, has been widely used worldwide. It has achieved remarkable results in treating recurrent or refractory Clostridium difficile infection (CDI) and is recommended by clinical guidelines in multiple countries.

[0003] Despite the continuous maturity of the FMT treatment system, its clinical application still faces key technical bottlenecks, especially in the preparation of bacterial solution. Currently, most medical institutions at home and abroad still mainly use manual methods to prepare bacterial solution, that is, manually processing fecal samples, manually adding protective solution, mixing and packaging for storage. However, this traditional method has many problems:

[0004] (1) Severe loss of bacterial activity: During the artificial preparation process, the samples were exposed to room temperature and air for a long time, resulting in the death of a large number of strict anaerobic bacteria in the feces due to exposure to oxygen and inappropriate temperature, and the overall activity and structure of the bacterial community were damaged.

[0005] (2) Unable to avoid light: The preparation environment is usually brightly lit, and some bacterial flora or their metabolites are easily destroyed by ultraviolet rays or strong light, which reduces the quality of the bacterial solution.

[0006] (3) The operation process cannot be completely anaerobic: manual preparation lacks a closed anaerobic operation space, and fecal samples are easily affected by oxygen in the air, which changes the original bacterial flora composition;

[0007] (4) Unstable temperature control: The ability to manually control temperature is limited. Temperature fluctuations may occur during the operation of the sample, which may promote the proliferation of harmful bacteria or the death of beneficial bacteria, and it is impossible to maintain the optimal temperature control conditions required for preparation.

[0008] (5) Poor repeatability and low standardization: Manual operation is highly dependent on the operator's experience, and the consistency of bacterial liquid concentration, composition and activity between different batches is poor, which affects the stability of the preparation quality;

[0009] (6) High contamination risk: The open preparation process is susceptible to contamination by external bacteria during sampling, mixing, and packaging. There is also the risk of operator-induced contamination, which affects the safety of the bacterial solution.

[0010] (7) Difficulty in meeting industrialization and regulatory requirements: With the expansion of the scale of FMT clinical application and the advancement of preparation industrialization, the existing manual preparation model is difficult to meet the high standards of quality control and traceability requirements.

[0011] In this context, there is an urgent need to establish an efficient, standardized, automated and traceable bacterial liquid preparation technology system to improve the clinical efficacy, safety and consistency of FMT and promote its industrialization and large-scale development. Summary of the Invention

[0012] The purpose of the present invention is to provide a bacterial liquid preparation system and a bacterial liquid preparation method to solve the problems existing in the above-mentioned prior art, realize full-process automation and standardized bacterial liquid preparation, and provide the necessary conditions for bacterial liquid preparation to meet the high standards of clinical and industrial requirements.

[0013] To achieve the above object, the present invention provides the following solutions:

[0014] The present invention provides a bacterial liquid preparation system, comprising a processing chamber, a control module, and a robot operation module, a preparation module, and a temperature control module disposed within the processing chamber. The processing chamber is a closed chamber made of opaque material and can provide an oxygen-free environment. The temperature control module can adjust the temperature within the processing chamber. The robot operation module can operate the preparation module under the control of the control module, thereby enabling the preparation module to prepare bacterial liquid.

[0015] Preferably, the preparation module includes an automatic liquid adding mechanism, a mixing mechanism, a sterilizing filtration mechanism and a low-temperature freezing mechanism. Sterile protective liquid is placed in the automatic liquid adding mechanism. The automatic liquid adding mechanism is used to add the sterile protective liquid into the sample container containing the sample. The robotic operation module can drive the mixing mechanism to act on the sample container, and stir the sample and sterile protective liquid in the sample container to form a homogeneous bacterial liquid suspension. The robotic operation module can pour the homogeneous bacterial liquid suspension formed in the sample container into the sterilizing filtration mechanism. The sterilizing filtration mechanism can process the homogeneous bacterial liquid suspension and form a clarified bacterial liquid solution. The robotic operation module can subpackage the clarified bacterial liquid solution. The low-temperature freezing mechanism can subpackage the clarified bacterial liquid solution.

[0016] Preferably, the automatic liquid adding mechanism includes a precision peristaltic pump and a liquid storage tank, the liquid storage tank is used to store sterile protective liquid, the precision peristaltic pump is connected between the liquid storage tank and the mixing mechanism, and the precision peristaltic pump is used to pass the sterile protective liquid in the liquid storage tank into the mixing mechanism.

[0017] Preferably, the mixing mechanism is a stirrer, and the stirrer is used to stir the sterile protective liquid and the sample in the sample container.

[0018] Preferably, the sterilization filtration mechanism includes a sterilization tank and a filter screen, wherein the filter screen is arranged in the middle of the sterilization tank and is used to filter solid impurities entering the sterilization tank, and the filter screen can allow the clarified bacterial solution to pass through.

[0019] Preferably, the preparation module further includes a plurality of filling tanks, the robotic operation module is capable of placing the filling tanks at the outlet of the sterilizing filtration mechanism, and filling the clarified bacterial liquid solution through the filling tanks, and the robotic operation module is capable of sealing the filling tanks containing the clarified bacterial liquid solution.

[0020] Preferably, the low-temperature freezing mechanism includes a freezing chamber, and the robot operation module can grab the sealed packaging cans and place the packaging cans into the freezing chamber for freezing.

[0021] Preferably, the robot operation module includes a plurality of robots with robotic arms, and the control module is an intelligent central control platform.

[0022] Preferably, a buffer transfer room is further included, which is arranged outside the processing chamber, and the operator can place the sample container containing the sample in the buffer transfer room. When the buffer transfer room transfers the sample container into the processing chamber, the buffer transfer room can be connected to the processing chamber.

[0023] The present invention further provides a bacterial liquid preparation method, using the bacterial liquid preparation system according to any one of the above technical solutions, comprising the following steps:

[0024] S1. Sample Registration: The donor stool sample information is registered and entered through the control module, assigned a unique batch number, and pre-associated with the label of the filling container to be used. The control module generates the corresponding preparation plan and parameter settings based on the input information;

[0025] S2. Sample Transfer into the Processing Chamber: The operator places the donor fecal sample to be processed into the buffer transfer chamber outside the processing chamber. The operator then closes the buffer transfer chamber, evacuates it, and fills it with inert gas to equalize the pressure. The operator then opens the inner door of the buffer transfer chamber leading to the processing chamber and transfers the sample container into the processing chamber. Upon receiving the sample injection command, the robotic operating module removes the sample container from the buffer transfer chamber and enters the processing chamber.

[0026] S3. Precooling: Precool the sample in the oxygen-free environment of the processing room;

[0027] S4. Adding protective liquid: The robot operation module controls the automatic adding mechanism to add sterile protective liquid to the sample container, so that the sterile protective liquid and the sample are mixed in a set ratio. At the same time, the control module controls the amount of liquid and the rate of addition;

[0028] S5. Mixing: The mixing mechanism, under the control of the robot operation module, mixes the sample with the sterile protective solution to form a bacterial solution mixture;

[0029] S6. Filtration: After mixing is completed, the robot operation module removes the sample container and slowly pours the homogenized bacterial suspension in the sample container into the sterile filtration mechanism for filtration to remove solid impurities in the homogenized bacterial suspension and make the filtered bacterial suspension purer;

[0030] S7. Subpackaging: The clarified bacterial solution is guided to the subpackaging area by the robotic operation module under anaerobic conditions and automatically dispensed into multiple sterile subpackaging cans. The control module simultaneously affixes a label corresponding to the sample registration, indicating the batch number and date, to each subpackaging can to complete the subpackaging process.

[0031] S8. Packaging: After the cans are filled, the robotic operation module moves each can to the packaging area and seals them to form finished bacterial solution cans. The robotic operation module then places the finished bacterial solution cans on a collection tray for freezing.

[0032] S9. Freezing: The robotic operation module grabs the packaged finished bacterial solution cans and transfers them to the low-temperature freezing mechanism in the processing room for quick freezing and preservation of the finished bacterial solution.

[0033] Compared with the prior art, the present invention has achieved the following technical effects:

[0034] The bacterial liquid preparation system and method provided by the present invention include a processing chamber, a control module, and a robotic operation module, a preparation module, and a temperature control module disposed in the processing chamber. The processing chamber is a closed chamber made of opaque material, thereby facilitating the light-proof conditions required for bacterial liquid preparation, preventing the bacterial flora or their metabolites from being damaged by ultraviolet rays or strong light, which would reduce the quality of the bacterial liquid. The processing chamber can provide an anaerobic environment, thereby facilitating the anaerobic conditions required for bacterial liquid preparation, preventing the sample from being affected by oxygen in the air and changing the original bacterial flora composition. The temperature control module can adjust the temperature within the processing chamber, thereby facilitating the low-temperature conditions required for bacterial liquid preparation. At the same time, automatic temperature control is achieved through the temperature control module to avoid unnecessary temperature fluctuations that affect bacterial growth. The robotic operation module can operate the preparation module under the control of the control module and enable the preparation module to prepare bacterial liquid. The automated bacterial liquid preparation achieved by the robotic operation module facilitates consistency in bacterial liquid preparation, saves labor costs, improves bacterial liquid preparation efficiency, reduces the risk of contamination, and achieves fully automated and standardized bacterial liquid preparation to meet the high standards of clinical and industrial needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0036] Figure 1 Schematic diagram of the structure of the bacterial liquid preparation system in Example 1;

[0037] Figure 2 This is a flow chart of the bacterial liquid preparation method in Example 2;

[0038] In the figure: 1-processing room, 2-robotic operation module, 3-automatic liquid adding mechanism, 4-mixing mechanism, 5-sterilization and filtration mechanism, 6-filling tank, 7-low-temperature freezing mechanism, 8-control module, 9-buffer transfer room. DETAILED DESCRIPTION

[0039] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0040] The purpose of the present invention is to provide a bacterial liquid preparation system and a bacterial liquid preparation method to solve the problems existing in the prior art, realize full-process automation and standardized bacterial liquid preparation, and provide the necessary conditions for bacterial liquid preparation to meet the high standards of clinical and industrial requirements.

[0041] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0042] Example 1

[0043] like Figure 1 As shown, this embodiment provides a bacterial liquid preparation system, including a processing chamber 1, a control module 8, and a robotic operation module 2, a preparation module, and a temperature control module disposed in the processing chamber 1. The processing chamber 1 is a closed chamber made of opaque material, thereby facilitating the light-proof conditions required for bacterial liquid preparation, preventing the bacterial flora or their metabolites from being damaged by ultraviolet rays or strong light, which would reduce the quality of the bacterial liquid. The processing chamber 1 can provide an anaerobic environment, thereby facilitating the anaerobic conditions required for bacterial liquid preparation, preventing the sample from being affected by oxygen in the air and changing the original bacterial flora composition. The temperature control module can adjust the temperature in the processing chamber 1, thereby facilitating the low temperature conditions required for bacterial liquid preparation. At the same time, the temperature control module can achieve automatic temperature control to avoid unnecessary temperature fluctuations that affect bacterial growth. The robotic operation module 2 can operate the preparation module under the control of the control module 8 and enable the preparation module to prepare bacterial liquid. The automated preparation of bacterial liquid by the robotic operation module 2 facilitates ensuring the consistency of bacterial liquid preparation, while saving labor costs, improving bacterial liquid preparation efficiency, and reducing the risk of contamination. This achieves fully automated and standardized bacterial liquid preparation, meeting the high standards of clinical and industrial requirements.

[0044] Specifically, the preparation module includes an automatic liquid adding mechanism 3, a mixing mechanism 4, a sterilizing and filtering mechanism 5 and a low-temperature freezing mechanism 7. Sterile protective liquid is placed in the automatic liquid adding mechanism 3. The automatic liquid adding mechanism 3 is used to add the sterile protective liquid to the sample container containing the sample. The robot operation module 2 can drive the mixing mechanism 4 to act on the sample container, and stir the sample and sterile protective liquid in the sample container to form a homogeneous bacterial liquid suspension. The robot operation module 2 can pour the homogeneous bacterial liquid suspension formed in the sample container into the sterilizing and filtering mechanism 5. The sterilizing and filtering mechanism 5 can process the homogeneous bacterial liquid suspension and form a clarified bacterial liquid solution. The robot operation module 2 can subpackage the clarified bacterial liquid solution, and the low-temperature freezing mechanism 7 can freeze the subpackaged clarified bacterial liquid solution at low temperature.

[0045] The automatic liquid adding mechanism 3 includes a precision peristaltic pump and a liquid storage tank. The liquid storage tank is used to store sterile protective liquid. The precision peristaltic pump is connected between the liquid storage tank and the mixing mechanism 4, and the precision peristaltic pump is used to pass the sterile protective liquid in the liquid storage tank into the mixing mechanism 4. At the same time, during the liquid adding process, sterile protective liquid (such as sterile saline containing 10% glycerol) can be automatically injected according to a preset proportion to prevent the membrane structure of the bacterial flora from being damaged due to freezing.

[0046] The mixing mechanism 4 is a stirrer, which is used to stir the sterile protective liquid and the sample in the sample container. As a preferred solution of this embodiment, the stirrer can be a high-speed vortex mixer or a low-speed constant temperature stirrer to ensure that the fecal sample and the sterile protective liquid are fully and homogeneously mixed.

[0047] The sterilizing filtration mechanism 5 includes a sterilizing tank and a filter screen. The filter screen is arranged in the middle of the sterilizing tank, and the filter screen is used to filter solid impurities entering the sterilizing tank. The filter screen can allow the clarified bacterial solution to pass through. In order to ensure the filtration effect, the filter screen can be set to be multi-layered and a sterile filter screen. The pore size of the filter screen is 0.1mm~0.5mm, which can effectively remove food residues, fibers and other non-usable impurities. At the same time, the sterilizing tank can be a closed container to avoid cross contamination.

[0048] The preparation module also includes multiple filling tanks 6. The robotic operation module 2 can place the filling tanks 6 at the outlet of the sterilization filtration mechanism 5 and fill the clarified bacterial liquid solution through the filling tanks 6. The robotic operation module 2 can also seal the filling tanks 6 containing the clarified bacterial liquid solution.

[0049] The low-temperature freezing mechanism 7 includes a freezing chamber. The robot operation module 2 can grab the sealed packaging cans 6 and place the packaging cans 6 into the freezing chamber for freezing.

[0050] The robot operation module 2 includes multiple robots with robotic arms, and the control module 8 is an intelligent central control platform. The intelligent central control platform has a graphical user interface (GUI) to realize parameter setting, process arrangement, equipment coordination and status monitoring. It has data recording and full-process traceability capabilities, and supports remote alarm and fault diagnosis, thereby realizing the automated preparation of bacterial solution, eliminating human errors, and improving the consistency, traceability and repeatability of bacterial solution. In addition, through the setting of the intelligent central control platform, the numbering management, full-process monitoring and traceability records of different donor samples can be realized, ensuring the standardized operation of the quality system and realizing intelligent batch management.

[0051] As a preferred solution of this embodiment, multiple robots in this embodiment serve as core control elements and are deployed at multiple locations in the processing chamber 1. The multiple robots are divided into: a wheeled multifunctional robotic arm robot (responsible for fine sample sampling, liquid filling, bacterial liquid packaging, capping and packaging, etc.), a vertical dual-arm interactive robot (adapted to tasks such as mixing, filtration, sample identification, and has high-degree-of-freedom operation capabilities) and a humanoid robot system (suitable for high-precision simulation of manual operation scenarios to enhance process flexibility and accuracy). In addition, the execution paths of all robots are preset and adjustable by the intelligent central control platform, and the end effector supports modular replacement to adapt to different operations.

[0052] This embodiment also includes a buffer transfer room 9, which is arranged outside the processing chamber 1, and the operator can place the sample container containing the sample in the buffer transfer room 9. When the buffer transfer room 9 transfers the sample container to the processing chamber 1, the buffer transfer room 9 can be connected to the processing chamber 1. The buffer transfer room 9 can realize the "anaerobic transfer" of samples and consumables, and prevent external air from entering the processing chamber 1 through vacuum extraction, nitrogen filling and the internal and external double door isolation structure.

[0053] In this embodiment, when designing the treatment chamber 1, the treatment chamber 1 can be filled with an inert gas such as high-purity nitrogen, thereby effectively protecting the important strict anaerobic bacteria in the bacterial flora and facilitating the realization of anaerobic operation throughout the process. As a preferred solution of this embodiment, an oxygen content sensor can also be used to dynamically monitor and control the oxygen content to be maintained below 0.5%, thereby forming a long-term stable anaerobic environment. By setting up a temperature control module, the reproduction of harmful bacteria can be inhibited and the activity of the bacterial flora can be maintained under low temperature (2°C to 8°C) and -40°C freezing conditions, thereby achieving low-temperature constant control protection. At the same time, the light source in the treatment chamber 1 can adopt low-intensity lighting to avoid the adverse effects of light on the bacterial flora and its metabolites, thereby ensuring the stability of the bacterial solution.

[0054] Through the above design, this embodiment constructs a fully enclosed bacterial liquid processing environment that integrates "light protection, oxygen-free, and low temperature" in one. Combined with a robotic automatic operation system, it realizes standardized control of the entire process of bacterial liquid from sample receipt, pretreatment, liquid addition and mixing, filtration, packaging to frozen storage.

[0055] Example 2

[0056] like Figure 2 As shown, this embodiment provides a method for preparing a bacterial liquid, using the bacterial liquid preparation system of Example 1, including the following steps:

[0057] S1. Sample registration: The information of the donor stool sample is registered and entered through the control module 8, assigned a unique batch number, and pre-associated with the filling container label to be used. The control module 8 generates the corresponding preparation plan and parameter settings based on the input information;

[0058] S2. Sample Transfer into Processing Chamber 1: The operator places the donor fecal sample to be processed in a sample container into the buffer transfer chamber 9 outside the processing chamber 1. The operator then closes the buffer transfer chamber 9, evacuates it, and fills it with inert gas to equalize the pressure. The operator then opens the inner door of the buffer transfer chamber 9 leading to the processing chamber 1 and transfers the sample container into the processing chamber 1. Upon receiving the sample injection command, the robotic operating module 2 removes the sample container from the buffer transfer chamber 9 and enters the processing chamber 1.

[0059] S3. Precooling: Precool the sample to approximately 4°C in the oxygen-free environment of processing chamber 1. The constant low temperature of processing chamber 1 quickly lowers the sample temperature, ensuring that the sample is subsequently processed at a low temperature, thereby reducing the loss of bacterial activity.

[0060] S4. Adding protective solution: The robotic operation module 2 controls the automatic liquid addition mechanism 3 to add sterile protective solution to the sample container, mixing the sterile protective solution and the sample in a set ratio. The sterile protective solution is, for example, a mixture of sterile saline and medical glycerin, with the glycerin concentration in the final bacterial solution mixture being approximately 10% (volume fraction) to protect the cell structure of the bacterial colony during the cryogenic freezing process. The liquid addition process is carried out in a closed, anaerobic environment. Simultaneously, the control module 8 controls the liquid addition amount and rate to ensure that it matches the sample volume and avoids severe impact on the sample.

[0061] S5. Mixing: Under the control of the robotic operating module 2, the mixing mechanism 4 thoroughly mixes the sample and the sterile protective solution to form a bacterial solution mixture. The robotic operating module 2 transfers the sample container containing the sterile protective solution to the mixing area, activates the mixing mechanism 4, and continues mixing at a preset speed and duration (e.g., medium speed for 2 minutes). During the mixing process, the processing chamber 1 remains dark and oxygen-free to ensure that the bacterial solution is not affected by oxygen and strong light.

[0062] S6. Filtration: After mixing is complete, the robotic operating module 2 removes the sample container and slowly pours the homogenized bacterial suspension in the sample container into the sterilizing filtration mechanism 5 for filtration. This removes solid impurities (such as undissolved large particles) in the homogenized bacterial suspension, making the filtered bacterial suspension purer. Furthermore, the filtration process can be performed in a closed pipeline and container, and the filtered solid waste is retained on the upper end of the filter for subsequent unified cleaning. The entire filtration step is completed in a fully enclosed, anaerobic environment to prevent the ingress of foreign bacteria.

[0063] S7. Subpackaging: The clarified bacterial solution is guided to the subpackaging area by the robotic operation module 2 under anaerobic conditions and automatically dispensed into multiple sterile subpackaging tanks 6 (such as sterile cryovials or transplant capsules). Each subpackaging tank 6 is filled with a predetermined volume of bacterial solution. The subpackaging process is maintained in an anaerobic environment to prevent oxygen exposure and contamination at the final stage. The control module 8 simultaneously attaches a label corresponding to the sample registration, indicating the batch number and date, to each subpackaging tank 6, thereby enabling subpackaging and product traceability.

[0064] S8. Packaging: When the filling of the sub-cans 6 is complete, the robotic operation module 2 sequentially moves each sub-can 6 to the packaging area and seals it to form finished bacterial solution cans. Depending on the specific container type of the sub-can 6, an automatic capping machine can be used to tighten the caps on the cryopreservation tubes, or a heat-sealing device can be used to seal the capsule containers to ensure that the sub-cans 6 are completely sealed. The finished bacterial solution cans are then placed by the robotic operation module 2 on a collection tray for freezing.

[0065] S9. Freezing: Robotic operating module 2 grabs the packaged finished bacterial solution cans and quickly transfers them to cryogenic freezing mechanism 7 in processing chamber 1. The temperature control module is activated to rapidly lower the temperature in cryogenic freezing mechanism 7 to approximately -40°C, allowing the finished bacterial solution to be quickly frozen. The entire transfer and freezing process is completed within minutes to maximize the preservation of active bacterial flora in the bacterial solution. Cryogenic freezing mechanism 7 can accommodate multiple portions of finished bacterial solution at a time and maintain a low temperature of -40°C until it is needed.

[0066] Example 3

[0067] This embodiment is a specific application example of the bacterial liquid preparation system in Example 1 and the bacterial liquid preparation method in Example 2.

[0068] In one actual operation, a 50-gram fresh fecal sample from a donor was selected and placed in a buffer transfer room 9, where it was registered and numbered. The buffer transfer room 9 uses an inert gas (such as high-purity nitrogen) to completely eliminate oxygen before transferring the sample to a fully enclosed, oxygen-free, light-proof, and low-temperature processing chamber 1. Upon receiving the command, the robotic operating module 2 retrieved the sample and placed it in the processing area. The sample was first pre-cooled to approximately 4°C in the constant temperature processing chamber 1 to reduce the metabolic activity of anaerobic bacteria and stabilize the bacterial flora.

[0069] Robotic operation module 2 then controls automatic liquid-adding mechanism 3 to add a prepared sterile protective solution (composed of sterile saline and medical glycerin) to the sample in a set ratio. The added volume is 180 ml, and the glycerin concentration is controlled at 10% (v / v). Guided by the robotic arm of robotic operation module 2, the sample and sterile protective solution are mixed by mixing mechanism 4 for 2 minutes, forming a stable, homogenous bacterial suspension.

[0070] After mixing, the bacterial solution is directed to a sterile filtration mechanism (5) equipped with multiple layers of filter screens. It then passes through four layers of 0.3mm pore-size filters, effectively removing undissolved debris and large impurities, resulting in a clear bacterial solution. A robotic arm then dispenses the filtered solution into ten sterilized 50mL cryovials, each containing 20mL of solution, and immediately caps the tubes. All cryovials are labeled with their corresponding sample numbers, ensuring complete traceability.

[0071] Finally, the filled and sealed bacterial liquid is transferred by the robotic arm to the -40°C low-temperature freezing mechanism 7 built into the processing chamber 1 for rapid freezing, so as to maintain the activity and structural stability of the bacterial flora to the greatest extent.

[0072] In this example, the prepared bacterial solution was stored at -40°C for 48 hours, then taken out and thawed. Anaerobic culture and quantitative detection showed that the total activity of the bacterial community remained above 90%. As a control, the bacterial solution prepared by traditional manual methods in an open environment and refrigerated at 4°C had a bacterial survival rate of approximately 70% to 80%. In addition, through comparison of multiple batches of parallel experiments, it was found that the coefficient of variation of the bacterial solution produced in this example was significantly lower than that of the manual preparation method in key indicators such as viable bacteria concentration and bacterial diversity, verifying its significant advantages in improving the consistency of the bacterial solution, standardization level and product quality stability.

[0073] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. A bacterial liquid preparation system, characterized by: The system comprises a processing chamber, a control module, and a robotic operation module, a preparation module, and a temperature control module disposed within the processing chamber. The processing chamber is a closed chamber made of opaque material and can provide an oxygen-free environment. The temperature control module can adjust the temperature within the processing chamber. The robotic operation module can operate the preparation module under the control of the control module and enable the preparation module to prepare a bacterial solution.

2. The bacterial liquid preparation system according to claim 1, characterized in that: The preparation module includes an automatic liquid-adding mechanism, a mixing mechanism, a sterilizing and filtering mechanism, and a low-temperature freezing mechanism. Sterile protective liquid is placed in the automatic liquid-adding mechanism. The automatic liquid-adding mechanism is used to add the sterile protective liquid into the sample container containing the sample. The robotic operation module can drive the mixing mechanism to act on the sample container and stir the sample and sterile protective liquid in the sample container to form a homogeneous bacterial liquid suspension. The robotic operation module can pour the homogeneous bacterial liquid suspension formed in the sample container into the sterilizing and filtering mechanism. The sterilizing and filtering mechanism can process the homogeneous bacterial liquid suspension and form a clarified bacterial liquid solution. The robotic operation module can subpackage the clarified bacterial liquid solution. The low-temperature freezing mechanism can subpackage the clarified bacterial liquid solution.

3. The bacterial liquid preparation system according to claim 2, characterized in that: The automatic liquid adding mechanism includes a precision peristaltic pump and a liquid storage tank. The liquid storage tank is used to store sterile protective liquid. The precision peristaltic pump is connected between the liquid storage tank and the mixing mechanism, and the precision peristaltic pump is used to pass the sterile protective liquid in the liquid storage tank into the mixing mechanism.

4. The bacterial liquid preparation system according to claim 2, characterized in that: The mixing mechanism is a stirrer, and the stirrer is used to stir the sterile protective liquid and the sample in the sample container.

5. The bacterial liquid preparation system according to claim 2, characterized in that: The sterilizing and filtering mechanism includes a sterilizing tank and a filter screen. The filter screen is arranged in the middle of the sterilizing tank and is used to filter solid impurities entering the sterilizing tank. The filter screen can allow the clarified bacterial solution to pass through.

6. The bacterial liquid preparation system according to claim 2, characterized in that: The preparation module also includes multiple filling tanks. The robotic operation module can place the filling tanks at the outlet of the sterilizing filtration mechanism and use the filling tanks to fill the clarified bacterial solution. The robotic operation module can also seal the filling tanks containing the clarified bacterial solution.

7. The bacterial liquid preparation system according to claim 6, characterized in that: The low-temperature freezing mechanism includes a freezing chamber, and the robot operation module can grab the sealed packaging cans and place the packaging cans into the freezing chamber for freezing.

8. The bacterial liquid preparation system according to claim 1, characterized in that: The robot operation module includes a plurality of robots with robotic arms, and the control module is an intelligent central control platform.

9. The bacterial liquid preparation system according to claim 1, characterized in that: The buffer transfer room is further provided. The buffer transfer room is arranged outside the processing chamber, and an operator can place a sample container containing a sample in the buffer transfer room. When the buffer transfer room transfers the sample container into the processing chamber, the buffer transfer room can be connected to the processing chamber.

10. A method for preparing a bacterial liquid, characterized in that: The bacterial liquid preparation system according to any one of claims 1 to 9 comprises the following steps: S1. Sample Registration: The donor stool sample information is registered and entered through the control module, assigned a unique batch number, and pre-associated with the label of the filling container to be used. The control module generates the corresponding preparation plan and parameter settings based on the input information; S2. Sample Transfer into the Processing Chamber: The operator places the donor fecal sample to be processed into the buffer transfer chamber outside the processing chamber. The operator then closes the buffer transfer chamber, evacuates it, and fills it with inert gas to equalize the pressure. The operator then opens the inner door of the buffer transfer chamber leading to the processing chamber and transfers the sample container into the processing chamber. Upon receiving the sample injection command, the robotic operating module removes the sample container from the buffer transfer chamber and enters the processing chamber. S3. Precooling: Precool the sample in the oxygen-free environment of the processing room; S4. Adding protective liquid: The robot operation module controls the automatic adding mechanism to add sterile protective liquid to the sample container, so that the sterile protective liquid and the sample are mixed in a set ratio. At the same time, the control module controls the amount of liquid and the rate of addition; S5. Mixing: The mixing mechanism, under the control of the robot operation module, mixes the sample with the sterile protective solution to form a bacterial solution mixture; S6. Filtration: After mixing is completed, the robot operation module removes the sample container and slowly pours the homogenized bacterial suspension in the sample container into the sterile filtration mechanism for filtration to remove solid impurities in the homogenized bacterial suspension and make the filtered bacterial suspension purer; S7. Subpackaging: The clarified bacterial solution is guided to the subpackaging area by the robotic operation module under anaerobic conditions and automatically dispensed into multiple sterile subpackaging cans. The control module simultaneously affixes a label corresponding to the sample registration, indicating the batch number and date, to each subpackaging can to complete the subpackaging process. S8. Packaging: After the cans are filled, the robotic operation module moves each can to the packaging area and seals them to form finished bacterial solution cans. The robotic operation module then places the finished bacterial solution cans on a collection tray for freezing. S9. Freezing: The robotic operation module grabs the packaged finished bacterial solution cans and transfers them to the low-temperature freezing mechanism in the processing room for quick freezing and preservation of the finished bacterial solution.

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