A polypeptide drug high-precision rapid detection analyzer

Abstract

The utility model discloses a kind of polypeptide drug high-precision rapid detection analyzers, including bottom plate, the bottom plate top side is fixed with sample processing component, the sample processing component one side is fixed with detection processing component, the sample processing component includes driving motor, the driving motor is fixed with bottom plate top by bolt, the bottom plate drive end fixed sleeve is equipped with sample disc, the sample disc top is equipped with a plurality of placing grooves.The utility model discloses a kind of polypeptide drug high-precision rapid detection analyzers, by the use of ion source and mass spectrometer, and optimized sample injection and processing process, greatly shorten the detection time.When the purity of common polypeptide drug sample is detected, traditional instrument needs 3 minutes on average, while the analyzer of the utility model only needs about 2 minutes, detection speed is improved by about 30%, can better meet the demand of polypeptide drug production line rapid detection.

Description

Technical Field

[0001] This utility model relates to the field of biomedical testing equipment, and in particular to a high-precision rapid detection and analysis instrument for polypeptide drugs. Background Technology

[0002] Peptide drugs are a class of biological macromolecules composed of amino acids linked by peptide bonds, with molecular sizes between traditional small-molecule chemical drugs and protein drugs. These drugs possess advantages such as high activity, high specificity, and low toxicity, and are mainly used in the treatment and diagnosis of major chronic diseases such as cancer, diabetes, metabolic diseases, and cardiovascular diseases. Due to their complex structure and the potential for impurities during production, they require rigorous quality control and purity identification using advanced analytical instruments such as high-performance liquid chromatography-mass spectrometry (HPLC-MS) to ensure drug safety and efficacy.

[0003] Currently, the commonly used detection instruments in the testing of peptide drugs have many shortcomings. For example, while traditional liquid chromatography (LC) can separate and analyze different components when detecting the purity of peptide drugs, the analysis speed is relatively slow, and a complete detection process often takes a long time. This is especially true for peptide drugs with complex components, where the detection efficiency is low and cannot meet the rapid detection requirements of large-scale production processes. Moreover, some detection instruments have limited detection accuracy and are not sensitive enough to detect trace impurities in peptide drugs, easily leading to missed detections and insufficient quality control of the final product. In addition, most existing instruments require complex operation settings and sample pretreatment by professional technicians, making the operation process cumbersome and requiring a high level of professional expertise from the operators, increasing labor costs and the difficulty of detection. Utility Model Content

[0004] To address the aforementioned problems, the purpose of this invention is to provide a high-precision, rapid detection and analysis instrument for polypeptide drugs.

[0005] The following technical solution is adopted: a high-precision rapid detection and analysis instrument for polypeptide drugs, including a base plate, a sample processing component fixedly disposed on one side of the top of the base plate, and a detection processing component fixedly disposed on one side of the sample processing component.

[0006] Optionally, the sample processing component includes a drive motor, which is fixed to the top of the base plate by bolts. A sample tray is fixedly sleeved on the drive end of the base plate. The top of the sample tray has several placement slots, which are arranged in a circular array around the reference axis of the sample tray.

[0007] Optionally, a T-shaped bracket is fixedly provided at the top of the base plate, and a sampling cylinder is fixedly provided on one side of the top of the T-shaped bracket. The sampling cylinder is located directly above the placement slot. An injection valve is fixedly provided at the top of the sampling cylinder. A filter assembly is threadedly connected to the outer wall of one side of the top of the sampling cylinder. A three-way pipe is threadedly connected to the inner wall of the end of the filter assembly away from the sampling cylinder. One end of the three-way pipe is connected to a column temperature chamber.

[0008] Optionally, a liquid phase pump is connected to the front end of the three-way pipe, and a liquid storage bottle is connected to the front end of the liquid phase pump.

[0009] Optionally, a diluent syringe is fixedly provided at the front of the top of the T-shaped bracket.

[0010] Optionally, the inner wall of the column oven is fixedly provided with a clamp, and the chromatographic column is fixedly engaged with the inner wall of the clamp.

[0011] Optionally, the detection and processing component includes an ion source, the top of which is connected to the bottom of a column oven in the sample processing component. A mass analyzer is connected to one side of the bottom of the ion source. A data processing system is connected to the side of the mass analyzer away from the ion source via a line. A display screen is fixedly installed on one side of the data processing system. An intelligent controller is fixedly installed at the front end of the mass analyzer. A human-machine interface is fixedly installed at the front end of the intelligent controller.

[0012] Optionally, a compartment is fixedly provided at the top of the base plate, the sample processing component is located inside the compartment, and a refrigeration system is fixedly provided at the top of the compartment.

[0013] Optionally, a stable power supply is fixedly provided at the top of the base plate.

[0014] The technical effects that can be achieved by the technical means of this utility model are as follows:

[0015] (1) In this invention, the detection time is greatly shortened by using the ion source and mass analyzer together, as well as by optimizing the sample introduction and processing procedures. When performing purity detection on common peptide drug samples, traditional instruments take an average of 3 minutes, while the analyzer of this invention only takes about 2 minutes, increasing the detection speed by about 30%, which can better meet the needs of rapid detection on peptide drug production lines.

[0016] (2) In this utility model, by setting up a chromatographic column and a mass analyzer, the combination of the two significantly enhances the detection capability of this utility model for trace impurities in polypeptide drugs. It can accurately detect impurity components with low content, which traditional detection instruments often cannot effectively identify under the same conditions. The detection accuracy is improved, ensuring stricter control over the quality of polypeptide drugs.

[0017] (3) The integrated sample processing and detection processing components in this invention greatly simplify the operation process. Operators no longer need to perform complex manual sample preprocessing and cumbersome instrument parameter settings; they can simply input the detection requirements through the human-computer interaction interface to automatically complete the detection work. Compared with traditional detection instruments, the training time for operators is shortened, the reliance on the professional skills of operators is reduced, and the overall efficiency of the detection work is improved. Attached Figure Description

[0018] Figure 1 This is a three-dimensional structural diagram of the present invention;

[0019] Figure 2 This is a three-dimensional structural diagram of the back of this utility model;

[0020] Figure 3 This is a three-dimensional structural diagram of the sample processing component of this utility model;

[0021] Figure 4 This is a schematic diagram of the column temperature chamber and its internal three-dimensional structure of the present invention;

[0022] Figure 5 This is a three-dimensional structural diagram of the detection and processing component of this utility model.

[0023] In the diagram: 1. Base plate; 2. Compartment; 3. Refrigeration system; 4. Stable power supply; 5. Sample processing assembly; 501. Drive motor; 502. Sample tray; 503. Placement slot; 504. T-shaped support; 505. Column oven; 506. Three-way valve; 507. Storage bottle; 508. Liquid phase pump; 509. Filter assembly; 510. Injection valve; 511. Diluent syringe; 512. Sampling cylinder; 513. Chromatographic column; 514. Clamps; 6. Detection and processing assembly; 601. Ion source; 602. Mass analyzer; 603. Data processing system; 604. Display screen; 605. Intelligent controller; 606. Human-machine interface. Detailed Implementation

[0024] To provide a clearer understanding of the technical features, objectives, and effects of this utility model, the specific embodiments of this utility model are now described with reference to the accompanying drawings.

[0025] In the description of this utility model, it should be noted that the orientations or positional relationships indicated by terms such as "upper," "lower," "inner," "outer," "front end," "rear end," "both ends," "one end," and "the other end" are based on the orientations or positional relationships shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. In addition, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0026] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installed," "equipped with," and "connected," etc., should be interpreted broadly. For example, "connected" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0027] A preferred embodiment of the high-precision rapid detection and analysis instrument for polypeptide drugs provided by this utility model is as follows: Figures 1 to 5 As shown: A high-precision rapid detection and analysis instrument for polypeptide drugs includes a base plate 1, a sample processing component 5 fixedly disposed on one side of the top of the base plate 1, and a detection processing component 6 fixedly disposed on one side of the sample processing component 5.

[0028] In this embodiment, the sample processing component 5 includes a drive motor 501, which is fixed to the top of the base plate 1 by bolts. The base plate 1 has a sample tray 502 fixedly sleeved on its drive end. The top of the sample tray 502 has a plurality of placement slots 503, which are arranged in a circular array around the reference axis of the sample tray 502.

[0029] With the above scheme, the several placement slots 503 in the sample tray 502 can hold multiple peptide drug samples to be tested. The sample tray 502 is driven to rotate by the drive motor 501, which facilitates the sampling tube 512 at the top of the tray to extract the samples and improves the detection efficiency.

[0030] In this embodiment, a T-shaped bracket 504 is fixedly provided at the top of the base plate 1, and a sampling cylinder 512 is fixedly provided on one side of the top of the T-shaped bracket 504. The sampling cylinder 512 is located directly above the placement groove 503. An inlet valve 510 is fixedly provided at the top of the sampling cylinder 512. A filter assembly 509 is threadedly connected to the outer wall of one side of the top of the sampling cylinder 512. A three-way pipe 506 is threadedly connected to the inner wall of the end of the filter assembly 509 away from the sampling cylinder 512. One end of the three-way pipe 506 is connected to a column temperature chamber 505.

[0031] Through the above scheme, the T-shaped support 504 serves to support the entire sample processing component 5. The sampling tube 512 extracts the sample to be tested from the placement slot 503, the injection valve 510 is opened, the filter component 509 is used for filtration, and then the sample is introduced into the chromatographic column 513. It should be noted that the two ends of the filter component 509 are threaded to the pipes for easy disassembly and cleaning. The three-way pipe 506 is used to connect the sampling tube 512, the storage bottle 507, and the chromatographic column 513.

[0032] In this embodiment, a liquid phase pump 508 is connected to the front end of the three-way pipe 506, and a liquid storage bottle 507 is connected to the front end of the liquid phase pump 508.

[0033] In the above scheme, the liquid phase pump 508 delivers the mobile phase from the storage bottle 507 at high pressure, stable and precise flow rate, and together with the sample extracted by the sampling tube 512, enters the chromatographic column 513 in the state of a mobile phase mixture.

[0034] In this embodiment, a diluent syringe 511 is fixedly provided at the front of the top of the T-shaped bracket 504.

[0035] The above method involves injecting diluent into the placement tank 503 to pre-dilute the material, which facilitates subsequent operations.

[0036] In this embodiment, a clamp 514 is fixedly provided on the inner wall of the column oven 505, and a chromatographic column 513 is fixedly engaged on the inner wall of the clamp 514.

[0037] In the above scheme, the chromatographic column 513 is the core separation component. Its special packing material causes different peptides to pass through at different speeds due to differences in interaction forces, thereby achieving separation. It is fixed in the column oven 505 by the clamps 514, and its upper and lower ends are connected to the outside.

[0038] In this embodiment, the detection and processing component 6 includes an ion source 601. The top of the ion source 601 is connected to the bottom of the column oven 505 in the sample processing component 5. A mass analyzer 602 is connected to one side of the bottom of the ion source 601. A data processing system 603 is connected to the side of the mass analyzer 602 away from the ion source 601 via a line. A display screen 604 is fixedly installed on one side of the data processing system 603. An intelligent controller 605 is fixedly installed at the front end of the mass analyzer 602. A human-machine interface 606 is fixedly installed at the front end of the intelligent controller 605.

[0039] In the above scheme, the ion source 601 receives the separated polypeptide liquid molecules from the chromatographic column 513 and converts them into gaseous ions under high temperature and high pressure gas flow. These ions are then transported to the mass analyzer 602, which can accurately detect the mass-to-charge ratio of the polypeptide drug molecules and their fragment ions, thereby accurately determining key indicators such as the molecular weight, structure, and impurity components of the polypeptide drug. The ion source 601, in conjunction with the mass analyzer 602, achieves comprehensive and accurate analysis and detection of polypeptide drugs. The data processing system 603 has built-in powerful data processing software that can receive detection data from the separation and detection module in real time and perform rapid analysis and processing using advanced algorithms. The detection results are presented on the display screen 604 in a clear and intuitive chart and data format, facilitating viewing and recording by the operator. The intelligent controller 605, as the core control unit of the entire analyzer, coordinates the work between the various modules. The operator only needs to input detection parameters such as detection items, sample numbers, and analysis methods through the simple human-machine interface 606, and the intelligent controller 605 will automatically control the operation of the cooling system 3, sample processing component 5, and detection processing component 6. In addition, the intelligent controller 605 also has fault diagnosis and early warning functions, which can promptly detect possible faults in various components of the instrument and prompt operators to take appropriate action.

[0040] In this embodiment, a compartment 2 is fixedly provided at the top of the base plate 1, the sample processing component 5 is located inside the compartment 2, and a refrigeration system 3 is fixedly provided at the top of the compartment 2.

[0041] Through the above scheme, the cooling system 3 is used to maintain the sample processing component 5 in a suitable temperature environment to ensure the stability of the sample and the accuracy of the test results, while the compartment 2 can prevent temperature changes to a certain extent.

[0042] In this embodiment, a stable power supply 4 is fixedly provided at the top of the base plate 1.

[0043] Through the above solution, the stable power supply 4 provides a stable power supply for the entire analyzer, avoiding the impact of voltage fluctuations on instrument performance.

[0044] Working principle: When operating and using this utility model, as follows... Figures 1 to 5As shown, in use, the sample tray 502 is rotated by the drive motor 501, and the diluent is injected into the placement tank 503 below it using the diluent syringe 511. Then, the placement tank 503 rotates to be directly below the sampling cylinder 512, and the injection valve 510 is opened. The sample drawn by the sampling cylinder 512 is filtered through the filter assembly 509 to initially filter out impurities. Then, the liquid phase pump 508 delivers the mobile phase from the storage bottle 507 at high pressure, a stable and precise flow rate. Together with the sample drawn by the sampling cylinder 512, the mobile phase mixture enters the chromatographic column 513. Its special packing material causes different peptides to pass through at different speeds due to differences in interaction forces, thereby achieving separation. The mixture is then delivered to the ion source 601 below. The source 601 receives separated polypeptide liquid molecules from the chromatographic column 513, converts them into gaseous ions under high temperature and high pressure, and delivers them to the mass analyzer 602. This analyzer accurately detects the mass-to-charge ratio of the polypeptide drug molecules and their fragment ions, thereby accurately determining key indicators such as the molecular weight, structure, and impurity components of the polypeptide drug. The data processing system 603 has built-in powerful data processing software that can receive detection data from the separation and detection modules in real time and perform rapid analysis using advanced algorithms. The detection results are presented on the display screen 604 in a clear and intuitive chart and data format. The intelligent controller 605, as the core control unit of the entire analyzer, coordinates the work between the various modules. Operators only need to input detection parameters such as detection items, sample numbers, and analysis methods through a simple human-machine interface 606, and the intelligent controller 605 will automatically control the operation of the cooling system 3, sample processing component 5, and detection processing component 6.

[0045] The above are merely illustrative embodiments of this utility model and are not intended to limit the scope of this utility model. Any equivalent changes and modifications made by those skilled in the art without departing from the concept and principles of this utility model should fall within the protection scope of this utility model. Furthermore, it should be noted that the components of this utility model are not limited to the overall application described above. Each technical feature described in the specification of this utility model can be used individually or in combination as needed. Therefore, this utility model naturally covers other combinations and specific applications related to the points of this utility model.

Claims

1. A high-precision rapid detection and analysis instrument for polypeptide drugs, comprising a base plate (1), characterized in that: A sample processing component (5) is fixedly provided on one side of the top of the base plate (1), and a detection processing component (6) is fixedly provided on one side of the sample processing component (5); The sample processing component (5) includes a drive motor (501), which is fixed to the top of the base plate (1) by bolts. The base plate (1) has a sample disk (502) fixedly sleeved on its drive end. The top of the sample disk (502) has a plurality of placement slots (503), which are arranged in a circular array around the reference axis of the sample disk (502).

2. The high-precision rapid detection and analysis instrument for polypeptide drugs according to claim 1, characterized in that: A T-shaped bracket (504) is fixedly provided at the top of the base plate (1). A sampling cylinder (512) is fixedly provided on one side of the top of the T-shaped bracket (504). The sampling cylinder (512) is located directly above the placement slot (503). An injection valve (510) is fixedly provided at the top of the sampling cylinder (512). A filter assembly (509) is threadedly connected to the outer wall of one side of the top of the sampling cylinder (512). A three-way pipe (506) is threadedly connected to the inner wall of the end of the filter assembly (509) away from the sampling cylinder (512). One end of the three-way pipe (506) is connected to a column temperature chamber (505).

3. The high-precision rapid detection and analysis instrument for polypeptide drugs according to claim 2, characterized in that: The front end of the three-way pipe (506) is connected to a liquid phase pump (508), and the front end of the liquid phase pump (508) is connected to a liquid storage bottle (507).

4. The high-precision rapid detection and analysis instrument for polypeptide drugs according to claim 2, characterized in that: A diluent syringe (511) is fixedly mounted on the front of the top of the T-shaped bracket (504).

5. The high-precision rapid detection and analysis instrument for polypeptide drugs according to claim 2, characterized in that: The inner wall of the column oven (505) is fixedly provided with a clamp (514), and the inner wall of the clamp (514) is fixedly engaged with a chromatographic column (513).

6. The high-precision rapid detection and analysis instrument for polypeptide drugs according to claim 1, characterized in that: The detection and processing component (6) includes an ion source (601). The top of the ion source (601) is connected to the bottom of the column oven (505) in the sample processing component (5). A mass analyzer (602) is connected to one side of the bottom of the ion source (601). A data processing system (603) is connected to the side of the mass analyzer (602) away from the ion source (601) via a line. A display screen (604) is fixedly installed on one side of the data processing system (603). An intelligent controller (605) is fixedly installed at the front end of the mass analyzer (602). A human-computer interaction interface (606) is fixedly installed at the front end of the intelligent controller (605).

7. The high-precision rapid detection and analysis instrument for polypeptide drugs according to claim 1, characterized in that: The bottom plate (1) is fixedly provided with a compartment (2), the sample processing component (5) is located inside the compartment (2), and the top of the compartment (2) is fixedly provided with a refrigeration system (3).

8. The high-precision rapid detection and analysis instrument for polypeptide drugs according to claim 1, characterized in that: A stable power supply (4) is fixedly installed at the top of the base plate (1).

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