Blood drug concentration monitoring system, two-dimensional liquid chromatography system

Blood drug concentration monitoring system, two-dimensional liquid chromatography system

Model:GI-3000YH

Brand: Innovative Universal

Specification: all-in-one machine

1. ProductsPurpose:

In clinical practice, it is used for qualitative and quantitative detection of organic compounds derived from human blood samples,Scope of detectable drugs: antiepileptic drugs, psychiatric drugs, hypnotic sedatives, anti-tumor drugs, antibiotics, anti tuberculosis drugs, analgesic drugs, circulatory system drugs, gastrointestinal drugs, or other drugs.

2、 Gong Gongcan andTechnical specifications：

1. Comprehensive functional parameters of the detection system

1.1 Detection and analysis method: High performance liquid chromatography is used;

1.2 The instrument system adopts technology: two-dimensional liquid chromatography technology,Having intuitive guidance for two-dimensional systems、operationinterface，Real time display of sample status for measurement；

★ 1.3 Dual quaternary low-pressure constant flow pump system, eight channel online deaerator and flow path.

★ 1.4 have10inchTFT high-resolution touch color screenAnd it has a large screen for direct control andTwo functions of computer software reverse control

1.5 Testing duration for each sample: 5-10 minutes;

1.6 SystemrepetitivenessRSD6 (qualitative)：≤0.5%；

1.7 SystemrepetitivenessRSD6 (quantitative)：≤1% ；

1.8 spiked recovery rate: within the range of 90% -110%;

1.9 onboardEquipped with concentration detection methods for commonly used therapeutic drugs in multiple disciplines6More than 0 types；

1.10 The instrument has the function of unmanned operation after operation, which can achieve automatic measurement, operation, standbyTurn off the lightsShutdown function.

1.11 has emergency function, which can urgently handle blood samples that need to be tested.

1.12 The instrument has multi item detection function, and can automatically detect multiple drugs in one batch. It can automatically replace different drug varieties and clean the pipeline without manual intervention.

★ 1.13 Sample processing automation，adoptPrecision metering pumpquantityAutomatic Extraction TechnologyChange the injection volume size at any time through the computerAnd it has eight independent mobile phases (reagents) and their flow paths. The equipment can automatically control the selection of different reagents and dosages, and perform online mixing and preparation of various drugs' required supporting detection reagents.

1.14 Chromatographic column has strong compatibility, and can be completed with one set of chromatographic columns6Testing of 0 drugs. Avoid frequent replacement of chromatography columns.

▲All hardware of the 1.15 instrument, except for the computer, is integrated into one box for better performanceJiaThe pipeline layout,Minimize system dead volume as much as possible, improve system duplicate detection accuracy, and obtainBetter electromagnetic compatibility performanceImprove the anti-interference ability of the system.

2、built-inquaterniongradientConstant flow pump:

★ 2.1 adoptdual servomotor，Independently separatedriveTwo rootsPrecision ball screw constant flow pump infusion system, plunger stroke2Adjustable from 0uL to 140uL,makeGradient mixing can be completed in a constant flow pump，removeIndependentGradient mixer，thusreduceInstrument systemDead volume，Improve the accuracy and speed of repeated detection in the system，Improve the detection accuracy, stability, and durability of the system.

2.2 Flow range:0.001-10.000ml/min； Set step size: 0.001mL/min

2.3 Built in online deaerator, the deaerator adopts high-efficiency technologyTeflon AF tube, deaerator dead volume<300uL

★ 2.4 Built in quaternary gradient proportional valve,System Two Four Element GradientsProportional valve lifespanall >510 million times，

2.5Equipped with real-time pressure detection display, high pressure limit, low pressure limit alarm, and automatic flow rate compensation with system pressure changes

2.6 Traffic accuracy:<±1%；

2.7 Gradient error:±1%

3、built-inautosampler：

3.1 Automatic sampler, to be usedHigh pressure injection,Mobile phase needle passingtechnologyNo need to clean the inner wall of the injection needle，Automatic cleaning of outer wall，canreduceSample residue.

3.2 Before injection, it is possible toautomatic cleaningInjection needle outer wall to reduce sample cross contamination

3.3 The online processing capability of 1000 µ l ultra large samples (typical value of 500 µ l), and the system automatically completes enrichment online.

3.4 Sample residue：less than0.005%

3.5 Number of sample bottle positions: There are two injection methods available,80 position (2mL ordinary sample bottle) and 192 position (two 96 well plates)

3.6 Injection linearity:≥0.999

4. Built in UVUV detector:

4.1 Wavelength range:190nm-700nm；

4.2 Spectral bandwidth:5nm；

4.3 Wavelength indication error:≤±1nm；

4.4 Wavelength repeatability:≤1nm

4.5 Baseline noise:≤±1×10^-5 AU(甲醇、1ml/min、254nm、20℃)；

4.6 Baseline drift:≤±3×10^-4 AU/h(甲醇、1ml/min、254nm、20℃)；

4.7 Detection concentration:≤2×10^-10G/ml (naphthalene);

4.8 Wavelength scanning: multi wavelength time programming（10 bands)

4.9 Measurement range:0.0001～2.0000AUFS

4.10 Linear range:≥10⁴

4.11 Pool volume:8μL；

4.12 DetectorEquipped with computer software anti control function

4.13 The detector adopts dual channel data and high precision24 bit AD conversion, signal sampling frequency up to 80Hz/s high-speed data collector, ensuring high-speed, low-noise, low drift, and ultra-high sensitivity detection of the detector.

5、Built in comprehensive separation and analysis unit：

5.1 Temperature control range：room temperature-10℃～60℃

5.2 Temperature control accuracy:≤±0.1℃；

★ 5.3 Adopting online caching technologyThe entire system only requires two chromatography columns,There is no need for a sample buffer column between one-dimensional and two-dimensional columns(Third pillar)，Using central cutting technology andPrecision valve controlTechnology, fast and accurate switching,Directly remove impurities from the sample、enrichment、Purification and transfer to a two-dimensional analytical column,Purified sampleProviding two-dimensional chromatography columns for further separation and detection, avoiding sample contamination, making sample detection faster and separation detection more effective, better meeting the needs of GMP and GLP management.

5.4 Temperature can be controlled in both directions:canRefrigeration and HeatingIntelligent temperature control.

5.5 Temperature setting resolution:0.1℃

5.6 Integrated UnitEquipped with computer software anti control function

6. Built inHigh pressure dilutionPump:

6.1 Flow range:0.001-10.000ml/min； Set step size: 0.001mL/min

6.2 Traffic accuracy:<±1%；

6.3 Maximum pump pressure:50Mpa

6.4 Computer control, with online automatic dilution function. No matter the injection volume, there is no need for nitrogen blowing operation, fully automatic processing, eliminating the trouble of manual intervention.

1. chromatographyworkstation:

   ★7.1 The two-dimensional chromatography control software has independent intellectual property rights and can ensure continuous free upgrades of software technology.

   7.2 Full Chinese operation menu, intuitive and convenient user-friendly interface

   7.3 The software hassatisfyGMP requirementsUser permission management,auditTracking function

   ★7.4 softwareDesigned uniformly by the original factoryHaving independent public and private instrument methods、analytical method、Setting of reporting methodsfunctionWhen modifying private methods, do not change public methods, which facilitates the establishment and management of sample table methods. Instrument method、analytical methodandEstablishment of reporting methods、modify、DeleteallHaving permission management andauditTracking function makes the database more secure and efficient.It can meet the needs of both clinical testing and scientific experiments.

   7.5 It has a sample table batch processing function, which means that after the sample table is established, all sample tests can be completed with one click. After the sample is completed, automatic column flushing and intelligent shutdown can be set to achieve unmanned operation.

   7.6 The software needs to be highly integrated, with data settings、collect、Analyze and view a software that is easy to operate.

   7.7 The software can perform full reverse control operation control, automatic data acquisition, spectrum processing, etc. on the system.

   7.8 The method file used can analyze the parameters, spectral data, and analysis reports of the chromatographlongLong term storage and unified management;

   7.9 The software comes withMySQL database management function, all key data is stored in the database, with data import and export functions.

   7.10 The workstation has the ability to compare spectra in multiple forms, which is beneficial for chromatographic research;

   7.11 Control methodHas computer reverse control function.

   7.12 working methodImplement data collection, calculation, organization, storage, and printing on the front and rear consoles

   IIIInstrument configuration

   1、Two dimensional liquid chromatographysystem a set

   built-inconfiguration：

   （1）Four element gradient constant flow pump Two sets

   （2）High voltageDilution pump a set

   （3）UVUV detector a set

   （4）Integrated Separation Analysis System a set

   （5）autosampler a set

   （6）degassingMachine（8Road OnlineOne set of system

   （7）Chromatography control software system a set

   （8）Analysis column a

   （9）SPESolid phase extraction columna

   2Supporting computer a set

   3One matching printer

4、 After sales service:

The product comes with a five-year warranty, free software upgrades, and lifetime service provided by the manufacturer.

Blood drug concentration monitoring system, two-dimensional liquid chromatography systemExplanation of professional terms

GMP (Good Manufacturing Practice) is a "good manufacturing practice" that mainly applies to the production process of drugs, food, and other products to ensure controllable product quality. It has strict standards in factory design, equipment management, and production processes.

GLP (Good Laboratory Practice) is a "good laboratory practice" that focuses on the quality management of laboratory research, such as non clinical drug studies, requiring experimental design, operation, data recording, and other compliance with regulations to ensure the authenticity and reliability of results.

Simply put, the production process of GMP tubes and the experimental process of GLP tubes are both aimed at ensuring the quality and safety of products or research.