CN209894753U - High-time-resolution automatic oral solid drug in-vitro dissolution rate analyzer - Google Patents
High-time-resolution automatic oral solid drug in-vitro dissolution rate analyzer Download PDFInfo
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- CN209894753U CN209894753U CN201920188458.2U CN201920188458U CN209894753U CN 209894753 U CN209894753 U CN 209894753U CN 201920188458 U CN201920188458 U CN 201920188458U CN 209894753 U CN209894753 U CN 209894753U
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Abstract
The utility model discloses an automatic oral solid medicine external degree of dissolution analysis appearance of high time resolution, include: the device comprises a flow cell drug dissolution device, an automatic sequence sample introduction device, a high-speed capillary electrophoresis separation detection device, a case and a data processing end, wherein the flow cell drug dissolution device, the automatic sequence sample introduction device and the high-speed capillary electrophoresis separation detection device are fixedly arranged on a bottom plate in the case; the flow cell drug dissolution device, the automatic sequence sample introduction device and the high-speed capillary electrophoresis separation detection device are connected through a conduit; the data processing end is arranged on the case; the device is used for detecting the time of second order in the dissolution process of the medicine and monitoring the real process of medicine release; the interference of the optical fiber medicine dissolution monitoring method on the hydrolysis of auxiliary materials and medicine components in the medicine dissolution process is solved, and the method is suitable for the simultaneous analysis of a complex multi-component formula medicine preparation and multiple active components with similar ultraviolet absorption characteristics and the research of a real dissolution process.
Description
Technical Field
The utility model relates to a medicine dissolves out analysis and detects technical field, concretely relates to automatic oral solid medicine external degree of dissolution analysis appearance of high time resolution.
Background
In-vitro dissolution analysis of oral solid drugs generally refers to accurate detection of dissolution rate and dissolution degree of solid drug preparations such as tablets, capsules and granules in a liquid environment simulating intestines and stomach of a human body, so as to reflect the characteristics of disintegration and dissolution release of the drugs in vivo, and evaluate the bioequivalence and bioavailability of the drugs. The drug dissolution analysis is an important index for evaluating the quality of the drug before clinical use, rapidly and accurately measures the dissolution curves of different dosage forms of drugs, objectively and reasonably evaluates the dissolution speed and degree of active drug ingredients from a drug preparation, and has important significance for drug research and development, quality control and evaluation, imitation drug quality and curative effect consistency evaluation and the like.
The dissolution analysis of the currently widely used drug dissolution apparatus for oral solid preparations mostly stays at the stage of manual sampling and off-line analysis and detection, mainly because the problems of easy blockage of a filter, trace drug adsorption and large workload of cleaning after determination exist, and online automatic sampling analysis and real-time monitoring are difficult to realize. The complex processes of manual sampling, filtering and off-line analysis have the defects of high working strength, multiple manual operation links, larger error and the like, and the analysis speed is limited, so that the accurate determination of the complete dynamic dissolution curve of the dissolved quick-release preparation is difficult to realize. The continuous monitoring of the medicine dissolution is realized by the adoption of the optical fiber medicine dissolution and CCD ultraviolet array monitoring method, but the interference of the hydrolysis of auxiliary materials and medicine components on the ultraviolet detection of the dissolution of the active medicine and the simultaneous detection of multiple active components of a medicine preparation with a complex formula, particularly different active components with similar ultraviolet absorption characteristics, can be encountered in the process of detecting the medicine dissolution.
By combining the factors, in the research of the dissolution rate of the oral solid preparation, an in-vitro dissolution rate analysis instrument of the oral solid preparation, which has the advantages of high time resolution, automation, self-assembly, low price, small volume, portability, simple operation and easy popularization, is necessary to design, realizes high-time resolution accurate online automatic drug dissolution detection, avoids the interference of the hydrolysis of auxiliary materials and other components in the drug dissolution process, and can be applied to the research of the real dissolution process of the complex multi-component formula drug preparation.
Disclosure of Invention
In order to achieve the above purpose, the technical solution adopted by the present invention is as follows:
an automatic high time resolution in vitro dissolution rate analyzer for oral solid drugs, comprising: the device comprises a flow cell drug dissolution device 1, an automatic sequence sample introduction device 2, a high-speed capillary electrophoresis separation detection device 3, a case 4 and a data processing end 5;
the flow cell drug dissolution device 1, the automatic sequence sample introduction device 2 and the high-speed capillary electrophoresis separation detection device 3 are fixedly arranged on the bottom plate in the case 4; the flow cell drug dissolution device 1, the automatic sequence sample introduction device 2 and the high-speed capillary electrophoresis separation detection device 3 are connected through a conduit; the data processing end 5 is arranged on the case 4;
a high time resolution automatic oral solid drug in vitro dissolution rate analyzer, the flow cell drug dissolution device 1 comprises: a dissolution medium bottle 11, a constant flow pump 12, a flow cell 13 and a constant temperature water bath 14; a constant flow pump conduit is arranged on the constant flow pump 12, and the dissolution medium bottle 11 is connected to the lower end of the flow cell 13 through the constant flow pump conduit; the flow cell 13 is a cylinder made of glass and having a diameter of 22.6 mm; the tablet support is arranged in the flow cell 13; the dissolution medium bottle 11 and the flow cell 13 are placed in a constant temperature water bath 14, and the heating temperature of the constant temperature water bath 14 is 37 +/-0.5 ℃.
The automatic sequence sample introduction device 2 comprises: the device comprises an electromagnetic valve 21, a waste liquid cup I22, a waste liquid cup II 27, an injector 23, an injection pump 24, a sample introduction capillary 25, a flow gate interface 26 and a stepping motor control valve 28; the flow cell 13 is connected with the waste liquid cup II 27 through a conduit; a back pressure pump conduit is arranged on the stepping motor control valve 28, the flow cell drug dissolution device 1 is connected to the stepping motor control valve 28 through the conduit of the back pressure pump, and the stepping motor control valve 28 is arranged at the sample inlet of the automatic sequence sample injection device 2; the other end of the stepping motor control valve 28 is connected with the flow gate interface 26 through a sample introduction capillary tube 25, the sample introduction capillary tube 25 is in butt joint with the separation capillary tube 35 at the inner end point of the flow gate interface 26, a slit is arranged at the butt joint end point, and the slit distance is 50 micrometers;
the electromagnetic valve 21 is provided with three interfaces, the separation capillary 35 is connected to one interface of the electromagnetic valve 21, and the other two interfaces of the electromagnetic valve 21 are respectively connected with the injector 23 and the waste liquid cup I22; the injector 23 is arranged on the injection pump 24, a tee joint is arranged in front of the injector 23, one end of the tee joint is connected with the electromagnetic valve, and the other end of the tee joint is connected with the waste liquid cup II 27.
The high-speed capillary electrophoresis separation detection device 3 includes: an ultraviolet visible detector 31, a detection probe 32, a numerical control high-voltage power supply 33, a buffer solution bottle 34, a separation capillary 35, a negative high-voltage electrode end 36 and a grounding electrode 37; a detection window with the effective length of 5 cm is provided with a capillary electrophoresis detection probe 32; the other end of the flow gate interface 26 is connected with a separation capillary 35, one end of which is connected with a grounding electrode 37, the other end of the separation capillary is connected with a buffer solution bottle 34, and the buffer solution bottle 34 is internally provided with a negative high-voltage electrode end 36 and an ultraviolet-visible detector 31.
The numerical control high voltage power supply 33 is connected with a negative high voltage electrode end 36 and a grounding electrode 37 through leads.
The case 4 is composed of: a box body consisting of a front panel 41, a bottom plate 42, an inner inserting plate 43, a right side plate 44, a rear panel 45, a top panel 46 and a left side plate 47; the cabinet 4 is made of ABS engineering plastics, and the top panel 46 is formed by connecting two plates by hinges; the front panel 41 is attached to the front of the top panel 46.
The data processing end 5 comprises a computer host 51 and a HUB multi-port transponder 53, the computer host 51 is connected to the HUB multi-port transponder 53 through a USB connecting line 52, and the HUB multi-port transponder 53 is provided with a control cable connecting port; the control cable connection port is respectively connected with the constant flow pump 12, the electromagnetic valve 21, the injection pump 24, the stepping motor control valve 28, the ultraviolet-visible detector 31, the detection probe 32 and the numerical control high-voltage power supply 33 through leads, and the numerical control high-voltage power supply 33 further comprises a negative high-voltage electrode end 36 and a grounding electrode 37.
The utility model discloses an automatic oral solid medicine external degree of dissolution analysis appearance of high time resolution, include: the device comprises a flow cell drug dissolution device, an automatic sequence sample introduction device, a high-speed capillary electrophoresis separation detection device, a case and a data processing end, wherein the flow cell drug dissolution device, the automatic sequence sample introduction device and the high-speed capillary electrophoresis separation detection device are fixedly arranged on a bottom plate in the case; the flow cell drug dissolution device, the automatic sequence sample introduction device and the high-speed capillary electrophoresis separation detection device are connected through a conduit; the data processing end is arranged on the case; the device is used for detecting the time of second order in the dissolution process of the medicine and monitoring the real process of medicine release; the interference of the optical fiber medicine dissolution monitoring method on the hydrolysis of auxiliary materials and medicine components in the medicine dissolution process is solved, and the method is suitable for the simultaneous analysis of a complex multi-component formula medicine preparation and multiple active components with similar ultraviolet absorption characteristics and the research of a real dissolution process; the equipment has small volume, convenient operation and easy popularization.
Drawings
FIG. 1 is a schematic view of a dissolution rate analyzer according to the present invention;
FIG. 2 is a schematic structural view of a drug-eluting portion of the flow cell of the present invention;
FIG. 3 is a schematic structural diagram of an automatic sequential sample injection part of the present invention;
FIG. 4 is a schematic structural diagram of the high-speed capillary electrophoresis separation detection device of the present invention;
fig. 5 is a schematic perspective view of the case of the present invention;
fig. 6 is a schematic diagram of the data processing system of the present invention.
The specific implementation mode is as follows:
the invention is further described below with reference to the accompanying drawings and specific embodiments.
Example 1
Referring to fig. 1 to 6, an automatic high time resolution in vitro dissolution analyzer for oral solid drugs comprises: the device comprises a flow cell drug dissolution device 1, an automatic sequence sample introduction device 2, a high-speed capillary electrophoresis separation detection device 3, a case 4 and a data processing end 5;
the flow cell drug dissolution device 1, the automatic sequence sample introduction device 2 and the high-speed capillary electrophoresis separation detection device 3 are fixedly arranged on the bottom plate in the case 4; the flow cell drug dissolution device 1, the automatic sequence sample introduction device 2 and the high-speed capillary electrophoresis separation detection device 3 are connected through a conduit; the data processing end 5 is arranged on the case 4;
the flow cell drug dissolution device 1 comprises: a dissolution medium bottle 11, a constant flow pump 12, a flow cell 13 and a constant temperature water bath 14;
the constant flow pump 12 (huiyouwei (beijing) fluid equipment limited) is provided with a constant flow pump conduit, and the dissolution medium bottle 11 is connected to the lower end of the flow cell 13 through the constant flow pump conduit;
the flow cell 13 is a cylinder body made of glass and having a diameter of 22.6 mm; the tablet support is arranged in the flow cell 13; the upper end of the flow cell is also provided with two layers of filtering membranes, and the pore diameters of the filtering membranes are respectively 2.7 mu m and 0.7 mu m;
the dissolution medium bottle 11 and the flow cell 13 are placed in a constant-temperature water bath 14, and the heating temperature of the constant-temperature water bath 14 is 37 +/-0.5 ℃;
the automatic sequence sample introduction device 2 comprises: the device comprises an electromagnetic valve 21, a waste liquid cup I22, a waste liquid cup II 27, an injector 23, an injection pump 24, a sample introduction capillary 25, a flow gate interface 26 and a stepping motor control valve 28;
the flow cell 13 is connected with the waste liquid cup II 27 through a conduit; a back pressure pump conduit is arranged on the stepping motor control valve 28, the flow cell drug dissolution device 1 is connected to the stepping motor control valve 28 through the conduit of the back pressure pump, and the stepping motor control valve 28 is arranged at the sample inlet of the automatic sequence sample injection device 2; the other end of the stepping motor control valve 28 is connected with the flow gate interface 26 through a sample introduction capillary tube 25, the sample introduction capillary tube 25 is in butt joint with the separation capillary tube 35 at the inner end point of the flow gate interface 26, a slit is arranged at the butt joint end point, and the slit distance is 50 micrometers;
the electromagnetic valve 21 (Shanghai Dan solenoid valve Co., Ltd.) is provided with three interfaces, the separation capillary 35 is connected to one interface of the electromagnetic valve 21, and the other two interfaces of the electromagnetic valve 21 are respectively connected with the injector 23 and the waste liquid cup I22;
the injector 23 is arranged on the injection pump 24, a tee joint is arranged in front of the injector 23, one end of the tee joint is connected with the outside of the electromagnetic valve, and the other end of the tee joint is connected with the waste liquid cup II 27;
the high-speed capillary electrophoresis separation detection device 3 includes: an ultraviolet visible detector 31, a detection probe 32, a numerical control high-voltage power supply 33, a buffer solution bottle 34, a separation capillary 35, a negative high-voltage electrode end 36 and a grounding electrode 37;
the separation capillary is a fused silica capillary (the chromatographic device of Jiangxi province, N.Y. in Hebei), the total length of the separation capillary 35 is 15 cm, and a detection window (a window with an outer protection layer burnt out by about 3 mm) with an effective length of 5 cm is also provided with a capillary electrophoresis detection probe 32;
one end of a separation capillary 35 connected with the other end of the flow door interface 26 is connected with a grounding electrode 37, the other end of the separation capillary is connected with a buffer solution bottle 34, and a negative high-voltage electrode end 36 and an ultraviolet-visible detector 31 are arranged in the buffer solution bottle 34;
the numerical control high-voltage power supply 33 is connected with a negative high-voltage electrode end 36 and a grounding electrode 37 through a lead;
the case 4 is composed of: a box body consisting of a front panel 41, a bottom plate 42, an inner inserting plate 43, a right side plate 44, a rear panel 45, a top panel 46 and a left side plate 47; the cabinet 4 is made of ABS engineering plastics, and the top panel 46 is formed by connecting two plates by hinges; the front panel 41 is connected to the front of the top panel 46;
the data processing end 5 comprises a computer host 51 and a HUB multi-port transponder 53, the computer host 51 is connected to the HUB multi-port transponder 53 through a USB connecting line 52, and the HUB multi-port transponder 53 is provided with a control cable connecting port; the tablet personal computer completes the parameter setting of the detector through control software, including the wavelength, the measuring range and the like of the ultraviolet detector and data acquisition parameters; after photoelectric conversion is realized by the ultraviolet detector, signals are transmitted into a tablet personal computer, and a continuously monitored electrophoresis spectrogram is output through a chromatographic workstation (Shanghai Vientiane instruments Co., Ltd.) in the computer; the electrophoresis spectrogram is processed in real time by self-designed software, and dissolution curves of different components are output.
The control cable connection port on the data processing end 5 is respectively connected with the constant flow pump 12, the electromagnetic valve 21, the injection pump 24, the stepping motor control valve 28, the ultraviolet visible detector 31, the detection probe 32 and the numerical control high-voltage power supply 33 through leads, and the numerical control high-voltage power supply 33 further comprises a negative high-voltage electrode end 36 and a grounding electrode 37;
combining the above specific implementation steps, the specific dissolution, sample injection and detection processes are as follows: pumping a large amount of fresh dissolution medium with the temperature of 37 +/-0.5 ℃ in a dissolution medium storage bottle 11 into the lower end of a flow cell 13 in a constant-temperature water bath 14 through a constant-flow pump 12 to realize open drug dissolution, enabling ultrapure water to be in contact with tablets on a stainless steel tablet rack, enabling the dissolved tablets to flow out from the upper end of the flow cell 13 through two layers of filter membranes with the pore diameters of 2.7 mu m and 0.7 mu m respectively, enabling one path of the effluent sample to enter a waste liquid cup II 27, enabling the other path of the effluent sample to enter a sample leading capillary 25 through back pressure controlled by a stepping motor control valve 28, controlling the sample leading flow rate to be 100 nL/min, enabling the sample leading time to be 1s, enabling the sample leading capillary 25 to be in butt joint with a separation capillary 35, applying sample feeding voltage of-5 kV at two ends of the separation capillary 35 through a numerical control high-voltage power supply 33, enabling the sample to enter the separation capillary 35 for electrophoresis from a flow gate interface 26 through electric sample feeding, enabling buffer solution in a syringe, the flow rate of buffer solution washing is 100 mu L/min, washing is carried out for 2s, and a switch for controlling the buffer solution washing by using an electromagnetic valve 21; applying a separation voltage of-15 kV to two ends of a separation capillary 35 through a numerical control high-voltage power supply 33, and carrying out real-time online continuous high-time resolution separation analysis detection on the tablet by using a capillary electrophoresis ultraviolet detector 31 to finish the dissolution process detection of the tablet; the data processing system tablet 51 may obtain a real-time continuous online electropherogram of the tablet.
While the invention has been described with respect to specific examples and embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention.
Claims (7)
1. An automatic high time resolution in vitro dissolution rate analyzer for oral solid drugs, comprising: the device comprises a flow cell drug dissolution device (1), an automatic sequence sample introduction device (2), a high-speed capillary electrophoresis separation detection device (3), a case (4) and a data processing end (5);
the method is characterized in that: the flow cell drug dissolution device (1), the automatic sequence sample introduction device (2) and the high-speed capillary electrophoresis separation detection device (3) are fixedly arranged on the bottom plate in the case (4); the flow cell drug dissolution device (1), the automatic sequence sample introduction device (2) and the high-speed capillary electrophoresis separation detection device (3) are connected through a conduit; the data processing end (5) is arranged on the case (4).
2. The high time resolution automatic oral solid drug in vitro dissolution rate analyzer according to claim 1, characterized in that: the flow cell drug dissolution device (1) comprises: a dissolution medium bottle (11), a constant flow pump (12), a flow cell (13) and a constant temperature water bath (14); a constant flow pump conduit is arranged on the constant flow pump (12), and the dissolution medium bottle (11) is connected to the lower end of the flow cell (13) through the constant flow pump conduit; the flow cell (13) is a cylinder body made of glass and with the diameter of 22.6 mm; the tablet support is arranged in the flow cell (13); the dissolution medium bottle (11) and the flow cell (13) are placed in a constant temperature water bath (14), and the heating temperature of the constant temperature water bath (14) is 37 +/-0.5 ℃.
3. The high time resolution automatic oral solid drug in vitro dissolution rate analyzer according to claim 2, characterized in that: the automatic sequence sample introduction device (2) comprises: the device comprises an electromagnetic valve (21), a waste liquid cup I (22), a waste liquid cup II (27), an injector (23), an injection pump (24), a sample introduction capillary tube (25), a flow gate interface (26) and a stepping motor control valve (28); the flow cell (13) is connected with the waste liquid cup II (27) through a conduit; a back pressure pump conduit is arranged on the stepping motor control valve (28), the flow cell drug dissolution device (1) is connected to the stepping motor control valve (28) through the conduit of the back pressure pump, and the stepping motor control valve (28) is arranged at the sample inlet of the automatic sequence sample injection device (2); the other end of the stepping motor control valve (28) is connected with the flow gate interface (26) through a sample introduction capillary tube (25), the sample introduction capillary tube (25) is butted with the separation capillary tube (35) at the inner end point of the flow gate interface (26), a slit is arranged at the butted end point, and the distance of the slit is 50 mu m;
the electromagnetic valve (21) is provided with three interfaces, the separation capillary (35) is connected to one interface of the electromagnetic valve (21), and the other two interfaces of the electromagnetic valve (21) are respectively connected with the injector (23) and the waste liquid cup I (22); the injector (23) is arranged on the injection pump (24), a tee joint is arranged in front of the injector (23), one end of the tee joint is connected with the outside of the electromagnetic valve, and the other end of the tee joint is connected with the waste liquid cup II (27).
4. The high time resolution automatic oral solid drug in vitro dissolution rate analyzer according to claim 3, characterized in that: the high-speed capillary electrophoresis separation detection device (3) comprises: the device comprises an ultraviolet visible detector (31), a detection probe (32), a numerical control high-voltage power supply (33), a buffer solution bottle (34), a separation capillary tube (35), a negative high-voltage electrode end (36) and a grounding electrode (37); a detection window with the effective length of 5 cm is provided with a capillary electrophoresis detection probe (32); one end of a separation capillary tube (35) which is connected with the other end of the flow door interface (26) is connected with a grounding electrode (37), the other end of the separation capillary tube is connected with a buffer solution bottle (34), and a negative high-voltage electrode end (36) and an ultraviolet visible detector (31) are arranged in the buffer solution bottle (34).
5. The high time resolution automatic oral solid drug in vitro dissolution rate analyzer according to claim 4, characterized in that: the numerical control high-voltage power supply (33) is connected with the negative high-voltage electrode end (36) and the grounding electrode (37) through a lead.
6. The high time resolution automatic oral solid drug in vitro dissolution rate analyzer according to claim 5, characterized in that: the case (4) is composed of: a box body consisting of a front panel (41), a bottom plate (42), an inner inserting plate (43), a right side plate (44), a rear panel (45), a top panel (46) and a left side plate (47); the box body material of the case (4) is made of ABS engineering plastics, and the top panel (46) is connected by two plates through hinges; the front panel (41) is connected to the front of the top panel (46).
7. The high time resolution automated oral solid drug in vitro dissolution analyzer according to claims 1, 2, 3, 4, 5 or 6, wherein: the data processing end (5) comprises a computer host (51) and a HUB multi-port transponder (53), the computer host (51) is connected to the HUB multi-port transponder (53) through a USB connecting line (52), and the HUB multi-port transponder (53) is provided with a control cable connecting port; the control cable connection port is respectively connected with the constant flow pump (12), the electromagnetic valve (21), the injection pump (24), the stepping motor control valve (28), the ultraviolet visible detector (31), the detection probe (32) and the numerical control high-voltage power supply (33) through leads, and the numerical control high-voltage power supply (33) further comprises a negative high-voltage electrode end (36) and a grounding electrode (37) which are connected.
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| CN201920188458.2U CN209894753U (en) | 2019-02-06 | 2019-02-06 | High-time-resolution automatic oral solid drug in-vitro dissolution rate analyzer |
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| CN201920188458.2U CN209894753U (en) | 2019-02-06 | 2019-02-06 | High-time-resolution automatic oral solid drug in-vitro dissolution rate analyzer |
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