Dissolution testing device integrated with automatic sampling pump

Abstract

The utility model belongs to the technical field of drug dissolution rate and release rate detection equipment, and particularly relates to a dissolution rate testing device integrated with an automatic sampling pump. Comprising a dissolution instrument and a sampling pump, the dissolution instrument comprises a base, the top end of the base is connected with a machine head of the dissolution instrument through a lifting device, the sampling pump is fixedly arranged at the top end of the base and located on the rear portion of the lifting device, and a plurality of dissolution cups and a plurality of liquid supplementing cups are arranged on the base; a sampling needle and a loop needle are arranged on the machine head of the dissolution instrument corresponding to each dissolution cup, a liquid supplementing needle is arranged on the machine head of the dissolution instrument corresponding to each liquid supplementing cup, and the sampling pump, the sampling needle, the loop needle and the liquid supplementing needle are respectively communicated with the valve group through corresponding pipelines. According to the utility model, the dissolution instrument and the sampling pump are integrated, so that the length of each pipeline is compressed to the maximum, and the problems that the temperature difference of the solution is large, the liquid residue in the pipeline is large, the sampling amount and the liquid supplementing amount are not accurate and the dissolved oxygen degree is influenced due to the fact that the related pipelines are too long are effectively solved.

Description

Technical Field

[0001] The utility model belongs to the technical field of drug dissolution and release rate detection equipment, in particular to a dissolution test device integrated with an automatic sampling pump. Background Art

[0002] In the process of drug development or production quality control, the measurement of drug dissolution or release is a key step. Manual or automatic dissolution apparatus is usually used to conduct routine in vitro drug dissolution and release tests.

[0003] The automatic dissolution apparatus used on the market consists of three functional modules: the dissolution apparatus main body, the automatic sampling pump, and the sample collector. The automatic sampling pump can exist as an independent functional machine (the automatic dissolution apparatus consists of the dissolution apparatus main body, the sampling pump, and the collector), or it can be integrated with the sample collector to form an automatic sampler (the automatic dissolution apparatus consists of the dissolution apparatus main body and the automatic sampler).

[0004] To meet the market's growing demand for high-efficiency dissolution testing, the market has gradually introduced 14-cup dissolution apparatuses, which adopt a left and right two-group partitioning layout (2 groups of 6 + 1), and directly integrate the rehydration cup into the dissolution apparatus mainframe. Six dissolution cups correspond to one rehydration cup, which can simultaneously conduct two batches of dissolution apparatus experiments and also support high-throughput screening experiments in R&D departments. Because the rehydration cup is directly integrated into the dissolution apparatus mainframe, the traditional spatial separation layout of dissolution apparatus + sampling pump + collector, or dissolution apparatus + automatic sampler, presents the following defects:

[0005] 1. The rehydration pipeline is particularly long. When rehydrating automatically after automatic sampling, the lysozyme needs to be pumped from the rehydration cup to the sampling pump first, and then the sampling pump is switched through the valve to inject it into the dissolution cup from the rinse pipeline or sampling pipeline. The rehydration pipeline, sampling pipeline, and rinse pipeline are too long, and the lysozyme stays in the pipeline for too long. The temperature of the lysozyme is significantly affected by the external temperature. The temperature difference has exceeded the allowable deviation range of 0.5°C, which cannot meet the regulatory requirements.

[0006] 2. The sampling pipeline, rinse pipeline, and fluid replenishment pipeline are too long. The automatic sampling and automatic fluid replenishment processes require the use of air to purge and empty the pipeline. Purge and emptying require repeated extraction of air. A large amount of air enters the dissolution cup, affecting the dissolved oxygen content of the lysozyme and causing the risk of deviation in the dissolution test data. Utility Model Content

[0007] In response to the problems existing in the above-mentioned prior art, the present invention provides a dissolution testing device with an integrated automatic sampling pump, and specifically discloses the following technical solutions:

[0008] A dissolution testing device with an integrated automatic sampling pump comprises a dissolution apparatus and a sampling pump, the dissolution apparatus comprises a base, the top of the base is connected to the dissolution apparatus head via a lifting device, the sampling pump is fixedly arranged at the top of the base and located at the rear of the lifting device, a plurality of dissolution cups and a plurality of rehydration cups are arranged on the base, a sampling needle and a loop needle are installed at a position corresponding to each dissolution cup on the dissolution apparatus head, a rehydration needle is installed at a position corresponding to each rehydration cup on the dissolution apparatus head, the sampling pump, the sampling needle, the loop needle and the rehydration needle are respectively connected to a valve group via corresponding pipelines, the valve group is also provided with an air inlet pipeline, and the pipeline between the loop needle and the valve group is also connected to a sample injection pipeline via a three-way valve.

[0009] Furthermore, the number of the dissolution cups is twelve and they are evenly divided into two groups. The two groups of dissolution cups are located on both sides of the lifting device respectively. The number of the rehydration cups is two. The two rehydration cups are arranged in the middle of the base and are used to rehydrate the two groups of dissolution cups respectively. The number of the sampling pumps is two, and all the sampling needles, loop needles and rehydration needles corresponding to each group of dissolution cups and a rehydration cup for its rehydration are connected to the same sampling pump.

[0010] Furthermore, a groove for the sampling pump to pass through is provided on the head of the dissolution apparatus at a position corresponding to the sampling pump.

[0011] Furthermore, a temperature probe is installed on the head of the dissolution apparatus corresponding to each dissolution cup, and the temperature probe is used to monitor the temperature of the solution in the dissolution cup.

[0012] Furthermore, a stirring assembly is installed on the head of the dissolution apparatus at a position corresponding to each dissolution cup, for stirring or rotating the solution in the dissolution cup to generate dissolution shear force.

[0013] Furthermore, the stirring assembly includes a stirring rod, a stirring element and a stirring motor. The stirring motor is fixed in the dissolution instrument head. The stirring rod is rotatably installed at the bottom of the dissolution instrument head and the top end is transmission-connected to the output shaft of the stirring motor. The stirring element is arranged on the bottom side wall of the stirring rod.

[0014] Furthermore, the sampling pump adopts a piston pump or a plunger pump.

[0015] Compared with the prior art, the beneficial effects of the present invention are:

[0016] In the utility model, the dissolution instrument and the sampling pump are integrated into one, and the sampling pump is designed to be close to the lifting device, so that the length of the pipeline from the sampling needle, the fluid infusion needle and the loop needle to the sampling pump is compressed to the extreme, thereby effectively solving the problems of large fluid infusion temperature difference, large solution residue in the pipeline, inaccurate automatic sampling volume and fluid infusion volume, and affected dissolved oxygen content caused by the relevant pipelines being too long. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the overall structure of the utility model.

[0018] Figure 2 for Figure 1 A partial enlarged view of point A in the middle.

[0019] Figure 3 This is a schematic diagram of the pipeline connection principle of the present utility model.

[0020] 1-base, 2-dissolution apparatus head, 3-lifting device, 4-sampling pump, 5-dissolution cup, 6-rehydration cup, 7-sampling needle, 8-loop needle, 9-rehydration needle, 10-temperature probe, 11-valve group, 12-three-way valve, 13-air inlet line, 14-sample injection line, 15-stirring rod, 16-stirring element. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described 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.

[0022] Reference Figure 1-3 , a dissolution testing device with an integrated automatic sampling pump, comprising a dissolution instrument and a sampling pump 4, the dissolution instrument comprising a base 1, the top of the base 1 being connected to a dissolution instrument head 2 via a lifting device 3, the lifting device 3 being able to drive the dissolution instrument head 2 to move up and down, the sampling pump 4 being fixedly arranged at the top of the base 1, located at the rear of the lifting device 3 and close to the lifting device 3, a plurality of dissolution cups 5 and a plurality of rehydration cups 6 are arranged on the base 1, a sampling needle 7 and a loop needle 8 are installed at the position corresponding to each dissolution cup 5 on the dissolution instrument head 2, a rehydration needle 9 is installed at the position corresponding to each rehydration cup 6 on the dissolution instrument head 2, the sampling pump 4, the sampling needle 7, the loop needle 8 and the rehydration needle 9 are respectively connected to a valve group 11 through corresponding pipelines, the valve group is also provided with an air inlet pipeline 13, and the pipeline between the loop needle 8 and the valve group 11 is also connected to a sample injection pipeline 14 through a three-way valve 12.

[0023] In this embodiment, the number of dissolution cups 5 is twelve and they are evenly divided into two groups, each group of six dissolution cups. The two groups of dissolution cups are located on both sides of the lifting device 3. The number of the rehydration cups 6 is two, and the two rehydration cups 6 are located in the middle of the base 1 and are used to rehydrate the two groups of dissolution cups respectively. The number of the sampling pumps 4 is two, and the two sampling pumps 4 are integrated. Each group of dissolution cups and all the sampling needles 7, loop needles 8, and rehydration needles 9 corresponding to the rehydration cup 6 for each group of dissolution cups are connected to the same sampling pump 4. In this embodiment, six dissolution cups 5 and one rehydration cup 6 constitute a test group. In this embodiment, there are two test groups in total, and two different groups of tests can be performed simultaneously, thereby improving efficiency.

[0024] In this embodiment, a groove for the sampling pump 4 to pass through is provided on the dissolution apparatus head 2 at a position corresponding to the sampling pump 4 , thereby preventing the sampling pump 4 from hindering the lifting and lowering of the dissolution apparatus head 2 .

[0025] In this embodiment, a temperature probe is installed at a position corresponding to each dissolution cup 5 on the dissolution instrument head 2. The temperature probe is used to monitor the temperature of the solution in the dissolution cup 5, thereby helping the tester to obtain temperature data in real time.

[0026] In this embodiment, a stirring assembly is installed at a position corresponding to each dissolution cup 5 on the dissolution apparatus head 2, for stirring the solution in the dissolution cup 5 to provide dissolution shear force for the dissolution experiment.

[0027] In this embodiment, the stirring assembly includes a stirring rod 15, a stirring element 16 and a stirring motor. The stirring motor is fixed in the dissolution apparatus head 2. The stirring rod 15 is rotatably installed at the bottom of the dissolution apparatus head 2 and the top end is transmission-connected to the output shaft of the stirring motor. The stirring element 16 is arranged on the bottom side wall of the stirring rod 15.

[0028] In this embodiment, the sampling pump 4 is a piston pump or a plunger pump.

[0029] Before sampling or rehydration, it is generally necessary to purge the pipeline. In this case, the valve group 11 can be adjusted to connect the air intake pipeline 13 with the sampling pump 4, so that sufficient air can be sucked in through the air intake pipeline 13. Then, the valve group 11 can be adjusted to connect the sampling pump 4 with the sampling needle 7 or the return needle 8, and then the air can be discharged to achieve the purge of the relevant pipelines.

[0030] Before sampling, it is necessary to rinse the pipeline connected to the sampling needle 7 and the pipeline connected to the loop needle 8. At this time, the valve group 11 can be adjusted first to connect the sampling pump 4 with the sampling needle 7 to complete the liquid aspiration operation. Then, the valve group 11 can be adjusted to connect the sampling pump 4 with the loop needle 8 to achieve the pipeline rinsing and flushing operation, thereby completing the rinsing of the relevant pipelines.

[0031] When sampling, the valve group 11 can be adjusted first to connect the sampling needle 7 with the sampling pump 4, thereby completing the quantitative sampling operation, and then the valve group 11 and the three-way valve 12 can be adjusted to connect the sampling pump 4 with the sample injection pipeline 14, so that the sample solution can be injected into the sample collector tube or liquid phase vial through the sample injection pipeline 14 to complete the sampling and collection of the sample;

[0032] When the dissolution experiment requires an equal amount of fluid replenishment after sampling, it is necessary to first adjust the valve group 11 to connect the sampling pump 4 with the fluid replenishment needle 9 to absorb the solution in the fluid replenishment cup 6, and then adjust the valve group 11 to connect the sampling pump 4 with the sampling needle 7 or the loop needle 8, so that the absorbed solution can be smoothly replenished into the dissolution cup 5.

[0033] The above description is merely a preferred embodiment of the present invention and does not limit the technical scope of the present invention. Therefore, any minor modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A dissolution testing device with an integrated automatic sampling pump, characterized in that: The dissolution apparatus comprises a dissolution apparatus and a sampling pump, wherein the dissolution apparatus comprises a base, the top of the base is connected to the dissolution apparatus head via a lifting device, the sampling pump is fixedly arranged at the top of the base and located at the rear of the lifting device, a plurality of dissolution cups and a plurality of rehydration cups are arranged on the base, a sampling needle and a loop needle are installed at a position corresponding to each dissolution cup on the dissolution apparatus head, a rehydration needle is installed at a position corresponding to each rehydration cup on the dissolution apparatus head, the sampling pump, the sampling needle, the loop needle and the rehydration needle are respectively connected to the valve group through corresponding pipelines, the valve group is also provided with an air inlet pipeline, and the pipeline between the loop needle and the valve group is also connected to a sample injection pipeline via a three-way valve.

2. A dissolution testing device with an integrated automatic sampling pump according to claim 1, characterized in that: There are twelve dissolution cups and they are evenly divided into two groups. The two groups of dissolution cups are located on both sides of the lifting device respectively. There are two rehydration cups. The two rehydration cups are arranged in the middle of the base and are used to rehydrate the two groups of dissolution cups respectively. There are two sampling pumps, and all sampling needles, loop needles and rehydration needles corresponding to each group of dissolution cups and a rehydration cup for rehydration are connected to the same sampling pump.

3. A dissolution testing device with an integrated automatic sampling pump according to claim 2, characterized in that: A groove for the sampling pump to pass through is provided on the head of the dissolution apparatus at a position corresponding to the sampling pump.

4. The dissolution testing device with an integrated automatic sampling pump according to claim 1, characterized in that: A temperature probe is installed on the head of the dissolution instrument corresponding to each dissolution cup, and the temperature probe is used to monitor the temperature of the solution in the dissolution cup.

5. The dissolution testing device integrated with an automatic sampling pump according to claim 1, characterized in that: A stirring assembly is installed on the head of the dissolution instrument at a position corresponding to each dissolution cup, and is used to stir or rotate the solution in the dissolution cup to generate dissolution shear force.

6. The dissolution testing device integrated with an automatic sampling pump according to claim 5, characterized in that: The stirring assembly includes a stirring rod, a stirring element and a stirring motor. The stirring motor is fixed in the dissolution instrument head. The stirring rod is rotatably installed at the bottom of the dissolution instrument head and the top end is transmission-connected to the output shaft of the stirring motor. The stirring element is arranged on the bottom side wall of the stirring rod.

7. The dissolution testing device integrated with an automatic sampling pump according to claim 1, characterized in that: The sampling pump is a piston pump or a plunger pump.

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