CN217359920U

CN217359920U - Full-automatic medicine dissolution instrument capable of continuously measuring medicine dissolution rate

Info

Publication number: CN217359920U
Application number: CN202123116616.XU
Authority: CN
Inventors: 李睿; 张磊; 陈剑锋; 张季
Original assignee: YaoPharma Co Ltd
Current assignee: YaoPharma Co Ltd
Priority date: 2021-12-13
Filing date: 2021-12-13
Publication date: 2022-09-02
Anticipated expiration: 2031-12-13

Abstract

The utility model relates to a full-automatic medicine dissolution instrument capable of continuously measuring medicine dissolution, which comprises a machine head, a machine base and a water bath box, wherein the machine head is arranged above the machine base through a lifting component, and the water bath box is arranged on the machine base; the water bath box is divided into an area A and an area B, and the area A and the area B are respectively provided with a device for placing the dissolving-out cup; the machine head is divided into an experimental area C and an experimental preparation area D. The relative position of the machine head and the water bath box can be changed through the rotating device, and the mutual corresponding relation between the A, B area and the C, D area is changed, so that the switching between an experimental area and an experimental preparation area is realized. The purpose of continuously measuring the dissolution rate is achieved by a continuous switching mode, so that the working efficiency is improved.

Description

Full-automatic medicine dissolution instrument capable of continuously measuring medicine dissolution rate

Technical Field

The invention relates to the technical field of medicines, in particular to a medicine dissolution instrument capable of continuously measuring medicine dissolution.

Background

The dissolution rate of the medicine is an important index for evaluating the quality of the oral solid preparation of the medicine. Dissolution testing is a simple in vitro test method to simulate the disintegration and dissolution of oral solid formulations in the gastrointestinal tract. From the development stage to the production stage, a great deal of dissolution test research needs to be carried out on the oral solid preparation so as to ensure the use effectiveness of the pharmaceutical preparation. To measure the dissolution of a drug requires the use of a dissolution apparatus. The degree of automation of the dissolution apparatus is related to the efficiency of the apparatus. The current commercial automatic dissolution apparatus has the following working procedures: (1) adding a solvent; (2) equilibrating the vehicle to the desired temperature, typically 37 ℃. + -. 0.5 ℃; (3) automatically feeding a sample by an instrument to start a test; (4) after the preset sampling time is reached, the instrument automatically samples; (5) automatically cleaning the dissolving-out cup after sampling; (6) after the dissolution cup is cleaned, the next batch of samples can be measured through the procedures of (1) and (2). The actual dissolution rate can not be measured continuously and automatically. Therefore, we have devised a drug dissolution analyzer in order to solve the above-mentioned problems.

SUMMERY OF THE UTILITY MODEL

The technical scheme of the utility model can reach and dissolve out the appearance and carry out step (5), (1) and (2) simultaneously when carrying out above-mentioned step (3), (4) to realize the continuous automatic survey of true degree of dissolving out.

The purpose of the utility model is realized through the following technical scheme.

A full-automatic medicine dissolution instrument capable of continuously measuring medicine dissolution is characterized by comprising a machine head, a machine base and a water bath box, wherein the machine head is arranged above the machine base through a lifting assembly, and the water bath box is arranged on the machine base; the water bath box is divided into an area A and an area B, and the area A and the area B are provided with devices for placing dissolving-out cups; the machine head is divided into a zone C and a zone D, the zone C comprises experiment units, each experiment unit comprises a stirring mechanism, a sampling needle, a liquid supplementing pipeline and a temperature detector, the zone D comprises an experiment preparation unit, and each experiment preparation unit comprises a cleaning pipe, a stirring mechanism, a solvent adding pipe and a temperature detector; the A, B two zones of the dissolution instrument respectively correspond to C, D two zones in the initial state, each set of experimental units in the C zone respectively corresponds to one dissolution cup in the A zone, and each set of experimental preparation units in the D zone respectively corresponds to the dissolution cup in the B zone; the machine head and the water bath tank can change relative positions through the rotating device, so that the area A and the area B can respectively correspond to the area D and the area C, each set of experiment unit in the area D respectively corresponds to one dissolving-out cup in the area A, and each set of experiment preparation unit in the area C respectively corresponds to one dissolving-out cup in the area B.

According to the full-automatic drug dissolution instrument, each set of experiment unit in the area C comprises the stirring mechanism, the sampling needle, the fluid infusion pipeline and the temperature detector, and the stirring mechanism realizes synchronous stirring through the synchronous speed regulation assembly. Every rabbling mechanism all includes the fixing base, sets up bayonet (mixing) shaft on the fixing base, and the top of fixing base is equipped with the synchronizing shaft. The sampling needle is butted with the automatic sampling device to realize automatic sampling. The liquid supplementing pipeline is butted with the solvent preparation instrument to realize automatic liquid supplementing. The temperature detector is used for monitoring the real-time temperature during sample feeding and sampling.

In the fully automatic drug dissolution instrument, each set of experiment preparation unit in the area D comprises a cleaning pipe, a stirring paddle, a solvent adding pipe and a temperature detector. The cleaning pipe is connected with the purification water tank through a pump to convey the purification water to clean the dissolution cup, and the cleaning pipe switches a channel through a three-way device to discharge the waste liquid after cleaning. The 6 sets of stirring paddles realize synchronous stirring through another synchronous speed regulation component. When the dissolution cup is washed, the cleaning efficiency is improved by stirring; after addition of the solvent, the equilibration time is shortened by stirring. The solvent liquid adding pipe is butted with the solvent preparation instrument to realize the automatic liquid adding of the solvent. The temperature detector is used for monitoring the real-time temperature of the solvent in the dissolution cup in the experimental preparation area.

The water bath tank of the fully automatic drug dissolution instrument can be a hollow cylinder, a cuboid or other possible shapes.

According to the full-automatic medicine dissolution instrument, the height between the machine head and the water bath tank can be adjusted through the lifting device, after the machine head is lifted to the maximum height, the experimental area and the experimental preparation area are switched through the rotating device, and the switching modes comprise the following two modes:

the first method is as follows: the machine head part is accurately rotated for 180 degrees through a rotating device;

the second method comprises the following steps: through the rotating device, the water bath box can be accurately rotated by 180 degrees.

The rotating device in the full-automatic medicine dissolving-out instrument can be a worm gear or other structures capable of realizing rotating effect.

When the full-automatic drug dissolution instrument is in an initial state, the AC area is an experimental area, and the BD area is an experimental preparation area; after the AC area finishes the experiment, the experimental area and the experimental preparation area are switched by the rotating device, so that the BC area is switched into the experimental area, and the AD area is switched into the experimental preparation area; after the experiment is completed in the BC area, the experimental area and the experimental preparation area are switched again through the rotating device, and the purpose of continuous measurement is realized by repeating the steps.

As a preferable technical solution, the fully automatic drug dissolution apparatus contains 12 dissolution cups, that is, the zone a and the zone B respectively contain 6 dissolution cups, and also contains 6 sets of experiment units in the zone C and 6 sets of experiment preparation units in the zone D, wherein each set of experiment unit and experiment preparation unit corresponds to one dissolution cup.

As a preferred technical scheme, the water bath box of the full-automatic medicine dissolving instrument is a hollow cylinder, and 12 dissolving cups are uniformly distributed in the water bath box.

Compared with the prior art, the technical scheme of the utility model, accessible experimental area realizes real continuous automatic survey medicine degree of dissolution with the switching in experiment preparation district. The experiment can be carried out continuously in multiple batches, so that the experiment efficiency is improved. Meanwhile, in the experimental process, the instrument is fully automatic, and experimental failure caused by human errors is reduced.

Drawings

FIG. 1 is a schematic view of the entire structure of embodiment 1;

FIG. 2 is a top view of the water bath tank of example 1;

FIG. 3 is a side view of the junction at region A, B of the water bath tank of example 1;

FIG. 4 is a partial bottom view of the nose part of embodiment 1;

FIG. 5 is a side view of the head part of embodiment 1;

FIG. 6 is a schematic view of a rotating device for driving the rotation of the hand piece in embodiment 1;

FIG. 7 is a schematic view showing the overall structure of embodiment 2;

fig. 8 is a schematic view of the entire structure of embodiment 3.

Detailed Description

In order to make the technical solution of the present invention clearer and clearer, the following describes the technical solution further with reference to the accompanying drawings.

Example 1

As shown in fig. 1, the structure of the present invention is schematically illustrated. Comprises a machine head (1-1) and a machine base (1-2). The machine head can move up and down through the lifting assembly (1-3). The machine base is provided with a water bath tank (1-4). The water bath tank is circular and is provided with 12 dissolving cup placing devices (1-5). As shown in FIG. 2, 12 dissolution cups are distributed in a circular water bath and divided into left and right A, B zones. The machine head part is positioned right above the water bath box.

The water bath cabinet as described above has an arched recess (3-4) at the boundary of the AB region, as shown in FIG. 3. The arched groove is provided with a heating circulating water pump (3-1), and the arched groove is connected with the water bath tank through an inlet (3-2) and an outlet (3-3).

As shown in fig. 4, the head is divided into two regions, left and right C, D. In the initial state of the instrument, the C, D areas of the head part respectively correspond to the A, B two areas of the water bath box. The zone C and the zone D are respectively driven by two groups of rotating motors with the same speed to drive the stirring mechanism to rotate. And a first motor (4-1) drives 6 stirring mechanisms in the C area through a belt to realize synchronous stirring of the stirring mechanisms in the area. Every rabbling mechanism in district C all includes the fixing base, sets up bayonet (mixing) shaft on the fixing base. And a second motor (4-2) drives 6 stirring mechanisms in the D area through a belt to realize synchronous stirring of the stirring mechanisms in the area. Every rabbling mechanism in D district all includes the fixing base, sets up bayonet (mixing) shaft on the fixing base. The first motor and the second motor can be respectively set with rotating speeds according to requirements.

The C area of the nose part is an instrument experiment area, and 6 sets of experiment units (5-1) are contained in the instrument experiment area, as shown in figure 5. Each set of experiment unit comprises a stirring rod, a sampling needle, a temperature detector and a liquid supplementing pipe. The stirring rod can be provided with a paddle or a basket according to the experiment requirement. The sampling needle, the temperature detector and the liquid supplementing pipe can move up and down through a lifting device in the machine head part. Wherein the sampling needle is in butt joint with the automatic sampler through a pipeline, and the automatic sampler controls the sampling needle to sample; wherein the temperature detector can measure the temperature of the solution in the dissolution cup before or during sampling; the liquid supplementing pipe is butted with a solvent preparation instrument and is used for supplementing liquid according to the requirement.

The D area of the nose part is an instrument experiment preparation area, and 6 sets of experiment preparation units (5-2) are contained in the D area, as shown in figure 5. Each set of experiment preparation unit comprises a cleaning tube, a stirring paddle, a solvent liquid feeding tube and a temperature detector. The cleaning tube, the stirring paddle, the solvent liquid feeding tube and the temperature detector can move up and down to a designated position through a lifting device in the machine head part. The cleaning pipe is connected with the purification water tank through a pump to convey purified water to clean the dissolving-out cup, and the cleaned waste liquid is discharged through a three-way device to automatically switch channels. When the dissolving-out cup is cleaned, the cleaning efficiency is improved by the stirring of the stirring paddle in the area, and the solvent balance time can be shortened by stirring. The solvent liquid adding pipe is butted with the solvent preparation instrument to realize automatic quantitative liquid adding of the solvent. The temperature detector is used for monitoring the real-time temperature of the solvent in the dissolution cup in the experimental preparation area.

The shape and material of the stirring paddle in the experiment unit of the area C are consistent with those specified in Chinese pharmacopoeia. The stirring paddle in the D zone experiment preparation unit aims to improve the cleaning efficiency and shorten the solvent balance time through stirring, and the shape and the material of the stirring paddle can be inconsistent with those of the C zone.

As shown in fig. 6, a worm gear (6-1) is arranged below the machine head part lifting component. The worm gear rotates to drive the intermediate shaft, so that the head part can accurately rotate 180 degrees. After the experiment in the AC area is completed, the machine head rotates 180 degrees, the BC area is switched into the experimental area, and the AD area is switched into the experimental preparation area. After the experiment in the BC area is finished, the machine head rotates 180 degrees again, and the continuous measurement is realized.

Example 2

In embodiment 1, the purpose of freely switching the experimental area and the experimental preparation area is achieved by rotating the head part, or the head part may be fixed and the purpose of freely switching the experimental area and the experimental preparation area is achieved by rotating the water bath box. FIG. 7 is a schematic view showing the structure of the dissolution apparatus. The machine head is positioned right above the water bath tank, and the lifting device is positioned outside the water bath tank. The machine head is lifted through the lifting device. The water bath box is circular, is provided with 12 dissolution cups, and is divided into A, B two zones in a manner shown by a dotted line. Correspondingly, the nose part is still divided into C, D two zones. A. B, C, D the function and structure of the four regions are as described in example 1. The center of the circular ring water bath box is provided with a worm gear and worm (7-1) structure. The intermediate shaft is driven to rotate through the rotation of the worm gear and the worm. The intermediate shaft is connected with the water bath tank, and the water bath tank can rotate 180 degrees. After the experiment in the AC area is completed, the machine head rotates 180 degrees, the BC area is switched into the experimental area, and the AD area is switched into the experimental preparation area. After the experiment in the BC area is finished, the machine head rotates 180 degrees again, and the continuous measurement is realized.

Example 3

The structure of the dissolution instrument of the utility model can be square. As shown in fig. 8. The water bath box was rectangular and 12 dissolution cups were arranged in 3 x 4 fashion and divided into A, B two zones as shown by the dashed lines. Correspondingly, the nose part is still divided into C, D two zones. A. B, C, D the function and structure of the four regions are as described in example 1. The connection part (8-1) of the lifting device and the machine head part rotates 180 degrees, so that the switching between an experimental area and an experimental preparation area is realized, and the purpose of continuous measurement is realized.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are also within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A full-automatic medicine dissolution instrument capable of continuously measuring medicine dissolution is characterized by comprising a machine head (1-1), a machine base (1-2) and a water bath tank (1-4), wherein the machine head (1-1) is arranged above the machine base (1-2) through a lifting assembly (1-3), and the water bath tank (1-4) is arranged on the machine base (1-2); the water bath box (1-4) is divided into an area A and an area B, and the area A and the area B are provided with devices (1-5) for placing dissolution cups; the machine head (1-1) is divided into a C area and a D area, the C area comprises experiment units (5-1), each experiment unit (5-1) comprises a stirring mechanism, a sampling needle, a liquid supplementing pipeline and a temperature detector, the D area comprises an experiment preparation unit (5-2), and each experiment preparation unit (5-2) comprises a cleaning pipe, a stirring mechanism, a solvent adding pipe and a temperature detector; the A, B two zones of the dissolution instrument respectively correspond to C, D two zones in the initial state, each set of experimental units in the C zone respectively corresponds to one dissolution cup in the A zone, and each set of experimental preparation units in the D zone respectively corresponds to the dissolution cup in the B zone; the machine head (1-1) and the water bath tank (1-4) can change relative positions through the rotating device (1-6), so that the area A and the area B can also respectively correspond to the area D and the area C, each set of experiment unit in the area D respectively corresponds to one dissolving-out cup in the area A, and each set of experiment preparation unit in the area C respectively corresponds to one dissolving-out cup in the area B.

2. The fully automatic drug dissolution apparatus according to claim 1, wherein the lifting assembly (1-3) is located in the middle of the water bath (1-4), the rotating device (1-6) is installed on the lifting assembly (1-3), and the handpiece (1-1) can horizontally rotate 180 °.

3. The fully automatic drug dissolution apparatus according to claim 1, wherein the lifting assembly (1-3) is located outside the water bath (1-4), the rotating device (1-5) is located in the middle of the water bath (1-4), and the water bath (1-4) can be horizontally rotated by 180 °.

4. The fully automatic drug dissolution apparatus according to claim 1, wherein the rotating means (1-5) is a worm gear.

5. The fully automatic drug dissolution apparatus according to claim 1, wherein the water bath tank (1-4) is a rectangular parallelepiped or a hollow cylinder.

6. The fully automatic drug dissolution apparatus according to claim 5, wherein the water bath tank (1-4) is a hollow cylinder, 6 devices (1-5) for placing dissolution cups are respectively arranged in the A zone and the B zone, 6 sets of experiment units are arranged in the C zone, and 6 sets of experiment preparation units are arranged in the D zone.

7. The full-automatic drug dissolution apparatus according to claim 6, wherein an arch-shaped groove (3-4) is provided below the junction of the water bath tank (1-4) A, B, and a heating circulating water pump (3-1) is provided at the arch-shaped groove (3-4).

8. The fully automatic drug dissolution apparatus according to claim 1, wherein the stirring mechanisms in the zone C and the zone D are synchronously stirred by two synchronous speed-regulating assemblies respectively driven by a first motor (4-1) and a second motor (4-2) rotating at the same speed; the first motor (4-1) and the second motor (4-2) can be respectively set with rotating speeds.

9. The fully automated drug dissolution machine according to claim 1, wherein the agitation mechanism is a stir bar.

10. The fully automated drug dissolution apparatus of claim 9 wherein the paddle is further mountable to a paddle or basket.