阅读说明：本技术 一种用于脂溶性药物的化学稳定性检测装置及方法 (Chemical stability detection device and method for fat-soluble medicine ) 是由 周彩华 于 2021-08-25 设计创作，主要内容包括：本发明涉及药物检测设备技术领域,具体来说是一种用于脂溶性药物的化学稳定性检测装置及方法,包括检测箱,检测箱内并排设置有若干透明的反应腔体,若干反应腔体共同与限位板连接；检测箱内设置有稳定性辅助检测件,稳定性辅助检测件包括光源组件、显示屏和摄像头：光源组件和显示屏分别设置于检测箱的两个对称侧壁上；摄像头贯通设置于限位板上；摄像头还与计算机电性连接；每个反应腔体的开口上均对应设置有密封盖体,每个密封盖体上均贯通设置有加样管。本发明实现了对脂溶性药物崩解程度的实时监测,便于与液相色谱联用,继而克服现有技术检测装置的技术缺陷。(The invention relates to the technical field of medicine detection equipment, in particular to a chemical stability detection device and a chemical stability detection method for a fat-soluble medicine, wherein the chemical stability detection device comprises a detection box, a plurality of transparent reaction cavities are arranged in the detection box side by side, and the reaction cavities are connected with a limiting plate together; be provided with the supplementary piece that detects of stability in the detection case, the supplementary piece that detects of stability includes light source subassembly, display screen and camera: the light source assembly and the display screen are respectively arranged on two symmetrical side walls of the detection box; the camera is arranged on the limiting plate in a penetrating manner; the camera is also electrically connected with the computer; all correspond on the opening of every reaction cavity and be provided with the sealed lid, all link up on every sealed lid and be provided with the application of sample pipe. The invention realizes the real-time monitoring of the disintegration degree of the fat-soluble medicine, is convenient to be used together with liquid chromatogram, and then overcomes the technical defects of the detection device in the prior art.)

1. The chemical stability detection device for the fat-soluble medicine is characterized by comprising a detection box (1), wherein a plurality of transparent reaction cavities (2) which are located at the same height are arranged in the detection box (1) side by side, and the reaction cavities (2) are connected with a limiting plate (3) together;

be provided with the supplementary piece that detects of chemical stability on detection case (1), the supplementary piece that detects of chemical stability includes control system, light source subassembly, display screen (4), camera (5) and operating panel (24), last still electric connection of control system has computer (23):

the light source assembly and the display screen (4) are respectively arranged on two symmetrical inner walls of the detection box (1);

the number of the cameras (5) is a plurality, the cameras are respectively arranged corresponding to the reaction cavities (2) and are arranged on the limiting plate (3) in a penetrating manner;

the operation panel (24) and the control system are respectively arranged on the outer wall of the detection box (1);

the control system is respectively and electrically connected with the display screen (4), the light source assembly, the camera (5), the computer (23) and the operation panel (24);

each reaction cavity (2) is provided with a sealing cover body (6) respectively, and each sealing cover body (6) is provided with a sample adding pipe (7) in a penetrating way.

2. The device for detecting chemical stability of a fat-soluble drug according to claim 1, wherein each of the reaction chambers (2) has an opening on a side wall thereof, and each of the openings is hermetically provided with an elastic membrane (8).

3. The device for detecting chemical stability of fat-soluble drugs according to claim 2, wherein the limiting plate (3) is slidably connected to the inner wall of the detection box (1), a plurality of simulation members (9) are disposed on the limiting plate (3) at positions corresponding to the elastic membrane (8), respectively, the simulation members (9) are used for adjusting the creep of the elastic membrane (8), and the simulation members (9) comprise:

the side wall of the lantern ring (10) is connected with the limiting plate (3) through a connecting rod;

the bottom end of the limiting rod (11) is provided with a connecting piece, the top end of the limiting rod penetrates through the sleeve ring (10) from bottom to top and is sleeved in the sleeve ring (10), the connecting piece comprises a limiting block (12) provided with a through groove and a roller (13), and the roller (13) is positioned in the through groove and is rotatably connected with the limiting block (12);

the spring (16) is sleeved on the limiting rod (11), and two ends of the spring are respectively abutted against the limiting block (12) and the lantern ring (10);

the edge of the cam (14) is provided with a slideway, and the roller (13) is connected with the cam (14) in a sliding way through the slideway; the cam (14) corresponds to the position of the elastic membrane (8) and is abutted against the elastic membrane (8);

and the motor (15) is connected with the limiting plate (3) through a connecting rod, and the output shaft of the motor is connected with the cam (14).

4. A chemical stability testing device for fat-soluble drugs according to claim 3, wherein the testing chamber (1), the space between the testing chamber (1) and the reaction chamber (2) is filled with fluid, the testing chamber (1) is further provided with an electric heating rod (18) for heating the fluid, and the electric heating rod (18) is electrically connected with the control system.

5. The device for detecting chemical stability of a fat-soluble drug according to claim 4, wherein the sample tubes (7) are commonly connected with a liquid storage tank (19) in a through manner, each sample tube (7) is provided with an electromagnetic valve (20), and the electromagnetic valves (20) are electrically connected with the control system.

6. The device for detecting chemical stability of a fat-soluble drug according to claim 5, wherein the light source assembly comprises a light emitter and a lamp housing (21), and the light emitter is disposed between the lamp housing (21) and the side wall of the detection box (1).

7. The device for detecting the chemical stability of the fat-soluble medicine according to claim 1, wherein a plurality of sampling tubes (22) are longitudinally arranged on the side wall of the reaction cavity (2) in a penetrating manner side by side, each sampling tube (22) is sleeved with a sealing cap (17), and each side wall of the reaction cavity (2) is longitudinally provided with scales.

8. The device for detecting chemical stability of fat-soluble drugs according to claim 1, wherein the light source assembly, the limiting plate (3) and the display screen (4) are arranged in parallel, and the height of the limiting plate (3) is higher than that of the light source assembly.

9. The use method of the device for detecting chemical stability of fat-soluble drug according to claim 6, comprising the following steps:

step one, placing a fat-soluble medicine to be detected into the reaction cavity (2), then respectively sealing the reaction cavity (2) through the sealing cover bodies (6), placing the reaction cavity (2) into the detection box (1) together, controlling the electric heating rod (18) through the control system to heat the fluid to 35-38 ℃, adjusting the height of the limiting plate (3), opening control buttons of the motor (15) and the electromagnetic valve (20), and adding a fixed material into each reaction cavity (2)Alkali liquor with certain quantity, then recording disintegration initial time t into the described control system₀；

Step two, simultaneously turning on the light-emitting body, the display screen (4) and the control switch of the camera (5), wherein light emitted by the light-emitting body penetrates through the reaction cavity (2) and is displayed on the display screen (4), shadow surface data shot by the camera (5) are sent to the computer (23), the computer (23) processes and identifies the image after acquiring the image, and the time for recording and acquiring the image is recorded as disintegration time t_xX is taken from a natural number more than or equal to 1, and the disintegration condition of the fat-soluble medicine is judged according to the shadow area,and recording the relation data of the disintegration time and the dissolution rate into the control system.

Technical Field

The invention relates to the technical field of medicine detection equipment, in particular to a device and a method for detecting chemical stability of a fat-soluble medicine.

Background

The fat-soluble medicine is a medicine which is insoluble in water and soluble in fat and organic solvents such as carbon tetrachloride, glycerol, grease and the like; compared with water-soluble drugs, fat-soluble drugs are more easily metabolized by the liver, and metabolites are excreted by the kidney. Many drugs are fat-soluble substances, which cannot be dissolved in water, blood or other body fluids, and before the drugs are put on the market, drug detection is required, wherein the important item is the detection of the physicochemical properties of the drugs, namely the detection of the physical and chemical properties of the drugs, the fat solubility and water solubility of the drugs affect the absorption, distribution, metabolism and excretion of the drugs, and the chemical stability affects the drug quality and the in vivo process.

In the prior art, the detection of the chemical stability of the fat-soluble medicine is usually judged by acidity detection, usually, the fat-soluble liquid medicine is mixed with an alkali solution, and the reaction of the medicine is measured by neutralization reaction; in the detection process, sampling is often carried out within a certain time, and the disintegration degree of the sample liquid is monitored by introducing the sample liquid into the liquid chromatogram, wherein in the process, the limitation of the certain time is not judged, and at the moment, the time limitation and sampling are carried out according to the guess of a detector; secondly, the relation between the disintegration amount of the fat-soluble medicine and the time cannot be analyzed, and the disintegration amount of the fat-soluble medicine in a certain time period can only be judged; thirdly, the disintegration degree of the fat-soluble medicine is judged only by liquid chromatography, so that the operation is complicated; finally, the time for complete disintegration cannot be judged; in summary, the detection of the chemical stability of the fat-soluble drug by using the prior art device is not able to achieve the purpose of real-time monitoring, and the operation is complex, so an auxiliary detection device capable of monitoring the disintegration degree of the fat-soluble drug is required to determine the chemical stability of the fat-soluble drug.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide a device and a method for detecting the chemical stability of a fat-soluble medicament.

In order to solve the technical problems, the invention adopts the following technical scheme:

a chemical stability detection device for a fat-soluble drug comprises a detection box, wherein a plurality of transparent reaction cavities which are located at the same height are arranged in the detection box side by side, and the reaction cavities are connected with a limiting plate together;

be provided with the supplementary piece that detects of chemical stability on the detection case, the supplementary piece that detects of chemical stability includes control system, light source subassembly, display screen, camera and operating panel, last still electric connection of control system has the computer:

the light source assembly and the display screen are respectively arranged on two symmetrical inner walls of the detection box;

the number of the cameras is a plurality, the cameras are respectively arranged corresponding to the reaction cavities and are arranged on the limiting plate in a penetrating manner;

the operation panel and the control system are respectively arranged on the outer wall of the detection box;

the control system is electrically connected with the display screen, the light source assembly, the camera, the computer and the operation panel respectively;

every be provided with the sealed lid on the reaction cavity respectively, every all link up on the sealed lid and be provided with the application of sample pipe.

Preferably, each side wall of the reaction cavity is provided with an opening, and each opening is hermetically provided with an elastic membrane.

Preferably, the limiting plate with detection case inner wall sliding connection, on the limiting plate, respectively with the position that the elasticity membrane corresponds is provided with a plurality of simulation pieces, the simulation piece is used for adjusting the elasticity membrane wriggling, the simulation piece includes:

the side wall of the lantern ring is connected with the limiting plate through a connecting rod;

the bottom end of the limiting rod is provided with a connecting piece, the top end of the limiting rod penetrates through the sleeve ring from bottom to top and is sleeved in the sleeve ring, the connecting piece comprises a limiting block provided with a through groove and a roller, and the roller is positioned in the through groove and is rotationally connected with the limiting block;

the spring is sleeved on the limiting rod, and two ends of the spring are respectively abutted against the limiting block and the lantern ring;

the edge of the cam is provided with a slideway, and the roller is connected with the cam in a sliding way through the slideway; the cam corresponds to the elastic membrane in position and abuts against the elastic membrane;

and the motor is connected with the limiting plate through a connecting rod, and an output shaft of the motor is connected with the cam.

Preferably, fluid is filled in the detection box and between the detection box and the reaction cavity, an electric heating rod for heating the fluid is further arranged in the detection box, and the electric heating rod is electrically connected with the control system.

Preferably, the sample adding pipes are connected with the liquid storage tank in a penetrating mode, each sample adding pipe is provided with an electromagnetic valve, and the electromagnetic valves are electrically connected with the control system.

Preferably, the light source component comprises a light-emitting body and a lampshade, and the light-emitting body is arranged between the lampshade and the side wall of the detection box.

Preferably, it is provided with a plurality of sampling pipes, every to link up side by side along vertically on the reaction cavity lateral wall all the cover is equipped with sealed cap on the sampling pipe, and every all be provided with the scale along vertically on the reaction cavity lateral wall.

Preferably, the light source assembly, the limiting plate and the display screen are arranged in parallel, and the height of the limiting plate is higher than that of the light source assembly.

The invention also provides a using method of the chemical stability detection device for the fat-soluble medicine, which comprises the following steps:

step one, placing a fat-soluble medicine to be detected into the reaction cavity, then respectively sealing the reaction cavity through the sealing cover bodies, placing the reaction cavities into the detection box together, controlling the electric heating rod through the control system to heat the fluid to 35-38 ℃, adjusting the height of the limiting plate, opening a control button of the motor and the electromagnetic valve, adding quantitative alkali liquor into each reaction cavity, and recording the initial disintegration time t into the control system₀；

Step two, simultaneously turning on the control switches of the luminous body, the display screen and the camera, wherein light emitted by the luminous body penetrates through the reaction cavity and is displayed on the display screen, shadow surface data shot by the camera respectively are sent to the computer, and the computer calculatesAfter the machine acquires the image, image processing and image recognition are carried out, and the time for recording and acquiring the image is recorded as disintegration time t_xX is taken from a natural number more than or equal to 1, and the disintegration condition of the fat-soluble medicine is judged according to the shadow area,and recording the relation data of the disintegration time and the dissolution rate into the control system.

Compared with the prior art, the invention has the beneficial effects that:

1. the chemical stability auxiliary detection piece is arranged and comprises a light source component, a display screen and a camera, wherein a luminous body of the light source component provides visible light, when the visible light irradiates a reaction cavity, disintegrated drug particles are dissolved in alkali liquor in the reaction cavity, when the visible light irradiates the surface of solid particles, the light cannot penetrate through the solid particles, a shadow surface corresponds to the solid particles on the display screen, after the visible light is shot by the camera, data are sent to a computer, the computer performs image processing and image recognition after obtaining images, and then the dissolution condition of the fat-soluble drug is judged according to the shadow area; this action may be performed in real time.

2. The simulation piece and the elastic membrane can be attached to the movement of the stomach of the human body better than the stirring in the prior art, so that the error is reduced;

the simulation piece comprises a lantern ring, a limiting rod, a spring, a cam and a motor, the cam rotates under the action of the motor, and the cam exerts an acting force on the elastic membrane at the moment so that the elastic membrane simulates the peristalsis of the intestines and stomach of a human body.

3. The reaction cavity is communicated with the liquid storage tank through the sample adding pipe, the sample adding pipes are provided with the electromagnetic valves, and the purpose of equal sample adding is realized by opening or closing the electromagnetic valves simultaneously during sample adding; the reaction cavities are multiple, and the detection of multiple parallel samples is realized for the same fat-soluble medicine, so that the experimental error is reduced.

4. The invention is also provided with an electric heating rod and fluid, the temperature of the fluid is controlled to 35-38 ℃ by controlling the electric heating rod, and then the simulation of the human stomach environment is realized through the fluid, the simulation piece and the elastic membrane together, so that the experimental error is reduced.

Drawings

FIG. 1 is a sectional view showing the internal structure of a detection chamber of a device for detecting chemical stability of a fat-soluble drug according to the present invention;

FIG. 2 is a top view of the internal structure of a detection box of the device for detecting chemical stability of fat-soluble drugs according to the present invention;

fig. 3 is a schematic diagram of the external structure of a chemical stability detection device for fat-soluble drugs according to the present invention.

Description of reference numerals:

1. a detection box; 2. a reaction chamber; 3. a limiting plate; 4. a display screen; 5. a camera; 6. sealing the cover body; 7. a sample adding pipe; 8. an elastic film; 9. a simulation member; 10. a collar; 11. a limiting rod; 12. a limiting block; 13. a roller; 14. a cam; 15. a motor; 16. a spring; 17. a sealing cap; 18. an electrical heating rod; 19. a liquid storage tank; 20. an electromagnetic valve; 21. a lamp shade; 22. a sampling tube; 23. a computer; 24. an operation panel 24.

Detailed Description

The following detailed description of specific embodiments of the invention is provided, but it should be understood that the scope of the invention is not limited to the specific embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention. The experimental methods in the examples of the present invention are all conventional methods unless otherwise specified.

A chemical stability detection device for a fat-soluble medicine comprises a detection box 1, wherein the detection box 1 is used for monitoring the chemical stability of the fat-soluble medicine in real time, a plurality of transparent reaction cavities 2 which are located at the same height are arranged in the detection box 1 side by side, light of a luminous body can conveniently penetrate through the reaction cavities 2, and the reaction cavities 2 are connected with a limiting plate 3 together, so that the unification of the positions of the reaction cavities 2 is realized, and the detection errors of a plurality of parallel samples are conveniently reduced; the limiting plate 3 is connected with the inner wall of the detection box 1 in a sliding mode, the inner wall of the detection box 1 is provided with a sliding chute, a plurality of limiting holes are arranged in the sliding chute side by side, the limiting plate 3 slides in the sliding chute and is screwed in the limiting holes through screws to achieve height adjustment of the limiting plate 3;

the chemical stability auxiliary detection device is arranged on the detection box 1 and comprises a control system, a light source assembly, a display screen 4, a camera 5 and an operation panel 24, the control system is also electrically connected with a computer 23, the light source assembly comprises a luminous body and a lampshade 21, the luminous body is arranged between the lampshade 21 and the side wall of the detection box 1, and the lampshade is used for protecting the luminous body; the light source assembly and the display screen 4 are respectively arranged on two symmetrical inner walls of the detection box 1, the light source assembly, the limiting plate 3 and the display screen 4 are arranged in parallel, light emitted by the luminous body can penetrate through the reaction cavities 2 and is displayed on the display screen 4, and light of the luminous body penetrates through each reaction cavity 2 in parallel;

the number of the cameras 5 is a plurality of cameras, the cameras are respectively arranged corresponding to the reaction cavity 2 and are arranged on the limiting plate 3 in a penetrating manner, the operation panel 24 and the control system are respectively arranged on the outer wall of the detection box 1, the control system is respectively electrically connected with the display screen 4, the light source assembly, the cameras 5, the computer 23 and the operation panel 24, when visible light irradiates the reaction cavity 2, disintegrated drug particles are dissolved in alkali liquor in the reaction cavity 2, when light irradiates the surface of the solid particles, the light cannot penetrate through the solid particles, at the moment, a shadow surface corresponds to the display screen 4, and after the visible light irradiates the surface of the solid particles, data are sent to the computer 23;

each reaction cavity 2 is provided with a sealing cover body 6, each sealing cover body 6 is provided with a sample adding pipe 7 in a penetrating way, the sample adding pipes 7 are connected with a liquid storage tank 19 in a penetrating way, each sample adding pipe 7 is provided with an electromagnetic valve 20, the electromagnetic valves 20 are electrically connected with the control system, and at the moment, when sample is added, the purpose of equal sample adding is realized by opening or closing the electromagnetic valves 20 simultaneously; the reaction cavities 2 are provided with a plurality of reaction cavities, so that the detection of a plurality of parallel samples can be realized simultaneously for the same fat-soluble medicine, and the experimental error is reduced.

An opening is formed in the side wall of each reaction cavity 2, an elastic membrane 8 is hermetically arranged on each opening, and the elastic membrane 8 is in a tightening state in a natural state, so that the liquid adding amount can be conveniently determined; on the limiting plate 3, respectively with the position that elasticity membrane 8 corresponds is provided with a plurality of simulation 9, simulation 9 is used for adjusting elasticity membrane 8 wriggling, simulation 9 includes:

the side wall of the lantern ring 10 is connected with the limiting plate 3 through a connecting rod;

the bottom end of the limiting rod 11 is provided with a connecting piece, the top end of the limiting rod penetrates through the lantern ring 10 from bottom to top and is sleeved in the lantern ring 10, the connecting piece comprises a limiting block 12 provided with a through groove and a roller 13, and the roller 13 is located in the through groove and is rotatably connected with the limiting block 12;

the spring 16 is sleeved on the limiting rod 11, and two ends of the spring respectively abut against the limiting block 12 and the lantern ring 10;

the edge of the cam 14 is provided with a slideway, and the roller 13 is connected with the cam 14 in a sliding way through the slideway; the cam 14 corresponds to the position of the elastic membrane 8 and is abutted against the elastic membrane 8;

the motor 15 is connected with the limiting plate 3 through a connecting rod, an output shaft of the motor is connected with the cam 14, the motor 15 drives the cam 14 to rotate, the cam 14 is connected with the roller 13 in a sliding mode, the roller 13 also promotes the rotation of the cam 14, after the cam 14 is abutted against the elastic membrane 8, the elastic membrane deforms, at the moment, the deformation of the elastic membrane 8 is close to the peristalsis of the stomach of a human body, and experimental errors are reduced; fluid is filled in the detection box 1 and between the detection box 1 and the reaction cavity 2, the fluid is mainly water, an electric heating rod 18 for heating the fluid is further arranged in the detection box 1, the electric heating rod 18 is electrically connected with the control system, the temperature of the fluid is controlled to 35-38 ℃ through controlling the electric heating rod 18, and then the simulation of the human stomach environment is realized through the fluid, the simulation piece 9 and the elastic membrane 8 together, so that the experimental error is reduced; the position adjustment of the limiting plate 3 realizes the adjustment of the peristaltic positions with different heights for different liquid adding quantities, and realizes more accurate gastrointestinal peristalsis simulation; in addition, the height of limiting plate 3 is higher than the light source subassembly, and the setting of limiting plate can not influence the light and see through reaction cavity 2 when, realizes prescribing a limit to the position of motor 15.

It is provided with a plurality of sampling pipes 22, every to link up side by side along vertically on the 2 lateral walls of reaction cavity all the cover is equipped with sealed cap 17 on the sampling pipe 22, and every the 2 lateral walls of reaction cavity all are provided with the scale along vertically, and the setting of sampling pipe 22 is convenient for sample the alkali solution of co-altitude not, realizes the purpose of regularly detecting on the liquid chromatogram detector then.

The invention also realizes circuit control, and particularly is also provided with a control system and an operation panel 24, wherein the operation panel 24, the electric heating rod 18, the motor 15, the luminous body, the display screen 4, the camera 5 and the electromagnetic valve 20 are respectively electrically connected with the controller, the camera 5 is also electrically connected with the computer 23, and the chemical stability real-time detection of the fat-soluble medicine is realized by operating on the operation panel 24 and then controlling the on-off of an electric appliance through the control system and the operation panel 24.

Principle of use

When the device is used, firstly, fat-soluble medicines to be detected are placed in a dry and clean reaction cavity, then the sealing cover bodies 6 are respectively covered on the reaction cavity 2 and are together placed in the detection box 1, water is added between the detection box 1 and the reaction cavity 2 until the water is over the maximum volume height of a detection alkali solution, then a control switch of the electric heating rod 18 is operated and opened on the operation panel 24, after the temperature of fluid is raised to 35-38 ℃, the control switch of the electromagnetic valve 20 is opened, and the alkali solution simultaneously enters different reaction cavities 2 through different sample adding pipes 7; the control switches of the motor 15, the light-emitting body, the display screen 4 and the camera 5 are turned on, the data are sent to the computer 23 through the shadow surface shot by the camera 5, the computer performs image processing and image recognition after acquiring the image, and then the dissolution condition of the fat-soluble medicine is judged according to the shadow area;

after the fat-soluble medicine is disintegrated for a certain time, the water in the detection box 1 is drained, then the solution in the middle of the reaction cavity 2 is selectively extracted by adopting a syringe needle, the liquid chromatography detection is carried out, and then the water is added into the detection box 1 for real-time monitoring.

It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.