A Disintegration Test Device for Shenkangning Capsules

Abstract

The present invention discloses a disintegration test device for Shenkangning capsules. The disintegration test device for Shenkangning capsules includes a kettle body, a water circulation system, a box body made of transparent material, a liquid inlet pipe, a corrosion-resistant elastic rubber sleeve, an elastic support seat, a liquid discharge pipeline, a fixed guide sleeve, a movable guide sleeve and a pneumatic system; the box body made of transparent material is suspended in the middle of the kettle body, and a plurality of one-way valves are arranged at the bottom of the box body; the water circulation system extracts the water at the bottom of the kettle body and discharges the water downward from the top of the box body; the liquid inlet pipe is arranged at the top of the kettle body and the bottom thereof penetrates through the top surface of the box body, and a valve is arranged at the upper opening of the liquid inlet pipe; the inlet of the corrosion-resistant elastic rubber sleeve is sleeved on the lower opening of the liquid inlet pipe; the elastic support seat is detachably arranged on the bottom surface of the inner cavity of the box body and supports the bottom surface of the corrosion-resistant elastic rubber sleeve. The present invention realizes the simulation process of gastric and intestinal digestion, and has good test effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical testing devices, and particularly to a disintegration testing device for Shenkangning capsules. Background Art

[0002] In the past, when producing Shenkangning capsules, the drying process in the extraction workshop has always used an ordinary vacuum drying oven for drying. The heat conductor of this equipment is steam. On the one hand, there are problems such as uneven heating and poor temperature control effect. The medicinal powder produced by this process has poor viscosity. On the other hand, since astragaloside IV and danshensu are thermosensitive substances, the temperature must be controlled during drying. To increase the content of astragaloside IV and danshensu, the drying process in the extraction workshop has now been changed to use a pulsating vacuum constant temperature drying oven for drying. The heat conductor of this equipment is hot water, and the temperature can be controlled at 80-90°C. Therefore, the content of the dry extract powder of Shenkangning capsules has increased by 40%. However, at the same time, the physical properties of the dry extract powder of Shenkangning capsules produced by this process have changed greatly, and problems such as strong viscosity of the medicinal powder, easy moisture absorption, and poor fluidity have occurred.

[0003] In response to the above problems, a disintegrator is often used to test the disintegration time limit of the finished product. The disintegration time limit refers to the limit of the time required for a solid preparation to completely disintegrate, dissolve, or break into particles and pass through a sieve in a specified medium by a specified method. For preparations for which dissolution, release, fusion time limit, or dispersion uniformity is specified, the disintegration time limit test is no longer carried out. For hard capsules and soft capsules, unless otherwise specified, take 6 test samples and check according to the tablet device and method (if the capsule floats on the liquid surface, a baffle can be added). Hard capsules should completely disintegrate within 30 minutes, and soft capsules should completely disintegrate within 1 hour. Soft capsules can be checked in artificial gastric juice instead. If 1 sample fails to meet the requirements for disintegration, another 6 samples should be taken for retesting, and all should meet the requirements.

[0004] During actual testing, the existing disintegrator simulates the digestion process in the digestive system by driving the rocker arm to lift and lower, but the simulation effect is average. After searching, CN102384964A - Improved Dissolution Testing Equipment, which simulates the flow process of drugs in the digestive system by setting multiple compartments, especially the change in the liquid HP value from the stomach to the intestine. CN102331483B - A conveying device for distributing medicaments into a dissolution testing device, providing a device for simulating the transportation in the digestive system. However, neither of the above two existing technologies considers the influence of gastric and intestinal peristalsis on drug digestion, thus affecting the disintegration time limit. In the existing technology CN201620704869.9, a pharmaceutical inspection disintegrator attempts to simulate peristaltic movements, but because the simulation process is achieved by shaking, the force is unreasonable and the simulation effect is poor. The force direction of the drug is single and the force position is limited to the contact surface, resulting in different force conditions for drugs at different positions and poor reference for the disintegration time limit test, and it also does not have the problems raised by the other two existing technologies.

[0005] In order to improve the disintegration time test results of Shenkangning Capsules, we need to redesign a disintegration device that is more suitable for the digestive system. Summary of the invention

[0006] The purpose of the present invention is to provide a disintegration test device for Shenkangning capsules, which solves the problem that the test effect of the existing disintegration instrument is poor.

[0007] To achieve the above object, the present invention provides the following technical solutions: a Shenkangning capsule disintegration test device, the Shenkangning capsule disintegration test device comprising a kettle, a water circulation system, a box body made of a transparent material, a liquid inlet pipe, a corrosion-resistant elastic rubber sleeve, an elastic support seat, a liquid discharge pipeline, a fixed guide sleeve, a movable guide sleeve and an air pressure system; wherein:

[0008] The transparent material box is suspended in the middle of the kettle body, and a plurality of one-way valves are arranged at the bottom of the box;

[0009] The water circulation system extracts water from the bottom of the kettle body and discharges the water downward from the top of the tank body;

[0010] The liquid inlet pipe is arranged on the top of the kettle body, and the bottom is arranged through the top surface of the box body, and a valve is arranged on the upper opening of the liquid inlet pipe;

[0011] The inlet of the corrosion-resistant elastic rubber sleeve is sleeved on the lower opening of the liquid inlet pipe;

[0012] The elastic support seat is detachably arranged on the bottom surface of the inner cavity of the box body and supported on the bottom surface of the corrosion-resistant elastic rubber sleeve;

[0013] The drainage pipeline includes a mounting seat, a filter, a valve, and a drainage pipe. The mounting seat is fixedly arranged at the bottom of the corrosion-resistant elastic rubber sleeve and supported on the elastic support seat. The mounting seat is provided with a channel. The filter is arranged on the top surface of the mounting seat and located at the upper opening of the channel. The drainage pipe is arranged on the mounting seat and communicated with the lower opening of the channel. The valve is arranged on the drainage pipe.

[0014] The fixed guide sleeve is sleeved on the upper part of the corrosion-resistant elastic rubber sleeve, and the inner cavity diameter of the fixed guide sleeve gradually decreases from top to bottom;

[0015] The movable guide sleeve is mounted on the lower part of the corrosion-resistant elastic rubber sleeve. The movable guide sleeve includes a power part and two half-tubes with the same structure. The two half-tubes are combined to dock with the lower opening of the fixed guide sleeve and leave a gap with the side of the corrosion-resistant elastic rubber sleeve. The power part drives the half-tubes to rotate and makes the inner side of the half-tubes abut against the bottom surface of the corrosion-resistant elastic rubber sleeve.

[0016] The air pressure system is communicated with the upper side surface of the corrosion-resistant elastic rubber sleeve.

[0017] Furthermore, the water circulation system includes a pumping pipe, a drain pipe, and a water pump. The water pump is arranged on the outside of the kettle body. The pumping pipe is connected to the bottom of the kettle body. The drain pipe runs through the kettle body and is connected to the top of the box body. The drain outlet of the box body is annular and flows downward along the outer side of the corrosion-resistant elastic rubber sleeve.

[0018] Furthermore, the outer contour of the corrosion-resistant elastic rubber sleeve includes a cylindrical upper part and a spherical lower part.

[0019] Furthermore, the elastic support seat includes a magnetic upper plate, a sliding rod, a sliding sleeve, a spring and a magnetic lower plate. The sliding rod is fixedly arranged on the bottom surface of the magnetic upper plate, the sliding sleeve is fixedly arranged on the top surface of the magnetic lower plate, the sliding rod is slidably arranged in the sliding sleeve, the spring is arranged in the sliding sleeve and supported at the bottom of the sliding rod, the magnetic upper plate is magnetically connected to the mounting seat, and the magnetic lower plate is magnetically connected to the bottom of the box.

[0020] Furthermore, the power part includes a motor, a right-angle gearbox, a rotating shaft and a mounting plate, the mounting plate is arranged on the side wall of the inner cavity of the box, the motor is mounted on the mounting plate, the right-angle gearbox is arranged on the mounting plate, the motor and the right-angle gearbox are connected in a transmission manner, the rotating shaft is arranged on the half pipe, and is fixedly connected to the output shaft of the right-angle gearbox.

[0021] Preferably, a heating device is provided on the side of the kettle body.

[0022] Beneficial effects:

[0023] The present application provides a disintegration device with a new structure, which simulates the process of drug digestion in the digestive system as much as possible, mainly simulating the change of the HP value of the solution from the stomach to the intestine and the all-round peristalsis of the drug in the stomach and the intestine, so that the force is more comprehensive.

[0024] The water in the kettle is heated by a heating device to achieve the purpose of providing a simulated stomach and intestinal temperature.

[0025] When the drug is placed in the stomach and intestines for the first time, it is flushed with heated water and the fixed guide sleeve and the movable guide sleeve cooperate to achieve a comprehensive massage of the corrosion-resistant elastic rubber sleeve, and the elastic support seat is used to achieve a peristaltic effect, and the force is more comprehensive. After the half tube of the movable guide sleeve is rotated, the inner side of the half tube rests on the bottom surface of the corrosion-resistant elastic rubber sleeve, and water hits the half tube and the corrosion-resistant elastic rubber sleeve, simulating the process of drug reflux, and the simulation effect is good.

[0026] Negative pressure is provided through the pneumatic system, the corrosion-resistant elastic rubber sleeve shrinks, the valve of the liquid discharge pipeline opens, the corrosion-resistant elastic rubber sleeve is discharged, and the particles are left. At this time, the liquid inlet pipe re-discharges new solution for the second disintegration test to simulate the effect in the intestine. Brief Description of the Drawings

[0027] Figure 1 Is the front view of the present invention;

[0028] Figure 2 Is the cross-sectional view of the present invention;

[0029] Figure 3 Is the top view of the movable guide sleeve of the present invention;

[0030] Figure 4 Is the top view of the lower part of the present invention;

[0031] Figure 5 Is the schematic diagram of the elastic support seat of the present invention.

[0032] In the figure: kettle body - 1, water circulation system - 2, box body - 3, liquid inlet pipe - 4, corrosion-resistant elastic rubber sleeve - 5, elastic support seat - 6, liquid discharge pipeline - 7, fixed guide sleeve - 8, movable guide sleeve - 9, pneumatic system - 10, one-way valve - 11, water suction pipe - 12, drain pipe - 13, water pump - 14, upper part - 15, lower part - 16, magnetic upper plate - 17, sliding rod - 18, sliding sleeve - 19, spring - 20, magnetic lower plate - 21, mounting seat - 22, half pipe - 23, motor - 24, right-angle gearbox - 25, rotating shaft - 26, mounting plate - 27, filter screen - 28, liquid discharge pipe - 29, heating device - 30. Detailed Description of the Invention

[0033] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0034] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", "front end", "rear end", "both ends", "one end", "the other end", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0035] In the description of the present invention, it should be noted that, unless otherwise clearly specified and defined, terms such as "installation", "provided with", "connection", etc. should be understood in a broad sense. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0036] Please refer to the attached drawings. An embodiment provided by the present invention is: a disintegration test device for Shenkangning capsules. The disintegration test device for Shenkangning capsules includes a kettle body 1, a water circulation system 2, a box body 3 made of transparent material, a liquid inlet pipe 4, a corrosion-resistant elastic rubber sleeve 5, an elastic support seat 6, a drainage pipeline 7, a fixed guide sleeve 8, a movable guide sleeve 9, and a pneumatic system 10; wherein:

[0037] The box body 3 made of transparent material is suspended in the middle of the kettle body 1, and a plurality of one-way valves 11 are arranged at the bottom of the box body. A heating device 30 is arranged on the side of the kettle body 1, and the heating device 30 can heat the kettle body 1 and the water in the kettle body 1, so as to form a constant temperature environment in the kettle body 1 to achieve the purpose of forming an environment similar to the internal cavity of the human body;

[0038] The water circulation system 10 extracts the water at the bottom of the kettle body 1 and discharges the water downward from the top of the box body 3. The water circulation system 10 includes a water suction pipe 12, a drainage pipe 13, and a water pump 14. The water pump 14 is arranged outside the kettle body 1. The water suction pipe 12 is communicated with the bottom of the kettle body 1. The drainage pipe 13 penetrates through the kettle body 1 and is communicated with the top of the box body 4. The drainage port of the box body 4 is annular and flows downward along the outer side surface of the corrosion-resistant elastic rubber sleeve 5. In this way, the drainage port of the box body 3 can fully wash the outer side surface of the corrosion-resistant elastic rubber sleeve 5, apply a downward force to the corrosion-resistant elastic rubber sleeve 5, and provide a constant temperature environment.

[0039] The liquid inlet pipe 4 is arranged at the top of the kettle body 1 and its bottom penetrates through the top surface of the box body 3. A valve is arranged at the upper opening of the liquid inlet pipe 4, and the valve opens and closes the liquid inlet pipe 4 as needed to form a closed environment at any time;

[0040] The inlet of the corrosion-resistant elastic rubber sleeve 5 is sleeved on the lower opening of the liquid inlet pipe 4. The outer contour of the corrosion-resistant elastic rubber sleeve 5 includes a cylindrical upper part 15 and a spherical-like lower part 16, and the spherical-like lower part 16 is the main test space;

[0041] The elastic support seat 6 is detachably arranged on the bottom surface of the inner cavity of the box body 3 and supported on the bottom surface of the corrosion-resistant elastic rubber sleeve 5. The elastic support seat 6 includes a magnetic upper plate 17, a slide rod 18, a sleeve 19, a spring 20 and a magnetic lower plate 21. The slide rod 18 is fixedly arranged on the bottom surface of the magnetic upper plate 17, and the sleeve 19 is fixedly arranged on the top surface of the magnetic lower plate 21. The slide rod 18 is slidably arranged in the sleeve 19, and the spring 20 is arranged in the sleeve 19 and supported at the bottom of the slide rod 18. The magnetic upper plate 17 is magnetically connected to the mounting seat 22, and the magnetic lower plate 21 is magnetically connected to the bottom of the box body 3. The setting of the elastic support seat 6 cooperates with the corrosion-resistant elastic rubber sleeve 5 to be subjected to the downward flushing force to achieve the purpose of simulating creep. At this time, the creep effect is relatively simple. In order to provide the creep effect, the present embodiment further provides a fixed guide sleeve 8 and a movable guide sleeve 9;

[0042] The fixed guide sleeve 8 is sleeved on the upper part of the corrosion-resistant elastic rubber sleeve 5, and the inner diameter of the fixed guide sleeve 8 is gradually reduced from top to bottom, so as to guide the water to the side of the corrosion-resistant elastic rubber sleeve 5 as much as possible;

[0043] The movable guide sleeve 9 is sleeved on the lower part of the corrosion-resistant elastic rubber sleeve 5. The movable guide sleeve 9 includes a power part and two half-tubes 23 with the same structure. The two half-tubes 23 are merged to dock with the lower end of the fixed guide sleeve 8, and a spacing is left with the side of the corrosion-resistant elastic rubber sleeve 5. The power part drives the half-tube 23 to rotate and makes the inner side of the half-tube 23 abut against the bottom surface of the corrosion-resistant elastic rubber sleeve 5. The power part includes a motor 24, a right-angle gearbox 25, a rotating shaft 26 and a mounting plate 27. The mounting plate 27 is arranged on the side wall of the inner cavity of the box body 3, and the motor 24 is mounted on the mounting plate 27. The right-angle gearbox 25 is arranged on the mounting plate 27, the motor 24 is drivably connected to the right-angle gearbox 25, the rotating shaft 26 is arranged on the half-tube 23, and is fixedly connected to the output shaft of the right-angle gearbox 25. The purpose of controlling the rotation of the half-tube 23 is achieved through the cooperation of the motor 24 and the right-angle gearbox 25. The stress condition of the corrosion-resistant elastic rubber sleeve 5 is adjusted by adjusting the posture of the half-tube 23. Specifically, when the half-tube 23 is against the bottom surface of the corrosion-resistant elastic rubber sleeve 5, the elastic contraction space of the corrosion-resistant elastic rubber sleeve 5 becomes smaller, providing thrust, limiting the movement of the drug, and forming a similar backflow effect.

[0044] The drainage pipeline 7 includes a mounting seat 22, a filter screen 28, a valve, and a drainage pipe 29. The mounting seat 22 is fixedly arranged at the bottom of the corrosion-resistant elastic rubber sleeve 5 and supported on the elastic support seat 6. The mounting seat 22 is provided with a channel. The filter screen 28 is arranged on the top surface of the mounting seat 22 and is located at the upper opening of the channel. The drainage pipe 29 is arranged on the mounting seat 22 and is connected to the lower opening of the channel. The valve is arranged on the drainage pipe 29.

[0045] The described pneumatic system 10 is connected to the upper side of the corrosion-resistant elastic rubber sleeve 5 to provide negative pressure and positive pressure. The pneumatic system 10 includes an air pump, an air extraction pump, and an air pipe line. The air pump is used to inflate the corrosion-resistant elastic rubber sleeve 5 to apply positive pressure and provide internal pressure for the corrosion-resistant elastic rubber sleeve 5. The air extraction pump extracts the gas inside the corrosion-resistant elastic rubber sleeve 5 to provide negative pressure, causing the corrosion-resistant elastic rubber sleeve 5 to deform and drain the liquid.

[0046] Specific working principle:

[0047] Principle of peristalsis:

[0048] Assemble the device as required. Place the drug inside the corrosion-resistant elastic rubber sleeve 5. Turn on the water pump 14 to pump the water at the bottom of the kettle body 1 into the box body 3 for flushing. During peristalsis, the elastic support seat 6 supports the corrosion-resistant elastic rubber sleeve 5. After the corrosion-resistant elastic rubber sleeve 5 is impacted by the water, the elastic support seat 6 provides reverse support to achieve reciprocating motion. The surface of the corrosion-resistant elastic rubber sleeve 5 is evenly stressed and has strong reliability.

[0049] To prevent the drug from refluxing during the process of achieving the gastric effect, the motor 24 controls the rotation of the half pipe 23 through the right-angle gearbox 5. The side of the half pipe 23 abuts against the bottom surface of the corrosion-resistant elastic rubber sleeve 5 to achieve the purpose of support. At this time, the water continues to flush the corrosion-resistant elastic rubber sleeve 5, and the support force provided by the half pipe 23 restricts the forward movement of the drug, simulating the reflux situation during the digestion process of the drug in the stomach.

[0050] Simulate the digestion process of the drug in the stomach and intestines. After the drug is first placed inside the corrosion-resistant elastic rubber sleeve 5, open the valve on the liquid discharge pipeline 7, and use the pneumatic system 10 to provide negative pressure to the corrosion-resistant elastic rubber sleeve 5 to drain the solution. After the drainage is completed, close the valve on the liquid discharge pipeline 7. Apply positive pressure through the pneumatic system 10, and input the solution through the liquid inlet pipe 4. Finally, close the valve on the liquid inlet pipe 4 and perform the peristalsis process through the water pump 14 to complete the simulation process of the digestion in the stomach and intestines.

[0051] For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and the present invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be encompassed by the present invention. Any reference signs in the claims should not be regarded as limiting the claimed rights.

Claims

1. A disintegration test device for Shenkangning capsules, Features: The Shenkangning capsule disintegration test device comprises a kettle body, a water circulation system, a transparent material box, a liquid inlet pipe, a corrosion-resistant elastic rubber sleeve, an elastic support seat, a liquid discharge pipeline, a fixed guide sleeve, a movable guide sleeve and an air pressure system; wherein: The transparent material box is suspended in the middle of the kettle body, and a plurality of one-way valves are arranged at the bottom of the box; The water circulation system extracts water from the bottom of the kettle body and discharges the water downward from the top of the tank body; The liquid inlet pipe is arranged on the top of the kettle body, and the bottom is arranged through the top surface of the box body, and a valve is arranged on the upper opening of the liquid inlet pipe; The inlet of the corrosion-resistant elastic rubber sleeve is sleeved on the lower opening of the liquid inlet pipe; The elastic support seat is detachably arranged on the bottom surface of the inner cavity of the box body and supported on the bottom surface of the corrosion-resistant elastic rubber sleeve; The drainage pipeline includes a mounting seat, a filter, a valve, and a drainage pipe. The mounting seat is fixedly arranged at the bottom of the corrosion-resistant elastic rubber sleeve and supported on the elastic support seat. The mounting seat is provided with a channel. The filter is arranged on the top surface of the mounting seat and located at the upper opening of the channel. The drainage pipe is arranged on the mounting seat and communicated with the lower opening of the channel. The valve is arranged on the drainage pipe. The fixed guide sleeve is sleeved on the upper part of the corrosion-resistant elastic rubber sleeve, and the inner cavity diameter of the fixed guide sleeve gradually decreases from top to bottom; The movable guide sleeve is mounted on the lower part of the corrosion-resistant elastic rubber sleeve. The movable guide sleeve includes a power part and two half-tubes with the same structure. The two half-tubes are combined to dock with the lower opening of the fixed guide sleeve and leave a gap with the side of the corrosion-resistant elastic rubber sleeve. The power part drives the half-tubes to rotate and makes the inner side of the half-tubes abut against the bottom surface of the corrosion-resistant elastic rubber sleeve. The air pressure system is connected to the upper side of the corrosion-resistant elastic rubber sleeve; the water circulation system includes a pumping pipe, a drain pipe, and a water pump. The water pump is arranged on the outside of the kettle body, the pumping pipe is connected to the bottom of the kettle body, the drain pipe runs through the kettle body and is connected to the top of the box body, the drain outlet of the box body is annular, and flows downward along the outer side of the corrosion-resistant elastic rubber sleeve; the elastic support seat includes a magnetic upper plate, a sliding rod, a sliding sleeve, a spring and a magnetic lower plate, the sliding rod is fixedly arranged on the bottom surface of the magnetic upper plate, the sliding sleeve is fixedly arranged on the top surface of the magnetic lower plate, the sliding rod is slidably arranged in the sliding sleeve, the spring is arranged in the sliding sleeve and supported at the bottom of the sliding rod, the magnetic upper plate is magnetically connected to the mounting seat, and the magnetic lower plate is magnetically connected to the bottom of the box body.

2. A Shenkangning capsule disintegration test device according to claim 1, Features: The outer contour of the corrosion-resistant elastic rubber sleeve includes a cylindrical upper part and a spherical lower part.

3. A Shenkangning capsule disintegration test device according to claim 1, Features: The described power part includes a motor, a right-angle gearbox, a rotating shaft and a mounting plate. The mounting plate is arranged on the side wall of the inner cavity of the box body. The motor is mounted on the mounting plate. The right-angle gearbox is arranged on the mounting plate. The motor is drivably connected to the right-angle gearbox. The rotating shaft is arranged on the half pipe and is fixedly connected to the output shaft of the right-angle gearbox.

4. A disintegration test device for Shenkangning capsules according to claim 3, characterized in that: A heating device is arranged on the side of the kettle body.

Images