A sustained-release pellet capsule dissolution testing device

Abstract

The utility model relates to the technical field of dissolution detection, disclose a kind of slow-release pellet capsule dissolution detection device, including water bath heating unit, dissolution cup, lifting frame unit, stirring unit and acid burette, by connecting acid burette on the mounting plate of stirring unit, and mounting plate is connected with the lifting frame unit of water bath heating unit rear end, realize water bath heating, stirring, titration and other function integration, simplify process, improve detection convenience, and water bath heating unit provides stable constant-temperature environment, ensure that dissolution process simulates human physiological temperature. By setting the lower end of mounting plate lower frame portion, the mounting plate is driven by lifting frame unit to move down, so that the stirring rod is inserted into dissolution cup, lower frame portion also follows to move down, so that lower frame portion can press down the upper end of dissolution cup, can effectively prevent dissolution cup from shaking when stirring, improve the stability of dissolution cup.

Description

Technical Field

[0001] This utility model relates to the field of dissolution testing technology, and in particular to a device for detecting the dissolution rate of sustained-release microcapsules. Background Technology

[0002] Dissolution rate of sustained-release microcapsules is a core indicator for evaluating their drug release characteristics, directly determining the drug's absorption efficiency and efficacy in the body. During dissolution testing, titrant is added periodically to monitor the chemical changes during the dissolution process.

[0003] However, the existing detection devices have the following shortcomings: 1. The existing detection devices have functions such as water bath heating, stirring, and titration that are scattered and cumbersome to operate; 2. The dissolution cup is not positioned stably and lacks effective fixation, making it easy to shake during stirring. Utility Model Content

[0004] This invention provides a device for detecting the dissolution rate of sustained-release microcapsules, which solves the problems of existing detection devices in the prior art, such as the dispersed functions of water bath heating, stirring, and titration, cumbersome operation, unstable positioning of the dissolution cup, lack of effective fixation of the dissolution cup, and easy shaking during stirring.

[0005] The technical problem solved by this utility model is achieved by the following technical solution: A device for detecting the dissolution rate of sustained-release microcapsules includes: A water bath heating unit, wherein the water bath heating unit is used for constant temperature heating; A dissolution cup is inserted into the upper end of the water bath heating unit; A lifting frame unit is disposed at the rear end of the water bath heating unit; A stirring unit, comprising a mounting plate connected to the lifting frame unit and a stirring part mounted on the mounting plate, wherein the lower end of the mounting plate is provided with a pressing frame part for pressing the dissolution cup; An acid burette, which is detachably mounted on the mounting plate.

[0006] In one specific implementation, the water bath heating unit includes: Water bath; A lid is detachably installed on the upper end of the water bath. The lid has an opening for inserting the dissolution cup and a heat dissipation vent. A drain valve pipe is installed on the water bath tank and is used to drain the liquid in the water bath tank; Both the water bath and the lid are made of transparent plastic.

[0007] In one specific implementation, the lifting frame unit includes: Lead screw drive unit; The positioning frame includes guide posts and reinforcing plates connected to both ends of the guide posts, with the lower reinforcing plate fixedly connected to the rear end of the water bath tank.

[0008] In one specific embodiment, the lead screw drive unit includes: An electric lead screw, wherein the motor of the electric lead screw is mounted on a reinforcing plate at the lower end of the positioning frame, and the upper end of the lead screw is rotatably connected to the reinforcing plate at the upper end of the positioning frame; Nut seat, which engages with the lead screw of the electric lead screw; A crossbeam plate is connected to the nut seat, and both ends of the crossbeam plate are positioned and sleeved on the guide post.

[0009] In one specific implementation, the mounting plate is fixedly connected to the crossbeam, and an opening for inserting the acid burette is provided at the front end of the mounting plate.

[0010] In one specific embodiment, the stirring section includes: A servo motor is mounted on the mounting plate, and the output end of the servo motor passes through the mounting plate. A stirring rod is connected to the output end of the servo motor, and the length of the stirring rod is less than the depth of the dissolution cup.

[0011] In one specific embodiment, the lower pressure frame includes: A connecting rod, the upper end of which is detachably connected to the lower end face of the mounting plate by screws; The lower end of the connecting rod is detachably connected to the pressure ring frame by screws; A rubber ring is fixedly disposed on the lower end face of the pressure ring frame.

[0012] In one specific implementation, the length of the connecting rod is less than the length of the stirring rod.

[0013] In one specific implementation, the mounting plate is further provided with a clamping part, the clamping part comprising: A clamping block is fixedly disposed on the upper end face of the mounting plate, and the clamping opening of the clamping block is aligned with the opening for inserting the acid burette. A rubber strip, which is fixedly disposed within the clamping opening of the clamping block; A locking bolt, the locking bolt being threaded onto one side of the clamping block.

[0014] The beneficial effects of this utility model are: 1. By connecting the acid burette to the mounting plate of the stirring unit, and connecting the mounting plate to the lifting frame unit at the rear of the water bath heating unit, the functions of water bath heating, stirring, titration and other functions are integrated, simplifying the process and improving the convenience of testing. The water bath heating unit provides a stable constant temperature environment to ensure that the dissolution process simulates the physiological temperature of the human body.

[0015] 2. By setting a pressure frame at the lower end of the mounting plate, when the lifting frame unit moves the mounting plate downwards and the stirring rod extends into the dissolution cup, the pressure frame also moves downwards, so that the pressure frame can press down on the upper end of the dissolution cup, which can effectively prevent the dissolution cup from shaking during stirring and improve the stability of the dissolution cup.

[0016] 3. By using an electric lead screw and nut seat, the lifting height can be precisely controlled, ensuring that the stirring rod can be accurately immersed in the dissolution cup, solving the problem of insufficient precision of manual lifting, and reducing the intensity of manual operation. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the overall structure of this utility model.

[0019] Figure 2 This is an overall side view of the present invention.

[0020] Figure 3 This is a schematic diagram of the water bath heating unit, dissolution cup, and lifting frame unit of this utility model.

[0021] Figure 4 This is a schematic diagram of the stirring unit and burette structure of this utility model.

[0022] Figure 5 for Figure 4 Enlarged view of A in the middle.

[0023] In the picture: Water bath heating unit; 110, water bath tank; 120, tank cover; 121, placement port; 122, heat dissipation port; 130, drain valve pipe; 200. Dissolving cup; 300. Lifting frame unit; 310. Screw drive unit; 311. Electric screw; 312. Nut seat; 313. Cross plate; 320. Positioning frame; 321. Guide column; 322. Reinforcing plate; 400. Stirring unit; 410. Mounting plate; 411. Opening; 420. Stirring section; 421. Servo motor; 422. Stirring rod; 430. Lower pressure frame; 431. Connecting rod; 432. Pressure ring frame; 433. Rubber ring; 440. Clamping part; 441. Clamping block; 442. Rubber strip; 443. Locking bolt; 500. Acid burette. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0025] Reference Figure 1-5 As shown, this utility model provides a device for detecting the dissolution rate of sustained-release microcapsules, comprising: Water bath heating unit 100, the water bath heating unit 100 is used for constant temperature heating; Dissolution cup 200 is inserted into the upper end of water bath heating unit 100; The lifting frame unit 300 is located at the rear end of the water bath heating unit 100; The stirring unit 400 includes a mounting plate 410 connected to the lifting frame unit 300 and a stirring part 420 mounted on the mounting plate 410. The lower end of the mounting plate 410 is provided with a lower pressing frame part 430 for pressing the dissolution cup 200. The lifting and lowering of the stirring unit 400 is controlled by the lifting frame unit 300, which can precisely control the lifting height and ensure that the lower end of the stirring unit 400 can be accurately immersed in the dissolution cup 200. This solves the problem of insufficient precision in manual lifting and lowering, while reducing the intensity of manual operation.

[0026] The acid burette 500 is detachably mounted on the mounting plate 410.

[0027] By connecting the acid burette 500 to the mounting plate 410 of the stirring unit 400, and connecting the mounting plate 410 to the lifting frame unit 300 at the rear end of the water bath heating unit 100, the functions of water bath heating, stirring, and titration are integrated, simplifying the process and improving the convenience of testing. Furthermore, the water bath heating unit 100 provides a stable and constant temperature environment, ensuring that the dissolution process simulates the physiological temperature of the human body. As one implementation method in this embodiment, refer to Figure 2-3 As shown, the water bath heating unit 100 includes: Water bath 110; The lid 120 is detachably installed on the upper end of the water bath 110. The lid 120 has a placement opening 121 for inserting the dissolution cup 200. The lid 120 also has a heat dissipation opening 122. The heat dissipation opening 122 facilitates the dissipation of steam generated by heating the water bath liquid in the water bath 110. Drain valve pipe 130 is installed on water bath 110 and is used to drain the liquid in water bath 110. Both the water bath 110 and the lid 120 are made of transparent plastic.

[0028] The transparent plastic water bath 110 and lid 120 allow for real-time observation of the capsule dissolution status in the dissolution cup 200 and the color change reaction during titration; the drain valve 130 facilitates quick replacement of the water bath liquid.

[0029] As one implementation method in this embodiment, refer to Figure 2-3 As shown, the lifting frame unit 300 includes: Screw drive unit 310; The positioning frame 320 includes a guide post 321 and a reinforcing plate 322 connected to both ends of the guide post 321. The lower reinforcing plate 322 is fixedly connected to the rear end of the water bath 110.

[0030] Furthermore, the lead screw drive unit 310 includes: Electric lead screw 311, the motor of electric lead screw 311 is mounted on the reinforcing plate 322 at the lower end of positioning frame 320, and the upper end of the lead screw of electric lead screw 311 is rotatably connected to the reinforcing plate 322 at the upper end of positioning frame 320; Nut seat 312, which is engaged with the lead screw of electric lead screw 311; The cross plate 313 is connected to the nut seat 312, and both ends of the cross plate 313 are positioned and sleeved on the guide post 321.

[0031] The electric lead screw 311, in conjunction with the nut seat 312, can precisely control the lifting height, ensuring that the stirring rod 422 can be accurately immersed in the dissolution cup 200, thus solving the problem of insufficient precision in manual lifting and reducing the intensity of manual operation.

[0032] As one implementation method in this embodiment, refer to Figure 4-5 As shown, the mounting plate 410 is fixedly connected to the cross plate 313, and an opening 411 for inserting an acid burette 500 is provided at the front end of the mounting plate 410.

[0033] As one implementation method in this embodiment, refer to Figure 4 As shown, the stirring unit 420 includes: Servo motor 421 is mounted on mounting plate 410, and the output end of servo motor 421 passes through mounting plate 410. Stirring rod 422 is connected to the output end of servo motor 421. The length of stirring rod 422 is less than the depth of dissolution cup 200.

[0034] As one implementation method in this embodiment, refer to Figure 4 As shown, the lower pressure frame 430 includes: Connecting rod 431, the upper end of which is detachably connected to the lower end face of mounting plate 410 by screws; The lower end of the connecting rod 431 is detachably connected to the pressure ring frame 432 by screws. Rubber ring 433 is fixedly installed on the lower end face of pressure ring frame 432.

[0035] Furthermore, the length of the connecting rod 431 is less than the length of the stirring rod 422.

[0036] Specifically, by providing a pressure frame 430 at the lower end of the mounting plate 410, when the lifting frame unit 300 moves the mounting plate 410 downward, causing the stirring rod 422 to extend into the dissolution cup 200, the pressure frame 430 also moves downward, allowing the pressure frame 430 to press down on the upper end of the dissolution cup 200, effectively preventing the dissolution cup 200 from shaking during stirring and improving the stability of the dissolution cup 200.

[0037] As one implementation method in this embodiment, refer to Figure 4-5 As shown, the mounting plate 410 is also provided with a clamping part 440, which includes: Clamping block 441 is fixedly installed on the upper end face of mounting plate 410, and the clamping mouth of clamping block 441 is aligned with the opening 411 for inserting acid burette 500. Rubber strip 442 is fixedly installed inside the clamping opening of clamping block 441; Locking bolt 443 is threaded and installed on one side of clamping block 441.

[0038] When installing the acid burette 500, insert the acid burette 500 into the clamping end of the clamping block 441 through the opening 411, and then fix the acid burette 500 in the clamping end by tightening the locking bolt 443.

[0039] In practical use, the dissolution testing device for this sustained-release microcapsule includes the following steps: 1. Add 2g of sodium chloride and 1000mL of hydrochloric acid solution (7mL of hydrochloric acid diluted with water to 1000mL) to a clean 1000mL dissolution vessel 200. Place the dissolution vessel 200 into a water bath 110.

[0040] 2. Turn on the water bath 110 and control its temperature to 37±2℃.

[0041] 3. Take one finished capsule and place it in the preheated dissolution cup 200. Using the electric lead screw 311 and nut seat 312, the stirring rod 422 can be immersed in the dissolution cup 200. Turn on the servo motor 421 to stir and start timing. Then add 3 drops of 1% starch indicator solution.

[0042] 4. Fill a clean, dry 50mL brown acid burette with a standard solution of known concentration and zero the burette.

[0043] 5. Starting from the start of the timing, titration can be performed on the solution in the dissolving vessel 200 throughout the entire time interval. Accurate titration must be performed at each exact moment, and the endpoint reading shown on the acid burette 500 must be recorded promptly. The titration endpoint is pure blue and remains unchanged for 30 seconds.

[0044] The foregoing has shown and described the basic principles, main features, and advantages of this utility model. Those skilled in the art should understand that this utility model is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of this utility model. Various changes and modifications can be made to this utility model without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claims. The scope of protection of this utility model is defined by the appended claims and their equivalents.

Claims

1. A device for detecting the dissolution rate of sustained-release microcapsules, characterized in that, include: A water bath heating unit (100) is used for constant temperature heating; Dissolution cup (200), which is inserted into the upper end of the water bath heating unit (100); A lifting frame unit (300) is disposed at the rear end of the water bath heating unit (100); The stirring unit (400) includes a mounting plate (410) connected to the lifting frame unit (300) and a stirring part (420) mounted on the mounting plate (410). The lower end of the mounting plate (410) is provided with a lower pressing frame part (430) for pressing the dissolution cup (200). An acid burette (500) is detachably mounted on the mounting plate (410).

2. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 1, characterized in that, The water bath heating unit (100) includes: Water bath (110); The lid (120) is detachably installed on the upper end of the water bath (110). The lid (120) has a placement opening (121) for inserting the dissolution cup (200) and a heat dissipation opening (122). A drain valve pipe (130) is provided on the water bath tank (110) for draining the liquid in the water bath tank (110); The water bath (110) and the lid (120) are both made of transparent plastic.

3. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 2, characterized in that, The lifting frame unit (300) includes: Screw drive unit (310); The positioning frame (320) includes a guide post (321) and a reinforcing plate (322) connected to both ends of the guide post (321). The lower reinforcing plate (322) is fixedly connected to the rear end of the water bath (110).

4. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 3, characterized in that, The lead screw drive unit (310) includes: An electric lead screw (311) is provided, the motor of which is mounted on a reinforcing plate (322) at the lower end of the positioning frame (320), and the upper end of the lead screw (311) is rotatably connected to the reinforcing plate (322) at the upper end of the positioning frame (320). Nut seat (312), which engages with the lead screw of the electric lead screw (311); A cross plate (313) is connected to the nut seat (312), and both ends of the cross plate (313) are positioned and sleeved on the guide post (321).

5. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 4, characterized in that: The mounting plate (410) is fixedly connected to the cross plate (313), and an opening (411) for inserting the acid burette (500) is provided at the front end of the mounting plate (410).

6. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 5, characterized in that, The stirring section (420) includes: Servo motor (421), the servo motor (421) is mounted on the mounting plate (410), and the output end of the servo motor (421) passes through the mounting plate (410). A stirring rod (422) is connected to the output end of the servo motor (421), and the length of the stirring rod (422) is less than the depth of the dissolution cup (200).

7. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 6, characterized in that, The lower pressure frame (430) includes: A connecting rod (431) is provided, the upper end of which is detachably connected to the lower end face of the mounting plate (410) by screws. The lower end of the connecting rod (431) is detachably connected to the pressure ring frame (432) by screws; A rubber ring (433) is fixedly disposed on the lower end face of the pressure ring frame (432).

8. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 7, characterized in that: The length of the connecting rod (431) is less than the length of the stirring rod (422).

9. The device for detecting the dissolution rate of sustained-release microcapsules according to claim 5, characterized in that: The mounting plate (410) is further provided with a clamping part (440), the clamping part (440) including: A clamping block (441) is fixedly disposed on the upper end face of the mounting plate (410), and the clamping mouth of the clamping block (441) is aligned with the opening (411) for inserting the acid burette (500). A rubber strip (442) is fixedly disposed within the clamping opening of the clamping block (441); A locking bolt (443) is threaded onto one side of the clamp (441).

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