Drug dissolution device

Abstract

The present application discloses a drug dissolution device, which belongs to the technical field of pharmaceutical inspection equipment. The drug dissolution device includes a dissolution device body, a water bath component, a dissolution mechanism and a fixing component; the dissolution device body includes a top cover, a dissolution cup, a first support plate and a second support plate, and the water bath component is arranged between the first support plate and the second support plate; the fixing device is arranged on the first support plate, and the dissolution component is arranged between the top cover and the first support plate. By setting the dissolution mechanism, it is suitable for drug dissolution testing of semi-solid preparations, by setting the water bath component to control the temperature during the drug dissolution process; by setting the fixing component to improve the stability of the dissolution cup, the parallel arrangement of the first support plate and the second support plate greatly improves the stability of the drug dissolution device, the drug dissolution device has simple accessories, is easy to assemble and is suitable for dissolution experiments of semi-solid preparations.

Description

Technical Field

[0001] The present application relates to a drug dissolution device, belonging to the technical field of pharmaceutical testing equipment. Background Art

[0002] The dissolution process of drug preparations in the body affects drug absorption and its bioavailability. As one of the detection methods for drug properties, the drug dissolution process plays an important role in the imitation of drug preparations and the evaluation of quality consistency. By testing the dissolution of drugs in vitro, the dissolution and absorption process of drugs in the body can be effectively simulated, the quality of drug preparations can be effectively judged, and the absorption of drug preparations in the body can be predicted. The dissolution methods currently used in the market include the basket method, the paddle method, the repeated cylinder method, the circulation cell method, etc. Different methods are used to evaluate the consistency of the in vitro and in vivo dissolution process for different drug preparations.

[0003] Most of the dissolution devices in the prior art are for solid preparations, such as tablets, capsules and granules. There are relatively few dissolution devices for semi-solid preparations such as pastes, gels and creams. There are three methods for in vitro release research and detection of semi-solid topical preparations: diffusion cell method, immersion cell method and circulation cell method. Among them, the immersion cell method is the most widely used. However, the immersion cell method requires the use of immersion cells, conversion kits, etc. to complete the experiment, which is troublesome to assemble, takes a long time to prepare and has high experimental costs. Therefore, how to provide a drug dissolution device that is simple to assemble, low in cost and suitable for semi-solid preparations is a problem that needs to be solved urgently. Utility Model Content

[0004] In order to solve the above problems, the present application proposes a drug dissolution device, which is suitable for drug dissolution testing of semi-solid preparations by setting a dissolution mechanism, and is suitable for controlling the temperature during the drug dissolution process by setting a water bath component; and is suitable for improving the stability of the dissolution cup by setting a fixed component. The first support plate and the second support plate are arranged in parallel, which greatly improves the stability of the drug dissolution device. The drug dissolution device has simple accessories, is easy to assemble and is suitable for dissolution experiments of semi-solid preparations.

[0005] According to one aspect of the present application, a drug dissolution device is provided, comprising a dissolution device body, a water bath assembly, a dissolution mechanism and a fixing assembly; the dissolution device body comprises a top cover, a dissolution cup, a first support plate and a second support plate, the water bath assembly is arranged between the first support plate and the second support plate; the fixing device is arranged on the first support plate, and the dissolution assembly is arranged between the top cover and the first support plate.

[0006] Optionally, the first support plate and the second support plate are arranged in parallel, and a plurality of placement holes are provided on the first support plate to place the dissolution cup; a support column is provided between the first support plate and the second support plate, and the support column is provided on the four corners of the first support plate, and a base is provided at the bottom of the second support plate.

[0007] Optionally, the dissolution component includes a plurality of rotating rods and a plurality of drug-carrying components, one end of the rotating rod is rotatably connected to the top cover, and the other end is connected to the drug-carrying component; the dissolution component corresponds to the dissolution cup; and the rotating rod is a retractable structure.

[0008] Optionally, the drug carrying assembly includes a drug carrying tray, a drug carrying screw cap, a gasket and a polycarbonate film; the drug carrying screw cap is arranged above the drug carrying tray, the drug carrying screw cap is threadedly connected to the drug carrying tray, a gasket is provided on the drug carrying tray, and the polycarbonate film is arranged above the gasket.

[0009] Optionally, a fixing hole is provided on the drug-loaded screw cap to be connected to a rotating rod; an inner wall of the fixing hole is provided with an internal thread, and an end of the rotating rod close to the drug-loaded assembly is provided with an external thread, and the rotating rod is threadedly connected to the drug-loaded screw cap.

[0010] Optionally, the water bath assembly includes a water bath box and a heating wire, and the heating wire is arranged at the center of the bottom of the water bath box.

[0011] Optionally, a limiting ring is sleeved on the upper end of the dissolution cup, the lower surface of the limiting ring abuts against the first support plate, and a limiting groove is provided on the limiting ring.

[0012] Optionally, the fixing assembly includes a plurality of limiting members, and the limiting members are arranged on the first supporting plate, and the limiting members correspond to the dissolution cups one by one.

[0013] Optionally, the limiting member includes a screw rod and a limiting block, one end of the screw rod is fixedly connected to the limiting block, and the other end of the screw rod is threadedly connected to the first support plate.

[0014] Optionally, the limit block is a 7-shaped structure, and the limit block is engaged with the limit groove.

[0015] The beneficial effects of this application include but are not limited to:

[0016] 1. The drug dissolution device provided in the present application is suitable for drug dissolution testing of semi-solid preparations by setting a dissolution mechanism. A water bath component is set to control the temperature during the drug dissolution process. A fixed component is set to improve the stability of the dissolution cup. The first support plate and the second support plate are set in parallel, which greatly improves the stability of the drug dissolution device. The drug dissolution device has simple accessories, is easy to assemble and is suitable for dissolution experiments of semi-solid preparations.

[0017] 2. The drug dissolution device provided in the present application is provided with a rotating rod and a drug loading component. The rotating rod rotates to drive the drug loading component to rotate, so as to facilitate the dissolution and dispersion of the drug, which is beneficial to improving the accuracy of the experiment; a gasket is provided on the drug loading tray, a polycarbonate film is placed on the gasket, and the drug loading screw cap is buckled on the drug loading tray and threadedly connected; the semi-solid drug to be tested is evenly coated on the center of the polycarbonate film, the drug loading component is placed in the dissolution cup, and the polycarbonate film enters the solvent in the dissolution cup by about 1 cm to determine the solubility and release rate of the semi-solid preparation drug; the rotating rod is threadedly connected to the fixing hole of the drug loading screw cap, which is convenient for disassembling the drug loading component and facilitating operations such as placing the drug.

[0018] 3. The drug dissolution device provided in the present application is provided with a limiting ring and a limiting groove on the limiting ring, and a limiting block is provided on the first support plate. The limiting block is engaged with the limiting groove to limit the position of the dissolution cup and improve the stability of the dissolution cup. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0020] Figure 1 It is a schematic diagram of the three-dimensional structure of the drug dissolution device involved in the embodiment of the present application;

[0021] Figure 2 This is a schematic diagram of the three-dimensional structure of the drug carrier assembly involved in the embodiment of the present application;

[0022] Figure 3 This is a schematic diagram of the cross-sectional structure of the drug carrier assembly involved in the embodiment of the present application;

[0023] Figure 4 It is a front view schematic diagram of a position limiting member involved in an embodiment of the present application;

[0024] Figure 5 It is a schematic diagram of the cross-sectional structure of the dissolution cup involved in the embodiment of the present application.

[0025] List of parts and reference numerals:

[0026] 1. Top cover; 2. First support plate; 3. Second support plate; 4. Placement hole; 5. Support column; 6. Base; 7. Rotating rod; 8. Drug tray; 9. Drug screw cap; 10. Washer; 11. Polycarbonate film; 12. Fixing hole; 13. Limiting ring; 14. Dissolution cup; 15. Limiting groove; 16. Limiting piece; 17. Screw; 18. Limiting block. DETAILED DESCRIPTION

[0027] In order to more clearly illustrate the overall concept of the present application, a detailed description is given below in an illustrative manner in conjunction with the accompanying drawings.

[0028] In order to more clearly understand the above-mentioned purposes, features and advantages of the present application, the present application is further described in detail below in conjunction with the accompanying drawings and specific implementation methods. It should be noted that the embodiments of the present application and the features in the embodiments can be combined with each other without conflict.

[0029] In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application may also be implemented in other ways different from those described herein. Therefore, the scope of protection of the present application is not limited to the specific embodiments disclosed below.

[0030] In addition, in the description of the present application, it should be understood that the terms "center", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0031] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0032] In this application, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or a communication; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0033] In the present application, unless otherwise clearly specified and limited, a first feature "above" or "below" a second feature may be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in an appropriate manner in any one or more embodiments or examples.

[0034] refer to Figure 1-Figure 5 The embodiment of the present application discloses a drug dissolution device, including a dissolution device body, a water bath assembly, a dissolution mechanism and a fixing assembly; the dissolution device body includes a top cover 1, a dissolution cup 14, a first support plate 2 and a second support plate 3, and the water bath assembly is arranged between the first support plate 2 and the second support plate 3; the fixing device is arranged on the first support plate 2, and the dissolution assembly is arranged between the top cover 1 and the first support plate 2.

[0035] Specifically, by setting up a dissolution mechanism, it is suitable for drug dissolution testing of semi-solid preparations. By setting up a water bath component, the temperature during the drug dissolution process can be controlled; by setting up a fixed component, the stability of the dissolution cup 14 can be improved. The drug dissolution device has simple accessories, is easy to assemble and is suitable for dissolution experiments of semi-solid preparations.

[0036] As an embodiment, the first support plate 2 and the second support plate 3 are arranged in parallel, and a plurality of placement holes 4 are provided on the first support plate 2 to place the dissolution cup 14; a support column 5 is provided between the first support plate 2 and the second support plate 3, and the support column 5 is provided on the four corners of the first support plate 2, and a base 6 is provided at the bottom of the second support plate 3.

[0037] Specifically, the present application does not make any specific limitation on the size and number of the placement holes 4, and those skilled in the art may make a selection based on actual conditions.

[0038] Specifically, the present application does not make a specific limitation on the height of the support column 5, and those skilled in the art may make a selection according to actual conditions.

[0039] Specifically, the first support plate 2 and the second support plate 3 arranged in parallel and the support column 5 between the first support plate 2 and the second support plate 3 greatly improve the stability of the drug dissolution device.

[0040] As an embodiment, the dissolution assembly includes a plurality of rotating rods 7 and a plurality of drug-carrying assemblies, one end of the rotating rod 7 is rotatably connected to the top cover 1, and the other end is connected to the drug-carrying assembly; the dissolution assembly corresponds to the dissolution cup 14; the rotating rod 7 is a retractable structure.

[0041] Specifically, the present application is also provided with a motor to drive the rotating rod 7 to rotate, and the rotation of the rotating rod 7 drives the drug-carrying assembly to rotate, so as to facilitate the dissolution and dispersion of the drug, thereby improving the accuracy of the experiment.

[0042] Specifically, the present application does not make a specific limitation on the length of the rotating rod 7, and those skilled in the art may make a selection according to actual conditions.

[0043] Specifically, the rotating rod 7 is an electrically retractable structure, which is not specifically limited in the present application, and those skilled in the art may select a suitable retractable structure according to actual conditions.

[0044] As an embodiment, the drug carrying assembly includes a drug carrying tray 8, a drug carrying screw cap 9, a gasket 10 and a polycarbonate film 11; the drug carrying screw cap 9 is arranged above the drug carrying tray 8, the drug carrying screw cap 9 is threadedly connected to the drug carrying tray 8, a gasket 10 is provided on the drug carrying tray 8, and the polycarbonate film 11 is arranged above the gasket 10.

[0045] Specifically, a gasket 10 is provided on the drug carrier 8, a polycarbonate film 11 is placed on the gasket 10, and a drug-carrying screw cap 9 is buckled on the drug carrier 8 and threadedly connected; the semi-solid drug to be tested is evenly coated on the center of the polycarbonate film 11, the drug-carrying assembly is placed in the dissolution cup 14, and the polycarbonate film 11 enters the solvent in the dissolution cup 14 by about 1 cm to determine the solubility and release rate of the semi-solid preparation drug.

[0046] Specifically, the medicine carrier 8 is provided with an internal thread, and the medicine carrier screw cap 9 is provided with an external thread matching the internal thread, and the two are threadedly connected.

[0047] Specifically, the gasket 10 is made of rubber.

[0048] Specifically, the polycarbonate film 11 has a diameter of 47 mm and a thickness of 0.05 um.

[0049] As an embodiment, a fixing hole 12 is provided on the drug-carrying screw cap 9 to connect with the rotating rod 7; an inner wall of the fixing hole 12 is provided with an internal thread, and an end of the rotating rod 7 close to the drug-carrying component is provided with an external thread, and the rotating rod 7 is threadedly connected with the drug-carrying screw cap 9.

[0050] Specifically, the rotating rod 7 is threadedly connected to the fixing hole 12 of the medicine-carrying screw cap 9, so as to facilitate the disassembly of the medicine-carrying assembly and facilitate operations such as placing medicines.

[0051] As an embodiment, the water bath assembly includes a water bath box and a heating wire, and the heating wire is arranged at the center of the bottom of the water bath box.

[0052] Specifically, a heating wire is provided to control the temperature during the drug dissolution process, and the heating wire is electrically connected to an external power source.

[0053] As an implementation manner, a limiting ring 13 is sleeved on the upper end of the dissolution cup 14 , the lower surface of the limiting ring 13 abuts against the first support plate 2 , and a limiting groove 15 is provided on the limiting ring 13 .

[0054] Specifically, the limiting ring 13 is fixedly connected to the upper portion of the dissolution cup 14 , and the lower surface of the limiting ring 13 abuts against the first support plate 2 , so as to limit the dissolution cup 14 in the placement hole 4 .

[0055] Specifically, the present application does not make any specific limitation on the number and shape of the limiting grooves 15, and those skilled in the art may make a selection according to actual conditions.

[0056] As an implementation manner, the fixing assembly includes a plurality of limit members 16 . The limit members 16 are disposed on the first support plate 2 , and the limit members 16 correspond to the dissolution cups 14 one by one.

[0057] Specifically, the present application does not make a specific limitation on the number of the limiting members 16 , and those skilled in the art may make a selection according to actual conditions.

[0058] As an implementation manner, the limiting member 16 includes a screw rod 17 and a limiting block 18 , one end of the screw rod 17 is fixedly connected to the limiting block 18 , and the other end of the screw rod 17 is threadedly connected to the first support plate 2 .

[0059] Specifically, the limiting block 18 is connected to the first support plate 2 via a screw 17 , and the limiting member 16 further limits the position of the dissolution cup 14 to improve the stability of the dissolution cup 14 .

[0060] As an implementation manner, the limiting block 18 is a 7-shaped structure, and the limiting block 18 is engaged with the limiting groove 15 .

[0061] Specifically, the limiting block 18 is correspondingly engaged with the limiting groove 15 to further limit the dissolution cup 14 to prevent the dissolution cup 14 from rotating and shifting to affect the experiment.

[0062] The working process of the drug dissolution device provided in this application is as follows:

[0063] Rotate and open the drug loading component, place the polycarbonate film 11 with the active layer facing upward on the gasket 10 of the drug loading tray 8, take the semi-solid preparation to be tested, place it in the center of the polycarbonate film 11, and evenly disperse it into a thin layer with a diameter of about 14 mm, rotate and screw on the drug loading screw cap 9, and then connect the fixed hole 12 of the assembled drug loading component with the rotating rod 7, and insert the drug loading component 1 cm below the solvent liquid surface in the dissolution cup 14, adjust the appropriate rotation speed and water bath temperature, and conduct dissolution and release experiments.

[0064] Each embodiment in this specification is described in a progressive manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the system embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0065] The above is only an embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A drug dissolution device, characterized in that: It includes a dissolution device body, a water bath component, a dissolution mechanism and a fixing component; the dissolution device body includes a top cover, a dissolution cup, a first support plate and a second support plate, the water bath component is arranged between the first support plate and the second support plate; the fixing component is arranged on the first support plate, and the dissolution mechanism is arranged between the top cover and the first support plate.

2. The drug dissolution device according to claim 1, characterized in that: The first support plate and the second support plate are arranged in parallel, and the first support plate is provided with a plurality of placement holes for placing the dissolution cup; a support column is arranged between the first support plate and the second support plate, and the support column is arranged on the four corners of the first support plate, and a base is arranged at the bottom of the second support plate.

3. A drug dissolution device according to claim 1, characterized in that: The dissolution mechanism includes a plurality of rotating rods and a plurality of drug-carrying components. One end of the rotating rod is rotatably connected to the top cover, and the other end is connected to the drug-carrying component. The dissolution mechanism corresponds to the dissolution cup. The rotating rod is a retractable structure.

4. A drug dissolution device according to claim 3, characterized in that: The drug carrying component includes a drug carrying tray, a drug carrying screw cap, a gasket and a polycarbonate film; the drug carrying screw cap is arranged above the drug carrying tray, the drug carrying screw cap is threadedly connected to the drug carrying tray, a gasket is arranged on the drug carrying tray, and the polycarbonate film is arranged above the gasket.

5. A drug dissolution device according to claim 4, characterized in that: The medicine-carrying screw cap is provided with a fixing hole to be connected with a rotating rod; the inner wall of the fixing hole is provided with an internal thread, and one end of the rotating rod close to the medicine-carrying assembly is provided with an external thread, and the rotating rod is threadedly connected with the medicine-carrying screw cap.

6. A drug dissolution device according to claim 1, characterized in that: The water bath assembly comprises a water bath box and a heating wire, and the heating wire is arranged at the center of the bottom of the water bath box.

7. A drug dissolution device according to claim 1, characterized in that: A limiting ring is sleeved on the upper end of the dissolution cup, the lower surface of the limiting ring abuts against the first support plate, and a limiting groove is provided on the limiting ring.

8. A drug dissolution device according to claim 1, characterized in that: The fixing assembly includes a plurality of limiting members, and the limiting members are arranged on the first supporting plate, and the limiting members correspond to the dissolution cups one by one.

9. A drug dissolution device according to claim 8, characterized in that: The limiting member comprises a screw rod and a limiting block, one end of the screw rod is fixedly connected to the limiting block, and the other end of the screw rod is threadedly connected to the first support plate.

10. A drug dissolution device according to claim 9, characterized in that: The limit block is a 7-shaped structure, and the limit block is engaged with the limit groove.

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