A solubility tester

Abstract

This invention relates to a solubility tester, comprising a base and a cover. The base contains several stirring drive devices. A mounting plate is horizontally mounted on the top of the base, with several sets of through holes on its surface. A heating device is located at each set of through holes on the mounting plate, and each heating device contains a test tube. Each test tube has a stir bar at its bottom, and each stir bar is driven to rotate by a stirring drive device. A test tube cap is fitted over the top of the test tube. The cover is fixedly mounted on the mounting plate and fitted over the outside of the heating devices. The cover includes a cover body and a cap hinged to one end of the cover body. The heating temperature of each set of test tubes can be controlled independently, and the stirring rate of the drug in each test tube can also be controlled independently by the stirring drive device, meeting the testing requirements for different environmental parameters. This allows for comparison of the dissolution curves of original drugs and generic drugs at the appropriate temperature and stirring speed.

Description

Technical Field

[0001] This invention belongs to the field of drug solubility testing technology, and specifically relates to a solubility tester. Background Technology

[0002] A drug solubility tester is used to check the rate and extent to which a drug dissolves from solid dosage forms such as tablets or capsules in a specified solvent. It can also be described as a method that simulates disintegration and dissolution in the gastrointestinal tract using an instrument. It is an effective means of checking the quality of a formulation and the level of its manufacturing process, and also a standard for evaluating the bioavailability of the active ingredient and the uniformity of the formulation. Currently, the dissolution testing methods for generic drugs are known and well-defined, so traditional dissolution testing can be used to obtain the drug's dissolution profile. However, the dissolution testing methods for new drugs are unknown, requiring the exploration of dissolution profiles using different temperatures, stirring speeds, and pH values. Existing technology lacks corresponding instruments and equipment capable of simulating different environmental parameters and simultaneously screening and comparing multiple groups of drugs. Therefore, it is necessary for those skilled in the art to propose a solubility tester. Summary of the Invention

[0003] To address the aforementioned problems, this invention discloses a solubility tester that can simultaneously perform dissolution tests on multiple groups of drugs under different environmental parameters, thereby determining the drug dissolution curves.

[0004] The specific technical solution is as follows:

[0005] A solubility tester includes a base and a cover. The base contains several stirring drive devices. A mounting plate is horizontally mounted on the top of the base. The mounting plate has several sets of through holes, each corresponding to a stirring drive device. A heating device is fixedly mounted on the upper surface of the mounting plate at each set of through holes. Several heating devices are arranged horizontally on the mounting plate. Each heating device contains at least one test tube. The bottom of each test tube is located above a through hole and corresponds to a stirring drive device. Each test tube has a stirring bar at its bottom, which is driven to rotate by a stirring drive device. A test tube cap is fitted over the top of the test tube. The top center of the test tube cap has an opening. Sampling needles and replenishing needles are embedded on both sides of the top of the test tube cap, with their lower ends extending into the test tube. The cover is fixedly mounted on the mounting plate and fitted over the heating devices. The cover includes a cover body and a cap hinged to one end of the cover body.

[0006] Further, the stirring driving device comprises a motor, a mounting sleeve and magnets; the periphery of the top end of the motor is fixedly arranged on the inner wall of the top end of the machine base through a connecting column, the mounting sleeve is sleeved on an output shaft of the motor, the mounting sleeve extends upward into the through hole, one magnet is respectively arranged on both sides of the top end of the mounting sleeve, the two magnets are arranged close to the bottom end of a test tube in the heating device, the top ends of the two magnets have opposite polarities and cooperate with a stirrer, so that the motor drives the two magnets to rotate, thereby driving the stirrer to rotate in the test tube.

[0007] Further, the heating device comprises a heating block, heating sheets and heat-insulation protective plates; the bottom of the heating block is fixedly arranged on a mounting plate through a fastener, and accommodating grooves for accommodating test tubes are longitudinally penetratingly arranged on both the left and right sides of the heating block; a mounting hole is formed in the center of the bottom of the heating block, and a temperature probe is arranged in the mounting hole; one heating sheet is respectively attached to the front end surface and the rear end surface of the heating block, and the heating sheets are connected with an external power supply through wires to heat the heating block; the number of the heat-insulation protective plates is two, and the two heat-insulation protective plates are respectively fixedly arranged at the front end and the rear end of the heating block, the two heat-insulation protective plates respectively press and position the two heating sheets, the bottom end of each heat-insulation protective plate is flush with the bottom end of the heating block, a folded plate is vertically arranged at the top end of each heat-insulation protective plate, the folded plate is attached to the top side wall of the heating block, positioning plates are vertically arranged on both the left and right sides of each heat-insulation protective plate, and the positioning plates are respectively attached to both sides of the heating block and extend to the opening.

[0008] Further, positioning grooves with a rectangular structure are formed at the lower ends of the outer walls of the front end and the rear end of the heating block, a protruding part matched with the width of the positioning groove is arranged on one side of the lower end of the heating sheet, and positioning of the heating block on the heating sheet is realized by embedding the protruding part into the positioning groove.

[0009] Further, screw holes are formed on side walls of the heating block at both sides of the opening, counter bores corresponding to the positions of the screw holes are formed on the positioning plates at both sides of the heat-insulation protective plate, so that a fastener penetrates through the counter bore and cooperates with the screw hole, thereby realizing fixed connection between the heat-insulation protective plate and the heating block.

[0010] Further, the cross section of the accommodating groove is of a circular structure, and an inner wall of the accommodating groove is attached to an outer wall of the test tube.

[0011] Further, the cover body is of a "匚"-shaped structure and horizontally placed on the mounting plate, the bottom end of the cover body is fixedly connected with the edge of the mounting plate, one end top of the cover body is hinged to one end of the lid body through a hinge, the lid body is of an L-shaped structure, and the lid body covers the top and one end of the cover body.

[0012] Further, one end of the machine base is provided with a touch display screen, and the other end of the machine base is provided with a heat dissipation fan.

[0013] Beneficial effects of the present invention are embodied in:

[0014] (1) The present invention uses several heating devices to heat multiple groups of test tubes, so that the heating temperature of each group of test tubes can be controlled individually, and the stirring rate of the drug in each test tube can also be controlled individually by the stirring drive device, which meets the test requirements of different environmental parameters, so that the dissolution curves of the original drug and the generic drug at different temperatures, speeds and pH values ​​are most similar.

[0015] (2) In this invention, the heating device heats the heating block by heating the heating element, thereby increasing the temperature of the heating block and heating the test tube through heat conduction, making the heating temperature more stable; the openings on both sides of the heating block allow real-time observation of the inside of the test tube, and the heat preservation plate can protect both ends of the heating block, thereby achieving a good heat preservation effect. Attached Figure Description

[0016] Figure 1 This is a front view of the solubility tester in this invention.

[0017] Figure 2 This is a schematic diagram of the back structure of the solubility tester in this invention.

[0018] Figure 3 This is a schematic diagram of the structure of the present invention after the cover is removed.

[0019] Figure 4 This is a top view of the mounting plate in this invention.

[0020] Figure 5 for Figure 4 Sectional view along the AA direction.

[0021] Figure 6 This is a schematic diagram of the test tube structure in this invention.

[0022] Figure 7 This is a schematic diagram of the stirring drive device in this invention.

[0023] Figure 8 This is a front view of the heating device in this invention.

[0024] Figure 9 for Figure 8 Sectional view along the AA direction.

[0025] Figure 10 This is a side view of the heating block in this invention.

[0026] Figure 11 This is a schematic diagram of the heating block in this invention.

[0027] Base 1, display screen 11, cooling fan 12, ventilation hole 13, mounting plate 14, through hole 141;

[0028] 2. Cover hood; 21. Receiver opening; 211. Cover body; 22.

[0029] Stirring drive device 3, motor 31, connecting column 32, mounting sleeve 33, magnet 34;

[0030] Heating device 4, heating block 41, receiving groove 411, opening 412, positioning groove 413, screw hole 414, mounting hole 415, temperature probe 416, heating element 42, protrusion 421, heat insulation and protection plate 43, folding plate 431, positioning plate 432, countersunk hole 433;

[0031] 5. Test tube 51. Test tube cap 52. Sip 53. Sampling needle 54. Liquid replenishment needle 55. Stirring bar 56. Detailed Implementation

[0032] To make the technical solution of this invention clearer and more explicit, the invention will be further described below with reference to the accompanying drawings. Any solution derived by equivalent substitution and conventional reasoning of the technical features of this invention falls within the protection scope of this invention. The fixed connections and fixed installations mentioned in this invention are all common connection methods in the mechanical field, including welding, bolt and nut connections, and screw connections.

[0033] In the description of this invention, it should be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0034] like Figure 1-6 As shown, Figure 1-6As shown, a solubility tester comprises a base 1 and a hood 2. A touch display screen 11 is arranged at the front end of the base 1, a heat dissipation fan 12 is arranged at the rear end of the base 1, and ventilation holes 13 are arranged on both sides of the base 1. Twelve stirring driving devices 3 and a control circuit are arranged inside the base 1, and the control circuit is electrically connected with the stirring devices, the display screen 11 and the heat dissipation fan 12. A mounting plate 14 is horizontally arranged on the top of the base 1, six groups of through holes 141 are opened on the surface of the mounting plate 14, and the number of the through holes 141 in each group is two. The position of each through hole 141 corresponds to the position of one stirring driving device 3 respectively, a heating device 4 is respectively and fixedly arranged at the position of each group of through holes 141 on the upper surface of the mounting plate 14, six heating devices 4 are transversely arranged on the mounting plate 14, two test tubes 5 can be placed in each heating device 4, the bottom of each test tube 5 is respectively located above one through hole 141 and corresponds to the position of one stirring driving device 3, a medium is contained in each test tube 5, and a stirring magnet 55 is arranged at the inner bottom end of each test tube 5, so that each stirring magnet 55 is driven to rotate by one stirring driving device 3 respectively. A test tube cap 51 is sleeved on the upper end of the test tube 5, a through opening 52 is opened in the center of the top of the test tube cap 51, a sampling needle 53 and a fluid replacement needle 54 are respectively embedded and arranged on both sides of the top of the test tube cap 51, the lower ends of the sampling needle 53 and the fluid replacement needle 54 both extend into the test tube 5, wherein the lower end of the sampling needle 53 extends to the lower end of the test tube 5, and the lower end of the fluid replacement needle 54 is located at the upper end of the test tube 5. The sampling needle 53 and the fluid replacement needle 54 are connected to an external sampling device and a fluid replacement device through pipelines, so that the instrument can be used in cooperation with a collector to realize automatic sampling.

[0035] The hood 2 is fixedly arranged on the mounting plate 14 and sleeved outside the plurality of heating devices 4. The hood 2 is made of a transparent material, and comprises a hood body 21 and a cover body 22 hinged to one end of the hood body 21. The hood body 21 is in a "匚"-shaped structure and horizontally placed on the mounting plate 14, the bottom end of the hood body 21 is fixedly connected with the edge of the mounting plate 14, one end top of the hood body 21 is hinged to one end of the cover body 22 through a hinge, the cover body 22 is in an L-shaped structure, the cover body 22 covers the top and one end of the hood body 21, an accommodating opening 211 is opened on one end side wall of the hood body 21, and the accommodating opening 211 is used for the pipelines of the fluid replacement needle 54 and the sampling needle 53 to pass through.

[0036] The stirring drive device 3 includes a motor 31, a mounting sleeve 33, and magnets 34. The top of the motor 31 is fixed to the inner wall of the top of the base 1 by connecting columns 32. All 12 motors 31 are cooled by cooling fans 12 during operation. The mounting sleeve 33 is sleeved on the output shaft of the motor 31 and extends upward into the through hole 141. A magnet 34 is set on each side of the top of the mounting sleeve 33. The two magnets 34 are set close to the bottom of the test tube 5 in the heating device 4. The stirring bar 55 has its own magnet 34 inside. The magnet 34 is set horizontally and has opposite polarities at both ends. The top polarities of the two magnets 34 on the mounting sleeve 33 are opposite and cooperate with the magnet 34 inside the stirring bar 55, so that the motor 31 drives the two magnets 34 to rotate, thereby driving the stirring bar 55 to rotate inside the test tube 5. The motor 31 in each stirring device is electrically connected to the control circuit.

[0037] By employing the aforementioned stirring drive device 3, the rotational speed of each motor 31 can be individually controlled by the control circuit, thereby allowing for individual control of the rotational speed of the stir bar 55 in the two test tubes 5 in the same group.

[0038] The heating device 4 includes a heating block 41, a heating element 42, and a heat insulation and protective plate 43. The heating block 41 is made of copper and has a rectangular structure. The bottom of the heating block 41 is fixed to the mounting plate 14 by fasteners, and all six heating blocks 41 are inclined along the vertical center. Each heating block 41 has a longitudinally penetrating groove 411 for accommodating test tubes 5 on both sides. Two grooves 411 correspond to a set of through holes 141. The cross-section of the groove 411 is circular, and the inner diameter of the groove 411 is adapted to the diameter of the test tube 5, so that the inner wall of the groove 411 fits snugly against the outer wall of the test tube 5. The lower end of the test tube 5 is embedded in the groove 411 and limited by the test tube cap 51, and the bottom of the test tube 5 is flush with the bottom of the heating block 41. Each heating block 41 has a long opening 412 on one side of each groove 411, through which the interior of the test tube 5 can be observed. The heating block 41 has a mounting hole 415 at its bottom center, into which a temperature probe 416 is embedded. The temperature probe 416 is electrically connected to the control circuit and is used to measure the temperature of the heating block 41 in real time and display it on the touch screen 11. A heating element 42 is attached to the front and rear surfaces of the heating block 41, and the width of the heating element 42 is adapted to the width of the heating block 41. The heating element 42 heats the heating block 41 through heat conduction, and the heating block 41 heats the test tube 5 through heat conduction. A rectangular positioning groove 413 is provided at the lower end of the outer wall of the front and rear ends of the heating block 41. A protrusion 421 with a width adapted to the positioning groove 413 is provided on one side of the lower end of the heating element 42. The heating block 41 is positioned on the heating element 42 by the protrusion 421 being embedded in the positioning groove 413. The bottom of the protrusion 421 is connected to the control circuit through a wire.

[0039] Two thermal insulation protective plates 43 are fixedly installed at the front and rear ends of the heating block 41, respectively. The two thermal insulation protective plates 43 press and position the two heating elements 42, achieving a heat insulation effect and preventing heat loss. The bottom end of the thermal insulation protective plate 43 is flush with the bottom end of the heating block 41. The top of each thermal insulation protective plate 43 is vertically provided with a folding plate 431, which is attached to the top side wall of the heating block 41. Positioning plates 432 are vertically provided on both the left and right sides of the thermal insulation protective plate 43. The positioning plates 432 are respectively attached to both sides of the heating block 41 and extend to the opening 412. Two screw holes 414 are opened on both side walls of the heating block 41 located at the opening 412. The two screw holes 414 are longitudinally distributed. The positioning plates 432 on both sides of the insulation and protective plate 43 are provided with countersunk holes 433 corresponding to the positions of the screw holes 414. The bolts are passed through the countersunk holes 433 and cooperate with the screw holes 414 to achieve a fixed connection between the insulation and protective plate 43 and the heating block 41.

[0040] By employing the aforementioned heating device 4, the control circuit can individually control the heating temperature of each heating device 4. The heating element 42 heats the heating block 41, thereby increasing the temperature of the heating block 41 and heating the test tube 5 through heat conduction, making the heating temperature more stable. The openings 412 on both sides of the heating block 41 allow for real-time observation of the interior of the test tube 5, and the heat insulation plate 43 can protect both ends of the heating block 41, thus achieving a good heat insulation effect.

[0041] Working principle: During use, test tube 5 is placed in each heating device 4, and the medium and drug are placed in the test tube 5. The heating temperature of each heating device 4 and the speed of each motor 31 are adjusted by operating the touch screen 11, so that the environmental parameters in each test tube 5 can be distinguished. Through multiple sets of tests, the environmental parameters of the original drug that are closest to the dissolution curve of the generic drug are selected.

[0042] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A solubility tester, comprising a base (1) and a cover (2), characterized in that, The base (1) is equipped with several stirring drive devices (3) inside. The top of the base (1) is equipped with a horizontal mounting plate (14). The surface of the mounting plate (14) is provided with several sets of through holes (141). The position of each through hole (141) corresponds to the position of a stirring drive device (3). A heating device (4) is fixedly installed on the upper surface of the mounting plate (14) at the position of each set of through holes (141). Several heating devices (4) are arranged horizontally on the mounting plate (14). Each heating device (4) contains at least one test tube (5). The bottom of each test tube (5) is located above a through hole (141) and is opposite to the position of a stirring drive device (3). Each test tube (5) is equipped with a stir bar (55) at the bottom of its interior, so that each stir bar (55) is driven to rotate by a stirring drive device (3). The test tube (5) is fitted with a test tube cap (51) at the top end. The test tube cap (51) has an opening (52) at the center of its top. The top two sides of the test tube cap (51) are respectively fitted with a sampling needle (53) and a liquid replenishment needle (54). The lower ends of the sampling needle (53) and the liquid replenishment needle (54) extend into the test tube (5). The machine cover (2) is fixedly installed on the mounting plate (14) and fitted on the outside of several heating devices (4). The machine cover (2) includes a cover body (21) and a cover body (22) hinged to one end of the cover body (21). The stirring drive device (3) includes a motor (31), a mounting sleeve (33), and a magnet (34). The top of the motor (31) is fixed to the inner wall of the top of the base (1) by connecting columns (32). The mounting sleeve (33) is sleeved on the output shaft of the motor (31). The mounting sleeve (33) extends upward into the through hole (141). A magnet (34) is set on each side of the top of the mounting sleeve (33). The two magnets (34) are close to the bottom of the test tube (5) in the heating device (4). The top polarities of the two magnets (34) are opposite and cooperate with the stir bar (55) to realize that the motor (31) drives the two magnets (34) to rotate, thereby driving the stir bar (55) to rotate inside the test tube (5). The heating device (4) comprises a heating block (41), heating sheets (42) and heat-insulation protection plates (43), wherein both the left and right sides of the heating block (41) are longitudinally provided with accommodating grooves (411) penetrating through for accommodating test tubes (5); a mounting hole (415) is formed in the center of the bottom of the heating block (41), and a temperature probe (416) is arranged in the mounting hole (415); one heating sheet (42) is respectively attached to the front and rear end surfaces of the heating block (41), and the heating sheets (42) are connected to an external power supply through wires and heat the heating block (41); the number of the heat-insulation protection plates (43) is two, the two heat-insulation protection plates are respectively and fixedly arranged at the front and rear ends of the heating block (41), the two heat-insulation protection plates (43) respectively press and position the two heating sheets (42), the bottom ends of the heat-insulation protection plates (43) are flush with the bottom end of the heating block (41), folded plates (431) are vertically arranged at the top ends of the heat-insulation protection plates (43), the folded plates (431) are attached to the top side wall of the heating block (41), positioning plates (432) are vertically arranged on the left and right sides of the heat-insulation protection plates (43), and the positioning plates (432) are respectively attached to the two sides of the heating block (41) and extend to the position of the opening (412).

2. The solubility tester according to claim 1, characterized in that, The lower ends of the outer walls of the front and rear ends of the heating block (41) are both provided with positioning grooves (413) of a rectangular structure, one side of the lower end of the heating sheet (42) is provided with a protruding part (421) adapted to the width of the positioning groove (413), and the protruding part (421) is embedded into the positioning groove (413) to realize positioning of the heating sheet (42) by the heating block (41).

3. The solubility tester according to claim 1, characterized in that, The heating block (41) is provided with screw holes (414) on both side walls where the opening (412) is located, the positioning plates (432) on both sides of the heat-insulation protection plate (43) are provided with counterbores (433) corresponding to the positions of the screw holes (414), so that a fastener penetrates through the counterbores (433) and cooperates with the screw holes (414), thereby realizing fixed connection between the heat-insulation protection plate (43) and the heating block (41).

4. The solubility tester according to claim 1, characterized in that, The cross section of the accommodating groove (411) is a circular structure, and the inner wall of the accommodating groove (411) is attached to the outer wall of the test tube (5).

5. A solubility tester according to claim 1, characterized in that, The cover body (21) is in a "匚"-shaped structure and horizontally placed on the mounting plate (14), the bottom end of the cover body (21) is fixedly connected with the edge of the mounting plate (14), the top of one end of the cover body (21) is hinged to one end of the cover (22) through a hinge, the cover (22) is in an L-shaped structure, and the cover (22) covers the top and one end of the cover body (21).

6. A solubility tester according to claim 1, characterized in that, One end of the base (1) is provided with a touch display screen (11), and the other end of the base (1) is provided with a heat dissipation fan (12).

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