Efficient dual-mode dissolving assisting device

Abstract

The invention discloses an indissolvable drug dual-mode hydrotropy method, which combines an ultrasonic vibration and mechanical vibration complementary mode, and stipulates different intervention conditions of ultrasonic vibration and mechanical vibration, thereby obviously shortening the hydrotropy time.

Description

Technical Field

[0001] The present invention relates to the field of liquid preparation processes in the intravenous admixture center of the medical industry, and particularly to the mechanical solubilization technology for poorly soluble drugs. Background Art

[0002] The three dissolution processes of easily caking and poorly soluble drugs are: the caking detaches from the inner wall of the medicine bottle, the caking dissolves into a turbid liquid, and the turbid liquid completely dissolves into a transparent liquid medicine.

[0003] During the process of the hospital intravenous admixture center dealing with the liquid preparation of poorly soluble drugs, the traditional method is to use mechanical vibration to help dissolve the drugs. The mechanical vibration solubilization technology performs relatively evenly in the above three dissolution stages. When dealing with the three dissolution processes of the above-mentioned poorly soluble drugs, the effects of different mechanical vibration technologies vary, but basically all have a certain effect, and the technology is relatively simple.

[0004] Currently, the ultrasonic solubilization technology is expanding its influence. In some application scenarios, it indeed shows extremely high solubilization efficiency. Therefore, there is a call to replace mechanical vibration solubilization with ultrasonic solubilization. However, in terms of dealing with the first two caking drugs, the performance of the ultrasonic technology is less than satisfactory. For this reason, some special auxiliary technologies have been developed to improve the problem of ultrasonic treatment of drug caking. These auxiliary technologies include completely immersing the medicine bottle in the water medium, increasing the ultrasonic power, improving the performance of the oscillator, improving the clamping method, and so on. These methods have a certain effect, but also have certain disadvantages and cannot be widely applied. Summary of the Invention

[0005] The present invention provides a method that comprehensively utilizes the advantages of the existing ultrasonic and mechanical vibration solubilization technologies to obtain the maximum effect, and moreover, provides a system that simultaneously applies the ultrasonic and mechanical vibration solubilization technologies.

[0006] Currently, in the two stages of the poorly soluble drug caking detaching from the inner wall of the medicine bottle and the caking dissolving into a turbid liquid, the mechanical vibration solubilization effect is relatively clear, and the efficiency is higher than that of manual work. The ultrasonic solubilization device is more complex, and the vibration effect is not prominent.

[0007] In the stage where the turbid liquid of the poorly soluble drug completely dissolves into a transparent liquid medicine, the ultrasonic solubilization effect is very significant, and the time-consuming is about 1 second. Moreover, in this stage, the structure of the ultrasonic solubilization device is simple and easy to implement. In this stage, although the mechanical vibration solubilization effect has a higher efficiency than manual work and is relatively stable, it is far less effective than the ultrasonic solubilization.

[0008] Therefore, the present invention uses mechanical vibration to assist in dissolving drugs in two stages: detaching the caked insoluble drugs from the inner wall of the medicine bottle and dissolving the caked drugs into a turbid liquid, thus avoiding the complexity of the ultrasonic-assisted dissolution device in this stage. Ultrasonic waves are used to assist in dissolving the turbid liquid into a transparent medicinal liquid, avoiding the disadvantage of poor dissolution effect of mechanical vibration in this stage. Through such a combination, the best dissolution effect can be achieved without increasing the difficulty of technical implementation.

[0009] Based on the above principle, the present invention improves the current single dissolution assistance process into a three-stage dissolution assistance process, that is, the usage method of the present invention:

[0010] The first stage of vibration-assisted dissolution: The purpose is to peel off the caked drugs adhering to the bottle wall. According to practical experience, the caked drugs adhering to the bottle wall are much more difficult to dissolve compared to ordinary caked drugs. Therefore, before injecting the solvent, a mechanical vibration is carried out in advance to make the caked drugs adhering to the bottle wall fall off.

[0011] The second stage of vibration-assisted dissolution: The purpose is to break up the caked drugs. The mechanical vibration method is used to accelerate the breaking of the caked drugs to form a suspension or a turbid liquid.

[0012] The second stage of vibration-assisted dissolution: The purpose is to make the turbid liquid become clear and transparent. By using the ultrasonic vibration-assisted dissolution method, the effect is very remarkable, and the drug particles can be completely dissolved in about 1 - 2 seconds.

[0013] The advantages and positive effects of the present invention are:

[0014] Compared with the existing single mechanical dissolution assistance technology or ultrasonic dissolution assistance technology, the present invention can make full use of the achievements of the existing dissolution assistance technology, overcome the limitations of a single technology, and significantly improve the working effect of the dissolution assistance device without significantly increasing the technical difficulty. Description of the Drawings

[0015] Figure 1 is a schematic diagram of the overall structure in the present invention.

[0016] Figure 2 is a schematic diagram of the vial clamping mechanism (1) in the present invention.

[0017] Figure 3 is a schematic diagram of the flange bearing seat assembly (105) in the present invention.

[0018] Figure 4 is a schematic diagram of the mechanical vibration mechanism (2) in the present invention.

[0019] Figure 5 is a schematic diagram of the ultrasonic vibration mechanism (3) in the present invention. Figure 6 is a schematic diagram of the floating tray assembly (314) in the present invention. Figure 7 This is a schematic diagram of the ultrasonic oscillator in the present invention. Detailed implementation manners

[0020] For a better understanding of the present invention, the present invention will be further described below in conjunction with specific embodiments and the accompanying drawings.

[0021] As Figure 1 shown, a high-efficiency mechanical vibration-assisted dissolution device includes a vial gripper mechanism (1), a mechanical vibration mechanism (2), and an ultrasonic vibration mechanism (3).

[0022] As Figure 2 shown, the vial gripper mechanism (1) includes a clamping drive motor (101), a connecting flange (102), a ball spline nut (103), a ball spline shaft (104), a flange bearing seat assembly (105), a bidirectional T-shaped lead screw (106), a right and left hand T-shaped nut (107), a linear guide rail (108), a linear guide rail slider 1 (109), a linear guide rail slider 2 (110), a gripper back plate 1 (111), a gripper back plate 2 (112), a gripper 1 (113), a gripper 2 (114), and a sensor (115).

[0023] As Figure 2 shown, the connecting flange (102) connects the clamping drive motor (101) and the ball spline nut (103), the bidirectional T-shaped lead screw (106) passes through the flange bearing seat assembly (105) and is rigidly connected to the ball spline shaft (104), and the other end of the ball spline shaft (104) passes through the ball spline nut (103).

[0024] As Figure 2 shown, the gripper 1 (113) is fixedly installed on one side of the gripper back plate 1 (111), the gripper back plate 1 (111) is installed on the linear guide rail slider 1 (109), the gripper 2 (114) is fixedly installed on one side of the gripper back plate 2 (112), the gripper back plate 2 (112) is installed on the linear guide rail slider 2 (110), the right and left hand T-shaped nut (107) is fixed on the gripper back plate 1 (111) and the gripper back plate 2 (112), and the bidirectional T-shaped lead screw (106) passes through the right and left hand T-shaped nut (107).

[0025] The sensor (115) is installed on the gripper 1 (113), the gripper 1 (113) is configured with a sensor seat, and the gripper 1 (113) and the gripper back plate 1 (111) are adaptively provided with installation holes and detection holes.

[0026] To achieve the function of clamping and restricting the vial as Figure 2As shown in the figure, the clamping drive motor (101) starts, and the rotational motion of the motor shaft is transmitted to the bidirectional T-shaped lead screw (106) through the connecting flange (102), the ball spline nut (103), and the ball spline shaft (104). The left- and right-handed T-shaped nuts (107) convert the rotational motion into a symmetric opening and closing motion, and conduct the opening and closing motion to the gripper 1 (113) and the gripper 2 (114), achieving the purpose of clamping and restricting the vial.

[0027] As Figure 3 shown in the figure, the flange bearing seat assembly (105) includes a pressure plate (1051), a bearing (1052), and a bearing seat (1053). The bearing (1052) is axially limited by the shoulders of the bidirectional T-shaped lead screw (106) and the ball spline shaft (104). The bearing (1052) is rotationally engaged with the bidirectional T-shaped lead screw (106), and the pressure plate (1051) and the bearing seat (1053) fix the bearing (1052).

[0028] As Figure 4 shown in the figure, the mechanical vibration mechanism (2) includes a vibration motor (21), a crank (22), a connecting rod (23), a linear guide slider 3 (24), a slider connector 1 (25), and a slider connector 2 (26).

[0029] The crank (22) is fixedly connected to the output shaft of the vibration motor (22). One end of the connecting rod (23) is hinged to the crank (22), and the other end of the connecting rod (23) is hinged to the slider connector 2 (26). The slider connector 2 (26) is fixed on the linear guide slider 3 (24), and the slider connector 1 (25) and the flange bearing seat assembly (105) are fixedly connected to the slider connector 2 (26).

[0030] To achieve the function of mechanically vibrating and assisting in dissolving the vial, as Figure 3 、 Figure 4 shown in the figure, when the vibration motor (21) starts, the rotational motion of the motor shaft is converted into a linear reciprocating motion of the slider connector 1 (25), the slider connector 2 (26), and the flange bearing seat assembly (105) through the crank (22) and the connecting rod (23). The linear reciprocating motion is transmitted to the gripper 1 (113) and the gripper 2 (114) through the bidirectional T-shaped lead screw (106) and the left- and right-handed T-shaped nuts (107). The gripper 1 (113) and the gripper 2 (114) enclose a restricted space. In this space, the vial is subjected to a two-way collision by the gripper 1 (113) and the gripper 2 (114) during the rapid reciprocating motion, forming a vibration-assisted dissolution effect in which the vial bears a large acceleration.

[0031] As Figure 5 、 Figure 6 shown in the figure, the ultrasonic vibration mechanism (3) includes an oscillator assembly (31) and an oscillator drive device (32).

[0032] The oscillator assembly (31) includes an ultrasonic oscillator (311), a soft pad (312), an oscillator base (313), and a floating support plate assembly (314).

[0033] The oscillator driving device (32) includes an oscillator lead screw motor (321), an oscillator T-nut (322), a linear guide rail 2 (323), and a linear guide rail slider 4 (324).

[0034] The ultrasonic oscillator (311) is fixedly installed on the soft pad (312), and the soft pad (312) and the floating support plate assembly (314) are fixedly installed on the oscillator base (313).

[0035] The oscillator lead screw motor (321) is connected in series with the oscillator T-nut (322). The oscillator T-nut (322) is fixedly installed on the oscillator base (313). The oscillator base (313) is fixedly installed on the linear guide rail slider 4 (324), and the linear guide rail slider 4 (324) is slidably installed on the linear guide rail 2 (323).

[0036] As Figure 7 shown, the front end of the ultrasonic oscillator is processed into a flat shape with a predetermined thickness. A U-shaped groove that penetrates and has a width smaller than the predetermined thickness is processed within the predetermined thickness at the very front end of the flat shape. The central plane of the U-shaped groove coincides with the central plane of the predetermined thickness, and transition arc surfaces are processed on both sides of the U-shaped groove.

[0037] To achieve the function of ultrasonic vibration-assisted dissolution of ampoules. As Figure 5 、 Figure 6 shown, when implementing ultrasonic vibration-assisted dissolution of ampoules, the oscillator lead screw motor (321) starts, pushing the oscillator assembly (31) forward. The ultrasonic oscillator (311) presses against the ampoule, conducting ultrasonic vibration to the ampoule to accelerate drug dissolution. After completing the vibration-assisted dissolution, the oscillator lead screw motor (321) drives the oscillator assembly (31) to move backward, and the ultrasonic oscillator (311) disengages from the ampoule.

[0038] As Figure 5 、 Figure 6 shown, the floating support plate assembly (314) includes a support plate (3141), a pin shaft (3142), a bottom plate (3143), an internal hexagon screw (3144), an external thread compression spring seat (3145), and a compression spring (3146).

[0039] The support plate (3141) is hinged to the oscillator base (313) through the pin shaft (3142), and the bottom plate (3143) is fixedly connected to the oscillator base (313).

[0040] The hexagon socket head screw (3144) is installed in the screw hole of the support plate (3141). The hexagon socket head screw (3144) passes through the slot hole of the bottom plate (3143). Since the diameter of the round head of the hexagon socket head screw (3144) is greater than the width of the slot hole, the hexagon socket head screw (3144) can define the horizontal position of the rotation of the support plate (3141).

[0041] The external thread compression spring seat (3145) is installed in the threaded hole of the bottom plate (3143). The compression spring (3146) is installed in the inner hole of the external thread compression spring seat (3145). The other end of the compression spring (3146) abuts against the lower surface of the support plate (3141), so that the support plate (3141) reaches the horizontal limit upward. And when a certain downward external force is applied to the support plate (3141), it will deflect downward, and after the external force disappears, it will return to the horizontal limit again.

[0042] Realize the functions of supporting the bottom and releasing the vial as Figure 1 、 Figure 6 As shown, the oscillator seat (313) has three positions: the vial release position, the vial bottom support position, and the ultrasonic vibration assisted dissolution position. The oscillator lead screw motor (321) drives the oscillator seat (313) to move forward, passing through the release position, the bottom support position, and the vibration assisted dissolution position in sequence. At the bottom support position, the vial is subjected to mechanical vibration assisted dissolution and liquid medicine injection and suction. When sucking the liquid medicine, in order to have low residual liquid, the syringe needle will touch the bottom of the bottle. When the stress borne by the needle tip is relatively large, the support plate (3141) will rotate and lower the height to reduce the stress borne by the needle tip.

Claims

1. A dual-mode solubilization assisting device, characterized in that It includes an ampoule clamping mechanism (1), a mechanical vibration mechanism (2) and an ultrasonic vibration mechanism (3). The clamping mechanism (1) is used for positioning and clamping the ampoule. The mechanical vibration mechanism (2) is used for applying mechanical vibration to the ampoule. The ultrasonic vibration mechanism (3) is used for applying ultrasonic vibration to the ampoule.

2. The vial clamping mechanism (1) according to claim 1, characterized in that: It includes a clamping drive motor (101), a connecting flange (102), a ball spline nut (103), a ball spline shaft (104), a flange bearing seat assembly (105), a bidirectional T-shaped lead screw (106), a right and left hand T-shaped nut (107), a linear guide rail 1 (108), a linear guide rail slider 1 (109), a linear guide rail slider 2 (110), a clamping back plate 1 (111), a clamping back plate 2 (112), a clamp 1 (113), a clamp 2 (114), and a sensor (115); The connecting flange (102) connects the clamping drive motor (101) and the ball spline nut (103). The bidirectional T-shaped lead screw (106) passes through the flange bearing seat assembly (105) and is rigidly connected to the ball spline shaft (104). The other end of the ball spline shaft (104) passes through the ball spline nut (103). The clamp 1 (113) is fixedly installed on one side of the clamping back plate 1 (111). The clamping back plate 1 (111) is installed on the linear guide rail slider 1 (109). The clamp 2 (114) is fixedly installed on one side of the clamping back plate 2 (112). The clamping back plate 2 (112) is installed on the linear guide rail slider 2 (110). The right and left hand T-shaped nut (107) is fixed on the clamping back plate 1 (111) and the clamping back plate 2 (112). The bidirectional T-shaped lead screw (106) passes through the right and left hand T-shaped nut (107). The clamp 1 (113) and the clamp 2 (114) enclose a space for defining the ampoule; The sensor (115) is installed on the clamp 1 (113). The clamp 1 (113) and the clamping back plate 1 (111) are adaptively opened with holes.

3. The vial clamping mechanism (1) according to the claim, characterized in that: The flange bearing seat assembly (105) includes a pressing plate (1051), a bearing (1052) and a bearing seat (1053). The bearing (1052) is axially limited by the shoulders of the bidirectional T-shaped lead screw (106) and the ball spline shaft (104). The bearing (1052) is rotationally matched with the bidirectional T-shaped lead screw (106). The pressing plate (1051) and the bearing seat (1053) fix the bearing (1052).

4. The mechanical vibration mechanism (2) according to claim 1, characterized in that: It includes a vibration motor (21), a crank (22), a connecting rod (23), a linear guide rail slider 3 (24), a slider connecting piece 1 (25) and a slider connecting piece 2 (26). The mechanical vibration mechanism is configured as follows: The crank (22) is fixedly connected to the output shaft of the vibration motor (22). One end of the connecting rod (23) is hinged to the crank (22), and the other end of the connecting rod (23) is hinged to the slider connector 2 (26). The slider connector 2 (26) is fixed on the linear guide slider 3 (24). The slider connector 1 (25) and the flange bearing seat assembly (105) are fixedly connected to the slider connector 2 (26).

5. The ultrasonic vibration mechanism (3) according to claim 1, characterized in that: It includes an oscillator assembly (31) and an oscillator driving device (32). The oscillator driving device (32) pushes the oscillator assembly (31) to press against or disengage from the vial.

6. The oscillator assembly (31) according to claim 5, characterized in that: It includes an ultrasonic oscillator (311), a soft pad (312), an oscillator seat (313), and a floating tray assembly (314); The ultrasonic oscillator (311) is fixedly installed on the soft pad (312), and the soft pad (312) and the floating tray assembly (314) are fixedly installed on the oscillator seat (313).

7. The oscillator driving device (32) according to claim 5, characterized in that: It includes an oscillator lead screw motor (321), an oscillator T-nut (322), a linear guide 2 (323), and a linear guide slider 4 (324); The oscillator lead screw motor (321) is connected in series with the oscillator T-nut (322). The oscillator T-nut (322) is fixedly installed on the oscillator seat (313). The oscillator seat (313) is fixedly installed on the linear guide slider 4 (324). The linear guide slider 4 (324) is slidably installed on the linear guide 2 (323).

8. The floating platen assembly (314) according to claim 6, characterized in that: It includes a tray (3141), a pin shaft (3142), a bottom plate (3143), an inner hexagon screw (3144), an external thread spring seat (3145), and a compression spring (3146); The tray (3141) is hinged to the oscillator seat (313) through the pin shaft (3142), and the bottom plate (3143) is fixedly connected to the oscillator seat (313); The inner hexagon screw (3144) is installed in the screw hole of the tray (3141). The inner hexagon screw (3144) passes through the slot hole of the bottom plate (3143). The diameter of the round head of the inner hexagon screw (3144) is greater than the width of the slot hole. The inner hexagon screw (3144) defines the horizontal limit for the rotation of the tray (3141). The external thread spring seat (3145) is installed in the threaded hole of the bottom plate (3143). One end of the compression spring (3146) is installed on the bottom surface of the inner hole of the external thread spring seat (3145), and the other end of the compression spring (3146) abuts against the lower surface of the tray (3141). The compression spring (3146) applies a certain upward pre-tension to the tray (3141), so that the tray (3141) stops at the horizontal limit.

9. The ultrasonic oscillator assembly according to claim 6, characterized in that: The front end of the ultrasonic oscillator is processed into a flat shape with a predetermined thickness. A U-shaped groove that penetrates and has a width smaller than the predetermined thickness is processed within the predetermined thickness at the very front end of the flat shape. The central plane of the U-shaped groove coincides with the central plane of the predetermined thickness, and transition arc surfaces are processed on both sides of the U-shaped groove.

10. The method of using a dual-mode solubilization assisting device according to any one of claims 1-8, characterized in that: The process of dual-mode solubilization assistance is as follows: S1. First solubilization vibration for peeling off drug caking adhered to the vial wall: The clamping drive motor (101) is started, driving the gripper 1 (113) and the gripper 2 (114) to move, enclosing a limited space for the vial to vibrate; A vial with poorly soluble drug caking is placed into the vial gripper mechanism (1); The vibration motor (22) of the mechanical vibration mechanism (2) is started, driving the gripper 1 (113) and the gripper 2 (114) to perform reciprocating linear motion, continuously knocking on the vial wall to cause the vial to vibrate; S2. Second solubilization vibration for crushing drug caking: Solvent is injected into the vial with poorly soluble drug, the vibration motor (22) of the mechanical vibration mechanism (2) is started, driving the gripper 1 (113) and the gripper 2 (114) to perform reciprocating linear motion, continuously knocking on the vial wall to cause the vial to vibrate; S3. Third solubilization vibration for clarifying the turbid liquid: The gripper 1 (113) and the gripper 2 (114) clamp the vial, the oscillator drive device (32) of the ultrasonic vibration mechanism (3) pushes the oscillator assembly (31) to press against the vial, after the ultrasonic oscillator (311) applies vibration for a predetermined time, the oscillator drive device (32) pushes the oscillator assembly (31) to disengage from the vial.

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