A sealing detection device for a medicine packaging bottle

Abstract

The application relates to the technical field of medical instrument detection, and discloses a sealing performance detection device for medicine packaging bottles, which comprises a base and a medicine glass bottle. A sealing part is arranged on the medicine glass bottle, a anti-falling part is arranged on the sealing part, and a positioning part is arranged on the anti-falling part. An adjusting part and a detection part are mounted on the base, and a detection table is arranged on the base. The sealing part comprises a plug, the plug is inserted into the bottle mouth of the medicine glass bottle, a sleeve is fixedly penetrated on the plug, a filling pipe is arranged in the sleeve, a piston sleeve is arranged on the filling pipe, and the filling pipe is slidably connected in the sleeve through the piston sleeve. The combination of the black silica gel inner container and the right-angle groove closed light path can eliminate the influence of the bottle wall refraction and the liquid scattering on the signal from the source, the receiving module can capture the light intensity change, and the small cracks and leakage can be identified.

Description

Technical Field

[0001] This invention relates to the field of medical device testing technology, specifically to a device for testing the sealing performance of pharmaceutical packaging bottles. Background Technology

[0002] The failure of the seal on pharmaceutical packaging bottles can directly lead to serious consequences. This is the fundamental reason for the development of testing technology. The core of this technology is to prevent the deterioration and contamination of pharmaceuticals during storage and transportation due to seal failure, and to ensure medication safety. It has undergone technological iterations from manual experience-based judgment to precision instrument testing, aiming to solve the safety risks and testing efficiency problems caused by seal failure in different eras.

[0003] Pharmaceutical packaging bottles must comply with the strict standards of the National Medical Products Administration. They must pass drug compatibility tests to prove that the bottle will not chemically react with the drug or release harmful substances that could contaminate the drug. The production process must comply with GMP, and every step from raw materials to finished products is strictly recorded and controlled. Ordinary packaging bottles, on the other hand, follow general industrial or food packaging standards. They only need to ensure that they are non-toxic and not easily broken, without having to consider the long-term stability of chemical reactions with the contents.

[0004] When using high-performance liquid chromatography or ultraviolet-visible spectrophotometry for detection, direct detection through the bottle can alter the optical path due to refracted light, causing distortion in the absorbance, peak area, and other signals read by the instrument. This can affect the calculation results of the active ingredient content and impurity content, and the refracted light can be misidentified as a leakage signal, masking the actual minor leakage and leading to misjudgment. To address these issues, a sealing detection device for pharmaceutical packaging bottles is proposed. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] To address the shortcomings of existing technologies, this invention provides a device for detecting the sealing of pharmaceutical packaging bottles, which solves the problem that when using photometry to detect pharmaceutical packaging bottles, refracted light changes the optical path, thus being misidentified as a leakage signal.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the present invention provides the following technical solution: a sealing performance testing device for a pharmaceutical packaging bottle, comprising a base and a pharmaceutical glass bottle, wherein the pharmaceutical glass bottle is provided with a sealing part, the sealing part is provided with an anti-detachment part, the anti-detachment part is provided with a positioning part, the base is equipped with an adjustment part and a testing part, and the base is provided with a testing platform, the sealing part includes a bottle stopper, the bottle stopper is inserted into the bottle mouth of the pharmaceutical glass bottle, a sleeve is fixedly inserted through the bottle stopper, an injection tube is provided inside the sleeve, a piston sleeve is fitted on the injection tube, the injection tube is slidably connected to the sleeve through the piston sleeve, one end of the injection tube is connected to a rotary joint, the other end of the injection tube has a water inlet and a water outlet and is slidably connected to a tube sleeve, a drain hole is provided on the tube sleeve, and a silicone inner liner is fixedly connected between the sleeve and the tube sleeve.

[0009] Preferably, the water outlet on the injection tube is fitted to the inner wall of the tube sleeve, the water outlet and the drain hole are aligned on the same vertical line, the drain hole is located outside the silicone inner liner, and the silicone inner liner is coated with black.

[0010] Preferably, the anti-detachment part includes an outer rod, which is fixedly connected to the bottle stopper, and an inner rod is slidably connected to the outer rod, with a spring elastically connecting the inner rod and the outer rod.

[0011] Preferably, the positioning part includes an inner ring, the bottle stopper is fixedly connected inside the inner ring, the outer wall of the inner ring is provided with a ball bearing, the inner ring is rotatably connected to an outer ring through the ball bearing, the outer ring is provided with a sliding hole, a sliding rod is slidably connected inside the sliding hole, the end of the sliding rod is fixedly connected to a positioning plate, the positioning plate is provided with a through hole for installing a rotary joint, the bottom of the positioning plate is provided with an annular groove, and the top of the positioning plate is fixedly connected to a bracket.

[0012] Preferably, the adjustment part includes a plate frame, which is installed on one side of the base. The plate frame has an adjustment slot one and an adjustment slot two. A stud is rotatably connected to both the adjustment slot one and the adjustment slot two. A mounting bracket one is threadedly connected to the stud in the adjustment slot one, and a mounting bracket two is threadedly connected to the stud in the adjustment slot two. An electric actuator is installed on the mounting bracket two.

[0013] Preferably, the machine plate frame is provided with two motors, the output shafts of the two motors are respectively fixedly connected to two studs, and the outer ring is mounted on the mounting bracket.

[0014] Preferably, the end of the inner rod is an arc-shaped structure, the end of the inner rod is on the circumferential path of the annular groove, and the movable end of the electric actuator is fixedly connected to the bracket.

[0015] Preferably, the detection unit includes a housing, a control panel is installed on one side of the housing, a right-angle slot is provided on the other side of the housing, a light source module is installed on the inner wall of one side of the right-angle slot, a receiving module is installed on the inner wall of the other side of the right-angle slot, and a sliding groove is provided on the base.

[0016] Preferably, the bottom of the chassis is equipped with a slider and is slidably connected to the slide groove, and the control panel is electrically connected to the light source module, the receiving module and the electric actuator respectively.

[0017] Preferably, a motor is installed inside the base, the output shaft of the motor is fixedly connected to the testing platform, and the medicine glass bottle abuts between the testing platform and the bottle stopper.

[0018] (III) Beneficial Effects

[0019] Compared with the prior art, the present invention provides a device for detecting the sealing performance of pharmaceutical packaging bottles, which has the following beneficial effects:

[0020] 1. The sealing detection device for the medicine packaging bottle adopts a combination of a black silicone inner liner and a right-angle groove to seal the optical path, eliminating the influence of bottle wall refraction and liquid scattering on the signal from the source. The receiving module can capture changes in light intensity and can identify tiny cracks and leaks.

[0021] 2. The sealing detection device for the medicine packaging bottle adopts a motor drive for the adjustment unit and automatic signal acquisition for the detection unit, replacing manual adjustment and observation. The height and pressure of the adjustment unit and the position movement of the detection unit can be adapted to medicine glass bottles of different sizes without the need to replace special clamps, thus reducing equipment investment costs.

[0022] 3. The sealing test device for this medicine packaging bottle uses food-grade silicone for the inner liner and pharmaceutical-grade butyl rubber for the stopper. Both have passed drug compatibility tests and release no harmful substances, meeting the requirements for medicine packaging materials. The control panel can record data such as light intensity curve, time, and operator for each bottle test, meeting the requirements for full-process traceability and facilitating subsequent quality review.

[0023] 4. The sealing test device for the medicine packaging bottle adopts the elastic locking of the anti-detachment part and the fine adjustment of the positioning part to ensure that the parts do not shift during the test. The equipment runs continuously without failure. The entire process is automated through the control panel, which is easy for ordinary operators to learn and reduces the reliance on professional skills. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the overall structure of a sealing performance testing device for pharmaceutical packaging bottles proposed in this invention.

[0025] Figure 2 This is a schematic diagram of the structure of the glass bottle for medicines according to the present invention;

[0026] Figure 3 This is an internal sectional view of the glass bottle containing the medicine of this invention;

[0027] Figure 4 This is an internal cross-sectional view of the silicone inner liner of the present invention;

[0028] Figure 5 This is a schematic diagram of the injection tube structure of the present invention;

[0029] Figure 6 This is a schematic diagram of the positioning disk of the present invention;

[0030] Figure 7 This is a schematic diagram of the structure of the adjustment part of the present invention;

[0031] Figure 8 This is a schematic diagram of the detection unit of the present invention.

[0032] In the diagram: 1. Base; 2. Medicine glass bottle; 3. Sealing part; 31. Bottle stopper; 32. Sleeve; 33. Injection tube; 34. Piston sleeve; 35. Rotary joint; 36. Water inlet; 37. Water outlet; 38. Tube sleeve; 39. Drain hole; 310. Silicone inner liner; 4. Anti-detachment part; 41. Outer rod; 42. Inner rod; 43. Spring; 5. Positioning part; 51. Inner ring; 52. Ball bearing; 53. Outer ring; 54. 55. Sliding hole; 56. Sliding rod; 57. Positioning plate; 58. Ring groove; 69. Bracket; 60. Adjustment unit; 61. Machine plate frame; 62. Adjustment groove one; 63. Adjustment groove two; 64. Stud; 65. Mounting bracket one; 66. Mounting bracket two; 67. Electric actuator; 78. Detection unit; 79. Chassis; 70. Control panel; 71. Right angle groove; 72. Light source module; 73. Receiving module; 74. Sliding groove; 75. Detection table. Detailed Implementation

[0033] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0034] Please see Figure 1 - Figure 8This invention provides a sealing performance testing device for pharmaceutical packaging bottles, comprising a base 1 and a pharmaceutical glass bottle 2. The pharmaceutical glass bottle 2 is provided with a sealing part 3 to construct an independent testing space and eliminate refractive interference. The sealing part 3 is provided with an anti-detachment part 4, and the anti-detachment part 4 is provided with a positioning part 5. An adjustment part 6 and a testing part 7 are installed on the base 1. A testing platform 8 is provided on the base 1 to support the pharmaceutical bottle and provide rotational power for dynamic testing. The sealing part 3 includes a bottle stopper 31, which is inserted into the bottle mouth of the pharmaceutical glass bottle 2. A sleeve 32 is fixedly inserted through the bottle stopper 31. An injection tube 33 is provided inside the sleeve 32, and a piston sleeve 34 is fitted onto the injection tube 33. The bottle stopper 31 is inserted into the bottle mouth, and in conjunction with the sealing effect of the piston sleeve 34, prevents… To prevent outside air from entering the bottle and avoid external impurities from interfering with the state of the medium in the detection chamber during the detection process, the injection tube 33 is slidably connected to the sleeve 32 through the piston sleeve 34. One end of the injection tube 33 is connected to a rotary joint 35, and the other end of the injection tube 33 has a water inlet hole 36 and a water outlet hole 37 and is slidably connected to a sleeve 38. A drain hole 39 is provided on the sleeve 38. A silicone inner liner 310 is fixedly connected between the sleeve 32 and the sleeve 38. After the black silicone inner liner 310 is injected with a medium such as methylene blue solution through the injection tube 33, it expands and adheres to the inner wall of the medicine glass bottle 2, avoiding direct contact between the medicine liquid in the bottle and the bottle wall, eliminating the interference of the optical properties of the medicine liquid on the detection. The solution can also flow into the bottle and contact the bottle wall, which facilitates the detection of the sealing properties by optical properties.

[0035] Furthermore, the water outlet 37 on the injection tube 33 fits into the inner wall of the sleeve 38, and the water outlet 37 and the drain hole 39 are aligned on the same vertical line. The drain hole 39 is located outside the silicone inner liner 310, and the silicone inner liner 310 is coated in black.

[0036] In this embodiment, the anti-detachment part 4 is used to ensure the stability of the detection and prevent the component from shifting. The anti-detachment part 4 includes an outer rod 41, which is fixedly connected to the bottle stopper 31. An inner rod 42 is slidably connected to the outer rod 41. A spring 43 is elastically connected between the inner rod 42 and the outer rod 41. The positioning part 5 is used to achieve precise positioning and ensure that the bottle rotates at a uniform speed without interference. The positioning part 5 includes an inner ring 51, in which the bottle stopper 31 is fixedly connected. A ball bearing 52 is provided on the outer wall of the inner ring 51. The inner ring 51 is rotatably connected to the outer ring 53 through the ball bearing 52. The inner ring 51 is rotatably connected to the outer ring 53 through the ball bearing 52, which drives the bottle stopper. The bottle stopper 31 and the medicine bottle rotate synchronously to achieve detection of the medicine bottle without blind spots. A sliding hole 54 is opened on the outer ring 53, and a sliding rod 55 is slidably connected in the sliding hole 54. A positioning plate 56 is fixedly connected to the end of the sliding rod 55. A through hole for installing the rotary joint 35 is opened on the positioning plate 56. An annular groove 57 is opened at the bottom of the positioning plate 56. The outer rod 41 is fixed to the bottle stopper 31. The inner rod 42 is inserted into the annular groove 57 of the positioning plate 56 under the elastic force of the spring 43, which restricts the radial displacement of the bottle stopper 31 and ensures that the silicone inner liner 310 always fits the bottle wall to avoid uneven thickness of the detection cavity. A bracket 58 is fixedly connected to the top of the positioning plate 56.

[0037] It is worth noting that the adjustment unit 6 is used to provide multi-directional adjustment power to adapt to different sizes of medicine bottles. The adjustment unit 6 includes a plate frame 61, which is installed on one side of the base 1. The plate frame 61 has an adjustment slot 1 62 and an adjustment slot 2 63. A stud 64 is rotatably connected to both the adjustment slot 1 62 and the adjustment slot 2 63. A mounting bracket 1 65 is threadedly connected to the stud 64 in the adjustment slot 1 62, and a mounting bracket 2 66 is threadedly connected to the stud 64 in the adjustment slot 2 63. An electric actuator 67 is installed on the mounting bracket 2 66. Two motors are installed in the plate frame 61. The output shafts of the two motors are fixedly connected to the two studs 64 respectively. The outer ring 53 is installed on the mounting bracket 1 65. The motors in the plate frame 61 drive the studs 64 in the adjustment slot 1 62. The rotation causes the mounting bracket 65 and outer ring 53 to move up and down, adapting to different heights of medicine glass bottles 2 and ensuring that the bottle stopper 31 is accurately inserted into the bottle mouth. The end of the inner rod 42 has an arc surface structure and is on the circumferential path of the annular groove 57. The arc surface design of the inner rod 42 allows the inner rod 42 to rotate along the circumferential path of the annular groove 57. During the rotation detection of the medicine bottle, the frictional stress between the buffer components is reduced to prevent the bottle stopper 31 from being damaged due to rigid connection. The movable end of the electric push rod 67 is fixedly connected to the bracket 58. The stud 64 of the adjusting groove 63 drives the mounting bracket 66 and the electric push rod 67 to move. The electric push rod 67 pushes the positioning plate 56 down through the bracket 58 to control the clamping pressure of the bottle stopper 31 on the medicine bottle, ensuring the sealing effect and avoiding crushing the medicine bottle.

[0038] It is worth noting that the detection unit 7 is used to capture optical signals and accurately determine seal failure and bottle quality. The detection unit 7 includes a housing 71. A control panel 72 is installed on one side of the housing 71, and a right-angle slot 73 is opened on the other side of the housing 71. A light source module 74, which uses an LED collimated light source, is installed on the inner wall of one side of the right-angle slot 73, and a receiving module 75, which uses a silicon photodiode module, is installed on the inner wall of the other side of the right-angle slot 73. The reflected light paths of the light source module 74 and the receiving module 75 are aligned to eliminate signal errors caused by light path misalignment. The base 1 has an opening The device has a slide groove 76, and a slider is installed at the bottom of the housing 71 and is slidably connected to the slide groove 76. The control panel 72 is electrically connected to the light source module 74, the receiving module 75 and the electric push rod 67 respectively. A motor is installed in the base 1, and the output shaft of the motor is fixedly connected to the detection platform 8. The motor in the base 1 drives the detection platform 8 to rotate at a uniform speed, which drives the medicine bottle to rotate synchronously. With the rotation and positioning of the positioning part 5, the medicine glass bottle 2 abuts between the detection platform 8 and the bottle stopper 31. The detection platform 8 provides a stable support surface to ensure that the medicine bottle does not tip over during the detection process and provides bottom support.

[0039] Working principle: The glass bottle 2 of the medicine to be tested is placed on the testing platform 8. The motor in the machine plate frame 61 of the adjustment unit 6 drives the stud 64 in the first adjustment groove 62 to rotate, which drives the first mounting frame 65 to move up and down along the first adjustment groove 62 until the bottle stopper 31 is inserted into the bottle mouth for sealing. The stud 64 in the second adjustment groove 63 rotates synchronously, which drives the second mounting frame 66 and the electric push rod 67 to move. The electric push rod 67 pushes the positioning plate 56 down through the bracket 58, thereby pushing the tube sleeve 38 down to the inner stretch silicone liner 310 inside the bottle through the injection tube 33. The inner rod 42 extends out of the outer rod 41 under the elastic force of the spring 43, and its arc end is inserted into the annular groove 57 of the positioning plate 56, so that the bottle stopper 31 and the testing platform 8 jointly hold the medicine bottle, avoid the bottle body shaking during the test and maintain the downward pressure to maintain the sealing effect.

[0040] The rotary joint 35 is connected to a hose and a liquid pump, and the methylene blue solution is injected into the silicone inner liner 310 through the water inlet 36 on the injection tube 33, causing the silicone inner liner 310 to expand and fill the bottle. The light source module 74 and the receiving module 75 are turned on through the control panel 72. The light passes through the bottle wall, is blocked by the silicone inner liner 310, and is reflected vertically to the receiving module 75, thereby detecting glass cracks. The motor in the base 1 drives the detection platform 8 to rotate at a uniform speed, which drives the medicine glass bottle 2 to rotate synchronously. At the same time, the inner ring 51 of the positioning part 5 rotates with the bottle body, so that every area of ​​the bottle body can be scanned by the light source module 74.

[0041] The electric actuator 67 pushes the positioning plate 56 downward, simultaneously continuing to push the injection tube 33 downward, causing the water outlet 37 to align with the drain hole 39. At this time, the solution enters from the water inlet 36 and exits through the drain hole 39 into the bottle, filling the space between the silicone inner liner 310 and the bottle wall. The actuator 71 is pushed to slide along the slide groove 76 via the slider, approaching the medicine glass bottle 2, making it easier for light to penetrate the bottle and the medicine liquid, and reflect it to the receiving module 75. Changes in the medium will cause abnormal scattering of light in this area, thereby detecting the sealing and the stability of the medicine in the bottle.

[0042] In addition to methylene blue solution, which has characteristic optical signals, phenolphthalein can also be used. If the solution reacts with the bottle or inner liner, the wavelength absorption characteristics of the reflected light will change. By detecting the change in the intensity of reflected light at a specific wavelength, the detection target can be changed from crack identification to solution change identification.

[0043] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

Claims

1. A device for detecting the sealing performance of a pharmaceutical packaging bottle, comprising a base (1) and a pharmaceutical glass bottle (2), characterized in that: The medicine glass bottle (2) is provided with a sealing part (3), the sealing part (3) is provided with an anti-detachment part (4), the anti-detachment part (4) is provided with a positioning part (5), the base (1) is provided with an adjustment part (6) and a detection part (7), and the base (1) is provided with a detection platform (8). The sealing part (3) includes a bottle stopper (31), which is inserted into the mouth of the medicine glass bottle (2). A sleeve (32) is fixedly inserted through the bottle stopper (31). An injection tube (33) is provided inside the sleeve (32). A piston sleeve (34) is fitted on the injection tube (33). The injection tube (33) is slidably connected to the sleeve (32) through the piston sleeve (34). One end of the injection tube (33) is connected to a rotary joint (35). The other end of the injection tube (33) is provided with a water inlet (36) and a water outlet (37) and is slidably connected to a sleeve (38). A drain hole (39) is provided on the sleeve (38). A silicone inner liner (310) is fixedly connected between the sleeve (32) and the sleeve (38). The water outlet (37) on the injection tube (33) fits the inner wall of the sleeve (38), the water outlet (37) and the drain hole (39) are aligned on the same vertical line, the drain hole (39) is located outside the silicone inner liner (310), and the silicone inner liner (310) is painted black. The detection unit (7) includes a housing (71), a control panel (72) is installed on one side of the housing (71), a right-angle groove (73) is provided on the other side of the housing (71), a light source module (74) is installed on one side of the inner wall of the right-angle groove (73), a receiving module (75) is installed on the other side of the inner wall of the right-angle groove (73), and a sliding groove (76) is provided on the base (1).

2. The sealing performance testing device for a pharmaceutical packaging bottle according to claim 1, characterized in that: The anti-detachment part (4) includes an outer rod (41), which is fixedly connected to the bottle stopper (31). An inner rod (42) is slidably connected in the outer rod (41), and a spring (43) is elastically connected between the inner rod (42) and the outer rod (41).

3. The sealing performance testing device for a pharmaceutical packaging bottle according to claim 2, characterized in that: The positioning part (5) includes an inner ring (51), the bottle stopper (31) is fixedly connected inside the inner ring (51), the outer wall of the inner ring (51) is provided with a ball (52), the inner ring (51) is rotatably connected to an outer ring (53) through the ball (52), the outer ring (53) is provided with a sliding hole (54), a sliding rod (55) is slidably connected inside the sliding hole (54), the end of the sliding rod (55) is fixedly connected to a positioning plate (56), the positioning plate (56) is provided with a through hole for installing a rotary joint (35), the bottom of the positioning plate (56) is provided with an annular groove (57), and the top of the positioning plate (56) is fixedly connected to a bracket (58).

4. The sealing performance testing device for a pharmaceutical packaging bottle according to claim 3, characterized in that: The adjustment unit (6) includes a plate frame (61), which is installed on one side of the base (1). The plate frame (61) is provided with an adjustment slot 1 (62) and an adjustment slot 2 (63). Both the adjustment slot 1 (62) and the adjustment slot 2 (63) are rotatably connected with studs (64). The studs (64) in the adjustment slot 1 (62) are threadedly connected to a mounting bracket 1 (65), and the studs (64) in the adjustment slot 2 (63) are threadedly connected to a mounting bracket 2 (66). An electric actuator (67) is installed on the mounting bracket 2 (66).

5. The sealing performance testing device for a pharmaceutical packaging bottle according to claim 4, characterized in that: The machine plate frame (61) is equipped with two motors, and the output shafts of the two motors are fixedly connected to two studs (64) respectively. The outer ring (53) is installed on the mounting bracket (65).

6. The sealing performance testing device for a pharmaceutical packaging bottle according to claim 4, characterized in that: The end of the inner rod (42) is an arc-shaped structure, and the end of the inner rod (42) is on the circumferential path of the annular groove (57). The movable end of the electric push rod (67) is fixedly connected to the bracket (58).

7. The sealing performance testing device for a pharmaceutical packaging bottle according to claim 1, characterized in that: The bottom of the chassis (71) is equipped with a slider and is slidably connected to the slide groove (76). The control panel (72) is electrically connected to the light source module (74), the receiving module (75) and the electric push rod (67) respectively.

8. The sealing performance testing device for a pharmaceutical packaging bottle according to claim 1, characterized in that: The base (1) is equipped with a motor, the output shaft of which is fixedly connected to the testing platform (8), and the medicine glass bottle (2) abuts between the testing platform (8) and the bottle stopper (31).

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