A device for measuring headspace oxygen content in naphthostat mesylate for injection.

Abstract

This utility model discloses a device for determining the headspace oxygen content of naphthostat mesylate for injection. The device features an ampoule crushing chamber at the bottom of the headspace analyzer, containing a flexible sealing bag. An observation window is located on the front of the chamber. A pressing plate is positioned in front of the chamber, and an inner push plate is connected to a metal crushing plate inside the bag via a magnetic block. An ampoule placement slot is located at the bottom of the chamber. The top of the flexible sealing bag has a sealing cap with a sampling port, an injection port, and a one-way valve. The sampling needle is inserted into the ampoule crushing chamber via a positioning frame and connected to the sealing plug. This device, through its rational structural design, can safely and conveniently crush injection vials, preventing glass fragments from flying and ensuring the device's airtightness, reducing the ingress of external air, and improving the accuracy of headspace oxygen content determination. It is easy to operate, provides precise positioning, and offers a reliable device for the quality testing of naphthostat mesylate for injection.

Description

Technical Field

[0001] This utility model belongs to the technical field of pharmaceutical testing equipment, specifically relating to a device for measuring the headspace oxygen content of injectable naphthostat mesylate. Background Technology

[0002] An ampoule headspace analyzer is an instrument specifically designed to detect the gas composition and related parameters in the headspace of injection vials. It primarily assesses the sealing performance of ampoules and whether the internal gas environment meets specified standards by sampling and analyzing the gas (such as oxygen and carbon dioxide) in the residual space at the top after the injection vial is sealed. It is widely used in the pharmaceutical and biological product fields to ensure the quality and stability of ampoule packaging products and avoid problems such as drug deterioration or ineffectiveness caused by poor sealing or abnormal gas composition.

[0003] However, the existing headspace oxygen content measuring device for naphthostat mesylate for injection is not convenient and safe enough to operate when processing injection vials to obtain test samples. It may cause glass fragments to fly when the injection vials break, which may injure the operators. On the other hand, the sealing of the device and the accuracy of sampling need to be improved. Inaccurate sampling may affect the final oxygen content measurement results, resulting in the inability to accurately assess the quality of the drug. Utility Model Content

[0004] The purpose of this invention is to provide a device for measuring the headspace oxygen content of naphamostat mesylate for injection, in order to solve the problems mentioned in the background art. These problems include: the existing devices for measuring the headspace oxygen content of naphamostat mesylate for injection are not convenient and safe to operate when processing injection vials to obtain test samples; the possibility of glass fragments flying when the injection vials break, causing injury to operators; and the need to improve the sealing and sampling accuracy of the device. Inaccurate sampling may affect the final oxygen content measurement results, leading to an inability to accurately assess the quality of the drug.

[0005] To achieve the above objectives, this utility model provides the following technical solution: a device for measuring the headspace oxygen content of naphthostat mesylate for injection, comprising a headspace analyzer;

[0006] A display screen is provided at the upper front of the headspace tester, a control button is provided at the bottom of the display screen, and a sampling needle is provided at the bottom of the headspace tester.

[0007] An ampoule crushing chamber is installed at the bottom of the headspace tester, a flexible sealing bag is installed inside the ampoule crushing chamber, and an observation window is installed at the middle of the front side of the ampoule crushing chamber.

[0008] Preferably, a pressing plate is provided at the front of the ampoule crushing box, and a push plate is provided at the inner side of the pressing plate.

[0009] Preferably, a magnetic block is provided at the bottom of the push plate, and a crushing plate is provided inside the flexible sealing bag. The crushing plate is made of metal, and the push plate and the crushing plate are connected by the magnetic block.

[0010] Preferably, an array of ampoule placement slots is provided at the bottom of the ampoule crushing box, and the bottom of the flexible sealing bag corresponds to the ampoule placement slot.

[0011] Preferably, a pyramidal array is arranged at the front side of the crushing plate. The pyramidal array is made of tungsten steel, and the ampoule is crushed by pressing with the pressing plate.

[0012] Preferably, the flexible sealing bag has a sealing opening at the top and a sealing cap inside the sealing opening.

[0013] Preferably, a sampling port is provided at the middle position inside the sealing cap, a sealing plug is provided inside the sampling port, an injection port is provided at the left side position of the sampling port, and a one-way valve is provided at the right side position of the sampling port.

[0014] Preferably, a positioning frame is provided on the outer side of the sampling needle, the headspace tester is connected to the ampoule crushing box through the positioning frame, and the sampling needle is connected to the sealing plug.

[0015] Compared with the prior art, this utility model provides a device for measuring the headspace oxygen content of injectable nafamostat mesylate, which has the following beneficial effects:

[0016] 1. The ampoule crushing box, with its flexible sealing bag, observation window, pressing plate, push plate, magnetic block, crushing plate, ampoule placement slots, and pyramidal design, encloses the entire injection bottle crushing process. Combined with the internal flexible sealing bag, it effectively prevents glass fragments from flying out during bottle breakage, protecting operators and reducing the risk of accidental injury. The combination of the pressing plate, push plate, and magnetic block simplifies the bottle crushing operation; operators simply press the pressing plate, which, along with the push plate, drives the crushing plate to crush the bottle, eliminating the need for complex operations and reducing labor intensity. The ampoule placement slots at the bottom of the crushing box correspond to the bottom of the flexible sealing bag, allowing for precise placement of the injection bottle and ensuring it is in the correct position during crushing, thus improving the success rate and stability. The tungsten carbide pyramidal design on the front of the crushing plate, with its high hardness and sharpness, easily crushes the injection bottle during pressing, improving crushing effect and efficiency, and ensuring the bottle is successfully crushed for subsequent testing.

[0017] 2. The design incorporates a sealing port, sealing cap, sampling port, sealing plug, injection port, and one-way valve. The combination of the sealing port and sealing cap effectively prevents external air from entering the flexible sealing bag, avoiding interference from external oxygen on the sample in the event of bottle breakage or subsequent testing. This ensures a relatively stable testing environment and improves the accuracy of headspace oxygen content measurement. The sampling port located in the middle of the sealing cap, along with the accompanying sealing plug, facilitates the insertion of the headspace analyzer's sampling needle for headspace oxygen sample collection. The sealing plug maintains a seal after the sampling needle is inserted and removed, further preventing air from entering. The one-way valve, located on the right side of the sampling port, effectively prevents liquid backflow during injection and also prevents external air from entering through the injection port, ensuring that the internal gas environment of the device remains undisturbed and guaranteeing the reliability of the test results. Attached Figure Description

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

[0019] Figure 2 This is a schematic diagram of the headspace testing instrument in this utility model.

[0020] Figure 3 This is a schematic diagram of the structure of the ampoule crushing box in this utility model.

[0021] Figure 4 This is a schematic diagram of the flexible sealing bag in this utility model.

[0022] Figure 5 This is a schematic diagram of the structure of the crushing plate in this utility model.

[0023] In the diagram: 1. Headspace tester; 2. Ampoule crushing chamber; 3. Display screen; 4. Control button; 5. Press plate; 6. Observation window; 7. Positioning frame; 8. Sampling needle; 9. Sealing cap; 10. Sampling port; 11. Liquid injection port; 12. Sealing plug; 13. One-way valve; 14. Sealing port; 15. Push plate; 16. Ampoule placement slot; 17. Magnetic block; 18. Crushing plate; 19. Flexible sealing bag; 20. Pyramid. Detailed Implementation

[0024] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0025] This utility model provides, for example Figure 1-5The apparatus shown is for measuring headspace oxygen content in naphamostat mesylate for injection, including a headspace analyzer 1;

[0026] A display screen 3 is provided at the upper front of the headspace tester 1, a control button 4 is provided at the bottom of the display screen 3, and a sampling needle 8 is provided at the bottom of the headspace tester 1.

[0027] An ampoule crushing chamber 2 is installed at the bottom of the headspace tester 1. A flexible sealing bag 19 is installed inside the ampoule crushing chamber 2. An observation window 6 is installed at the middle of the front side of the ampoule crushing chamber 2.

[0028] A pressing plate 5 is provided at the front of the ampoule crushing box 2, and a push plate 15 is provided at the inner side of the pressing plate 5.

[0029] A magnetic block 17 is provided at the bottom of the push plate 15, and a crushing plate 18 is provided inside the flexible sealing bag 19. The crushing plate 18 is made of metal material, and the push plate 15 and the crushing plate 18 are connected by the magnetic block 17.

[0030] An array of ampoule placement slots 16 is arranged at the bottom of the ampoule crushing box 2, and the bottom of the flexible sealing bag 19 corresponds to the ampoule placement slots 16.

[0031] A pyramid 20 is arranged in an array at the front side of the crushing plate 18. The pyramid 20 is made of tungsten steel. The ampoule is crushed by pressing the pressing plate 5.

[0032] A sealing opening 14 is provided at the top of the flexible sealing bag 19, and a sealing cap 9 is provided inside the sealing opening 14.

[0033] A sampling port 10 is provided in the middle of the inside of the sealing cap 9. A sealing plug 12 is provided inside the sampling port 10. An injection port 11 is provided on the left side of the sampling port 10. A one-way valve 13 is provided on the right side of the sampling port 10.

[0034] A positioning frame 7 is provided on the outer side of the sampling needle 8. The headspace tester 1 is connected to the ampoule crushing box 2 through the positioning frame 7. The sampling needle 8 is connected to the sealing plug 12.

[0035] In this embodiment, the specific implementation steps of a device for measuring headspace oxygen content of injectable naphamostat mesylate are as follows: Open the ampoule crushing chamber 2, place the injectable naphamostat mesylate to be tested into the ampoule placement slot 16. The ampoule placement slots 16 are arranged in an array, and multiple injection bottles can be placed as needed. The bottom of the flexible sealing bag 19 corresponds to the ampoule placement slot 16 to ensure that the injection bottle is in a suitable position for subsequent operations. A magnetic block is provided at the bottom of the push plate 15. 17. The crushing plate 18 inside the flexible sealing bag 19 is made of metal. The push plate 15 and the crushing plate 18 are connected by a magnetic block 17. After ensuring a stable connection, the ampoule crushing box 2 is closed. By pressing the pressing plate 5 on the front side of the ampoule crushing box 2, the pressing plate 5 moves the inner push plate 15 towards the injection bottle. The push plate 15 moves the crushing plate 18 closer to the injection bottle. The tungsten carbide pyramids 20 arranged in an array on the front side of the crushing plate 18 will break when they approach the injection bottle. The headspace analyzer 1 can effectively break injection vials. Throughout the process, the operator can observe the breakage of the injection vials through the observation window 6. After breakage, the headspace analyzer 1 is connected to the ampoule breakage box 2 through the positioning frame 7 on the outside of the sampling needle 8, ensuring a tight connection. Then, the sampling needle 8 is connected to the sealing plug 12 to complete the sampling preparation. The one-way valve 13 can prevent liquid backflow and the entry of outside air. The measurement program is started by the control button 4 of the headspace analyzer 1. The headspace analyzer 1 obtains the headspace oxygen sample in the injection vial through the sampling needle 8 and performs content determination. The measurement results will be displayed on the display screen 3. The operator can record relevant data for subsequent analysis. After the measurement is completed, the sampling needle 8 is first pulled out from the sealing plug 12, and then the headspace analyzer 1 is separated from the ampoule breakage box 2. The ampoule breakage box 2 is opened, and the broken injection vial fragments are taken out. At this time, the fragments are in the flexible sealing bag 19. The ampoule placement slot 16 is cleaned to prepare for the next test.

[0036] like Figure 1-5 As shown, an ampoule crushing chamber 2 is located at the bottom of the headspace tester 1. A flexible sealing bag 19 is located inside the ampoule crushing chamber 2. An observation window 6 is located at the middle of the front side of the ampoule crushing chamber 2. A pressing plate 5 is located at the front side of the ampoule crushing chamber 2. A push plate 15 is located inside the pressing plate 5. A magnetic block 17 is located at the bottom of the push plate 15. A crushing plate 18 is located inside the flexible sealing bag 19. The crushing plate 18 is made of metal. The push plate 15 and the crushing plate 18 are connected by the magnetic block 17. An array of ampoule placement slots 16 is arranged at the bottom of the ampoule crushing chamber 2. The bottom of the flexible sealing bag 19 corresponds to the ampoule placement slots 16. A pyramid 20 is arranged in an array at the front side of the crushing plate 18. The pyramid 20 is made of tungsten steel. The ampoules are crushed by pressing with the pressing plate 5.

[0037] Preferably, the ampoule crushing box 2 is designed to enclose the injection bottle crushing process within, and together with the internal flexible sealing bag 19, it can effectively prevent glass fragments from flying out when the injection bottle breaks, protecting the operator and reducing the risk of accidental injury. The combination design of the pressing plate 5, the push plate 15, and the magnetic block 17 makes the injection bottle crushing operation simple. The operator only needs to press the pressing plate 5, and the push plate 15 will drive the crushing plate 18 to crush the injection bottle. No complicated operation is required, reducing labor intensity. The ampoule placement slots 16 arranged in the bottom array of the ampoule crushing box 2 correspond to the bottom of the flexible sealing bag 19, which can accurately place the injection bottle and ensure that the injection bottle is in the right position when crushing, improving the crushing success rate and stability. The tungsten carbide pyramids 20 arranged in the front array of the crushing plate 18 have high hardness and sharpness, which can easily crush the injection bottle during the pressing process, improving the crushing effect and efficiency, and ensuring that the injection bottle can be crushed smoothly for subsequent testing.

[0038] like Figure 1-4 As shown, a sealing port 14 is provided at the top of the flexible sealing bag 19, a sealing cover 9 is provided inside the sealing port 14, a sampling port 10 is provided in the middle of the sealing cover 9, a sealing plug 12 is provided inside the sampling port 10, an injection port 11 is provided on the left side of the sampling port 10, and a one-way valve 13 is provided on the right side of the sampling port 10.

[0039] Preferably, the cooperation between the sealing port 14 and the sealing cap 9 can effectively prevent outside air from entering the flexible sealing bag 19, avoiding interference from external oxygen on the sample during the breakage of the injection bottle and subsequent testing, ensuring the relative stability of the testing environment, thereby improving the accuracy of headspace oxygen content determination. The sampling port 10 and the equipped sealing plug 12 located in the middle of the sealing cap 9 facilitate the insertion of the sampling needle 8 of the headspace analyzer 1 to collect headspace oxygen samples. The sealing plug 12 can maintain a sealed state after the sampling needle 8 is inserted and pulled out, further preventing air from entering. The one-way valve 13 is located on the right side of the sampling port 10, which can effectively prevent liquid backflow during injection, and at the same time prevent outside air from entering from the injection port 11, ensuring that the gas environment inside the device is not disturbed and ensuring the reliability of the test results.

[0040] like Figure 1-5 As shown, a positioning frame 7 is provided on the outer side of the sampling needle 8. The headspace tester 1 is connected to the ampoule crushing box 2 through the positioning frame 7, and the sampling needle 8 is connected to the sealing plug 12.

[0041] Optionally, the positioning frame 7 on the outside of the sampling needle 8 is plugged into the ampoule crushing chamber 2, providing precise positioning and guidance for the sampling needle 8. This allows the sampling needle 8 to accurately align with the sealing plug 12 during sampling, greatly improving the accuracy and reliability of sampling and avoiding detection errors caused by sampling position deviation. The positioning frame 7 enables the plugging connection between the headspace tester 1 and the ampoule crushing chamber 2. This connection method enhances the structural stability between the two and effectively prevents the sampling operation from being affected by device shaking or positional displacement throughout the entire testing process, ensuring the smooth progress of the sampling process. The plugging connection between the sampling needle 8 and the sealing plug 12 ensures the sealing of the device during sampling. The sealing plug 12 tightly wraps around the sampling needle 8, preventing outside air from entering the flexible sealing bag 19 and also preventing internal gas leakage, thus ensuring the accuracy and stability of headspace oxygen content measurement.

[0042] Finally, it should be noted that the above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Although the present utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. An apparatus for measuring headspace oxygen content in naphthostat mesylate for injection, comprising a headspace analyzer (1); The headspace tester (1) is provided with a display screen (3) at the upper front position, and a control button (4) is provided at the bottom of the display screen (3). The headspace tester (1) is provided with a sampling needle (8) at the bottom. Its features are: An ampoule crushing box (2) is provided at the bottom of the headspace tester (1), a flexible sealing bag (19) is provided inside the ampoule crushing box (2), and an observation window (6) is provided at the middle of the front side of the ampoule crushing box (2).

2. The apparatus for determining headspace oxygen content of naphthostat mesylate for injection according to claim 1, characterized in that: A pressing plate (5) is provided at the front of the ampoule crushing box (2), and a push plate (15) is provided at the inner side of the pressing plate (5).

3. The apparatus for determining headspace oxygen content of naphthostat mesylate for injection according to claim 2, characterized in that: A magnetic block (17) is provided at the bottom of the push plate (15), and a crushing plate (18) is provided inside the flexible sealing bag (19). The crushing plate (18) is made of metal material, and the push plate (15) and the crushing plate (18) are connected by the magnetic block (17).

4. The apparatus for determining headspace oxygen content of naphthostat mesylate for injection according to claim 3, characterized in that: An ampoule placement slot (16) is arranged in an array at the bottom of the ampoule crushing box (2), and the bottom of the flexible sealing bag (19) corresponds to the ampoule placement slot (16).

5. The apparatus for determining headspace oxygen content of naphthostat mesylate for injection according to claim 4, characterized in that: A pyramid (20) is arranged in an array at the front side of the crushing plate (18). The pyramid (20) is made of tungsten steel. The ampoule is crushed by pressing the pressing plate (5).

6. The apparatus for determining headspace oxygen content of naphthostat mesylate for injection according to claim 1, characterized in that: The flexible sealing bag (19) has a sealing opening (14) at the top and a sealing cap (9) inside the sealing opening (14).

7. The apparatus for determining headspace oxygen content of naphthostat mesylate for injection according to claim 6, characterized in that: A sampling port (10) is provided in the middle of the inside of the sealing cap (9), a sealing plug (12) is provided in the inside of the sampling port (10), an injection port (11) is provided on the left side of the sampling port (10), and a one-way valve (13) is provided on the right side of the sampling port (10).

8. The apparatus for determining headspace oxygen content of naphthostat mesylate for injection according to claim 1, characterized in that: A positioning frame (7) is provided on the outer side of the sampling needle (8). The headspace tester (1) is connected to the ampoule crushing box (2) through the positioning frame (7). The sampling needle (8) is connected to the sealing plug (12).

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