Inhaled preparation sealing performance test tool

Abstract

The utility model belongs to the technical field of airtightness testing, and particularly discloses an inhalation preparation airtightness testing tool which comprises a shell and a gland fixed above the shell. A circular groove is formed in the upper surface of the shell, a first sealing ring is arranged on the inner side of the circular groove, a lower cavity is formed below the circular groove, an inhalation preparation bottle body is arranged in the lower cavity, an inhalation preparation atomization device is arranged above the inhalation preparation bottle body, a through hole is formed in the middle of the gland, and the inhalation preparation atomization device penetrates through the through hole and the first sealing ring. A second sealing ring is arranged between the inhalation preparation bottle body and the inhalation preparation atomization device, the structural design is optimized, the split type gland is adopted to be matched with the lower cavity, and the double sealing rings are combined to isolate the leakage risk of the inhalation preparation atomization device and the inhalation preparation bottle body, so that the sealing performance of the bottle body is accurately detected, and the sealing performance of the inhalation preparation atomization device and the inhalation preparation bottle body is improved. The split type gland and locking screw design is adopted, the sealing pressure can be adjusted conveniently, and the sealing reliability is ensured.

Description

Technical Field

[0001] This utility model relates to the field of airtightness testing technology, specifically to a tooling for testing the airtightness of inhaled preparations. Background Technology

[0002] Inhaled formulations are drug-device combination products consisting of a drug prescription and a nebulizer. They are typically delivered to the lungs via the mouth or nose using a device. The efficacy of drug administration and treatment is determined by four factors: the physicochemical properties of the drug, the nebulization performance of the device, the patient's operating skills, and the user's dependence. Drug-device combination products naturally have high research and development barriers.

[0003] Inhalers typically contain precisely measured doses of medication used to treat respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Poor packaging sealing can lead to leakage of the contents (medication, propellant, carrier, etc.) or intrusion of external substances (air, moisture, microorganisms), altering drug concentration, dosage uniformity, or drug form (such as clumping of dry powder). This directly results in inaccurate dosage to the patient, affecting treatment efficacy and potentially delaying treatment due to insufficient dosage or causing adverse reactions due to excessive dosage.

[0004] Currently, the pressure decay method is one of the commonly used methods for sealing tests in the pharmaceutical industry. Its principle is to determine the presence of leaks by detecting pressure changes within a closed system. However, traditional sealing test fixtures often struggle to distinguish between leaks in the inhalation formulation bottle itself and leaks at the nebulizer interface, potentially leading to false positives and affecting product quality assessment. Utility Model Content

[0005] The purpose of this invention is to provide a tooling for testing the sealing performance of inhaled formulations, thereby solving the problems mentioned in the background art.

[0006] To achieve the above objectives, this utility model provides the following technical solution: a testing fixture for the sealing performance of inhaled preparations, comprising a housing and a cap fixed above the housing; a circular groove is formed on the upper surface of the housing, a first sealing ring is provided inside the circular groove, a lower chamber is formed below the circular groove, an inhaled preparation bottle is disposed in the lower chamber, an inhaled preparation nebulizer is disposed above the inhaled preparation bottle, a through hole is formed in the middle of the cap, the inhaled preparation nebulizer passes through the through hole and the first sealing ring, and a second sealing ring is provided between the inhaled preparation bottle and the inhaled preparation nebulizer. By optimizing the structural design, using a split cap and lower chamber, combined with double sealing rings to isolate the leakage risk of the inhaled preparation nebulizer and the inhaled preparation bottle respectively, the sealing performance of the bottle itself can be accurately tested.

[0007] As a preferred embodiment of this invention, a detection hole is provided on the side of the housing for detection.

[0008] As a preferred embodiment of this invention, a recessed groove is provided at the bottom of the lower chamber. The purpose of the recessed groove is to prevent a local vacuum from forming at the bottom of the medicine after the test, which would make it difficult to remove the medicine.

[0009] As a preferred embodiment of this invention, the lower outer circle of the inhalation preparation nebulizer is at the same level as the first sealing ring to ensure good sealing between the inhalation preparation nebulizer and the first sealing ring.

[0010] In a preferred embodiment of this invention, the housing has several threaded holes on its upper surface, and the gland has several screw holes. The screw holes are aligned with the threaded holes and connected to locking screws. The locking screws are used to adjust the pressure of the gland against the first sealing ring.

[0011] In a preferred embodiment of this invention, a compression protrusion is fixed below the pressure cap, and the compression protrusion contacts the first sealing ring. The lower outer circle of the inhalation preparation nebulizer is at the same level as the first sealing ring. As the locking screw is tightened, the compression protrusion of the pressure cap moves downward, compressing the first sealing ring and causing it to form a shape that wraps around the lower outer circle of the inhalation preparation nebulizer, thereby achieving a sealing effect.

[0012] Compared with the prior art, the beneficial effects of this utility model are:

[0013] This invention employs a double-sealing structure with a first and a second sealing ring, effectively distinguishing between leaks from the atomizing device and the bottle body. This avoids misjudgments caused by the non-sealed structure of the atomizing device itself in traditional testing, thus improving detection accuracy. The separate cap and locking screw design facilitates adjustment of the sealing pressure and ensures reliable sealing. The recessed groove at the bottom of the lower chamber prevents negative pressure adsorption and facilitates sample removal after testing. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the exploded structure of this utility model;

[0015] Figure 2 This is a schematic diagram of the internal structure of this utility model.

[0016] In the diagram: 1. Shell; 101. Circular groove; 102. Lower chamber; 103. Detection hole; 104. Threaded hole; 105. Recessed groove; 2. Cap; 201. Through hole; 202. Screw hole; 203. Extruded convex circle; 3. First sealing ring; 4. Inhalation preparation bottle body; 5. Inhalation preparation nebulizer; 6. Second sealing ring; 7. Locking screw. Detailed Implementation

[0017] 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.

[0018] In the description of this utility model, it should be noted that the terms "vertical", "up", "down", "horizontal", 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 utility model 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 utility model.

[0019] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0020] Please see Figure 1-2 This utility model provides a technical solution: a test fixture for the sealing performance of inhaled preparations, including a housing 1 and a cap 2 fixed on top of the housing 1; a circular groove 101 is formed on the upper surface of the housing 1, a first sealing ring 3 is provided inside the circular groove 101, a lower chamber 102 is formed below the circular groove 101, an inhaled preparation bottle 4 is arranged in the lower chamber 102, an inhaled preparation nebulizer 5 is arranged above the inhaled preparation bottle 4, a through hole 201 is formed in the middle of the cap 2, the inhaled preparation nebulizer 5 passes through the through hole 201 and the first sealing ring 3, and a second sealing ring 6 is provided between the inhaled preparation bottle 4 and the inhaled preparation nebulizer 5. By optimizing the structural design, using a split cap 2 to cooperate with the lower chamber, and combining double sealing rings to isolate the leakage risk of the inhaled preparation nebulizer 5 and the inhaled preparation bottle 4 respectively, the sealing performance of the bottle itself can be accurately tested.

[0021] Furthermore, a detection hole 103 is provided on the side of the housing 1 for detection.

[0022] Furthermore, a recessed groove 105 is provided at the bottom of the lower chamber 102. The purpose of the recessed groove 105 is to prevent a local vacuum from forming at the bottom of the medicine after the test, which would make it difficult to remove the medicine.

[0023] Furthermore, the lower outer circle of the inhalation preparation nebulizer 5 is at the same level as the first sealing ring 3 to ensure good sealing between the inhalation preparation nebulizer 5 and the first sealing ring 3.

[0024] Furthermore, the housing 1 has several threaded holes 104 on its upper surface, and the pressure cap 2 has several screw holes 202. The screw holes 202 are aligned with the threaded holes 104 and connected to locking screws 7. The locking screws 7 are used to adjust the pressure cap 2 to compress the first sealing ring 3.

[0025] Furthermore, a compression protrusion 203 is fixed below the pressure cap 2, and the compression protrusion 203 contacts the first sealing ring 3. The lower outer circle of the inhalation preparation nebulizer 5 is at the same horizontal plane as the first sealing ring 3. As the locking screw 7 is tightened, the compression protrusion 203 of the pressure cap 2 moves downward, compressing the first sealing ring 3, causing it to form a shape that wraps around the lower outer circle of the inhalation preparation nebulizer 5, thereby achieving a sealing effect.

[0026] The inhalation dosage form bottle 4 is placed in the lower chamber 102. The inhalation dosage form nebulizer 5 passes through the through hole 201 of the cap 2 and the first sealing ring 3, and forms a seal with the bottle body through the second sealing ring 6. The downward pressure of the cap 2 is adjusted by the locking screw 7, causing the extrusion convex circle 203 to press down on the first sealing ring 3, deforming it and tightly wrapping the lower outer circle of the nebulizer, ensuring the seal between the nebulizer and the test fixture. A certain pressure (positive or negative pressure) is applied to the test chamber through the detection hole 103 on the side of the housing 1. If there is a leak in the bottle body, the pressure will change through the leak point and be detected by the pressure sensor. Since the first sealing ring 3 and the second sealing ring 6 isolate the leakage path of the nebulizer and the bottle body respectively, the interference of the nebulizer itself can be eliminated, ensuring that the test results only reflect the sealing performance of the bottle body. After the test is completed, since the lower chamber 102 has a recessed groove 105 at the bottom, the problem of the bottle body being difficult to remove due to negative pressure adsorption at the bottom can be avoided, improving the ease of operation.

[0027] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A tooling for testing the sealing performance of inhaled formulations, characterized in that: Includes a housing (1) and a pressure cap (2) fixed on top of the housing (1); a circular groove (101) is provided on the upper surface of the housing (1), a first sealing ring (3) is provided inside the circular groove (101), a lower chamber (102) is provided below the circular groove (101), an inhalation preparation bottle body (4) is provided in the lower chamber (102), an inhalation preparation atomizing device (5) is provided above the inhalation preparation bottle body (4), a through hole (201) is provided in the middle of the pressure cap (2), the inhalation preparation atomizing device (5) passes through the through hole (201) and the first sealing ring (3), and a second sealing ring (6) is provided between the inhalation preparation bottle body (4) and the inhalation preparation atomizing device (5).

2. The inhalation formulation sealing test fixture according to claim 1, characterized in that: The housing (1) has a detection hole (103) on its side.

3. The inhalation formulation sealing test fixture according to claim 1, characterized in that: The bottom of the lower chamber (102) is provided with a recessed groove (105).

4. The inhalation formulation sealing test fixture according to claim 1, characterized in that: The lower outer circle of the inhalation preparation atomizing device (5) is at the same level as the first sealing ring (3).

5. The inhalation formulation sealing test fixture according to claim 1, characterized in that: The housing (1) has several threaded holes (104) on its top, and the cover (2) has several screw holes (202). The screw holes (202) are aligned with the threaded holes (104) and connected with locking screws (7).

6. The inhalation formulation sealing test fixture according to claim 1, characterized in that: A compression convex circle (203) is fixed below the pressure cap (2), and the compression convex circle (203) contacts the first sealing ring (3).

Images