Bottle cap assembly, double-cavity cartridge bottle packing material for injection and packing material assembly

Abstract

The bottle cap assembly, the double-cavity clamping type bottle packing material for injection and the packing material assembly are characterized in that the bottle cap assembly is used for sealing a double-cavity clamping type bottle and comprises a top plug and a top cover; the top plug is limited in the top cover and used for sealing a bottle opening of the double-cavity clamping type bottle. The top cover is used for pressing and fixing the top plug so that the top plug can seal the bottle opening of the double-cavity clamping type bottle and seal the double-cavity clamping type bottle. The bottle cap assembly is used for implementing integrated self-plugging and capping sealing on the double-cavity clamping type bottle in the freeze dryer, a feasible scheme is provided for rapid sealing of the double-cavity clamping type bottle in an existing freeze-drying process, low-quality sealing is avoided, and therefore the freeze-drying efficiency and the freeze-drying quality are improved.

Description

Technical Field

[0001] This application relates to the fields of biopharmaceuticals, cosmetics, or medical aesthetics, and more specifically, to a bottle cap assembly. Background Technology

[0002] Currently, most lyophilized products on the market use vials as drug containers. Before injection, a sterile syringe is used to draw the reconstituted solution from a separate container, and then the solution is injected into the drug container for reconstitution, extraction, and administration. This results in relatively poor dosing accuracy and patient compliance. Dual-chamber cartridge vials offer a superior alternative. A dual-chamber cartridge vial is divided into two chambers by a stopper. The front chamber contains the lyophilized drug, and the rear chamber contains the reconstituted solution. During use, the reconstituted solution is pushed through a bypass into the front chamber to reconstitute the lyophilized drug. Once completely dissolved, pushing the stopper to the top completes the injection process. Dual-chamber cartridge vials are an innovative drug packaging technology in the global biopharmaceutical, cosmetic, and medical aesthetics fields. They are compatible with various drug delivery devices and offer advantages such as ease of use, high patient safety, and good compliance, making their application prospects very broad.

[0003] However, existing dual-chamber cartridge packaging materials cannot complete the integrated self-pressing and capping process within a freeze dryer. Therefore, an innovative packaging material is needed that can achieve integrated sealing within the freeze dryer chamber to meet the airtightness requirements of the freeze-drying process and enable the packaging material to meet future drug delivery methods. For example, the sealing device and sealing component for containers disclosed in CN102259723A have high sealing performance; however, they cannot meet the requirement that product moisture is sublimated and discharged from the container (mainly gas) during the freeze-drying process. Therefore, this type of packaging material cannot be directly used in the freeze-drying process and may require an additional capping step, increasing time costs. Furthermore, it may affect the freeze-drying effect of the drug in the container during container transfer.

[0004] CN117208401A discloses a bottle cap and a dual-chamber cartridge bottle. After freeze-drying, the partition in the freeze dryer can directly apply pressure to the bottle cap, switching it from a half-capped state to a full-capped state, thus sealing the dual-chamber cartridge bottle. However, the bottle cap is positioned before capping by a hook part inside its cavity engaging with a groove on the annular protrusion on the outer circumference of the bottle mouth. If the freeze dryer partition applies uneven force due to uneven placement of the dual-chamber cartridge bottle, the bottle cap may tilt during capping. Since the hook part is an asymmetrical column shape, it may be difficult to press down the tilted side properly after the cap has tilted. Furthermore, the inner cap may slip off in the half-capped state, reducing the efficiency of water sublimation during freeze-drying.

[0005] Furthermore, CN117228154A discloses a combined bottle cap and a dual-cavity cartridge bottle. The combined bottle cap has an inner cap and an outer cap. The first snap-fit ​​member of the outer cap contacts the outer wall of the inner cap and is fixed relative to the inner cap by a hook-shaped structure, thus potentially avoiding the problem of incomplete sealing caused by cap tilting during the capping process. However, when the outer cap is in a half-capped state, due to the very limited contact area between the first snap-fit ​​member and the outer wall of the inner cap, the outer cap may not be stably positioned at the outer edge of the inner cap during freeze-drying, causing the outer cap to detach.

[0006] In addition, existing dual-chamber cartridge packaging materials have problems such as lack of anti-rotation structure, excessive crimping force, and core removal of injection needles when used to obtain freeze-dried products. The following will provide feasible solutions to these problems based on the dual-chamber cartridge packaging material proposed in this application.

[0007] Therefore, there is an urgent need for a cap assembly that can solve the above problems and is stably compatible with dual-chamber cartridge bottles. This assembly should be able to reliably self-press and seal within the freeze dryer chamber, thereby improving the freeze-drying efficiency and quality of freeze-dried products, filling the current gap in the domestic dual-chamber cartridge bottle packaging material field, and enhancing the core competitiveness of products. Utility Model Content

[0008] This application aims to provide a solution that can overcome at least one of the aforementioned defects of the prior art.

[0009] In one aspect of this application, a bottle cap assembly is provided, comprising a top stopper and a top cap for sealing a dual-chamber cartridge bottle. The top stopper is positioned within the top cap to seal the bottle opening of the dual-chamber cartridge bottle; the top cap is used to press and secure the top stopper, thereby sealing the bottle opening of the dual-chamber cartridge bottle and sealing the dual-chamber cartridge bottle. After the top stopper is pre-assembled into the top cap, the top stopper and top cap are integrally formed, eliminating the need for a stopper assembly. The top cap can directly achieve a stopper seal by pressing the top stopper. Furthermore, this method eliminates the need to additionally remove the stopper assembly to provide further capping for the dual-chamber cartridge bottle. The application of the top cap on dual-chamber cartridge bottles significantly reduces the operation steps and time required for self-stopping and capping of the dual-chamber cartridge bottle, improves the sealing efficiency of the dual-chamber cartridge bottle in the freeze-drying process, and avoids the number of operation failures caused by additional operation steps. When failed operations are difficult to remedy in the freeze-drying process using conventional methods, the integrated operation of the top cap for self-stopping and capping is particularly important for ensuring the efficiency of the freeze-drying process.

[0010] In some embodiments of this application, the dual-chamber cartridge may include: an inner cavity, a body, a neck, and a mouth. The mouth may have a central opening connected to the inner cavity, the inner diameter of which is smaller than the inner diameters of the mouth and neck. One outer wall of the body may have a bypass protrusion. After the dual-chamber cartridge has completed the freeze-drying process and is placed in a protective sleeve, the bypass protrusion of the body can be secured at the apex of the inner wall of the sleeve, preventing the dual-chamber cartridge from rotating along its longitudinal axis under external force when stored in the sleeve. During the process of attaching or detaching the injection needle from the dual-chamber cartridge, rotation is required on the threaded structure of the cartridge. Therefore, the bypass protrusion prevents the injection needle from rotating with the cartridge, thus preventing the needle from spinning freely and achieving efficient attachment and removal of the injection needle from the dual-chamber cartridge.

[0011] In some embodiments of this application, the top stopper may include a stopper cap and a stopper plunger, the diameter of which is equal to or slightly larger than the inner diameter of the bottle mouth opening. After the stopper plunger is inserted into the bottle mouth opening, the lower surface of the stopper cap is completely in contact with the upper surface of the bottle mouth.

[0012] In some embodiments of this application, the top cap may include an upper end, a middle end, and a lower end; the upper end may have a top plate, threads, and an opening; the middle end may have a raised ring; optionally, the lower end may have a raised strip; the inner wall of the top cap fits against the bottle neck, the bottle neck, and at least a portion of the bottle body; when the top cap moves toward the bottle neck, the top plate at the upper end presses the top plug into the bottle neck, causing the top plug to embed into the bottle neck. The center of the top plate has a top plate opening, and the upper end of the top cap secures the pre-assembled top plug through the top plate, and continues to lock the top plug in place after it is embedded into the bottle neck.

[0013] After the middle and lower ends are fitted to the outer wall of the bottle, the top cap can completely seal the bottle mouth, neck, and at least part of the bottle body, thus providing a complete seal for the bottle mouth with the fitted stopper, increasing the sealing effect. When the lower end has raised strips, the strips contract radially along the top cap, making the lower end fit more tightly with the bottle body, further preventing the top cap from loosening and slipping, and increasing the sealing effect for the dual-chamber cartridge bottle. The raised ring is used to match the sheath, and the opening allows moisture in the product to sublimate and drain from the dual-chamber cartridge bottle, further reducing the moisture content of the freeze-dried product in the dual-chamber cartridge bottle during the freeze-drying process. The thread is used for threaded engagement with a sterile injection needle.

[0014] In some embodiments of this application, the top stopper may further include a sealing portion protruding above the stopper cap, the sealing portion being inserted into the top plate opening of the top plate of the top cap, wherein when the top stopper is inserted into the bottle neck, its sealing portion protrudes longitudinally from the top plate opening. During the pre-assembly of the top stopper into the top cap, the sealing portion can be embedded into the top plate opening, its edge portion tightly fitting the circumferential outer edge of the top plate opening, and ultimately partially protruding from the upper edge of the top plate opening. By inserting and fitting the sealing portion into the top plate opening during the pre-assembly of the top stopper, and cooperating with the top stopper positioning point to limit the stopper cap, the top stopper can be more stably fixed in the top cap. Therefore, external forces applied to the top cap during actual production, such as vibration or suspension, will not affect the fixation of the top plug within the top cap, thus preventing the top plug from falling out of the top cap before the capping operation. In addition, after the top plug seals the bottle opening, a gap is provided between the top plug and the top cap. After the injection needle is inserted into the top plug, the volume of pressure it receives extends into the gap at the outer edge, which can prevent pressure from concentrating on the sealing part, thereby preventing the injection needle from removing the core.

[0015] In some embodiments of this application, the upper end of the top cap may also have a top plug positioning point, which protrudes from the inner wall of the upper end in the direction of the top cap's axis, for fixing the top plug that fits into the bottle neck. This further fixation of the top plug by the top plug positioning point improves the sealing stability of the top plug.

[0016] In some embodiments of this application, the number of stopper positioning points is four, five, or more. These positioning points extend radially along the top cap and are evenly spaced circumferentially on the upper inner wall, providing a uniform fixing force to the stopper. When the stopper tends to slip out, it is difficult for the stopper to generate greater displacement in any direction than in other directions, thus making it more difficult for the stopper to slip out of the bottle neck. Furthermore, the positioning points can also be used to position the stopper before it is pressed into the bottle neck; the stopper is limited by these positioning points, preventing it from sliding out of the bottle neck on its own.

[0017] In some embodiments of this application, the upper end of the top cap may also be provided with a protrusion protruding towards the axis of the top cap on its inner wall. The top cap can be limited at the bottle mouth by the protrusion before capping, so that sublimated water in the inner cavity can be discharged through the opening. Therefore, the protrusion helps to provide gas exchange and water discharge for the dual-chamber cartridge bottle. After the top stopper is pressed into the bottle mouth, the top cap is simultaneously capped and fixed. The protruding structure of the protrusion makes the upper end fit more tightly with the bottle mouth, which helps to maintain the fixation of the top cap at the bottle mouth after capping and improves the stability of the capping seal.

[0018] In some embodiments of this application, the number of protrusions is two or three or more; preferably, the maximum length of the protrusions protruding towards the axis of the top cover is 0.10mm-0.30mm. Similarly, the protrusions are evenly spaced around the inner wall of the upper end, so that the upper end fits evenly with the bottle mouth, and the top cover cannot slip off from one side, further improving the stability of the top cover in the double-chamber cartridge bottle.

[0019] In some embodiments of this application, the protrusion is trapezoidal, semi-circular, semi-elliptical, or rectangular in shape. Preferably, the protrusion is trapezoidal. When the protrusion is trapezoidal, the upper tangent angle between the face of the protrusion facing the top cap axis and its side surface is preferably 30°-45°. More preferably, the upper tangent angle between the face of the protrusion facing the top cap axis and its side surface is 30°. When the protrusion is trapezoidal, the upper end fits the bottle mouth more tightly, and the top cap can be stably fitted onto the dual-chamber cartridge bottle. When the upper tangent angle and the lower tangent angle of the face of the protrusion facing the top cap axis are both 30° and 30°, the capping process will not cause structural damage to the top cap due to excessive pressure, while maintaining a high fit between the top cap and the dual-chamber cartridge bottle, thus improving the capping efficiency and accuracy in the freeze-drying process.

[0020] In some embodiments of this application, the lower end is shaped as a cylinder or an octagonal prism. Preferably, the lower end is an octagonal prism with an octagonal surface structure. After the dual-chamber cartridge is placed in a sheath with an octagonal structure, the lower end can match and fit with the octagonal inner wall of the sheath. This fitting method between the lower end and the sheath secures the dual-chamber cartridge inside the sheath, preventing the dual-chamber cartridge and cap assembly from rotating along their own longitudinal axis due to external forces. Therefore, it ensures efficient screwing and unscrewing of the sterile injection needle onto the dual-chamber cartridge packaging material.

[0021] According to another aspect of this application, a dual-chamber cartridge packaging material for injection is provided, which includes the cap assembly and the dual-chamber cartridge provided in this application.

[0022] According to another aspect of this application, an injection dual-chamber cartridge vial packaging assembly is also provided, which includes the dual-chamber cartridge vial assembly and a sheath provided in this application. The sheath can mate with the lower end and bypass protrusion to secure the dual-chamber cartridge vial packaging.

[0023] In some embodiments of this application, the lower end of the bottle cap assembly of the packaging material is octagonal prism in shape, the sheath is octagonal prism in shape with an octagonal inner wall, and the bypass protrusion of the dual-chamber cartridge bottle of the packaging material is located at the apex of the octagon on the inner wall of the sheath; and the top of the inner wall of the sheath has a horizontal protrusion, which is assembled with the lower end of the bottle cap assembly of the packaging material by an interference fit to further clamp the top stopper and the dual-chamber cartridge bottle. By utilizing the interference fit between the sheath and the lower end of the bottle cap assembly, the sheath and the bottle cap assembly apply a pulling force to each other, thereby clamping the dual-chamber cartridge bottle in the middle. This allows the top stopper and the top cap to fit more tightly with the bottle opening and the bottle neck, respectively, improving the sealing performance of the packaging material.

[0024] Compared with the prior art, this application has at least one of the following technical effects:

[0025] 1. This application provides an integrated self-pressurizing stopper and capping seal for a bottle cap assembly and a dual-chamber cartridge bottle in a freeze dryer.

[0026] 2. This application can improve the airtightness of the stopper and the mouth of the double-chamber cartridge bottle.

[0027] 3. This application can improve the sealing performance of the sealing cap assembly and the dual-chamber cartridge bottle.

[0028] 4. This application can reduce the time required to seal the double-chamber cartridge vials in the freeze-drying process by reducing the number of operation steps, and at the same time avoid the freeze-drying effect being reduced due to sealing failure in the freeze dryer, thereby improving freeze-drying efficiency and freeze-drying quality.

[0029] 5. The dual-chamber cartridge bottle packaging material of this application can effectively keep the bottle cap from rotating and prevent the top stopper from being removed, which helps to facilitate the efficient use of the injection needle and the dual-chamber cartridge bottle packaging material assembly. Attached Figure Description

[0030] The above and other objects, features, and advantages of this application will become more apparent from the more detailed description of the embodiments of this application in conjunction with the accompanying drawings. The drawings are provided to further illustrate the embodiments of this application and form part of the specification. They are used together with the embodiments of this application to explain this application and do not constitute a limitation thereof. In the drawings, the same reference numerals generally represent the same components or steps.

[0031] Figure 1 The diagram illustrates the structure of the dual-chamber cartridge bottle 1 and the top stopper 2 of this application.

[0032] Figure 2A The diagram shows a schematic representation of the structure of the top cover 3 of this application.

[0033] Figure 2B The illustration shows another structural schematic diagram of the top cover 3 of this application.

[0034] Figure 3 The illustration shows another structure of the top plug 2 and yet another structure of the top cover 3 of this application.

[0035] Figure 4A The figure shows a schematic diagram of the structure of the top plug positioning point 303 of this application.

[0036] Figure 4B The figure shows another structural schematic diagram of the top plug positioning point 303 of this application.

[0037] Figure 5 The figure shows a schematic diagram of the structure of the upper part 30 of this application.

[0038] Figure 6 The figure shows a structural schematic diagram of the maximum length of the protrusion 304 in this application.

[0039] Figure 7 The figure shows a schematic diagram of the structure of the upper and lower chamfers of the protrusion 304 in this application.

[0040] Figure 8 The illustration shows a structural schematic diagram of the dual-chamber cartridge bottle packaging material assembly of this application.

[0041] Explanation of reference numerals in the attached figures

[0042] 1-Double-chamber cartridge bottle 2-Top stopper 3-Top cap 4-Sheath

[0043] 10-Bottle mouth 11-Neck 12-Bottle body 13-Inner cavity

[0044] 20-Plug cap 21-Plug plunger 22-Sealing part 30-Upper end

[0045] 31-Middle section 32-Lower section 100-Bottle opening 120-Bypass protrusion

[0046] 200-Gap section 300-Top plate 301-Thread 302-Opening

[0047] 303 - Top plug positioning point; 304 - Protrusion; 310 - Protruding ring; 320 - Protruding strip

[0048] 321-convex mouth Detailed Implementation

[0049] As described above, this application discloses a bottle cap assembly, which includes a top plug 2 and a top cap 3 for sealing a dual-chamber cartridge bottle 1. The dual-chamber cartridge bottle 1 can be placed in a freeze-drying support used in existing freeze-drying processes, and the dual-chamber cartridge bottle packaging material can be fixed and placed upright or upside down in the freeze-drying support and sheath; the bottle cap assembly can be made of any material suitable for achieving the bottle cap sealing function. The top plug 2 is confined within the top cap 3 for sealing the bottle opening 10 of the dual-chamber cartridge bottle 1; the top cap 3 is used to press and fix the top plug 2, such that the top plug 2 seals the bottle opening 10 of the dual-chamber cartridge bottle 1, and seals the dual-chamber cartridge bottle 1; wherein, the process of pressing and fixing the top plug 2 with the top cap 3 to seal the bottle opening 10 of the dual-chamber cartridge bottle 1 may include the following steps:

[0050] The top plug 2 is pre-assembled into the top cap 3; and the top cap 3 with the top plug 2 pre-assembled is placed above the bottle mouth 10 of the double-chamber cartridge bottle 1, and the top cap 3 is pressed down to press the top plug 2. The top cap 3 can be pressed down by mechanical clamping, pneumatic drive, pneumatic clamp drive, or spring pressing, etc.

[0051] In this application, the dual-cavity cartridge bottle 1 includes: an inner cavity 13, a bottle body 12, a neck 11, and a bottle mouth 10. The bottle mouth 10 has a centrally located opening 100 connected to the inner cavity 13, and the inner diameter of the opening 100 is smaller than the inner diameters of the bottle mouth 10 and the neck 11. One side of the outer wall of the bottle body 12 has a bypass protrusion 120. Those skilled in the art will understand that the dimensions of the inner cavity 13, bottle body 12, neck 11, and bottle mouth 10 of the dual-cavity cartridge bottle 1 can be adjusted to fit the size range of commonly used freeze-drying supports. For example, changing the vertical length of one or more parts of the dual-cavity cartridge bottle 1 or changing the radial length of one or more parts of the dual-cavity cartridge bottle 1 does not depart from the scope of protection of this application.

[0052] In this application, the top stopper 2 includes a stopper cap 20 and a stopper plunger 21. The diameter of the stopper plunger 21 can be equal to or slightly larger than the inner diameter of the bottle opening 100. After the stopper plunger 21 is inserted into the bottle opening 100, the lower surface of the stopper cap 20 completely fits against the upper surface of the bottle opening 10 to achieve a seal on the bottle opening 10. In particular, the top stopper 2 is made of elastic rubber material, so the diameter of the stopper plunger 21 can be adjusted within the range of the diameter of the bottle opening 100 after the stopper plunger 21 is pressed. The diameter of the stopper plunger 21 can be slightly larger than the diameter of the bottle opening 100 to ensure a tight seal.

[0053] In this application, the top cap 3 includes an upper end 30, a middle end 31, and a lower end 32. The upper end 30 has a top plate 300, a thread 301, and an opening 302; the middle end 31 has a raised ring 310; and the lower end 32 optionally has a raised strip 320. The inner wall of the top cap 3 fits against the bottle neck 20, the bottle neck 21, and at least a portion of the bottle body 22. When the top cap 3 faces the bottle neck 10, the top plate 300 of the upper end 30 presses the top plug 2 into the bottle neck 10, causing the top plug 2 to embed into the bottle neck 10. After the bottle neck 10 of the dual-chamber cartridge bottle 1 is sealed, the top plate 300 fits tightly against the top cap 20 to secure the top plug 2. The opening 302 allows sublimated water in the product to drain, the thread 301 is used for threaded engagement with a sterile injection needle, and the raised ring 310 can be matched with a sheath.

[0054] It should be noted that the lower end 32 of the top cap 3 can be cylindrical or prismatic, and its length in the vertical direction is adjustable. Therefore, the lower end 32 can fit a small portion, a large portion, or the entire bottle body 12 to achieve better sealing and to meet the dimensional requirements of the top cap 3 in the freeze-drying process. The raised strip 320 is used to increase the friction between the lower end 32 and the sleeve to improve the mutual fixing effect; in particular, the raised strip 320 can also be removed. The shape of the lower end 32 can be cylindrical or prismatic to prevent the top cap 3 from slipping off due to rotational centrifugal force or from sliding relative to the dual-chamber cartridge bottle 1, thus affecting the sealing performance.

[0055] Specifically, the length of the middle end 31 of the top cap 3 along the direction of the neck 11 and the bottle body 12 is adjustable, and the convex ring 310 can be adjusted to fit the lower part of the upper end 30 at its highest point to accommodate the sealing requirements of the double-cavity cartridge bottle 1 for different degrees of sealing of the top cap 3. For example, it may be necessary to reduce the length of the top cap 3 along the direction of the bottle body 12 or the volume of the top cap 3 to meet the size requirements of the freeze-drying support for the double-cavity cartridge bottle 1 and the top cap 3 in the freeze-drying process. Specifically, the top plate 300 has a top plate opening at its center, and the lower edge of the circumferential side of the top plate opening to its upper edge may have an inclination angle β in the vertical direction. The upper edge of the circumferential side of the top plate opening has a larger opening length than the lower edge of the circumferential side. The circumferential edge surface of the top plate opening may be curved or flat.

[0056] In this application, the top stopper 2 may further include a sealing portion 22 protruding above the stopper cap 20. The sealing portion 22 can be inserted into the opening of the top plate. When the top stopper 2 is fully embedded in the bottle mouth 10, i.e., when the double-chamber cartridge bottle 1 is stopped, its sealing portion 22 is embedded in the opening of the top plate and partially protrudes longitudinally from the opening of the top plate. Those skilled in the art will understand that the size of the sealing portion 22 may be slightly larger than the opening size of the lower periphery of the top plate opening. During the pre-assembly of the top stopper 2 into the top cap 3, the top stopper 2 needs to be fixed by the upper end 30, and the surface of the sealing portion 22 may undergo slight deformation to insert into and embed into the opening of the top plate from the lower periphery of the top plate opening.

[0057] Therefore, during the pre-assembly of the top plug 2 into the top cover 3, the sealing portion 22 can be embedded into the top plate opening, with its edge portion tightly fitting the circumferential outer edge of the top plate opening, and ultimately partially protruding from the upper edge of the top plate opening. By setting the radial length L of the sealing portion to have a longer radial length, the tightness of the fit between its edge portion and the circumferential outer edge of the top plate opening is improved, further preventing the top plug 2 from slipping out of the top plate 300. In addition, by adjusting the size of β, the circumferential lower edge of the top plate opening and the sealing portion 22 can have a tighter fit relative to the circumferential upper edge of the top plate opening, so that the top plate opening tightly surrounds and fixes the sealing portion 22.

[0058] In some embodiments, the radial length L of the sealing portion 22 can be 2.0mm-5.0mm. Specifically, the radial length L of the sealing portion 22 can be 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, etc. The diameter of the sealing portion 22 is 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, or 5.0mm; preferably, the radial length L of the sealing portion 22 can be 3.0mm-4.0mm, specifically, the radial length L of the sealing portion 22 can preferably be 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, or 4.0mm. The tilt angle β can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, or 10°, etc.

[0059] In some implementations, the circumferential downward opening length of the top plate opening can be 1.5mm-5.0mm. Specifically, the circumferential downward opening length of the top plate opening can be 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, or 4.0mm. The diameter of the top plate opening is 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, or 5.0mm; preferably, the circumferential downward opening length of the top plate opening can be 2.5mm-4.0mm, specifically, the circumferential downward opening length of the top plate opening can preferably be 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, or 4.0mm.

[0060] By making the radial length L of the sealing portion 22 slightly larger than the circumferential lower edge opening length of the top plate opening, the sealing portion 22 fits more closely with the circumferential outer edge of the top plate opening, so that the top plate opening as a whole effectively fits and fixes the sealing portion 22. On this basis, the circumferential edge provides further support, so that the top plug 2 as a whole does not slip off. Preferably, β is set to 0°, so that the top plate opening can provide good fixation for the sealing portion 22 when there is no tilt angle in the vertical direction, while avoiding excessive resistance when the sealing portion 22 is inserted into the top plate opening, making it difficult to insert. In another case, when it is necessary to set a certain tilt angle in the vertical direction of the top plate opening to improve the limiting effect of the top plate 300 on the top plug 2, β can also be set to 5° to improve the fixation degree of the sealing portion 22, without affecting the insertion and embedding of the sealing portion 22 into the top plate opening. Those skilled in the art can adjust the radial length L, tilt angle β, and circumferential downward opening length of the top plate opening of the sealing part 22 appropriately based on the above-mentioned parameter references according to the actual application of the bottle cap assembly, so as to adapt the degree of fit and fixation between the sealing part 22 and the top plate 300.

[0061] Specifically, the diameter of the cap 20 of the top stopper 2 can be slightly smaller than the inner diameter of the top cap 3. Due to the engagement between the top stopper positioning point 303 and the cap 20, the top stopper 2 can be tightly fixed to the bottle opening 100, achieving a seal. In this case, setting the diameter of the cap 20 to be slightly smaller than the inner diameter of the top cap 3 leaves a small gap 200 between the surface of the cap 20 and the inner wall of the upper end 30. Thus, when the top stopper 2 is pressed down by the top cap 3, the pressure-bearing volume of the cap 20 extends towards the pre-reserved gap 200 around it, preventing the cap 20 from bulging out towards the top plate opening above it due to pressure. Therefore, when an injection needle, such as a microneedle (MFN), is inserted into the bottle opening 10 through the middle of the cap 20, the cap 20 will not exert pressure on the inside of the needle at the insertion position, thereby preventing the needle tip from cutting the cap 20 and causing core extraction, i.e., generating rubber fragments that fall into the needle tip and the inner cavity of the dual-chamber cartridge, thus preventing product contamination.

[0062] In some implementations, the diameter of the cap 20 can range from 5.0 mm to 10.0 mm. Specifically, the diameter of the cap 20 can be 5.0 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm, 6.0 mm, 6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm, 7.0 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm, 7.9 mm, 8.0 mm, 8.1 mm, 8.2 mm, 8.3 mm, 8.4 mm, 8.5 mm, etc. The diameter of the cap 20 is preferably 6.0mm-8.0mm, specifically, the diameter of the cap 20 is preferably 6.0mm, 6.1mm, 6.2mm, 6.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm or 10.0mm; preferably, the diameter of the cap 20 is 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm or 8.0mm.

[0063] In some embodiments, the diameter of the upper end 30 of the top cover 3 can range from 5.0mm to 10.0mm. Specifically, the diameter of the upper end 30 can be 5.0mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, 5.6mm, 5.7mm, 5.8mm, 5.9mm, 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm, 8.0mm, 8.1mm, 8.2mm, 8.3mm, 8.4mm, 8. The diameter of the upper end 30 can be 5mm, 8.6mm, 8.7mm, 8.8mm, 8.9mm, 9.0mm, 9.1mm, 9.2mm, 9.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm, or 10.0mm; preferably, the diameter of the upper end 30 can be in the range of 6.0mm-8.0mm, specifically, the diameter of the upper end 30 can preferably be 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm, or 8.0mm.

[0064] More preferably, the diameter of the stopper cap 20 can be configured to be 7.0 mm, and the inner diameter of the upper end 30 of the mating top cap 3 can be configured to be 7.3 mm. This leaves a 0.3 mm long gap 200 between the surface of the stopper cap 20 and the inner wall of the upper end 30. During the assembly of the top cap 2 or the insertion of the injection needle, the stopper cap 20 is compressed, increasing in diameter. The gap 200 can accommodate the increased volume of the stopper cap 20, preventing upward pressure. It should be noted that, according to the bottle cap assembly of the embodiments of this application, those skilled in the art can appropriately adjust the diameter of the stopper cap 20 and the diameter of the upper end 30 based on the above-mentioned parameter references according to the actual application of the bottle cap assembly, to adapt to the use of the bottle cap assembly with the freeze-drying support of the freeze dryer, with the packaging sheath, and / or with the syringe. For example, the stability of the pre-assembly of the top stopper 2 can be adjusted by appropriately adjusting the diameter of the stopper cap 20; a tighter or easier-to-remove capping of the dual-chamber cartridge bottle 1 can be maintained by appropriately adjusting the diameter of the top end 30; and after adjusting the diameter of the stopper cap 20 and the diameter of the top end 30 respectively, in order to appropriately avoid the impact of pressure on the stopper cap 20 on the assembly and use of the bottle cap assembly, the size relationship between the diameter of the stopper cap 20 and the diameter of the top end 30 can be appropriately adjusted to provide a suitable gap 200, etc.

[0065] By inserting and fitting the sealing part 22 into the opening of the top plate during the pre-assembly process of the top plug 2, and by using the top plug positioning point 303 to limit the cap 20, the top plug 2 can be stably fixed in the top cover 3. Therefore, mechanical processes implemented on the top cover 3 during the freeze-drying process, such as vibration and suspension, will not affect the fixation of the top plug 2 in the top cover 3, thereby preventing the top plug 2 from falling out of the top cover 3 before the capping operation, ensuring the capping qualification rate after freeze-drying; the gap part 200 of the cap 20 can also prevent core removal when it is used with an injection needle, thereby ensuring product quality and efficient use.

[0066] In this application, the upper end 30 of the top cover 3 also has a top plug positioning point 303, which protrudes from the inner wall of the upper end 30 in the direction of the axis of the top cover 3, and is used to fix the top plug 2 that fits into the bottle mouth 10. Specifically, the top plug positioning points 303 extend radially along the upper end 30 and are evenly spaced circumferentially on the inner wall of the top plug positioning points 303. The shape of the top plug positioning points 303 can be cylindrical or prism. In addition, the number of them and the spacing length / radius between multiple top plug positioning points 303 can be adjusted to maintain optimal fixation of the top plug 2.

[0067] In this application, the number of top stopper positioning points 303 is four or five or more. Specifically, the number of top stopper positioning points 303 can be even to maintain a symmetrical arrangement along the center of the upper end 30, providing a more stable fixing function for the top stopper 2. Preferably, the number of top stopper positioning points 303 is four or eight to provide a relatively stable fixing function for the top stopper 2; more preferably, the number of top stopper positioning points 303 is eight to provide the most stable fixing function for the top stopper 2. The top stopper positioning points 303 can also be used to position the top stopper 2 before it is pressed into the bottle neck 10. The top stopper 2 is limited by the top stopper positioning points 303 to prevent it from sliding off the bottle neck 10 on its own.

[0068] In this application, the upper end 30 of the top cap 3 is further provided with a protrusion 304 protruding in the direction of the axis of the top cap 3 on its inner wall. The top cap 3 can be limited on the bottle mouth 10 by the protrusion 304 before capping, so that the sublimated water in the inner cavity 13 can be discharged through the opening 302. Therefore, the provision of the protrusion 304 helps to provide gas exchange and sublimated water discharge for the dual-cavity cartridge bottle 1. Those skilled in the art will understand that the protrusion 304 will not hinder the movement of the top stopper 2 during the process of the top stopper 2 being inserted into the bottle mouth 10. Since the protrusion 304 is evenly distributed on the inner wall of the upper end 30, and the top plate 300 can apply pressure evenly to the entire surface of the cap 20 pre-assembled into the upper end 30 when the top plate is capped, the top stopper 2 can be stably and horizontally inserted into the bottle mouth 10.

[0069] In this application, the number of protrusions 304 is two or three or more; preferably, the maximum length (D) of the protrusions 304 protruding in the direction of the axis of the top cover 3 can be 0.10mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, 0.15mm, 0.16mm, 0.17mm, 0.18mm, 0.19mm, 0.20mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm or 0.30mm. Specifically, D can be 0.15mm to 0.30mm; more preferably, D can be 0.20mm to 0.28mm, which prevents the top cap 3 from deforming due to excessive pressure during capping, and ensures good sealing performance and prevents slippage after capping; more preferably, D can be 0.23mm to 0.28mm, which avoids deformation of the top cap 3 due to pressure during capping, and ensures good sealing performance and prevents slippage after capping. It should be noted that the value of D can be adjusted when the material of the protrusion 304 is different, to achieve optimal positioning of the top cap 3 before capping and optimal improvement in the fit between the upper end 30 and the dual-chamber cartridge bottle 1. Preferably, when the outer diameter of the bottle mouth 10 is 7.3mm, D can be 0.23mm, 0.25mm, or 0.28mm, and the protrusion 304 can provide optimal stability after capping.

[0070] In this application, the shape of the protrusion 304 can be trapezoidal, semi-circular, semi-elliptical, or rectangular. Preferably, the shape of the protrusion 304 is trapezoidal. When the shape of the protrusion 304 is preferably a trapezoid with its short side close to the bottle mouth 10, the upper end 30 fits more tightly with the bottle mouth 10, and the top cover 3 can fit very stably on the dual-chamber cartridge bottle 1 to maintain good airtightness.

[0071] When the protrusion 304 is trapezoidal in shape, preferably, the upper tangent angle (θ) between the surface of the protrusion 304 facing the axis of the top cover 3 and its side surface can be any angle between 0° and 90°. More preferably, θ can be between 30° and 45°. Specifically, θ can be 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, or 45°. It should be noted that when θ is less than 30°, the effect of the protrusion 304 in improving the tightness of the fit between the top cover 3 and the bottle mouth 10 may be significantly weakened; when θ is greater than 45°, the protrusion 304 may significantly hinder the capping process, causing the top cover 3 to deform or even be damaged during the capping process. Therefore, θ can preferably be any angle between 30° and 45°; more preferably, θ can be 30°, so that the protrusion 304 can provide a better fit between the top cap 3 and the bottle mouth 10, and will not adversely hinder the capping process.

[0072] Furthermore, when the protrusion 304 is trapezoidal, it is preferable that the angle (α) between the face of the protrusion 304 facing the axis of the top cover 3 and its side surface is any angle between 0° and 90°. Since the pressure during the capping process is mainly affected by the value of θ, when α and θ have the same value, the protrusion 304 can have a stable axisymmetric structure, which is not easily deformed or damaged during the capping or storage process. Therefore, this application further prefers α to be 30° to improve the efficiency and deformation resistance of the protrusion 304. More preferably, both θ and α of the protrusion 304 are 30°, so that the top cover 3 will not be structurally damaged due to excessive force during the capping process. At the same time, the top cover 3 and the double-cavity cartridge bottle 1 can fit together very tightly, which also improves the efficiency and accuracy of capping the double-cavity cartridge bottle 1.

[0073] This application also discloses a packaging material for a dual-chamber cartridge vial for injection, comprising the aforementioned cap assembly and dual-chamber cartridge vial 1, and a packaging material assembly for a dual-chamber cartridge vial for injection, comprising the packaging material and a sheath 4 for use therewith. It should be noted that the packaging material for a dual-chamber cartridge vial for injection may include any combination of the cap assembly and the dual-chamber cartridge vial 1 that can be formed and / or maintained through any of the combinations disclosed in this application.

[0074] The sheath 4 proposed in this application is an octagonal prism with an open top, and its structure is as follows: Figure 8 As shown, the inner wall of the sleeve 4 has an octagonal shape. After the double-chamber cartridge bottle 1 completes the freeze-drying process and is sealed by the top cap 3, the double-chamber cartridge bottle 1 can be pressed into the sleeve. During this process, the lower end 32 of the top cap 3 is in contact with the inner wall of the sleeve 4 and cannot slide relative to it, and the bypass protrusion 120 of the bottle body 12 is fixed at the octagonal vertex of the inner wall of the sleeve and cannot slide relative to the inner wall of the sleeve 4.

[0075] In this application, the lower end 32 is cylindrical or octagonal prism, preferably octagonal prism, and is fixedly assembled with the sleeve 4 for fixing and storing the dual-chamber cartridge bottle 1 through an interference fit. Specifically, the upper outer edge of the lower end 32 near the middle end 31 has a protrusion 321, the top of the sleeve 4 is stretched and confined on the protrusion 321, and the top cap 3 and the sleeve 4 exert force towards each other and clamp together in the middle. Through this interference fit between the lower end 32 and the sleeve 4, when the dual-chamber cartridge bottle 1 is placed in the sleeve 4, the fixation between the top cap 3 and the top plug 2 therein and the bottle mouth 10 is more tight, effectively preventing leakage, rotation, and falling off.

[0076] Specifically, in some implementations, the reconstituted lyophilized product in the dual-chamber cartridge 1 is administered subcutaneously via an injection needle for the treatment of skin diseases or cosmetic applications. The needle hub of the injection needle has a threaded structure. When the MFN is installed onto the top cap 3 to extract the product or removed from the top cap 3, its threaded structure engages or is removed by rotating with the thread 301 of the top cap 3. During this process, the lower end 32 of the top cap 3 is fixed in place by the octagonal inner wall of the sheath 4, preventing rotation. The bypass protrusion 120 of the dual-chamber cartridge 1 is also fixed in place by the apex of the octagonal inner wall of the sheath 4. Therefore, by selecting the octagonal prism-shaped lower end 32 and fitting it with the sheath 4, the dual-chamber cartridge packaging assembly is protected from rotation during the screwing / removal of the injection needle, avoiding free spin during screwing / removal of the sterile injection needle and improving the efficiency of the dual-chamber cartridge packaging assembly.

[0077] Currently, most lyophilized products on the market use vials as drug containers. Before injection, a sterile syringe is used to draw the reconstituted solution from a separate container, and then the reconstituted solution is injected into the drug container for reconstitution, extraction, and administration. This process results in relatively poor dosing accuracy and user compliance. However, the vial cap assembly and dual-chamber cartridge packaging material of this application effectively utilize the front chamber to hold the lyophilized drug and the rear chamber to hold the reconstituted solution. Furthermore, during use, the reconstituted solution can be bypassed and flow into the front chamber to reconstitute the lyophilized drug by pushing the bottom stopper, eliminating the need for multiple extractions. This greatly improves the convenience for subjects or patients, enabling self-injection.

[0078] On the other hand, the cap assembly of this application can also simultaneously cap and seal the dual-chamber cartridge bottle within the freeze dryer, maintaining the low moisture content of the freeze-dried product and thus ensuring product quality stability. Therefore, this application can utilize the cap assembly and dual-chamber cartridge bottle to prepare and store various pharmaceutical formulations, medical aesthetic products, and cosmetics, such as insulin, growth factors, vaccines, chemotherapy drugs, hormonal drugs, facial filler hyaluronic acid, mesotherapy, facial serums, and custom perfumes, thereby enhancing the application prospects and scope of the products prepared through freeze-drying.

[0079] Example

[0080] This application provides a general and / or specific description of the materials and methods used in the experiments. Unless otherwise specified, all reagents and instruments used are commercially available products.

[0081] Example 1

[0082] A bottle cap assembly includes a top stopper 2 and a top cap 3 for sealing a dual-chamber cartridge bottle 1. The top cap 3 has the following structure: Figure 2AAs shown. The double-chamber cartridge bottle 1 achieves a seal between the top cap 3 and the top stopper 2, and also seals the bottle opening 10 of the double-chamber cartridge bottle 1 through the top stopper. Specifically,

[0083] First, the top stopper 2 is positioned inside the top cover 3 by the top stopper positioning point 303, and the top cover 3 is placed on the bottle mouth 10 so that the stopper 21 naturally faces the bottle mouth opening 100 for freeze drying.

[0084] Then, after freeze-drying, the top cap 3 is pressed down to fit the top plug 2 into the mouth 10 of the double-chamber cartridge bottle 1. The top cap 3 includes an upper end 30, a middle end 31 and a lower end 32. The upper end 30 has a top plate 300 located at its center, a thread 301 located at the edge of the upper end 30 and an opening 302, which is located above the middle end 31. The lower end 32 is located below the middle end 31, and the lower end 32 has an opening below it. After the top plug 2 is initially inserted into the mouth 10, the top cap 3 is pressed down until the upper end 30 is completely fitted onto the mouth 10. During this process, the inner wall of the upper end 30 fits against the mouth 10 and the neck 11, while the inner walls of the middle end 31 and the lower end 32 fit against the bottle body 12.

[0085] The top plate 300 is a hollow cylindrical structure with a shortened middle section. When the top cover 3 is pressed down by external force, the top stopper 2 is pressed to the bottle mouth 10 through the lower surface of the top plate 300, so that the top stopper 2 is further embedded into the bottle mouth 10 until the stopper 21, whose diameter is slightly larger than the inner diameter of the bottle mouth, is completely embedded into the bottle mouth 10 under pressure. The lower surface of the stopper cap 20 is completely in contact with the upper surface of the bottle mouth 10, so that the top stopper 2 can be used to seal the double-chamber cartridge bottle 1. No additional stoppering device is required for sealing, which reduces the additional process and time required to seal the double-chamber cartridge bottle 1, and also avoids the impact of inaccurate sealing on the production efficiency of the freeze-drying process.

[0086] Specifically, when the top cap 3 is configured to press the top plug 2 to fully embed into the bottle mouth 10, the inner wall of the upper surface of the middle end 31 can also fully fit with the upper surface of the bottle body 12; therefore, while the top cap 3 seals the bottle mouth opening 100 with the top plug 2, the top cap 3 also seals the top plug 2 embedded in the bottle mouth, and seals the bottle mouth 10, the bottle neck 11 and at least a part of the bottle body 12 through the top plug 2, thus achieving a complete sealing of the double-cavity cartridge bottle 1.

[0087] The upper end 30 has a diameter of 7.3 mm, and a gap 200 is left between it and the cap 20 with a diameter of 7.0 mm; the upper end 30 also has a top plug positioning point 303, such as Figure 4A and Figure 5As shown, the top stopper positioning point 303 is located below the top plate 300 and protrudes from the inner wall of the upper end 30 towards the axis of the top cover 3. After the top stopper 2 is fully inserted into the bottle neck 10, the top stopper positioning point 303 fits against the stopper cap 20. The stopper cap 20 is subjected to pressure from the top stopper positioning point 303 towards the axis of the top cover 3, thereby increasing the friction between the stopper cap 20 and the inner wall of the upper end 30, preventing the top stopper 2 from loosening or slipping out of the top cover 3 during the pre-assembly process due to improper fitting. There are four top stopper positioning points 303, evenly distributed on the inner wall of the upper end 30.

[0088] The upper end 30 also has a protrusion 304, such as Figure 6 As shown, the protrusion 304 is located below the top stopper positioning point 303 and protrudes from the inner wall of the upper end 30 in the direction of the axis of the top cover 3. After the top stopper 2 is fully embedded in the bottle mouth 10, the protrusion 304 fits against the outer wall of the bottle mouth 10, and the bottle mouth 10 is subjected to pressure from the protrusion 304 in the direction of the axis of the top cover 3, thereby increasing the friction between the bottle mouth 10 and the inner wall of the upper end 30, preventing the top cover 3 from slipping off after sealing due to incomplete fitting, and improving the sealing performance of the double-cavity cartridge bottle 1. The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is set to 0.15mm, and the shape of the protrusion 304 is semi-circular, with two protrusions distributed on both sides of the inner wall of the upper end 30.

[0089] The lower end 32 is cylindrical. The protruding ring 310 of the middle end 31 and the protruding strip 320 of the lower end 32 can increase the fit between the top cover 3 and the bottle body 22 after the top cover 3 is attached to the double-cavity cartridge bottle 1, and further improve the stability of the fit between the top cover 3 and the double-cavity cartridge bottle 1.

[0090] The cap assembly was subjected to stopper and cap sealing tests. It was found that some of the top stoppers 2 slipped off from the top cap 3 in the freeze dryer, and the fit between the top cap 3 and the bottle mouth 20 of the double-chamber cartridge bottle 1 was not firm enough, and it could be pulled off the double-chamber cartridge bottle 1 with a small force.

[0091] Example 2

[0092] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.25mm, and the other structures and parameters are the same as in Example 1. A stopper and cap sealing test was performed on the bottle cap assembly, and it was found that some of the top stoppers 2 slipped off from the top cap 3, and the fit between the top cap 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was still not firm enough, and they could be easily pulled out.

[0093] Example 3

[0094] The shape of the protrusion 304 is replaced with a trapezoid, wherein the upper tangent angle of the surface of the protrusion 304 facing the axis of the top cover 3 is 45°, and the lower tangent angle between the surface of the protrusion 304 facing the axis of the top cover 3 and its side surface is 30°. The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.30mm, and the number of top plug positioning points 303 is replaced with 8, such as... Figure 4B As shown, the other structures and parameters are the same as in Example 1.

[0095] The cap assembly was subjected to a stopper and capping seal test. Due to the increase in the number of top stopper positioning points 303, the fit between the top stopper 2 and the top cap 3 was improved, and the top stopper 2 no longer slipped off the top cap 3. The capping process requires the application of very large pressure, which caused deformation and damage to part of the top cap 3 structure.

[0096] Example 4

[0097] The upper chamfer of the surface of the protrusion 304 facing the axis of the top cover 3 is replaced with 30°, such as... Figure 7 As shown, the other structures and parameters are the same as in Example 3. A stopper and capping sealing test was performed on the bottle cap assembly. The fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off the top cap 3. However, after replacing the upper chamfer of the face of the protrusion 304 facing the axis of the top cap 3 with 30°, it was found that the capping process still required a large pressure, causing deformation and damage to part of the top cap 3 structure, and still having a certain impact on the sealing performance of the top cap 3.

[0098] Example 5

[0099] The upper chamfer of the face of the protrusion 304 facing the axis of the top cover 3 is replaced with 30°, and the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.10 mm. Other structures and parameters are the same as in Example 3. A stopper and capping seal test was performed on the bottle cap assembly. It was found that the fit between the top stopper 2 and the top cover 3 was high, and the top stopper 2 did not slip off the top cover 3. After replacing the upper chamfer of the face of the protrusion 304 facing the axis of the top cover 3 with 30° and the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.10 mm, the capping process did not require a large pressure. However, the fit between some top covers 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was not firm enough, and they could be pulled out after applying a certain force.

[0100] Example 6

[0101] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.15mm, and other structures and parameters are the same as in Example 5. A stopper and capping sealing test was performed on the cap assembly. It was found that the fit between the top stopper 2 and the top cap 3 was relatively high, and the top stopper 2 did not slip off from the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.15mm, the capping process did not require a large pressure, but the fit between some top caps 3 and the bottle mouth 10 of the dual-chamber cartridge bottle 1 was still not firm enough, and they could still be pulled out after applying a certain force.

[0102] Example 7

[0103] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.20mm, and other structures and parameters are the same as in Example 5. A stopper and capping sealing test was performed on the cap assembly. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off from the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.20mm, the capping process did not require a large pressure. The fit between the top cap 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was improved, and the fit was more secure. It was less likely to be pulled out after applying greater force, and only occasionally did it pull out or fall off.

[0104] Example 8

[0105] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 was replaced with 0.23 mm, and the other structures and parameters were the same as in Example 5. A stopper and capping sealing test was performed on the cap assembly. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off from the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.23 mm, a certain amount of pressure was required during the capping process, but no deformation or damage was caused to the top cap 3 structure. The fit between the top cap 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was significantly improved, and it was not pulled out after applying a large force.

[0106] Example 9

[0107] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 was replaced with 0.25 mm, and the other structures and parameters were the same as in Example 5. A stopper and capping sealing test was performed on the bottle cap assembly. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off from the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.25 mm, a certain amount of pressure was required during the capping process, but it did not cause deformation or damage to the top cap 3 structure. The fit between the top cap 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was also significantly improved, and it was not pulled out after applying a large force.

[0108] Example 10

[0109] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 was replaced with 0.28 mm, and the other structures and parameters were the same as in Example 5. A stopper and capping sealing test was performed on the bottle cap assembly. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off from the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.28 mm, the capping process required greater pressure, but it did not cause deformation or damage to the top cap 3 structure. The fit between the top cap 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was significantly improved, and it was not pulled out after applying greater force.

[0110] Example 11

[0111] The structure of the top cap 3 of the bottle cap assembly in Example 8 is adjusted to reduce the volume of the top cap 3, such as... Figure 2B As shown. Specifically, in Embodiment 2, the length of the top cap 3 extending along the neck 11 and the bottle body 12 is shortened, thereby shortening the length of the middle end 31. Furthermore, the position of the convex ring 310 relative to the neck 11 and the bottle body 12 is moved upward, and it fits against the lower part of the upper end 30. In addition, the convex strip 320 of the lower end 32 is removed, and the non-convex strip portion of the lower end 32 is extended downward along the bottle body 12. The upper part of the lower end 32 near the middle end 31 is shortened radially to form a convex opening 321.

[0112] It should be noted that in this embodiment, the extended lower end 32 is shaped as an octagonal prism, and its inner wall can still fit at least a portion of the bottle body 12 of the double-cavity cartridge bottle 1. Furthermore, the structure of the adjusted top cap 3, except for the middle end 31 and the lower end 32, is the same as that of the top cap 3 in embodiment 10. The number of top stopper positioning points 303 is 8, evenly distributed on the inner wall of the upper end 30.

[0113] The cap assembly was subjected to a stopper and capping seal test. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off from the top cap 3. The capping process required a large amount of pressure, but it did not cause deformation or damage to the top cap 3. The fit between the top cap 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was significantly improved, and it was not pulled out after a large force was applied.

[0114] Example 12

[0115] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.25mm, and other structures and parameters are the same as in Example 11. A stopper and capping sealing test was performed on the bottle cap assembly. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off from the top cap 3. The capping process required a large pressure, but it did not cause deformation or damage to the top cap 3. The fit between the top cap 3 and the bottle opening 10 of the dual-chamber cartridge bottle 1 was significantly improved, and it was not pulled out after applying a large force.

[0116] Example 13

[0117] The structure of the top plate 300 of the top plug 2 and top cap 3 in the bottle cap assembly of Example 12 is adjusted to improve the degree of restraint exerted by the top plate 300 on the top plug 2 when it is pre-assembled into the top cap 3, such as... Figure 3 As shown. Specifically, the top plug 2 has a sealing portion 22 protruding upward along the axial direction of its cap 20 on its upper surface. The top plate opening is circular, the sealing portion 22 is cylindrical with a radial length L = 3.6 mm, the top plate opening is circular with a lower inner diameter of 3.4 mm, and the tilt angle β of the top plate opening is 0. The other structures and corresponding parameters of the top plug 2 and the top cover 3 are the same as in Embodiment 11.

Claims

1. A bottle cap assembly, characterized in that, Used for sealed double-chamber cartridge bottles, wherein... The bottle cap assembly includes a top stopper and a top cap; The top plug is positioned within the top cover to seal the mouth of the dual-chamber cartridge bottle; The top cap is used to press and fix the top plug, so that the top plug seals the bottle opening of the dual-chamber cartridge bottle; and to seal the dual-chamber cartridge bottle.

2. The bottle cap assembly according to claim 1, characterized in that, in, The dual-cavity cartridge bottle includes: an inner cavity, a bottle body, a neck, and a bottle mouth. The bottle mouth has a central opening that connects to the inner cavity, and the inner diameter of the bottle mouth opening is smaller than the inner diameter of the bottle mouth and the neck. The outer wall of one side of the bottle has a bypass protrusion.

3. The bottle cap assembly according to claim 2, characterized in that, in, The top stopper includes a stopper cap and a stopper post. The diameter of the stopper post is equal to or slightly larger than the inner diameter of the bottle mouth opening. After the stopper post is inserted into the bottle mouth opening, the lower surface of the stopper cap is completely in contact with the upper surface of the bottle mouth.

4. The bottle cap assembly according to claim 3, characterized in that, in, The top cover includes an upper end, a middle end, and a lower end; The upper end has a top plate, threads and an opening, the middle end has a convex ring, and optionally the lower end has a convex strip. The inner wall of the top cover fits against the bottle mouth, the bottle neck and at least a portion of the bottle body. The top plate has an opening at its center. When the top cover moves toward the bottle mouth, the top plate at the upper end presses the top plug into the bottle mouth, causing the top plug to embed into the bottle mouth.

5. The bottle cap assembly according to claim 4, characterized in that, in, The top stopper also includes a sealing portion protruding above the stopper cap, the sealing portion being inserted into the top plate opening of the top plate of the top cover, and when the top stopper is embedded in the bottle mouth, the sealing portion protrudes longitudinally from the top plate opening of the top plate.

6. The bottle cap assembly according to claim 4, characterized in that, in, The upper end of the top cover also has a top plug positioning point, which protrudes from the inner wall of the upper end in the direction of the axis of the top cover, and is used to fix the top plug that fits into the bottle mouth.

7. The bottle cap assembly according to claim 6, characterized in that, in, The number of the top plug positioning points is 4 or 5 or more.

8. The bottle cap assembly according to claim 4, characterized in that, in, The upper end of the top cover is provided with a protrusion protruding in the direction of the top cover axis on its inner wall, which is used for positioning the top plug before it is pressed into the bottle mouth, and at the same time improves the fit between the upper end and the dual-cavity cartridge bottle.

9. The bottle cap assembly according to claim 8, characterized in that, in, The number of protrusions is two or three or more; The maximum length of the protrusion protruding toward the axis of the top cover is 0.10mm-0.30mm.

10. The bottle cap assembly according to claim 8, characterized in that, in, The shape of the protrusion is trapezoidal, semi-circular, semi-elliptical, or rectangular; When the protrusion is trapezoidal in shape, the upper tangent angle between the surface of the protrusion facing the axis of the top cover and its side surface is 30°-45°.

11. The bottle cap assembly according to claim 10, characterized in that, in, The protrusion is trapezoidal in shape; The upper tangent angle between the protrusion facing the axis of the top cover and its side surface is 30°.

12. The bottle cap assembly according to claim 4, characterized in that, in, The lower end is shaped like a cylinder or an octagonal prism.

13. The bottle cap assembly according to claim 12, characterized in that, in, The lower end is octagonal in shape.

14. A dual-chamber cartridge packaging material for injection, characterized in that, It includes the cap assembly and the dual-chamber cartridge bottle as described in any one of claims 1 to 13.

15. A dual-chamber cartridge vial packaging assembly for injection, characterized in that, It includes the packaging material and sheath for the dual-chamber cartridge vial for injection as described in claim 14.

16. The packaging material assembly according to claim 15, characterized in that, in, The lower end of the bottle cap assembly of the packaging material is octagonal prism in shape, the sheath is octagonal prism in shape with an octagonal inner wall, and the bypass protrusion of the dual-chamber cartridge bottle of the packaging material is located at the apex of the octagon on the inner wall of the sheath; and The top of the inner wall of the sheath has a horizontal protrusion, which is assembled with the lower end of the bottle cap assembly of the packaging material by an interference fit, so as to further clamp the top stopper and the dual-chamber cartridge bottle with the lower end.

Images