Cap assembly, packaging structure of dual-chamber cartridge bottle for injection and assemblies thereof

Abstract

A bottle cap assembly for sealing a dual-chamber cartridge bottle includes a top stopper and a top cap. The top stopper is pressed into the dual-chamber cartridge bottle by a stoppering assembly to seal the bottle. The top cap secures the top stopper and seals the bottle opening. The stoppering assembly includes a pressing fixture and a retaining fixture. The bottle cap assembly and dual-chamber cartridge bottle disclosed in this application can achieve high-precision and excellent self-pressurizing sealing in a freeze dryer using the stoppering assembly. This reduces the time cost and operational complexity required for stopping and capping dual-chamber cartridge bottles in the overall freeze-drying process, improving freeze-drying efficiency and product quality.

Description

[Technical Field]

[0001] This case involves the fields of biopharmaceuticals, cosmetics, or medical aesthetics, and more specifically, a bottle cap assembly. [Previous Technology]

[0002] Currently, the vast majority of lyophilized products on the market use vials as drug containers. Before injection, a sterile syringe is used to draw the reconstituted solution from another container, and then the reconstituted solution is injected into the drug container for reconstitution, extraction, and administration. This results in relatively poor drug delivery 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 them a promising option for widespread application.

[0003] However, existing dual-chamber cartridge packaging materials cannot complete the integrated operation of self-pressing and capping within a freeze dryer. Therefore, an innovative packaging material that can achieve integrated sealing within the freeze dryer cavity is needed to meet the airtightness requirements of freeze-drying technology and enable the packaging material to meet future drug delivery methods. For example, the container holding device disclosed in CN112550910A has high sealing performance; however, it cannot meet the requirement that the product moisture is sublimated and discharged from the container (mainly gas) during the freeze-drying process to complete self-sealing. Therefore, this type of packaging material cannot be directly applied in freeze-drying technology and may require additional capping steps, increasing time costs. Furthermore, it may affect the freeze-drying effect of the drug in the container during container transfer.

[0004] CN115214989A discloses a container sealing device that can be installed on the neck of a container, comprising an outer cover, an inner cover, and a sealing chamber component. It adopts an inclined snap-fit ​​and positioning stop structure, allowing the outer cover and inner cover to rotate relative to each other without longitudinal displacement. However, the outer cover and the container neck, as well as the inner cover and the outer cover, achieve pre-capping limit and post-capping sealing through the inclined snap-fit ​​and threaded engagement. Therefore, when the container is sealed under the force of the partition in the freeze dryer, uneven force is easily caused by reasons such as uneven container placement, resulting in the tilting of the inner cover and / or the outer cover. After tilting, it may be difficult to press the tilted side down and snap it in place normally by continuing to apply force through the components in the freeze dryer. In addition, the fit and fixation between the inner cover and the outer cover is difficult to complete in the freeze dryer.

[0005] Further, CN108820429A discloses an injection vial assembly structure, in which the cap has a claw that engages with a first and a second groove on the vial body. The first groove of this structure is relatively shallow, making it easy to adjust after tilting when the cap is not fully sealed, and the process of pressing the claw further down to the second groove is more stable. However, the cap's ability to be limited by the first groove is weak, and it is easy for it to slip off during freeze-drying when moisture in the formulation drains from the gap between the vial opening and the rubber stopper, causing the rubber stopper to at least partially seal the vial opening and resulting in reduced drainage efficiency. This will affect the quality of the freeze-dried powder injection product to some extent. As can be seen from the above, during the semi-closed process of the vial opening during freeze-drying, the cap's limiting function should neither be too firm nor too easy to loosen.

[0006] In addition, existing dual-chamber cartridge packaging materials have problems such as lack of anti-rotation structure, excessive fastening force and core removal of injection needle when used to obtain freeze-dried products. In the following, feasible solutions to the above problems will be provided based on the dual-chamber cartridge packaging material proposed in this case.

[0007] Therefore, there is an urgent need for a cap assembly that can solve the above problems and is stably matched with dual-chamber cartridge bottles. It can stably perform self-pressing and sealing within the freeze dryer cavity to improve the freeze-drying efficiency and quality of freeze-dried products, fill the current gap in the domestic dual-chamber cartridge bottle packaging material field, and enhance the core competitiveness of products. [Summary of the Invention]

[0008] This case aims to provide a solution that can overcome at least one of the above-mentioned defects of the prior art.

[0009] According to one aspect of this application, a bottle cap assembly is provided, which may include a top stopper and a top cap for sealing a dual-chamber cartridge bottle. The top stopper seals the bottle opening of the dual-chamber cartridge bottle; the top stopper is pressed by a stopper assembly to engage with the dual-chamber cartridge bottle, thereby achieving a seal on the dual-chamber cartridge bottle; the top cap is used to fix the top stopper and seal the bottle opening of the dual-chamber cartridge bottle; wherein, the stopper assembly may include a pressing fixture and a retaining fixture.

[0010] In some embodiments of this invention, the dual-cavity cartridge bottle may include: an inner cavity, a bottle body, a neck, and a bottle mouth. The center of the bottle mouth may have an opening connected to the inner cavity, and the inner diameter of the bottle mouth opening is smaller than the inner diameters of the bottle mouth and neck. One outer wall of the bottle body may have a bypass. When the dual-cavity cartridge bottle is placed on a freeze-drying support, the upper opening of the freeze-drying support is larger than the lower opening. Therefore, the upper opening facilitates the insertion of the bypass, while the lower opening appropriately secures the dual-cavity cartridge bottle, preventing it from easily falling out of the fixing module, thus avoiding tilting or falling during the freeze-drying process.

[0011] In some embodiments of this case, the top stopper may include a stopper cap and a stopper plunger. The diameter of the plunger is slightly larger than the inner diameter of the bottle opening. After the plunger is inserted into the bottle opening, the lower surface of the stopper cap is completely in contact with the upper surface of the bottle opening. Since the diameter of the plunger is slightly larger than the inner diameter of the bottle opening, when the top stopper is pressed by the stoppering assembly, the pressure provided by the stoppering assembly must be greater than the pressure between the outer wall of the plunger and the inner wall of the bottle opening. After the top stopper is fitted into the bottle opening of the dual-chamber cartridge, the top stopper will not slip out of the bottle opening due to the friction between the plunger and the bottle opening, thus ensuring the safe sealing of the lyophilized medicine in the dual-chamber cartridge.

[0012] In some embodiments of this case, the pressing fixture may be a column with an opening at the bottom and a recess at the center of the upper surface, and a protruding pressing column may be provided on the lower inner wall of the pressing fixture; when the top stopper moves toward the bottle mouth, the pressing column presses the top stopper to move toward the bottle mouth, so that the top stopper is embedded in the bottle mouth.

[0013] In some embodiments of this case, the number of pressure columns is two, three or more. The pressure columns are evenly distributed on the lower inner wall of the pressing fixture. When the top stopper moves toward the bottle mouth, the pressure columns can provide a uniform downward pressure to the stopper cap, so that the top stopper, which is positioned by the fixture, is horizontally fitted into the bottle mouth. It is not easy for its edges to lift or sink in during the fitting process, which helps to maintain the accuracy of the stopper pressing.

[0014] In some embodiments of this case, the retaining fixture is configured such that its inner wall fits against the bottle neck and bottle body, and its upper end protrudes beyond the bottle neck; and when the top stopper moves toward the bottle neck, the inner wall of the pressing fixture fits against and slides against at least a portion of the outer wall of the retaining fixture. The fitting and sliding of the pressing fixture and the retaining fixture during the stoppering process allows the pressing fixture to press the top stopper in the vertical direction along the outer wall of the retaining fixture, ensuring the movement stability of the pressing fixture itself, and ensuring that the pressing column always provides vertical pressure to the stopper cap, further improving the accuracy of stoppering.

[0015] In some embodiments of this invention, the retaining fixture may also be provided with a protrusion, which supports and fixes the top stopper before it is inserted into the bottle neck, so as to align the stopper with the opening of the bottle neck; and the protrusion secures the top stopper after it is inserted into the bottle neck. The protrusion securing the top stopper after insertion prevents the top stopper from being in an abnormal insertion state, such as the outer edge of the top stopper cap being raised or part of the outer edge being recessed into the bottle neck opening, or the stopper not being fully engaged in the bottle neck opening. Therefore, the retaining fixture also facilitates fine-tuning of the top stopper insertion, further improving the accuracy of the stopper insertion.

[0016] In some embodiments of this invention, the number of protrusions is two, three or more. The protrusions extend radially along the retaining fixture and are evenly spaced circumferentially on the inner wall of the retaining fixture. When the top stopper is subjected to force and moves toward the bottle mouth, the stopper cap as a whole can move horizontally and evenly toward the bottle mouth, and is not prone to tilting. In this way, the occurrence of stoppering failure can be significantly reduced.

[0017] In some embodiments of this invention, the top cover may include a body and a base. The body may have a top plate and an annular thread. The inner wall of the top cover fits against the bottle mouth and bottle neck; and the base of the top cover fits completely against the upper surface of the bottle body. After the top plate of the top cover is secured to the top stopper base of the bottle mouth and fits against the upper surface of the bottle body, the top cover seals the bottle mouth, bottle neck, and the connection between the bottle neck and the bottle body, thereby providing a complete seal for the bottle mouth with the top stopper fitted, increasing the sealing effect of the bottle mouth; the annular thread is used for thread engagement with a sterile injection needle.

[0018] In some embodiments of this invention, the process of sealing the double-chamber cartridge bottle by pressing the top stopper with the pressure-fitting assembly includes the following steps: placing the top stopper in the holding fixture by fitting it against the outer wall of the bottle opening of the double-chamber cartridge bottle to position the top stopper relative to the bottle opening; pressing the top stopper into the bottle opening of the double-chamber cartridge bottle by pressing the pressure-fitting fixture; and removing the pressure-fitting fixture and the holding fixture. The placement of the top stopper in the holding fixture to position it relative to the bottle opening means that the top stopper is held and positioned by the holding fixture and does not slide off towards the bottle opening due to gravity, thereby causing the stopper to block the bottle opening. Therefore, the protrusion of the holding fixture helps to provide gas exchange and moisture sublimation for the double-chamber cartridge bottle.

[0019] According to another aspect of this case, another bottle cap assembly is provided, wherein the bottle cap assembly may include a top stopper and a top cap for sealing a dual-chamber cartridge bottle. The top stopper is confined within the top cap for sealing the opening of the dual-chamber cartridge bottle; the top cap is used to press and fix the top stopper, such that the top stopper seals the opening of the dual-chamber cartridge bottle; and to seal the dual-chamber cartridge bottle; wherein the process of pressing and fixing the top stopper with the top cap, such that the top stopper seals the opening of the dual-chamber cartridge bottle, includes the following steps:

[0020] The top stopper is pre-assembled into the top cap; the top cap with the pre-assembled top stopper is placed above the mouth of the dual-chamber cartridge bottle, and the top cap is pressed down. After the top stopper is pre-assembled into the top cap, the top stopper and the 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 remove the stopper assembly for further capping of 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 dual-chamber cartridge bottles, improves the sealing efficiency of dual-chamber cartridge bottles in freeze-drying technology, and avoids the number of operation failures caused by more 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 freeze-drying technology.

[0021] In some embodiments of this case, the dual-chamber cartridge may include: an inner cavity, a bottle body, a neck, and a bottle mouth. The center of the bottle mouth may have an opening connected to the inner cavity, and the inner diameter of the bottle mouth opening is smaller than the inner diameters of the bottle mouth and neck. One outer wall of the bottle body may have a bypass protrusion. After the dual-chamber cartridge is freeze-dried and placed in a protective sleeve, the bypass protrusion of the bottle body can be secured at the apex of the inner wall of the protective sleeve, preventing the dual-chamber cartridge from rotating along its longitudinal axis under external force when stored in the protective 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 dual-chamber cartridge. Therefore, the bypass protrusion secures the dual-chamber cartridge, preventing the injection needle from rotating with the dual-chamber cartridge and thus preventing the injection needle from spinning freely. This achieves efficient screwing and detachment of the injection needle from the dual-chamber cartridge.

[0022] In some embodiments of this case, the top stopper may include 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.

[0023] In some embodiments of this invention, the top cover 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 cover fits against the bottle mouth, the bottle neck, and at least a portion of the bottle body; when the top cover moves toward the bottle mouth, the top plate at the upper end presses the top plug toward the bottle mouth, causing the top plug to embed into the bottle mouth. The center of the top plate has a top plate opening; the upper end of the top cover secures the pre-assembled top plug through the top plate, and continues to secure the top plug after it is embedded into the bottle mouth.

[0024] After the middle and lower ends are fitted to the outer wall of the bottle, the top cap can completely seal the bottle mouth, bottle neck, and at least part of the bottle body, thereby providing a complete seal for the bottle mouth with the fitted top stopper and increasing the sealing effect of the bottle mouth. When the lower end has convex strips, the convex 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 of the dual-chamber cartridge bottle. The convex ring is used to match the sheath, and the opening facilitates the sublimation and discharge of water from the product from the dual-chamber cartridge bottle, so as to further reduce the moisture content of the freeze-dried product in the dual-chamber cartridge bottle in the freeze-drying technology. The thread is used to engage with the thread of a sterile injection needle.

[0025] In some embodiments of this invention, 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 cover, wherein when the top stopper is inserted into the bottle neck, its sealing portion protrudes longitudinally from the top plate opening of the top plate. During the pre-assembly of the top stopper into the top cover, the sealing portion can be inserted into the top plate opening, its edge portion being tightly fitted with 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 in conjunction with the top stopper positioning point to limit the stopper cap, the top stopper can be more stably fixed in the top cover. 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.

[0026] In some embodiments of this invention, 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 axis and is used to fix the top plug that fits into the bottle mouth. The top plug is further fixed by the top plug positioning point, which improves the sealing stability of the top plug.

[0027] In some embodiments of this case, the number of top stopper positioning points is four or five or more. The top stopper 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 top stopper. When the top stopper shows a tendency to slip out, it is difficult for the top stopper to generate a displacement greater than in other directions in any direction, thus making it more difficult for the top stopper to slip out of the bottle opening. Furthermore, the top stopper positioning points can also be used to position the top stopper before it is pressed into the bottle opening; the top stopper is limited by the top stopper positioning points, preventing it from sliding out of the bottle opening on its own.

[0028] In some embodiments of this invention, the upper end of the top cap may also be provided with a protrusion protruding in the direction of the top cap axis on its inner wall. The top cap can be limited at the bottle mouth by the protrusion before capping, so that the sublimated water in the inner cavity can be discharged through the opening. Therefore, the provision of 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 is conducive to maintaining the fixation of the top cap at the bottle mouth after capping and improving the stability of the capping seal.

[0029] In some embodiments of this invention, the number of protrusions is two or three or more; preferably, the maximum length of the protrusions protruding in the direction of the top cap axis is 0.10 mm-0.30 mm. Similarly, the protrusions are evenly spaced around the upper inner wall, so that the upper end fits evenly with the bottle mouth, and the top cap cannot slip off from one side, further improving the stability of the top cap on the double-chamber cartridge bottle.

[0030] In some embodiments of this case, the protrusion is trapezoidal, semi-circular, semi-elliptical or rectangular in shape, preferably trapezoidal; when the protrusion is trapezoidal, the upper tangent angle between the face of the protrusion facing the top cover axis and its side surface is preferably 30°-45°, more preferably, the upper tangent angle between the face of the protrusion facing the top cover axis and its side surface is 30°; and when the protrusion is trapezoidal, the lower tangent angle between the face of the protrusion facing the top cover axis and its side surface is even more preferably 30°. When the protrusion is trapezoidal, the upper end fits the bottle mouth better, and the top cap can fit stably on the double-chamber cartridge bottle. When the upper tangent angle of the protrusion facing the axis of the top cap and the lower tangent angle of its side are 30°, the capping process will not cause structural damage to the top cap due to excessive pressure. At the same time, it can maintain a high fit between the top cap and the double-chamber cartridge bottle, improving the capping efficiency and accuracy in the freeze-drying process.

[0031] In some embodiments of this invention, 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 against the octagonal inner wall of the sheath. This fitting method of the lower end with 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, thus ensuring efficient screwing and removal of the sterile injection needle on the dual-chamber cartridge packaging material.

[0032] According to another aspect of this case, a dual-chamber cartridge bottle packaging material for injection is provided, which includes the cap assembly and the dual-chamber cartridge bottle provided in this case.

[0033] According to another aspect of this case, an injection dual-chamber cartridge vial packaging material assembly is also provided, which includes the dual-chamber cartridge vial assembly and a sheath provided in this case. The sheath can mate with the lower end and bypass protrusion to fix the dual-chamber cartridge vial packaging material.

[0034] In some embodiments of this invention, the lower end of the bottle cap assembly of the packaging material is octagonal prism in shape, the sheath is octagonal prism in shape, its inner wall is octagonal, and the bypass protrusion of the double-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 interference fit, so as to further clamp the top stopper and the double-chamber cartridge bottle with the lower end. By using 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 double-chamber cartridge bottle in the middle, so that the top stopper and the top cap can fit more tightly with the bottle opening and the bottle mouth respectively, thereby improving the sealing performance of the packaging material.

[0035] According to another aspect of this application, a bottle cap assembly is provided, wherein the bottle cap assembly may include a top stopper and a top cap for sealing a dual-chamber cartridge bottle. The top stopper is positioned within the top cap for sealing the opening of the dual-chamber cartridge bottle; the top cap is used to press and fix the top stopper, such that the top stopper seals the opening of the dual-chamber cartridge bottle; and to seal the dual-chamber cartridge bottle; the top cap may include an upper end, the upper end may have a top plate, and the top plate has a top plate opening at its center. The top stopper may also include a sealing portion, the sealing portion being inserted into the top plate opening of the top plate. The pressing and fixing of the top stopper by the top cap, such that the top stopper seals the opening of the dual-chamber cartridge bottle, may include the following steps:

[0036] The top stopper is pre-assembled into the top cap; the top cap with the pre-assembled top stopper is placed above the mouth of the dual-chamber cartridge bottle, and the top cap is pressed down. After the top stopper is pre-assembled into the top cap, the top stopper and the top cap are integrally formed, eliminating the need for a stopper assembly. The top cap can directly achieve stopper sealing by pressing the top stopper. Furthermore, this method also eliminates the need to remove the stopper assembly for further capping of 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 dual-chamber cartridge bottles, improves the sealing efficiency of dual-chamber cartridge bottles in freeze-drying technology, and avoids the number of operation failures caused by more 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 freeze-drying technology.

[0037] In some embodiments of this invention, the upper end also has a fitting portion, which is located on the side of the top plate opening of the top plate near the top plug. The sealing portion cooperates with the fitting portion to be inserted into the top plate opening of the top plate. During the capping process, since the fitting portion has a chamfer along the side near the top plug, the sealing portion slides along the edge of the fitting portion when it is inserted into the top plate opening. This is suitable for the sealing portion to smoothly complete the fitting with the top plate opening under a small force, avoiding uneven force on the sealing portion and deformation that would affect the capping process or the airtightness of the capping, thereby improving the efficiency of the capping process.

[0038] In some embodiments of this case, the dual-chamber cartridge can include: an inner cavity, a bottle body, a neck, and a bottle mouth. The center of the bottle mouth may have an opening connected to the inner cavity, and the inner diameter of the bottle mouth opening is smaller than the inner diameters of the bottle mouth and neck. One outer wall of the bottle body may have a bypass protrusion. After the dual-chamber cartridge is freeze-dried and placed in a protective sleeve, the bypass protrusion of the bottle body can be secured at the apex of the inner wall of the protective sleeve, preventing the dual-chamber cartridge from rotating along its longitudinal axis under external force when stored in the protective sleeve. During the process of attaching or removing the sterile injection needle from or from the dual-chamber cartridge, rotation is required on the threaded structure of the dual-chamber cartridge. Therefore, the bypass protrusion secures the dual-chamber cartridge, preventing it from rotating with the sterile injection needle, thus preventing the sterile injection needle from spinning idly, thereby achieving efficient screwing and removal of the sterile injection needle from the dual-chamber cartridge packaging material.

[0039] In some embodiments of this case, the top stopper may include 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.

[0040] In some embodiments of this invention, the top cover may further include a base plate; the upper end may also have threads and an opening, and the inner wall of the top cover fits against the bottle mouth; when the top cover moves towards the bottle mouth, the upper plate presses the top plug into the bottle mouth, causing the top plug to embed into the bottle mouth. The upper end of the top cover fixes the pre-assembled top plug through the top plate, and continues to secure the top plug after it is embedded in the bottle mouth; after the base plate fits against the outer wall of the bottle, the top cover as a whole can seal the bottle mouth and the connection between the bottle neck and the bottle body, thereby providing a complete seal for the bottle mouth with the top plug, increasing the sealing effect of the bottle mouth. The top cover has the characteristics of small volume and quick loading and unloading, which can improve the self-pressing and capping efficiency of the double-chamber cartridge bottle in the freeze-drying process. When the base plate extends downward along the bottle body, its fit with the bottle body further prevents the top cover from loosening and slipping, increasing the sealing effect of the double-chamber cartridge bottle. The opening allows moisture in the product to sublimate from the dual-chamber vial, further reducing the moisture content of the freeze-dried product in the vial during lyophilization. The threads are for engagement with the threads of a sterile injection needle.

[0041] The base can be a hollow, open-bottomed cylinder or an octagonal prism. Preferably, the base is an octagonal prism with an octagonal surface structure. After the dual-chamber vial has undergone freeze-drying and is placed in the sheath, the base matches and fits into the octagonal inner wall of the sheath. This method of base-sheath fitting also secures the dual-chamber vial, preventing it from rotating along its longitudinal axis due to external forces during storage, thus ensuring efficient screwing and removal of the injection needle from the top cap. Furthermore, the base and sheath are fixed by an interference fit assembly, with force applied from both ends of the packaging material towards the center to further compress the top stopper, improving the sealing of the top stopper and top cap.

[0042] In some embodiments of this invention, 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 inserted 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; through this method of inserting and fitting the sealing portion into the top plate opening during the pre-assembly of the top stopper, and using 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 in actual production, such as vibration or suspension, will not affect the fixation of the top stopper in the top cap, thereby preventing the top stopper from falling out of the top cap before the capping operation; in addition, after the top stopper seals the bottle neck opening, a gap is provided between the top stopper and the top cap. After the injection needle is inserted into the top stopper, its compressed volume extends into the gap at the outer edge, which can prevent pressure from concentrating on the sealing portion, thereby preventing the core removal phenomenon when the injection needle is inserted.

[0043] In some embodiments of this invention, 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 axis and is used to fix the top plug that fits into the bottle mouth. The top plug is further fixed by the top plug positioning point, which improves the sealing stability of the top plug.

[0044] In some embodiments of this case, the number of top stopper positioning points is four or five or more. These positioning points also extend radially along the top cap and are evenly spaced circumferentially on the upper inner wall, providing a uniform fixing force to the top stopper. When the top stopper shows a tendency to slip out, it is difficult for the top stopper to generate a displacement greater than in other directions in any direction, thus making it more difficult for the top stopper to slip out of the bottle opening. Furthermore, the top stopper positioning points can also be used to position the top stopper before it is pressed into the bottle opening; the top stopper is limited by the positioning points, preventing it from sliding out of the bottle opening on its own.

[0045] In some embodiments of this invention, the upper end of the top cap may also be provided with a protrusion protruding in the direction of the top cap axis on its inner wall. The top cap can be limited at the bottle mouth by the protrusion before capping, so that the moisture in the product in the inner cavity can be discharged through the opening by sublimation. Therefore, the setting of the protrusion helps to provide gas exchange and moisture sublimation 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 is conducive to maintaining the fixation of the top cap after capping and improving the stability of the capping seal.

[0046] In some embodiments of this case, the number of protrusions is two or three or more; preferably, the maximum length of the protrusions protruding in the direction of the top cap axis is 0.10 mm-0.30 mm. 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 cap does not slip off from one side, further improving the stability of the top cap on the double-cavity cartridge bottle.

[0047] In some embodiments of this case, the protrusion is trapezoidal, semi-circular, semi-elliptical or rectangular in shape, preferably trapezoidal; when the protrusion is trapezoidal, the upper tangent angle between the face of the protrusion facing the top cover axis and its side surface is preferably 30°-45°, more preferably, the upper tangent angle between the face of the protrusion facing the top cover axis and its side surface is 30°; and when the protrusion is trapezoidal, the lower tangent angle between the face of the protrusion facing the top cover axis and its side surface is even more preferably 30°. When the protrusion is trapezoidal, the upper end fits the bottle mouth better, and the top cap can fit stably on the double-chamber cartridge bottle. When the upper and lower tangent angles of the protrusion facing the axis of the top cap and its side are 30° and 30° respectively, the capping process will not cause structural damage to the top cap due to excessive pressure. At the same time, it maintains a high degree of fit between the top cap and the double-chamber cartridge bottle, improving the capping efficiency and accuracy in the freeze-drying process using the top cap.

[0048] In some embodiments of this case, the upper end also has a demolding hole, which is located at the connection between the top plate and the thread; preferably, the number of demolding holes is four or five or more. The demolding hole connects the upper and lower sides of the top plate and the opening of the top plate, making it convenient to open and close the mold when producing the top cover, thereby improving the production efficiency of the top cover; since it is not connected to the outer side of the upper end, the demolding hole will not affect the airtightness of the entire upper end or even the top cover, maintaining the normal function of the top cover.

[0049] In some embodiments of this case, the chassis also has internal protrusions located on the inner wall of the chassis on the side away from the upper end and protruding towards the axis of the top cover; preferably, the number of internal protrusions is 2, 3, 4, 5 or more. When the top cover maintains a seal on the dual-chamber cartridge bottle, the chassis, due to the internal protrusions, increases the contact pressure between itself and the bottle, generating greater adhesion strength, making it impossible for the top cover to loosen during the sealed storage and transfer of the dual-chamber cartridge bottle; in addition, when multiple internal protrusions are evenly distributed on the inner side of the chassis, the stress on the chassis can be effectively dispersed, further improving the top cover's resistance to loosening.

[0050] In some embodiments of this invention, the chassis has openings on both sides of the internal protrusion along its edge away from the upper end. Preferably, the number of openings on both sides of the protrusion is 4, 6, 8, 10, or more. When the internal protrusion is in contact with the bottle body, it can extend to the openings on both sides of the protrusion, so that no large frictional force needs to be overcome during the capping process. In this way, the internal protrusion will not significantly hinder the capping process.

[0051] According to another aspect of this case, a dual-chamber cartridge bottle packaging material for injection is also provided, which includes a cap assembly and a dual-chamber cartridge bottle provided in this case.

[0052] According to another aspect of this case, an injection dual-chamber cartridge vial packaging material assembly is also provided, which includes the dual-chamber cartridge vial assembly and sheath provided in this case. The sheath can cooperate with the chassis and bypass protrusion to fix the dual-chamber cartridge vial packaging material.

[0053] In some embodiments of this invention, the base of the bottle cap assembly of the packaging material is cylindrical or octagonal prism in shape, preferably octagonal prism. The sheath includes a sheath body and a flange, which is octagonal prism in shape with an octagonal inner wall. 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. The top of the inner wall of the sheath has a horizontal protrusion, which is assembled with the base of the bottle cap assembly of the packaging material through an interference fit to further clamp the top stopper and the dual-chamber cartridge bottle with the base. By using the interference fit between the sheath and the base 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.

[0054] Compared with the prior art, the present invention has at least one of the following technical effects:

[0055] 1. This case provides an integrated self-pressurizing stopper and capping seal for bottle cap assembly and dual-chamber cartridge bottles in a freeze dryer.

[0056] 2. This invention can improve the airtightness of the bottle stopper and the mouth of the double-chamber cartridge bottle.

[0057] 3. This invention can improve the sealing performance of the sealing cap assembly and the double-chamber cartridge bottle.

[0058] 4. This invention can shorten the time required to seal the double-chamber cartridge bottle in the freeze-drying technology 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.

[0059] 5. The dual-chamber cartridge bottle packaging material of this case 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.

[0060] 6. The bottle cap assembly provided in this case has a good fit structure between the top stopper and the top cap, and between the top cap and the double-chamber cartridge bottle, so that the stopper and cap can be pressed and sealed quickly and smoothly.

Implementation Method

[0063] This case first discloses a bottle cap assembly, which includes a top plug 3 and a top cap 4 for sealing a dual-chamber cartridge bottle 1. Specifically, the dual-chamber cartridge bottle 1 can be placed in a freeze-drying support used in existing freeze-drying technologies, and when the dual-chamber cartridge bottle 1 is fixed to the bottle cap assembly and placed in the freeze-drying support, the bottle cap assembly can also be adapted to be placed in a freeze-drying support used in existing freeze-drying technologies; the bottle cap assembly can be made of any material suitable for achieving the bottle cap sealing function. The top plug 3 is used to seal the bottle opening 10 of the dual-chamber cartridge bottle 1. The top plug 3 is pressed by a stopper assembly to engage with the dual-chamber cartridge bottle 1, thereby achieving a seal on the dual-chamber cartridge bottle 1; when the stopper assembly presses the top plug 3, the method of driving the stopper assembly can be mechanical pressing, pneumatic driving, pneumatic clamp driving, or spring pressing.

[0064] The top cap 4 disclosed in this case is used to fix the top plug 3 and seal the bottle opening 10 of the double-chamber cartridge bottle 1; wherein, the stopper assembly includes a pressing fixture 21 and a retaining fixture 20, and the process of the top plug 3 being pressed by the stopper assembly to fit into the double-chamber cartridge bottle 1 to achieve the sealing of the double-chamber cartridge bottle 1 includes the following steps:

[0065] The top plug 3 is placed in the retaining fixture 20 by fitting it against the outer wall of the bottle opening 10 of the dual-chamber cartridge bottle 1, thereby positioning the top plug 3 relative to the bottle opening 10 of the dual-chamber cartridge bottle 1; the top plug 3 is pressed into the bottle opening 10 of the dual-chamber cartridge bottle 1 by pressing the pressing fixture 21; and the pressing fixture 21 and the retaining fixture 20 are removed. It should be noted that when the dimensions of some or all of the structures of the dual-chamber cartridge bottle 1 change, the dimensions of the top plug 3, the pressing fixture 21 and the retaining fixture 20 can also be changed accordingly to adapt to the dimensions of the dual-chamber cartridge bottle 1, so as to complete the sealing of the bottle opening.

[0066] In this case, 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 bottle mouth opening 100 connected to the inner cavity 13 at its center. The inner diameter of the bottle mouth 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 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 within the size range suitable for placement in a freeze-drying support without changing its original function. For example, increasing the vertical length of one or more parts of the dual-cavity cartridge bottle 1 or increasing the radial length of one or more parts of the dual-cavity cartridge bottle 1 does not depart from the protection scope of this case.

[0067] When the dual-cavity cartridge bottle 1 is placed on the freeze-drying support, the upper opening of the freeze-drying support is larger than the lower opening. Therefore, the upper opening facilitates the insertion of the bypass 120, while the lower opening can properly fix the dual-cavity cartridge bottle 1, making it difficult for it to fall off from the fixing module, so as to avoid the dual-cavity cartridge bottle 1 from tipping over during the freeze-drying process.

[0068] In this case, the top stopper 3 includes a stopper cap 30 and a stopper plunger 31. The diameter of the stopper plunger 31 is slightly larger than the inner diameter of the bottle opening 100 of the bottle neck 10. After the stopper cap 30 is pressed to insert the stopper plunger 31 into the bottle opening 100, the lower surface of the stopper cap 30 is completely in contact with the upper surface of the bottle neck 10. In particular, the diameter of the stopper plunger 31 can be adjusted within the range of the diameter of the stopper plunger 31 when it is pressed into the bottle opening 100. In addition, in order to maintain the seal after the stopper is pressed, the diameter of the stopper plunger 31 cannot be less than or equal to the diameter of the bottle opening 100.

[0069] In this case, the stopper assembly has one configuration as shown in Figure 2A and another configuration as shown in Figure 2B. The pressing fixture 21 is a column with an opening at the bottom and a recess at the center of the upper surface. In the configuration shown in Figure 2A, a protruding pressing post 210 is provided on the lower inner wall of the pressing fixture 21. When the top stopper 3 moves toward the bottle mouth 10, the pressing post 210 presses the top stopper 3 to move toward the bottle mouth 10, so that the top stopper 3 is embedded in the bottle mouth 10. The pressing fixture 21 can be a cylinder or a prism, and the shape of the pressing post 210 can be a cylinder, a prism, or an ellipsoid. The contact surface between the pressing post 210 and the stopper cap 30 of the top stopper 3 can be a plane or a curved surface.

[0070] In this case, the number of pressure columns 210 is two or three or more. In particular, all pressure columns 210 are arranged in a centrally symmetrical, axially symmetrical or uniformly spaced manner along the center of the lower inner wall of the press-in fixture 21, thereby ensuring the uniform distribution of pressure columns 210 on the lower inner wall of the press-in fixture 21.

[0071] In another configuration shown in Figure 2B, the inner wall of the central recess of the pressing fixture 21 is no longer provided with a pressing post 210. When the top stopper 3 moves toward the bottle mouth 10, the pressing fixture 21 directly abuts against the top stopper 3 by relying on its central recess to press it toward the bottle mouth 10. In this way, without using a retaining fixture 20 with a long upper protrusion, the pressing fixture 21 can also ensure that it provides sufficient pressing length to the top stopper 3 so that it is firmly fitted into the bottle mouth 10 without additional pressing posts 210, thereby simplifying the manufacturing technology of the pressing assembly.

[0072] In this case, the retaining fixture 20 is configured such that its inner wall fits against the bottle mouth 10 and the bottle body 11, and its upper end protrudes from the bottle mouth 10; and when the top plug 3 moves toward the bottle mouth 10, the inner wall of the retaining fixture 21 is pressed against and slides against at least a portion of the outer wall of the retaining fixture 20. The length of the upper end of the retaining fixture 20 protruding from the bottle mouth 10 may be no less than the top plug 3 limited by the protrusion 200, or it may be less than the top plug 3 limited by the protrusion 200; when the length of the upper end of the retaining fixture 20 protruding from the bottle mouth 10 may be greater than the top plug 3 limited by the protrusion 200, the retaining fixture 20 can protect the top plug 3, prevent the top plug 3 from slipping off or popping out from the retaining fixture 20 during the capping process, and improve the capping stability.

[0073] In this case, the retaining fixture 20 is further provided with a protrusion 200, which supports and fixes the top plug 3 before it is inserted into the bottle neck 10, so that the plug 31 is aligned with the bottle neck opening 100 of the bottle neck 10; and the protrusion 200 locks the top plug 3 in place after it is inserted into the bottle neck 10. Those skilled in the art will understand that the protrusion 200 does not significantly hinder the movement of the top plug 3 during insertion into the bottle neck 10. Since the protrusion 200 is evenly distributed on the inner wall of the retaining fixture 20, and the pressure column 210 applies pressure evenly to the plug cap 30, the top plug 3 will be horizontally inserted into the bottle neck 10 without being subjected to any larger or smaller force in any direction. The shape of the protrusion 200 can be trapezoidal, semi-circular, semi-elliptical, or rectangular, and its contact surface with the side of the plug cap 30 of the top plug 3 can be flat or curved.

[0074] In this case, the number of protrusions 200 is two or three or more. It should be noted that the protrusions 200 extend radially along the retaining fixture 20 and are evenly spaced circumferentially on the inner wall of the retaining fixture 20. The number of protrusions 200 and the interval length / radius between multiple protrusions 200 can be adjusted to maintain optimal positioning and locking of the top plug 3.

[0075] In this case, the top cover 4 includes a main body and a base 41. The main body has a top plate 400 and an annular thread 401. The inner wall of the top cover 4 fits against the bottle mouth 10 and the bottle neck 11. The base 41 of the top cover 4 is completely fitted against the upper surface of the bottle body 12. After the bottle mouth 10 of the dual-chamber cartridge bottle 1 is sealed, the top plate 400 is fitted against the stopper cap 30 to secure the stopper 3. The annular thread 401 is used to engage with the thread of a sterile injection needle.

[0076] This application discloses a dual-chamber cartridge vial packaging material for injection, comprising the aforementioned cap assembly and dual-chamber cartridge vial 1, which can be used to properly preserve lyophilized products. It should be noted that the dual-chamber cartridge vial packaging material for injection may include any combination of the cap assembly and dual-chamber cartridge vial 1 formed and / or maintained through any of the combinations disclosed in this application.

[0077] Further, this case discloses another bottle cap assembly, wherein the bottle cap assembly includes a top plug 2' and a top cap 3' for sealing a dual-chamber cartridge bottle 1'. As shown in Figure 4, the dual-chamber cartridge bottle 1' can be placed in a freeze-drying support used in existing freeze-drying technologies, and the dual-chamber cartridge bottle packaging 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 positioned 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' on the top cap 3', such that the top plug 2' seals the bottle opening 10' of the dual-chamber cartridge bottle 1', may include the following steps:

[0078] The top plug 2' is pre-assembled into the top cap 3'; and the top cap 3' with the top plug 2' 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.

[0079] In this case, 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 bottle mouth opening 100' connected to the inner cavity 13' at its center. The inner diameter of the bottle mouth 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 protection scope of this case.

[0080] In this case, 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 down. The diameter of the stopper plunger 21' can be slightly larger than the diameter of the bottle opening 100' to ensure a tight seal.

[0081] In this case, the top cover 3', as shown in Figure 5A, 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 cover 3' fits against the bottle mouth 20, the bottle neck 21, and at least a portion of the bottle body 22. When the top cover 3' faces the bottle mouth 10', the top plate 300' of the upper end 30' presses the top plug 2' into the bottle mouth 10', causing the top plug 2' to embed into the bottle mouth 10'. After the bottle mouth 10' of the double-cavity cartridge bottle 1' is sealed, the top plate 300' fits tightly against the top plug 20' to secure the top plug 2'. The opening 302' allows sublimated water in the product to drain out, the thread 301' is used for threaded engagement with a sterile injection needle, and the convex ring 310' can be matched with a sheath.

[0082] It should be noted that the lower end 32' of the top cap 3' can be cylindrical or prismatic, as shown in Figure 5B. 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 size requirements of the freeze-drying technology for the top cap 3'. The raised strip 320' is used to increase the friction between the lower end 32' and the mating 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.

[0083] 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' 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 is 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 technology. Specifically, the center of the top plate 300' has a top plate opening, 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 a curved surface or a plane.

[0084] In this case, as shown in FIG6, the top stopper 2' may further include: a sealing portion 22' protruding above the stopper cap 20', the sealing portion 22' being inserted into the top plate opening. When the top stopper 2' is fully embedded in the bottle mouth 10', i.e., when the double-cavity cartridge bottle 1' is stopped, its sealing portion 22' is embedded in the top plate opening and partially protrudes longitudinally from the top plate opening. 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 circumferential edge 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 itself in the top plate opening from the lower circumferential edge of the top plate opening.

[0085] 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 lower circumferential edge of the top plate opening and the sealing portion 22' can have a tighter fit relative to the upper circumferential edge of the top plate opening, so that the top plate opening tightly surrounds and fixes the sealing portion 22'.

[0086] In some embodiments, the radial length L' of the sealing portion 22' can be 2.0 mm - 5.0 mm. Specifically, the radial length L' of the sealing portion 22' can be 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, or 5.0 mm; preferably, the radial length L' of the sealing portion 22' can be 3.0 mm - 4.0 mm. Specifically, the radial length L' of the sealing portion 22' can preferably be 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm. The tilt angle β' can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, or 10°, etc.

[0087] In some embodiments, the circumferential downward opening length of the top plate opening can be 1.5 mm - 5.0 mm, specifically, the circumferential downward opening length of the top plate opening can be 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, or 5.0 mm; preferably, the circumferential downward opening length of the top plate opening can be 2.5 mm - 4.0 mm. Specifically, the circumferential downward opening length of the top plate opening can preferably be 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm or 4.0 mm.

[0088] 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 lower 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' does not slip off as a whole. Preferably, setting β' to 0°, 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' based on the actual application of the bottle cap assembly, in order to adapt the degree of fit and fixation between the sealing part 22' and the top plate 300'.

[0089] 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 cooperation 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, the diameter of the cap 20' is set to be slightly smaller than the inner diameter of the top cap 3', leaving a small gap 200' between the surface of the cap 20' and the inner wall of the upper end 30', as shown in Figure 8. In this way, when the top stopper 2' is pressed by the top cap 3', the pressure volume of the cap 20' extends to the gap 200' reserved around it, and the cap 20' will not bulge out towards the top plate opening above it due to pressure. Therefore, when an injection needle, such as a micro fine needle (MFN), is inserted into the bottle neck 10' from the middle of the stopper cap 20', the stopper cap 20' will not apply pressure to the inside of the needle at the insertion position, thereby avoiding the needle tip cutting the stopper cap 20' and causing core removal, i.e., generating rubber fragments that fall into the needle tip and the inner cavity of the dual-chamber cartridge, thus avoiding product contamination.

[0090] In some embodiments, 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, 8.6 mm, 8.7 mm, 8.8 mm, 8.9 mm, or 9.0 mm. The diameter of the cap 20' is preferably 6.0 mm to 8.0 mm, specifically, the diameter of the cap 20' is preferably 6.0 mm to 8.0 mm.

[0091] In some embodiments, the diameter of the upper end 30' of the top cover 3' can range from 5.0 mm to 10.0 mm. Specifically, the diameter of the upper end 30' 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, 8.6 mm, 8.7 mm, 8.8 mm, 8.9 mm, etc. The diameter of the upper end 30' is preferably 6.0 mm to 8.0 mm, specifically, the ...

[0092] 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 stopper 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 this embodiment, 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 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.

[0093] 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 cooperating with the top plug positioning point 303' to limit the plug cap 20', the top plug 2' can be stably fixed in the top cover 3'. Therefore, the mechanical techniques implemented on the top cover 3' in the freeze-drying technology, 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, and ensuring the capping qualification rate after freeze-drying; the gap part 200' of the plug cap 20' can also prevent core removal when it is used with an injection needle, thereby ensuring product quality and efficient use.

[0094] In this case, the upper end 30' of the top cap 3' also has a top plug positioning point 303', as shown in Figures 7A and 7B. The top plug positioning point 303' protrudes from the inner wall of the upper end 30' in the direction of the axis of the top cap 3', and is used to fix the top plug 2' that fits into the bottle mouth 10'. Specifically, the top plug positioning point 303' extends radially along the upper end 30' and is evenly spaced circumferentially on the inner wall of the top plug positioning point 303'. The shape of the top plug positioning point 303' can be cylindrical or prism. In addition, its number and the interval length / radius between multiple top plug positioning points 303' can be adjusted to maintain optimal fixation of the top plug 2'.

[0095] In this case, the number of top stopper positioning points 303' is four or five or more. In particular, the number of top stopper positioning points 303' can be even to maintain their symmetrical arrangement along the center of the upper end 30', so as to provide 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 more 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 mouth 10', and the top stopper 2' is limited by the top stopper positioning points 303' to prevent it from sliding off into the bottle mouth 10' on its own.

[0096] In this case, the upper end 30' of the top cap 3' is also provided with a protrusion 304' protruding in the direction of the axis of the top cap 3', as shown in FIG9. 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 evenly apply pressure to the entire surface of the cap 20' pre-assembled into the upper end 30' when the top stopper is pressed, the top stopper 2' can be stably and horizontally inserted into the bottle mouth 10'.

[0097] In this case, 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 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm or 0.30 mm. Specifically, D' can be 0.15 mm to 0.30 mm; more preferably, D' can be 0.20 mm to 0.28 mm, which prevents the top cap 3' from deforming due to excessive pressure during capping, and ensures good sealing performance and prevents slippage after capping; even better, D' can be 0.23 mm to 0.28 mm, which can prevent deformation of the top cap 3' due to pressure during capping, and ensure good sealing performance and prevent 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 7.3 mm, D' can be 0.23 mm, 0.25 mm, or 0.28 mm, and the protrusion 304' can provide optimal stability after the top cap 3' is capped.

[0098] In this case, 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 near the bottle opening 10', the upper end 30' fits more tightly with the bottle opening 10', and the top cap 3' can fit very stably on the double-cavity cartridge bottle 1' to maintain good airtightness.

[0099] 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 cap 3' and its side surface can be any angle between 0° and 90°, as shown in Figure 10. More preferably, θ' can be 30° to 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 cap 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 cap 3' to deform or even be damaged during the capping process. Therefore, θ' can be preferably selected as 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', without adversely hindering the capping process.

[0100] Furthermore, when the protrusion 304' is trapezoidal in shape, it is even more preferable that the downward angle (α') between the surface 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 magnitude of θ', when α' and θ' have the same value, the protrusion 304' can have a stable axisymmetric structure and is not easily deformed or damaged during the capping or storage process. Therefore, in this case, it is even more preferable to select α' as 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'.

[0101] 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' used therewith, as shown in Figure 11. 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.

[0102] The sheath 4' proposed in this case is an octagonal prism with an open top, as shown in Figure 11. The inner wall of the sheath 4' has an octagonal shape. After the double-chamber cartridge bottle 1' has completed the freeze-drying process and is sealed by the top cap 3', the double-chamber cartridge bottle 1' can be pressed into the sheath. During this process, the lower end 32' of the top cap 3' is in contact with the inner wall of the sheath 4' and cannot slide relative to it. Furthermore, the bypass protrusion 120' of the bottle body 12' is fixed at the octagonal vertex of the inner wall of the sheath and cannot slide relative to the inner wall of the sheath 4'.

[0103] In this case, the lower end 32' is cylindrical or octagonal prism, preferably octagonal prism, and is fixedly assembled with the sleeve 4' used to fix and store the double-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 first protrusion 321', the top of the sleeve 4' is stretched and confined on the first 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 double-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 tighter, effectively preventing leakage, rotation, and falling off.

[0104] Specifically, in some embodiments, the reconstituted lyophilized product in the dual-chamber cartridge 1' is injected subcutaneously via an injection needle for the treatment of skin diseases or medical aesthetic 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 the threaded structure with the thread 301' of the top cap 3'. During this process, the lower end 32' of the top cap 3' is fixed and prevented from rotating by the octagonal inner wall of the sheath 4', and the bypass protrusion 120' of the dual-chamber cartridge 1' is also fixed and prevented from rotating by the apex of the octagonal inner wall of the sheath 4'. Therefore, by selecting the octagonal prism-shaped lower end 32' and matching it with the sheath 4', the dual-chamber cartridge packaging assembly can be kept unaffected by rotation during the screwing / removal of the injection needle, thus avoiding free rotation of the sterile injection needle during screwing / removal and improving the efficiency of the dual-chamber cartridge packaging assembly.

[0105] To provide an advantageous integrated sealing fit for a dual-chamber cartridge vial 1' with a longer neck, this application also discloses a packaging material for an injection dual-chamber cartridge vial, comprising another cap assembly and a dual-chamber cartridge vial 1' as described below, as shown in Figure 12. It should be noted that the packaging material for the injection dual-chamber cartridge vial can include any combination formed and / or maintained through any of the cap assemblies and dual-chamber cartridge vials 1' proposed in this application.

[0106] That is, in this case, another bottle cap assembly is proposed, wherein the bottle cap assembly includes a top plug 2' and a top cap 3' for sealing a double-chamber cartridge bottle 1'. The double-chamber cartridge bottle 1' can be placed in a freeze-drying support and sheath 4' used in existing freeze-drying technology, and the double-chamber cartridge bottle packaging can be fixed and placed upright or upside down in the freeze-drying support; the bottle cap assembly can be made of any material suitable for achieving the bottle cap sealing function. The top plug 2' is limited within the top cap 3' for sealing the bottle opening 10' of the double-chamber cartridge bottle 1'; the top cap 3' is used to press and fix the top plug 2', so that the top plug 2' seals the bottle opening 10' of the double-chamber cartridge bottle 1'; and seals the double-chamber cartridge bottle 1'; wherein the process of pressing and fixing the top plug 2' on the top cap 3' so that the top plug 2' seals the bottle opening 10' of the double-chamber cartridge bottle 1' may include the following steps:

[0107] Pre-assemble the top plug 2` into the top cap 3`; and place the top cap 3` with the top plug 2` assembled on top of the bottle mouth 10` of the double-chamber cartridge bottle 1`, and press the top cap 3` down. The method of driving the top cap 3` to press down can be mechanical clamping, pneumatic drive, pneumatic clamp drive or spring pressing, etc.

[0108] In this case, 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 bottle mouth opening 100' connected to the inner cavity 13' at its center. The inner diameter of the bottle mouth 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 protection scope of this case.

[0109] In this case, 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 down. The diameter of the stopper plunger 21' can be slightly larger than the diameter of the bottle opening 100' to ensure a tight seal.

[0110] In this case, as shown in Figure 13A, the top cap 3' includes an upper end 30'. Unlike the other bottle cap assembly described above, the middle end 31 and the lower end 32 are replaced by a base plate 31'. The upper end 30' has a top plate 300', a thread 301', and an opening 302'. The inner wall of the top cap 3' fits against the bottle mouth 10'. When the top cap 3' faces the bottle mouth 10', the top plate 300' of the upper end 30' presses the top plug 2' into the bottle mouth 10', causing the top plug 2' to embed into the bottle mouth 10'. After the bottle mouth 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 out, and the thread 301' is used for threaded engagement with the injection needle.

[0111] It should be noted that the length of the base 31' in the vertical direction is adjustable. Therefore, the base 31' can fit only the connection between the neck 11' and the bottle body 12', or it can fit at least a portion of the bottle body 12' to achieve better sealing and to adapt to the size requirements of the top cap 3' for freeze-drying technology. The shape of the base 31' can be set as a cylinder or a polygonal prism, as shown in Figure 13B, to prevent the top cap 3' from slipping off due to centrifugal force or from sliding relative to the dual-chamber cartridge bottle 1', thus affecting the sealing performance.

[0112] In particular, the center of the top plate 300' also has a top plate opening, 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 a curved surface or a plane.

[0113] In this case, the top stopper 2' may further include: a sealing portion 22' protruding above the stopper cap 20', as shown in FIG14A. The sealing portion 22' can be inserted into the top plate opening. When the top stopper 2' is fully embedded in the bottle mouth 10', that is, when the double-cavity cartridge bottle 1' is stopped, its sealing portion 22' is embedded in the top plate opening and partially protrudes longitudinally from the top plate opening. 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 circumferential edge of the top plate opening. During the process of pre-assembling 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 top plate opening from the lower circumferential edge of the top plate opening.

[0114] 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. Alternatively, by setting the radial length L' of the sealing portion 22' 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 can be improved, further preventing the top plug 2' from slipping out of the top plate 300'. Furthermore, by adjusting the size of β', the lower circumferential edge of the top plate opening and the sealing portion 22' can have a tighter fit relative to the upper circumferential edge of the top plate opening, so that the top plate opening tightly surrounds and fixes the sealing portion 22'.

[0115] In some embodiments, the radial length L' of the sealing portion 22' can be 2.0 mm - 5.0 mm. Specifically, the radial length L' of the sealing portion 22' can be 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, or 5.0 mm; preferably, the radial length L' of the sealing portion 22' can be 3.0 mm - 4.0 mm. Specifically, the radial length L' of the sealing portion 22' can preferably be 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm. The tilt angle β' can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, or 10°, etc.

[0116] In some embodiments, the circumferential downward opening length of the top plate opening can be 1.5 mm - 5.0 mm, specifically, the circumferential downward opening length of the top plate opening can be 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, or 5.0 mm; preferably, the circumferential downward opening length of the top plate opening can be 2.5 mm - 4.0 mm. Specifically, the circumferential downward opening length of the top plate opening can preferably be 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm or 4.0 mm.

[0117] 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 to the circumferential lower edge of the top plate opening. The top plate opening effectively fits and fixes the sealing portion 22', and the circumferential edge provides further support, preventing the top plug 2' from slipping off. Preferably, setting β' to 0° allows the top plate opening to provide good fixation for the sealing portion 22' without any 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 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 actual application of the bottle cap assembly, in order to adapt the degree of fit and fixation between the sealing part 22' and the top plate 300'.

[0118] Specifically, the diameter of the cap 20' of the top plug 2' can be slightly smaller than the inner diameter of the top cover 3'. Due to the cooperation between the top plug positioning point 303' and the cap 20', the top plug 2' can be tightly fixed to the top cover 3' to achieve a seal. In this case, the diameter of the cap 20' is designed to be slightly smaller than the inner diameter of the top cover 3', so that a small gap 200' is left between the surface of the cap 20' and the inner wall of the upper end 30', as shown in Figure 17. In this way, when the top plug 2' is pressed by the top cover 3', the pressure volume of the cap 20' extends to the gap 200' reserved around it, and the cap 20' will not bulge out of the top plate opening in the middle due to the pressure. Therefore, when the injection needle, such as a micro fine needle (MFN), is inserted into the bottle neck 10' from the middle of the stopper 20', the stopper 20' will not apply pressure to the inside of the needle at the insertion position, thereby avoiding the needle tip cutting the stopper 20' and causing core removal, that is, the stopper 20' being cut and producing rubber fragments that fall into the needle tip and the inner cavity of the dual-chamber cartridge, thus avoiding product contamination.

[0119] In some embodiments, 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, 8.6 mm, 8.7 mm, 8.8 mm, 8.9 mm, 9.0 mm, etc. The diameter of the cap 20' can be 6.0 mm to 8.0 mm, specifically, the ...1 mm to 8.0 mm, specifically, the diameter of the cap 20' can be 6.1 mm to 8.0 mm, specifically, the diameter of the cap 20' can be 6.1 mm to 8.2 mm, the diameter of the cap 20' can be 6.1 mm to 8.2 mm, the diameter of the cap 20' can be 6.2 mm to 8.3 mm, the diameter of the cap 20' can be 7.3 mm to 8.4 mm, the diameter of the cap 20' can be 7.3 mm to 8.4 mm, the diameter of the cap 20' can be 7.3 mm to 8.4

[0120] In some embodiments, the diameter of the upper end 30' of the top cover 3' can range from 5.0 mm to 10.0 mm. Specifically, the diameter of the upper end 30' 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, 8.6 mm, 8.7 mm, 8.8 mm, 8.9 mm, etc. The diameter of the upper end 30' is preferably 6.0 mm to 8.0 mm, specifically, the ...

[0121] 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 stopper 2' or the insertion of the injection needle, the diameter of the stopper cap 20' increases due to compression. 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 this embodiment, 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 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.

[0122] By inserting and fitting the sealing part 22' into the top plate opening during the pre-assembly process of the top plug 2', and cooperating with the top plug positioning point 303' to limit the plug cap 20', the top plug 2' can be stably limited in the top cover 3'. Therefore, when external forces are applied to the top cover 3' in actual production, such as vibration or suspension, it 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; in addition, the gap part 200' of the plug cap 20' can also prevent core removal when it is used with the injection needle, which also ensures product quality and efficient use of packaging materials.

[0123] In this case, the upper end 30' of the top cap 3' also has a top plug positioning point 303', as shown in Figures 15A and 15B. The top plug positioning point 303' protrudes from the inner wall of the upper end 30' in the direction of the axis of the top cap 3', and is used to fix the top plug 2' that fits into the bottle mouth 10'. Specifically, the top plug positioning point 303' extends radially along the upper end 30' and is evenly spaced circumferentially on the inner wall of the top plug positioning point 303'. The shape of the top plug positioning point 303' can be cylindrical or prism. In addition, its number and the interval length / radius between multiple top plug positioning points 303' can be adjusted to maintain optimal fixation of the top plug 2'.

[0124] In this case, the number of top stopper positioning points 303' is four or five or more. In particular, the number of top stopper positioning points 303' can be even to maintain their symmetrical arrangement along the center of the upper end 30', so as to provide 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 more stable fixing function for the top stopper 2'; more preferably, the number of top stopper positioning points 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 mouth 10'. The top stopper 2' is limited by the top stopper positioning points 303' to prevent it from sliding off into the bottle mouth 10' on its own.

[0125] In this case, the upper end 30' of the top cover 3' is also provided with a protrusion 304' protruding in the direction of the axis of the top cover 3' on its inner wall. The top cover 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 water discharge for the dual-chamber 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 evenly apply pressure 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'.

[0126] In this case, 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 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm or 0.30 mm. Specifically, D' can be 0.15 mm to 0.30 mm; more preferably, D' can be 0.20 mm to 0.28 mm, which prevents the top cap 3' from deforming due to excessive pressure during capping, and ensures good sealing performance and prevents slippage after capping; even better, D' can be 0.23 mm to 0.28 mm, which can prevent deformation of the top cap 3' due to pressure during capping, and ensure good sealing performance and prevent 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 double-chamber cartridge bottle 1'. When the outer diameter of the bottle mouth 10' is 7.3 mm, D' is preferably 0.23 mm, 0.25 mm, or 0.28 mm, so that the protrusion 304' can provide the most stable fixation for the top cap 3'.

[0127] In this case, the shape of the protrusion 304' can be trapezoidal, semi-circular, semi-elliptical, or rectangular. Preferably, the protrusion 304' is trapezoidal. When the shape of the protrusion 304' is preferably a trapezoid with its short side near the bottle opening 10', the upper end 30' fits more tightly with the bottle opening 10', and the top cover 3' can fit very stably on the double-cavity cartridge bottle 1' to maintain good airtightness.

[0128] When the protrusion 304' is trapezoidal in shape, the upper tangent angle (θ') between the surface of the protrusion 304' facing the axis of the top cap 3' and its side surface can be any angle between 0° and 90°, as shown in Figure 18. Further, θ' can be 30° to 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 cap 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 cap 3' to deform or even be damaged during the capping process. Therefore, θ` can be preferably selected as 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`, without adversely hindering the capping process.

[0129] Furthermore, when the protrusion 304' is trapezoidal in shape, the angle (α') between the face of the protrusion 304' facing the axis of the top cover 3' and its side can also be any angle between 0° and 90°. Since the pressure during the capping process is mainly affected by the magnitude of θ', when α' and θ' have the same value, the protrusion 304' can have the most stable axisymmetric structure, and is not prone to deformation or damage during the capping or storage process. Therefore, in this case, α' can be 30° to improve the efficiency and deformation resistance of the protrusion 304'. More preferably, θ' and α' of the protrusion 304' are both 30°, so that the capping process of the top cover 3' will not cause structural damage to the top cover 3' due to excessive pressure, while also maintaining a tight fit between the top cover 3' and the double-chamber cartridge bottle 1', which can improve the capping efficiency and accuracy of the double-chamber cartridge bottle 1' in the freeze-drying process.

[0130] In this case, the upper end 30' of the bottle cap assembly also has a demolding hole 305', as shown in Figures 15C and 16. The demolding hole 305' is located at the connection between the top plate 300' and the thread 301'. The demolding hole 305' partially connects the two sides of the opening of the top plate. In this way, when manufacturing the top cap 3', the manufacturing module can be easily opened through the demolding hole 305' for mold closing, which is conducive to the mass production of the entire top cap 3' and improves production efficiency. The number of demolding holes 305' can be 4 or 5 or more, for example, 4 holes evenly distributed on the outer periphery of the top plate 300' at the upper end 30'. This arrangement of demolding holes 305' does not affect the fit between the sealing part 22' / top plug positioning point 303' and the surrounding top cap 3' / top plug 2'', and therefore does not affect the airtightness of the top cap 3'.

[0131] In this case, the upper end 30' also has a fitting portion 306', as shown in FIG14B. The fitting portion 306' is located on the side of the top plate opening of the top plate 300' near the top plug 2', that is, the side that contacts the plug cap 20'. The sealing portion 22' can cooperate with the fitting portion 306' to be suitable for insertion into the top plate opening of the top plate 300' of the top cover 3'. Specifically, the fitting portion 306' has a slope facing the top plug 3'. This slope smoothly tightens the contact surface between the top plate 300' and the top plug 2' from the side of the top plate opening near the top plug 2' to the other side, that is, a chamfered shape, so that when the sealing portion 22' of the top plug 2' is fitted into the top plate opening, its outer edge can slide along the slope of the fitting portion 306', reducing the force required for the fitting process, thereby further improving the fitting success rate of the sealing portion 22' and the top plate opening, and improving the sealing efficiency.

[0132] In this case, the chassis 31' may also have an internal protrusion 310', as shown in Figure 13C. The internal protrusion 310' is located on the inner wall of the chassis 31' away from the upper end 30', i.e., the top cover 3'; the inner wall at the lowest end, and protrudes towards the top cover 3' along the axial direction. When the top cover 3' seals the double-cavity cartridge bottle 1', due to the presence of the internal protrusion 310', the contact pressure between the bottle body 12' and the chassis 31' at the internal protrusion 310' increases, and the fit is tighter, enhancing the fixing stability of the top cover 3' on the double-cavity cartridge bottle 1', resulting in better airtightness of the entire packaging material. The number of internal protrusions 310' can be an appropriate number, such as 2, 3, 4, 5 or more, and preferably evenly distributed on the radial cross-section of the chassis 31' to form a stable shape, thereby improving the fixing stability of the top stopper 3'. Furthermore, when multiple internal protrusions are evenly distributed on the inner side of the chassis, for example, when four internal protrusions 310' are evenly distributed at 90° on the radial section of the cylindrical chassis 31' at the lower edge of the inner side of the chassis, the stress on the chassis can be effectively dispersed, making the chassis 31' less likely to gradually loosen due to long-term sealed use or temperature changes, thereby further improving the top cover's resistance to loosening.

[0133] Advantageously, openings 311' on both sides of the inner protrusion 310' can be provided on the edge of the base 31' away from the upper end 30', i.e., the lowermost edge of the top cover 3'. The number of openings 311' on both sides of the inner protrusion 310' can be matched with the number of inner protrusions 310', so the number can be 4, 6, 8, 10 or more. When the top cover 3' is in contact with the bottle body 12' and the inner protrusion 310' is squeezed, the openings 311' on both sides of the inner protrusion 310' can deform and extend to one or both sides, reducing the force required for sealing and improving sealing efficiency.

[0134] This application further proposes a packaging material for a dual-chamber cartridge vial for injection, comprising another cap assembly and a dual-chamber cartridge vial 1' as described above, and a packaging material assembly for a dual-chamber cartridge vial for injection, comprising the packaging material and a sheath 4' used therewith, as shown in Figure 19. 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 proposed in this application.

[0135] The upper outer edge of the chassis 31' near the upper end 30' has a first protrusion 321'. The top of the inner wall of the sleeve 4' is stretched to create a horizontal protrusion, which is confined to the first protrusion 321' of the chassis 31'. The top cover 3' and the sleeve 4' achieve an interference fit, exerting force in opposite directions and clamping the top plug 2' and the double-cavity cartridge bottle 1' in the middle. In addition, the bypass protrusion 120' of the bottle body 12' is fixed at the octagonal vertex of the inner wall of the sleeve 4' and cannot slide relative to the inner wall of the sleeve 4'. Through the above method, when the double-cavity cartridge bottle packaging material is placed in the sleeve 4', the top cover 3' and the top plug 2' therein are more tightly fixed to the bottle mouth 10', effectively preventing air leakage, rotation, and falling off.

[0136] In this case, the chassis 31' is cylindrical or octagonal, and the sleeve 4' includes the sleeve body 40' and the flange 41'. When the top cover 3' and the sleeve 4' are interference-fitted, the top cover 3' and the double-chamber cartridge bottle 1' are tightly fixed to each other. Since the bottle mouth 10', neck 11', and bottle body 12' of the double-chamber cartridge bottle 1' are cylindrical, during the process of screwing the injection needle to the top cover 3' and / or removing it from the top cover 3', the top cover 3' will cause the double-chamber cartridge bottle 1 to rotate together due to the force. When the chassis 31' is cylindrical, its smooth outer surface is difficult to be well limited by the inner wall of the sleeve 4'. When the injection needle is screwed / removed, the top cover 3' may cause the entire double-chamber cartridge bottle 1 to rotate together, thereby causing the injection needle to spin freely and unable to be fixed / removed from the top cover 3'.

[0137] Therefore, the base 31' of the bottle cap assembly configured with the packaging material is octagonal prism in shape, and the sheath body 40' is also octagonal prism in shape, so that the outer wall of the base 31' and the inner wall of the sheath body 40' are both octagonal, as shown in Figure 19. In this way, the bypass protrusion 120' of the double-cavity cartridge bottle 1' of the packaging material assembly can be limited to the octagonal vertex (B'-B') on the inner wall of the sheath 4'. During the capping process, the bottle body 12' will generate a large frictional force with the inner wall of the base 31'. When the top cap 3' is subjected to external force such as an injection needle, due to the interference fit between the base 31' and the inner wall of the sheath 4' and their mutual fixation (A'-A'), the top cap 3' will not slip off or slide relative to the double-cavity cartridge bottle 1', further stabilizing the packaging material as a whole, avoiding affecting the airtightness of the double-cavity cartridge bottle 1', and improving the efficiency of use.

[0138] In particular, the lower end of the sheath 4' may also have an interference fit structure, and the lower end of the sheath body 40' may be provided with a second protrusion 400', which is pressed and fastened to the flange 41', so that the sheath body 40' and the flange 41' are interference fit and fixed to each other (C'-C'). In this way, the fixing stability of the sheath body 40' can be improved, and the sheath body 40' and the packaging material can be prevented from rotating together.

[0139] Specifically, in some embodiments, the reconstituted lyophilized product in the dual-chamber cartridge 1' is injected subcutaneously via an injection needle for the treatment of skin diseases or cosmetic procedures. The needle hub of the injection needle has a threaded structure. When the injection needle is installed on the top cap 3' for product injection or removed from the top cap 3', its threaded structure engages or is removed by rotating the threaded structure with the thread 301' of the top cap 3'. During this process, the base 31' of the top cap 3' is fixed and prevented from rotating by the octagonal inner wall of the sheath 4', and the bypass protrusion 120' of the dual-chamber cartridge 1' is also fixed and prevented from rotating by the apex of the inner wall of the sheath 4'. Therefore, by selecting an octagonal prism-shaped base 31' and matching it with the sheath 4', the dual-chamber cartridge packaging assembly can be kept unaffected by rotation during the screwing / removal of the injection needle, thus avoiding the dry rotation of the sterile injection needle during screwing / removal and improving the utilization efficiency of the dual-chamber cartridge packaging assembly.

[0140] 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 another container, and then the reconstituted solution is injected into the drug container for reconstitution, extraction, and administration. This results in relatively poor administration accuracy and user compliance. However, the vial cap assembly and dual-chamber cartridge packaging of this invention 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 ease of use for subjects or patients, enabling self-injection.

[0141] On the other hand, the cap assembly of this invention 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 invention can utilize the cap assembly and dual-chamber cartridge bottle to prepare and store various pharmaceutical preparations, 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 using freeze-drying technology.

[0142] Example

[0143] This invention 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 conventional reagent products.

[0144] Example 1

[0145] A bottle cap assembly includes a top stopper 3 and a top cap 4 for sealing a dual-chamber cartridge bottle 1. The structure of the dual-chamber cartridge bottle 1 is shown in Figure 1. The top stopper 3 is used to seal the bottle mouth of the dual-chamber cartridge bottle 1. The dual-chamber cartridge bottle 1 achieves the sealing of the bottle mouth 10 by the top stopper 3 through a stopper assembly. The stopper assembly includes a pressing fixture 21 and a retaining fixture 20, the structure of which is shown in Figure 2A. The dual-chamber cartridge bottle 1 has a bottle mouth 10, a bottle neck 11, a bottle body 12, and an inner cavity 13 extending from the bottle mouth to the bottle body. The top stopper has a stopper cap 30 and a stopper post 31. The stopper post 31 needs to be fully embedded into the opening 100 at the center of the bottle mouth 10, and the lower surface of the stopper cap 30 needs to be fully fitted with the upper surface of the bottle mouth 10 in order to achieve a seal on the bottle mouth 10.

[0146] Therefore, in this embodiment, a stopper assembly is used to seal the bottle opening 10 using the top stopper 3. Specifically,

[0147] (1) First, the stopper assembly includes a retaining fixture 20, which is open at both the upper and lower ends. The inner wall of the retaining fixture 20 is attached to the outer surface of the bottle mouth 10 and the bottle body 12. The retaining fixture 20 is pressed until it is completely attached to the upper end of the bottle body 12. The retaining fixture 20 is tightly attached to the bottle mouth 10 and the bottle body 12, and has a large friction force. Therefore, the retaining fixture 20 is not easy to fall off the double-cavity cartridge bottle 1. In addition, the upper end of the retaining fixture 20 protrudes from the bottle mouth 10.

[0148] Next, the top plug 3 is placed in the retaining fixture 20. Specifically, the top plug is placed on the upper end of the retaining fixture 20, protruding from the protrusion 200 of the retaining fixture 20. The protrusion 200 can support the stopper cap 30 to fix the position of the top plug 3, so that the stopper 31 is aligned with the bottle opening 100, so as to facilitate the insertion of the stopper 31 into the bottle opening 100 when it moves down. In particular, there are two protrusions 200, which are respectively provided on both sides of the upper end of the retaining fixture 20.

[0149] Then, the inner wall of the pressing fixture 21 of the stopper assembly is pressed against the outer wall of the holding fixture 20 and slid downward. The lower end of the pressing fixture 21 is open, the upper surface is closed and the center is concave downward. A pressing post 210 protruding along the axis of the pressing fixture 21 is provided on one side of the inner wall of the concave part. During the downward sliding of the pressing fixture 21, the pressing post 210 can contact and apply downward pressure to the stopper cap 30 to realize the pressing of the top stopper 3 as a whole towards the bottle mouth 10 until the stopper post 31 is completely embedded in the bottle mouth 10. After the stopper post 31 is completely embedded in the bottle mouth 10, the stopper cap 30 can be just locked at the lower end of the protrusion 200. Therefore, the protrusion 200 can further lock the top stopper 3 to prevent it from falling off. It is important to note that before the stopper 31 is fully embedded in the bottle neck 10, the height of the retaining fixture 20 protruding from the bottle neck 10 is less than the height of the outer side of the upper surface of the pressing fixture 21 protruding from the bottle neck 10. Therefore, before the stopper 31 is fully embedded in the bottle neck 10, the pressing fixture 21 will not be obstructed by the retaining fixture 20 and will not be able to move downward, thus avoiding incomplete engagement between the top stopper 3 and the bottle neck 10. In particular, there are two pressing rods 210, which are respectively arranged on both sides of the inner wall of the recess on the upper surface of the pressing fixture 21 to apply a uniform downward pressure to the top stopper 3.

[0150] Finally, remove the pressing fixture 21 and the retaining fixture 20. The stopper assembly is only used to seal the bottle mouth 10 with the top stopper 3. Therefore, it needs to be removed after sealing so that the subsequent capping can be sealed.

[0151] (2) Use the top cover 4 to fix the top plug 3 and seal the bottle mouth 10 of the double-cavity cartridge bottle 1 through the top plug 3. The structure of the top cover 4 is shown in Figure 3. It includes a main body and a base plate 41. The main body has a top plate 400 located at the center of the upper end of the top cover 4 and an annular thread 401 located at the upper edge of the top cover 4. It is set above the base plate 41. The bottom of the base plate 41 is an opening. After the top plug 3 is fully embedded in the bottle mouth 10, the top cover 4 is pressed down and put on the bottle mouth 10. During this process, the inner wall of the main body and the base plate 41 fits against the bottle mouth 10 and the bottle neck 11. Therefore, after pressing the top cover 4 until the base plate 41 is fully fitted with the upper surface of the bottle body 12, there is a large friction between the top cover 4 and the double-cavity cartridge bottle 1, which can prevent the top cover 4 from falling off and improve the sealing performance of the double-cavity cartridge bottle 1.

[0152] The top plate 400 has a double-layer structure. The upper layer is a hollow cylinder, and the lower layer is a cylinder with an inner diameter equal to the inner diameter of the hollow part of the upper hollow cylinder. After the bottom plate 41 is completely attached to the upper surface of the bottle body 12, the top plate 400 can support the top plug 3 embedded in the bottle mouth 10 through the lower cylinder, so as to prevent the top plug 3 from falling out of the bottle mouth 10 and improve the airtightness of the double-cavity cartridge bottle 1.

[0153] Example 2

[0154] A bottle cap assembly includes a top stopper 2'' and a top cap 3' for sealing a dual-chamber cartridge bottle 1'. The structure of the top cap 3' is shown in Figure 5A. The dual-chamber cartridge bottle 1' achieves a seal between the top stopper 2' and the bottle opening 10' through the top cap 3', and also seals the bottle opening 10' of the dual-chamber cartridge bottle 1' through the top stopper. Specifically,

[0155] 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.

[0156] Then, after the freeze-drying is completed, the top cap 3' is pressed down to fit into the bottle 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 set 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 cap 2' is initially inserted into the bottle mouth 10', the top cap 3' is pressed down until the upper end 30' is completely fitted onto the bottle mouth 10'. During this process, the inner wall of the upper end 30' fits against the bottle mouth 10' and the bottle neck 11', while the inner walls of the middle end 31' and the lower end 32' fit against the bottle body 12'.

[0157] The top plate 300' is a hollow cylindrical structure with a shortened middle. 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', which has a diameter 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 to participate in the 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 freeze-drying technology.

[0158] Specifically, when the top cap 3' is configured to press the top plug 2' to be fully embedded in the bottle mouth 10', the inner wall of the upper surface of the middle end 31' can also be fully fitted 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'.

[0159] The upper end 30' has a diameter of 7.3 mm, and a gap 200' is left between it and the stopper cap 20' with a diameter of 7.0 mm; the upper end 30' also has a top stopper positioning point 303', as shown in Figures 7A and 8. The top stopper positioning point 303' is located below the top plate 300' 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 inserted into the bottle mouth 10', the top stopper positioning point 303' fits against the stopper cap 20', and the stopper cap 20' is subjected to pressure from the top stopper positioning point 303' in the direction of 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 poor fitting. There are 4 top stopper positioning points 303', which are evenly distributed on the inner wall of the upper end 30'.

[0160] The upper end 30' also has a protrusion 304', as shown in Figure 9. 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-chamber cartridge bottle 1'. The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is set to 0.15 mm, 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'.

[0161] The lower end 32' is cylindrical in shape. The protruding ring 310' of the middle end 31' and the protruding strip 320' of the lower end 32' can both be used to 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', thereby further improving the stability of the fit between the top cover 3' and the double-cavity cartridge bottle 1'.

[0162] When the cap assembly was subjected to a stopper and cap sealing test, 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 out from the double-chamber cartridge bottle 1' with a small force.

[0163] Example 3

[0164] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.25 mm, and the other structures and parameters are the same as in Embodiment 2. A stopper and cap sealing test was performed on the bottle cap assembly. 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 opening 10' of the double-chamber cartridge bottle 1' was still not firm enough and could be easily pulled out.

[0165] Example 4

[0166] The shape of the protrusion 304' is replaced with a trapezoid, wherein the upper chamfer of the surface of the protrusion 304' facing the axis of the top cover 3' is 45°, and the lower chamfer of 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 0.30 mm, and the number of top plug positioning points 303' is replaced with 8, as shown in Figure 7B. Other structures and parameters are the same as in Embodiment 2.

[0167] When the cap assembly was tested for compression and sealing, the number of top stopper positioning points 303' was increased, thereby improving the fit between the top stopper 2' and the top cap 3', and the top stopper 2' no longer slipped off the top cap 3'; the capping process requires very high pressure, which caused deformation and damage to part of the structure of the top cap 3'.

[0168] Example 5

[0169] The upper chamfer of the face of the protrusion 304' facing the axis of the top cap 3' is replaced with 30°, as shown in Figure 10. Other structures and parameters are the same as in Embodiment 4. 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 from the top cap 3'. 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 structure of the top cap 3', which still had a certain impact on the sealing performance of the top cap 3'.

[0170] Example 6

[0171] The upper chamfer of the face of the protrusion 304' facing the axis of the top cap 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 4. The cap assembly was subjected to a stopper and capping sealing test. 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 upper chamfer of the face of the protrusion 304' facing the axis of the top cap 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 does not require a large pressure. However, the fit between some top caps 3' and the bottle mouth 10' of the double-chamber cartridge bottle 1' is not firm enough, and they can be pulled out after applying a certain force.

[0172] Example 7

[0173] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.15 mm, and the other structures and parameters are the same as in Example 6. 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 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 0.15 mm, the capping process did not require a large pressure, but the fit between some of the top caps 3' and the bottle opening 10' of the double-chamber cartridge bottle 1' was still not firm enough, and they could still be pulled out after applying a certain force.

[0174] Example 8

[0175] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.20 mm, and the other structures and parameters are the same as in Example 6. 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 0.20 mm, the capping process did not require a large pressure, and the fit between the top cap 3' and the bottle mouth 10' of the double-chamber cartridge bottle 1' was improved. The fit was more secure, and it was less likely to be pulled out after applying greater force, with only occasional instances of pull-out.

[0176] Example 9

[0177] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.23 mm, and the other structures and parameters are the same as in Example 6. 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 0.23 mm, a certain amount of pressure was required during the capping process, but no deformation or damage was caused to the top cap 3'. 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.

[0178] Example 10

[0179] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.25 mm, and the other structures and parameters are the same as in Example 6. 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 no deformation or damage was caused 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 also significantly improved, and it was not pulled out after applying a large force.

[0180] Example 11

[0181] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.28 mm, and the other structures and parameters are the same as in Example 6. 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.

[0182] Example 12

[0183] The structure of the top cap 3' of the bottle cap assembly in Example 9 is adjusted to reduce the volume of the top cap 3', as shown in FIG5B. Specifically, the length of the portion of the top cap 3' extending along the neck 11' and the bottle body 12' in Example 3 is shortened, the length of the middle end 31' is shortened, and the position of the convex ring 310' relative to the neck 11' and the bottle body 12' is further moved upward and fitted to 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', and the upper part of the lower end 32' near the middle end 31' is shortened radially to form the first convex opening 321'.

[0184] 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 11. The number of top stopper positioning points 303' is 8, which are evenly distributed on the inner wall of the upper end 30'.

[0185] A stopper and capping sealing test was conducted 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 structure of 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.

[0186] Example 13

[0187] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.25 mm, and the other structures and parameters are the same as in Example 12. 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 double-chamber cartridge bottle 1' was significantly improved, and it was not pulled out after applying a large force.

[0188] Example 14

[0189] The structure of the top plate 300' of the top plug 2' and top cap 3' in the bottle cap assembly of Example 13 is adjusted to improve the degree of restriction of the top plug 2' by the top plate 300' when it is pre-assembled into the top cap 3', as shown in Figure 6. Specifically, the top plug 2' has a sealing portion 22' that protrudes upward along the axial direction of the top plug 2' on the upper surface of its cap 20'. The shape of the top plate opening is circular, the shape of the sealing portion 22' is cylindrical, its radial length L' = 3.6 mm, the shape of the top plate opening is circular, its circumference and lower edge inner diameter is 3.4 mm, and the tilt angle β' of the top plate opening is 5°. The other structures and corresponding parameters of the top plug 2' and top cap 3' are the same as in Example 12.

[0190] Example 15

[0191] A bottle cap assembly includes a top stopper 2' and a top cap 3' for sealing a dual-chamber cartridge bottle 1'. The structure of the top cap 3' is shown in Figure 13A. The top cap 3' achieves a seal between the top stopper 2' and the bottle opening 10' of the dual-chamber cartridge bottle 1', and also seals the bottle opening 10' of the dual-chamber cartridge bottle 1' through the top stopper. Specifically:

[0192] First, the top stopper 2` is positioned inside the top cover 3` through 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.

[0193] 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' and a base 31'. 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'. The bottom of the base 31' is an opening. 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 wall of the base 31' partially fits against the bottle body 12'.

[0194] The top plate 300' is a hollow cylindrical structure with a shortened middle. 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', which has a diameter 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 to participate in the 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 freeze-drying technology.

[0195] Specifically, when the top cover 3' is set to press the top plug 2' to be fully embedded in the bottle mouth 10', the inner wall of the base 31' can also partially fit with the top of the bottle body 12'; therefore, while the top cover 3' seals the bottle mouth opening 100' with the top plug 2', the top cover 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'.

[0196] The upper end 30' has a diameter of 7.3 mm, and a gap 200' is left between it and the stopper cap 20' with a diameter of 7.0 mm; the upper end 30' also has a top stopper positioning point 303', as shown in Figures 17, 15A and 15B. The top stopper positioning point 303' is located below the top plate 300' 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 inserted into the bottle mouth 10', the top stopper positioning point 303' fits against the stopper cap 20', and the stopper cap 20' is subjected to pressure from the top stopper positioning point 303' in the direction of 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 poor fitting. There are 4 top stopper positioning points 303', which are evenly distributed on the inner wall of the upper end 30'.

[0197] The upper end 30' also has a protrusion 304', which 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 0.20 mm, the shape of the protrusion 304' is set to trapezoidal, the number is 2, and it is distributed on both sides of the inner wall of the upper end 30'. The upper and lower chamfers of its surface in the direction of the axis of the top cover 3' and its side surface are both 30°. The base 31' is cylindrical in shape. A stopper and capping seal test was conducted on the cap assembly. It was found that the top stopper 2' and the top cap 3' fit well, and the top stopper 2' did not slip off from the top cap 3'. The capping process did not cause deformation of the top cap 3', and the top cap 3' and the dual-chamber cartridge bottle 1 were well-fitted and fixed, with only occasional instances of detachment.

[0198] Example 16

[0199] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.23 mm, and the remaining structure and parameters are the same as in Example 15. The bottle cap assembly was subjected to stopper sealing and capping sealing tests. 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, the capping process did not cause deformation of the top cap 3', and the top cap 3' did not fall off.

[0200] Example 17

[0201] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.25 mm, and the remaining structure and parameters are the same as in Example 15. The bottle cap assembly was subjected to stopper sealing and cap sealing tests. 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, the capping process did not cause deformation of the top cap 3', and the top cap 3' did not fall off.

[0202] Example 18

[0203] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.28 mm, and the remaining structure and parameters are the same as in Example 15. The bottle cap assembly was subjected to stopper sealing and capping sealing tests. 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 did not cause deformation of the top cap 3', and the top cap 3' did not fall off.

[0204] Example 19

[0205] The structure of the top cap 3' of the bottle cap assembly in Example 17 is adjusted to increase the volume of the top cap 3', as shown in Figure 13B. Specifically, the base 31' of Example 16 is extended downward along the bottle body 12' so that the extended base 31' can seal at least a portion of the bottle body 12'. It should be noted that the shape of the downwardly extending base 31' is set as an octagonal prism, and the structure of the adjusted top cap 3' is the same as before the adjustment, except for the base 31'. The number of top stopper positioning points 303' is 8, evenly distributed on the inner wall of the upper end 30'.

[0206] The cap assembly was subjected to stopper sealing and capping sealing tests. 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 structure of 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.

[0207] Example 20

[0208] The structure of the top plate 300' of the top plug 2' and top cap 3' of the bottle cap assembly in Example 19 is adjusted to improve the tightness of the top plug 2' pre-assembly into the top cap 3'. Specifically, the top plug 2' has a sealing portion 22' that protrudes upward along the axial direction of the top plug 2' on the upper surface of its cap 20'. The shape of the top plate opening is circular with a lower edge diameter of 3.4 mm. The sealing portion 22' is cylindrical with a radial length L' = 3.6 mm, as shown in Figure 14A. The inclination angle β' from the lower edge to the upper edge of the top plate opening is 5°. Other structures and parameters are the same as in Example 18.

[0209] Example 21

[0210] The structure of the top plate 300' of the top cap 3' of the bottle cap assembly in Example 20 is adjusted so that the sealing portion 22' can more effectively engage with the opening of the top plate during the capping process. Specifically, an engaging portion 306' is provided on the side of the top plate opening near the top plug 2', and the engaging portion 306' is a chamfer along the middle of the top plate opening toward the side of the top plate opening near the top plug 2'. During capping, the edge of the sealing portion 22' can slide along the engaging portion 306' to more easily insert into the top plate opening, as shown in FIG14B. Correspondingly, the inclination angle β' from the circumferential lower edge to its upper edge of the top plate opening is no longer provided, and other structures and parameters are the same as in Example 19.

[0211] Example 22

[0212] The structure of the base 31' of the top cap 3' of the bottle cap assembly in Example 21 is adjusted to improve the tightness of the fit between the base 31' and the bottle body 12'. Specifically, four internal protrusions 310' are equidistantly arranged on the inner wall of the side of the base 31' away from the upper end 30', and openings 311' on both sides of each internal protrusion 310' are provided, as shown in Figure 13C. Other structures are the same as in Example 20. [Simplified Explanation of the Diagram]

[0061] The above and other objects, features, and advantages of this invention will become more apparent through a more detailed description of the embodiments of this invention in conjunction with the accompanying drawings. The drawings are used to provide a further understanding of the embodiments of this invention and form part of the specification. They are used together with the embodiments of this invention to explain this invention and do not constitute a limitation thereof. In the drawings, the same reference numerals generally represent the same components or steps.

[0062] Figure 1 illustrates a structural schematic diagram of the dual-chamber cartridge bottle 1 and the top stopper 3 of this invention. Figure 2A illustrates a structural schematic diagram of one type of stopper assembly of this invention. Figure 2B illustrates another structural schematic diagram of the stopper assembly of this invention. Figure 3 illustrates a structural schematic diagram of the top cap 4 of this invention. Figure 4 illustrates a structural schematic diagram of the dual-chamber cartridge bottle 1' and the top stopper 2' of this invention. Figure 5A illustrates a structural schematic diagram of the top cap 3' of this invention. Figure 5B illustrates another structural schematic diagram of the top cap 3' of this invention. Figure 6 illustrates another structural schematic diagram of the top stopper 2' and yet another structural schematic diagram of the top cap 3' of this invention. Figure 7A illustrates a structural schematic diagram of the top stopper positioning point 303' of this invention. Figure 7B illustrates another structural schematic diagram of the top stopper positioning point 303' of this invention. Figure 8 illustrates a structural schematic diagram of the upper end 30' of this invention. Figure 9 illustrates a structural schematic diagram of the maximum length of the protrusion 304' of this invention. Figure 10 illustrates a structural schematic diagram of the upper and lower chamfers of the protrusion 304' of this invention. Figure 11 illustrates a structural schematic diagram of the dual-cavity cartridge bottle packaging assembly of this invention. Figure 12 illustrates a structural schematic diagram of the dual-cavity cartridge bottle 1' and top stopper 2' of this invention. Figure 13A illustrates a structural schematic diagram of the top cap 3' of this invention. Figure 13B illustrates another structural schematic diagram of the top cap 3' of this invention. Figure 13C illustrates yet another structural schematic diagram of the top cap 3' of this invention. Figure 14A illustrates another structural schematic diagram of the top stopper 2' and yet another structural schematic diagram of the top cap 3' of this invention. Figure 14B illustrates a structural schematic diagram of the fitting part 306' of the top cap 3' of this invention. Figure 15A illustrates a structural schematic diagram of the top stopper positioning point 303' of this invention. Figure 15B illustrates another structural schematic diagram of the top stopper positioning point 303' of this invention. Figure 15C illustrates a top view of the demolding hole 305' of this invention. Figure 16 illustrates a structural schematic diagram of the demolding hole 305' of this invention. Figure 17 illustrates a structural schematic diagram of the upper end 30' of this invention. Figure 18 illustrates the structural schematic diagram of the maximum length, upper chamfer, and lower chamfer of the protrusion 304' in this case. Figure 19 illustrates the structural schematic diagram of the dual-cavity cartridge bottle packaging material assembly in this case.

Claims

1. A bottle cap assembly for sealing a dual-chamber cartridge bottle, the dual-chamber cartridge bottle comprising: The bottle has an inner cavity, a bottle body, a neck, and a mouth; the cap assembly includes a top stopper and a top cap; the top stopper seals the mouth of the dual-cavity cartridge bottle; the top stopper is pressed into the dual-cavity cartridge bottle by a stopper assembly to achieve a seal; and the top cap is used to fix the top stopper and seal the mouth of the dual-cavity cartridge bottle; wherein the top cap includes a body and a base, the body having a top plate and annular threads, the inner wall of the top cap conforming to the mouth and the neck, and the base of the top cap completely conforming to the upper surface of the bottle body; wherein the stopper assembly includes a pressing fixture and a retaining fixture.

2. The bottle cap assembly as claimed in claim 1, wherein, The bottle neck has a central opening that connects to the inner cavity, and the inner diameter of the bottle neck opening is smaller than the inner diameter of the bottle neck and the bottle body; one side of the outer wall of the bottle body has a bypass.

3. The bottle cap assembly as claimed in claim 2, wherein, The top stopper includes a stopper cap and a stopper plunger. The diameter of the stopper plunger is slightly larger than the inner diameter of the bottle opening. After the stopper plunger is inserted into the bottle opening, the lower surface of the stopper cap is completely in contact with the upper surface of the bottle opening.

4. The bottle cap assembly as claimed in claim 2, wherein, The retaining fixture is configured such that its inner wall fits against the bottle opening and the bottle body, and its upper end protrudes from the bottle opening; and when the top plug moves toward the bottle opening, the inner wall of the pressing fixture fits against and slides against at least a portion of the outer wall of the retaining fixture.

5. The bottle cap assembly as claimed in claim 4, wherein, The retaining fixture is also provided with a protrusion that supports and fixes the top plug before it is inserted into the bottle neck, so that the plug of the top plug is aligned with the opening of the bottle neck; and the protrusion secures the top plug after it is inserted into the bottle neck.

6. The bottle cap assembly as claimed in claim 5, wherein, The number of protrusions is two or three or more.

7. The bottle cap assembly as claimed in any one of claims 1 to 6, wherein, The process of sealing the dual-chamber cartridge bottle by pressing the top plug with the stopper assembly includes the following steps: placing the top plug in the retaining fixture by fitting it against the outer wall of the bottle opening of the dual-chamber cartridge bottle to position the top plug relative to the bottle opening of the dual-chamber cartridge bottle; pressing the top plug with the pressing fixture to fit it into the bottle opening of the dual-chamber cartridge bottle; and removing the pressing fixture and the retaining fixture.

8. A bottle cap assembly for sealing a double-chamber cartridge bottle, wherein, The bottle cap assembly includes a top stopper and a top cap; the top stopper is positioned within the top cap for sealing the opening of the dual-chamber cartridge bottle; the top cap is used to press and secure the top stopper, thereby sealing the opening of the dual-chamber cartridge bottle and sealing the dual-chamber cartridge bottle; wherein the top cap includes an upper end, the upper end also having a protrusion that protrudes from the inner wall of the upper end toward the axis of the top cap; wherein the upper tangent angle between the surface of the protrusion toward the axis of the top cap and its side surface is 30°-45°.

9. The bottle cap assembly as claimed in claim 8, wherein, The dual-cavity cartridge includes: an inner cavity bottle body, a neck, and a bottle mouth. The bottle mouth has a central opening that connects to the inner cavity. The inner diameter of the bottle mouth opening is smaller than the inner diameter of the bottle mouth and the neck. One side of the outer wall of the bottle body has a bypass protrusion.

10. The bottle cap assembly as claimed in claim 9, wherein, 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 opening. After the stopper post is inserted into the bottle opening, the lower surface of the stopper cap is completely in contact with the upper surface of the bottle opening.

11. The bottle cap assembly as claimed in claim 9, wherein, The top cover also includes a middle end and a lower end; the upper end has a top plate, threads and an opening, the middle end has a raised ring, and optionally the lower end has a raised 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 center of the top plate has a top plate opening, and when the top cover moves toward the bottle mouth, the top plate at the upper end presses the top plug into the bottle mouth, so that the top plug is embedded in the bottle mouth.

12. The bottle cap assembly as claimed in claim 8, wherein, The top cover also includes a base plate; the upper end has a top plate, threads and an opening, and the inner wall of the top cover fits against the bottle opening; the center of the top plate has a top plate opening, and when the top cover moves toward the bottle opening, the top plate at the upper end presses the top plug into the bottle opening, so that the top plug is embedded in the bottle opening.

13. The bottle cap assembly as claimed in claim 11, wherein, The top stopper also includes: a stopper cap and 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 inserted into the bottle neck, the sealing portion protrudes longitudinally from the top plate opening of the top plate.

14. The bottle cap assembly as claimed in claim 12, wherein, The top stopper also includes: a stopper cap and 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 inserted into the bottle neck, the sealing portion protrudes longitudinally from the top plate opening of the top plate.

15. The bottle cap assembly as claimed in claim 14, wherein, The upper end also has a fitting part located on the side of the top plate opening of the top plate near the top plug. The sealing part cooperates with the fitting part to be inserted into the top plate opening of the top plate of the top cover.

16. The bottle cap assembly as claimed in claim 11 or 12, wherein, 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 top cover axis, and is used to fix the top plug that fits into the bottle mouth.

17. The bottle cap assembly as claimed in claim 16, wherein, The number of positioning points for the top plug is 4 or 5 or more.

18. The bottle cap assembly as claimed in claim 12, wherein, The upper end also has a demolding hole located at the connection between the top plate and the thread.

19. The bottle cap assembly as claimed in claim 18, wherein, The number of demolding holes is 4 or 5 or more.

20. The bottle cap assembly as claimed in claim 12, wherein, The chassis also has an internal protrusion located on the inner wall of the chassis on the side away from the upper end and protruding toward the axis of the top cover.

21. The bottle cap assembly as claimed in claim 20, wherein, The number of internal bumps is two or three or more.

22. The bottle cap assembly as claimed in claim 20, wherein, The chassis has openings on both sides of the protrusion along its edge away from the upper end.

23. The bottle cap assembly as claimed in claim 22, wherein, The number of openings on both sides of the bump is 4 or 6 or more.

24. The bottle cap assembly as claimed in claim 12, wherein, The lower end is shaped like a cylinder or an octagonal prism.

25. The bottle cap assembly as claimed in claim 24, wherein, The lower end is octagonal in shape.

26. The bottle cap assembly as claimed in claim 13, wherein, The chassis is cylindrical or octagonal.

27. The bottle cap assembly as claimed in claim 26, wherein, The chassis is octagonal in shape.

28. A dual-chamber cartridge packaging material for injection, comprising a cap assembly and a dual-chamber cartridge as described in any one of claims 1 to 27.

29. An injection dual-chamber cartridge packaging assembly comprising the injection dual-chamber cartridge packaging and sheath as described in claim 28.

30. The packaging material assembly as claimed in claim 29, wherein, The lower end of the bottle cap assembly of the packaging material is octagonal prism in shape, the sleeve is octagonal prism in shape, its inner wall is octagonal, 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 sleeve; and the top of the inner wall of the sleeve has a horizontal protrusion, which is assembled with the lower end of the bottle cap assembly of the packaging material by interference fit, so as to further clamp the top stopper and the dual-chamber cartridge bottle with the lower end.

31. The packaging material assembly as claimed in claim 29, wherein, The base of the bottle cap assembly of the packaging material is octagonal prism in shape. The sleeve includes a sleeve body and a flange. The sleeve is octagonal prism in shape. The inner wall of the sleeve body is octagonal. 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 sleeve body. The top of the inner wall of the sleeve body has a horizontal protrusion. It is assembled with the base of the bottle cap assembly of the packaging material by interference fit to further clamp the top stopper and the dual-chamber cartridge bottle with the base.

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