Vial cap assembly

Abstract

Disclosed in the present application is a vial cap assembly for sealing a dual-cavity cartridge vial, comprising a top stopper and a top cap, wherein the top stopper is pressed by means of a stoppering assembly to engage with the dual-cavity cartridge vial, thus sealing the dual-cavity cartridge vial, and the top cap fixes the top stopper and provides a hermetic closure for a vial mouth of the dual-cavity cartridge vial; the stoppering assembly comprises a press-fitting jig and a holding jig. Within a freeze dryer, by means of the stoppering assembly, the vial cap assembly and the dual-cavity cartridge vial disclosed in the present application can realize high-precision self-stoppering sealing with good hermeticity, while reducing the time cost and operational complexity required for stoppering and capping of the dual-cavity cartridge vial during the overall freeze-drying process, improving freeze-drying efficiency and the quality of freeze-dried products.

Description

A bottle cap assembly TECHNICAL FIELD

[0001] The present application relates to the field of biopharmaceuticals or cosmetics or medical aesthetics, and more particularly, to a bottle cap assembly. BACKGROUND

[0002] Most of the freeze-dried products on the market use a vial as a drug container. Before injection, a sterile syringe is used to extract a reconstituting agent from another container containing the reconstituting agent, and then the reconstituting agent is injected into the drug container for reconstitution, extraction, and administration. The precision of administration and the use compliance are relatively poor. The dual-chamber cartridge bottle packaging can provide a better choice. The dual-chamber cartridge bottle is divided into two chambers by a middle plug. The front chamber is used to hold freeze-dried drugs, and the rear chamber is used to hold reconstituting agents. During use, the reconstituting agent can flow into the front chamber through a bypass to reconstitute the freeze-dried drugs by pushing the bottom plug. After complete dissolution, the bottom plug is pushed to the top to complete the injection process. The dual-chamber cartridge bottle is an innovative drug packaging in the global biopharmaceutical or cosmetic or medical aesthetic field. It has the advantages of compatibility with various drug administration devices, convenience of use, patient safety, and high compliance, and has a very wide application prospect.

[0003] However, the existing dual-chamber cartridge bottle packaging cannot complete the integrated sealing operation process in the freeze-dryer. Therefore, an innovative packaging material that can achieve integrated sealing in the cavity of the freeze-dryer is needed to meet the sealing requirements of the freeze-drying process, so that the packaging material can meet future drug administration methods. The container holding device disclosed in CN112550910A has high sealing performance, but it cannot meet the requirement of self-sealing after the product moisture is sublimated and discharged from the container (mainly gas) during freeze-drying. Therefore, this type of packaging material cannot be directly applied in the freeze-drying process, and an additional capping step may be required, which increases the time cost and may affect the freeze-drying effect of the drugs in the container during container transfer.

[0004] CN115214989A discloses a container closure device capable of being installed on the neck of a container, which includes an outer cap, an inner cap, and a closure chamber member. An inclined buckle and a positioning stopper structure are adopted to enable the outer cap and the inner cap to rotate relative to each other without longitudinal displacement. However, the outer cap and the container neck, and the inner cap and the outer cap are limited and sealed by the inclined buckle and the threaded cooperation before and after capping, respectively. Therefore, when the container is sealed in the freeze-dryer, uneven force may be applied due to uneven placement of the container, causing the inner cap and / or the outer cap to tilt. After tilting, it may be difficult to press the tilted side normally by the continued force of the components in the freeze-dryer. In addition, the cooperation and fixation between the inner cap and the outer cap cannot be completed in the freeze-dryer.

[0005] Further, CN108820429A discloses an injection bottle combination structure, a cover opening of the bottle cap is provided with a clamping jaw matched with a first clamping groove and a second clamping groove of the bottle body, the first clamping groove is relatively shallow, so that the bottle cap is easy to adjust when it is inclined and not completely sealed, and the process of continuously pressing the clamping jaw to the second clamping groove is more stable. However, the bottle cap has weak limiting ability due to the first clamping groove, and is easy to slip when the moisture in the preparation is discharged from the gap between the bottle opening and the rubber plug during freeze-drying, so that the rubber plug at least partially seals the bottle opening, resulting in reduced drainage efficiency, which will affect the quality of the freeze-dried powder injection product to some extent. As can be seen from the above, during the semi-sealing process of the bottle opening during freeze-drying, the limiting of the bottle cap cannot be too firm, nor can it be easily loosened.

[0006] In addition, the existing double-cavity clamp type bottle packaging material also has the problems of lack of anti-rotation structure, excessive buckling force and injection needle core taking when obtaining the freeze-dried product and cooperating with the injection needle. In the following, the double-cavity clamp type bottle packaging material according to the present application will provide a feasible solution to the above problems.

[0007] Therefore, there is an urgent need for a bottle cap assembly that can solve the above problems and stably match the double-cavity clamp type bottle, so as to stably self-press and seal in the cavity of the freeze-dryer, improve the freeze-drying efficiency and quality of the freeze-dried product, fill the gap in the field of double-cavity clamp type bottle packaging materials in China, and improve the core competitiveness of the product. SUMMARY

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

[0009] According to an aspect of the present application, a bottle cap assembly is provided, which can include a top plug and a top cap for sealing a double-cavity clamp type bottle. The top plug seals the bottle opening of the double-cavity clamp type bottle; the top plug is pressed by a press-in jig and a holding jig to be embedded with the double-cavity clamp type bottle, so as to achieve sealing of the double-cavity clamp type bottle; the top cap is used to fix the top plug and seal the bottle opening of the double-cavity clamp type bottle.

[0010] In some embodiments of the present application, the double-cavity clamp type bottle can include an inner cavity, a bottle body, a bottle neck and a bottle opening, the center of the bottle opening can be provided with a bottle opening opening connected with the inner cavity, the inner diameter of the bottle opening opening is smaller than the inner diameter of the bottle opening and the bottle neck; the side outer wall of the bottle body can have a bypass. When the double-cavity clamp type bottle is placed on the freeze-drying support, the upper opening of the freeze-drying support is larger than the lower opening, so that the upper opening is convenient for the insertion of the bypass, and the lower opening can appropriately fix the double-cavity clamp type bottle, so that it is not easy to fall off from the fixing module, so as to avoid the inclination or falling of the double-cavity clamp type bottle during freeze-drying.

[0011] In some embodiments of the present application, the top plug can include a plug cap and a plug column, the diameter of the plug column is slightly larger than the inner diameter of the bottle opening of the bottle mouth, and the lower surface of the plug cap is completely fitted with the upper surface of the bottle mouth after the plug column is embedded in the bottle opening. Because the diameter of the plug column is slightly larger than the inner diameter of the bottle opening, the pressure provided by the pressure plug assembly needs to be greater than the pressure between the outer wall of the plug column and the inner wall of the bottle opening when the top plug is pressed by the pressure plug assembly; after the top plug is embedded in the bottle mouth of the double-cavity carton bottle, the top plug will not be affected by external forces such as gravity and centrifugal force due to the friction between the plug column and the bottle opening, so as to ensure the safe sealing of the freeze-dried medicine in the double-cavity carton bottle.

[0012] In some embodiments of the present application, the pressure-in tool can be a column with an opening at the bottom and a recess at the center of the upper surface, and a protruding pressure column can be arranged on the inner wall of the lower part of the pressure-in tool; when the top plug moves towards the bottle mouth, the pressure column presses the top plug to move towards the bottle mouth, so that the top plug is embedded in the bottle mouth.

[0013] In some embodiments of the present application, the number of pressure columns is two or more. The pressure columns are uniformly distributed on the inner wall of the lower part of the pressure-in tool, and when the top plug moves towards the bottle mouth, the pressure columns can provide uniform downward pressure to the plug cap, so that the top plug positioned by the holding tool is horizontally embedded in the bottle mouth, and the edges of the top plug are not easy to be raised or sunken during embedding, which helps to maintain the accuracy of the pressure plug.

[0014] In some embodiments of the present application, the holding tool is arranged such that its inner wall is fitted with the bottle mouth and the bottle body, and its upper end protrudes from the bottle mouth; and when the top plug moves towards the bottle mouth, the inner wall of the pressure-in tool is fitted with and slides along at least part of the outer wall of the holding tool. The fitting and sliding of the pressure-in tool and the holding tool during the pressure plug process enable the pressure-in tool to press the top plug in the vertical direction of the outer wall of the holding tool, which ensures the stability of the movement of the pressure-in tool itself and makes the pressure columns always provide vertical pressure to the plug cap, thereby further improving the accuracy of the pressure plug.

[0015] In some embodiments of the present application, the holding tool can also be provided with a protruding part, which holds and fixes the top plug before the top plug is embedded in the bottle mouth, so that the plug column is aligned with the opening of the bottle mouth; and the protruding part clamps the top plug after the top plug is embedded in the bottle mouth. The protruding part clamps the top plug after the top plug is embedded in the bottle mouth, which is used to avoid the top plug from being in an abnormal embedded state after being embedded in the bottle mouth, such as the outer edge of the plug cap being raised or part of the outer edge being sunken into the bottle opening, or the plug column of the top plug not being completely embedded in the bottle opening. Therefore, the holding tool also helps to fine-tune the embedding of the top plug, further improving the accuracy of the pressure plug.

[0016] In some embodiments of the present application, the number of protrusions is two or more. The protrusions extend radially along the inner wall of the holding jig and are evenly spaced circumferentially. When the stopper is forced to move towards the bottle mouth, the cap can move uniformly towards the bottle mouth as a whole, and is less likely to move obliquely. In this way, the occurrence of stopper failure can be significantly reduced.

[0017] In some embodiments of the present application, the top cover can include a main body and a bottom disc. The main body can have a top disc and an annular thread. The inner wall of the top cover is in contact with the bottle mouth and the bottle neck. The bottom disc of the top cover is in complete contact with the upper surface of the bottle body. The main body of the top cover can be clamped into the bottle mouth by the top disc. After the bottom disc of the top cover is in contact with the upper surface of the bottle body, the top cover seals the bottle mouth, the bottle neck, and the connection between the bottle neck and the bottle body, thereby providing complete sealing of the bottle mouth with the stopper embedded therein, and increasing the sealing effect of the bottle mouth. The annular thread is used to engage with the thread of the sterile injection needle.

[0018] In some embodiments of the present application, the process of pressing the stopper into the bottle mouth of the dual-chamber vial via the pressing assembly to achieve sealing of the dual-chamber vial includes the following steps: placing the stopper in the holding jig to achieve positioning of the stopper relative to the bottle mouth of the dual-chamber vial by contacting the outer wall of the bottle mouth of the dual-chamber vial with the holding jig; pressing the stopper into the bottle mouth of the dual-chamber vial by the pressing jig; and removing the pressing jig and the holding jig. The step of placing the stopper in the holding jig to achieve positioning of the stopper relative to the bottle mouth of the dual-chamber vial means that the stopper is positioned by the holding jig and is not affected by gravity to slide off the bottle mouth, and then the stopper column blocks the bottle mouth. Therefore, the protrusions of the holding jig help to provide gas exchange and moisture sublimation for the dual-chamber vial.

[0019] According to another aspect of the present application, another bottle cap assembly is provided, which can include a stopper and a top cover for sealing a dual-chamber vial. The stopper is positioned in the top cover for sealing the bottle mouth of the dual-chamber vial. The top cover is used to press and fix the stopper so that the stopper seals the bottle mouth of the dual-chamber vial. The process of pressing and fixing the stopper by the top cover so that the stopper seals the bottle mouth of the dual-chamber vial includes the following steps:

[0020] The top plug is pre-assembled into the top cover; the top cover assembled with the top plug is placed above the bottle opening of the double-chamber carton bottle, and the top cover is pressed downward. After the top plug is pre-assembled into the top cover, the top plug is integrally formed with the top cover, and the top cover can be directly sealed by pressing the top plug without introducing a pressure plug assembly. In addition, by this way, the pressure plug assembly does not need to be additionally removed to provide further capping of the double-chamber carton bottle. The application of the top cover on the double-chamber carton bottle significantly reduces the operation steps and time required for self-pressure plug sealing and capping of the double-chamber carton bottle, improves the sealing efficiency of the double-chamber carton bottle in the freeze-drying process, and avoids the number of failed operations caused by more operation steps. When the failed operation cannot be remedied in the conventional way in the freeze-drying process, the self-pressure plug and capping integrated operation of the top cover is particularly important to ensure the efficiency of the freeze-drying process.

[0021] In some embodiments of the present application, the double-chamber carton bottle can include an inner chamber, a bottle body, a bottle neck, and a bottle opening, the center of the bottle opening can be provided with a bottle opening opening connected with the inner chamber, the inner diameter of the bottle opening opening is smaller than the inner diameter of the bottle opening and the bottle neck; the side outer wall of the bottle body can have a bypass protrusion. After the double-chamber carton bottle completes the freeze-drying process and is placed in the sheath, the bypass protrusion of the bottle body can be clamped at the apex of the inner wall of the sheath, so that the double-chamber carton bottle will not rotate along its longitudinal axis when it is stored in the sheath under the action of external force. During the engagement or disengagement of the injection needle with the double-chamber carton bottle, the injection needle needs to be rotated on the threaded structure of the double-chamber carton bottle, therefore, the double-chamber carton bottle is fixed by the bypass protrusion to prevent rotation, which can avoid the co-rotation of the injection needle and the double-chamber carton bottle, and further avoid the idling of the injection needle, thereby realizing the efficient screwing and dismounting of the injection needle on the double-chamber carton bottle.

[0022] In some embodiments of the present application, the top plug can include a plug cap and a plug column, the diameter of the plug column is equal to or slightly larger than the inner diameter of the bottle opening opening of the bottle opening, and after the plug column is embedded in the bottle opening opening, the lower surface of the plug cap completely matches the upper surface of the bottle opening.

[0023] In some embodiments of the present application, the top cover can include an upper end, a middle end, and a lower end; the upper end can have a top disc, a thread, and an opening, the middle end can have a convex ring, and the lower end can have a convex strip, the inner wall of the top cover matches the bottle opening, the bottle neck, and at least part of the bottle body; when the top cover moves towards the bottle opening, the top disc of the upper end presses the top plug to move inwardly to the bottle opening, so that the top plug is embedded in the bottle opening. The center of the top disc has a top disc opening, the upper end of the top cover fixes the pre-assembled top plug through the top disc, and the top plug is further clamped after being embedded in the bottle opening.

[0024] The middle end, the lower end and the outer wall of the bottle body are attached, and the top cover can seal the bottle opening, the bottle neck and at least a part of the bottle body as a whole, thereby providing complete sealing of the bottle opening with the top plug embedded therein, and increasing the sealing effect of the bottle opening. When the lower end has protrusions, the protrusions are radially contracted between them, making the lower end more tightly attached to the bottle body, further preventing the top cover from loosening and slipping off, and increasing the sealing effect of the double-cavity carton bottle. The protruding ring is used to match the sheath, and the opening is beneficial to the sublimation of water in the product from the double-cavity carton bottle, so as to further reduce the water content of the freeze-dried product in the double-cavity carton bottle in the freeze-drying process. The threads are used to engage with the threads of the sterile injection needle.

[0025] In some embodiments of the present application, the top plug can further include: a sealing portion protruding above the cap, the sealing portion being inserted into the top disc opening of the top disc of the top cover, and the sealing portion of the top plug protruding longitudinally out of the top disc opening of the top disc when the top plug is embedded in the bottle opening. During the pre-assembly of the top plug into the top cover, the sealing portion can be embedded in the top disc opening, the edge portion thereof being tightly attached to the circumferential outer edge of the top disc opening, and finally partially protruding above the upper edge of the top disc opening. By inserting and embedding the sealing portion into the top disc opening during the pre-assembly of the top plug, and cooperating with the top plug positioning point to limit the cap, the top plug can be more stably fixed in the top cover. Therefore, the external force applied to the top cover in actual production, such as shaking, hanging, etc., will not affect the fixation of the top plug in the top cover, thereby avoiding the top plug from falling off the top cover 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 cover, and after the injection needle is inserted into the top plug, the volume of the injection needle under pressure extends into the gap at the outer edge, which can prevent the pressure from concentrating on the sealing portion, thereby preventing the injection needle from taking core.

[0026] In some embodiments of the present application, the upper end of the top cover can further have a top plug positioning point protruding from the inner wall of the upper end towards the axis of the top cover, for fixing the top plug embedded in the bottle opening. Through the further fixation of the top plug by the top plug positioning point, the sealing stability of the top plug is improved.

[0027] In some embodiments of the present application, the number of top plug positioning points is 4 or more than 5. The top plug positioning points are uniformly arranged on the inner wall of the upper end along the radial direction of the top cover and are circumferentially spaced, which can provide uniform fixing force to the top plug. When the top plug tends to slip, it is difficult for the top plug to displace in any direction more than in other directions, so the top plug is more difficult to slip out of the bottle opening. In addition, the top plug positioning points can also be used for positioning the top plug before it is pressed into the bottle opening, and the top plug is limited by the top plug positioning points to avoid it from slipping into the bottle opening by itself.

[0028] In some embodiments of the present application, the upper end of the top cover can further be provided with a protrusion on the inner wall thereof, which protrudes towards the axis of the top cover. The top cover can be limited by the protrusion on the bottle mouth before the capping, so that the sublimation moisture in the inner cavity is discharged through the opening. Therefore, the provision of the protrusion helps to provide gas exchange and moisture discharge for the double-cavity carton bottle. After the top plug is pressed into the bottle mouth, the top cover is simultaneously capped and fixed. The protruding structure of the protrusion makes the upper end fit the bottle mouth more tightly, which is conducive to maintaining the fixation of the top cover on the bottle mouth after capping, and improves the stability of the capping seal.

[0029] In some embodiments of the present application, the number of protrusions is 2 or more than 3. Preferably, the maximum length of the protrusion protruding towards the axis of the top cover is 0.10-0.30 mm. Similarly, the protrusions are uniformly arranged in the circumferential direction on the inner wall of the upper end, so that the upper end uniformly fits the bottle mouth, and the top cover cannot slip from a certain side, further improving the stability of the fixation of the top cover on the double-cavity carton bottle.

[0030] In some embodiments of the present application, the shape of the protrusion is trapezoidal, semicircular, semi-elliptical or rectangular. Preferably, the shape of the protrusion is trapezoidal. When the shape of the protrusion is trapezoidal, the upper cutting angle between the surface of the protrusion towards the axis of the top cover and the side surface thereof is preferably 30-45°, and further preferably, the upper cutting angle is 30°. When the shape of the protrusion is trapezoidal, the lower cutting angle between the surface of the protrusion towards the axis of the top cover and the side surface thereof is further preferably 30°. When the shape of the protrusion is trapezoidal, the upper end fits the bottle mouth more tightly, and the top cover can be highly stably fitted on the double-cavity carton bottle. When the upper cutting angle between the surface of the protrusion towards the axis of the top cover and the side surface thereof is 30° and the lower cutting angle is 30°, the capping process of the top cover will not cause damage to the structure of the top cover due to excessive capping force, and the highly fitting of the top cover on the double-cavity carton bottle can be maintained, thereby improving the capping efficiency and capping accuracy in the freeze-drying process.

[0031] In some embodiments of the present application, the shape of the lower end is cylindrical or octagonal. Preferably, the shape of the lower end is octagonal, which has an octagonal surface structure. After the double-cavity carton bottle is placed in the sheath with the octagonal structure, the lower end can match and fit with the octagonal inner wall of the sheath. This fitting mode of the lower end and the sheath can fix the double-cavity carton bottle inside the sheath, so that the double-cavity carton bottle and the bottle cap assembly cannot rotate along the longitudinal axis thereof due to external force, thereby ensuring the efficient screwing and removal of the sterile injection needle on the double-cavity carton bottle package.

[0032] According to another aspect of the present application, there is provided a double-cavity carton bottle package for injection, which comprises the bottle cap assembly and the double-cavity carton bottle provided by the present application.

[0033] According to another aspect of the present application, a dual-chamber carton bottle package assembly for injection is also provided, which comprises the dual-chamber carton bottle assembly and the sheath provided by the present application. The sheath can cooperate with and fix the lower end and the bypass protrusion of the dual-chamber carton bottle package assembly.

[0034] In some embodiments of the present application, the lower end of the bottle cap assembly of the package assembly is in the shape of an octagonal prism, the sheath is in the shape of an octagonal prism, the inner wall of the sheath is octagonal, and the bypass protrusion of the dual-chamber carton bottle of the package assembly is located at the vertex of the octagonal inner wall of the sheath; and the top of the inner wall of the sheath has a protrusion in the horizontal direction, which is assembled with the lower end of the bottle cap assembly of the package assembly by interference fit to further clamp the stopper and the dual-chamber carton 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 exert pulling force on each other, thereby clamping the dual-chamber carton bottle in the middle, which can make the stopper and the top cap more tightly embedded with the bottle opening and the bottle opening, respectively, and improve the sealing performance of the package assembly.

[0035] According to another aspect of the present application, a bottle cap assembly is provided, which can comprise a stopper and a top cap for sealing a dual-chamber carton bottle. The stopper is limited in the top cap for sealing the bottle opening of the dual-chamber carton bottle; the top cap is used to press and fix the stopper so that the stopper seals the bottle opening of the dual-chamber carton bottle; and the dual-chamber carton bottle is sealed; the top cap can comprise an upper end, and the upper end can have a top disc with a top disc opening in the center. The stopper can also comprise a sealing portion inserted into the top disc opening of the top disc. Wherein, the step of pressing and fixing the stopper so that the stopper seals the bottle opening of the dual-chamber carton bottle can comprise:

[0036] The stopper is pre-assembled into the top cap; the top cap with the stopper assembled is placed above the bottle opening of the dual-chamber carton bottle, and the top cap is pressed downward. After the stopper is pre-assembled into the top cap, the stopper is integrally formed with the top cap, and the pressure plug assembly does not need to be introduced, and the top cap can directly realize the pressure plug sealing by pressing the stopper. In addition, by this way, the pressure plug assembly does not need to be additionally removed to provide further pressure cover to the dual-chamber carton bottle. The application of the top cap to the dual-chamber carton bottle significantly reduces the operation steps and time required for the self-pressure plug sealing and pressure cover of the dual-chamber carton bottle, improves the sealing efficiency of the dual-chamber carton bottle in the freeze-drying process, and avoids the number of operation failures caused by more operation steps. When the failed operation is difficult to be remedied in the conventional way in the freeze-drying process, the self-pressure plug and pressure cover integrated operation of the top cap is particularly important to ensure the efficiency of the freeze-drying process.

[0037] In some embodiments of the present application, the upper end further has a fitting portion located on one side of the top disc opening of the top disc near the top plug, and the sealing portion cooperates with the fitting portion to be inserted into the top disc opening. 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 being inserted into the top disc opening, which is suitable for smoothly completing the fitting of the sealing portion with the top disc opening under smaller force, avoiding deformation of the sealing portion due to uneven force and affecting the capping process or the air tightness of the capping, so as to improve the efficiency of the capping process.

[0038] In some embodiments of the present application, the double-cavity vial can include an inner cavity, a vial body, a vial neck, and a vial mouth, the center of the vial mouth can be provided with a vial mouth opening connected with the inner cavity, the inner diameter of the vial mouth opening is smaller than the inner diameter of the vial mouth and the vial neck, and one side of the outer wall of the vial body can have a bypass protrusion. After the double-cavity vial completes the freeze-drying process and is placed in a sheath, the bypass protrusion of the vial body can be clamped at the vertex of the inner wall of the sheath, so that the double-cavity vial will not rotate along its longitudinal axis when it is stored in the sheath under external force. During the process of engaging or disengaging the sterile injection needle with the double-cavity vial, the sterile injection needle needs to be rotated on the threaded structure of the double-cavity vial, therefore, the double-cavity vial is fixed by the bypass protrusion to prevent rotation, which can avoid the co-rotation of the sterile injection needle and the double-cavity vial, and further avoid the idling of the sterile injection needle, thereby achieving efficient screwing and dismounting of the sterile injection needle on the double-cavity vial package material.

[0039] In some embodiments of the present application, the top plug can include a plug cap and a plug column, the diameter of the plug column is equal to or slightly larger than the inner diameter of the vial mouth opening of the vial mouth, and after the plug column is inserted into the vial mouth opening, the lower surface of the plug cap completely matches the upper surface of the vial mouth.

[0040] In some embodiments of the present application, the top cover can further include a bottom disc, the upper end can further have a thread and an opening, the inner wall of the top cover matches the vial mouth, and when the top cover moves towards the vial mouth, the top disc of the upper end presses the top plug to move into the vial mouth, so that the top plug is inserted into the vial mouth. The upper end of the top cover fixes the pre-assembled top plug through the top disc, and continues to clamp the top plug after the top plug is inserted into the vial mouth. After the bottom disc matches the outer wall of the vial body, the whole top cover can seal the vial mouth and the connection between the vial neck and the vial body, thereby providing complete sealing of the vial mouth with the inserted top plug and increasing the sealing effect of the vial mouth. The top cover has the characteristics of small size and fast assembly and disassembly, which can improve the self-plugging and capping efficiency of the double-cavity vial in the freeze-drying process. When the bottom disc extends downward along the vial body, the matching between the bottom disc and the vial body further prevents the top cover from loosening and slipping off, thereby increasing the sealing effect of the double-cavity vial. The opening is beneficial for sublimation of water in the product from the double-cavity vial, so as to further reduce the water content of the freeze-dried product in the double-cavity vial in the freeze-drying process. The thread is used for threaded engagement with the sterile injection needle.

[0041] The bottom disc can be a hollow, open-bottomed cylinder or octagonal prism. Preferably, the bottom disc is an octagonal prism, which has an octagonal surface structure. After the completion of the freeze-drying process and the placement of the double-cavity ampoule in the sheath, the bottom disc matches and fits with the octagonal inner wall of the sheath. This fitting of the bottom disc and the sheath can also secure the double-cavity ampoule, so that the double-cavity ampoule cannot rotate along its longitudinal axis when stored due to external force, thereby ensuring efficient screwing and removal of the injection needle on the top cover. In addition, the bottom disc and the sheath are assembled and fixed by interference fit, and the package material exerts force from the upper and lower ends to the middle to further compress the top plug, thereby improving the sealing level of the top plug and the top cover.

[0042] In some embodiments of the present application, when the top plug is embedded in the bottle opening, the sealing portion longitudinally protrudes from the top disc opening of the top disc. During the pre-assembly of the top plug into the top cover, the sealing portion can be embedded in the top disc opening, with the edge portion closely fitted with the circumferential outer edge of the top disc opening, and finally partially protruding above the top disc opening. By inserting and fitting the sealing portion into the top disc opening during the pre-assembly of the top plug, and by limiting the position of the plug cap with the top plug positioning point, the top plug can be more stably fixed in the top cover. Therefore, in actual production, external forces such as shaking and suspension will not affect the fixation of the top plug in the top cover, thereby avoiding the top plug from falling out of the top cover 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 cover. After the injection needle is inserted into the top plug, the volume of the injection needle under pressure extends into the outer edge gap, which can prevent pressure from concentrating on the sealing portion, thereby preventing the injection needle from being inserted into the top plug.

[0043] In some embodiments of the present application, the upper end of the top cover can also have a top plug positioning point protruding from the inner wall of the upper end toward the axis of the top cover, which is used to fix the top plug embedded in the bottle opening. Through the further fixation of the top plug positioning point on the top plug, the sealing stability of the top plug is improved.

[0044] In some embodiments of the present application, the number of top plug positioning points is 4 or 5 or more. The top plug positioning points are also uniformly arranged along the radial direction of the top cover and are uniformly spaced in the circumferential direction on the inner wall of the upper end, which can provide uniform fixing force to the top plug. When the top plug tends to slip, it is difficult for the top plug to produce displacement in any direction greater than in other directions, so it is more difficult for the top plug to slip out of the bottle opening. In addition, the top plug positioning point can also be used for positioning the top plug before it is pressed into the bottle opening. The top plug is limited by the top plug positioning point, thereby preventing it from slipping out of the bottle opening on its own.

[0045] In some embodiments of the present application, the upper end of the top cover can further be provided with a protrusion protruding towards the axis of the top cover on the inner wall thereof, and the top cover can be limited on the bottle mouth by the protrusion before capping, so that the moisture of the product in the inner cavity is discharged by sublimation through the opening; therefore, the provision of the protrusion helps to provide gas exchange and moisture sublimation discharge for the double-cavity carton bottle. After the top plug is pressed into the bottle mouth, the top cover is simultaneously capped and fixed, and the protruding structure of the protrusion makes the upper end fit the bottle mouth more tightly, which is conducive to maintaining the fixation of the top cover after capping and improving the stability of the capping seal.

[0046] In some embodiments of the present application, the number of protrusions is 2 or more than 3; preferably, the maximum length of the protrusion protruding towards the axis of the top cover is 0.10-0.30 mm. The protrusions are uniformly arranged in a ring shape on the inner wall of the upper end, so that the upper end uniformly fits the bottle mouth, the top cover does not slip from one side, and the stability of the fixation of the top cover on the double-cavity carton bottle is further improved.

[0047] In some embodiments of the present application, the shape of the protrusion is trapezoidal, semicircular, semi-elliptical or rectangular, preferably, the shape of the protrusion is trapezoidal; when the shape of the protrusion is trapezoidal, the upper cutting angle between the face of the protrusion protruding towards the axis of the top cover and the side thereof is preferably 30-45°, further preferably, the upper cutting angle is 30°; and when the shape of the protrusion is trapezoidal, it is further preferred that the lower cutting angle between the face of the protrusion protruding towards the axis of the top cover and the side thereof is formed, and still further preferably, the lower cutting angle is 30°. When the shape of the protrusion is trapezoidal, the upper end fits the bottle mouth more tightly, and the top cover can be highly stably fitted on the double-cavity carton bottle; when the upper cutting angle between the face of the protrusion protruding towards the axis of the top cover and the side thereof is 30° and the lower cutting angle is 30°, the capping process of the top cover will not cause damage to the structure of the top cover due to excessive capping force, while maintaining high fitting degree of the top cover and the double-cavity carton bottle, and improving the capping efficiency and capping accuracy in the freeze-drying process using the top cover.

[0048] In some embodiments of the present application, the upper end further has a demolding hole at the connection between the top disc and the thread; preferably, the number of demolding holes is 4 or more than 5. The demolding hole communicates the top disc and the upper and lower sides of the opening of the top disc, so that the mold can be conveniently opened and the film can be conveniently combined during the production of the top cover, thereby improving the production efficiency of the top cover; since it does not communicate with the outer side of the upper end, the demolding hole will not affect the air tightness of the entire upper end and even the top cover, and the normal function of the top cover is maintained.

[0049] In some embodiments of the present application, the base further has internal protrusions located on the inner wall of the base on the side away from the upper end and protruding towards the axis of the cap; preferably, the number of internal protrusions is 2 or 3 or 4 or 5 or more. When the cap keeps the double-chamber carton bottle airtight, the base increases the contact pressure with the bottle body due to the internal protrusions, resulting in greater fitting strength, so that the cap cannot be loosened during the airtight storage and transfer of the double-chamber carton bottle; in addition, when the multiple internal protrusions are evenly distributed on the inner side of the base, the stress received by the base can be effectively dispersed, further improving the anti-loosening ability of the cap.

[0050] In some embodiments of the present application, the base further has protrusion-side openings on both sides of the internal protrusions along the edge of the base on the side away from the upper end; preferably, the number of protrusion-side openings is 4 or 6 or 8 or 10 or more. When the internal protrusions fit the bottle body, they can extend to the protrusion-side openings, so that there is no need to overcome large friction during capping, so that the internal protrusions do not significantly hinder the capping process.

[0051] According to another aspect of the present application, a double-chamber carton bottle packaging material for injection is also provided, which comprises a bottle cap assembly and a double-chamber carton bottle provided by the present application.

[0052] According to another aspect of the present application, a double-chamber carton bottle packaging material assembly for injection is also provided, which comprises a double-chamber carton bottle assembly and a sheath provided by the present application. The sheath can cooperate with the base and the bypass protrusion to fix the double-chamber carton bottle packaging material.

[0053] In some embodiments of the present application, the shape of the base of the bottle cap assembly of the packaging material is a cylinder or an octagonal prism, preferably an octagonal prism, the sheath comprises a sheath body and a flange, which is an octagonal prism in shape, the inner wall of which is an octagon, and the bypass protrusion of the double-chamber carton bottle of the packaging material is located at the vertex of the octagon of the inner wall of the sheath; and the top of the inner wall of the sheath has a protrusion in the horizontal direction, which is assembled with the base of the bottle cap assembly of the packaging material by interference fit to further clamp the stopper and the double-chamber carton 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 exert pulling force on each other, thereby clamping the double-chamber carton bottle in the middle, so that the stopper and the cap can be more tightly embedded with the bottle opening and the bottle mouth, respectively, thereby improving the sealing performance of the packaging material.

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

[0055] 1. The present application provides an integrated self-plug and capping sealing of the bottle cap assembly and the double-chamber carton bottle in the freeze dryer.

[0056] 2. The present application can improve the air tightness of the stopper and the double-chamber carton bottle opening.

[0057] 3、The application can improve the sealing degree of the sealing bottle cap assembly and the double-cavity carton bottle.

[0058] 4、The application can shorten the time required for sealing the double-cavity carton bottle in the freeze-drying process by reducing the operation steps, and avoid the failure of sealing in the freeze dryer, thereby improving the freeze-drying efficiency and quality.

[0059] 5、The double-cavity carton bottle packaging material of the application can effectively maintain the rotation stop of the bottle cap and prevent the core from being taken, which helps the efficient use of the injection needle and the double-cavity carton bottle packaging material assembly.

[0060] 6、The application provides a good cooperation structure between the top plug and the top cover of the bottle cap assembly, and between the top cover and the double-cavity carton bottle, so that the plug pressing and cap sealing can be quickly and smoothly realized. BRIEF DESCRIPTION OF DRAWINGS

[0061] The above and other objects, features and advantages of the present application will become more apparent from the following detailed description of embodiments of the present application, taken in conjunction with the accompanying drawings. The drawings provided below, which are for illustrative purposes only, and are not intended to limit the present application, serve to provide a further understanding of the application. In the drawings, the same reference numerals generally refer to the same components or steps throughout the drawings.

[0062] FIG. 1 illustrates a structural schematic diagram of the double-cavity carton bottle 1 and the top plug 3 of the application.

[0063] FIG. 2A illustrates a structural schematic diagram of one of the plug pressing assemblies of the application.

[0064] FIG. 2B illustrates another structural schematic diagram of the plug pressing assembly of the application.

[0065] FIG. 3 illustrates a structural schematic diagram of the top cover 4 of the application.

[0066] FIG. 4 illustrates a structural schematic diagram of the double-cavity carton bottle 1' and the top plug 2' of the application.

[0067] FIG. 5A illustrates a structural schematic diagram of the top cover 3' of the application.

[0068] FIG. 5B illustrates another structural schematic diagram of the top cover 3' of the application.

[0069] FIG. 6 illustrates another structural schematic diagram of the top plug 2' and yet another structural schematic diagram of the top cover 3' of the application.

[0070] FIG. 7A illustrates a structural schematic diagram of the top plug positioning point 303' of the application.

[0071] FIG. 7B illustrates another structural schematic diagram of the top plug positioning point 303' of the application.

[0072] Figure 8 illustrates a structural schematic diagram of the upper end 30' of the present application.

[0073] Figure 9 illustrates a structural schematic diagram of the maximum length of the protrusion 304' of the present application.

[0074] Figure 10 illustrates a structural schematic diagram of the upper cut angle and the lower cut angle of the protrusion 304' of the present application.

[0075] Figure 11 illustrates a structural schematic diagram of the double-cavity carton bottle packaging assembly of the present application.

[0076] Figure 12 illustrates a structural schematic diagram of the double-cavity carton bottle 1' and the top plug 2' of the present application.

[0077] Figure 13A illustrates a structural schematic diagram of the top cover 3' of the present application.

[0078] Figure 13B illustrates another structural schematic diagram of the top cover 3' of the present application.

[0079] Figure 13C illustrates yet another structural schematic diagram of the top cover 3' of the present application.

[0080] Figure 14A illustrates another structural schematic diagram of the top plug 2' and yet another structural schematic diagram of the top cover 3' of the present application.

[0081] Figure 14B illustrates a structural schematic diagram of the fitting portion 306' of the top cover 3' of the present application.

[0082] Figure 15A illustrates a structural schematic diagram of the top plug positioning point 303' of the present application.

[0083] Figure 15B illustrates another structural schematic diagram of the top plug positioning point 303' of the present application.

[0084] Figure 15C illustrates a top view of the demolding hole 305' of the present application.

[0085] Figure 16 illustrates a structural schematic diagram of the demolding hole 305' of the present application.

[0086] Figure 17 illustrates a structural schematic diagram of the upper end 30' of the present application.

[0087] Figure 18 illustrates a structural schematic diagram of the maximum length, the upper cut angle and the lower cut angle of the protrusion 304' of the present application.

[0088] Figure 19 illustrates a structural schematic diagram of the double-cavity carton bottle packaging assembly of the present application.

[0089] Explanation of Reference Marks 1 - Double-chambered Cartridge Bottle 3 - Stopper 4 - Top Cap 1' - Double-chambered Cartridge Bottle 2' - Stopper 3' - Top Cap 4' - Sheath 1" - Double-chambered Cartridge Bottle 2" - Stopper 3" - Top Cap 4" - Sheath 10 - Bottle Mouth 11 - Bottle Neck 12 - Bottle Body 13 - Inner Chamber 10' - Bottle Mouth 11' - Bottle Neck 12' - Bottle Body 13' - Inner Chamber 10" - Bottle Mouth 11" - Bottle Neck 12" - Bottle Body 13" - Inner Chamber 20 - Holding Jig 21 - Press-in Jig 30 - Cap 31 - Plug Column 41 - Base Plate 20' - Cap 21' - Plug Column 22' - Sealing Portion 20" - Cap 21" - Plug Column 22" - Sealing Portion 30' - Upper End 31' - Middle End 32' - Lower End 30" - Base Plate 40" - Sheath Main Body 41" - Flange 100 - Bottle Mouth Opening 120 - Bypass 200 - Protrusion Portion 210 - Press Column 100' - Bottle Mouth Opening 120' - Bypass Protrusion 100" - Bottle Mouth Opening 120" - Bypass Protrusion 200' - Gap Portion 200" - Gap Portion 400 - Top Plate 401 - Annular Thread 300' - Top Plate 301' - Thread 302' - Opening 303' - Stopper Positioning Point 304' - Protrusion Portion 310' - Protruding Ring 320' - Protruding Strip 321' - First Notch 300" - Top Plate 301" - Thread 302" - Opening 303" - Stopper Positioning Point 304" - Protrusion Portion 305" - Demolding Hole 306" - Fitting Portion 310" - Internal Protruding Block 311" - Opening on Both Sides of Protruding Block 321" - First Notch 400" - Second Notch DETAILED DESCRIPTION

[0090] The present application first discloses a bottle cap assembly, which comprises a stopper 3 and a top cap 4, and is used for sealing a double-chambered cartridge bottle 1. In particular, the double-chambered cartridge bottle 1 can be placed in a freeze-drying support used in an existing freeze-drying process, and the bottle cap assembly can also be adapted to be placed in the freeze-drying support when the double-chambered cartridge bottle 1 is fixed with the bottle cap assembly and is placed in the freeze-drying support in a normal manner. The bottle cap assembly can be made of any material that is suitable for achieving the sealing function of the bottle cap. The stopper 3 is used for sealing a bottle mouth 10 of the double-chambered cartridge bottle 1, and the stopper 3 is pressed into the double-chambered cartridge bottle 1 via a press-in assembly to achieve the sealing of the double-chambered cartridge bottle 1. When the press-in assembly presses the stopper 3, the press-in assembly can be driven in a mechanical pressing manner, a gas pressure driving manner, a pneumatic clamp driving manner or a spring pressing manner.

[0091] The top cover 4 disclosed in the present application is used to fix the top plug 3 and seal the bottle mouth 10 of the double-cavity carton bottle 1; wherein the plug assembly comprises a pressing jig 21 and a holding jig 20, and the process of pressing the top plug 3 via the plug assembly to embed the top plug 3 with the double-cavity carton bottle 1 to achieve the sealing of the double-cavity carton bottle 1 comprises the following steps:

[0092] The top plug 3 is placed in the holding jig 20 by fitting the holding jig 20 with the outer wall of the bottle mouth 10 of the double-cavity carton bottle 1 to achieve the positioning of the top plug 3 relative to the bottle mouth 10 of the double-cavity carton bottle 1; the top plug 3 is pressed by the pressing jig 21 to embed into the bottle mouth 10 of the double-cavity carton bottle 1; and the pressing jig 21 and the holding jig 20 are removed. It should be noted that when the size of part or all of the structure of the double-cavity carton bottle 1 changes, the size of the top plug 3, the pressing jig 21 and the holding jig 20 can also change accordingly to adapt to the size of the double-cavity carton bottle 1 to complete the sealing of the bottle mouth.

[0093] In the present application, the double-cavity carton bottle 1 comprises an inner cavity 13, a bottle body 12, a bottle neck 11 and a bottle mouth 10, the center of the bottle mouth 10 is provided with a bottle mouth opening 100 connected with the inner cavity 13, the inner diameter of the bottle mouth opening 100 is smaller than the inner diameter of the bottle mouth 10 and the bottle neck 11; the outer wall of one side of the bottle body 12 has a bypass 120. Those skilled in the art can understand that the size of the inner cavity 13, the bottle body 12, the bottle neck 11 and the bottle mouth 10 of the double-cavity carton bottle 1 can be adjusted within the size range suitable for placing into the freeze-drying support without changing its original function, such as increasing the vertical length of one or more parts of the double-cavity carton bottle 1, increasing the radial length of one or more parts of the double-cavity carton bottle 1, etc., all of which do not deviate from the protection scope of the present application.

[0094] When the double-cavity carton bottle 1 is placed on the freeze-drying support, the upper opening of the freeze-drying support is larger than the lower opening, so the upper opening is convenient for the insertion of the bypass 120, and the lower opening can appropriately fix the double-cavity carton bottle 1 so that it is not easy to fall off from the fixing module, so as to avoid the double-cavity carton bottle 1 from falling over during the freeze-drying process.

[0095] In the present application, the top plug 3 comprises a plug cap 30 and a plug column 31, the diameter of the plug column 31 is slightly larger than the inner diameter of the bottle mouth opening 100 of the bottle mouth 10, and after the plug cap 30 is pressed to embed the plug column 31 into the bottle mouth opening 100, the lower surface of the plug cap 30 completely fits with the upper surface of the bottle mouth 10. In particular, the diameter of the plug column 31 can be adjusted within the diameter range of the plug column 31 pressed and embedded into the bottle mouth opening 100; in addition, in order to maintain the sealing after pressing, the diameter of the plug column 31 cannot be less than or equal to the diameter of the bottle mouth opening 100.

[0096] In the present application, the pressing assembly has one configuration as shown in FIG. 2A and another configuration as shown in FIG. 2B. The pressing jig 21 is a cylinder with an opening at the lower end and a recess at the center of the upper surface. In the configuration shown in FIG. 2A, the protruding pressing columns 210 are arranged on the inner wall of the lower end of the pressing jig 21. When the stopper 3 moves towards the bottle mouth 10, the pressing columns 210 press the stopper 3 to move towards the bottle mouth 10, so that the stopper 3 is embedded in the bottle mouth 10. The pressing jig 21 can be a cylinder or a prism, and the shape of the pressing columns 210 can be a cylinder, a prism or an ellipsoid. The contact surface between the pressing columns 210 and the cap 30 of the stopper 3 can be a plane or a curved surface.

[0097] In the present application, the number of the pressing columns 210 is two or more. In particular, all the pressing columns 210 are arranged in a central symmetry, an axial symmetry or a uniform interval along the center of the inner wall of the lower end of the pressing jig 21, so as to ensure the uniform distribution of the pressing columns 210 on the inner wall of the lower end of the pressing jig 21.

[0098] In another configuration shown in FIG. 2B, the inner wall of the recess at the center of the pressing jig 21 is not provided with the pressing columns 210. When the stopper 3 moves towards the bottle mouth 10, the pressing jig 21 directly abuts against the stopper 3 by means of the recess at the center to press it to move towards the bottle mouth 10. In this way, without using the holding jig 20 with a long protrusion at the upper end, the pressing jig 21 can also ensure to provide sufficient pressing length to the stopper 3 to firmly embed it in the bottle mouth 10 without additionally arranging multiple pressing columns 210, so as to simplify the manufacturing process of the pressing assembly.

[0099] In the present application, the holding jig 20 is arranged such that its inner wall is in contact with the bottle mouth 10 and the bottle body 11, and its upper end protrudes from the bottle mouth 10. When the stopper 3 moves towards the bottle mouth 10, the inner wall of the pressing jig 21 is in contact with and slides along at least a part of the outer wall of the holding jig 20. The length of the upper end of the holding jig 20 protruding from the bottle mouth 10 can be not less than the stopper 3 limited by the protruding part 200, or can be less than the stopper 3 limited by the protruding part 200. When the length of the upper end of the holding jig 20 protruding from the bottle mouth 10 can be greater than the stopper 3 limited by the protruding part 200, the holding jig 20 can protect the stopper 3 from slipping off or jumping out of the holding jig 20 during the pressing process, thereby improving the stability of the pressing.

[0100] In the present application, the holding fixture 20 is further provided with protrusions 200, which hold and fix the stopper 3 before the stopper 3 is inserted into the bottle mouth 10, so that the plug column 31 is aligned with the bottle mouth opening 100 of the bottle mouth 10; and the protrusions 200 clamp the stopper 3 after the stopper 3 is inserted into the bottle mouth 10. Those skilled in the art can understand that the protrusions 200 do not significantly hinder the movement of the stopper 3 during the process of inserting the stopper 3 into the bottle mouth 10, because the protrusions 200 are uniformly distributed on the inner wall of the holding fixture 20, and the pressure columns 210 uniformly apply pressure to the plug cap 30, so that the stopper 3 will be horizontally inserted into the bottle mouth 10 without any greater or smaller directional component. The shape of the protrusions 200 can be trapezoidal, semicircular, semi-elliptical or rectangular, and the contact surface of the protrusions 200 with the side surface of the plug cap 30 of the stopper 3 can be flat or curved.

[0101] In the present application, the number of protrusions 200 is two or more. It should be noted that the protrusions 200 extend radially along the holding fixture 20 and are uniformly spaced circumferentially on the inner wall of the holding fixture 20, and the number of protrusions 200 and the spacing length / arc between the plurality of protrusions 200 can be adjusted to maintain the optimal positioning and clamping of the stopper 3.

[0102] In the present application, the top cover 4 includes a main body and a bottom disc 41, the main body has a top disc 400 and an annular thread 401, the inner wall of the top cover 4 is fitted with the bottle mouth 10 and the bottle neck 11; and the bottom disc 41 of the top cover 4 is completely fitted with the upper surface of the bottle body 12. After the top cover 4 is completely capped on the bottle mouth 10 of the double-chamber carton bottle 1, the top disc 400 is arranged above the plug cap 30 to press and fix the stopper 3; and the annular thread 401 is used for thread engagement with the sterile injection needle.

[0103] The present application discloses a double-chamber carton bottle package for injection, which includes the bottle cap assembly and the double-chamber carton bottle 1 described above, and can be used to well preserve the freeze-dried products. It should be noted that the double-chamber carton bottle package for injection can include any combination of the bottle cap assembly and the double-chamber carton bottle 1 formed and / or maintained by any combination disclosed in the present application.

[0104] Further, the application discloses another bottle cap assembly, wherein the bottle cap assembly comprises a top plug 2' and a top cap 3' for sealing a double-cavity carton bottle 1'. The double-cavity carton bottle 1' shown in FIG. 4 can be placed in a freeze-drying support used in the existing freeze-drying process, and the double-cavity carton bottle packaging material can be fixed and placed upright or upside down in the freeze-drying support and sheath; the bottle cap assembly can be made of any material suitable for achieving the sealing function of the bottle cap. The top plug 2' is limited in the top cap 3' and used for sealing the bottle mouth 10' of the double-cavity carton bottle 1'; the top cap 3' is used for pressing and fixing the top plug 2' so that the top plug 2' seals the bottle mouth 10' of the double-cavity carton bottle 1' and seals the double-cavity carton bottle 1'; wherein the process of pressing and fixing the top plug 2' in the top cap 3' so that the top plug 2' seals the bottle mouth 10' of the double-cavity carton bottle 1' can include the following steps:

[0105] preassembling the top plug 2' into the top cap 3'; and placing the top cap 3' with the assembled top plug 2' above the bottle mouth 10' of the double-cavity carton bottle 1' and pressing the top cap 3' downward to press the top plug 2'. The driving mode of the top cap 3' downward can be mechanical compression, air pressure driving, pneumatic clamp driving or spring pressing, etc.

[0106] In the application, the double-cavity carton bottle 1' comprises an inner cavity 13', a bottle body 12', a bottle neck 11' and a bottle mouth 10', the center of the bottle mouth 10' is provided with a bottle mouth opening 100' connected with the inner cavity 13', and the inner diameter of the bottle mouth opening 100' is smaller than the inner diameter of the bottle mouth 10' and the bottle neck 11'; one side outer wall of the bottle body 12' has a bypass protrusion 120'. Those skilled in the art can understand that the size of the inner cavity 13', the bottle body 12', the bottle neck 11' and the bottle mouth 10' of the double-cavity carton bottle 1' can be adjusted to adapt to the size range of the commonly used freeze-drying support, such as changing the vertical length of one or more parts of the double-cavity carton bottle 1', changing the radial length of one or more parts of the double-cavity carton bottle 1', etc., which does not deviate from the protection scope of the application.

[0107] In the application, the top plug 2' comprises a plug cap 20' and a plug column 21', the diameter of the plug column 21' can be equal to or slightly larger than the inner diameter of the bottle mouth opening 100', and after the plug column 21' is embedded in the bottle mouth opening 100', the lower surface of the plug cap 20' completely matches the upper surface of the bottle mouth 10' to achieve the sealing of the bottle mouth 10'. In particular, the top plug 2' is made of elastic rubber material, so the diameter of the plug column 21' can be adjusted within the diameter range of the bottle mouth opening 100' after the plug column 21' is pressed under force, and the diameter of the plug column 21' can be slightly larger than the diameter of the bottle mouth opening 100' to ensure the tightness of the sealing.

[0108] In the present application, the top cover 3' as shown in FIG. 5A comprises an upper end 30', a middle end 31' and a lower end 32'; the upper end 30' has a top disc 300', a thread 301' and an opening 302', the middle end 31' has a convex ring 310', and the lower end 32' optionally has a convex strip 320'; the inner wall of the top cover 3' is in close contact with the bottle mouth 20, the bottle neck 21 and at least a portion of the bottle body 22; when the top cover 3' is directed towards the bottle mouth 10', the top disc 300' of the upper end 30' presses the stopper 2' to move into the bottle mouth 10', so that the stopper 2' is embedded in the bottle mouth 10'. After the bottle mouth 10' of the double-chamber carton bottle 1' is capped, the top disc 300' is tightly attached above the stopper 20' to press the stopper 2'. The opening 302' can discharge the sublimated moisture in the product, the thread 301' is used for thread engagement with a sterile injection needle, and the convex ring 310' can match a sheath.

[0109] It should be noted that the shape of the lower end 32' of the top cover 3' can be cylindrical or prismatic, as shown in FIG. 5B, and the length in the vertical direction can be adjusted, so that the lower end 32' can be in close contact with a small portion of the bottle body 12', or in close contact with a large portion or the entire bottle body 12', to achieve better sealing performance and to meet the size requirements of the top cover 3' in the freeze-drying process. The convex strip 320' is used to increase the friction between the lower end 32' and the matching sheath, to improve the fixing effect of mutual cooperation; in particular, the convex strip 320' can also be removed. The shape of the lower end 32' can be cylindrical or prismatic, to avoid the top cover 3' from slipping off due to rotational centrifugal force or relative sliding with the double-chamber carton bottle 1' to affect the sealing performance.

[0110] In particular, the length of the middle end 31' of the top cover 3' in the direction of the bottle neck 11' and the bottle body 12' can be adjusted, and the convex ring 310' can be adjusted to be in close contact with the lower part of the upper end 30' to adapt to the sealing requirements of the top cover 3' in different degrees of gasketing with the double-chamber carton bottle 1', for example, the length of the top cover 3' in the direction of the bottle body 12' or the volume of the top cover 3' needs to be reduced to meet the size requirements of the double-chamber carton bottle 1' and the top cover 3' in the freeze-drying support in the freeze-drying process. In particular, the center of the top disc 300' has a top disc opening, and the circumferential lower edge to the upper edge of the top disc opening can have an inclination angle β' in the vertical direction, and the circumferential upper edge of the top disc opening has a greater opening length than the circumferential lower edge; the circumferential edge surface of the top disc opening can be curved or planar.

[0111] In the present application, as shown in FIG. 6, the top plug 2' can further comprise a sealing portion 22' protruding above the plug cap 20', which can be inserted into the top disc opening. When the top plug 2' is completely embedded into the bottle mouth 10', i.e. the double-cavity cartridge bottle 1' is completed, the sealing portion 22' of the top plug 2' is embedded into the top disc opening and partially protrudes longitudinally from the top disc opening. Those skilled in the art can understand that the size of the sealing portion 22' can be slightly larger than the opening size of the circumferential lower edge of the top disc opening. During the process of pre-assembling the top plug 2' into the top cover 3', the top plug 2' needs to be fixed by the upper end 30', and the surface of the sealing portion 22' can be slightly deformed to be inserted and embedded into the top disc opening from the circumferential lower edge of the top disc opening.

[0112] Therefore, during the process of pre-assembling the top plug 2' into the top cover 3', the sealing portion 22' can be embedded into the top disc opening, the edge portion of which closely fits the circumferential outer edge of the top disc opening and finally partially protrudes from the upper edge of the top disc opening. By setting the radial length L' of the sealing portion, the edge portion of which has a longer radial length, the close fitting of the edge portion of the sealing portion 22' and the circumferential outer edge of the top disc opening can be improved, further preventing the top plug 2' from slipping out of the top disc 300'. In addition, by adjusting the size of β', the circumferential lower edge of the top disc opening and the sealing portion 22' can have a closer fitting than the circumferential upper edge of the top disc opening, so that the top disc opening closely surrounds and fixes the sealing portion 22'.

[0113] In some embodiments, the radial length L' of the sealing portion 22' can be 2.0mm-5.0mm, in particular, the radial length L' of the sealing portion 22' can be 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the radial length L' of the sealing portion 22' can be 3.0mm-4.0mm, in particular, the radial length L' of the sealing portion 22' can preferably be 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm. The inclination angle β' can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9° or 10°, etc.

[0114] In some embodiments, the circumferential lower edge opening length of the top disc opening can be 1.5mm-5.0mm, in particular, the circumferential lower edge opening length of the top disc opening can be 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the circumferential lower edge opening length of the top disc opening can be 2.5mm-4.0mm, in particular, the circumferential lower edge opening length of the top disc opening can preferably be 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm.

[0115] By setting the radial length L' of the sealing portion 22' slightly larger than the circumferential lower edge opening length of the top disc opening, the sealing portion 22' is more fitted with the circumferential lower edge of the top disc opening, so that the top disc opening effectively fits and fixes the sealing portion 22' as a whole, and the circumferential edge provides further support on this basis, so that the whole top plug 2' does not slip off. Preferably, β' is set to 0°, so that the top disc opening can provide good fixation of the sealing portion 22' without any inclination angle in the vertical direction, while avoiding excessive resistance when the sealing portion 22' is inserted into the top disc opening; in another case, when the top disc opening needs to be set with a certain inclination angle in the vertical direction to improve the limiting effect of the top disc 300' on the top plug 2', β' can also be set to 5° to improve the fixation of the sealing portion 22', while not affecting the insertion and embedding of the sealing portion 22' into the top disc opening. Those skilled in the art can appropriately adjust the radial length L' of the sealing portion 22', the inclination angle β' and the circumferential lower edge opening length of the top disc opening based on the above-mentioned parameter benchmarks to adaptively adjust the fitting and fixing degree of the sealing portion 22' and the top disc 300'.

[0116] In particular, the diameter of the stopper cap 20' of the stopper 2' can be slightly smaller than the inner diameter of the top cover 3', and the stopper 2' can be tightly fixed with the bottle opening 100' due to the cooperation of the stopper positioning point 303' and the stopper cap 20', so as to achieve sealing. In this case, the diameter of the stopper cap 20' is set to be slightly smaller than the inner diameter of the top cover 3', so that a small gap part 200' is left between the surface of the stopper cap 20' and the inner wall of the upper end 30', as shown in FIG. 8. In this way, when the stopper 2' is pressed tightly by the top cover 3', the stopper cap 20' will not protrude upward in the middle of the top disc opening due to the expansion of the compressed volume of the stopper cap 20' to the gap part 200' reserved around it. Therefore, when the injection needle, such as a micro fine needle (MFN), is inserted into the middle of the stopper cap 20' from the bottle opening 10', the stopper cap 20' will not apply pressure to the inside of the needle at the insertion position, thereby avoiding the core sampling caused by the cutting of the stopper cap 20' by the needle tip, i.e. the generation of rubber fragments and the falling of the fragments into the needle and the inner cavity of the dual-chamber cartridge, thereby avoiding the contamination of the product.

[0117] In some embodiments, the diameter of the stopper cap 20' can range from 5.0 mm to 10.0 mm, and in particular, the diameter of the stopper 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, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm, 9.7 mm, 9.8 mm, 9.9 mm or 10.0 mm; preferably, the diameter of the stopper cap 20' can range from 6.0 mm to 8.0 mm, and in particular, the diameter of the stopper cap 20' can preferably be 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 or 8.0 mm.

[0118] 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, 9.0 mm, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm, 9.7 mm, 9.8 mm, 9.9 mm or 10.0 mm; preferably, the diameter of the upper end 30' can range from 6.0 mm to 8.0 mm, specifically, the diameter of the upper end 30' can preferably be 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 or 8.0 mm.

[0119] More preferably, the diameter of the stopper cap 20' can be configured as 7.0 mm, and the inner diameter of the upper end 30' of the top cover 3' that cooperates with the stopper cap 20' can be configured as 7.3 mm, so that a gap part 200' with a length of 0.3 mm is left between the surface of the stopper cap 20' and the inner wall of the upper end 30', and the stopper cap 20' is extruded and the diameter is increased during the assembly of the top plug 2' or the insertion of the injection needle, and the gap part 200' can accommodate the increased volume of the stopper cap 20', thereby avoiding the generation of upward pressure. It should be noted that in the bottle cap assembly according to the embodiments of the present application, those skilled in the art can appropriately adjust the diameter of the stopper cap 20' and the diameter of the upper end 30' based on the above-mentioned parameter benchmarks according to the actual application of the bottle cap assembly, so as to adapt to the cooperation of the bottle cap assembly with the freeze-drying support of the freeze-dryer, the cooperation with the packaging sheath and / or the cooperation with the syringe. For example, the diameter of the stopper cap 20' can be appropriately adjusted to adjust the stability of the pre-assembly of the top plug 2'; the diameter of the upper end 30' can be appropriately adjusted to keep the bottle cap assembly more tightly sealed or more easily detached from the double-chamber carton bottle 1'; and after the diameter of the stopper cap 20' and the diameter of the upper end 30' are adjusted respectively, in order to appropriately avoid the influence of the extrusion of 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 upper end 30' can be appropriately adjusted to provide a suitable gap part 200', etc.

[0120] The stopper 2' can be stably fixed in the top cover 3' by inserting and fitting the sealing part 22' into the top disc opening and limiting the position of the stopper 2' by the stopper positioning point 303' during the pre-assembly process of the stopper 2'. Therefore, the mechanical process such as shaking and suspension performed on the top cover 3' during the freeze-drying process will not affect the fixation of the stopper 2' in the top cover 3', thereby avoiding the stopper 2' from falling out of the top cover 3' before the capping operation, ensuring the capping qualification rate after freeze-drying. The gap part 200' of the stopper cap 20' can also avoid core taking when used with a syringe, thereby ensuring product quality and efficient use.

[0121] In the present application, the upper end 30' of the top cover 3' also has a stopper positioning point 303', as shown in FIGS. 7A and 7B, which protrudes from the inner wall of the upper end 30' towards the axis of the top cover 3' and is used to fix the stopper 2' fitted with the bottle mouth 10'. Specifically, the stopper positioning point 303' is uniformly arranged along the radial direction of the upper end 30' and is arranged on the inner wall of the stopper positioning point 303'. The shape of the stopper positioning point 303' can be cylindrical or prismatic, and in addition, the number of stopper positioning points 303' and the interval length / arc between the plurality of stopper positioning points 303' can be adjusted to maintain optimal fixation of the stopper 2'.

[0122] In the present application, the number of stopper positioning points 303' is 4 or 5 or more. In particular, the number of stopper positioning points 303' can be an even number to maintain its symmetrical arrangement along the center of the upper end 30' to provide more stable fixation of the stopper 2'. Preferably, the number of stopper positioning points 303' is 4 or 8 to provide more stable fixation of the stopper 2'; more preferably, the number of stopper positioning points 303' is 8 to provide the most stable fixation of the stopper 2'. The stopper positioning point 303' can also be used for positioning the stopper 2' before being pressed into the bottle mouth 10'. The stopper 2' is limited by the stopper positioning point 303' to avoid its independent slipping out of the bottle mouth 10'.

[0123] In the present application, the upper end 30' of the top cover 3' is further provided with a protruding part 304' protruding towards the axis direction of the top cover 3' on the inner wall thereof, as shown in FIG. 9, the top cover 3' can be limited on the bottle mouth 10' by the protruding part 304' before pressing, so that the sublimation moisture in the inner cavity 13' is discharged through the opening 302'; therefore, the provision of the protruding part 304' helps to provide the double-cavity carton bottle 1' with gas exchange and sublimation moisture discharge. Those skilled in the art can understand that the protruding part 304' will not hinder the movement of the top plug 2' during the process of embedding the top plug 2' into the bottle mouth 10', because the protruding part 304' is uniformly distributed on the inner wall of the upper end 30', and the top disc 300' can uniformly apply pressure to the entire surface of the plug cap 20' pre-assembled into the upper end 30' when pressing, therefore, the top plug 2' can be stably embedded horizontally into the bottle mouth 10'.

[0124] In the present application, the number of protruding parts 304' is 2 or more than 3; preferably, the maximum length (D') of the protruding part 304' protruding towards the axis direction of the top cover 3' can be 0.10mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, 0.15mm, 0.16mm, 0.17mm, 0.18mm, 0.19mm, 0.20mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm or 0.30mm. Specifically, D' can be 0.15mm-0.30mm; further preferably, D' can be 0.20mm-0.28mm, which can prevent the top cover 3' from deforming due to excessive pressure when pressing, and the top cover 3' has good sealing performance after pressing and is not easy to slip off; more preferably, D' can be 0.23mm-0.28mm, which can avoid the top cover 3' from deforming due to pressure when pressing, and the top cover 3' has good sealing performance after pressing and is not easy to slip off. It should be noted that when the material of the protruding part 304' is different, the value of D' can be adjusted to achieve the optimal limitation of the top cover 3' before pressing and the optimal improvement of the adhesion between the upper end 30' and the double-cavity carton bottle 1'. Preferably, when the outer diameter of the bottle mouth 10' is 7.3mm, D' can be 0.23mm, 0.25mm or 0.28mm, and the protruding part 304' can provide the optimal stability of the top cover 3' after pressing.

[0125] In the present application, the shape of the protruding part 304' can be trapezoidal, semicircular, semi-elliptical or rectangular, preferably the shape of the protruding part 304' is trapezoidal. When the shape of the protruding part 304' is trapezoidal with its short side adjacent to the bottle mouth 10', the adhesion tightness of the upper end 30' to the bottle mouth 10' is relatively optimal, and the top cover 3' can be highly stably adhered to the double-cavity carton bottle 1' to maintain good sealing performance.

[0126] When the shape of the protrusion 304' is trapezoidal, preferably, the upper cutting angle (θ') of the face of the protrusion 304' towards the axis direction of the cap 3' and the side face thereof can be any angle between 0° and 90°, as shown in FIG. 10. Further preferably, θ' can be 30°-45°, and 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 protrusion 304' can significantly weaken the effect of improving the close-fitting of the cap 3' and the bottle mouth 10'; when θ' is greater than 45°, the protrusion 304' can significantly hinder the capping process, causing the cap 3' to deform or even be damaged during the capping process. Therefore, it can be preferred that θ' is any angle in the range of 30°-45°; more preferably, θ' can be 30°, so that the protrusion 304' can provide a better close-fitting effect of the cap 3' and the bottle mouth 10' and not adversely hinder the capping process.

[0127] In addition, when the shape of the protrusion 304' is trapezoidal, it is further preferred that the lower cutting angle (α') of the face of the protrusion 304' towards the axis direction of the cap 3' and the side face thereof is any angle between 0° and 90°. Since the pressure of the capping process is mainly affected by the size of θ', when α' and θ' have the same value, the protrusion 304' can have a stable axisymmetric structure and is not prone to deformation or damage during the capping process or storage process. Therefore, the present application further preferably α' is 30° to improve the use efficiency and deformation resistance of the protrusion 304', and more preferably, θ' and α' of the protrusion 304' are both 30°, so that the cap 3' will not be structurally damaged due to excessive force during the capping process, and the cap 3' and the double-chamber carton bottle 1' can be highly and closely fitted, which also improves the efficiency and accuracy of capping the double-chamber carton bottle 1'.

[0128] The present application also discloses a double-chamber carton bottle package for injection, which comprises the bottle cap assembly and the double-chamber carton bottle 1' described above, and a double-chamber carton bottle package assembly for injection, which comprises the double-chamber carton bottle package for injection and a sheath 4' used in cooperation therewith, as shown in FIG. 11. It should be noted that the double-chamber carton bottle package for injection can comprise any combination of the bottle cap assembly and the double-chamber carton bottle 1' that can be formed and / or maintained by any combination disclosed in the present application.

[0129] The sheath 4' of the present application is an open-top octagonal prism, as shown in FIG. 11. The inner wall of the sheath 4' has an octagonal shape. After the double-chamber carton bottle 1' completes the freeze-drying process and is sealed by the cap 3', the double-chamber carton bottle 1' can be pressed into the sheath. During this process, the lower end 32' of the cap 3' is attached to the inner wall of the sheath 4' and cannot slide relative to the sheath 4'. In addition, the bypass protrusion 120' of the bottle body 12' is fixed at the vertex of the octagonal inner wall of the sheath 4' and cannot slide relative to the inner wall of the sheath 4'.

[0130] In the present application, the lower end 32' is in the shape of a cylinder or an octagonal prism, and can preferably be an octagonal prism. The lower end 32' is fixedly assembled with the sheath 4' for storing the double-chamber carton bottle 1' by interference fit. Specifically, the lower end 32' has a first notch 321' near the upper outer edge of the middle end 31'. The top end of the sheath 4' is stretched and limited on the first notch 321'. The cap 3' and the sheath 4' are forced towards each other and clamped in the middle. By this interference fit between the lower end 32' and the sheath 4', when the double-chamber carton bottle 1' is placed in the sheath 4', the cap 3' and the stopper 2' therein are fixed more tightly with the bottle mouth 10', effectively avoiding air leakage, rotation, and falling off, etc.

[0131] Specifically, in some embodiments, the reconstituted freeze-dried product in the double-chamber carton bottle 1' is injected subcutaneously by a syringe needle for the treatment of skin diseases or medical aesthetic applications. The needle seat of the syringe needle has a threaded structure. When the MFN is installed on the cap 3' to extract the product or removed from the cap 3', the threaded structure is engaged or removed by rotating with the threads 301' of the cap 3'. During this process, the lower end 32' of the cap 3' is fixed by the octagonal inner wall of the sheath 4' to prevent rotation, and the bypass protrusion 120' of the double-chamber carton bottle 1' is also fixed by the vertex of the octagonal inner wall of the sheath 4' to prevent rotation. Therefore, by selecting the lower end 32' in the shape of an octagonal prism and cooperating with the sheath 4', the double-chamber carton bottle packaging assembly can be kept from being affected by rotation when the syringe needle is screwed on / detached, so as to avoid idling when the sterile syringe needle is screwed on / detached, and improve the use efficiency of the double-chamber carton bottle packaging assembly.

[0132] In order to provide an integrated sealing fit that is advantageous for the double-chamber carton bottle 1' with a longer neck, the present application also discloses a double-chamber carton bottle packaging for injection, which comprises another cap assembly and a double-chamber carton bottle 1' as described below, as shown in FIG. 12. It should be noted that the double-chamber carton bottle packaging for injection can include any combination formed and / or maintained by the combination of any of the cap assemblies and double-chamber carton bottles 1' proposed in the present application.

[0133] That is, in the present application, another bottle cap assembly is correspondingly proposed, wherein the bottle cap assembly comprises a top plug 2` and a top cap 3` for sealing a double-cavity carton bottle 1`. The double-cavity carton bottle 1` can be placed in a lyophilization support and sheath 4` used in the existing lyophilization process, and the double-cavity carton bottle packaging material can be fixed and placed upright or inverted in the lyophilization 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 in the top cap 3` for sealing the bottle mouth 10` of the double-cavity carton 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 mouth 10` of the double-cavity carton bottle 1`; and seals the double-cavity carton bottle 1`; wherein the process of pressing and fixing the top plug 2` in the top cap 3` so that the top plug 2` seals the bottle mouth 10` of the double-cavity carton bottle 1` can include the following steps:

[0134] Pre-assemble the top plug 2` into the top cap 3`; and place the top cap 3` with the top plug 2` assembled above the bottle mouth 10` of the double-cavity carton bottle 1`, and press the top cap 3` downward. The driving mode of the top cap 3` downward can be mechanical compression, pneumatic driving, pneumatic clamp driving or spring pressing, etc.

[0135] In the present application, the double-cavity carton bottle 1` comprises an inner cavity 13`, a bottle body 12`, a bottle neck 11` and a bottle mouth 10`, the center of the bottle mouth 10` is provided with a bottle mouth opening 100` connected with the inner cavity 13`, the inner diameter of the bottle mouth opening 100` is smaller than the inner diameter of the bottle mouth 10` and the bottle neck 11`; the outer wall of one side of the bottle body 12` has a bypass protrusion 120`. Those skilled in the art can understand that the size of the inner cavity 13`, the bottle body 12`, the bottle neck 11` and the bottle mouth 10` of the double-cavity carton bottle 1` can be adjusted to adapt to the size range of commonly used lyophilization supports, such as changing the vertical length of one or more parts of the double-cavity carton bottle 1`, changing the radial length of one or more parts of the double-cavity carton bottle 1`, etc., without departing from the protection scope of the present application.

[0136] In the present application, the top plug 2` comprises a plug cap 20` and a plug column 21`, the diameter of the plug column 21` can be equal to or slightly larger than the inner diameter of the bottle mouth opening 100`, after the plug column 21` is embedded in the bottle mouth opening 100`, the lower surface of the plug cap 20` completely matches the upper surface of the bottle mouth 10` to achieve the sealing of the bottle mouth 10`. In particular, the top plug 2` is made of elastic rubber material, so the diameter of the plug column 21` can be adjusted within the diameter range of the bottle mouth opening 100` after the plug column 21` is pressed under force, and the diameter of the plug column 21` can be slightly larger than the diameter of the bottle mouth opening 100` to ensure the tightness of the sealing.

[0137] In the present application, the top cover 3` as shown in FIG. 13A comprises an upper end 30`, which is different from the above-mentioned another type of bottle cap assembly in that the middle end 31 and the lower end 32 are replaced by the bottom disc 31`; the upper end 30` has a top disc 300`, a thread 301` and an opening 302`, and the inner wall of the top cover 3` is attached to the bottle mouth 10`; when the top cover 3` is directed towards the bottle mouth 10`, the top disc 300` of the upper end 30` presses the stopper 2` to move into the bottle mouth 10`, so that the stopper 2` is embedded in the bottle mouth 10`. After the bottle mouth 10` of the double-chamber carton bottle 1` is capped, the top disc 300` is tightly attached above the plug cap 20` to press the stopper 2`. The opening 302` can discharge the sublimated moisture in the product, and the thread 301` is used to engage with the thread of the injection needle.

[0138] It should be noted that the length of the bottom disc 31` in the vertical direction can be adjusted, so that the bottom disc 31` can only attach to the connecting portion of the bottle neck 11` and the bottle body 12`, or can additionally attach to at least a portion of the bottle body 12` to achieve better capping tightness and adapt to the size requirements of the top cover 3` in the freeze-drying process. The shape of the bottom disc 31` can be set as a cylinder or a multi-prism, as shown in FIG. 13B, to avoid the top cover 3` from slipping off or generating relative sliding with the double-chamber carton bottle 1` due to the rotational centrifugal force, thereby affecting the tightness.

[0139] In particular, the center of the top disc 300` also has a top disc opening, and the circumferential lower edge to the upper edge of the top disc opening can have an inclination angle β` in the vertical direction, and the circumferential upper edge of the top disc opening has a greater opening length than the circumferential lower edge; the circumferential edge surface of the top disc opening can be curved or flat.

[0140] In the present application, the stopper 2` can also comprise a sealing portion 22` protruding above the plug cap 20`, as shown in FIG. 14A, which can be inserted into the top disc opening; when the stopper 2` is completely embedded in the bottle mouth 10`, i.e. the double-chamber carton bottle 1` is completed, the sealing portion 22` of the stopper 2` is embedded in the top disc opening and partially protrudes longitudinally from the top disc opening. As can be understood by those skilled in the art, the size of the sealing portion 22` can be slightly larger than the opening size of the circumferential lower edge of the top disc opening, and in the process of pre-assembling the stopper 2` into the top cover 3`, the stopper 2` needs to be fixed by the upper end 30`, and the surface of the sealing portion 22` can be slightly deformed to be inserted into and embedded in the top disc opening from the circumferential lower edge of the top disc opening.

[0141] Therefore, in the process of preassembling the top plug 2' into the top cover 3', the sealing portion 22' can be embedded into the top disc opening, the edge portion of which closely fits the circumferential outer edge of the top disc opening and eventually partially protrudes above the upper edge of the top disc opening. The radial length L' of the sealing portion 22' can also be set to be relatively long to improve the close fit of the edge portion of the sealing portion 22' with the circumferential outer edge of the top disc opening, so as to further prevent the top plug 2' from slipping out of the top disc 300'. In addition, the size of β' can also be adjusted to make the circumferential lower edge of the top disc opening have a closer fit with the sealing portion 22' than the circumferential upper edge of the top disc opening, so as to tightly surround the sealing portion 22' with the top disc opening.

[0142] In some embodiments, the radial length L' of the sealing portion 22' can be 2.0mm-5.0mm, in particular, the radial length L' of the sealing portion 22' can be 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the radial length L' of the sealing portion 22' can be 3.0mm-4.0mm, in particular, the radial length L' of the sealing portion 22' can preferably be 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm. The inclination angle β' can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9° or 10°, etc.

[0143] In some embodiments, the circumferential lower edge opening length of the top disc opening can be 1.5mm-5.0mm, in particular, the circumferential lower edge opening length of the top disc opening can be 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the circumferential lower edge opening length of the top disc opening can be 2.5mm-4.0mm, in particular, the circumferential lower edge opening length of the top disc opening can preferably be 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm.

[0144] By setting the radial length L` of the sealing portion 22` slightly larger than the circumferential lower edge opening length of the top disc opening, the sealing portion 22` is more fitted with the circumferential lower edge of the top disc opening, and the top disc opening enables the overall effective fitting and fixation of the sealing portion 22`, and the circumferential edge provides further support on this basis, so that the whole plug 2` does not slip off. Preferably, β` is set to 0°, and when the top disc opening has no inclination angle in the vertical direction, the top disc opening can provide good fixation for the sealing portion 22`, while avoiding excessive resistance when the sealing portion 22` is inserted into the top disc opening. In another case, when the top disc opening needs to have a certain inclination angle in the vertical direction to improve the limiting effect of the top disc 300` on the plug 2, β` can also be set to 5° to improve the fixation of the sealing portion 22`, while not affecting the insertion and embedding of the sealing portion 22` into the top disc opening. Those skilled in the art can adjust the radial length L` of the sealing portion 22`, the inclination angle β` and the circumferential lower edge opening length of the top disc opening according to the actual application of the bottle cap assembly on the basis of the above parameters, to adaptively adjust the fitting and fixation degree of the sealing portion 22` and the top disc 300`.

[0145] In particular, the diameter of the cap 20 of the stopper 2' can be slightly smaller than the inner diameter of the top cover 3', and the stopper 2' can be tightly fixed with the top cover 3' to achieve sealing due to the cooperation of the stopper positioning point 303' and the cap 20. 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 part 200 is left between the surface of the cap 20 and the inner wall of the upper end 30, as shown in FIG. 17. In this way, when the stopper 2' is pressed by the top cover 3', the compressed volume of the cap 20 extends to the gap part 200 reserved around the cap 20, so that the cap 20 will not protrude upward in the middle of the top disc due to compression. Therefore, when the injection needle, such as a micro fine needle (MFN), is inserted into the bottle opening 10 from the middle of the cap 20, the cap 20 will not apply pressure to the inside of the needle at the insertion position, thereby avoiding coring, i.e., the cap 20 is cut to produce rubber fragments and fall into the needle and the inner cavity of the dual-chamber cartridge, and avoiding product contamination.

[0146] In some embodiments, the diameter of the cap 20 can range from 5.0 mm to 10.0 mm, and in particular, 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, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm, 9.7 mm, 9.8 mm, 9.9 mm, or 10.0 mm; preferably, the diameter of the cap 20 can range from 6.0 mm to 8.0 mm, and in particular, the diameter of the cap 20 can preferably be 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, or 8.0 mm.

[0147] 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, 9.0 mm, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm, 9.7 mm, 9.8 mm, 9.9 mm or 10.0 mm; preferably, the diameter of the upper end 30" can range from 6.0 mm to 8.0 mm, specifically, the diameter of the upper end 30" can preferably be 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 or 8.0 mm.

[0148] More preferably, the diameter of the stopper cap 20" can be configured as 7.0 mm, and the inner diameter of the upper end 30" of the top cover 3" that cooperates with the stopper cap 20" can be configured as 7.3 mm, so that a gap part 200" with a length of 0.3 mm is left between the surface of the stopper cap 20" and the inner wall of the upper end 30", and the stopper cap 20" is extruded and the diameter is increased during the assembly of the top plug 2" or the insertion of the injection needle, and the gap part 200" can accommodate the increased volume of the stopper cap 20", so as to avoid the generation of upward pressure. It should be noted that in the bottle cap assembly according to the embodiments of the present application, those skilled in the art can appropriately adjust the diameter of the stopper cap 20" and the diameter of the upper end 30" based on the above-mentioned parameter benchmarks according to the actual application of the bottle cap assembly, so as to adapt to the cooperation of the bottle cap assembly with the freeze-drying support of the freeze-dryer, the cooperation with the packaging sheath and / or the cooperation with the syringe. For example, the stability of the pre-assembly of the top plug 2" can be adjusted by appropriately adjusting the diameter of the stopper cap 20"; the more tightly sealed or more easily detached seal of the double-chamber carton bottle 1" can be maintained by appropriately adjusting the diameter of the upper end 30"; and after the diameter of the stopper cap 20" and the diameter of the upper end 30" are adjusted respectively, in order to appropriately avoid the influence of the extrusion of 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 upper end 30" can be appropriately adjusted to provide a suitable gap part 200", etc.

[0149] The stopper 2` can be stably positioned in the top cover 3` by inserting and fitting the sealing part 22` into the top disc opening during the pre-assembly process of the top plug 2` and limiting the plug cap 20` with the top plug positioning point 303`. Therefore, when external force is applied to the top cover 3` in actual production, such as shaking, suspension, etc., the fixation of the top plug 2` in the top cover 3` will not be affected, thereby avoiding 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 avoid core taking when used with a syringe, thereby ensuring product quality and efficient use of packaging materials.

[0150] In the present application, the top cover 3` also has a top plug positioning point 303` at the upper end 30`, as shown in FIGS. 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 cover 3`, for fixing the top plug 2` embedded with the bottle mouth 10`. Specifically, the top plug positioning point 303` extends radially along the upper end 30` and is uniformly arranged in the inner wall of the top plug positioning point 303` in a ring shape, the shape of the top plug positioning point 303` can be cylindrical or prismatic, in addition, the number and the interval length / arc of the plurality of top plug positioning points 303` can be adjusted to maintain optimal fixation of the top plug 2`.

[0151] In the present application, the number of top plug positioning points 303` is 4 or 5 or more. In particular, the number of top plug positioning points 303` can be even to maintain its symmetrical arrangement along the center of the upper end 30` to provide more stable fixation function for the top plug 2`. Preferably, the number of top plug positioning points 303` is 4 or 8 to provide a relatively stable fixation function for the top plug 2`; more preferably, the number of top plug positioning points is 8 to provide the most stable fixation function for the top plug 2`. The top plug positioning point 303` can also be used for positioning the top plug 2` before being pressed into the bottle mouth 10`, the top plug 2` is limited by the top plug positioning point 303` to avoid its autonomous slipping out of the bottle mouth 10`.

[0152] In the present application, the upper end 30` of the top cover 3` is further provided with a protruding part 304` protruding towards the axis direction of the top cover 3` on the inner wall thereof, and the top cover 3` can be limited by the protruding part 304` on the bottle mouth 10` before pressing, so that the sublimation moisture in the inner cavity 13` is discharged through the opening 302`. Therefore, the provision of the protruding part 304` helps to provide gas exchange and moisture discharge for the double-cavity carton bottle 1`. Those skilled in the art can understand that the protruding part 304` will not hinder the movement of the top plug 2` during the embedding of the top plug 2` into the bottle mouth 10`, because the protruding part 304` is uniformly distributed on the inner wall of the upper end 30`, and the top disc 300` can uniformly apply pressure to the entire surface of the plug cap 20` pre-assembled into the upper end 30` when pressing the plug, so that the top plug 2` can be stably embedded horizontally into the bottle mouth 10`.

[0153] In the present application, the number of protruding parts 304` is 2 or more than 3; preferably, the maximum length (D`) of the protruding part 304` protruding towards the axis direction of the top cover 3` can be 0.10mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, 0.15mm, 0.16mm, 0.17mm, 0.18mm, 0.19mm, 0.20mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm or 0.30mm. Specifically, D` can be 0.15mm-0.30mm; further preferably, D` can be 0.20mm-0.28mm, which can prevent the top cover 3` from deforming due to excessive pressure when pressing, and the top cover 3` has good sealing performance after pressing and is not easy to slip off; more preferably, D` can be 0.23mm-0.28mm, which can prevent the top cover 3` from deforming due to pressure when pressing, and the top cover 3` has good sealing performance after pressing and is not easy to slip off. It should be noted that when the material of the protruding part 304` is different, the value of D` can be adjusted to achieve the optimal limitation of the top cover 3` before pressing and the optimal improvement of the adhesion between the upper end 30` and the double-cavity carton bottle 1`. When the outer diameter of the bottle mouth 10` is 7.3mm, D` is preferably 0.23mm, 0.25mm or 0.28mm, so that the protruding part 304` can provide the most stable fixation for the top cover 3`.

[0154] In the present application, the shape of the protruding part 304` can be trapezoidal, semicircular, semi-elliptical or rectangular, preferably the shape of the protruding part 304` is trapezoidal. When the shape of the protruding part 304` is trapezoidal with the short side adjacent to the bottle mouth 10`, the adhesion tightness of the upper end 30` to the bottle mouth 10` is relatively optimal, and the top cover 3` can be highly stably adhered to the double-cavity carton bottle 1` to maintain good sealing performance.

[0155] When the shape of the protrusion 304' is trapezoidal, the upper cut angle (θ') of the side surface of the face of the protrusion 304' towards the axis direction of the top cover 3' can be any angle between 0° and 90°, as shown in FIG. 18. Further, θ' can be 30°-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' on improving the close-fitting of the top cover 3' and the bottle mouth 10' can be significantly weakened; when θ' is greater than 45°, the protrusion 304' can significantly hinder the capping process, causing the top cover 3' to deform or even be damaged during the capping process. Therefore, θ' can be preferably any angle in the range of 30°-45°; more preferably, θ' can be 30°, so that the protrusion 304' can provide a better close-fitting effect of the top cover 3' and the bottle mouth 10' and does not adversely hinder the capping process.

[0156] In addition, when the shape of the protrusion 304' is trapezoidal, it is further preferred that the lower cut angle (α') of the side surface of the face of the protrusion 304' towards the axis direction of the top cover 3' can also be any angle between 0° and 90°. Since the pressure of the capping process is mainly affected by the size 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 process or storage process. Therefore, the present application further preferably α' can be 30° to improve the use efficiency and deformation resistance of the protrusion 304'. More preferably, θ' and α' of the protrusion 304' are both 30°, which will not cause structural damage to the top cover 3' due to excessive capping force, while also maintaining the close-fitting of the top cover 3' and the double-chamber carton bottle 1', which can improve the capping efficiency and accuracy of the double-chamber carton bottle 1' in the freeze-drying process.

[0157] In the present application, the upper end 30' of the bottle cap assembly also has a demolding hole 305', as shown in FIGS. 15C and 16, the demolding hole 305' is located at the connection between the top disc 300' and the thread 301', and the two sides of the top disc opening are partially communicated through the demolding hole 305', so that the top cover 3' can be conveniently opened and closed during manufacturing by the demolding hole 305', thereby facilitating the batch manufacturing of the entire top cover 3' and improving 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 disc 300' of the upper end 30'. The arrangement of such demolding holes 305' does not affect the cooperation between the sealing part 22' / top plug positioning point 303' and the surrounding top cover 3' / top plug 2', and therefore does not affect the air tightness of the top cover 3'.

[0158] In the present application, the upper end 30` also has a fitting portion 306`, as shown in FIG. 14B, which is located on the side of the top disc opening of the top disc 300` close to the top plug 2`, i.e. the side in contact with the plug cap 20`. The sealing portion 22` can be fitted with the fitting portion 306` to be inserted into the top disc opening of the top cover 3` of the top disc 300`. Specifically, the fitting portion 306` has a slope towards the top plug 3`, which smoothly tightens the contact surface of the top disc 300` and the top plug 2` from one side of the top disc opening to the other side, i.e. chamfered shape, so that when the sealing portion 22` of the top plug 2` is fitted into the top disc opening, the outer edge thereof can slide along the slope of the fitting portion 306`, reducing the force required for fitting, to further improve the success rate of fitting the sealing portion 22` into the top disc opening, and to improve the sealing efficiency.

[0159] In the present application, the bottom disc 31` can also have an internal protrusion 310`, as shown in FIG. 13C, which is located on the inner wall of the bottom disc 31` away from the upper end 30`, i.e. the top cover 3`, the inner wall of the lowermost end, and protrudes in the axial direction towards the top cover 3`. When the top cover 3` seals the double-chambered carton bottle 1`, due to the presence of the internal protrusion 310`, the contact pressure between the bottle body 12` and the bottom disc 31` at the internal protrusion 310` increases, and the fit is tighter, enhancing the fixation stability of the top cover 3` on the double-chambered carton bottle 1`, making the entire packaging material more airtight. The number of internal protrusions 310` can be an appropriate number, for example, 2 or 3 or 4 or 5 or more, and preferably evenly distributed on the radial section of the bottom disc 31` to form a stable shape, thereby improving the fixation stability of the top plug 3`. In addition, when multiple internal protrusions are evenly distributed on the inside of the bottom disc, for example, 4 internal protrusions 310` are evenly distributed at 90° on the inside of the bottom disc at the lower edge of the cylindrical bottom disc 31`, the stress on the bottom disc can be effectively dispersed, making the bottom disc 31` less likely to gradually loosen due to long-term airtight use or temperature changes, to further improve the anti-loosening ability of the top cover.

[0160] Advantageously, the bottom disc 31` can also have protrusion side openings 311` on both sides of the internal protrusion 310` along the edge of the bottom disc 31` away from the upper end 30`, i.e. the edge of the top cover 3` at the lowermost end, and the number of protrusion side openings 311` can be coordinated with the number of internal protrusions 310`, so the number of protrusion side openings 311` can be 4 or 6 or 8 or 10 or more. When the top cover 3` is fitted with the bottle body 12` and the internal protrusion 310` is subjected to pressure, the protrusion side openings 311` can be deformed and extended to one side / two sides, reducing the force required for sealing, to improve the sealing efficiency.

[0161] The application also provides a double-cavity carton bottle package for injection, which comprises the bottle cap assembly and the double-cavity carton bottle 1` mentioned above, and a double-cavity carton bottle package assembly for injection, which comprises the double-cavity carton bottle package for injection and a sheath 4` used in cooperation with the double-cavity carton bottle package for injection, as shown in FIG. 19. It should be noted that the double-cavity carton bottle package for injection can comprise any combination of the bottle cap assembly and the double-cavity carton bottle 1` formed and / or maintained by any combination proposed in the application.

[0162] The first first protrusion 321` of the bottom disc 31` near the upper outer edge of the upper end 30` has a first first protrusion 321`, and the top end of the inner wall of the sheath 4` is stretched to generate a protrusion in the horizontal direction and is limited on the first first protrusion 321` of the bottom disc 31`, and the top cap 3` and the sheath 4` achieve interference fit, and the top plug 2` and the double-cavity carton bottle 1` are clamped in the middle by the force in opposite directions. In addition, the bypass protrusion 120` of the bottle body 12` is clamped at the octagonal vertex of the inner wall of the sheath 4` and cannot slide relative to the inner wall of the sheath 4`. In the above manner, when the double-cavity carton bottle package is placed in the sheath 4`, the top cap 3` and the top plug 2` therein are fixed more tightly with the bottle mouth 10`, effectively avoiding air leakage, rotation, falling off and the like.

[0163] In the application, the shape of the bottom disc 31` is a cylinder or an octagonal prism, and the sheath 4` comprises a sheath body 40` and a flange 41`. When the top cap 3` and the sheath 4` are interference fit, the top cap 3` and the double-cavity carton bottle 1` are fixed tightly with each other. Since the bottle mouth 10`, the bottle neck 11` and the bottle body 12` of the double-cavity carton bottle 1` are cylindrical, during the process of screwing and / or detaching the injection needle with / from the top cap 3`, the top cap 3` is driven to rotate together with the double-cavity carton bottle 1` due to the force. When the shape of the bottom disc 31` is a cylinder, its smooth outer surface is difficult to be well limited by the inner wall of the sheath 4`, and when the injection needle is screwed / detached, the top cap 3` may drive the entire double-cavity carton bottle 1` to rotate together, so that the injection needle is idle and cannot be fixed / unfixed with / from the top cap 3`.

[0164] Therefore, the shape of the bottom disc 31` of the bottle cap assembly of the package assembly is an octagonal prism, and the shape of the sheath body 40` is an octagonal prism, so that the outer wall of the bottom disc 31` and the inner wall of the sheath body 40` are both octagonal, as shown in FIG. 19. In this way, the bypass protrusion 120` of the double-cavity carton bottle 1` of the package assembly can be limited at the octagonal vertex (B`-B`) of the inner wall of the sheath 4`, and the bottle body 12` will generate a large friction force with the inner wall of the bottom disc 31` during the capping process; when the top cap 3` is subjected to external force from, for example, the injection needle, the interference fit between the bottom disc 31` and the inner wall of the sheath 4` and the mutual fixation (A`-A`) make the top cap 3` not slide off or relatively slide with the double-cavity carton bottle 1`, further making the package assembly as a whole stable and immovable, avoiding the influence on the air tightness of the double-cavity carton bottle 1` and improving the use efficiency.

[0165] In particular, the lower end of the sheath 4` can also have an interference fit structure, and the lower end of the sheath body 40` can be provided with a second protrusion 400`, which is clamped on the flange 41` by pressing, 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` can be prevented from rotating with the packaging material.

[0166] Specifically, in some embodiments, the lyophilized product in the double-chamber carton bottle 1` is subcutaneously injected through an injection needle for the treatment of skin diseases or medical aesthetics. The needle seat of the injection needle has a threaded structure, which is engaged or removed by rotating the threaded structure of the needle seat with the threads 301` of the top cover 3` when the injection needle is installed on the top cover 3` for product injection or removed from the top cover 3`. During this process, the bottom disc 31` of the top cover 3` is fixed and prevented from rotating by the octagonal inner wall of the sheath 4`, and the bypass protrusion 120` of the double-chamber carton bottle 1` is also fixed and prevented from rotating by the apex of the inner wall of the sheath 4`. Therefore, by selecting an octagonal bottom disc 31` and cooperating with the sheath 4`, the double-chamber carton bottle packaging assembly can be prevented from rotating when the injection needle is screwed on or removed, so as to avoid idling when the sterile injection needle is screwed on or removed, and improve the use efficiency of the double-chamber carton bottle packaging assembly.

[0167] At present, most of the lyophilized products on the market use a vial as a drug container. Before injection, a sterile syringe is used to extract a reconstitution solvent from another container containing the reconstitution solvent, and then the reconstitution solvent is injected into the drug container for reconstitution, extraction and administration. The drug administration precision and use compliance are relatively poor. The bottle cap assembly and the double-chamber carton bottle packaging of the present application can effectively use the front chamber to contain lyophilized drugs and the rear chamber to contain reconstitution solvent. During use, the reconstitution solvent can be pushed through the bypass to flow into the front chamber to reconstitute the lyophilized drugs, without the need for multiple extractions, thereby greatly improving the convenience of use for subjects or patients, and enabling self-injection by subjects or patients.

[0168] On the other hand, the bottle cap assembly of the present application can also simultaneously perform capping and sealing of the double-chamber carton bottle in a lyophilizer, so as to maintain the low moisture content of the lyophilized product and maintain the quality stability of the product. Therefore, the bottle cap assembly and the double-chamber carton bottle of the present application can be used to prepare and store various drug preparations, medical aesthetic products and cosmetics, such as insulin, growth factors, vaccines, chemotherapy drugs, hormone drugs, facial filler hyaluronic acid, water and light needles, facial essence and customized perfumes, and improve the application prospect and application range of the above-mentioned products prepared by the lyophilization process.

[0169] Embodiments

[0170] The materials used in the experiments and the experimental methods are generally and / or specifically described in the present application. The reagents or instruments not specified by the manufacturer are all conventional reagent products that can be purchased on the market.

[0171] Example 1

[0172] A bottle cap assembly includes a top plug 3 and a top cap 4 for sealing a double- cavity carton bottle 1. The structure of the double-cavity carton bottle 1 is shown in FIG. 1, and the top plug 3 is used to seal the bottle mouth 10 of the double-cavity carton bottle 1. The double-cavity carton bottle 1 is sealed by the top plug 3 through a pressing plug assembly, wherein the pressing plug assembly includes a pressing jig 21 and a holding jig 20, and the structure thereof is shown in FIG. 2A. The double-cavity carton 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 plug has a plug cap 30 and a plug column 31. The plug column 31 needs to be completely embedded in the opening 100 in the center of the bottle mouth 10, and the lower surface of the plug cap 30 needs to be completely attached to the upper surface of the bottle mouth 10, so as to achieve sealing of the bottle mouth 10.

[0173] Therefore, in the present embodiment, the pressing plug assembly is used to complete the sealing of the bottle mouth 10 by the top plug 3. Specifically,

[0174] (1) First, the pressing plug assembly includes a holding jig 20, the upper and lower ends of which are open. The inner wall of the holding jig 20 is attached to the outer surface of the bottle mouth 10 and the bottle body 12. The holding jig 20 is pressed until it is completely attached to the upper end of the bottle body 12. The holding jig 20 is tightly attached to the bottle mouth 10 and the bottle body 12, and has a large friction force. Therefore, the holding jig 20 is not easy to fall off the double-cavity carton bottle 1. In addition, the upper end of the holding jig 20 protrudes from the bottle mouth 10.

[0175] Next, the top plug 3 is placed in the holding jig 20. Specifically, the top plug is placed on the protruding part 200 of the holding jig 20, which protrudes from the upper end of the holding jig 20. The protruding part 200 can hold the plug cap 30 to fix the position of the top plug 3, so that the plug column 31 is aligned with the bottle mouth opening 100, facilitating the embedding of the plug column 31 into the bottle mouth opening 100 when it is moved downward. In particular, the number of protruding parts 200 is two, which are respectively arranged on both sides of the upper end of the holding jig 20.

[0176] Then, the inner wall of the pressing jig 21 of the pressing assembly is slid down to be attached to the outer wall of the holding jig 20, the lower end of the pressing jig 21 is open, the upper surface is closed and the center is concave downward, a pressing column 210 is arranged on the inner wall side of the concave part of the pressing jig 21 in the axial direction of the pressing jig 21, and the pressing column 210 can contact and apply downward pressure to the plug cap 30 during the downward sliding of the pressing jig 21, so as to realize the movement of the whole pressing plug 3 to the bottle mouth 10, until the plug column 31 is completely embedded in the bottle mouth 10; after the plug column 31 is completely embedded in the bottle mouth 10, the plug cap 30 can be clamped just below the protruding part 200, so that the protruding part 200 can further clamp the pressing plug 3 to prevent it from falling off. It should be noted that before the plug column 31 is completely embedded in the bottle mouth 10, the height of the holding jig 20 protruding from the bottle mouth 10 is less than the height of the upper surface of the pressing jig 21 protruding from the bottle mouth 10; therefore, before the plug column 31 is completely embedded in the bottle mouth 10, the pressing jig 21 cannot move downward due to the obstruction of the holding jig 20, which avoids the incomplete embedding of the pressing plug 3 and the bottle mouth 10. In particular, the number of pressing columns 210 is two, which are arranged on both sides of the inner wall of the concave part of the upper surface of the pressing jig 21, so as to apply uniform downward pressure to the pressing plug 3.

[0177] Finally, the pressing jig 21 and the holding jig 20 are removed, and the pressing assembly is only used to seal the bottle mouth 10 with the pressing plug 3, so it needs to be removed after sealing is completed, so as to facilitate subsequent capping.

[0178] (2) The top cap 4 is used to fix the pressing plug 3 and seal the bottle mouth 10 of the double-cavity carton bottle 1 through the pressing plug 3. The structure of the top cap 4 is shown in FIG. 3, which includes a main body and a bottom disc 41, the main body has a top disc 400 at the center of the upper end of the top cap 4 and an annular thread 401 at the edge of the upper end of the top cap 4, which is arranged above the bottom disc 41, and the lower part of the bottom disc 41 is open; after the pressing plug 3 is completely embedded in the bottle mouth 10, the top cap 4 is pressed downward and fitted on the bottle mouth 10, and in this process, the inner walls of the main body and the bottom disc 41 are attached to the bottle mouth 10 and the bottle neck 11; therefore, after the top cap 4 is pressed until the bottom disc 41 is completely attached to the upper surface of the bottle body 12, the top cap 4 has a large friction with the double-cavity carton bottle 1, which can prevent the top cap 4 from falling off, so as to improve the sealing performance of the double-cavity carton bottle 1.

[0179] The top disc 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 layer, after the bottom disc 41 is completely attached to the upper surface of the bottle body 12, the top disc 400 can hold the pressing plug 3 embedded in the bottle mouth 10 through the lower layer, so as to prevent the pressing plug 3 from falling out of the bottle mouth 10, and improve the sealing performance of the double-cavity carton bottle 1.

[0180] Example 2

[0181] A bottle cap assembly, comprising a top plug 2''and a top cap 3' for sealing a double-cavity carton bottle 1'. Wherein, the structure of the top cap 3' is shown in Fig. 5A. The double-cavity carton bottle 1' is sealed by the top plug 2' through the top cap 3', and the bottle opening 100' of the double-cavity carton bottle 1' is sealed through the top plug 2'. Specifically,

[0182] Firstly, the top plug 2' is limited inside the top cap 3' by the top plug positioning point 303', and the top cap 3' is placed on the bottle opening 100', so that the plug column 21' naturally faces the bottle opening 100', and the freeze-drying is carried out.

[0183] Then, after the freeze-drying is completed, the top plug 2' is pressed into the bottle opening 100' by the top cap 3', and the top cap 3' comprises an upper end 30', a middle end 31' and a lower end 32', the upper end 30' has a top disc 300' in the center, a thread 301' and an opening 302' at the edge of the upper end 30', the middle end 31' is arranged above the upper end 30', the lower end 32' is arranged below the middle end 31', and the lower end 32' is below the opening; after the top plug 2' is initially embedded in the bottle opening 100', the top cap 3' is pressed downward until the upper end 30' is completely sleeved on the bottle opening 100', and in this process, the inner wall of the upper end 30' is attached to the bottle opening 100' and the bottle neck 11', and the inner wall of the middle end 31' and the lower end 32' is attached to the bottle body 12'.

[0184] The top disc 300' is a hollow cylindrical structure with a shortened middle part. During the process of pressing the top cap 3' downward by external force, the top plug 2' is pressed into the bottle opening 100' by the lower surface of the top disc 300', so that the top plug 2' is further embedded into the bottle opening 100', until the plug column 21' with a diameter slightly larger than the inner diameter of the bottle opening 100' is completely embedded into the bottle opening 100' under the action of pressure, and the lower surface of the plug cap 20' is completely attached to the upper surface of the bottle opening 100', so as to seal the double-cavity carton bottle 1' by the top plug 2', without the need of additional plug pressing device for sealing, which reduces the additional process and time required for sealing the double-cavity carton bottle 1', and avoids the influence of inaccurate sealing on the production efficiency of the freeze-drying process.

[0185] In particular, when the top cap 3' is arranged to press the top plug 2' to be completely embedded in the bottle opening 100', the upper surface inner wall of the middle end 31' can also be completely attached to the upper surface of the bottle body 12' ; therefore, while the top cap 3' seals the bottle opening 100' by the top plug 2', the top cap 3' also seals the top plug 2' embedded in the bottle opening 100', and seals the bottle opening 100', the bottle neck 11' and at least a part of the bottle body 12' through the top plug 2', so as to realize the overall sealing of the double-cavity carton bottle 1'.

[0186] The diameter of the upper end 30' is 7.3 mm, and a gap 200' is left between the upper end 30' and the plug cap 20' with a diameter of 7.0 mm; the upper end 30' also has a stopper positioning point 303', as shown in FIGS. 7A and 8, which is located below the top disc 300' and protrudes from the inner wall of the upper end 30' towards the axis of the top cover 3'. After the stopper 2' is completely inserted into the bottle mouth 10', the stopper positioning point 303' is in contact with the plug cap 20', and the plug cap 20' is pressed by the stopper positioning point 303' towards the axis of the top cover 3', thereby increasing the friction between the plug cap 20' and the inner wall of the upper end 30', preventing the stopper 2' from loosening or slipping out of the top cover 3' during the pre-assembly process due to loose fitting. The number of stopper positioning points 303' is four, evenly distributed on the inner wall of the upper end 30'.

[0187] The upper end 30' also has a protrusion 304', as shown in FIG. 9, which is arranged below the stopper positioning point 303' and protrudes from the inner wall of the upper end 30' towards the axis of the top cover 3'. After the stopper 2' is completely inserted into the bottle mouth 10', the protrusion 304' is in contact with the outer wall of the bottle mouth 10', and the bottle mouth 10' is pressed by the protrusion 304' towards 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 out after the closure due to loose fitting, and improving the sealing performance of the double-cavity carton 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 set to semicircular, with a number of two, distributed on both sides of the inner wall of the upper end 30'.

[0188] The lower end 32' is in the shape of a cylinder. The convex ring 310' of the middle end 31' and the convex strip 320' of the lower end 32' can both be used to increase the fitting degree of the top cover 3' and the bottle body 22' after the top cover 3' is fitted with the double-cavity carton bottle 1', further improving the stability of the fitting of the top cover 3' and the double-cavity carton bottle 1'.

[0189] The bottle cap assembly was subjected to a stopper pressing and cap sealing test, and it was found that some stoppers 2' slipped out of the top cover 3' and fell off in the freeze-drying machine, and the fitting of the top cover 3' and the bottle mouth 20' of the double-cavity carton bottle 1' was not firm enough, and the top cover 3' could be easily pulled out of the double-cavity carton bottle 1' with a small force.

[0190] Example 3

[0191] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' was replaced with 0.25 mm, and the other structures and parameters were the same as in Example 2. The bottle cap assembly was subjected to a stopper pressing and cap sealing test, and it was found that some stoppers 2' slipped out of the top cover 3' and fell off, and the fitting of the top cover 3' and the bottle mouth 10' of the double-cavity carton bottle 1' was still not firm enough, and the top cover 3' could be easily pulled out.

[0192] Example 4

[0193] The shape of the protruding part 304' is replaced by a trapezoid, wherein the upper cutting angle of the face of the protruding part 304' toward the axis direction of the top cover 3' is 45°, and the lower cutting angle of the face of the protruding part 304' toward the axis direction of the top cover 3' and the side face thereof is 30°. The maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.30 mm, and the number of the top plug positioning points 303' is replaced by 8, as shown in FIG. 7B, and other structures and parameters are the same as those in Embodiment 2.

[0194] The bottle cap assembly is subjected to the plug pressing and cap sealing test. Since the number of the top plug positioning points 303' is increased, the fit of the top plug 2' and the top cover 3' is improved, and the top plug 2' no longer slips off from the top cover 3'. A very large pressure needs to be applied in the cap pressing process, thus causing deformation and damage of part of the structure of the top cover 3'.

[0195] Embodiment 5

[0196] The upper cutting angle of the face of the protruding part 304' toward the axis direction of the top cover 3' is replaced by 30°, as shown in FIG. 10, and other structures and parameters are the same as those in Embodiment 4. The bottle cap assembly is subjected to the plug pressing and cap sealing test, and the fit of the top plug 2' and the top cover 3' is high, and the top plug 2' does not slip off from the top cover 3'. After the upper cutting angle of the face of the protruding part 304' toward the axis direction of the top cover 3' is replaced by 30°, it is found that a large pressure still needs to be applied in the cap pressing process, thus causing deformation and damage of part of the structure of the top cover 3', and the sealing performance of the top cover 3' is still affected to a certain extent.

[0197] Embodiment 6

[0198] The upper cutting angle of the face of the protruding part 304' toward the axis direction of the top cover 3' is replaced by 30°, and the maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.10 mm, and other structures and parameters are the same as those in Embodiment 4. The bottle cap assembly is subjected to the plug pressing and cap sealing test, and it is found that the fit of the top plug 2' and the top cover 3' is high, and the top plug 2' does not slip off from the top cover 3'. After the upper cutting angle of the face of the protruding part 304' toward the axis direction of the top cover 3' is replaced by 30° and the maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.10 mm, the cap pressing process does not need to apply a large pressure, but the fit of part of the top cover 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is not firm enough, and can be pulled out after a certain force is applied.

[0199] Embodiment 7

[0200] The maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.15mm, and other structures and parameters are the same as those in Embodiment 6. The compression plug and capping sealing test is performed on the bottle cap assembly, and it is found that the fit degree of the top plug 2' and the top cap 3' is high, and the top plug 2' is not slipped out of the top cap 3'. After the maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.15mm, the capping process does not need to apply a large pressure, but the fit of part of the top cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is still not firm enough, and it can still be pulled out after a certain force is applied.

[0201] Embodiment 8

[0202] The maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.20mm, and other structures and parameters are the same as those in Embodiment 6. The compression plug and capping sealing test is performed on the bottle cap assembly, and it is found that the fit degree of the top plug 2' and the top cap 3' is high, and the top plug 2' is not slipped out of the top cap 3'. After the maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.20mm, the capping process does not need to apply a large pressure, and the fit of the top cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is improved, and the cooperation and fixation are relatively firm, and it is not easy to be pulled out after a larger force is applied, and only occasionally appears to be pulled out and fallen off.

[0203] Embodiment 9

[0204] The maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.23mm, and other structures and parameters are the same as those in Embodiment 6. The compression plug and capping sealing test is performed on the bottle cap assembly, and it is found that the fit degree of the top plug 2' and the top cap 3' is high, and the top plug 2' is not slipped out of the top cap 3'. After the maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.23mm, a certain pressure needs to be applied in the capping process, but it does not cause the deformation and damage of part of the structure of the top cap 3'; the fit degree of the top cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is obviously improved, and it is not pulled out after a larger force is applied.

[0205] Embodiment 10

[0206] The maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.25mm, and other structures and parameters are the same as those in Embodiment 6. The compression plug and capping sealing test is performed on the bottle cap assembly, and it is found that the fit degree of the top plug 2' and the top cap 3' is high, and the top plug 2' is not slipped out of the top cap 3'. After the maximum length of the protruding part 304' protruding from the inner wall of the upper end 30' is replaced by 0.25mm, a certain pressure needs to be applied in the capping process, but it does not cause the deformation and damage of part of the structure of the top cap 3'; the fit degree of the top cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is also obviously improved, and it is not pulled out after a larger force is applied.

[0207] Example 11

[0208] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced by 0.28 mm, and other structures and parameters are the same as those in Example 6. The bottle cap assembly is subjected to compression plug and capping sealing test, and it is found that the fit degree of the top plug 2' and the top cap 3' is high, and the top plug 2' is not slipped out of the top cap 3'; after the maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced by 0.28 mm, a larger pressure needs to be applied during the capping process, but it does not cause deformation and damage to part of the structure of the top cap 3'; the fit degree of the top cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is obviously improved and is not pulled out after a larger force is applied.

[0209] Example 12

[0210] 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 FIG. 5B. Specifically, the length of the top cap 3' in Example 3 extending along the bottle neck 11' and the bottle body 12' is shortened, the length of the middle end 31' is shortened, the position of the convex ring 310' relative to the bottle neck 11' and the bottle body 12' is further moved upward, and the lower part of the upper end 30' is fitted. In addition, the convex strip 320' of the lower end 32' is removed, and the non-convex strip part of the lower end 32' is extended downward along the bottle body 12', the lower end 32' is shortened in the radial direction near the upper part of the middle end 31', and the first notch 321' is formed.

[0211] It should be noted that the shape of the extended lower end 32' in this embodiment is set as an octagonal prism, the inner wall of which can still fit at least part of the bottle body 12' of the double-cavity carton bottle 1', and the structure of the adjusted top cap 3' is the same as that of the top cap 3' in Example 11 except the middle end 31' and the lower end 32'. The number of top plug positioning points 303' is 8, which are evenly distributed on the inner wall of the upper end 30'.

[0212] The bottle cap assembly is subjected to compression plug and capping sealing test, and it is found that the fit degree of the top plug 2' and the top cap 3' is high, and the top plug 2' is not slipped out of the top cap 3'; a larger pressure needs to be applied during the capping process, but it does not cause deformation and damage to part of the structure of the top cap 3'; the fit degree of the top cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is obviously improved and is not pulled out after a larger force is applied.

[0213] Example 13

[0214] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced by 0.25 mm, and the other structures and parameters are the same as those of Example 12. The bottle cap assembly is subjected to compression and capping sealing test, and it is found that the fit between the top plug 2' and the top cap 3' is high, and the top plug 2' is not detached from the top cap 3'; a larger pressure needs to be applied during capping, but no deformation or damage to the structure of the top cap 3' occurs; the fit between the top cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is significantly improved, and the top cap 3' is not pulled out after a larger force is applied.

[0215] Example 14

[0216] The structure of the top plug 2' and the top disc 300' of the top cap 3' of the bottle cap assembly in Example 13 is adjusted to improve the degree of limitation of the top plug 2' when it is pre-assembled into the top cap 3' by the top disc 300', as shown in FIG. 6. Specifically, the top plug 2' is provided with a sealing portion 22' protruding upward along the axial direction of the top plug 2' on the upper surface of the plug cap 20', the shape of the top disc opening is circular, the shape of the sealing portion 22' is cylindrical, the radial length L' = 3.6 mm, the shape of the top disc opening is circular, the inner diameter of the circumferential lower edge is 3.4 mm, and the inclination angle β' of the top disc opening is 5°. The other structures and corresponding parameters of the top plug 2' and the top cap 3' are the same as those of Example 12.

[0217] Example 15

[0218] A bottle cap assembly includes a top plug 2` and a top cap 3` for sealing a double-cavity carton bottle 1`. The structure of the top cap 3` is shown in FIG. 13A. The double-cavity carton bottle 1` is sealed by the top plug 2` through the top cap 3`, and the bottle mouth 10` of the double-cavity carton bottle 1` is sealed through the top plug. Specifically:

[0219] First, the top plug 2` is limited inside the top cap 3` by the top plug positioning point 303`, and the top cap 3` is placed on the bottle mouth 10` so that the plug column 21' naturally faces the bottle opening 100`, and the freeze-drying is performed.

[0220] Then, after the freeze-drying is completed, the top plug 2` is pressed into the bottle mouth 10` of the double-cavity carton bottle 1` by the top cap 3`, and the top cap 3` includes an upper end 30` and a bottom disc 31`. The upper end 30` has a top disc 300` located at the center thereof, a thread 301` located at the edge of the upper end 30`, and an opening 302`. The bottom disc 31` has an opening below. After the top plug 2` is initially embedded in the bottle mouth 10`, the top cap 3` is pressed downward until the upper end 30` is completely fitted on the bottle mouth 10`, and in this process, the inner wall of the upper end 30` is fitted with the bottle mouth 10` and the bottle neck 11`, and the inner wall of the bottom disc 31` is partially fitted with the bottle body 12`.

[0221] The top disc 300' is a hollow cylinder structure with a middle shortened part. During the process of pressing the top cap 3' downward by external force, the top plug 2' is pressed to the bottle mouth 10' through the lower surface of the top disc 300', so that the top plug 2' is further embedded into the bottle mouth 10'. Until the plug column 21' with a diameter slightly larger than the inner diameter of the bottle mouth is completely embedded into the bottle mouth 10' under the action of pressure, and the lower surface of the plug cap 20' completely matches the upper surface of the bottle mouth 10', the double-cavity carton bottle 1' is sealed by the top plug 2'. Therefore, the additional plug pressing device is not needed to participate in the sealing, which reduces the additional process and time required for sealing the double-cavity carton bottle 1', and avoids the influence of inaccurate sealing on the production efficiency of the freeze-drying process.

[0222] In particular, when the top cap 3' is arranged to press the top plug 2' to be completely embedded into the bottle mouth 10', the inner wall of the bottom disc 31' can also partially match the top end of the bottle body 12'. Therefore, when the top cap 3' seals the bottle mouth opening 100' by 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'. In this way, the overall sealing of the double-cavity carton bottle 1' is realized.

[0223] The upper end 30' has a diameter of 7.3 mm, and a gap part 200' is left between the upper end 30' and the plug cap 20' with a diameter of 7.0 mm. The upper end 30' also has a top plug positioning point 303', which is located below the top disc 300' and protrudes from the inner wall of the upper end 30' in the direction of the axis of the top cap 3', as shown in FIGS. 17, 15A and 15B. After the top plug 2' is completely embedded into the bottle mouth 10', the top plug positioning point 303' matches the plug cap 20', and the plug cap 20' is pressed by the top plug positioning point 303' in the direction of the axis of the top cap 3', so that the friction between the plug cap 20' and the inner wall of the upper end 30' is increased, preventing the top plug 2' from loosening or slipping out of the top cap 3' during the pre-assembly process due to loose fitting. The number of top plug positioning points 303' is 4, which are evenly distributed on the inner wall of the upper end 30'.

[0224] The upper end 30' also has a protruding portion 304', which is arranged below the top plug 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 plug 2' is completely embedded in the bottle mouth 10', the protruding portion 304' is in contact with the outer wall of the bottle mouth 10', and the bottle mouth 10' is pressed in the direction of the axis of the top cover 3' by the protruding portion 304', so that the friction between the bottle mouth 10' and the inner wall of the upper end 30' is increased, preventing the top cover 3' from slipping off after the sealing due to the loose fitting, and improving the sealing performance of the double-cavity carton bottle 1'. The maximum length of the protruding portion 304' protruding from the inner wall of the upper end 30' is set to 0.20 mm, the shape of the protruding portion 304' is set to trapezoidal, and the number is 2, which is distributed on both sides of the inner wall of the upper end 30', and the upper and lower cutting angles of the face in the direction of the axis of the top cover 3' and the side face are both 30°. The shape of the bottom disc 31' is cylindrical. The bottle cap assembly is subjected to plug pressing and cover sealing test, and it is found that the fitting degree of the top plug 2' and the top cover 3' is good, and the top plug 2' does not fall off from the top cover 3'; the cover sealing process does not cause deformation of the top cover 3', and the top cover 3' is well fixed with the double-cavity carton bottle 1', and only occasionally falls off.

[0225] Example 16

[0226] The maximum length of the protruding portion 304' protruding from the inner wall of the upper end 30' is replaced by 0.23 mm, and the rest of the structure and parameters are the same as in Example 15. The bottle cap assembly is subjected to plug pressing and cover sealing test, and it is found that the fitting degree of the top plug 2' and the top cover 3' is high, and the top plug 2' does not fall off from the top cover 3'; after the maximum length of the protruding portion 304' protruding from the inner wall of the upper end 30' is replaced by 0.23 mm, the cover sealing process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0227] Example 17

[0228] The maximum length of the protruding portion 304' protruding from the inner wall of the upper end 30' is replaced by 0.25 mm, and the rest of the structure and parameters are the same as in Example 15. The bottle cap assembly is subjected to plug pressing and cover sealing test, and it is found that the fitting degree of the top plug 2' and the top cover 3' is high, and the top plug 2' does not fall off from the top cover 3'; after the maximum length of the protruding portion 304' protruding from the inner wall of the upper end 30' is replaced by 0.25 mm, the cover sealing process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0229] Example 18

[0230] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced by 0.28 mm, and the rest of the structure and parameters are the same as in Example 15. The bottle cap assembly is subjected to compression plug sealing and capping sealing tests in sequence, and it is found that the fit between the plug 2' and the cap 3' is high, and the plug 2' does not slip off the 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 does not cause deformation of the cap 3', and the cap 3' does not fall off.

[0231] Example 19

[0232] The structure of the cap 3' of the bottle cap assembly in Example 17 is adjusted to increase the volume of the cap 3', as shown in FIG. 13B. Specifically, the bottom disc 31' in Example 16 is extended downward along the bottle body 12, so that the extended bottom disc 31' can seal at least part of the bottle body 12. It should be noted that the shape of the downwardly extended bottom disc 31' is set to an octagonal prism, and the structure of the adjusted cap 3' is the same as before the adjustment except for the bottom disc 31'. The number of plug positioning points 303' is 8, which are evenly distributed on the inner wall of the upper end 30'.

[0233] The bottle cap assembly is subjected to compression plug sealing and capping sealing tests in sequence, and it is found that the fit between the plug 2' and the cap 3' is high, and the plug 2' does not slip off the cap 3'. The capping process requires a relatively large pressure, but does not cause deformation and damage to part of the structure of the cap 3'. The fit between the cap 3' and the bottle mouth 10' of the double-cavity carton bottle 1' is significantly improved, and the cap 3' is not pulled out after a relatively large force is applied.

[0234] Example 20

[0235] The structure of the plug 2' and the top disc 300' of the cap 3' of the bottle cap assembly in Example 19 is adjusted to improve the fixing tightness of the pre-assembled plug 2' into the cap 3'. Specifically, the plug 2' is provided with a sealing portion 22' protruding upward along the axial direction of the plug 2' on the upper surface of the plug cap 20', and the shape of the top disc opening is set to a circle, with a lower edge diameter of 3.4 mm. The shape of the sealing portion 22' is cylindrical, with a radial length L' = 3.6 mm, as shown in FIG. 14A. The inclination angle β' of the circumferential lower edge to the upper edge of the top disc opening is 5°, and the rest of the structure and parameters are the same as in Example 18.

[0236] Example 21

[0237] The structure of the top disc 300` of the top cover 3` of the bottle cap assembly in Example 20 is adjusted so that the closure part 22` can be more effectively fitted with the top disc opening during the capping process. Specifically, a fitting part 306` is provided on the side of the top disc opening close to the top plug 2`, which is a chamfer along the middle of the top disc opening to the side of the top disc opening close to the top plug 2`. When capping, the edge of the closure part 22` can slide along the fitting part 306` to be more easily inserted into the top disc opening, as shown in FIG. 14B. Accordingly, the inclined angle β` of the circumferential lower edge of the top disc opening to the upper edge thereof is no longer provided, and the other structures and parameters are the same as in Example 19.

[0238] Example 22

[0239] The structure of the bottom disc 31` of the top cover 3` of the bottle cap assembly in Example 21 is adjusted to improve the close-fitting of the bottom disc 31` with the bottle body 12`. Specifically, four internal protrusions 310` are provided equidistantly on the inner wall of the side of the bottom disc 31` away from the upper end 30`, and protrusion two-side openings 311` are provided on both sides of each internal protrusion 310`, as shown in FIG. 13C. The other structures are the same as in Example 20.

Claims

1. A bottle cap assembly for sealing a double-cavity carton bottle, wherein the bottle cap assembly comprises a top plug and a top cap; the top plug seals a bottle mouth of the double-cavity carton bottle; the top plug is pressed by a pressing plug assembly to fit into the double-cavity carton bottle to achieve sealing of the double-cavity carton bottle; the top cap is used to fix the top plug and seal the bottle mouth of the double-cavity carton bottle; and the pressing plug assembly comprises a pressing jig and a holding jig. 2.The bottle cap assembly according to claim 1, wherein the double-cavity carton bottle comprises an inner cavity, a bottle body, a bottle neck and a bottle mouth, a center of the bottle mouth is provided with a bottle mouth opening connected with the inner cavity, an inner diameter of the bottle mouth opening is smaller than an inner diameter of the bottle mouth and the bottle neck; and a bypass is formed on a side outer wall of the bottle body. 3.The bottle cap assembly according to claim 2, wherein the top plug comprises a plug cap and a plug column, a diameter of the plug column is slightly larger than the inner diameter of the bottle mouth opening of the bottle mouth, and a lower surface of the plug cap completely fits an upper surface of the bottle mouth after the plug column is fitted into the bottle mouth opening. 4.The bottle cap assembly according to claim 2, wherein the holding jig is provided with an inner wall fitting the bottle mouth and the bottle body and an upper end protruding from the bottle mouth; and an inner wall of the pressing jig fits and slides with at least a part of an outer wall of the holding jig when the top plug moves to the bottle mouth. 5.The bottle cap assembly according to claim 4, wherein the holding jig is further provided with a protruding part, the protruding part supports and fixes the top plug before the top plug is fitted into the bottle mouth to align the plug column with the bottle mouth opening of the bottle mouth; and the protruding part clamps the top plug after the top plug is fitted into the bottle mouth. wherein 6.The bottle cap assembly according to claim 5, wherein the number of the protruding parts is two or more. 7.The bottle cap assembly according to claim 1, wherein the top cap comprises a main body and a bottom disc, the main body is provided with a top disc and an annular thread, an inner wall of the top cap fits the bottle mouth and the bottle neck; and the bottom disc of the top cap completely fits an upper surface of the bottle body. 8.The bottle cap assembly according to any one of claims 1-7, wherein the process that the top plug is pressed by the pressing plug assembly to fit into the double-cavity carton bottle to achieve sealing of the double-cavity carton bottle comprises the following steps: the top plug is placed in the holding jig to achieve positioning of the top plug relative to the bottle mouth of the double-cavity carton bottle by fitting the holding jig with an outer wall of the bottle mouth of the double-cavity carton bottle; the top plug is pressed by the pressing jig to fit into the bottle mouth of the double-cavity carton bottle; and the pressing jig and the holding jig are removed. 9.A bottle cap assembly for sealing a double-cavity carton bottle, wherein the bottle cap assembly comprises a top plug and a top cap; the top plug is positioned in the top cap to seal a bottle mouth of the double-cavity carton bottle; the top cap is used to press and fix the top plug so that the top plug seals the bottle mouth of the double-cavity carton bottle and seals the double-cavity carton bottle. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10. The bottle cap assembly of claim 9, wherein, the double-cavity cassette bottle comprises an inner cavity, a bottle body, a bottle neck and a bottle mouth, the bottle mouth is provided with a bottle mouth opening connected with the inner cavity, the inner diameter of the bottle mouth opening is smaller than the inner diameter of the bottle mouth and the bottle neck; the outer wall of one side of the bottle body is provided with a bypass protrusion.

11. The bottle cap assembly of claim 10, wherein, the top plug comprises a plug cap and a plug column, the diameter of the plug column is equal to or slightly larger than the inner diameter of the bottle mouth opening of the bottle mouth, after the plug column is embedded into the bottle mouth opening, the lower surface of the plug cap is completely attached to the upper surface of the bottle mouth.

12. The bottle cap assembly of claim 9, wherein, the top cap comprises an upper end, a middle end and a lower end; the upper end is provided with a top disc, a thread and an opening, the middle end is provided with a convex ring, and the lower end is optionally provided with a convex strip, the inner wall of the top cap is attached to the bottle mouth, the bottle neck and at least a part of the bottle body; the center of the top disc is provided with a top disc opening, when the top cap moves towards the bottle mouth, the top disc of the upper end presses the top plug to move into the bottle mouth, so that the top plug is embedded into the bottle mouth.

13. The bottle cap assembly of claim 9, wherein, the top cap comprises an upper end and a bottom disc; the upper end is provided with a top disc, a thread and an opening, the inner wall of the top cap is attached to the bottle mouth; the center of the top disc is provided with a top disc opening, when the top cap moves towards the bottle mouth, the top disc of the upper end presses the top plug to move into the bottle mouth, so that the top plug is embedded into the bottle mouth.

14. The bottle cap assembly of claim 12, wherein, the top plug further comprises a sealing part protruding above the plug cap, the sealing part is inserted into the top disc opening of the top disc of the top cap, when the top plug is embedded into the bottle mouth, the sealing part protrudes longitudinally from the top disc opening of the top disc.

15. The bottle cap assembly of claim 13, wherein, the top plug further comprises a sealing part protruding above the plug cap, the sealing part is inserted into the top disc opening of the top disc of the top cap, when the top plug is embedded into the bottle mouth, the sealing part protrudes longitudinally from the top disc opening of the top disc.

16. The bottle cap assembly of claim 15, wherein, the upper end is further provided with an embedding part, the embedding part is located on one side of the top disc opening of the top disc close to the top plug, the sealing part cooperates with the embedding part to be inserted into the top disc opening of the top disc of the top cap.

17. The bottle cap assembly of claim 12 or 13, wherein, the upper end of the top cap is further provided with a top plug positioning point, the top plug positioning point protrudes from the inner wall of the upper end towards the axis of the top cap, for fixing the top plug embedded into the bottle mouth.

18. The bottle cap assembly of claim 17, wherein, the number of the top plug positioning points is 4 or 5 or more.

19. The bottle cap assembly of claim 13, wherein, the upper end is further provided with a demolding hole, the demolding hole is located at the connection between the top disc and the thread; preferably, the number of the demolding holes is 4 or 5 or more.

20. The bottle cap assembly of claim 13, wherein, the bottom disc further has internal protrusions located on the inner wall of the bottom disc 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 or 3 or more.

21. The bottle cap assembly of claim 20, wherein, the bottom disc is provided with protrusion-side openings on both sides of the protrusions along the edge of the bottom disc on the side away from the upper end; preferably, the number of protrusion-side openings is 4 or 6 or more.

22. The bottle cap assembly of claim 12, wherein, the lower end is in the shape of a cylinder or an octagonal prism; preferably, the lower end is in the shape of an octagonal prism.

23. The bottle cap assembly of claim 13, wherein, the bottom disc is in the shape of a cylinder or an octagonal prism; preferably, the bottom disc is in the shape of an octagonal prism.

24. A dual-chamber carton for injection, comprising the bottle cap assembly of any one of claims 1-23 and a dual-chamber carton.

25. A dual-chamber carton for injection assembly, comprising the dual-chamber carton for injection of claim 24 and a sheath.

26. The package assembly of claim 25, wherein, the lower end of the bottle cap assembly of the carton is in the shape of an octagonal prism, the sheath is in the shape of an octagonal prism, the inner wall of the sheath is octagonal, and the bypass protrusion of the dual-chamber carton of the carton is located at the octagonal vertex of the inner wall of the sheath; and the top of the inner wall of the sheath has protrusions in the horizontal direction and is assembled with the lower end of the bottle cap assembly of the carton by interference fit to further clamp the top plug and the dual-chamber carton with the lower end.

27. The package assembly of claim 25, wherein, the bottom disc of the bottle cap assembly of the carton is in the shape of an octagonal prism, the sheath comprises a sheath body and a flange, the sheath is in the shape of an octagonal prism, the inner wall of the sheath body is octagonal, and the bypass protrusion of the dual-chamber carton of the carton is located at the octagonal vertex of the inner wall of the sheath body; and the top of the inner wall of the sheath body has protrusions in the horizontal direction and is assembled with the bottom disc of the bottle cap assembly of the carton by interference fit to further clamp the top plug and the dual-chamber carton with the bottom disc. ​

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