Bottle cap assembly

Abstract

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

Description

Technical Field

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

[0002] At present, the vast majority of freeze-dried products on the market use vials as drug containers. Before injection, it is necessary to first draw the reconstitution solvent from another container containing the reconstitution solvent with a sterile syringe, and then inject the reconstitution solvent into the drug container for reconstitution, extraction, and administration. The dosing accuracy and user compliance are relatively poor, while the dual-chamber cartridge packaging can provide a better choice. The dual-chamber cartridge is divided into two chambers by a middle stopper. The front chamber is used to hold the freeze-dried drug, and the rear chamber is used to hold the reconstitution solvent. During use, the reconstitution solvent can be flowed into the front chamber through the bypass by pushing the bottom stopper to reconstitute the freeze-dried drug. After complete dissolution, continue to push the bottom stopper to the top to complete the injection process. The dual-chamber cartridge is an innovative drug packaging in the global fields of biopharmaceuticals, cosmetics, or medical aesthetics. It is compatible with a variety of dosing devices, has the advantages of convenient use, high patient safety and compliance, and has a very broad application prospect.

[0003] However, the existing dual-chamber cartridge packaging cannot complete the integrated operation process of self-plugging and capping in the freeze dryer. Therefore, it is necessary to design an innovative packaging material that can achieve integrated sealing in the freeze dryer cavity to meet the requirements of the airtightness of the freeze-drying process and enable the packaging material to meet future dosing methods. For example, the closing device and sealing component for a container disclosed in CN102259723A have high sealing performance, but cannot meet the sublimation and discharge of product moisture from the container (mainly gas) during the freeze-drying process. Therefore, such packaging materials cannot be directly applied in the freeze-drying process and may require additional capping steps, increasing the time cost and possibly affecting the freeze-drying effect of the drug in the container during the transfer of the container.

[0004] CN117208401A discloses a bottle cap and a dual-chamber cartridge. After the freeze-drying is completed, the partition in the freeze dryer can directly apply pressure to the bottle cap to switch the bottle cap from the semi-closed state to the fully closed state to seal the dual-chamber cartridge. However, the bottle cap is limited before capping by the hooking part on the inner side of its cavity and the clamping groove on the outer peripheral surface of the annular protrusion of the mouth of the dual-chamber cartridge. If the partition of the freeze dryer applies uneven force due to reasons such as the uneven placement of the dual-chamber cartridge, it is easy to cause the inclination of the bottle cap during the capping process. Since the shape of the hooking part is an asymmetric cylinder up and down, it may be difficult to press down the tilted side normally by continuing to apply pressure after the bottle cap is tilted. In addition, there is a risk that the inner cap slips downward in the semi-closed state, reducing the efficiency of moisture sublimation during the freeze-drying process.

[0005] Furthermore, CN117228154A discloses a combined bottle cap and a dual-chamber cartridge bottle. The combined bottle cap has an inner cap and an outer cap. The first engaging member of the outer cap contacts the outer wall of the inner cap and is fixed relative to the inner cap through the barb-shaped structure of the first engaging member. Therefore, it may be possible to avoid the problem of poor sealing caused by the inclination of the bottle cap during the capping process. However, when the outer cap is in the semi-cap state, since the contact area between the first engaging member and the outer wall of the inner cap is very limited, the outer cap may not be stably positioned at the outer edge of the inner cap during the freeze-drying process, resulting in the detachment of the outer cap.

[0006] In addition, when the existing packaging materials for dual-chamber cartridge bottles obtain freeze-dried products and cooperate with injection needles, there are also problems in use such as the lack of an anti-rotation structure, excessive crimping force, and core extraction of the injection needle. In the following text, feasible solutions to the above problems will be provided based on the packaging materials for dual-chamber cartridge bottles proposed in this application.

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

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

[0009] In one aspect of this application, a bottle cap assembly is provided. The bottle cap assembly may include a top plug and a top cover for sealing a dual-chamber cartridge bottle. The top plug is limited within the top cover and is used to seal the mouth of the dual-chamber cartridge bottle; the top cover is used to press and fix the top plug so that the top plug seals the mouth of the dual-chamber cartridge bottle; and to seal the dual-chamber cartridge bottle. Among them, the process of the top cover pressing and fixing the top plug so that the top plug seals the mouth of the dual-chamber cartridge bottle includes the following steps:

[0010] Pre-assemble the top plug into the top cover; place the top cover with the pre-assembled top plug above the mouth of the dual-chamber cartridge bottle and press the top cover downward. After the top plug is pre-assembled into the top cover, the top plug and the top cover are integrally formed, and there is no need to introduce a plugging component. The top cover can directly achieve plugging and sealing by pressing the top plug. In addition, in this way, there is no need to additionally remove the plugging component to provide further capping for the dual-chamber cartridge bottle. The application of the top cover on the dual-chamber cartridge bottle significantly reduces the operation steps and time required for self-plugging and sealing and capping of the dual-chamber cartridge bottle, improves the sealing efficiency of the dual-chamber cartridge bottle in the freeze-drying process, and avoids the number of operation failures caused by more operation steps. When it is difficult to remedy the failed operation in the freeze-drying process in a conventional manner, the integrated operation of self-plugging and capping of the top cover is particularly important for ensuring the freeze-drying process efficiency.

[0011] In some embodiments of the present application, the dual-chamber cartridge may include: an inner chamber, a cartridge body, a bottleneck, and a bottle mouth. An opening of the bottle mouth connected to the inner chamber may be provided at the center of the bottle mouth, and the inner diameter of the opening of the bottle mouth is smaller than the inner diameters of the bottle mouth and the bottleneck; a bypass protrusion may be provided on one outer wall of the cartridge body. After the dual-chamber cartridge completes the freeze-drying process and is placed in the sheath, the bypass protrusion of the cartridge body can be clamped at the vertex of the inner wall of the sheath, so that the dual-chamber cartridge will not rotate along its longitudinal axis under the action of external force when stored in the sheath. During the process of the injection needle being engaged with or removed from the dual-chamber cartridge, it needs to rotate on the threaded structure of the dual-chamber cartridge. Therefore, the dual-chamber cartridge is fixed against rotation by the bypass protrusion, which can prevent the injection needle from co-rotating with the dual-chamber cartridge, thereby avoiding the idle rotation of the injection needle, and thus realizing the efficient screwing and removal of the injection needle on the dual-chamber cartridge.

[0012] In some embodiments of the present application, the top plug may include a plug cap and a plug post. The diameter of the plug post is equal to or slightly larger than the inner diameter of the opening of the bottle mouth. After the plug post is inserted into the opening of the bottle mouth, the lower surface of the plug cap is completely fitted with the upper surface of the bottle mouth.

[0013] In some embodiments of the present application, the top cover may include an upper end, a middle end, and a lower end; the upper end may have a top plate, a thread, and an opening, the middle end may have a convex ring, and optionally the lower end may have a rib. The inner wall of the top cover fits with the bottle mouth, the bottleneck, and at least a part of the cartridge body; when the top cover moves towards the bottle mouth, the top plate at the upper end presses the top plug to move into the bottle mouth, so that the top plug is inserted into the bottle mouth. The center of the top plate has an opening of the top plate. The upper end of the top cover fixes the pre-assembled top plug through the top plate and continues to clamp the top plug after the top plug is inserted into the bottle mouth.

[0014] After the middle end and the lower end are fitted with the outer wall of the cartridge body, the top cover as a whole can seal the bottle mouth, the bottleneck, and at least a part of the cartridge body, thereby providing a complete seal for the bottle mouth fitted with the top plug and increasing the sealing effect on the bottle mouth. When the lower end has ribs, the ribs contract radially along the top cover, making the fit between the lower end and the cartridge body closer, further preventing the top cover from loosening and slipping, and increasing the sealing effect on the dual-chamber cartridge. The convex ring is used to match the sheath, and the opening can facilitate the sublimation and discharge of moisture in the product from the dual-chamber cartridge to further reduce the moisture content of the freeze-dried product in the dual-chamber cartridge during the freeze-drying process. The thread is used for threaded engagement with the sterile injection needle.

[0015] In some embodiments of the present application, the top plug may further include a sealing portion protruding above the plug cap. The sealing portion is inserted into the top plate opening of the top cover. When the top plug is inserted into the bottle mouth, its sealing portion protrudes longitudinally from the top plate opening of the top plate. During the process of pre-assembling the top plug into the top cover, the sealing portion can be inserted into the top plate opening, and its edge portion is closely attached to the circumferential outer edge of the top plate opening and finally partially protrudes from the upper edge of the top plate opening. By inserting and fitting the sealing portion into the top plate opening during the pre-assembly of the top plug and cooperating with the top plug positioning point to limit the plug cap, the top plug can be more stably fixed in the top cover. Therefore, the external forces applied to the top cover during actual production, such as shock and suspension, will not affect the fixation of the top plug in the top cover, thus preventing the top plug from falling off the top cover before the capping operation. In addition, after the top plug seals the bottle mouth opening, there is a gap portion provided between the top plug and the top cover. After the injection needle is inserted into the top plug, the compressed volume extends outward to the gap portion at the outer edge, which can prevent the pressure from concentrating on the sealing portion, thus avoiding core taking by the injection needle.

[0016] In some embodiments of the present application, the upper end of the top cover may further have a top plug positioning point protruding from the inner wall of the upper end in the direction of the axis of the top cover for fixing the top plug fitted with the bottle mouth. By further fixing the top plug through the top plug positioning point, the sealing stability of the top plug is improved.

[0017] 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 extend radially along the top cover and are evenly spaced circumferentially on the inner wall of the upper end, which can provide uniform fixing force for the top plug. When the top plug shows a tendency to slip off, it is difficult for the top plug to displace more in any direction than in other directions. Therefore, it is more difficult for the top plug to slip off the bottle mouth. In addition, the top plug positioning point can also be used for positioning the top plug before it is pressed into the bottle mouth. The top plug is limited by the top plug positioning point to prevent it from slipping into the bottle mouth autonomously.

[0018] In some embodiments of the present application, the inner wall of the upper end of the top cover may further be provided with a protruding portion protruding in the direction of the axis of the top cover. The top cover can be limited on the bottle mouth through the protruding portion before capping, so that the sublimated moisture in the inner cavity can be discharged through the opening. Therefore, the setting of the protruding portion helps to provide gas exchange and moisture discharge for the double-chamber cartridge bottle. After the top plug is pressed into the bottle mouth, the top cover is simultaneously capped and fixed. The protruding structure of the protruding portion makes the upper end fit more closely with the bottle mouth, which is beneficial to maintaining the fixation of the top cover on the bottle mouth after capping and improving the stability of the capping tightness.

[0019] In some embodiments of the present application, the number of the convex portions is two or three or more; preferably, the maximum length of the convex portion protruding in the direction of the top cover axis is 0.10 mm - 0.30 mm. Similarly, the convex portions are evenly spaced circumferentially on the inner wall of the upper end, so that the upper end fits evenly with the bottle mouth, and the top cover cannot slip off from one side, further improving the stability of the fixation of the top cover on the double-chamber cartridge bottle.

[0020] In some embodiments of the present application, the shape of the convex portion is trapezoidal, semi-circular, semi-elliptical or rectangular. Preferably, the shape of the convex portion is trapezoidal; when the shape of the convex portion is trapezoidal, preferably, the upper cutting angle between the surface of the convex portion in the direction of the top cover axis and its side surface is 30° - 45°, and further preferably, the upper cutting angle between the surface of the convex portion in the direction of the top cover axis and its side surface is 30°; and when the shape of the convex portion is trapezoidal, further preferably, a lower cutting angle is formed between the surface of the convex portion in the direction of the top cover axis and its side surface, and more preferably, the lower cutting angle is 30°. When the shape of the convex portion is trapezoidal, the fitting tightness between the upper end and the bottle mouth is relatively good, and the top cover can be stably fitted on the double-chamber cartridge bottle at a high level; when the upper cutting angle between the surface of the convex portion in the direction of the top cover axis and its side surface is 30° and the lower cutting angle is 30°, the capping process of the top cover will not cause structural damage to the top cover due to excessive capping force, and at the same time, it can also maintain a high-level fit between the top cover and the double-chamber cartridge bottle, improving the capping efficiency and capping accuracy in the freeze-drying process.

[0021] In some embodiments of the present application, the shape of the lower end is cylindrical or octagonal prism. Preferably, the shape of the lower end is octagonal prism, which has an octagonal surface structure. After the double-chamber cartridge bottle is placed in a sheath with an octagonal structure, the lower end can be matched and fitted with the octagonal inner wall of the sheath. This way of fitting the lower end with the sheath can fix the double-chamber cartridge bottle inside the sheath, so that the double-chamber cartridge bottle and the bottle cap assembly will not rotate along their own longitudinal axes due to external force, thus ensuring the efficient screwing and removal of the sterile injection needle on the packaging material of the double-chamber cartridge bottle.

[0022] According to another aspect of the present application, there is provided a packaging material for an injectable double-chamber cartridge bottle, which includes the bottle cap assembly and the double-chamber cartridge bottle provided by the present application.

[0023] According to still another aspect of the present application, there is further provided a packaging material assembly for an injectable double-chamber cartridge bottle, which includes the double-chamber cartridge bottle assembly and the sheath provided by the present application. The sheath can cooperate with the lower end and the bypass protrusion to fix the packaging material of the double-chamber cartridge bottle.

[0024] In some embodiments of the present application, the lower end of the cap assembly of the packaging material has an octagonal prism shape, the sheath has an octagonal prism shape, its inner wall is octagonal, and the bypass protrusion of the dual-chamber cartridge of the packaging material is located at the vertices of the octagon on 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 lower end of the cap assembly of the packaging material by interference fit to further clamp the top plug and the dual-chamber cartridge with the lower end. By utilizing the interference fit between the sheath and the lower end of the cap assembly, the sheath and the cap assembly apply tensile forces to each other, thereby clamping the dual-chamber cartridge towards the middle, so that the top plug and the top cap can be more tightly fitted with the bottle mouth opening and the bottle mouth respectively, improving the sealing performance of the packaging material.

[0025] According to another aspect of the present application, a cap assembly is provided, wherein the cap assembly may include a top plug and a top cap for sealing a dual-chamber cartridge. The top plug is limited within the top cap and is used to seal the bottle mouth of the dual-chamber cartridge; the top cap is used to press and fix the top plug so that the top plug seals the bottle mouth of the dual-chamber cartridge; and to seal the dual-chamber cartridge; the top cap may include an upper end, the upper end may have a top plate, and the center of the top plate has a top plate opening. The top plug may further include a sealing portion, and the sealing portion is inserted into the top plate opening of the top plate. Among them, the top cap pressing and fixing the top plug so that the top plug seals the bottle mouth of the dual-chamber cartridge may include the following steps:

[0026] Pre-assemble the top plug into the top cap; place the top cap already assembled with the top plug above the bottle mouth of the dual-chamber cartridge and press the top cap downward. After the top plug is pre-assembled into the top cap, the top plug and the top cap are integrally formed, and there is no need to introduce a plug pressing assembly. The top cap can directly achieve plug pressing and sealing by pressing the top plug; in addition, in this way, there is no need to additionally remove the plug pressing assembly to provide further capping for the dual-chamber cartridge. The application of the top cap on the dual-chamber cartridge significantly reduces the operation steps and time required for self-plug pressing and capping of the dual-chamber cartridge, improves the sealing efficiency of the dual-chamber cartridge in the freeze-drying process, and avoids the number of operation failures caused by more operation steps. When it is difficult to remedy the failed operation in the freeze-drying process in a conventional manner, the self-plug pressing and capping integrated operation of the top cap is particularly important for ensuring the freeze-drying process efficiency.

[0027] In some embodiments of the present application, the upper end further has a fitting portion, the fitting portion is located on the side of the top plate opening of the top plate close to the top plug, and the sealing portion cooperates with the fitting portion to be inserted into the top plate opening of the top plate. During the capping process, since the fitting portion has a chamfer along the side close to the top plug, the sealing portion slides along the edge of the fitting portion when being inserted into the top plate opening, which is suitable for enabling the sealing portion to smoothly complete the fitting with the top plate opening under a small applied force, avoiding deformation of the sealing portion due to uneven force and affecting the capping process or the capping airtightness, so as to improve the efficiency of the capping process.

[0028] In some embodiments of the present application, the dual-chamber cartridge may include: an inner cavity, a bottle body, a bottleneck, and a bottle mouth. An opening of the bottle mouth connected to the inner cavity may be provided at the center of the bottle mouth, and the inner diameter of the opening of the bottle mouth is smaller than the inner diameters of the bottle mouth and the bottleneck; a bypass protrusion may be provided on one outer wall of the bottle body. After the dual-chamber cartridge completes the freeze-drying process and is placed in the sheath, the bypass protrusion of the bottle body can be clamped at the vertex of the inner wall of the sheath, so that the dual-chamber cartridge will not rotate along its longitudinal axis under external force when stored in the sheath. During the process of the sterile injection needle being engaged with or removed from the dual-chamber cartridge, it needs to rotate on the threaded structure of the dual-chamber cartridge. Therefore, the dual-chamber cartridge is fixed against rotation by the bypass protrusion, which can prevent the sterile injection needle from co-rotating with the dual-chamber cartridge, and further prevent the sterile injection needle from idling, thereby achieving efficient screwing and removal of the sterile injection needle on the packaging material of the dual-chamber cartridge.

[0029] In some embodiments of the present application, the top plug may include a plug cap and a plug post. The diameter of the plug post is equal to or slightly larger than the inner diameter of the opening of the bottle mouth. After the plug post is inserted into the opening of the bottle mouth, the lower surface of the plug cap fits completely with the upper surface of the bottle mouth.

[0030] In some embodiments of the present application, the top cover may further include a chassis; the upper end may further have a thread and an opening, and the inner wall of the top cover fits with the bottle mouth; when the top cover moves towards the bottle mouth, the top plate at the upper end presses the top plug to move into the bottle mouth, so that the top plug is inserted into the bottle mouth. The upper end of the top cover fixes the pre-assembled top plug through the top plate and continues to clamp the top plug after the top plug is inserted into the bottle mouth; after the chassis fits with the outer wall of the bottle body, the whole top cover can seal the bottle mouth and the connection between the bottleneck and the bottle body, thereby providing complete sealing of the bottle mouth with the top plug inserted, increasing the sealing effect of the bottle mouth. The top cover has the characteristics of small volume and fast loading and unloading, which can improve the self-plugging and capping efficiency of the dual-chamber cartridge in the freeze-drying process. When the chassis extends downward along the bottle body, its fit with the bottle body further prevents the top cover from loosening and slipping, increasing the sealing effect of the dual-chamber cartridge. The opening can facilitate the sublimation of moisture in the product from the dual-chamber cartridge to further reduce the moisture content of the freeze-dried product in the dual-chamber cartridge during the freeze-drying process. The thread is used for threaded engagement with the sterile injection needle.

[0031] The chassis can be a hollow cylinder or octagonal prism with an opening at the bottom. Preferably, the chassis is an octagonal prism, which has an octagonal surface structure. After the dual-chamber cartridge completes the freeze-drying process and is placed in the sheath, the chassis matches and fits with the octagonal inner wall of the sheath. This way of fitting the chassis with the sheath can also clamp the dual-chamber cartridge, so that the dual-chamber cartridge will not rotate along its longitudinal axis under external force when stored, thus ensuring efficient screwing and removal of the injection needle on the top cover. In addition, the chassis and the sheath are assembled and fixed by interference fit, and force is applied from the upper and lower ends of the packaging material towards the middle to further compress the top plug, improving the sealing degree of the top plug and the top cover.

[0032] In some embodiments of the present application, when the top plug is inserted into the bottle mouth, its sealing portion longitudinally protrudes from the top plate opening of the top disc. During the process of pre-assembling the top plug into the top cover, the sealing portion can be inserted into the top plate opening, and its edge portion is closely attached to the circumferential outer edge of the top plate opening, and finally partially protrudes from the upper edge of the top plate opening; by inserting and fitting the sealing portion into the top plate opening during the pre-assembly process of the top plug and cooperating with the top plug positioning point to limit the plug cap, the top plug can be more stably fixed in the top cover. Therefore, the external forces applied to the top cover during actual production, such as vibration and suspension, will not affect the fixation of the top plug in the top cover, thus avoiding the top plug falling off from the top cover before the capping operation; in addition, after the top plug seals the bottle mouth opening, there is a gap portion provided between the top plug and the top cover. After the injection needle is inserted into the top plug, the volume under pressure extends outward into the edge gap portion, which can prevent the pressure from concentrating on the sealing portion, thus avoiding the core-taking phenomenon when the injection needle is inserted.

[0033] In some embodiments of the present application, the upper end of the top cover may further have a top plug positioning point, which protrudes from the inner wall of the upper end in the direction of the axis of the top cover and is used to fix the top plug fitted with the bottle mouth. Through the further fixation of the top plug by the top plug positioning point, the sealing stability of the top plug is improved.

[0034] 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 also extend radially along the top cover and are evenly spaced circumferentially on the inner wall of the upper end, which can provide uniform fixing force for the top plug. When the top plug shows a tendency to slip, it is difficult for the top plug to displace more in any direction than in other directions, so it is more difficult for the top plug to slip out of the bottle mouth. In addition, the top plug positioning point can also be used for positioning the top plug before it is pressed into the bottle mouth. The top plug is limited by the top plug positioning point to prevent it from slipping into the bottle mouth autonomously.

[0035] In some embodiments of the present application, the upper end of the top cover may further be provided with a protruding portion protruding in the direction of the axis of the top cover on its inner wall. The top cover can be limited on the bottle mouth by the protruding portion before capping, so that the moisture of the product in the inner cavity can be sublimated and discharged through the opening; therefore, the setting of the protruding portion helps to provide gas exchange and moisture sublimation and discharge for the double-chamber cartridge bottle. After the top plug is pressed into the bottle mouth, the top cover is simultaneously capped and fixed. The protruding structure of the protruding portion makes the upper end fit more closely with the bottle mouth, which is beneficial to maintaining the fixation of the top cover after capping and improving the stability of the capping tightness.

[0036] In some embodiments of the present application, the number of protruding portions is 2 or 3 or more; preferably, the maximum length of the protruding portion protruding in the direction of the axis of the top cover is 0.10 mm - 0.30 mm. The protruding portions are evenly spaced circumferentially on the inner wall of the upper end, so that the upper end fits evenly with the bottle mouth and the top cover does not slip off from one side, further improving the stability of the fixation of the top cover on the double-chamber cartridge bottle.

[0037] In some embodiments of the present application, the shape of the raised portion is trapezoidal, semi-circular, semi-elliptical or rectangular. Preferably, the shape of the raised portion is trapezoidal; when the shape of the raised portion is trapezoidal, preferably, the upper cutting angle between the surface of the raised portion facing the axis of the top cover and its side surface is 30°-45°, and further preferably, the upper cutting angle between the surface of the raised portion facing the axis of the top cover and its side surface is 30°; and when the shape of the raised portion is trapezoidal, further preferably, the lower cutting angle is formed between the surface of the raised portion facing the axis of the top cover and its side surface, and more preferably, the lower cutting angle is 30°. When the shape of the raised portion is trapezoidal, the tightness of the upper end fitting with the bottle mouth is relatively good, and the top cover can be stably fitted on the dual-chamber cartridge bottle at a high level; when the upper cutting angle between the surface of the raised portion facing the axis of the top cover and its side surface is 30° and the lower cutting angle is 30°, the capping process of the top cover will not cause structural damage to the top cover due to excessive capping force, and at the same time, the high fitting degree between the top cover and the dual-chamber cartridge bottle is maintained, improving the capping efficiency and capping accuracy in the freeze-drying process using the top cover.

[0038] In some embodiments of the present application, the upper end further has a demolding hole, and the demolding hole is located at the connection between the top plate and the thread; preferably, the number of demolding holes is 4 or 5 or more. The demolding hole communicates with the upper and lower sides of the top plate and the opening of the top plate, facilitating mold opening and closing during the production of the top cover, thereby improving the production efficiency of the top cover; since it does not communicate with the outside of the upper end, the demolding hole will not affect the airtightness of the entire upper end and even the top cover, maintaining the normal function of the top cover.

[0039] In some embodiments of the present application, the chassis further has internal protrusions, and the internal protrusions are located on the inner wall of the chassis on the side away from the upper end and protrude in the direction of the axis of the top cover; preferably, the number of internal protrusions is 4 or 5 or more. When the top cover maintains the airtightness of the dual-chamber cartridge bottle, the chassis increases the contact pressure with the bottle body due to the internal protrusions, generating greater fitting strength, so that the top cover cannot become loose during the airtight storage and transfer of the dual-chamber cartridge bottle; in addition, when multiple internal protrusions are evenly distributed on the inner side of the chassis, the stress received by the chassis can be effectively dispersed, further improving the anti-loosening ability of the top cover.

[0040] In some embodiments of the present application, on both sides of the internal protrusion along the edge of the chassis on the side away from the upper end, there are also openings on both sides of the protrusion, preferably, the number of openings on both sides of the protrusion is 4 or 5 or more. When the internal protrusion fits the bottle body, it can extend towards the openings on both sides of the protrusion, so that there is no need to overcome a large frictional force during the capping process. In this way, the internal protrusion will not significantly hinder the capping process.

[0041] According to another aspect of the present application, there is also provided an injection dual-chamber cartridge bottle packaging material, which includes a bottle cap assembly provided by the present application and a dual-chamber cartridge bottle.

[0042] According to another aspect of the present application, there is also provided an injection double-chamber cartridge packaging component, which includes the double-chamber cartridge component provided by the present application and a sheath. The sheath can cooperate with the chassis and the bypass protrusion to fix the double-chamber cartridge packaging material.

[0043] In some embodiments of the present application, the shape of the chassis of the cap assembly of the packaging material is cylindrical or octagonal prism, preferably octagonal prism. The sheath includes a sheath body and a flange, the shape of which is octagonal prism, and its inner wall is octagonal. The bypass protrusion of the double-chamber cartridge of the packaging material is located at the vertex of the octagon on the inner wall of the sheath; and there is a protrusion along the horizontal direction at the top of the inner wall of the sheath, which is assembled with the chassis of the cap assembly of the packaging material by interference fit to further clamp the top plug and the double-chamber cartridge with the chassis. By using the interference fit between the sheath and the chassis of the cap assembly, the sheath and the cap assembly apply tensile forces to each other, thereby clamping the double-chamber cartridge towards the middle, so that the top plug and the top cover can be more tightly fitted with the bottle mouth opening and the bottle mouth respectively, improving the sealing performance of the packaging material.

[0044] Compared with the prior art, the present application has at least one of the following technical effects:

[0045] 1. The present application provides an integrated self-pressing plug and capping seal for the cap assembly and the double-chamber cartridge in a freeze dryer.

[0046] 2. The present application can improve the airtightness between the bottle plug and the bottle mouth of the double-chamber cartridge.

[0047] 3. The present application can improve the sealing degree between the capping assembly for sealing and the double-chamber cartridge.

[0048] 4. The present application can reduce the time required for sealing the double-chamber cartridge in the freeze-drying process by reducing the operation steps, and at the same time avoid the reduction of the freeze-drying effect caused by sealing failure in the freeze dryer, thereby improving the freeze-drying efficiency and freeze-drying quality.

[0049] 5. The double-chamber cartridge packaging material of the present application can effectively maintain the anti-rotation of the bottle cap and prevent the top plug from being cored, which helps the efficient cooperation and use of the injection needle and the double-chamber cartridge packaging component.

[0050] 6. There is a good matching structure between the top plug and the top cover of the cap assembly provided by the present application, and between the top cover and the double-chamber cartridge, so that the plugging and capping can be achieved quickly and smoothly. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] By describing the embodiments of the present application in more detail in conjunction with the drawings, the above and other objects, features, and advantages of the present application will become more obvious. The drawings are used to provide a further understanding of the embodiments of the present application, and constitute a part of the specification, and are used to explain the present application together with the embodiments of the present application, and do not constitute a limitation to the present application. In the drawings, the same reference numerals generally represent the same components or steps.

[0052] Figure 1 Illustrates the structural schematic diagrams of the double-chamber cartridge bottle 1 and the top plug 2 of the present application.

[0053] Figure 2A Illustrates the structural schematic diagram of the top cover 3 of the present application.

[0054] Figure 2B Illustrates another structural schematic diagram of the top cover 3 of the present application.

[0055] Figure 3 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.

[0056] Figure 4A Illustrates the structural schematic diagram of the top plug positioning point 303 of the present application.

[0057] Figure 4B Illustrates another structural schematic diagram of the top plug positioning point 303 of the present application.

[0058] Figure 5 Illustrates the structural schematic diagram of the upper end 30 of the present application.

[0059] Figure 6 Illustrates the structural schematic diagram of the maximum length of the convex portion 304 of the present application.

[0060] Figure 7 Illustrates the structural schematic diagrams of the upper chamfer and the lower chamfer of the convex portion 304 of the present application.

[0061] Figure 8 Illustrates the structural schematic diagram of the packaging material assembly of the double-chamber cartridge bottle of the present application.

[0062] Figure 9 Illustrates the structural schematic diagrams of the double-chamber cartridge bottle 1' and the top plug 2' of the present application.

[0063] Figure 10A Illustrates the structural schematic diagram of the top cover 3' of the present application.

[0064] Figure 10B Illustrates another structural schematic diagram of the top cover 3' of the present application.

[0065] Figure 10C Illustrates yet another structural schematic diagram of the top cover 3' of the present application.

[0066] Figure 11A 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.

[0067] Figure 11B Illustrates the structural schematic diagram of the fitting portion 306' of the top cover 3' of the present application.

[0068] Figure 12A The figure shows a schematic structural diagram of the top plug positioning point 303' of the present application.

[0069] Figure 12B The figure shows another schematic structural diagram of the top plug positioning point 303' of the present application.

[0070] Figure 12C The figure shows a top view of the demolding hole 305' of the present application.

[0071] Figure 13 The figure shows a schematic structural diagram of the demolding hole 305' of the present application.

[0072] Figure 14 The figure shows a schematic structural diagram of the upper end 30' of the present application.

[0073] Figure 15 The figure shows a schematic structural diagram of the maximum length, upper cutting angle and lower cutting angle of the convex part 304' of the present application.

[0074] Figure 16 The figure shows a schematic structural diagram of the double-chamber cartridge bottle packaging material assembly of the present application.

[0075] Explanation of reference numerals

[0076] 1 - Double-chamber cartridge bottle; 2 - Top plug; 3 - Top cover; 4 - Sheath

[0077] 1' - Double-chamber cartridge bottle; 2' - Top plug; 3' - Top cover; 4' - Sheath

[0078] 10 - Bottle mouth; 11 - Bottle neck; 12 - Bottle body; 13 - Inner cavity

[0079] 10' - Bottle mouth; 11' - Bottle neck; 12' - Bottle body; 13' - Inner cavity

[0080] 20 - Plug cap; 21 - Plug post; 22 - Sealing part; 20' - Plug cap

[0081] 21' - Plug post; 22' - Sealing part; 30 - Upper end; 31 - Middle end

[0082] 32 - Lower end; 30' - Upper end; 31' - Chassis; 40' - Sheath main body

[0083] 41' - Flange; 100 - Bottle mouth opening; 120 - Bypass protrusion; 100' - Bottle mouth opening

[0084] 120 - Bypass protrusion; 200 - Gap part; 200' - Gap part; 300 - Top plate

[0085] 301 - Thread; 302 - Opening; 303 - Top plug positioning point; 304 - Convex part

[0086] 310 - Convex ring 320 - Convex strip 321 - First convex notch 300’ - Top plate

[0087] 301’ - Thread 302’ - Opening 303’ - Top plug positioning point 304’ - Protrusion

[0088] 305’ - Demolding hole 306’ - Fitting part 310’ - Internal convex block 311’ - Openings on both sides of the convex block

[0089] 321’ - First convex notch 400’ - Second convex notch Specific implementation mode

[0090] A bottle cap assembly disclosed in the present application, wherein the bottle cap assembly includes a top plug 2 and a top cover 3 for sealing a double - chamber cartridge bottle 1. The double - chamber cartridge bottle 1 can be placed in a freeze - drying bracket used in the existing freeze - drying process as shown, and the packaging material of the double - chamber cartridge bottle can be fixed and placed upright or upside - down in the freeze - drying bracket and the sheath; the bottle cap assembly can be made of any material suitable for realizing the airtight function of the bottle cap. The top plug 2 is limited in the top cover 3 and is used to seal the bottle mouth 10 of the double - chamber cartridge bottle 1; the top cover 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 - chamber cartridge bottle 1 and seals the double - chamber cartridge bottle 1. Among them, the process of the top cover 3 pressing and fixing the top plug 2 so that the top plug 2 seals the bottle mouth 10 of the double - chamber cartridge bottle 1 may include the following steps: Figure 1 As shown, it can be placed in a freeze - drying bracket used in the existing freeze - drying process, and the packaging material of the double - chamber cartridge bottle can be fixed and placed upright or upside - down in the freeze - drying bracket and the sheath; the bottle cap assembly can be made of any material suitable for realizing the airtight function of the bottle cap. The top plug 2 is limited in the top cover 3 and is used to seal the bottle mouth 10 of the double - chamber cartridge bottle 1; the top cover 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 - chamber cartridge bottle 1 and seals the double - chamber cartridge bottle 1. Among them, the process of the top cover 3 pressing and fixing the top plug 2 so that the top plug 2 seals the bottle mouth 10 of the double - chamber cartridge bottle 1 may include the following steps:

[0091] Pre - assemble the top plug 2 into the top cover 3; and place the top cover 3 with the top plug 2 assembled thereon above the bottle mouth 10 of the double - chamber cartridge bottle 1, and press the top cover 3 downward to press the top plug 2. The way to drive the top cover 3 to press down can be mechanical pressing, pneumatic drive, pneumatic fixture drive or spring pressing, etc.

[0092] In the present application, the double - chamber cartridge bottle 1 includes: an inner cavity 13, a bottle body 12, a bottleneck 11 and a bottle mouth 10. A bottle mouth opening 100 connected to the inner cavity 13 is provided at the center of the bottle mouth 10, and the inner diameter of the bottle mouth opening 100 is smaller than the inner diameters of the bottle mouth 10 and the bottleneck 11; a bypass protrusion 120 is provided on one outer wall of the bottle body 12. Those skilled in the art can understand that the dimensions of the inner cavity 13, the bottle body 12, the bottleneck 11 and the bottle mouth 10 of the double - chamber cartridge bottle 1 can be adjusted to adapt to the size range of common freeze - drying brackets, such as changing the vertical length of one or more parts of the double - chamber cartridge bottle 1, changing the radial length of one or more parts of the double - chamber cartridge bottle 1, etc., all of which do not depart from the protection scope of the present application.

[0093] In this application, the top plug 2 includes a plug cap 20 and a plug post 21. The diameter of the plug post 21 can be equal to or slightly larger than the inner diameter of the bottle mouth opening 100. After the plug post 21 is inserted into the bottle mouth opening 100, the lower surface of the plug cap 20 fits perfectly with 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 post 21 can be adjusted within the range of the diameter that can be inserted into the bottle mouth opening 100 after the plug post 21 is pressed forcefully. The diameter of the plug post 21 can be slightly larger than the diameter of the bottle mouth opening 100 to ensure the tightness of the seal.

[0094] In this application, the top cover 3 is as Figure 2A shown, including an upper end 30, a middle end 31, and a lower end 32; the upper end 30 has a top plate 300, a thread 301, and an opening 302, the middle end 31 has a convex ring 310, and the lower end 32 optionally has a rib 320. The inner wall of the top cover 3 fits with the bottle mouth 20, the bottleneck 21, and at least a part of the bottle body 22; when the top cover 3 faces the bottle mouth 10, the top plate 300 of the upper end 30 presses the top plug 2 to move into the bottle mouth 10, so that the top plug 2 is inserted into the bottle mouth 10. After the bottle mouth 10 of the double-chamber cartridge bottle 1 is capped, the top plate 300 fits tightly above the plug cap 20 to press and fix the top plug 2. The opening 302 can discharge the sublimated moisture in the product, the thread 301 is used for threaded engagement with the sterile injection needle, and the convex ring 310 can match the sheath.

[0095] It should be noted that the shape of the lower end 32 of the top cover 3 can be a cylinder or a prism, as Figure 2B shown, and its length in the vertical direction is adjustable. Therefore, the lower end 32 can fit a small part of the bottle body 12, or can fit most parts of the bottle body 12 or completely fit the entire bottle body 12 to achieve better capping tightness and meet the dimensional requirements of the top cover 3 for the freeze-drying process. The rib 320 is used to increase the friction between the lower end 32 and the sheath that can cooperate, so as to improve the effect of mutual cooperation and fixation; in particular, the rib 320 can also be removed. The shape of the lower end 32 can be a cylinder or a prism to prevent the top cover 3 from slipping off due to rotational centrifugal force or relative sliding with the double-chamber cartridge bottle 1, which may affect the sealing performance.

[0096] In particular, the length of the middle end 31 of the top cover 3 in the direction of the bottleneck 11 and the bottle body 12 is adjustable, and the convex ring 310 can be adjusted to fit the lower part of the upper end 30 at most to meet the different degrees of capping and fitting tightness requirements of the double-chamber cartridge bottle 1 for the top cover 3. For example, it is necessary to reduce the length of the top cover 3 in the direction of the bottle body 12 or the volume of the top cover 3 to meet the dimensional requirements of the freeze-drying bracket for the double-chamber cartridge bottle 1 and the top cover 3 in the freeze-drying process. In particular, the center of the top plate 300 has a top plate opening, and the circumferential lower edge to the upper edge of the top plate opening can have an inclination angle β in the vertical direction. The circumferential upper edge of the top plate opening has a larger opening length relative to the circumferential lower edge; the circumferential edge surface of the top plate opening can be a curved surface or a flat surface.

[0097] In the present application, as Figure 3 shown, the top plug 2 may further include a sealing portion 22 protruding above the plug cap 20. The sealing portion 22 can be inserted into the top plate opening. When the top plug 2 is completely embedded in the bottle mouth 10, that is, when the dual-chamber cartridge bottle 1 is completed with plugging, its sealing portion 22 is embedded in the top plate opening and partially protrudes longitudinally from the top plate opening. Those skilled in the art 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 plate 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 generate a slight deformation to be inserted and embedded into the top plate opening from the circumferential lower edge of the top plate opening.

[0098] Therefore, during the process of pre-assembling the top plug 2 into the top cover 3, the sealing portion 22 can be embedded in the top plate opening, and its edge portion is closely attached to the circumferential outer edge of the top plate opening, and finally partially protrudes from the upper edge of the top plate opening; by setting the radial length L of the sealing portion, it has a longer radial length to improve the tightness of the attachment of its edge portion to the circumferential outer edge of the top plate opening, and further prevent the top plug 2 from slipping off from the top plate 300. In addition, by adjusting the size of β, the circumferential lower edge of the top plate opening and the sealing portion 22 can have a closer degree of attachment to the circumferential upper edge of the top plate opening, so that the top plate opening tightly surrounds and fixes the sealing portion 22.

[0099] In some embodiments, the radial length L of the sealing portion 22 can be 2.0 mm - 5.0 mm. Specifically, the radial length L of the sealing portion 22 can be 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm or 5.0 mm; preferably, the radial length L of the sealing portion 22 can be 3.0 mm - 4.0 mm. Specifically, the radial length L of the sealing portion 22 can be preferably 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm or 4.0 mm. The inclination angle β can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9° or 10°, etc.

[0100] In some embodiments, the circumferential lower edge opening length of the top plate opening can be 1.5 mm - 5.0 mm. Specifically, the circumferential lower edge opening length of the top plate opening can be 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm or 5.0 mm; preferably, the circumferential lower edge opening length of the top plate opening can be 2.5 mm - 4.0 mm. Specifically, the circumferential lower edge opening length of the top plate opening can preferably be 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm or 4.0 mm.

[0101] By making the radial length L of the sealing part 22 slightly larger than the circumferential lower edge opening length of the top plate opening, the sealing part 22 fits more closely with the circumferential lower edge of the top plate opening, so that the entire top plate opening effectively fits and fixes the sealing part 22. On this basis, the circumferential edge provides further support, preventing the entire top plug 2 from slipping off. Preferably, when β is set to 0°, that is, when the top plate opening has no inclination angle in the vertical direction, good fixation of the sealing part 22 can be provided, while avoiding excessive resistance when the sealing part 22 is inserted into the top plate opening and making it difficult to embed; in another case, when it is necessary to set a certain inclination angle in the vertical direction for the top plate opening to improve the limiting effect of the top plate 300 on the top plug 2, β can also be set to 5° to improve the fixation degree of the sealing part 22, while not affecting the insertion and embedding of the sealing part 22 into the top plate opening. Those skilled in the art can appropriately adjust the radial length L of the sealing part 22, the inclination angle β, and the circumferential lower edge opening length of the top plate opening based on the actual application of the bottle cap assembly to adaptively adjust the fitting and fixation degree between the sealing part 22 and the top plate 300.

[0102] Particularly, the diameter of the plug cap 20 of the top plug 2 can be slightly smaller than the inner diameter of the top cover 3. Due to the cooperation between the top plug positioning point 303 and the plug cap 20, the top plug 2 can be tightly fixed with the bottle mouth opening 100 to achieve sealing. In this case, setting the diameter of the plug cap 20 slightly smaller than the inner diameter of the top cover 3 leaves a small gap part 200 between the surface of the plug cap 20 and the inner wall of the upper end 30, such as Figure 5As shown in the figure, when the top plug 2 is pressed by the top cover 3, since the compressed volume of the plug cap 20 extends to the clearance part 200 reserved around it, the plug cap 20 will not bulge upward toward the top plate opening in the middle due to compression. Therefore, when an injection needle, such as a micro fine needle (MFN), is inserted into the bottle mouth 10 from the middle of the plug cap 20, the plug cap 20 will not apply pressure to the inside of the needle at the insertion position, thus avoiding the tip of the needle cutting the plug cap 20 to cause coring, that is, generating rubber fragments and falling into the needle and the inner cavity of the double-chamber cartridge bottle, thereby avoiding product contamination.

[0103] In some embodiments, the diameter range of the plug cap 20 can be 5.0 mm - 10.0 mm. Specifically, the diameter of the plug 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 range of the plug cap 20 can be 6.0 mm - 8.0 mm. Specifically, the diameter of the plug 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.

[0104] In some embodiments, the diameter of the upper end 30 of the top cover 3 may range from 5.0 mm to 10.0 mm. Specifically, the diameter of the upper end 30 may 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 may range from 6.0 mm to 8.0 mm. Specifically, the diameter of the upper end 30 may 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.

[0105] More preferably, the diameter of the plug cap 20 may be configured to be 7.0 mm, and the inner diameter of the upper end 30 of the top cover 3 cooperating therewith may be configured to be 7.3 mm. In this way, a clearance portion 200 with a length of 0.3 mm is left between the surface of the plug cap 20 and the inner wall of the upper end 30. When the plug cap 20 is pressed during the assembly of the top plug 2 or the insertion of the injection needle, the diameter of the plug cap 20 increases, and the clearance portion 200 can accommodate the increased volume of the plug cap 20, 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 plug cap 20 and the diameter of the upper end 30 based on the actual application of the bottle cap assembly on the above parameter basis to adapt to the cooperation of the bottle cap assembly with the freeze-drying bracket of the freeze-dryer, the cooperation with the packaging material sheath, and / or the cooperation with the syringe. For example, the pre-assembly stability of the top plug 2 can be adjusted by appropriately adjusting the diameter of the plug cap 20; the tighter or easier-to-dismantle capping of the double-chamber cartridge bottle 1 can be maintained by appropriately adjusting the diameter of the upper end 30; and after separately adjusting the diameter of the plug cap 20 and the diameter of the upper end 30, in order to appropriately avoid the influence of the pressure on the plug cap 20 on the assembly and use of the bottle cap assembly, the size relationship between the diameter of the plug cap 20 and the diameter of the upper end 30 can be adjusted appropriately to provide an appropriate clearance portion 200, etc.

[0106] By inserting and fitting the sealing part 22 into the top plate opening during the pre-assembly process of the top plug 2 and cooperating with the top plug positioning point 303 to limit the plug cap 20, the top plug 2 can be stably fixed in the top cover 3. Therefore, mechanical processes such as vibration and suspension performed on the top cover 3 during the freeze-drying process will not affect the fixation of the top plug 2 in the top cover 3, thus preventing the top plug 2 from falling off the top cover 3 before the capping operation and ensuring the capping qualification rate after freeze-drying; the configuration of the gap part 200 of the plug cap 20 can also prevent core-taking when it is used in conjunction with an injection needle, thereby ensuring product quality and efficient use.

[0107] In the present application, the upper end 30 of the top cover 3 further has a top plug positioning point 303, such as Figure 4A , Figure 4B shown, the top plug positioning point 303 protrudes from the inner wall of the upper end 30 towards the axis direction of the top cover 3 for fixing the top plug 2 fitted with the bottle mouth 10. Specifically, the top plug positioning point 303 extends radially along the upper end 30 and is circumferentially arranged at equal intervals on the inner wall of the top plug positioning point 303. The shape of the top plug positioning point 303 can be a cylinder or a prism. In addition, its quantity and the interval length / radian between multiple top plug positioning points 303 can be adjusted to maintain the optimal fixation of the top plug 2.

[0108] In the present application, the number of the top plug positioning points 303 is 4 or 5 or more. In particular, the number of the top plug positioning points 303 can be an even number to maintain its symmetrical arrangement along the center of the upper end 30 to provide a more stable fixing function for the top plug 2. Preferably, the number of the top plug positioning points 303 is 4 or 8 to provide a relatively stable fixing function for the top plug 2; more preferably, the number of the top plug positioning points 303 is 8 to provide the most stable fixing function for the top plug 2. The top plug positioning point 303 can also be used for positioning the top plug 2 before it is pressed into the bottle mouth 10. The top plug 2 is limited by the top plug positioning point 303 to prevent it from slipping off the bottle mouth 10 by itself.

[0109] In the present application, the upper end 30 of the top cover 3 further has a convex part 304 protruding towards the axis direction of the top cover 3 on its inner wall, such as Figure 6 shown, the top cover 3 can be limited on the bottle mouth 10 by the convex part 304 before capping so that the sublimated moisture in the inner cavity 13 can be discharged through the opening 302; therefore, the setting of the convex part 304 helps to provide gas exchange and sublimated moisture discharge for the double-chamber cartridge bottle 1. Those skilled in the art can understand that the convex part 304 will not hinder the movement of the top plug 2 during the process of the top plug 2 being inserted into the bottle mouth 10. Since the convex part 304 is evenly distributed on the inner wall of the upper end 30 and the top plate 300 can uniformly apply pressure to the entire surface of the plug cap 20 pre-assembled into the upper end 30 during plug pressing, the top plug 2 can be stably inserted into the bottle mouth 10 horizontally.

[0110] In this application, the number of the protruding portions 304 is two or three or more; preferably, the maximum length (D) of the protruding portion 304 protruding in the axial direction of the top cover 3 can be 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm or 0.30 mm. Specifically, D can be 0.15 mm to 0.30 mm; more preferably, D can be 0.20 mm to 0.28 mm, which can prevent the top cover 3 from being deformed due to excessive pressure during capping, and after capping, the top cover 3 has good airtightness and is not easy to slip off; most preferably, D can be 0.23 mm to 0.28 mm, which can avoid the deformation of the top cover 3 due to pressure during capping, and after capping, the top cover 3 has good airtightness and is not easy to slip off. It should be noted that when the materials of the protruding portions 304 are different, the value of D can be adjusted to achieve the optimal limit of the top cover 3 before capping and the optimal improvement of the fitting degree between the upper end 30 and the double-chamber cartridge 1. Preferably, when the outer diameter of the bottle mouth 10 is 7.3 mm, D can be 0.23 mm, 0.25 mm or 0.28 mm, and the protruding portion 304 can provide the optimal stability of the top cover 3 after capping.

[0111] In this application, the shape of the protruding portion 304 can be trapezoidal, semi-circular, semi-elliptical or rectangular. Preferably, the shape of the protruding portion 304 is trapezoidal. When the shape of the protruding portion 304 is preferably trapezoidal with its short side adjacent to the bottle mouth 10, the fitting tightness between the upper end 30 and the bottle mouth 10 is relatively good, and the top cover 3 can be stably fitted on the double-chamber cartridge 1 to maintain good airtightness.

[0112] When the shape of the protruding portion 304 is trapezoidal, preferably, the upper cutting angle (θ) between the surface of the protruding portion 304 in the axial direction of the top cover 3 and its side surface can be any angle between 0° and 90°, such as Figure 7As shown. Further preferably, 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 raised portion 304 in improving the tightness of the fit between the top cover 3 and the bottle mouth 10 may be significantly weakened; when θ is greater than 45°, the raised portion 304 may significantly hinder the capping process, causing the top cover 3 to deform or even be damaged during the capping process. Therefore, θ can preferably be any angle within 30° - 45°; more preferably, θ can be 30°, so that the raised portion 304 can not only provide a good fit effect between the top cover 3 and the bottle mouth 10, but also does not adversely hinder the capping process.

[0113] In addition, when the shape of the raised portion 304 is trapezoidal, it is further preferably that the lower cutting angle (α) between the surface of the raised portion 304 facing the axis direction of the top cover 3 and its side surface is any angle between 0° - 90°. Since the magnitude of the pressure during the capping process is mainly affected by the magnitude of θ, when α has the same value as θ, the raised portion 304 can have a stable axisymmetric structure and is not easily deformed or damaged during the capping process or storage process. Therefore, the present application further preferably sets α to 30° to improve the use efficiency and anti-deformation ability of the raised portion 304. And more preferably, both θ and α of the raised portion 304 are 30°. During the capping process, the top cover 3 will not be structurally damaged due to excessive force application, and at the same time, the top cover 3 and the double-chamber cartridge vial 1 can be highly tightly fitted, which also improves the efficiency and accuracy of capping the double-chamber cartridge vial 1.

[0114] The present application also discloses an injection double-chamber cartridge vial packaging material, which includes the above-mentioned bottle cap assembly and the double-chamber cartridge vial 1, and an injection double-chamber cartridge vial packaging material assembly, which includes the injection double-chamber cartridge vial packaging material and a sheath 4 used in cooperation therewith, as Figure 8 shown. It should be noted that the injection double-chamber cartridge vial packaging material can include any combination formed and / or held by the bottle cap assembly and the double-chamber cartridge vial 1 in any combination form disclosed in the present application.

[0115] The sheath 4 proposed in the present application is an octagonal prism with an open top, and its structure is as Figure 8 shown. The inner wall of the sheath 4 has an octagonal shape. After the double-chamber cartridge vial 1 completes the freeze-drying process and is sealed by the top cover 3, the double-chamber cartridge vial 1 can be pressed into the sheath for placement. During this process, the lower end 32 of the top cover 3 fits with the inner wall of the sheath 4 and cannot slide relative to it, and the bypass protrusion 120 of the bottle body 12 is clamped at the octagonal vertices of the inner wall of the sheath and also cannot slide relative to the inner wall of the sheath 4.

[0116] In the present application, the shape of the lower end 32 is a cylinder or an octagonal prism, and preferably an octagonal prism, and is fixedly assembled with the sheath 4 for fixedly storing the dual-chamber cartridge 1 by interference fit; specifically, the upper outer edge of the lower end 32 close to the middle end 31 has a first convex notch 321, the top end of the sheath 4 is stretched and limited on the first convex notch 321, and the top cover 3 and the sheath 4 apply force towards each other and clamp towards the middle. By this interference fit method of the lower end 32 and the sheath 4, when the dual-chamber cartridge 1 is placed in the sheath 4, the fixation between the top cover 3 and the top plug 2 therein and the bottle mouth 10 is tighter, effectively avoiding situations such as air leakage, rotation, and detachment.

[0117] Specifically, in some embodiments, the lyophilized product reconstituted in the dual-chamber cartridge 1 is subcutaneously injected through an injection needle for the treatment of skin diseases or aesthetic medical applications. The needle holder of the injection needle has a threaded structure. When installing the MFN onto the top cover 3 to extract the product or removing it from the top cover 3, its threaded structure is engaged or removed with the thread 301 of the top cover 3 by rotation. During this process, the lower end 32 of the top cover 3 is fixed by the octagonal inner wall of the sheath 4 to maintain anti-rotation, and the bypass protrusion 120 of the dual-chamber cartridge 1 is also fixed against rotation by the vertices of the octagonal inner wall of the sheath 4. Therefore, by selecting the lower end 32 with an octagonal prism shape and cooperating with the sheath 4, the rotation of the dual-chamber cartridge packaging component during the screwing / removing of the injection needle can be avoided, so as to prevent the idling during the screwing / removing of the sterile injection needle and improve the use efficiency of the dual-chamber cartridge packaging component.

[0118] To provide a favorable integrated sealing fit for the dual-chamber cartridge 1' with a longer bottleneck, the present application also discloses a packaging material for an injection dual-chamber cartridge, which includes the above-mentioned another cap assembly and the dual-chamber cartridge 1', as Figure 9 shown. It should be noted that the packaging material for an injection dual-chamber cartridge may include any combination formed and / or maintained by any combination of the cap assemblies proposed in the present application and the dual-chamber cartridge 1'.

[0119] In the present application, correspondingly, a cap assembly is also proposed, wherein the cap assembly includes a top plug 2' and a top cover 3' for sealing the dual-chamber cartridge 1'. The dual-chamber cartridge 1' can be placed in the lyophilization bracket and the sheath 4' used in the existing lyophilization process, and the packaging material of the dual-chamber cartridge can be fixed and placed upright or upside down in the lyophilization bracket; the cap assembly can be made of any material suitable for realizing the cap sealing function. The top plug 2' is limited within the top cover 3' for sealing the bottle mouth 10' of the dual-chamber cartridge 1'; the top cover 3' is used to press and fix the top plug 2' so that the top plug 2' seals the bottle mouth 10' of the dual-chamber cartridge 1'; and to seal the dual-chamber cartridge 1'; wherein, the process of the top cover 3' pressing and fixing the top plug 2' so that the top plug 2' seals the bottle mouth 10' of the dual-chamber cartridge 1' may include the following steps:

[0120] Pre-assemble the top plug 2' into the top cover 3'; and place the top cover 3' with the pre-assembled top plug 2' above the bottle mouth 10' of the double-chamber cartridge bottle 1', and press down the top cover 3'. The way to drive the top cover 3' to press down can be mechanical pressing, pneumatic driving, pneumatic fixture driving or spring pressing, etc.

[0121] In this application, the double-chamber cartridge bottle 1' includes: an inner cavity 13', a bottle body 12', a bottleneck 11' and a bottle mouth 10'. A bottle mouth opening 100' connected to the inner cavity 13' is provided at the center of the bottle mouth 10'. The inner diameter of the bottle mouth opening 100' is smaller than the inner diameters of the bottle mouth 10' and the bottleneck 11'; a bypass protrusion 120' is provided on the outer wall of one side of the bottle body 12'. Those skilled in the art can understand that the sizes of the inner cavity 13', the bottle body 12', the bottleneck 11' and the bottle mouth 10' of the double-chamber cartridge bottle 1' can be adjusted to adapt to the size range of common freeze-drying scaffolds, such as changing the vertical length of one or more parts of the double-chamber cartridge bottle 1', changing the radial length of one or more parts of the double-chamber cartridge bottle 1', etc., which are all within the protection scope of this application.

[0122] In this application, the top plug 2' includes a plug cap 20' and a plug post 21'. The diameter of the plug post 21' can be equal to or slightly larger than the inner diameter of the bottle mouth opening 100'. After the plug post 21' is embedded in the bottle mouth opening 100', the lower surface of the plug cap 20' is completely attached to 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. Therefore, the diameter of the plug post 21' can be adjusted within the diameter range that can be embedded in the bottle mouth opening 100' after the plug post 21' is pressed by force. The diameter of the plug post 21' can be slightly larger than the diameter of the bottle mouth opening 100' to ensure the tightness of the seal.

[0123] In this application, the top cover 3' is as Figure 10A shown, including an upper end 30' and a chassis 31'; the upper end 30' has a top plate 300', a thread 301' and an opening 302'. The inner wall of the top cover 3' fits with the bottle mouth 10'; when the top cover 3' faces the bottle mouth 10', the top plate 300' of the upper end 30' presses the top plug 2' to move into the bottle mouth 10' so that the top plug 2' is embedded in the bottle mouth 10'. After the bottle mouth 10' of the double-chamber cartridge bottle 1' is capped, the top plate 300' is closely attached above the plug cap 20' to press and fix the top plug 2'. The opening 302' can discharge the sublimated moisture in the product, and the thread 301' is used for thread engagement with the injection needle.

[0124] It should be noted that the length of the chassis 31' in the vertical direction is adjustable. Therefore, the chassis 31' can only fit the connection part of the bottleneck 11' and the bottle body 12', or can additionally fit at least a part of the bottle body 12' to achieve better capping tightness and adapt to the size requirements of the top cover 3' for the freeze-drying process and other effects. The shape of the chassis 31' can be set as a cylinder or a prism, such asFigure 10B as shown, to prevent the top cover 3' from slipping off due to rotational centrifugal force or relative sliding with the double-chamber cartridge bottle 1' and affecting the sealing performance.

[0125] Specifically, the center of the top plate 300' also has a top plate opening. The circumferential lower edge to the upper edge of the top plate opening may have an inclination angle β' in the vertical direction, and the circumferential upper edge of the top plate opening has a larger opening length relative to the circumferential lower edge; the circumferential edge surface of the top plate opening can be a curved surface or a flat surface.

[0126] In the present application, the top plug 2' may further include: a sealing portion 22' protruding above the plug cap 20', as Figure 11A shown. The sealing portion 22' can be inserted into the top plate opening. When the top plug 2' is completely inserted into the bottle mouth 10', that is, when the double-chamber cartridge bottle 1' is completed with plugging, its sealing portion 22' is inserted into the top plate opening and partially protrudes longitudinally from the top plate 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 plate 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 produce a small deformation to be inserted and embedded into the top plate opening from the circumferential lower edge of the top plate opening.

[0127] Therefore, during the process of pre-assembling the top plug 2' into the top cover 3', the sealing portion 22' can be inserted into the top plate opening, and its edge portion is closely attached to the circumferential outer edge of the top plate opening and finally partially protrudes from the upper edge of the top plate opening. The radial length L' of the sealing portion 22' can also be set to have a longer radial length to improve the tightness of the fit between its edge portion and the circumferential outer edge of the top plate opening, so as to further prevent the top plug 2' from slipping off the top plate 300'. In addition, by adjusting the size of β', the circumferential lower edge of the top plate opening and the sealing portion 22' have a closer fit degree relative to the circumferential upper edge of the top plate opening, so that the top plate opening tightly surrounds and fixes the sealing portion 22'.

[0128] In some embodiments, the radial length L' of the sealing portion 22' can be 2.0 mm - 5.0 mm. Specifically, the radial length L' of the sealing portion 22' can be 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, or 5.0 mm; preferably, the radial length L' of the sealing portion 22' can be 3.0 mm - 4.0 mm. Specifically, the radial length L' of the sealing portion 22' can preferably be 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm. The tilt angle β' can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, or 10°, etc.

[0129] In some embodiments, the circumferential lower edge opening length of the top plate opening can be 1.5 mm - 5.0 mm. Specifically, the circumferential lower edge opening length of the top plate opening can be 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, or 5.0 mm; preferably, the circumferential lower edge opening length of the top plate opening can be 2.5 mm - 4.0 mm. Specifically, the circumferential lower edge opening length of the top plate opening can preferably be 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm.

[0130] By making the radial length L' of the sealing part 22' slightly larger than the circumferential lower edge opening length of the top plate opening, the sealing part 22' fits more closely to the circumferential lower edge of the top plate opening. The top plate opening enables the overall effective fitting and fixing of the sealing part 22', and the circumferential edge provides further support on this basis, preventing the entire plug 2' from slipping off. Preferably, β' is set to 0°. When the top plate opening has no inclination angle in the vertical direction, it can provide good fixation for the sealing part 22', while avoiding excessive resistance when the sealing part 22' is inserted into the top plate opening and making it difficult to embed. In another case, when it is necessary to set a certain inclination angle in the vertical direction for the top plate opening to improve the limiting effect of the top plate 300' on the plug 2, β' can also be set to 5° to increase the fixing degree of the sealing part 22' without affecting the insertion and embedding of the sealing part 22' into the top plate opening. Those skilled in the art can appropriately adjust the radial length L', inclination angle β' of the sealing part 22' and the circumferential lower edge opening length of the top plate opening based on the actual application of the bottle cap assembly to adaptively adjust the fitting and fixing degree between the sealing part 22' and the top plate 300'.

[0131] Specifically, the diameter of the plug cap 20' of the plug 2' can be slightly smaller than the inner diameter of the top cover 3'. Due to the cooperation between the plug positioning point 303' and the plug cap 20', the plug 2' can be tightly fixed to the top cover 3' to achieve sealing. In this case, the diameter of the plug cap 20' is designed to be slightly smaller than the inner diameter of the top cover 3', leaving a small gap part 200' between the surface of the plug cap 20' and the inner wall of the upper end 30', as Figure 14 shown. In this way, when the plug 2' is pressed by the top cover 3', since the compressed volume of the plug cap 20' extends to the reserved gap part 200' around it, the plug cap 20' will not protrude towards the top plate opening in the middle and above due to compression. Therefore, when inserting an injection needle, such as a micro fine needle (MFN), into the bottle mouth 10' through the middle of the plug cap 20', the plug cap 20' will not apply pressure to the inside of the needle at the insertion position, thus avoiding the core-taking phenomenon where the tip of the needle cuts the plug cap 20', that is, the plug cap 20' is cut to generate rubber fragments and fall into the needle tip and the inner cavity of the double-chamber cartridge bottle, preventing product contamination.

[0132] In some embodiments, the diameter of the plug cap 20' can range from 5.0 mm to 10.0 mm. Specifically, the diameter of the plug 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 plug cap 20' can range from 6.0 mm to 8.0 mm. Specifically, the diameter of the plug 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.

[0133] In some embodiments, the diameter range of the upper end 30' of the top cover 3' can be 5.0 mm - 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 range of the upper end 30' can be 6.0 mm - 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.

[0134] More preferably, the diameter of the plug cap 20' can be configured to be 7.0 mm, and the inner diameter of the upper end 30' of the top cover 3' cooperating therewith can be configured to be 7.3 mm. In this way, a clearance portion 200' with a length of 0.3 mm is left between the surface of the plug cap 20' and the inner wall of the upper end 30'. When the plug cap 20' is squeezed during the assembly of the top plug 2' or the insertion of the injection needle, the diameter increases, and the clearance portion 200' can accommodate the increased volume of the plug cap 20', 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 plug cap 20' and the diameter of the upper end 30' based on the actual application of the bottle cap assembly on the above parameter basis to adapt to the cooperation of the bottle cap assembly with the freeze-drying bracket of the freeze dryer, the cooperation with the packaging material sheath, and / or the cooperation with the syringe. For example, the pre-assembly stability of the top plug 2' can be adjusted by appropriately adjusting the diameter of the plug cap 20'; the tighter capping or easier disassembly of the double-chamber cartridge bottle 1' can be maintained by appropriately adjusting the diameter of the upper end 30'; and after separately adjusting the diameter of the plug cap 20' and the diameter of the upper end 30', in order to appropriately avoid the influence of the pressure on the plug cap 20' on the assembly and use of the bottle cap assembly, the size relationship between the diameter of the plug cap 20' and the diameter of the upper end 30' can be appropriately adjusted to provide an appropriate clearance portion 200', etc.

[0135] During the pre-assembly process of the top plug 2', by inserting and fitting the sealing part 22' into the opening of the top plate and cooperating with the top plug positioning point 303' to limit the plug cap 20', the top plug 2' can be stably positioned in the top cover 3'. Therefore, when an external force is applied to the top cover 3' during actual production, such as vibration or suspension, it will not affect the fixation of the top plug 2' in the top cover 3', thus avoiding the top plug 2' falling off from the top cover 3' before the capping operation and ensuring the capping qualification rate after freeze-drying. In addition, the configuration of the gap part 200' of the plug cap 20' can also prevent core-taking when it is used in conjunction with an injection needle, which also ensures product quality and the efficient use of packaging materials.

[0136] In the present application, the upper end 30' of the top cover 3' also has a top plug positioning point 303', as Figure 12A , Figure 12B shown, the top plug positioning point 303' protrudes from the inner wall of the upper end 30' towards the axis of the top cover 3' for fixing the top plug 2' fitted with the bottle mouth 10'. Specifically, the top plug positioning point 303' extends radially along the upper end 30' and is evenly arranged at intervals circumferentially on the inner wall of the top plug positioning point 303'. The shape of the top plug positioning point 303' can be a cylinder or a prism. In addition, its quantity and the interval length / radian between multiple top plug positioning points 303' can be adjusted to maintain the optimal fixation of the top plug 2'.

[0137] In the present application, the number of the top plug positioning points 303' is 4 or 5 or more. In particular, the number of the top plug positioning points 303' can be an even number to maintain its symmetrical arrangement along the center of the upper end 30' and provide a more stable fixation function for the top plug 2'. Preferably, the number of the 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 the 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 it is pressed into the bottle mouth 10'. The top plug 2' is limited by the top plug positioning point 303' to prevent it from slipping towards the bottle mouth 10' autonomously.

[0138] In the present application, on the inner wall of the upper end 30' of the top cover 3', there is also a protruding portion 304' protruding towards the axis direction of the top cover 3'. Before capping, the top cover 3' can be limited on the bottle mouth 10' through the protruding portion 304', so that the sublimated moisture in the inner cavity 13' can be discharged through the opening 302'. Therefore, the setting of the protruding portion 304' helps to provide gas exchange and moisture discharge for the double-chamber cartridge bottle 1'. Those skilled in the art can understand that the protruding portion 304' will not hinder the movement of the top plug 2' during the process of the top plug 2' being inserted into the bottle mouth 10'. Since the protruding portion 304' is evenly distributed on the inner wall of the upper end 30', and the top plate 300' can evenly apply pressure to the entire surface of the plug cap 20' pre-assembled into the upper end 30' during plugging, the top plug 2' can be stably inserted horizontally into the bottle mouth 10'.

[0139] In the present application, the number of the protruding portions 304' is two or three or more; preferably, the maximum length (D') of the protruding portion 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 to 0.30mm; further preferably, D' can be 0.20mm to 0.28mm, which can make the top cover 3' not easily deformed due to excessive pressure during capping, and the sealing performance of the top cover 3' is better after capping and not easily slip off; more preferably, D' can be 0.23mm to 0.28mm, which can avoid the deformation of the top cover 3' due to pressure during capping, and the sealing performance of the top cover 3' is better after capping and not easily slip off. It should be noted that when the material of the protruding portion 304' is different, the value of D' can be adjusted to achieve the optimal limit of the top cover 3' before capping and the optimal improvement of the fitting degree between the upper end 30' and the double-chamber cartridge 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 portion 304' can provide the most stable fixation for the top cover 3'.

[0140] In the present application, the shape of the protruding portion 304' can be trapezoidal, semi-circular, semi-elliptical or rectangular. Preferably, the shape of the protruding portion 304' is trapezoidal. When the shape of the protruding portion 304' is preferably trapezoidal with the short side adjacent to the bottle mouth 10', the fitting tightness between the upper end 30' and the bottle mouth 10' is better, and the top cover 3' can be highly stably fitted on the double-chamber cartridge bottle 1' to maintain good tightness.

[0141] When the shape of the convex portion 304' is trapezoidal, the upper cutting angle (θ') between the surface of the convex portion 304' facing the axis direction of the top cover 3' and its side surface can be any angle between 0° and 90°, such as Figure 15 shown. 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 convex portion 304' in improving the tightness of the fit between the top cover 3' and the bottle mouth 10' may be significantly weakened; when θ' is greater than 45°, the convex portion 304' may cause an obvious obstruction to the capping process, causing the top cover 3' to deform or even be damaged during the capping process. Therefore, θ' can preferably be any angle between 30° and 45°; more preferably, θ' can be 30°, so that the convex portion 304' can not only provide a good fit effect between the top cover 3' and the bottle mouth 10', but also does not cause an adverse obstruction to the capping process.

[0142] In addition, when the shape of the convex portion 304' is trapezoidal, it is further preferred that the lower cutting angle (α') between the surface of the convex portion 304' facing the axis direction of the top cover 3' and its side surface can also be any angle between 0° and 90°. Since the pressure magnitude during the capping process is mainly affected by the magnitude of θ', when α' has the same value as θ', the convex portion 304' can have the most stable axisymmetric structure and is not likely to deform or be damaged during the capping process or storage process. Therefore, the present application further preferably α' can be 30° to improve the service efficiency and anti-deformation ability of the convex portion 304'. More preferably, both θ' and α' of the convex portion 304' are 30°. Its capping process on the top cover 3' will not cause structural damage to the top cover 3' due to excessive capping force, and at the same time, it can also maintain a high degree of tight fit between the top cover 3' and the dual-chamber cartridge bottle 1', which can improve the capping efficiency and accuracy of the dual-chamber cartridge bottle 1' in the freeze-drying process.

[0143] In the present application. The upper end 30' also has a demolding hole 305', as Figure 12C and Figure 13 shown. The demolding hole 305' is located at the connection between the top plate 300' and the thread 301', and partially communicates with both sides of the top plate opening through the demolding hole 305'. In this way, when the top cover 3' is manufactured, the manufacturing module can conveniently mold through the demolding hole 305' for mold closing, thus facilitating the mass production 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 plate 300' of the upper end 30'. This arrangement of the demolding holes 305' does not affect the fit between the sealing portion 22' / top plug positioning point 303' and the surrounding top cover 3' / top plug 2'', so it does not affect the airtightness of the top cover 3'.

[0144] In the present application, the upper end 30' further has a fitting portion 306', as Figure 11B shown. The fitting portion 306' is located on the side of the top plate opening of the top plate 300' close to the top plug 2', that is, the side in contact with the plug cap 20'. The sealing portion 22' can cooperate with the fitting portion 306' to be adapted to be inserted into the top plate opening of the top plate 300' of the top cover 3'. Specifically, the fitting portion 306' has an inclined surface facing the top plug 3'. This inclined surface smoothly tightens the contact surface between the top plate 300' and the top plug 2' from the side of the top plate opening close to the top plug 2' to the other side, that is, in a chamfer shape. When the sealing portion 22' of the top plug 2' is fitted into the top plate opening, its outer edge can slide along the inclined surface of the fitting portion 306', reducing the force required for the fitting process, so as to further improve the fitting success rate of the sealing portion 22' and the top plate opening, and improve the capping efficiency.

[0145] In the present application, the bottom plate 31' may further have internal bumps 310', as Figure 10C shown. The internal bumps 310' are located on the inner wall of the bottom plate 31' on the side away from the upper end 30', that is, the inner wall at the lowermost end of the top cover 3; and protrude axially toward the top cover 3'. When the top cover 3' seals the double-chamber cartridge 1', due to the existence of the internal bumps 310', the contact pressure between the bottle body 12' and the bottom plate 31' at the internal bumps 310' increases and the fitting is closer, enhancing the fixing stability of the top cover 3' on the double-chamber cartridge 1' and making the airtightness of the entire packaging material better. The number of the internal bumps 310' can be an appropriate number, such as 4 or 5 or more, and preferably evenly distributed on the radial section of the bottom plate 31' to form a stable shape, so as to improve the fixing stability of the top plug 3'. In addition, when multiple internal bumps are evenly distributed on the inner side of the bottom plate, for example, when 4 internal bumps 310' are evenly distributed at 90 degrees on the radial section of the cylindrical bottom plate 31' at the inner side lower edge, the stress received by the bottom plate can be effectively dispersed, making the bottom plate 31' less likely to gradually loosen due to long-term airtight use or temperature changes, so as to further improve the anti-loosening ability of the top cover.

[0146] Advantageously, on the edge of the bottom plate 31' along the side away from the upper end 30', that is, the lowermost edge of the top cover 3', bump-side openings 311' can be provided on both sides of the internal bumps 310'. The number of the bump-side openings 311' can be coordinated with the number of the internal bumps 310', so the number can be 8 or 10 or more. When the top cover 3' fits with the bottle body 12' and the internal bumps 310' are squeezed, the bump-side openings 311' can deform and extend to one side / both sides of the bump-side openings 311', reducing the force required for capping, so as to improve the capping efficiency.

[0147] The present application further provides a packaging material for a dual-chamber cartridge for injection, which includes the above-mentioned another cap assembly and the dual-chamber cartridge 1', and a packaging material assembly for a dual-chamber cartridge for injection, which includes the packaging material for a dual-chamber cartridge for injection and a sheath 4' used in cooperation therewith, as Figure 16 shown. It should be noted that the packaging material for a dual-chamber cartridge for injection may include any combination that can be formed and / or maintained by any combination proposed in the present application between the cap assembly and the dual-chamber cartridge 1'.

[0148] The upper outer edge of the chassis 31' close to the upper end 30' has a first lug 321'. When the top of the inner wall of the sheath 4' is stretched, a horizontal protrusion is generated and limited on the first lug 321' of the chassis 31'. The top cover 3' and the sheath 4' achieve an interference fit, applying force towards each other and clamping the stopper 2' and the dual-chamber cartridge 1' in the middle. In addition, the bypass protrusion 120' of the bottle body 12' is clamped at the octagonal vertices 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 packaging material for a dual-chamber cartridge for injection is placed in the sheath 4', the top cover 3' and the stopper 2' therein are more tightly fixed to the bottle mouth 10', effectively avoiding air leakage, rotation, detachment and other situations.

[0149] In the present application, the shape of the chassis 31' is a cylinder or an octagonal prism, and the sheath 4' includes a sheath main body 40' and a flange 41'. When the top cover 3' and the sheath 4' are in interference fit, the top cover 3' and the dual-chamber cartridge 1' are tightly fixed to each other. Since the bottle mouth 10', the bottleneck 11' and the bottle body 12' of the dual-chamber cartridge 1' are cylindrical, during the screwing and / or disassembling of the injection needle with the top cover 3', the top cover 3' drives the dual-chamber cartridge 1' to rotate together due to the force. When the shape of the chassis 31' is a cylinder, its smooth outer surface is difficult to be well-positioned by the inner wall of the sheath 4'. When the injection needle is screwed / disassembled, the top cover 3' may drive the entire dual-chamber cartridge 1' to rotate together, causing the injection needle to rotate idly and unable to be fixed / disassembled from the top cover 3'.

[0150] Therefore, the shape of the chassis 31' of the cap assembly of the packaging material assembly is an octagonal prism, and the shape of the sheath main body 40' is an octagonal prism, so that the outer wall of the chassis 31' and the inner wall of the sheath main body 40' are both octagons, as Figure 16As shown. In this way, the bypass protrusion 120' of the double-chamber cartridge bottle 1' of the packaging component can be limited at the octagonal vertices (B'-B') on the inner wall of the sheath 4'. During the capping process, a relatively large frictional force will be generated between the bottle body 12' and the inner wall of the chassis 31'. When an external force such as an injection needle acts on the top cap 3', due to the interference fit and mutual fixation (A'-A') between the chassis 31' and the inner wall of the sheath 4', the top cap 3' will not slip or produce relative sliding with the double-chamber cartridge bottle 1', further making the overall packaging stable and immovable, avoiding the influence on the airtightness of the double-chamber cartridge bottle 1' and improving the use efficiency.

[0151] Specifically, the lower end of the sheath 4' may also have an interference fit structure. A second convex mouth 400' may be provided at the lower end of the sheath main body 40'. It is press-fitted and fastened on the flange 41' to achieve an interference fit and mutual fixation (C'-C') between the sheath main body 40' and the flange 41'. In this way, the fixing stability of the sheath main body 40' can be improved, and the co-rotation of the sheath main body 40' and the packaging can be avoided.

[0152] Specifically, in some embodiments, the lyophilized product reconstituted in the double-chamber cartridge bottle 1' is subcutaneously injected through an injection needle for the treatment of skin diseases or aesthetic medicine. The needle seat of the injection needle has a threaded structure. When installing the injection needle on the top cap 3' for product injection or removing it from the top cap 3', the threaded structure is engaged or removed with the thread 301' of the top cap 3' by rotation. During this process, the chassis 31' of the top cap 3' is fixed by the octagonal inner wall of the sheath 4' to remain non-rotating, and the bypass protrusion 120' of the double-chamber cartridge bottle 1' is also fixed and non-rotating by the vertices on the inner wall of the sheath 4'. Therefore, by selecting the octagonal prism-shaped chassis 31' and matching it with the sheath 4', the double-chamber cartridge bottle packaging component can be kept unaffected by the rotation during the screwing / removing of the injection needle, so as to avoid idling during the screwing / removing of the sterile injection needle and improve the use efficiency of the double-chamber cartridge bottle packaging component.

[0153] At present, the vast majority of lyophilized products on the market use vials as drug containers. Before injection, it is necessary to first draw the reconstitution solvent from another container containing the reconstitution solvent with a sterile syringe, and then inject the reconstitution solvent into the drug container for reconstitution, extraction, and administration. The dosing accuracy and use compliance are relatively poor. While using the cap assembly and the double-chamber cartridge bottle packaging of the present application can effectively utilize the front chamber to contain the lyophilized drug and the rear chamber to contain the reconstitution solvent. And during use, the reconstitution solvent can be flowed into the front chamber through the bypass by pushing the bottom plug to reconstitute the lyophilized drug, without multiple extractions, thus greatly facilitating the use for the subjects or patients and enabling self-injection by the subjects or patients.

[0154] On the other hand, the bottle cap assembly of the present application can also simultaneously perform capping and sealing on the double-chamber cartridge in the freeze dryer, maintaining the low moisture content of the freeze-dried product, thereby maintaining the quality stability of the product. Therefore, the present application can use the bottle cap assembly and the double-chamber cartridge to complete the preparation and storage of various pharmaceutical preparations, medical beauty products and cosmetics such as insulin, growth factors, vaccines, chemotherapy drugs, hormone drugs, facial hyaluronic acid filling, water light injection, facial essence and customized perfume, thereby improving the application prospects and application scope of the above-mentioned products prepared by the freeze-drying process.

[0155] Example

[0156] The present invention provides a general and / or specific description of the materials and test methods used in the test. The reagents or instruments used without indicating the manufacturer are all conventional reagent products that can be obtained through commercial purchase.

[0157] Example 1

[0158] A bottle cap assembly, comprising a top plug 2 and a top cover 3, is used to seal a double-chamber cartridge bottle 1. The structure of the top cover 3 is as follows: Figure 2A The double-chamber cartridge bottle 1 uses the top cover 3 to seal the top plug 2 to the bottle mouth, and seals the bottle mouth 10 of the double-chamber cartridge bottle 1 through the top plug. Specifically,

[0159] First, the top plug 2 is positioned inside the top cover 3 through the top plug positioning point 303, and the top cover 3 is placed on the bottle mouth 10 so that the plug 21 naturally faces the bottle mouth opening 100 for freeze drying.

[0160] Then, after the freeze-drying is completed, the top plug 2 is pressed through the top cover 3 to be embedded in the bottle mouth 10 of the double-chamber cartridge bottle 1. The top cover 3 includes an upper end 30, a middle end 31 and a lower end 32. The upper end 30 has a top plate 300 located at its center, a thread 301 and an opening 302 located at the edge of the upper end 30, which is arranged above the middle end 31, and the lower end 32 is located below the middle end 31. The lower end 32 is an opening; after the top plug 2 is initially embedded in the bottle mouth 10, the top cover 3 is pressed downward until the upper end 30 is completely covered on the bottle mouth 10. During this process, the inner wall of the upper end 30 is in contact with the bottle mouth 10 and the bottleneck 11, while the inner walls of the middle end 31 and the lower end 32 are in contact with the bottle body 12.

[0161] The top plate 300 is a hollow cylindrical structure shortened in the middle. When the top cover 3 is pressed downward by external force, the top plug 2 is pressed to the bottle mouth 10 through the lower surface of the top plate 300, so that the top plug 2 is further embedded in 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 in the bottle mouth 10 under the action of pressure, and the lower surface of the plug cap 20 is completely in contact with the upper surface of the bottle mouth 10, so that the double-chamber cartridge bottle 1 is sealed with the top plug 2, and no additional plugging device is required to participate in the sealing, which reduces the additional process and time required for sealing the double-chamber cartridge bottle 1, and avoids the influence of inaccurate sealing on the production efficiency of the freeze-drying process.

[0162] In particular, the top cover 3 is configured so that when the top plug 2 is pressed to be completely embedded in the bottle mouth 10, the inner wall of the upper surface of the middle end 31 can also be completely fitted with the upper surface of the bottle body 12; therefore, while the top cover 3 uses the top plug 2 to seal the bottle mouth opening 100, the top cover 3 also seals the top plug 2 embedded in the bottle mouth, and seals the bottle mouth 10, the bottleneck 11 and at least a portion of the bottle body 12 through the top plug 2, thereby achieving a sealed cap for the entire double-chamber cartridge bottle 1.

[0163] The diameter of the upper end 30 is 7.3 mm, and a gap 200 is left between the plug cap 20 with a diameter of 7.0 mm; the upper end 30 also has a top plug positioning point 303, such as Figure 4A and Figure 5 As shown in the figure, the top plug positioning point 303 is located below the top plate 300 and protrudes from the inner wall of the upper end 30 in the direction of the axis of the top cover 3. After the top plug 2 is completely embedded in the bottle mouth 10, the top plug positioning point 303 fits with 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 cover 3, thereby increasing the friction between the plug cap 20 and the inner wall of the upper end 30, preventing the top plug 2 from loosening or slipping off the top cover 3 during the pre-assembly process due to loose fitting. The number of top plug positioning points 303 is 4, evenly distributed on the inner wall of the upper end 30.

[0164] The upper end 30 also has a raised portion 304, such as Figure 6 As shown, the protrusion 304 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 protrusion 304 fits against the outer wall of the bottle mouth 10, and the bottle mouth 10 is subjected to the pressure of the protrusion 304 in the direction of the axis of the top cover 3, thereby increasing the friction between the bottle mouth 10 and the inner wall of the upper end 30, preventing the top cover 3 from slipping off after sealing due to loose fitting, and improving the sealing performance of the double-chamber cartridge bottle 1. The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is set to 0.15mm, and the shape of the protrusion 304 is set to be semicircular, the number is 2, and it is distributed on both sides of the inner wall of the upper end 30.

[0165] The shape of the lower end 32 is cylindrical. The convex ring 310 of the middle end 31 and the convex strip 320 of the lower end 32 can increase the degree of fit between the top cover 3 and the bottle body 22 after the top cover 3 is attached to the double-chamber cartridge bottle 1, further improving the stability of the attachment of the top cover 3 to the double-chamber cartridge bottle 1.

[0166] For the plugging and capping seal tests of the bottle cap assembly, it was found that some of the top plugs 2 slipped and fell out of the top cover 3 in the freeze dryer, and the fit between the top cover 3 and the mouth 20 of the double-chamber cartridge bottle 1 was not firm enough, and it could be pulled out from the double-chamber cartridge bottle 1 with a small force.

[0167] Example 2

[0168] The maximum length by which the protruding part 304 protrudes from the inner wall of the upper end 30 is replaced with 0.25 mm, and other structures and parameters are the same as in Example 1. For the plugging and capping seal tests of the bottle cap assembly, it was found that some of the top plugs 2 slipped and fell out of the top cover 3, and the fit between the top cover 3 and the mouth 10 of the double-chamber cartridge bottle 1 was still not firm enough and could be easily pulled out.

[0169] Example 3

[0170] The shape of the protruding part 304 is replaced with a trapezoid. Among them, the upper cutting angle of the surface of the protruding part 304 facing the axis of the top cover 3 is 45°, and the lower cutting angle between the surface of the protruding part 304 facing the axis of the top cover 3 and its side surface is 30°. The maximum length by which the protruding part 304 protrudes from the inner wall of the upper end 30 is replaced with 0.30 mm, and the number of top plug positioning points 303 is replaced with 8, as Figure 4B shown, and other structures and parameters are the same as in Example 1.

[0171] For the plugging and capping seal tests of the bottle cap assembly, since the number of top plug positioning points 303 is increased, the degree of fit between the top plug 2 and the top cover 3 is improved, and the top plug 2 no longer slips and falls out of the top cover 3; a very large pressure needs to be applied during the capping process, resulting in deformation and damage of some structures of the top cover 3.

[0172] Example 4

[0173] The upper cutting angle of the surface of the protruding part 304 facing the axis of the top cover 3 is replaced with 30°, as Figure 7 shown, and other structures and parameters are the same as in Example 3. For the plugging and capping seal tests of the bottle cap assembly, the degree of fit between the top plug 2 and the top cover 3 is relatively high, and the top plug 2 does not slip and fall out of the top cover 3; after replacing the upper cutting angle of the surface of the protruding part 304 facing the axis of the top cover 3 with 30°, it is found that a relatively large pressure still needs to be applied during the capping process, resulting in deformation and damage of some structures of the top cover 3, and there is still a certain impact on the sealing performance of the top cover 3.

[0174] Example 5

[0175] The upper chamfer angle of the surface of the convex part 304 in the axial direction of the top cover 3 is replaced with 30°, and the maximum length of the convex part 304 protruding from the inner wall of the upper end 30 is replaced with 0.10 mm. Other structures and parameters are the same as those in Embodiment 3. For the cap assembly, plugging and capping sealing tests are carried out. It is found that the fitting degree between the plug 2 and the top cover 3 is relatively high, and the plug 2 does not slip off from the top cover 3; after replacing the upper chamfer angle of the surface of the convex part 304 in the axial direction of the top cover 3 with 30° and the maximum length of the convex part 304 protruding from the inner wall of the upper end 30 with 0.10 mm, a large pressure does not need to be applied during the capping process, but the fitting between some top covers 3 and the mouth 10 of the double-chamber cartridge bottle 1 is not firm enough and can be pulled out after a certain force is applied.

[0176] Embodiment 6

[0177] The maximum length of the convex part 304 protruding from the inner wall of the upper end 30 is replaced with 0.15 mm. Other structures and parameters are the same as those in Embodiment 5. For the cap assembly, plugging and capping sealing tests are carried out. It is found that the fitting degree between the plug 2 and the top cover 3 is relatively high, and the plug 2 does not slip off from the top cover 3; after replacing the maximum length of the convex part 304 protruding from the inner wall of the upper end 30 with 0.15 mm, a large pressure does not need to be applied during the capping process, but the fitting between some top covers 3 and the mouth 10 of the double-chamber cartridge bottle 1 is still not firm enough and will still be pulled out after a certain force is applied.

[0178] Embodiment 7

[0179] The maximum length of the convex part 304 protruding from the inner wall of the upper end 30 is replaced with 0.20 mm. Other structures and parameters are the same as those in Embodiment 5. For the cap assembly, plugging and capping sealing tests are carried out. It is found that the fitting degree between the plug 2 and the top cover 3 is relatively high, and the plug 2 does not slip off from the top cover 3; after replacing the maximum length of the convex part 304 protruding from the inner wall of the upper end 30 with 0.20 mm, a large pressure does not need to be applied during the capping process, the fitting between the top cover 3 and the mouth 10 of the double-chamber cartridge bottle 1 is improved, the cooperation and fixation are relatively firm, and it is more difficult to be pulled out after a greater force is applied, and only occasionally is it pulled out and detached.

[0180] Embodiment 8

[0181] The maximum length of the convex part 304 protruding from the inner wall of the upper end 30 is replaced with 0.23 mm. Other structures and parameters are the same as those in Embodiment 5. For the cap assembly, plugging and capping sealing tests are carried out. It is found that the fitting degree between the plug 2 and the top cover 3 is relatively high, and the plug 2 does not slip off from the top cover 3; after replacing the maximum length of the convex part 304 protruding from the inner wall of the upper end 30 with 0.23 mm, a certain pressure needs to be applied during the capping process, but no deformation and damage of some structures of the top cover 3 are caused; the fitting degree between the top cover 3 and the mouth 10 of the double-chamber cartridge bottle 1 is significantly improved and is not pulled out after a large force is applied.

[0182] Example 9

[0183] The maximum length by which the protruding portion 304 protrudes from the inner wall of the upper end 30 is replaced with 0.25 mm, and other structures and parameters are the same as in Example 5. For the cap assembly, plug pressing and capping sealing tests are carried out. It is found that the fitting degree between the plug 2 and the top cover 3 is relatively high, and the plug 2 does not slip off and fall from the top cover 3; after replacing the maximum length by which the protruding portion 304 protrudes from the inner wall of the upper end 30 with 0.25 mm, a certain pressure needs to be applied during the capping process, but no deformation or damage to some structures of the top cover 3 is caused; the fitting degree between the top cover 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 is also significantly improved, and it is not pulled out after applying a large force.

[0184] Example 10

[0185] The maximum length by which the protruding portion 304 protrudes from the inner wall of the upper end 30 is replaced with 0.28 mm, and other structures and parameters are the same as in Example 5. For the cap assembly, plug pressing and capping sealing tests are carried out. It is found that the fitting degree between the plug 2 and the top cover 3 is relatively high, and the plug 2 does not slip off and fall from the top cover 3; after replacing the maximum length by which the protruding portion 304 protrudes from the inner wall of the upper end 30 with 0.28 mm, a large pressure needs to be applied during the capping process, but no deformation or damage to some structures of the top cover 3 is caused; the fitting degree between the top cover 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 is significantly improved, and it is not pulled out after applying a large force.

[0186] Example 11

[0187] The structure of the top cover 3 of the cap assembly in Example 8 is adjusted to reduce the volume of the top cover 3, as Figure 2B shown. Specifically, the length of the extending part of the top cover 3 along the bottleneck 11 and the bottle body 12 in Example 2 is shortened, so that the length of the middle end 31 is shortened, and further the position of the convex ring 310 relative to the bottleneck 11 and the bottle body 12 is moved upward and fits with the lower part of the upper end 30. In addition, the convex strip 320 at 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, and the upper part of the lower end 32 close to the middle end 31 is shortened radially to form a first convex opening 321.

[0188] It should be noted that in this embodiment, the shape of the extended lower end 32 is set as an octagonal prism, and its inner wall can still fit at least a part of the bottle body 12 of the double-chamber cartridge bottle 1, and the structures of the adjusted top cover 3 except the middle end 31 and the lower end 32 are the same as those of the top cover 3 in Example 10. The number of plug positioning points 303 is 8, and they are evenly distributed on the inner wall of the upper end 30.

[0189] The bottle cap assembly was subjected to plugging and capping sealing tests, and it was found that the top plug 2 had a high degree of fit with the top cover 3, and the top plug 2 did not slip off the top cover 3; the capping process required a large pressure to be applied, but did not cause deformation or damage to the partial structure of the top cover 3; the fit between the top cover 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was significantly improved, and it was not pulled out after applying a large force.

[0190] Example 12

[0191] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced to 0.25 mm, and the other structures and parameters are the same as those of Example 11. The bottle cap assembly is subjected to plugging and capping sealing tests, and it is found that the top plug 2 and the top cover 3 have a high degree of fit, and the top plug 2 does not slip off from the top cover 3; the capping process requires a large pressure to be applied, but does not cause deformation and damage to the structure of the top cover 3; the fit between the top cover 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 is significantly improved, and it is not pulled out after applying a large force.

[0192] Embodiment 13

[0193] The structures of the top plug 2 and the top plate 300 of the top cover 3 of the bottle cap assembly in Example 12 are adjusted to improve the degree of limitation of the top plug 2 by the top plate 300 when the top plug 2 is preassembled into the top cover 3, such as Figure 3 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 its plug cap 20, the top plate opening is set to be circular, the sealing portion 22 is cylindrical, its radial length L=3.6mm, the top plate opening is circular, its circumferential lower edge inner diameter is 3.4mm, and the inclination angle β of the top plate opening is 0. The other structures and corresponding parameters of the top plug 2 and the top cover 3 are the same as those of Example 11.

[0194] Embodiment 14

[0195] A bottle cap assembly, comprising a top plug 2' and a top cover 3', is used to seal a double-chamber cartridge bottle 1'. The structure of the top cover 3' is as follows: Figure 10A As shown. The double-chamber cartridge bottle 1' uses the top cover 3' to seal the top plug 2' to the bottle mouth, and the bottle mouth 10' of the double-chamber cartridge bottle 1' is sealed through the top plug. Specifically,

[0196] First, the top plug 2' is positioned inside the top cover 3' through the top plug positioning point 303', and the top cover 3' is placed on the bottle mouth 10' so that the plug 21' naturally faces the bottle mouth opening 100' for freeze drying.

[0197] Then, after freeze-drying is completed, the top plug 2' is pressed by the top cover 3' to fit into the bottle mouth 10' of the double-chamber cartridge vial 1'. The top cover 3' includes an upper end 30' and a chassis 31'. The upper end 30' has a top plate 300' at its center, a thread 301' and an opening 302' at the edge of the upper end 30'. There is an opening below the chassis 31'. After the top plug 2' is initially inserted into the bottle mouth 10', the top cover 3' is pressed downward until the entire upper end 30' is sleeved on the bottle mouth 10'. During this process, the inner wall of the upper end 30' fits with the bottle mouth 10' and the bottleneck 11', while the inner wall of the chassis 31' partially fits with the bottle body 12'.

[0198] The top plate 300' is a hollow cylindrical structure with a shortened middle. During the process of pressing the top cover 3' downward by an external force, the top plug 2' is pressed to the bottle mouth 10' through the lower surface of the top plate 300', so that the top plug 2' is further inserted 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 inserted into the bottle mouth 10' under pressure, and the lower surface of the plug cap 20' is completely fitted with the upper surface of the bottle mouth 10', so as to seal the double-chamber cartridge vial 1' by using the top plug 2'. There is no need for an additional plug pressing device to participate in the sealing, which reduces the additional process and time required for sealing the double-chamber cartridge vial 1', and also avoids the impact of inaccurate sealing on the production efficiency of the freeze-drying process.

[0199] Particularly, when the top cover 3' is set to press the top plug 2' to completely fit into the bottle mouth 10', the inner wall of the chassis 31' can also partially fit with the top of the bottle body 12'. Therefore, while the top cover 3' seals the bottle mouth opening 100' by using the top plug 2', the top cover 3' also seals the top plug 2' inserted into the bottle mouth, and seals the bottle mouth 10', the bottleneck 11' and at least a part of the bottle body 12' through the top plug 2', thus realizing the overall capping and sealing of the double-chamber cartridge vial 1'.

[0200] The diameter of the upper end 30' is 7.3 mm, and there is a clearance part 200' between it and the plug cap 20' with a diameter of 7.0 mm. The upper end 30' also has a top plug positioning point 303', as Figure 14 、 Figure 12A and Figure 12B shown. The top plug positioning point 303' is located below the top plate 300' and protrudes from the inner wall of the upper end 30' in the direction of the axis of the top cover 3'. After the top plug 2' is completely inserted into the bottle mouth 10', the top plug positioning point 303' fits with the plug cap 20', and the plug cap 20' is subjected to the pressure of the top plug positioning point 303' in the direction of the axis of the top cover 3', so that the friction force between the plug cap 20' and the inner wall of the upper end 30' increases, preventing the partial loosening or slipping of the top plug 2' from the top cover 3' during the pre-assembly process due to loose fitting. The number of the top plug positioning points 303' is 4, and they are evenly distributed on the inner wall of the upper end 30'.

[0201] The upper end 30' also has a convex 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 inserted into the bottle mouth 10', the convex portion 304' fits against the outer wall of the bottle mouth 10', and the bottle mouth 10' is subjected to the pressure of the convex portion 304' in the direction of the axis of the top cover 3', thereby increasing the frictional force between the bottle mouth 10' and the inner wall of the upper end 30', preventing the top cover 3' from slipping off after capping due to loose fitting, and improving the sealing performance of the double-chamber cartridge bottle 1'. The maximum length of the convex portion 304' protruding from the inner wall of the upper end 30' is set to 0.20 mm. The shape of the convex portion 304' is trapezoidal, the number is 2, and they are distributed on both sides of the inner wall of the upper end 30'. The angles between the surface facing the axis of the top cover 3' and the upper and lower cutting angles of its side surface are both 30°. The shape of the chassis 31' is cylindrical. After performing plug pressing and capping sealing tests on the bottle cap assembly, it is found that the fit between the top plug 2' and the top cover 3' is good, and the top plug 2' does not slip off from the top cover 3'; during the capping process, the top cover 3' is not deformed, and the cooperation and fixation between the top cover 3' and the double-chamber cartridge bottle 1' are good, and only occasional detachment occurs.

[0202] Example 15

[0203] The maximum length of the convex portion 304' protruding from the inner wall of the upper end 30' is replaced with 0.23 mm, and the remaining structures and parameters are the same as those in Example 14. After performing plug pressing and capping sealing tests on the bottle cap assembly successively, it is found that the fit between the top plug 2' and the top cover 3' is relatively high, and the top plug 2' does not slip off from the top cover 3'; after replacing the maximum length of the convex portion 304' protruding from the inner wall of the upper end 30' with 0.23 mm, the capping process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0204] Example 16

[0205] The maximum length of the convex portion 304' protruding from the inner wall of the upper end 30' is replaced with 0.25 mm, and the remaining structures and parameters are the same as those in Example 14. After performing plug pressing and capping sealing tests on the bottle cap assembly successively, it is found that the fit between the top plug 2' and the top cover 3' is relatively high, and the top plug 2' does not slip off from the top cover 3'; after replacing the maximum length of the convex portion 304' protruding from the inner wall of the upper end 30' with 0.25 mm, the capping process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0206] Example 17

[0207] The maximum length by which the protrusion 304' protrudes from the inner wall of the upper end 30' is replaced with 0.28 mm, and the remaining structure and parameters are the same as those in Embodiment 14. The plugging and capping sealing tests are successively carried out on the bottle cap assembly. It is found that the fitting degree between the plug 2' and the top cover 3' is relatively high, and the plug 2' does not slip off from the top cover 3'; after replacing the maximum length by which the protrusion 304' protrudes from the inner wall of the upper end 30' with 0.28 mm, the capping process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0208] Embodiment 18

[0209] The structure of the top cover 3' of the bottle cap assembly in Embodiment 16 is adjusted to increase the volume of the top cover 3', as Figure 10B shown. Specifically, the chassis 31' in Embodiment 16 is extended downward along the bottle body 12' so that the extended chassis 31' can seal at least a part of the bottle body 12'. It should be noted that the shape of the downward-extended chassis 31' is set as an octagonal prism, and the structure of the adjusted top cover 3' except the chassis 31' is the same as that before adjustment. The number of plug positioning points 303' is 8, and they are evenly distributed on the inner wall of the upper end 30'.

[0210] The plugging and capping sealing tests are successively carried out on the bottle cap assembly. It is found that the fitting degree between the plug 2' and the top cover 3' is relatively high, and the plug 2' does not slip off from the top cover 3'; a relatively large pressure needs to be applied during the capping process, but it does not cause deformation and damage to some structures of the top cover 3'; the fitting degree between the top cover 3' and the bottle mouth 10' of the double-chamber cartridge bottle 1' is significantly improved, and it is not pulled out after a relatively large force is applied.

[0211] Embodiment 19

[0212] The structures of the plug 2' and the top plate 300' of the top cover 3' of the bottle cap assembly in Embodiment 18 are adjusted to improve the fixing tightness of the pre-assembled plug 2' into the top cover 3'. Specifically, a sealing portion 22' protruding upward along the axis of the plug 2' is provided on the upper surface of the plug cap 20' of the plug 2'. The shape of the opening of the top plate is set as a circle, the diameter of its lower edge is 3.4 mm, the shape of the sealing portion 22' is a cylinder, and its radial length L' = 3.6 mm, as Figure 11A shown. The inclination angle β' from the circumferential lower edge to the upper edge of the opening of the top plate is 0°, and the other structures and parameters are the same as those in Embodiment 18.

[0213] Embodiment 20

[0214] The structure of the top plate 300' of the top cover 3' of the bottle cap assembly in Embodiment 19 is adjusted so that during the capping process, the sealing portion 22' can be more effectively engaged with the top plate opening. Specifically, a fitting portion 306' is provided on the side of the top plate opening close to the top plug 2'. The fitting portion 306' is a chamfer extending from the middle of the top plate opening to the side of the top plate opening close to the top plug 2'. During capping, the edge of the sealing portion 22' can slide along the fitting portion 306' to more easily insert into the top plate opening, as Figure 11B shown. Correspondingly, the inclination angle β' from the circumferential lower edge to the upper edge of the top plate opening is no longer provided, and other structures and parameters are the same as those in Embodiment 19.

[0215] Embodiment 21

[0216] The structure of the bottom plate 31' of the top cover 3' of the bottle cap assembly in Embodiment 20 is adjusted to improve the tightness of the fit between the bottom plate 31' and the bottle body 12'. Specifically, 4 internal bumps 310' are equidistantly provided on the inner wall of the bottom plate 31' on the side far from the upper end 30', and openings 311' on both sides of the bump are provided on both sides of each internal bump 310', as Figure 10C shown. Other structures are the same as those in Embodiment 20.

Claims

1. A bottle cap assembly for sealing a double-chamber cartridge bottle (1), wherein: The bottle cap assembly comprises a top plug (2) and a top cover (3); The top plug (2) is limited in position within the top cover (3) and is used to seal the bottle mouth (10) of the double-chamber cartridge bottle (1); The top cover (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-chamber cartridge bottle (1); and to seal the double-chamber cartridge bottle (1).

2. The bottle cap assembly according to claim 1, wherein: The double-chamber cartridge bottle (1) comprises: an inner cavity (13), a bottle body (12), a bottle neck (11) and a bottle mouth (10); a bottle mouth opening (100) connected to the inner cavity (13) is arranged at the center of the bottle mouth (10); the inner diameter of the bottle mouth opening (100) is smaller than the inner diameters of the bottle mouth (10) and the bottle neck (11); One side outer wall of the bottle body (12) is provided with a bypass protrusion (120).

3. The bottle cap assembly according to claim 2, wherein: The top plug (2) comprises a plug cap (20) and a plug rod (21); the diameter of the plug rod (21) is equal to or slightly larger than the inner diameter of the bottle mouth opening (100) of the bottle mouth (10); after the plug rod (21) is inserted into the bottle mouth opening (100), the lower surface of the plug cap (20) is completely in contact with the upper surface of the bottle mouth (10).

4. The bottle cap assembly according to any one of claims 1 to 3, wherein: The top cover (3) comprises an upper end (30), a middle end (31) and a lower end (32); The upper end (30) has a top plate (300), a thread (301) and an opening (302), the middle end (31) has a convex ring (310), and the lower end (32) optionally has a convex strip (320), and the inner wall of the top cover (3) is in contact with the bottle mouth (10), the bottle neck (11) and at least a portion of the bottle body (12); The center of the top plate (300) has a top plate opening. When the top cover (3) moves toward the bottle mouth (10), the top plate (300) at the upper end (30) presses the top plug (2) to move into the bottle mouth (10), so that the top plug (2) is embedded in the bottle mouth (10).

5. The bottle cap assembly according to claim 4, wherein: The top plug (2) further comprises: a sealing portion (22) protruding above the plug cap (20), wherein the sealing portion (22) is inserted into a top plate opening of the top plate (300) of the top cover (3), and when the top plug (2) is inserted into the bottle mouth (10), the sealing portion (22) protrudes longitudinally from the top plate opening of the top plate (300).

6. The bottle cap assembly according to claim 4, wherein: The upper end (30) of the top cover (3) also has a top plug positioning point (303), which protrudes from the inner wall of the upper end (30) in the axial direction of the top cover (3) and is used to fix the top plug (2) engaged with the bottle mouth (10).

7. The bottle cap assembly according to claim 6, wherein: The number of the top plug positioning points (303) is 4 or 5 or more.

8. The bottle cap assembly according to claim 4, wherein: The upper end (30) of the top cover (3) is also provided with a protrusion (304) on its inner wall, which protrudes in the axial direction of the top cover (3) and is used to position the top plug (2) before being pressed into the bottle mouth (10), and at the same time improve the fit between the upper end (30) and the double-chamber cartridge bottle (1).

9. The bottle cap assembly according to claim 8, wherein: The number of the protrusions (304) is 2 or 3 or more; Preferably, the maximum length (D) of the protruding portion (304) protruding in the axial direction of the top cover (3) is 0.10 mm-0.30 mm.

10. The bottle cap assembly according to claim 8, wherein: The shape of the protrusion (304) is trapezoidal, semicircular, semi-elliptical or rectangular. Preferably, the shape of the protrusion (304) is trapezoidal; Preferably, when the shape of the protrusion (304) is a trapezoid, the upper cutting angle (θ) between the surface of the protrusion (304) facing the axial direction of the top cover (3) and its side surface is 30°-45°. More preferably, the upper cutting angle (θ) between the surface of the protrusion (304) facing the axial direction of the top cover (3) and its side surface is 30°. It is further preferred that when the shape of the protrusion (304) is a trapezoid, the surface of the protrusion (304) facing the axial direction of the top cover (3) forms a lower cutting angle (α) with its side surface.

11. The bottle cap assembly according to any one of claims 1 to 10, wherein the process of pressing and fixing the top plug (2) on the top cover (3) so that the top plug (2) seals the bottle mouth (10) of the double-chamber cartridge bottle (1) comprises the following steps: Pre-assembling the top plug (2) into the top cover (3); The top cover (3) equipped with the top plug (2) is placed above the bottle mouth (10) of the double-chamber cartridge bottle (1), and the top cover (3) is pressed downward.

12. The bottle cap assembly according to claims 4 to 11, wherein: The lower end (32) is in the shape of a cylinder or an octagonal prism; Preferably, the lower end (32) is in the shape of an octagonal prism.

13. A double-chamber cartridge packaging material for injection, comprising the bottle cap assembly according to any one of claims 1 to 12 and a double-chamber cartridge (1).

14. A dual-chamber cartridge bottle packaging material assembly for injection, comprising the dual-chamber cartridge bottle packaging material for injection according to claim 13 and a sheath (4).

15. The packaging material assembly according to claim 14, wherein: The lower end (32) of the bottle cap assembly of the packaging material is in the shape of an octagonal prism, the sheath (4) is in the shape of an octagonal prism, the inner wall of which is an octagon, and the bypass protrusion (120) of the double-chamber cartridge bottle (1) of the packaging material is located at the octagonal vertex of the inner wall of the sheath (4); and The top of the inner wall of the sheath (4) has a protrusion in the horizontal direction, which is assembled with the lower end (32) of the bottle cap assembly of the packaging material through interference fit, so as to further clamp the top plug (2) and the double-chamber cartridge bottle (1) with the lower end (32).

16. A bottle cap assembly for sealing a double-chamber cartridge bottle (1'), wherein: The bottle cap assembly comprises a top plug (2') and a top cover (3'); The top plug (2') is limited in the top cover (3') and is used to seal the bottle mouth (10') of the double-chamber cartridge bottle (1'); The top cover (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-chamber cartridge bottle (1'); and to seal the double-chamber cartridge bottle (1'); The top cover (3') comprises an upper end (30'), the upper end (30') has a top plate (300'), and the center of the top plate (300') has a top plate opening; The top plug (2') comprises a sealing portion (22'), and the sealing portion (22') is inserted into the top plate opening of the top plate (300') of the top cover (3'); The upper end (30') also has a fitting portion (306'), which is located on a side of the top plate opening of the top plate (300') close to the top plug (2'), and the sealing portion (22') cooperates with the fitting portion (306') to be inserted into the top plate opening of the top plate (300') of the top cover (3').

17. The bottle cap assembly according to claim 16, wherein: The double-chamber cartridge bottle (1') comprises: an inner cavity (13'), a bottle body (12'), a bottle neck (11') and a bottle mouth (10'); a bottle mouth opening (100') connected to the inner cavity (13') is arranged at the center of the bottle mouth (10'); the inner diameter of the bottle mouth opening (100') is smaller than the inner diameters of the bottle mouth (10') and the bottle neck (11'); One side outer wall of the bottle body (12') is provided with a bypass protrusion (120').

18. The bottle cap assembly according to claim 17, wherein: The top plug (2') comprises a plug cap (20') and a plug rod (21'); the diameter of the plug rod (21') is equal to or slightly larger than the inner diameter of the bottle mouth opening (100') of the bottle mouth (10'); after the plug rod (21') is inserted into the bottle mouth opening (100'), the lower surface of the plug cap (20') is completely fitted with the upper surface of the bottle mouth (10').

19. The bottle cap assembly according to any one of claims 16 to 18, wherein: The top cover (3') also includes a bottom plate (31'); The upper end (30') also has a top plate (300'), a thread (301') and an opening (302'), and the inner wall of the top cover (3') fits with the bottle mouth (10'); When the top cover (3') moves toward the bottle mouth (10'), the top plate (300') of the upper end (30') presses the top plug (2') to move into the bottle mouth (10'), so that the top plug (2') is embedded in the bottle mouth (10').

20. The bottle cap assembly according to claim 19, wherein: When the top plug (2') is inserted into the bottle mouth (10'), the sealing portion (22') protrudes longitudinally from the top plate opening of the top plate (300').

21. The bottle cap assembly according to claim 19, wherein: The upper end (30') of the top cover (3') also has a top plug positioning point (303'), which protrudes from the inner wall of the upper end (30') toward the axial direction of the top cover (3') and is used to fix the top plug (2') engaged with the bottle mouth (10').

22. The bottle cap assembly according to claim 21, wherein: The number of the top plug positioning points (303') is 4 or 5 or more.

23. The bottle cap assembly according to claim 19, wherein: The upper end (30') of the top cover (3') is also provided with a protrusion (304') on its inner wall, which protrudes toward the axial direction of the top cover (3') and is used to position the top plug (2') before being pressed into the bottle mouth (10'), and at the same time improve the fit between the upper end (30') and the double-chamber cartridge bottle (1').

24. The bottle cap assembly according to claim 23, wherein: The number of the protrusions (304') is 2 or 3 or more; Preferably, the maximum length (D') of the protruding portion (304') protruding toward the axial direction of the top cover (3') is 0.10 mm to 0.30 mm.

25. The bottle cap assembly according to claim 23, wherein: The shape of the protrusion (304') is trapezoidal, semicircular, semi-elliptical or rectangular. Preferably, the shape of the protrusion (304') is trapezoidal; Preferably, when the shape of the protrusion (304') is a trapezoid, the upper cutting angle (θ') between the surface of the protrusion (304') facing the axial direction of the top cover (3') and its side surface is 30°-45°, and more preferably, the upper cutting angle (θ') between the surface of the protrusion (304') facing the axial direction of the top cover (3') and its side surface is 30°; It is further preferred that when the shape of the protrusion (304') is a trapezoid, the surface of the protrusion (304') facing the axial direction of the top cover (3') forms a lower cut angle (α') with its side surface.

26. The bottle cap assembly according to any one of claims 16 to 25, wherein the process of pressing and fixing the top plug (2') on the top cover (3') so that the top plug (2') seals the bottle mouth (10') of the double-chamber cartridge (1') comprises the following steps: Pre-assembling the top plug (2') into the top cover (3'); The top cover (3') equipped with the top plug (2') is placed above the bottle mouth (10') of the double-chamber cartridge bottle (1'), and the top cover (3') is pressed downward.

27. The bottle cap assembly according to claim 19, wherein: The upper end (30') further has a demoulding hole (305'), and the demoulding hole (305') is located at the connection between the top plate (300') and the thread (301'); Preferably, the number of the demoulding holes (305') is 4 or 5 or more.

28. The bottle cap assembly according to claim 19, wherein: The bottom plate (31') further comprises an internal protrusion (310'), wherein the internal protrusion (310') is located on the inner wall of the bottom plate (31') away from the upper end (30') and protrudes toward the axis direction of the top cover (3'); Preferably, the number of the internal protrusions (310') is 4 or 5 or more.

29. The bottle cap assembly according to claim 28, wherein: The bottom plate (31') is provided with openings (311') on both sides of the inner protrusion (310') along its edge away from the upper end (30'); Preferably, the number of the openings (311') on both sides of the protrusion is 8 or 10 or more.

30. The bottle cap assembly according to claims 19 to 29, wherein: The bottom plate (31') is in the shape of a cylinder or an octagonal prism; Preferably, the bottom plate (31') is in the shape of an octagonal prism.

31. A double-chamber cartridge packaging material for injection, comprising the bottle cap assembly according to any one of claims 16 to 30 and a double-chamber cartridge (1').

32. A dual-chamber cartridge bottle packaging material assembly for injection, comprising the dual-chamber cartridge bottle packaging material for injection according to claim 31 and a sheath (4').

33. The packaging material assembly according to claim 32, wherein: The bottom plate (31') of the bottle cap assembly of the packaging material is in the shape of an octagonal prism, the sheath (4') comprises a sheath body (40') and a flange (41'), the sheath (4') is in the shape of an octagonal prism, the inner wall of the sheath body (40') is an octagon, and the bypass protrusion (120') of the double-chamber cartridge bottle (1') of the packaging material is located at the octagonal vertex of the inner wall of the sheath body (40'); as well as The top of the inner wall of the sheath body (40') has a protrusion in the horizontal direction, which is assembled with the bottom plate (31') of the bottle cap assembly of the packaging material through interference fit, so as to further clamp the top plug (2') and the double-chamber cartridge bottle (1') with the bottom plate (31').

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