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 can seal the bottle opening of the double-cavity clamping type bottle and seal the double-cavity clamping type bottle. The bottle cap assembly is used for implementing integrated self-plugging and capping sealing on the double-cavity clamping type bottle in the freeze dryer, a feasible scheme is provided for rapid sealing of the double-cavity clamping type bottle in an existing freeze-drying process, low-quality sealing is avoided, and therefore the freeze-drying efficiency and the freeze-drying quality are improved.

Description

Technical Field

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

[0002] At present, most of the freeze-dried products on the market use vials as drug containers. Before injection, it is necessary to use a sterile syringe to extract the resolvent from another container containing the resolvent, and then inject the resolvent into the drug container for reconstitution, extraction and administration. The administration accuracy and use compliance are relatively poor, and the double-chamber cartridge packaging material can provide a better choice. The double-chamber cartridge is divided into two chambers by a middle stopper, of which the front chamber is used to hold the freeze-dried drug and the rear chamber is used to hold the resolvent. When in use, the resolvent can be pushed into the front chamber through the bypass by pushing the bottom stopper to reconstitute the freeze-dried drug. After it is completely dissolved, continue to push the bottom stopper to the top to complete the injection process. The double-chamber cartridge is an innovative drug packaging in the global biopharmaceutical, cosmetic or medical beauty fields. It is compatible with a variety of drug delivery devices, has the advantages of convenient use, patient safety and high compliance, and has a very broad application prospect.

[0003] However, the existing double-chamber cartridge packaging materials cannot complete the integrated operation process of self-pressing plugs and capping in the freeze dryer, so it is necessary to design an innovative packaging material that can achieve integrated sealing in the freeze dryer cavity to meet the requirements of airtightness of the freeze-drying process, so that the packaging material can meet the future drug delivery method. For example, the closure device and sealing component for the container disclosed in CN102259723A have high sealing properties, but cannot meet the requirement that the product moisture is sublimated and discharged from the container (mainly gas) during the freeze-drying process. Therefore, this type of packaging material cannot be directly used in the freeze-drying process, and may require additional capping steps, which increases time costs, and may affect the freeze-drying effect of the drug in the container when the container is transferred.

[0004] CN117208401A discloses a bottle cap and a double-chamber cartridge bottle. After freeze drying, the partition in the freeze dryer can directly apply pressure to the bottle cap, so that the bottle cap switches from a half-covered state to a full-covered state, and the double-chamber cartridge bottle is sealed. However, the bottle cap is limited before capping by the hook part on the inner side of the cavity and the clamping groove of the annular protrusion on the outer peripheral surface of the bottle mouth of the double-chamber cartridge bottle. If the freeze dryer partition applies uneven force due to uneven placement of the double-chamber cartridge bottle, it is easy to cause the bottle cap to tilt during the capping process; because the shape of the hook 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 tilts. In addition, the inner cover has the risk of sliding down in the half-covered state, which reduces the efficiency of water sublimation during the freeze drying process.

[0005] Furthermore, CN117228154A discloses a combined bottle cap and a double-chamber cartridge bottle, wherein the combined bottle cap comprises an inner cap and an outer cap, wherein the first clamping member of the outer cap contacts the outer wall of the inner cap and is fixed relative to the inner cap by the barb-shaped structure of the first clamping member, thereby possibly avoiding the problem of loose capping caused by the tilt of the bottle cap during the capping process. However, when the outer cap is in a half-capped state, since the contact area between the first clamping member and the outer wall of the inner cap is very limited, the outer cap may not be stably limited to the outer edge of the inner cap during the freeze-drying process, causing the outer cap to fall off.

[0006] In addition, the existing double-chamber cartridge bottle packaging materials have problems in obtaining freeze-dried products and cooperating with injection needles, such as lack of anti-rotation structure, excessive crimping force and injection needle coring. The following will provide feasible solutions to the above problems based on the double-chamber cartridge bottle packaging proposed in this application.

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

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

[0009] In one aspect of the present application, a bottle cap assembly is provided, wherein 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 in the top cover for sealing the bottle 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 bottle mouth of the dual-chamber cartridge bottle; and the dual-chamber cartridge bottle is sealed; wherein the process of pressing and fixing the top plug by the top cover so that the top plug seals the bottle 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 equipped with the top plug above the bottle mouth of the double-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 formed as one piece, and there is no need to introduce a plugging assembly. 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 assembly to provide further capping of the double-chamber cartridge bottle. The application of the top cover on the double-chamber cartridge bottle significantly reduces the operating steps and time required for the self-plugging and capping of the double-chamber cartridge bottle, improves the sealing efficiency of the double-chamber cartridge bottle in the freeze-drying process, and avoids the number of operation failures caused by more operating steps. When the failed operation is difficult to remedy in the conventional way in the freeze-drying process, the self-plugging and capping integrated operation of the top cover is particularly important for ensuring the efficiency of the freeze-drying process.

[0011] In some embodiments of the present application, a double-chamber cartridge may include: an inner cavity, a bottle body, a bottleneck and a bottle mouth, wherein a bottle mouth opening connected to the inner cavity may be provided at the center of the bottle mouth, and the inner diameter of the bottle mouth opening is smaller than the inner diameter of the bottle mouth and the bottleneck; and a bypass protrusion may be provided on one side of the outer wall of the bottle body. After the double-chamber cartridge is placed in the sheath after the freeze-drying process is completed, the bypass protrusion of the bottle body may be fixed at the vertex of the inner wall of the sheath, so that the double-chamber cartridge will not be rotated along its longitudinal axis by external force when stored in the sheath. When the injection needle is connected to the double-chamber cartridge or removed from the double-chamber cartridge, it needs to rotate on the threaded structure of the double-chamber cartridge. Therefore, the double-chamber cartridge is fixed and stopped by the bypass protrusion, which can prevent the injection needle from rotating together with the double-chamber cartridge, thereby preventing the injection needle from idling, thereby realizing efficient threading and removal of the injection needle from the double-chamber cartridge.

[0012] In some embodiments of the present application, the top plug may include a plug cap and a plug rod, the diameter of the plug rod is equal to or slightly larger than the inner diameter of the bottle mouth opening of the bottle mouth, and after the plug rod is embedded in the bottle mouth opening, 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 the lower end may optionally have a convex strip, and the inner wall of the top cover fits the bottle mouth, the bottle neck and at least a part of the bottle body; when the top cover moves toward 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 embedded in the bottle mouth. The center of the top plate has a top plate opening, and 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 embedded in the bottle mouth.

[0014] After the middle end and the lower end are fitted with the outer wall of the bottle body, the top cover as a whole can seal the bottle mouth, the bottleneck and at least a part of the bottle body, thereby providing a complete seal for the bottle mouth with the top plug, and increasing the sealing effect of the bottle mouth. When the lower end has a convex strip, the convex strips contract radially along the top cover, so that the lower end and the bottle body fit more closely, further avoiding the loosening and slipping of the top cover, and increasing the sealing effect of the double-chamber cartridge bottle. 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 double-chamber cartridge bottle, so as to further reduce the moisture content of the freeze-dried product in the double-chamber cartridge bottle during the freeze-drying process. The thread is used to engage with the thread of a 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 being inserted into the top plate opening of the top plate of the top cover, and when the top plug is embedded in the bottle mouth, its sealing portion protrudes longitudinally from the top plate opening of the top plate. In the process of preassembling the top plug into the top cover, the sealing portion can be embedded in the top plate opening, and its edge portion is tightly fitted with 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 when preassembling 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, in actual production, external forces exerted on the top cover, such as vibration, suspension, etc., will not affect the fixation of the top plug in the top cover, thereby preventing the top plug from falling off from the top cover before the capping operation; in addition, after the top plug seals the bottle mouth opening, a gap portion is provided between the top plug and the top cover. After the injection needle is inserted into the top plug, its compressed volume extends to the gap portion at the outer edge, which can prevent the pressure from being concentrated on the sealing portion, thereby preventing the injection needle from removing the core.

[0016] In some embodiments of the present application, the top end of the top cover may also have a top plug positioning point, which protrudes from the inner wall of the top end toward the axis of the top cover and is used to fix the top plug engaged with the bottle mouth. The top plug positioning point further fixes the top plug, thereby improving the sealing stability of the top plug.

[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 annularly on the inner wall of the upper end, which can provide uniform fixed force on the top plug. When the top plug has a tendency to slip, it is difficult for the top plug to produce a displacement greater than other directions in any direction, so it is more difficult for the top plug to slip from the bottle mouth. In addition, the top plug positioning points can also be used to position the top plug before it is pressed into the bottle mouth. The top plug is limited by the top plug positioning points to prevent it from slipping toward the bottle mouth on its own.

[0018] In some embodiments of the present application, the upper end of the top cover may be provided with a protrusion on its inner wall that protrudes toward the axis of the top cover. The top cover may be limited on the bottle mouth by the protrusion before capping, so that the sublimated water in the inner cavity can be discharged through the opening; therefore, the provision of the protrusion helps to provide gas exchange and water discharge for the double-chamber cartridge bottle. After the top plug is pressed into the bottle mouth, the top cover is capped and fixed at the same time. The protruding structure of the protrusion makes the upper end fit more closely with the bottle mouth, which is conducive to maintaining the fixation of the top cover on the bottle mouth after capping, and improving the stability of the capping seal.

[0019] In some embodiments of the present application, the number of the protrusions is 2 or 3 or more; preferably, the maximum length of the protrusions protruding toward the axis of the top cover is 0.10 mm to 0.30 mm. Similarly, the protrusions 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 top cover fixed on the double-chamber cartridge bottle.

[0020] In some embodiments of the present application, the shape of the raised portion is trapezoidal, semicircular, 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 direction of the top cover and its side surface is 30°-45°, further preferably, the upper cutting angle between the surface of the raised portion facing the axis direction of the top cover and its side surface is 30°; and when the shape of the raised portion is trapezoidal, further preferably, the surface of the raised portion facing the axis direction of the top cover and its side surface form a lower cutting angle, and further preferably, the lower cutting angle is 30°. When the shape of the raised portion is a trapezoid, the upper end fits tightly with the bottle mouth, and the top cover can be highly stably fitted on the double-chamber cartridge bottle; when the upper cutting angle of 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 top cover can maintain a high fit with the double-chamber cartridge bottle, thereby 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 a cylinder or an octagonal prism. Preferably, the shape of the lower end is an octagonal prism with an octagonal surface structure. After the double-chamber cartridge bottle is placed in the sheath with an octagonal structure, the lower end can match and fit 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 axis due to external force, thereby ensuring efficient screw connection and removal of the sterile injection needle on the double-chamber cartridge bottle packaging material.

[0022] According to another aspect of the present application, a dual-chamber cartridge bottle packaging material for injection is provided, which includes the bottle cap assembly provided in the present application and the dual-chamber cartridge bottle.

[0023] According to another aspect of the present application, a dual-chamber cartridge bottle packaging material assembly for injection is also provided, which includes the dual-chamber cartridge bottle assembly provided in the present application and a sheath. The sheath can cooperate with the lower end and the bypass protrusion to fix the dual-chamber cartridge bottle packaging material.

[0024] In some embodiments of the present application, the lower end of the bottle cap assembly of the packaging material is shaped like an octagonal prism, the sheath is shaped like an octagonal prism, and its inner wall is an octagon. The bypass protrusion of the double-chamber cartridge bottle of the packaging material is located at the octagonal vertex of the inner wall of the sheath; and the top of the inner wall of the sheath has a protrusion in the horizontal direction, which is assembled with the lower end of the bottle cap assembly of the packaging material through interference fit to further clamp the top plug and the double-chamber cartridge bottle with the lower end. By utilizing the interference fit between the lower end of the sheath and the bottle cap assembly, the sheath and the bottle cap assembly apply tension to each other, thereby clamping the double-chamber cartridge bottle toward 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, thereby improving the sealing performance of the packaging material.

[0025] According to another aspect of the present application, a bottle cap assembly is provided, wherein the bottle cap assembly may include a top plug and a top cover, and is used to seal a double-chamber cartridge bottle. The top plug is limited in the top cover, and is used to seal the bottle mouth of the double-chamber cartridge bottle; the top cover is used to press and fix the top plug, so that the top plug seals the bottle mouth of the double-chamber cartridge bottle; and the double-chamber cartridge bottle is sealed. The top cover presses and fixes the top plug, so that the top plug seals the bottle mouth of the double-chamber cartridge bottle, and may include the following steps:

[0026] Pre-assemble the top plug into the top cover; place the top cover equipped with the top plug above the bottle mouth of the double-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 formed as one piece, and there is no need to introduce a plugging assembly. 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 assembly to provide further capping of the double-chamber cartridge bottle. The application of the top cover on the double-chamber cartridge bottle significantly reduces the operating steps and time required for the self-plugging and capping of the double-chamber cartridge bottle, improves the sealing efficiency of the double-chamber cartridge bottle in the freeze-drying process, and avoids the number of operation failures caused by more operating steps. When the failed operation is difficult to remedy in the conventional way in the freeze-drying process, the self-plugging and capping integrated operation of the top cover is particularly important for ensuring the efficiency of the freeze-drying process.

[0027] In some embodiments of the present application, a double-chamber cartridge may include: an inner cavity, a bottle body, a bottleneck and a bottle mouth, wherein a bottle mouth opening connected to the inner cavity may be provided at the center of the bottle mouth, and the inner diameter of the bottle mouth opening is smaller than the inner diameter of the bottle mouth and the bottleneck; and a bypass protrusion may be provided on one side of the outer wall of the bottle body. After the double-chamber cartridge is placed in the sheath after the freeze-drying process is completed, the bypass protrusion of the bottle body may be fixed at the vertex of the inner wall of the sheath, so that the double-chamber cartridge will not be rotated along its longitudinal axis by external force when stored in the sheath. When the sterile injection needle is connected to the double-chamber cartridge or removed from the double-chamber cartridge, it needs to rotate on the threaded structure of the double-chamber cartridge. Therefore, the double-chamber cartridge is fixed and stopped by the bypass protrusion, which can prevent the sterile injection needle from rotating together with the double-chamber cartridge, and further prevent the sterile injection needle from idling, thereby realizing efficient threading and removal of the sterile injection needle on the packaging material of the double-chamber cartridge.

[0028] In some embodiments of the present application, the top plug may include a plug cap and a plug rod, the diameter of the plug rod is equal to or slightly larger than the inner diameter of the bottle mouth opening of the bottle mouth, and after the plug rod is embedded in the bottle mouth opening, the lower surface of the plug cap is completely fitted with the upper surface of the bottle mouth.

[0029] In some embodiments of the present application, the top cover may include an upper end and a bottom plate; the upper end may have a top plate, a thread and an opening, and the inner wall of the top cover fits with the bottle mouth; when the top cover moves toward 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 embedded in 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 embedded in the bottle mouth; after the bottom plate fits with the outer wall of the bottle body, the top cover as a whole can seal the bottle mouth and the connection between the bottleneck and the bottle body, thereby providing a complete seal for the bottle mouth with the top plug embedded, and increasing the sealing effect of the bottle mouth. The top cover has the characteristics of small size and fast loading and unloading, which can improve the self-pressing and capping efficiency of the double-chamber cartridge bottle in the freeze-drying process. When the bottom plate extends downward along the bottle body, its fit with the bottle body further prevents the top cover from loosening and slipping, thereby increasing the sealing effect of the double-chamber cartridge bottle. The opening can facilitate the sublimation of water in the product from the double chamber cartridge, so as to further reduce the water content of the freeze-dried product in the double chamber cartridge during the freeze-drying process. The thread is used for threading with a sterile injection needle.

[0030] The chassis can be a hollow cylinder or an octagonal prism with an opening at the bottom. Preferably, the chassis is an octagonal prism with an octagonal surface structure. After the double-chamber cartridge bottle has completed 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 and the sheath can also fix the double-chamber cartridge bottle, so that the double-chamber cartridge bottle will not rotate along its longitudinal axis due to external force when stored, thereby ensuring efficient screw connection 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 to the middle to further compress the top plug, thereby improving the sealing degree of the top plug and the top cover.

[0031] In some embodiments of the present application, the top plug may further include: a sealing portion protruding above the plug cap, the sealing portion being inserted into the top plate opening of the top plate of the top cover, and when the top plug is inserted into the bottle mouth, its sealing portion protrudes longitudinally from the top plate opening of the top plate. In the process of pre-assembling the top plug into the top cover, the sealing portion can be embedded in the top plate opening, and its edge portion is tightly fitted with 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, in actual production, external forces exerted on the top cover, such as vibration, suspension, etc., will not affect the fixation of the top plug in the top cover, thereby preventing the top plug from falling off from the top cover before the capping operation; in addition, after the top plug seals the bottle mouth opening, a gap portion is provided between the top plug and the top cover. After the injection needle is inserted into the top plug, its compressed volume extends into the gap portion at the outer edge, which can prevent the pressure from being concentrated on the sealing portion, thereby avoiding the coring phenomenon when the injection needle is inserted.

[0032] In some embodiments of the present application, the top end of the top cover may also have a top plug positioning point, which protrudes from the inner wall of the top end toward the axis of the top cover and is used to fix the top plug engaged with the bottle mouth. The top plug positioning point further fixes the top plug, thereby improving the sealing stability of the top plug.

[0033] 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 annularly on the inner wall of the upper end, which can provide uniform fixing force on the top plug. When the top plug has a tendency to slip, it is difficult for the top plug to produce a displacement greater than other directions in any direction, so it is more difficult for the top plug to slip from the bottle mouth. In addition, the top plug positioning points can also be used to position the top plug before it is pressed into the bottle mouth. The top plug is limited by the top plug positioning points to prevent it from slipping toward the bottle mouth on its own.

[0034] In some embodiments of the present application, the upper end of the top cover may be provided with a protrusion protruding toward the top cover axis on its inner wall, and the top cover may be limited on the bottle mouth by the protrusion before capping, so that the moisture of the product in the inner cavity can be discharged through sublimation through the opening; therefore, the provision of the protrusion helps to provide gas exchange and moisture sublimation discharge for the double-chamber cartridge bottle. After the top plug is pressed into the bottle mouth, the top cover is capped and fixed at the same time, and the protruding structure of the protrusion makes the upper end fit more closely with the bottle mouth, which is conducive to maintaining the fixation of the top cover after capping and improving the stability of the capping seal.

[0035] In some embodiments of the present application, the number of the protrusions is 2 or 3 or more; preferably, the maximum length of the protrusions protruding toward the axis of the top cover is 0.10 mm to 0.30 mm. The protrusions 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 top cover fixed on the double-chamber cartridge bottle.

[0036] In some embodiments of the present application, the shape of the raised portion is trapezoidal, semicircular, 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 direction of the top cover and its side surface is 30°-45°, further preferably, the upper cutting angle between the surface of the raised portion facing the axis direction of the top cover and its side surface is 30°; and when the shape of the raised portion is trapezoidal, further preferably, the surface of the raised portion facing the axis direction of the top cover and its side surface form a lower cutting angle, and further preferably, the lower cutting angle is 30°. When the shape of the raised portion is a trapezoid, the upper end fits tightly with the bottle mouth, and the top cover can be highly stably fitted on the double-chamber cartridge bottle; when the upper cutting angle of 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 top cover and the double-chamber cartridge bottle are kept highly fitted, thereby improving the capping efficiency and capping accuracy in the freeze-drying process using the top cover.

[0037] According to another aspect of the present application, a double-chamber cartridge bottle packaging material for injection is also provided, which includes a bottle cap assembly and a double-chamber cartridge bottle provided in the present application.

[0038] According to another aspect of the present application, a dual-chamber cartridge bottle packaging material assembly for injection is also provided, which includes the dual-chamber cartridge bottle assembly provided in the present application and a sheath. The sheath can cooperate with the bottom plate and the bypass protrusion to fix the dual-chamber cartridge bottle packaging material.

[0039] In some embodiments of the present application, the bottom plate of the bottle cap assembly of the packaging material is in the shape of a cylinder or an octagonal prism, and the bottom plate is preferably in the shape of an octagonal prism. The sheath includes a sheath body and a flange, and is in the shape of an octagonal prism, and its inner wall is an octagon. The bypass protrusion of the double-chamber cartridge bottle of the packaging material is located at the octagonal vertex of the inner wall of the sheath; and the top of the inner wall of the sheath has a protrusion in the horizontal direction, and is assembled with the bottom plate of the bottle cap assembly of the packaging material through interference fit, so as to further clamp the top plug and the double-chamber cartridge bottle with the bottom plate. By utilizing the interference fit between the sheath and the bottom plate of the bottle cap assembly, the sheath and the bottle cap assembly apply a pulling force to each other, thereby clamping the double-chamber cartridge bottle toward 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, thereby improving the sealing performance of the packaging material.

[0040] Compared with the prior art, the present invention has at least one of the following technical effects:

[0041] 1. The present application provides a bottle cap assembly and an integrated self-pressing plug and a press cap seal for a double-chamber cartridge bottle in a freeze dryer.

[0042] 2. The present application can improve the air tightness between the bottle stopper and the mouth of the double-chamber cartridge bottle.

[0043] 3. The present application can improve the sealing degree between the sealing bottle cap assembly and the double-chamber cartridge bottle.

[0044] 4. The present application can reduce the time required to seal the double-chamber cartridge bottle in the freeze-drying process by reducing the operating steps, while avoiding the reduction of the freeze-drying effect caused by the failure of sealing in the freeze dryer, thereby improving the freeze-drying efficiency and freeze-drying quality.

[0045] 5. The double-chamber cartridge bottle packaging material of the present application can effectively prevent the bottle cap from rotating and prevent the top plug from being cored out, which helps to efficiently coordinate the use of the injection needle and the double-chamber cartridge bottle packaging material assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] By describing the embodiments of the present application in more detail in conjunction with the accompanying drawings, the above and other purposes, features and advantages of the present application will become more apparent. The accompanying drawings are used to provide a further understanding of the embodiments of the present application and constitute a part of the specification. Together with the embodiments of the present application, they are used to explain the present application and do not constitute a limitation of the present application. In the accompanying drawings, the same reference numerals generally represent the same components or steps.

[0047] Figure 1 The figure shows a schematic structural diagram of a double-chamber cartridge bottle 1 and a top plug 2 of the present application.

[0048] Figure 2A The figure shows a schematic structural diagram of the top cover 3 of the present application.

[0049] Figure 2B Another structural schematic diagram of the top cover 3 of the present application is shown in the figure.

[0050] Figure 3 The figure shows another structure of the top plug 2 and yet another structural schematic diagram of the top cover 3 of the present application.

[0051] Figure 4A The figure shows a schematic structural diagram of the top plug positioning point 303 of the present application.

[0052] Figure 4B Another structural schematic diagram of the top plug positioning point 303 of the present application is shown.

[0053] Figure 5 The figure shows a schematic structural diagram of the upper end 30 of the present application.

[0054] Figure 6 The figure shows a schematic structural diagram of the maximum length of the protrusion 304 of the present application.

[0055] Figure 7 The figure shows a schematic structural diagram of the upper and lower cut corners of the raised portion 304 of the present application.

[0056] Figure 8 The figure shows a schematic structural diagram of the double-chamber cartridge bottle packaging material assembly of the present application.

[0057] Fig. 9 The figure shows a schematic structural diagram of a double-chamber cartridge bottle 1' and a top plug 2' of the present application.

[0058] Fig. 10A The figure shows a schematic structural diagram of the top cover 3' of the present application.

[0059] Fig. 10B The figure shows another structural schematic diagram of the top cover 3' of the present application.

[0060] Fig.11 The figure shows another structure of the top plug 2' and yet another structure schematic diagram of the top cover 3' of the present application.

[0061] Fig. 12A The figure shows a schematic structural diagram of the top plug positioning point 303' of the present application.

[0062] Fig. 12B Another structural schematic diagram of the top plug positioning point 303 ′ of the present application is shown.

[0063] Fig.13 The figure shows a schematic structural diagram of the upper end 30 ′ of the present application.

[0064] Fig.14 The figure shows a schematic structural diagram of the maximum length, upper cutting angle and lower cutting angle of the protrusion 304 ′ of the present application.

[0065] Fig.15 The figure shows a schematic structural diagram of the double-chamber cartridge bottle packaging material assembly of the present application.

[0066] Description of Reference Numerals

[0067] 1-Dual chamber cartridge 2-Top stopper 3-Top cover 4-Sheath

[0068] 1'-Dual chamber cartridge 2'-Top stopper 3'-Top cover 4'-Sheath

[0069] 10-bottle mouth 11-neck 12-bottle body 13-inner cavity

[0070] 10'-bottle mouth 11'-neck 12'-bottle body 13'-inner cavity

[0071] 20-plug cap 21-plug rod 22-sealing part 20'-plug cap

[0072] 21'- plug 22'- sealing part 30- upper end 31- middle end

[0073] 32-lower end 30'-upper end 31'-chassis 40'-sheath body

[0074] 41'-flange 100-bottle opening 120-bypass protrusion 100'-bottle opening

[0075] 120- bypass protrusion 200- gap 200'- gap 300- top plate

[0076] 301-thread 302-opening 303-top plug positioning point 304-protrusion

[0077] 310- convex ring 320- convex strip 321- first convex opening 300'- top plate

[0078] 301'-thread 302'-opening 303'-top plug positioning point 304'-protrusion

[0079] 321'- first protrusion 400'- second protrusion DETAILED DESCRIPTION

[0080] The present application discloses a bottle cap assembly, wherein the bottle cap assembly includes a top plug 2 and a top cover 3, which are used to seal a double-chamber cartridge bottle 1. The double-chamber cartridge bottle 1 is as shown in FIG. Figure 1 As shown, it can be placed in the freeze-drying support used in the existing freeze-drying process, and the double-chamber cartridge bottle packaging material can be fixed and placed upright or inverted in the freeze-drying support and the sheath; the bottle cap assembly can be made of any material suitable for realizing the bottle cap sealing function. 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; 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 may include the following steps:

[0081] The top plug 2 is preassembled into the top cover 3; and 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 to press the top plug 2. The top cover 3 can be pressed downward by mechanical pressing, pneumatic driving, pneumatic clamp driving, or spring pressing.

[0082] In the present application, the double-chamber cartridge 1 comprises: an inner cavity 13, a bottle body 12, a bottleneck 11 and a bottle mouth 10, wherein a bottle mouth opening 100 connected to the inner cavity 13 is arranged 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; and a bypass protrusion 120 is arranged on one side of the outer wall of the bottle body 12. It can be understood by those skilled in the art 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 1 can be adjusted to suit the size range of commonly used freeze-drying racks, such as changing the vertical length of one or more parts of the double-chamber cartridge 1, changing the radial length of one or more parts of the double-chamber cartridge 1, etc., all without departing from the protection scope of the present application.

[0083] In the present application, the top plug 2 includes a plug cap 20 and a plug rod 21. The diameter of the plug rod 21 can be equal to or slightly larger than the inner diameter of the bottle mouth opening 100. 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 to achieve sealing of the bottle mouth 10. In particular, the top plug 2 is made of elastic rubber material, so the diameter of the plug rod 21 can be adjusted within the diameter range of the bottle mouth opening 100 that the plug rod 21 can be inserted into after being pressed by force. The diameter of the plug rod 21 can be slightly larger than the diameter of the bottle mouth opening 100 to ensure the tightness of the seal.

[0084] In this application, the top cover 3 is as shown in FIG. Figure 2A As shown, it includes an upper end 30, a middle end 31 and a lower end 32; the upper end 30 has a top plate 300, a thread 301 and an opening 302, the middle end 31 has a convex ring 310, and the lower end 32 optionally has a convex strip 320, and the inner wall of the top cover 3 fits with the bottle mouth 20, the bottle neck 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 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 tightly fitted on the plug cap 20 to press the top plug 2. The opening 302 can discharge the sublimated water in the product, the thread 301 is used to engage with the thread of the sterile injection needle, and the convex ring 310 can match the sheath.

[0085] It should be noted that the shape of the lower end 32 of the top cover 3 can be a cylinder or a prism, such as Figure 2B As shown, its length in the vertical direction is adjustable, so the lower end 32 can fit a small part of the bottle body 12, or can fit most of the bottle body 12 or completely fit the entire bottle body 12, so as to achieve better sealing performance and adapt to the size requirements of the top cover 3 in the freeze-drying process. The convex strip 320 is used to increase the friction between the lower end 32 and the matching sheath to improve the effect of mutual matching and fixing; in particular, the convex strip 320 can also be removed. The shape of the lower end 32 can be cylindrical or multi-prism to prevent the top cover 3 from slipping due to the centrifugal force of rotation or from sliding relative to the double-chamber cartridge bottle 1 to affect the sealing performance.

[0086] In particular, the length of the middle end 31 of the top cover 3 along the direction of the bottleneck 11 and the bottle body 12 can be adjusted, and the convex ring 310 can be adjusted to fit the lower part of the upper end 30 at the highest, so as to meet the sealing requirements of the double-chamber cartridge bottle 1 for different degrees of pressing and fitting of the top cover 3. For example, it is necessary to reduce the length of the top cover 3 along the direction of the bottle body 12 or the volume of the top cover 3 to meet the size requirements of the freeze-drying support 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 of the top plate opening to its upper edge may have an inclination angle β along the vertical direction, and the circumferential upper edge of the top plate opening has a larger opening length than the circumferential lower edge; the circumferential edge surface of the top plate opening may be a curved surface or a flat surface.

[0087] In this application, if Figure 3 As shown, the top plug 2 may also include: a sealing portion 22 protruding above the plug cap 20, and the sealing portion 22 may be inserted into the top plate opening. When the top plug 2 is completely embedded in the bottle mouth 10, that is, when the double-chamber cartridge bottle 1 is completed, the 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. In 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 slight deformation to be inserted from the circumferential lower edge of the top plate opening and embedded in the top plate opening.

[0088] 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 tightly fitted with 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 fit between its edge portion and the circumferential outer edge of the top plate opening, and 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 can have a tighter fit relative to the circumferential upper edge of the top plate opening, so that the top plate opening tightly surrounds the fixed sealing portion 22.

[0089] 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 m, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the radial length L of the sealing portion 22 can be 3.0mm-4.0mm, specifically, the radial length L of the sealing portion 22 can be preferably 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm. The inclination angle β can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9° or 10°, etc.

[0090] In some embodiments, the circumferential lower edge opening length of the top disk opening can be 1.5mm-5.0mm. Specifically, the circumferential lower edge opening length of the top disk opening can be 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm m, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the circumferential lower edge opening length of the top plate opening may be 2.5mm-4.0mm, specifically, the circumferential lower edge opening length of the top plate opening may preferably be 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm.

[0091] By making the radial length L of the sealing portion 22 slightly larger than the opening length of the circumferential lower edge of the top plate opening, the sealing portion 22 fits more closely with the circumferential lower edge of the top plate opening, so that the top plate opening as a whole effectively fits and fixes the sealing portion 22, and the circumferential edge provides further support on this basis, so that the top plug 2 as a whole does not slip off. Preferably, when β is set to 0°, when the top plate opening has no inclination angle in the vertical direction, the sealing portion 22 can be well fixed, and the sealing portion 22 can be prevented from being difficult to insert when being plugged into the top plate opening due to excessive resistance; in another case, when the top plate opening needs to be set to a certain inclination angle in the vertical direction to enhance the limiting effect of the top plate 300 on the top plug 2, β can also be set to 5° to improve the fixing degree of the sealing portion 22, while not affecting the plugging and embedding of the sealing portion 22 into the top plate opening. Those skilled in the art can appropriately adjust the radial length L, the inclination angle β and the circumferential lower edge opening length of the sealing portion 22 based on the above-mentioned parameter standards according to the actual application of the bottle cap assembly, so as to adaptively adjust the degree of fit and fixation between the sealing portion 22 and the top plate 300.

[0092] In particular, 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 to the bottle mouth opening 100 to achieve sealing. In this case, the diameter of the plug cap 20 is set to be slightly smaller than the inner diameter of the top cover 3, so that a small gap 200 is left between the surface of the plug cap 20 and the inner wall of the upper end 30. Figure 5 As shown. In this way, when the top plug 2 is pressed by the top cover 3, the compressed volume of the plug cap 20 extends toward the gap 200 reserved around it, and the plug cap 20 will not bulge toward the top plate opening above the middle due to the pressure. Therefore, when the injection needle, such as a micro fine needle (MFN), is inserted from the middle of the plug cap 20 into the bottle mouth 10, the plug cap 20 will not apply pressure to the inside of the needle at the insertion position, thereby preventing the needle tip from cutting the plug cap 20 and coring, that is, generating rubber fragments that fall into the needle head and the inner cavity of the double-chamber cartridge bottle, thereby preventing the product from being contaminated.

[0093] 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 range from 5.0 mm to 10.0 mm. Specifically, the diameter of the plug cap 20 can range from 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 m, 8.6mm, 8.7mm, 8.8mm, 8.9mm, 9.0mm, 9.1mm, 9.2mm, 9.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm or 10.0mm; preferably, the diameter range of the plug cap 20 can be 6.0mm-8.0mm, specifically, the diameter of the plug cap 20 can preferably be 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm or 8.0mm.

[0094] 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 range from 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, 10.0 mm, 10.1 mm, 10.2 mm, 10.3 mm, 10.4 mm, 10.5 mm 5mm, 8.6mm, 8.7mm, 8.8mm, 8.9mm, 9.0mm, 9.1mm, 9.2mm, 9.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm or 10.0mm; Preferably, the diameter range of the upper end 30 can be 6.0mm-8.0mm, specifically, the diameter of the upper end 30 can preferably be 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm or 8.0mm.

[0095] 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 that matches it can be configured to be 7.3 mm. In this way, a gap 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. The plug cap 20 is squeezed and its diameter increases during the assembly process of the top plug 2 or the insertion process of the injection needle. The gap portion 200 can accommodate the increased volume of the plug cap 20 to avoid the generation of upward pressure. It should be noted that in the bottle cap assembly according to the embodiment 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 above-mentioned parameter reference according to the actual application of the bottle cap assembly, so as to adapt to the matching of the bottle cap assembly with the freeze-drying support of the freeze dryer, the matching with the packaging material sheath and / or the matching use with the syringe. For example, the stability of the pre-assembly of the top plug 2 can be adjusted by appropriately adjusting the diameter of the plug cap 20; the diameter of the upper end 30 can be appropriately adjusted to maintain a tighter seal or a more easily removable seal on the double-chamber cartridge bottle 1; and after adjusting the diameters of the plug cap 20 and the upper end 30 respectively, 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, a suitable gap portion 200 can be provided by appropriately adjusting the size relationship between the diameter of the plug cap 20 and the diameter of the upper end 30, etc.

[0096] By inserting and fitting the sealing portion 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, the mechanical processes implemented on the top cover 3 during the freeze-drying process, such as shaking, hanging, etc., will not affect the fixation of the top plug 2 in the top cover 3, thereby preventing the top plug 2 from falling off from the top cover 3 before the capping operation, and ensuring the qualified rate of the capping after the freeze-drying is completed; the configuration of the gap portion 200 of the plug cap 20 can also prevent the core from being removed when it is used with an injection needle, thereby ensuring product quality and efficient use.

[0097] In the present application, the upper end 30 of the top cover 3 also has a top plug positioning point 303, such as Figure 4A , Figure 4B As shown, the top plug positioning points 303 protrude from the inner wall of the upper end 30 toward the axis direction of the top cover 3, and are used to fix the top plug 2 engaged with the bottle mouth 10. Specifically, the top plug positioning points 303 extend radially along the upper end 30 and are evenly spaced annularly on the inner wall of the top plug positioning points 303. The top plug positioning points 303 may be in the shape of a cylinder or a prism. In addition, the number of the top plug positioning points 303 and the interval length / arc between the multiple top plug positioning points 303 may be adjusted to maintain optimal fixation of the top plug 2.

[0098] 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 their symmetrical arrangement along the center of the upper end 30, so as 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, so as 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, so as to provide the most stable fixing function for the top plug 2. The top plug positioning points 303 can also be used to position the top plug 2 before being pressed into the bottle mouth 10. The top plug 2 is limited by the top plug positioning points 303 to prevent it from sliding toward the bottle mouth 10 on its own.

[0099] In the present application, the upper end 30 of the top cover 3 is also provided with a protrusion 304 protruding toward the axial direction of the top cover 3 on its inner wall. Figure 6 As shown, the top cover 3 can be limited on the bottle mouth 10 by the protrusion 304 before pressing the cap, so that the sublimated water in the inner cavity 13 can be discharged through the opening 302; therefore, the provision of the protrusion 304 helps to provide gas exchange and sublimated water discharge for the double-chamber cartridge bottle 1. Those skilled in the art can understand that the protrusion 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 protrusion 304 is evenly distributed on the inner wall of the upper end 30, and the top plate 300 can evenly apply pressure to the entire surface of the plug cap 20 pre-assembled into the upper end 30 during the pressing, the top plug 2 can be stably and horizontally inserted into the bottle mouth 10.

[0100] In the present application, the number of protrusions 304 is 2 or 3 or more; preferably, the maximum length (D) of the protrusion 304 protruding toward the axial 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, so that the top cover 3 is not easily deformed by excessive pressure when it is pressed, and the top cover 3 has a good sealing performance after pressing, and it is not easy to slip off; more preferably, D can be 0.23mm to 0.28mm, which can avoid the top cover 3 from being deformed due to pressure when it is pressed, and the top cover 3 has a good sealing performance after pressing, and it is not easy to slip off. It should be noted that when the material of the raised portion 304 is different, the value of D can be adjusted to achieve the optimal limit of the top cover 3 before pressing and the optimal improvement of the fit between the upper end 30 and the double-chamber cartridge bottle 1. Preferably, when the outer diameter of the bottle mouth 10 is 7.3mm, D can be 0.23mm, 0.25mm or 0.28mm, and the raised portion 304 can provide the optimal stability of the top cover 3 after pressing.

[0101] In the present application, the shape of the protrusion 304 can be a trapezoid, a semicircle, a semi-ellipse or a rectangle, and preferably, the shape of the protrusion 304 is a trapezoid. When the shape of the protrusion 304 is preferably a trapezoid whose short side is close to the bottle mouth 10, the upper end 30 and the bottle mouth 10 fit tightly, and the top cover 3 can be highly stably fitted on the double-chamber cartridge bottle 1 to maintain good airtightness.

[0102] 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 can be any angle between 0° and 90°, such as Figure 7As shown. Further preferably, θ can be 30° to 45°, specifically, θ can be 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44° or 45°. It should be noted that when θ is less than 30°, the effect of the raised portion 304 on 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, it can be preferred that θ is any angle between 30° and 45°; more preferably, θ can be 30°, so that the raised portion 304 can provide a better fit between the top cover 3 and the bottle mouth 10, and does not cause adverse obstacles to the capping process.

[0103] In addition, when the shape of the raised portion 304 is a trapezoid, it is further preferred that the lower cut angle (α) between the surface of the raised portion 304 facing the axis direction of the top cover 3 and its side is any angle between 0°-90°. Since the pressure during the capping process is mainly affected by the size of θ, when α and θ have the same value, 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 prefers that α is 30° to improve the use efficiency and anti-deformation ability of the raised portion 304, and more preferably, θ and α of the raised portion 304 are both 30°, so that the top cover 3 will not be structurally damaged due to a large force during the capping process, and the top cover 3 and the double-chamber cartridge bottle 1 can be highly tightly fitted, which also improves the efficiency and accuracy of capping the double-chamber cartridge bottle 1.

[0104] The present application also discloses a double-chamber cartridge bottle packaging material for injection, which includes the bottle cap assembly and the double-chamber cartridge bottle 1, and a double-chamber cartridge bottle packaging material assembly for injection, which includes the double-chamber cartridge bottle packaging material for injection and a sheath 4 used in conjunction with the double-chamber cartridge bottle packaging material, such as Figure 8 It should be noted that the dual-chamber cartridge bottle packaging material for injection may include any combination of a bottle cap assembly and a dual-chamber cartridge bottle 1 that can be formed and / or maintained by any combination form disclosed in the present application.

[0105] The sheath 4 proposed in the present application is an octagonal prism with an upper opening, and its structure is as follows: Figure 8 As shown, the inner wall of the sheath 4 has an octagonal shape, and after the double-chamber cartridge bottle 1 completes the freeze-drying process and is sealed by the top cover 3, the double-chamber cartridge bottle 1 can be pressed into the sheath and placed. In 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 fixed at the octagonal vertex of the inner wall of the sheath and cannot slide relative to the inner wall of the sheath 4.

[0106] In the present application, the shape of the lower end 32 is a cylinder or an octagonal prism, and can be preferably an octagonal prism, and is fixedly assembled with the sheath 4 for fixing and storing the double-chamber cartridge bottle 1 through interference fit; specifically, the upper outer edge of the lower end 32 close to the middle end 31 has a first protrusion 321, the top end of the sheath 4 is stretched and limited on the first protrusion 321, and the top cover 3 and the sheath 4 apply force to each other and clamp toward the middle. Through the interference fit between the lower end 32 and the sheath 4, when the double-chamber cartridge bottle 1 is placed in the sheath 4, the top cover 3 and the top plug 2 therein are more tightly fixed to the bottle mouth 10, effectively avoiding leakage, rotation, falling off, etc.

[0107] Specifically, in some embodiments, the freeze-dried product after reconstitution in the double-chamber cartridge bottle 1 is subcutaneously injected through an injection needle for skin disease treatment or medical beauty applications. The needle seat of the injection needle has a threaded structure. When the MFN is installed on the top cover 3 to extract the product or removed from the top cover 3, its threaded structure is engaged or removed by rotation with the thread 301 of the top cover 3. During this process, the lower end 32 of the top cover 3 is fixed by the octagonal inner wall of the sheath 4 to prevent rotation, and the bypass protrusion 120 of the double-chamber cartridge bottle 1 is also fixed by the vertex of the octagonal inner wall of the sheath 4 to prevent rotation. Therefore, by selecting the lower end 32 of the octagonal prism shape and cooperating with the sheath 4, the double-chamber cartridge bottle packaging material assembly can be kept from being affected by the rotation when the injection needle is screwed / removed, so as to avoid idling when the sterile injection needle is screwed / removed, and improve the use efficiency of the double-chamber cartridge bottle packaging material assembly.

[0108] In order to provide an advantageous integrated sealing fit for a double-chamber cartridge bottle 1' having a longer neck, the present application further discloses a double-chamber cartridge bottle packaging material for injection, which comprises the above-mentioned another bottle cap assembly and a double-chamber cartridge bottle 1', such as Fig. 9 It should be noted that the dual-chamber cartridge bottle packaging material for injection may include any combination formed and / or maintained by any combination of the bottle cap assembly and the dual-chamber cartridge bottle 1 ' proposed in the present application.

[0109] In the present application, a bottle cap assembly is also proposed accordingly, wherein the bottle cap assembly includes a top plug 2' and a top cover 3', which are used to seal a double-chamber cartridge bottle 1'. The double-chamber cartridge bottle 1' can be placed in a freeze-drying rack and a sheath 4' used in an existing freeze-drying process, and the packaging material of the double-chamber cartridge bottle can be fixed and placed upright or inverted in the freeze-drying rack; the bottle cap assembly can be made of any material suitable for realizing the bottle cap sealing function. 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'; wherein, the process of pressing and fixing the top plug 2' in the top cover 3' so that the top plug 2' seals the bottle mouth 10' of the double-chamber cartridge bottle 1' may include the following steps:

[0110] The top plug 2' is preassembled into the top cover 3'; and 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. The top cover 3' can be pressed downward by mechanical pressing, pneumatic driving, pneumatic clamp driving, or spring pressing.

[0111] In the present application, the double-chamber cartridge 1' comprises: an inner cavity 13', a bottle body 12', a bottleneck 11' and a bottle mouth 10', wherein a bottle mouth opening 100' connected to the inner cavity 13' is arranged 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'; and a bypass protrusion 120' is arranged on one side of the outer wall of the bottle body 12'. It can be understood by those skilled in the art 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 1' can be adjusted to suit the size range of commonly used freeze-drying racks, such as changing the vertical length of one or more parts of the double-chamber cartridge 1', changing the radial length of one or more parts of the double-chamber cartridge 1', etc., all without departing from the protection scope of the present application.

[0112] In the present 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' is completely in contact with the upper surface of the bottle mouth 10' to achieve 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 diameter range of the bottle mouth opening 100' after the plug post 21' is pressed by force, and 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.

[0113] In this application, the top cover 3 'is as Fig. 10A As shown, it includes an upper end 30' and a bottom plate 31'; the upper end 30' 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' 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' fits tightly on the plug cap 20' to press the top plug 2'. The opening 302' can discharge the sublimated water in the product, and the thread 301' is used to engage with the injection needle thread.

[0114] It should be noted that the length of the bottom plate 31' in the vertical direction is adjustable, so the bottom plate 31' can only fit the connecting portion between the bottleneck 11' and the bottle body 12', or can additionally fit at least a portion of the bottle body 12', so as to achieve better sealing performance and meet the size requirements of the top cover 3' in the freeze-drying process. The shape of the bottom plate 31' can be set to be a cylinder or a polygonal column, such as Fig. 10B As shown, the top cover 3' is prevented from slipping off due to the centrifugal force of rotation or from sliding relative to the double-chamber cartridge bottle 1', thereby affecting the sealing performance.

[0115] In particular, the center of the top plate 300' also has a top plate opening, and the circumferential lower edge of the top plate opening to its upper edge may have an inclination angle β' along the vertical direction, and the circumferential upper edge of the top plate opening has a larger opening length than the circumferential lower edge; the circumferential edge surface of the top plate opening may be a curved surface or a flat surface.

[0116] In the present application, the top plug 2' may further include: a sealing portion 22' protruding above the plug cap 20', such as Fig.11 As shown, 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 double-chamber cartridge bottle 1' is completed, the 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. In 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 slight deformation to be inserted from the circumferential lower edge of the top plate opening and embedded in the top plate opening.

[0117] 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 tightly fitted with 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 out of the top plate 300'. In addition, by adjusting the size of β', the circumferential lower edge of the top plate opening and the sealing portion 22' have a tighter fit relative to the circumferential upper edge of the top plate opening, so that the top plate opening tightly surrounds the fixed sealing portion 22'.

[0118] In some embodiments, the radial length L' of the sealing portion 22' can be 2.0mm-5.0mm. Specifically, the radial length L' of the sealing portion 22' can be 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm m, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the radial length L' of the sealing portion 22' can be 3.0mm-4.0mm, specifically, the radial length L' of the sealing portion 22' can be preferably 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm. The inclination angle β' can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9° or 10°, etc.

[0119] In some embodiments, the circumferential lower edge opening length of the top disk opening can be 1.5mm-5.0mm. Specifically, the circumferential lower edge opening length of the top disk opening can be 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm m, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the circumferential lower edge opening length of the top plate opening may be 2.5mm-4.0mm, specifically, the circumferential lower edge opening length of the top plate opening may preferably be 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm.

[0120] By making the radial length L' of the sealing portion 22' slightly larger than the opening length of the circumferential lower edge of the top plate opening, the sealing portion 22' fits more closely with the circumferential lower edge of the top plate opening, and the top plate opening is opened so that the top plate opening as a whole effectively fits and fixes the sealing portion 22', and the circumferential edge provides further support on this basis, so that the top plug 2' as a whole does not slip off. Preferably, when β' is set to 0°, when the top plate opening has no inclination angle in the vertical direction, the sealing portion 22' can be well fixed, and the sealing portion 22' is prevented from being difficult to insert when being plugged into the top plate opening due to excessive resistance; in another case, when the top plate opening needs to be set to a certain inclination angle in the vertical direction to enhance the limiting effect of the top plate 300' on the top plug 2, β' can also be set to 5° to improve the fixing degree of the sealing portion 22', and at the same time, it does not affect the plugging and inserting of the sealing portion 22' into the top plate opening. Those skilled in the art can appropriately adjust the radial length L', the inclination angle β' and the circumferential lower edge opening length of the sealing portion 22', the top plate opening and the above-mentioned parameter reference according to the actual application of the bottle cap assembly, so as to adaptively adjust the degree of fit and fixation between the sealing portion 22' and the top plate 300'.

[0121] In particular, 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' and the top cover 3' can be tightly fixed to each other 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', so that a small gap 200' is left between the surface of the plug cap 20' and the inner wall of the upper end 30'. Fig.13 As shown. In this way, when the top plug 2' is pressed by the top cover 3', the compressed volume of the plug cap 20' extends to the gap 200' reserved around it, and the plug cap 20' will not bulge toward the top plate opening above the middle due to the pressure. Therefore, when the injection needle, such as a micro fine needle (MFN), is inserted from the middle of the plug cap 20' into the bottle mouth 10', the plug cap 20' will not apply pressure to the inside of the needle at the insertion position, thereby preventing the needle tip from cutting the plug cap 20' and coring, that is, the plug cap 20' is cut to produce rubber fragments that fall into the needle head and the inner cavity of the double-chamber cartridge bottle, thereby preventing the product from being contaminated.

[0122] In some embodiments, the diameter of the plug cap 20' can range from 5.0mm to 10.0mm. Specifically, the diameter of the plug cap 20' can range from 5.0mm to 10.0mm. Specifically, the diameter of the plug cap 20' can range from 5.0mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, 5.6mm, 5.7mm, 5.8mm, 5.9mm, 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm, 8.0mm, 8.1mm, 8.2mm, 8.3mm, 8.4mm, 8.5mm m, 8.6mm, 8.7mm, 8.8mm, 8.9mm, 9.0mm, 9.1mm, 9.2mm, 9.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm or 10.0mm; preferably, the diameter range of the plug cap 20' can be 6.0mm-8.0mm, specifically, the diameter of the plug cap 20' can preferably be 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm or 8.0mm.

[0123] 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 range from 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, 10.0 mm, 10.1 mm, 10.2 mm, 10.3 mm, 10.4 mm, 10.5 mm 5mm, 8.6mm, 8.7mm, 8.8mm, 8.9mm, 9.0mm, 9.1mm, 9.2mm, 9.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm or 10.0mm; preferably, the diameter range of the upper end 30' can be 6.0mm-8.0mm, specifically, the diameter of the upper end 30' can preferably be 6.0mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7.0mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm or 8.0mm.

[0124] 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' that matches it can be configured to be 7.3 mm, so that a gap 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'. The plug cap 20' is squeezed and its diameter increases during the assembly process of the top plug 2' or the insertion process of the injection needle. The gap portion 200' can accommodate the increased volume of the plug cap 20' to avoid the generation of upward pressure. It should be noted that in the bottle cap assembly according to the implementation scheme 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 above-mentioned parameter reference according to the actual application of the bottle cap assembly, so as to adapt to the matching of the bottle cap assembly with the freeze-drying support of the freeze dryer, the matching with the packaging material sheath and / or the matching use with the syringe. For example, the stability of the pre-assembly of the top plug 2' can be adjusted by appropriately adjusting the diameter of the plug cap 20'; the diameter of the upper end 30' can be appropriately adjusted to maintain a tighter seal or a more easily removable seal on the double-chamber cartridge bottle 1'; and after adjusting the diameters of the plug cap 20' and the upper end 30' respectively, in order to appropriately avoid the influence of the pressure of 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 a suitable gap portion 200', etc.

[0125] By inserting and fitting the sealing portion 22' into the top plate opening during the pre-assembly process of the top plug 2', and cooperating with the top plug positioning point 303' to limit the plug cap 20', the top plug 2' can be stably limited in the top cover 3'. Therefore, when external forces are applied to the top cover 3' in actual production, such as vibration, suspension, etc., it will not affect the fixation of the top plug 2' in the top cover 3', thereby preventing the top plug 2' from falling off from the top cover 3' before the capping operation, and ensuring the qualified rate of the capping after the freeze-drying is completed; in addition, the configuration of the gap portion 200' of the plug cap 20' can also prevent the core from being taken out when it is used with an injection needle, and also ensure the product quality and efficient use of packaging materials.

[0126] In the present application, the upper end 30' of the top cover 3' further has a top plug positioning point 303', such as Fig. 12A , Fig. 12B As shown, the top plug positioning point 303' protrudes from the inner wall of the upper end 30' toward the axis direction of the top cover 3', and is used to fix the top plug 2' engaged with the bottle mouth 10'. Specifically, the top plug positioning points 303' extend radially along the upper end 30' and are evenly spaced annularly on the inner wall of the top plug positioning points 303'. The top plug positioning points 303' can be in the shape of a cylinder or a prism. In addition, the number of the top plug positioning points 303' and the interval length / radian between the multiple top plug positioning points 303' can be adjusted to maintain the optimal fixation of the top plug 2'.

[0127] 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 their symmetrical arrangement along the center of the upper end 30', so as 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, so as to provide a relatively stable fixing function for the top plug 2'; more preferably, the number of the top plug positioning points is 8, so as to provide the most stable fixing function for the top plug 2'. The top plug positioning points 303' can also be used to position the top plug 2' before being pressed into the bottle mouth 10'. The top plug 2' is limited by the top plug positioning points 303' to prevent it from slipping off to the bottle mouth 10' on its own.

[0128] In the present application, the upper end 30' of the top cover 3' is also provided with a protrusion 304' protruding toward the axial direction of the top cover 3' on its inner wall. The top cover 3' can be limited on the bottle mouth 10' by the protrusion 304' before pressing the cap, so that the sublimated water in the inner cavity 13' can be discharged through the opening 302'; therefore, the provision of the protrusion 304' helps to provide gas exchange and water discharge for the double-chamber cartridge bottle 1'. Those skilled in the art can understand that the protrusion 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 protrusion 304' is evenly distributed on the inner wall of the upper end 30', and the top plate 300' can evenly apply pressure to the entire surface of the plug cap 20' preassembled into the upper end 30' during the pressing, the top plug 2' can be stably and horizontally inserted into the bottle mouth 10'.

[0129] In the present application, the number of protrusions 304' is 2 or 3 or more; preferably, the maximum length (D') of the protrusion 304' protruding toward the axial 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, so that the top cover 3' is not easily deformed by excessive pressure when pressing the cap, and the top cover 3' has a good sealing performance after pressing the cap, and it is not easy to slip off; more preferably, D' can be 0.23mm to 0.28mm, which can avoid the top cover 3' from being deformed due to pressure when pressing the cap, and the top cover 3' has a good sealing performance after pressing the cap, and it is not easy to slip off. It should be noted that when the material of the raised portion 304' is different, the value of D' can be adjusted to achieve the optimal limit of the top cover 3' before pressing the cap and the optimal improvement of the fit between the upper end 30' and the double-chamber cartridge bottle 1'. When the outer diameter of the bottle mouth 10' is 7.3mm, D' is preferably 0.23mm, 0.25mm or 0.28mm, so that the raised portion 304' can provide the most stable fixation for the top cover 3'.

[0130] In the present application, the shape of the protrusion 304' can be a trapezoid, a semicircle, a semi-ellipse or a rectangle. Preferably, the shape of the protrusion 304' is a trapezoid. When the shape of the protrusion 304' is preferably a trapezoid with the short side close to the bottle mouth 10', the upper end 30' and the bottle mouth 10' fit tightly, and the top cover 3' can be highly stably fitted on the double-chamber cartridge bottle 1' to maintain good airtightness.

[0131] When the shape of the protrusion 304' is a trapezoid, the upper cutting angle (θ') between the surface of the protrusion 304' facing the axis direction of the top cover 3' and its side surface can be any angle between 0° and 90°, such as Fig.14 As shown. Further, θ' can be 30° to 45°, specifically, θ' can be 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44° or 45°. It should be noted that when θ' is less than 30°, the effect of the raised portion 304' on 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, it is preferred that θ' is any angle between 30° and 45°; more preferably, θ' can be 30°, so that the raised portion 304' can provide a better fit between the top cover 3' and the bottle mouth 10', and does not cause adverse obstacles to the capping process.

[0132] In addition, when the shape of the raised portion 304' is a trapezoid, it is further preferred that the lower cut angle (α') of the surface of the raised portion 304' facing the axis direction of the top cover 3' and its side surface can also be any angle between 0°-90°. Since the pressure during the capping process is mainly affected by the size of θ', when α' and θ' have the same value, the raised portion 304' can have the most stable axisymmetric structure, which is not easy to deform or damage during the capping process or storage process. Therefore, the present application further prefers that α' can be 30° to improve the use efficiency and anti-deformation ability of the raised portion 304'. More preferably, θ' and α' of the raised portion 304' are both 30°, and the capping process of the top cover 3' will not cause structural damage to the top cover 3' due to excessive capping force, and at the same time, the top cover 3' can be kept in close contact with the height of the double-chamber cartridge bottle 1', which can improve the capping efficiency and accuracy of the double-chamber cartridge bottle 1' in the freeze-drying process.

[0133] The present application further proposes a double-chamber cartridge bottle packaging material for injection, which includes the above-mentioned bottle cap assembly and the double-chamber cartridge bottle 1', and a double-chamber cartridge bottle packaging material assembly for injection, which includes the double-chamber cartridge bottle packaging material for injection and a sheath 4' used in conjunction with the double-chamber cartridge bottle packaging material, such as Fig.15 It should be noted that the dual-chamber cartridge bottle packaging material for injection may include any combination of the bottle cap assembly and the dual-chamber cartridge bottle 1 ' that can be formed and / or maintained by any combination form proposed in this application.

[0134] The upper outer edge of the bottom plate 31' near the upper end 30' has a first first protrusion 321', and the top end of the inner wall of the sheath 4' is stretched to produce a protrusion in the horizontal direction, and is limited on the first first protrusion 321' of the bottom plate 31'. The top cover 3' and the sheath 4' achieve an interference fit, apply forces in opposite directions, and clamp the top plug 2' and the double-chamber cartridge bottle 1' in the middle. In addition, the bypass protrusion 120' of the bottle body 12' is fixed at the octagonal vertex of the inner wall of the sheath 4', and cannot slide relative to the inner wall of the sheath 4'. In the above manner, when the double-chamber cartridge bottle packaging material is placed in the sheath 4', the top cover 3' and the top plug 2' therein are more tightly fixed to the bottle mouth 10', effectively avoiding leakage, rotation, falling off, etc.

[0135] In the present application, the bottom plate 31' is in the shape of a cylinder or an octagonal prism, and the sheath 4' includes a sheath body 40' and a flange 41'. When the top cover 3' and the sheath 4' are interference fit, the top cover 3' and the double-chamber cartridge bottle 1' are tightly fixed to each other. Since the bottle mouth 10', the bottleneck 11' and the bottle body 12' of the double-chamber cartridge bottle 1' are cylindrical, when the injection needle is screwed to the top cover 3' and / or removed from the top cover 3', the top cover 3' drives the double-chamber cartridge bottle 1' to produce a co-rotation tendency due to the force. When the bottom plate 31' is in the shape of a cylinder, its smooth outer surface is difficult to be well limited by the inner wall of the sheath 4'. When the injection needle is screwed / removed, the top cover 3' may drive the entire double-chamber cartridge bottle 1' to rotate together, thereby causing the injection needle to rotate idly and unable to be fixed / released from the top cover 3'.

[0136] Therefore, the bottom plate 31' of the bottle cap assembly configured with the packaging material assembly is in the shape of an octagonal prism, and the sheath body 40' is in the shape of an octagonal prism, so that the outer wall of the bottom plate 31' and the inner wall of the sheath body 40' are both octagonal. Fig.15 As shown. In this way, the bypass protrusion 120' of the double-chamber cartridge bottle 1' of the packaging material assembly can be limited to the octagonal vertex (B'-B') of the inner wall of the sheath 4', and the bottle body 12' will generate a large friction force with the inner wall of the bottom plate 31' during the capping process; when the top cover 3' is subjected to external force such as an injection needle, the bottom plate 31' and the inner wall of the sheath 4' are interference-fitted and fixed to each other (A'-A'), so that the top cover 3' will not slip off or slide relative to the double-chamber cartridge bottle 1', further making the overall packaging material stable and motionless, avoiding the airtightness of the double-chamber cartridge bottle 1' from being affected, and improving the use efficiency.

[0137] In particular, the lower end of the sheath 4' may also have an interference fit structure, and the lower end of the sheath body 40' may be provided with a second protrusion 400', which is pressed and buckled on the flange 41', so that the sheath body 40' and the flange 41' are interference fit and fixed to each other (C'-C'). In this way, the fixing stability of the sheath body 40' can be improved, and the sheath body 40' and the packaging material can be prevented from rotating together.

[0138] Specifically, in some embodiments, the freeze-dried product after reconstitution in the double-chamber cartridge bottle 1' is subcutaneously injected through an injection needle for skin disease treatment or medical beauty. The needle seat of the injection needle has a threaded structure. When the injection needle is installed on the top cover 3' for product injection or removed from the top cover 3', its threaded structure is engaged or removed by rotation with the thread 301' of the top cover 3'. In this process, the bottom plate 31' of the top cover 3' is fixed by the octagonal inner wall of the sheath 4' to prevent rotation, and the bypass protrusion 120' of the double-chamber cartridge bottle 1' is also fixed by the vertex of the inner wall of the sheath 4' to prevent rotation. Therefore, by selecting the bottom plate 31' in the shape of an octagonal prism and cooperating with the sheath 4', the double-chamber cartridge bottle packaging material assembly can be kept from being affected by the rotation when the injection needle is screwed / removed, so as to avoid idling when the sterile injection needle is screwed / removed, and improve the use efficiency of the double-chamber cartridge bottle packaging material assembly.

[0139] At present, most of the freeze-dried products on the market use vials as drug containers. Before injection, it is necessary to first use a sterile syringe to extract the resolvent from another container containing the resolvent, and then inject the resolvent into the drug container for reconstitution, extraction and administration. The administration accuracy and use compliance are relatively poor. However, the bottle cap assembly and double-chamber cartridge bottle packaging material of the present application can effectively use the front chamber to hold the freeze-dried drugs and the rear chamber to hold the resolvent. And when in use, the resolvent can be pushed into the front chamber through a bypass by pushing the bottom plug to reconstitute the freeze-dried drugs, without the need for multiple extractions, which greatly facilitates the use convenience of the subjects or patients and enables the subjects or patients to inject themselves.

[0140] 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.

[0141] Example

[0142] 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.

[0143] Example 1

[0144] 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 2AThe 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,

[0145] 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.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] 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 5As 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.

[0150] 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.

[0151] The lower end 32 is in the shape of a cylinder. The convex ring 310 of the middle end 31 and the convex strip 320 of the lower end 32 can increase the 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, and further improve the stability of the attachment between the top cover 3 and the double-chamber cartridge bottle 1.

[0152] The bottle cap assembly was subjected to plugging and capping sealing tests, and it was found that part of the top plug 2 slipped off the top cover 3 in the freeze dryer, and the top cover 3 was not firmly fitted to the bottle mouth 20 of the double-chamber cartridge bottle 1, and could be pulled out of the double-chamber cartridge bottle 1 with less force.

[0153] Example 2

[0154] 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 in Example 1. The bottle cap assembly is subjected to plugging and capping sealing tests, and it is found that part of the top plug 2 slips off from the top cover 3, and the top cover 3 is still not firmly fitted with the bottle mouth 10 of the double-chamber cartridge bottle 1 and can be easily pulled out.

[0155] Example 3

[0156] The shape of the protrusion 304 is replaced with a trapezoid, wherein the upper cutting angle of the surface of the protrusion 304 facing the axis direction of the top cover 3 is 45°, and the lower cutting angle of the surface of the protrusion 304 facing the axis direction of the top cover 3 and its side surface is 30°. The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.30mm, and the number of the top plug positioning points 303 is replaced with 8, such as Figure 4B As shown, other structures and parameters are the same as those in Example 1.

[0157] The bottle cap assembly is subjected to plugging and capping sealing tests. Since the number of top plug positioning points 303 is increased, the fit between the top plug 2 and the top cover 3 is improved, and the top plug 2 no longer slips off the top cover 3; the capping process requires applying very large pressure, which causes deformation and damage to part of the structure of the top cover 3.

[0158] Example 4

[0159] The upper cutting angle of the surface of the protrusion 304 facing the axis direction of the top cover 3 is replaced with 30°, as shown in FIG. Figure 7 As shown, other structures and parameters are the same as those in Example 3. The bottle cap assembly was subjected to plugging and capping sealing tests. The top plug 2 and the top cover 3 had a high degree of fit, and the top plug 2 did not slip off from the top cover 3; after the upper cutting angle of the surface of the protrusion 304 facing the axis direction of the top cover 3 was replaced with 30°, it was found that a large pressure still needed to be applied during the capping process, causing deformation and damage to part of the structure of the top cover 3, which still had a certain impact on the sealing performance of the top cover 3.

[0160] Example 5

[0161] The upper cut angle of the surface of the protrusion 304 facing the axis direction of the top cover 3 is replaced with 30°, and the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.10 mm, and the other structures and parameters are the same as those in Example 3. 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; after the upper cut angle of the surface of the protrusion 304 facing the axis direction of the top cover 3 is replaced with 30°, and the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.10 mm, the capping process does not require a large pressure to be applied, but the fit between the top cover 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 is not firm enough, and can be pulled out after applying a certain force.

[0162] Example 6

[0163] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.15 mm, and the other structures and parameters are the same as those of Example 5. 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; after the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.15 mm, the capping process does not require a large pressure to be applied, but the fit between some of the top cover 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 is still not firm enough, and it can still be pulled out after a certain force is applied.

[0164] Example 7

[0165] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.20 mm, and the other structures and parameters are the same as those in Example 5. 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; after the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.20 mm, the capping process does not require a large pressure to be applied, the fit between the top cover 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 is improved, the fit is relatively firm, and it is less likely to be pulled out after applying a greater force, and only occasionally pulls out and falls off.

[0166] Example 8

[0167] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.23 mm, and the other structures and parameters are the same as those in Example 5. 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; after the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.23 mm, a certain amount of pressure needs to be applied during the capping process, but no deformation or damage is caused 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.

[0168] Example 9

[0169] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.25 mm, and the other structures and parameters are the same as those in Example 5. 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; after the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.25 mm, a certain amount of pressure needs to be applied during the capping process, but no deformation or damage is caused 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 also significantly improved, and it is not pulled out after applying a large force.

[0170] Example 10

[0171] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.28 mm, and the other structures and parameters are the same as those in Example 5. 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; after the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 is replaced with 0.28 mm, the capping process needs to apply a large pressure, 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.

[0172] Embodiment 11

[0173] The structure of the top cover 3 of the bottle cap assembly in Example 8 is adjusted to reduce the volume of the top cover 3, such as Figure 2B Specifically, the length of the portion of the top cover 3 extending 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 the position of the convex ring 310 relative to the bottleneck 11 and the bottle body 12 is further moved upward and fits with the lower part of the upper end 30. In addition, the convex strip 320 of the lower end 32 is removed, and the non-convex strip portion of the lower end 32 is extended downward along the bottle body 12, and the upper part of the lower end 32 close to the middle end 31 is shortened in the radial direction to form a first convex opening 321.

[0174] It should be noted that the shape of the extended lower end 32 in this embodiment is set to be an octagonal prism, and its inner wall can still fit at least a portion of the bottle body 12 of the double-chamber cartridge bottle 1, and the structure of the adjusted top cover 3 except the middle end 31 and the lower end 32 is the same as the top cover 3 in Example 10. The number of the top plug positioning points 303 is 8, which are evenly distributed on the inner wall of the upper end 30.

[0175] 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.

[0176] Example 12

[0177] 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.

[0178] Example 13

[0179] 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.

[0180] Embodiment 14

[0181] 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: Fig. 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,

[0182] 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.

[0183] Then, after freeze drying is completed, the top cover 3' is used to press the top plug 2' to fit into the bottle mouth 10' of the double-chamber cartridge bottle 1'. The top cover 3' includes an upper end 30' and a bottom plate 31'. The upper end 30' has a top plate 300' located at its center, a thread 301' located at the edge of the upper end 30', and an opening 302'; the bottom of the bottom plate 31' is an opening. After the top plug 2' is initially inserted into 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' fits with the bottle mouth 10' and the bottleneck 11', and the inner wall of the bottom plate 31' fits with part of the bottle body 12'.

[0184] The top plate 300' is a hollow cylindrical structure shortened in the middle. When an external force is applied to press the top cover 3' downward, 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 impact of inaccurate sealing on the production efficiency of the freeze-drying process.

[0185] In particular, the top cover 3' is configured so that when the top plug 2' is pressed to completely embed into the bottle mouth 10', the inner wall of the bottom plate 31' can also partially fit with the top end 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 neck 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'.

[0186] The upper end 30' has a diameter of 7.3 mm, and a gap 200' is left between the plug cap 20' having a diameter of 7.0 mm; the upper end 30' also has a top plug positioning point 303', such as Fig.13 , Fig. 12A and Fig. 12B As 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' toward the axis direction 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 subjected to the pressure of the top plug positioning point 303' toward the axis direction 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 being loosened 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'.

[0187] The upper end 30' also has a protrusion 304', which is arranged below the top plug positioning point 303' and protrudes from the inner wall of the upper end 30' in the direction of the axis of the top cover 3'. After the top plug 2' is completely embedded in the bottle mouth 10', the protrusion 304' fits with 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 the capping due to loose fitting, thereby improving the sealing performance of the double-chamber card bottle 1'. The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is set to 0.20mm, and the shape of the protrusion 304' is set to be trapezoidal, the number is 2, and it is distributed on both sides of the inner wall of the upper end 30', and the upper and lower cutting angles of the surface facing the axis direction of the top cover 3' and its side are both 30°. The shape of the bottom plate 31' is cylindrical. The bottle cap assembly was subjected to plugging and capping sealing tests, and it was found that the top plug 2' and the top cover 3' had a good fit, and the top plug 2' did not slip out of the top cover 3'; the capping process did not cause deformation of the top cover 3', and the top cover 3' and the double-chamber cartridge bottle 1' were well fixed and only occasionally fell off.

[0188] Embodiment 15

[0189] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.23mm, and the remaining structures and parameters are the same as those of Example 14. 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'; after the maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.23mm, the capping process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0190] Example 16

[0191] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.25mm, and the remaining structures and parameters are the same as those of Example 14. 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'; after the maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.25mm, the capping process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0192] Embodiment 17

[0193] The maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.28mm, and the remaining structures and parameters are the same as those of Example 14. 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'; after the maximum length of the protrusion 304' protruding from the inner wall of the upper end 30' is replaced with 0.28mm, the capping process does not cause deformation of the top cover 3', and the top cover 3' does not fall off.

[0194] Embodiment 18

[0195] The structure of the top cover 3' of the bottle cap assembly in Example 16 is adjusted to increase the volume of the top cover 3', such as Fig. 10B Specifically, the bottom plate 31' in Example 16 is extended downward along the bottle body 12', so that the extended bottom plate 31' can seal at least a portion of the bottle body 12'. It should be noted that the bottom plate 31' extending downward is shaped as an octagonal prism, and the structure of the top cover 3' after adjustment is the same as before adjustment except for the bottom plate 31'. The number of the top plug positioning points 303' is 8, evenly distributed on the inner wall of the upper end 30'.

[0196] The bottle cap assembly was subjected to plugging closure 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 out of 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 a large force was applied.

[0197] Embodiment 19

[0198] The structures of the top plug 2' and the top plate 300' of the top cover 3' of the bottle cap assembly in Example 18 are adjusted to improve the fixing tightness of the top plug 2' pre-assembled into the top cover 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 shape of the top plate opening is set to be circular, the diameter of its lower edge is 3.4mm, the shape of the sealing portion 22' is cylindrical, and its radial length L'=3.6mm, as shown in FIG. Fig.11 The inclination angle β' from the circumferential lower edge of the top plate opening to its upper edge is 0°, and the other structures and parameters are the same as those of the eighteenth embodiment.

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').

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') comprises an upper end (30') and a bottom plate (31'); The upper end (30') 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'); The center of the top plate (300') is provided with 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').

20. The bottle cap assembly according to claim 19, 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 the 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').

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 claims 19 to 26, 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.

28. A double-chamber cartridge packaging material for injection, comprising the bottle cap assembly according to any one of claims 16 to 27 and a double-chamber cartridge (1').

29. A dual-chamber cartridge bottle packaging material assembly for injection, comprising the dual-chamber cartridge bottle packaging material for injection according to claim 28 and a sheath (4').

30. The packaging material assembly according to claim 29, 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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