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

Abstract

The bottle cap assembly, the double-cavity clamping type bottle packing material for injection and the packing material assembly are characterized in that the bottle cap assembly is used for sealing a double-cavity clamping type bottle and comprises a top plug and a top cover; the top plug is limited in the top cover and used for sealing a bottle opening of the double-cavity clamping type bottle. The top cover is used for pressing and fixing the top plug, so that the top plug seals a bottle opening of the double-cavity clamping bottle; and the double-cavity clamping type bottle is sealed. According to the bottle cap assembly and the double-cavity clamping type bottle using the bottle cap assembly, integrated plug pressing and cover pressing sealing can be conducted on the double-cavity clamping type bottle in a freeze dryer, and the freeze-drying efficiency and the freeze-drying product quality are improved.

Description

TECHNICAL FIELD

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

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

[0003] After the product in the double-chamber carton bottle is freeze-dried, the bottle opening needs to be sealed for long-term storage to ensure low moisture of the product. Common sealing techniques include aluminum cap crimping processes. The bottle opening of the double-chamber carton bottle is sealed by installing an aluminum cap and a rubber pad on the inner side. Under pressure from the top, an angled metal disc presses against the lower end of the aluminum cap and is pressed into the back side of the bottle opening. However, the aluminum cap can produce powder from the aluminum material during the crimping process, which can fall into the freeze-dried product and cause contamination. In addition, the double-chamber carton bottle is a hard glass container, which can produce size deviations during the manufacturing process. If a plastic top cap is selected, it cannot be expected to perfectly fit the bottle opening due to size deviations when it is embedded in the bottle opening.

[0004] Therefore, by grinding the bottle opening of the double-chamber carton bottle through an additional process, a high-precision size can be obtained. By using PEEK or PSF as the material of the top cap, which is strong and not easily broken, the friction caused by the rough surface of the ground bottle opening can prevent the bottle opening or the top cap from rotating.

[0005] Therefore, it would be more efficient and clean to freeze-dry the ungrounded dual-chamber carton bottle and seal the bottle opening with a suitable plug and cap by uniform force. However, the conventional dual-chamber carton bottle packaging material cannot complete the plug pressing and sealing in the freeze-dryer, which leads to the need for additional steps to transfer the dual-chamber carton bottle and complete the sealing in other components, which brings additional process costs and may also contaminate the product. Therefore, it is necessary to design an innovative packaging material that can achieve self-plug pressing and sealing in the freeze-dryer cavity to meet the airtightness requirement of the freeze-drying process, so that the packaging material can meet the future drug delivery method. The closure device and sealing component for a container disclosed in CN102259723A has high sealing performance, but it cannot meet the requirement of product moisture sublimation from the container (mainly gas) during freeze-drying, so this type of packaging material cannot be directly applied in the freeze-drying process, and an additional capping step may be required, which increases the time cost and may affect the freeze-drying effect of the drug in the container during container transfer.

[0006] CN117208401A discloses a bottle cap and a dual-chamber carton bottle. When the freeze-drying is completed, the partition plate in the freeze-dryer can directly apply pressure to the bottle cap to switch the bottle cap from a half-cap state to a full-cap state, thereby sealing the dual-chamber carton bottle. However, the bottle cap of the dual-chamber carton bottle is limited by the hooking part on the inner side of the cavity and the clamping groove of the annular protruding part on the outer peripheral surface of the dual-chamber carton bottle before capping. If the partition plate of the freeze-dryer does not apply uniform pressure due to uneven placement of the dual-chamber carton bottle, the bottle cap may be tilted during capping. Since the shape of the hooking part is an asymmetric column, the tilted bottle cap may not be able to be normally pressed down by further applying pressure. In addition, the inner cap has a risk of sliding off downward in the half-cap state, which reduces the efficiency of water sublimation during freeze-drying.

[0007] Further, CN117228154A discloses a combined bottle cap and dual-chamber carton bottle. The combined bottle cap has an inner cap and an outer cap. The first clamping member of the outer cap is in contact with 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, so that the problem of loose sealing caused by tilting of the bottle cap during capping can be avoided. However, when the outer cap is in the half-cap state, the contact area between the first clamping member and the outer wall of the inner cap is very limited, and the outer cap may not be stably limited to the outer edge of the inner cap during freeze-drying, causing the outer cap to fall off.

[0008] In addition, the existing double-chamber carton bottle packaging material is sealed by installing an aluminum cap and a rubber gasket on the inner side, and the process is completed by a press-in process. In order to seal, the rubber seal is fixed by crimping while being pressed in. The compressed volume of the rubber protrudes from the hole of the aluminum cap. The compressed rubber exerts pressure on the hole where the volume escapes. When the injection needle is inserted here, the rubber exerts pressure on the inside of the needle, which can generate rubber fragments, i.e. coring phenomenon. When the lyophilized product is obtained and fitted with the injection needle, the double-chamber carton bottle packaging material according to the present application will provide a feasible solution to the problem hereinafter.

[0009] Therefore, there is an urgent need for a bottle cap assembly that can solve the above problems and is stably matched with a double-chamber carton bottle, which can stably complete self-pressing and capping in the lyophilizer cavity to improve the lyophilization efficiency and quality of the lyophilized product, fill the gap in the field of double-chamber carton bottle packaging materials in China at present, and improve the core competitiveness of the product. Content of the utility model

[0010] The present application aims to provide a solution that can overcome at least one of the above-mentioned defects of the prior art.

[0011] According to an aspect of the present application, a bottle cap assembly is provided, wherein the bottle cap assembly can include a top plug and a top cap for sealing a double-chamber carton bottle. The top plug is limited in the top cap for sealing the bottle mouth of the double-chamber carton bottle; the top cap is used to press and fix the top plug, so that the top plug seals the bottle mouth of the double-chamber carton bottle; and the double-chamber carton bottle is sealed. After the top plug is pre-assembled into the top cap, the top plug is integrally formed with the top cap, without the need to introduce a press-in assembly, and the top cap can directly realize press-in sealing by pressing the top plug. In addition, in this way, there is also no need to additionally remove the press-in assembly to provide further capping for the double-chamber carton bottle. The application of the top cap on the double-chamber carton bottle significantly reduces the operation steps and time required for self-pressing and capping of the double-chamber carton bottle, improves the sealing efficiency of the double-chamber carton bottle in the lyophilization process, and avoids the number of operation failures caused by more operation steps. When the failed operation is difficult to be remedied in the conventional way in the lyophilization process, the self-pressing and capping integrated operation of the top cap is particularly important to ensure the efficiency of the lyophilization process.

[0012] In some embodiments of the present application, the double-cavity carton bottle can include an inner cavity, a bottle body, a bottle neck, and a bottle mouth, the center of the bottle mouth can be provided with a bottle mouth opening connected with the inner cavity, the inner diameter of the bottle mouth opening is smaller than the inner diameter of the bottle mouth and the bottle neck; the outer wall of one side of the bottle body can have a bypass protrusion. After the double-cavity carton bottle completes the freeze-drying process and is placed in the sheath, the bypass protrusion of the bottle body can be clamped at the vertex of the inner wall of the sheath, so that the double-cavity carton bottle will not rotate along its longitudinal axis when it is stored in the sheath due to external force. During the process of engaging or disengaging the sterile injection needle with the double-cavity carton bottle, it is necessary to rotate on the threaded structure of the double-cavity carton bottle, therefore, the double-cavity carton bottle is fixed by the bypass protrusion to prevent rotation, which can avoid the co-rotation of the sterile injection needle and the double-cavity carton bottle, and further avoid the idling of the sterile injection needle, thereby achieving efficient screwing and dismounting of the sterile injection needle on the double-cavity carton bottle packaging material.

[0013] In some embodiments of the present application, the top plug can include a plug cap and a plug column, the diameter of the plug column is equal to or slightly larger than the inner diameter of the bottle mouth opening of the bottle mouth, and after the plug column is embedded in the bottle mouth opening, the lower surface of the plug cap is completely matched with the upper surface of the bottle mouth.

[0014] In some embodiments of the present application, the top cover can include an upper end and a bottom disc; the upper end can have a top disc, a thread, and an opening, the inner wall of the top cover is matched with the bottle mouth; when the top cover moves towards the bottle mouth, the top disc of the upper end presses the top plug to move inwardly to 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 disc, and continues to clamp the top plug after the top plug is embedded in the bottle mouth; after the bottom disc is matched with the outer wall of the bottle body, the whole top cover can seal the bottle mouth and the connection between the bottle neck and the bottle body, thereby providing complete sealing of the bottle mouth with the embedded top plug and increasing the sealing effect of the bottle mouth. The top cover has the characteristics of small size and fast assembly and disassembly, which can improve the self-plugging and capping efficiency of the double-cavity carton bottle in the freeze-drying process. When the bottom disc extends downward along the bottle body, the matching between the bottom disc and the bottle body further prevents the top cover from loosening and slipping off, thereby increasing the sealing effect of the double-cavity carton bottle. The opening can facilitate the sublimation of water in the product from the double-cavity carton bottle, so as to further reduce the water content of the freeze-dried product in the double-cavity carton bottle in the freeze-drying process. The thread is used for threaded engagement with the sterile injection needle.

[0015] In some embodiments of the present application, the bottom disc is a hollow, open-bottomed cylinder or octagonal prism. Preferably, the bottom disc is an octagonal prism, which has an octagonal surface structure, and after the double-cavity carton bottle completes the freeze-drying process and is placed in the sheath, the bottom disc is matched and embedded with the octagonal inner wall of the sheath. This way of embedding the bottom disc with the sheath can also clamp the double-cavity carton bottle, so that the double-cavity carton bottle will not rotate along its longitudinal axis when it is stored due to external force, thereby ensuring the efficient screwing and dismounting of the injection needle on the top cover. In addition, the bottom disc and the sheath are assembled and fixed by interference fit, and the 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.

[0016] In some embodiments of the present application, the top plug can further comprise a sealing portion protruding above the plug cap, the sealing portion being inserted into the top disc opening of the top disc of the top cap, and the sealing portion of the top plug protruding longitudinally above the top disc opening of the top disc when the top plug is embedded into the bottle opening. During the pre-assembly of the top plug into the top cap, the sealing portion can be embedded into the top disc opening, the edge portion of the sealing portion being closely fitted with the circumferential outer edge of the top disc opening, and finally partially protruding above the upper edge of the top disc opening; in this way, the sealing portion is inserted and fitted into the top disc opening during the pre-assembly of the top plug, and the plug cap is limited by the positioning point of the top plug, so that the top plug can be more stably fixed in the top cap. Therefore, in actual production, external forces such as shaking, hanging, etc. will not affect the fixation of the top plug in the top cap, thereby avoiding the top plug from falling off the top cap before the capping operation; in addition, after the top plug seals the bottle opening, a gap is provided between the top plug and the top cap, and after the injection needle is inserted into the top plug, the volume of the injection needle under pressure extends into the outer edge gap, which can prevent the pressure from concentrating on the sealing portion, thereby avoiding the core taking phenomenon when the injection needle is inserted.

[0017] In some embodiments of the present application, the upper end of the top cap can further have a top plug positioning point protruding from the inner wall of the upper end towards the top cap axis, for fixing the top plug embedded in the bottle opening. Through the further fixation of the top plug by the top plug positioning point, the sealing stability of the top plug is improved.

[0018] In some embodiments of the present application, the number of top plug positioning points is 4 or more than 5. The top plug positioning points are also uniformly arranged along the radial direction of the top cap and are uniformly spaced in the circumferential direction on the inner wall of the upper end, which can provide uniform fixing force to the top plug. When the top plug tends to slip, it is difficult for the top plug to displace in any direction more than in other directions, so it is more difficult for the top plug to slip out of the bottle opening. In addition, the top plug positioning point can also be used for positioning the top plug before it is pressed into the bottle opening, and the top plug is limited by the top plug positioning point to avoid its autonomous slipping out of the bottle opening.

[0019] In some embodiments of the present application, the upper end of the top cap can further have a protruding portion protruding from the inner wall of the upper end towards the top cap axis, and the top cap can be limited by the protruding portion on the bottle opening before capping, so that the moisture of the product in the inner cavity is sublimed and discharged through the opening; therefore, the provision of the protruding portion helps to provide gas exchange and moisture sublimation discharge for the double-cavity cartridge bottle. After the top plug is pressed into the bottle opening, the top cap is simultaneously capped and fixed, and the protruding structure of the protruding portion makes the upper end fit more closely with the bottle opening, which is conducive to maintaining the fixation of the top cap after capping, and improving the stability of the capping seal.

[0020] In some embodiments of the present application, the number of protrusions is 2 or more than 3; preferably, the maximum length of the protrusions protruding towards the axis of the top cover is 0.10-0.30 mm. The protrusions are evenly arranged in the circumferential direction on the inner wall of the upper end, so that the upper end and the bottle mouth are evenly fitted, the top cover does not slip from one side, and the stability of the top cover on the double-cavity cartridge bottle is further improved.

[0021] In some embodiments of the present application, the shape of the protrusions is trapezoidal, semicircular, semi-elliptical or rectangular, preferably the shape of the protrusions is trapezoidal; when the shape of the protrusions is trapezoidal, preferably, the upper cutting angle of the surface of the protrusions towards the axis of the top cover and the side surface thereof is 30-45°, further preferably, the upper cutting angle of the surface of the protrusions towards the axis of the top cover and the side surface thereof is 30°. When the shape of the protrusions is trapezoidal, the fitting tightness of the upper end and the bottle mouth is relatively good, and the top cover can be highly stably fitted on the double-cavity cartridge bottle; when the upper cutting angle of the surface of the protrusions towards the axis of the top cover and the side surface thereof is 30° and the lower cutting angle thereof is 30°, the pressing process of the top cover will not cause damage to the structure of the top cover due to excessive pressing force, while maintaining high fitting degree of the top cover and the double-cavity cartridge bottle, and improving the pressing efficiency and precision in the freeze-drying process using the top cover.

[0022] According to another aspect of the present application, a double-cavity cartridge bottle packaging material for injection is also provided, which comprises the bottle cap assembly and the double-cavity cartridge bottle provided by the present application.

[0023] According to still another aspect of the present application, a double-cavity cartridge bottle packaging material assembly for injection is also provided, which comprises the double-cavity cartridge bottle assembly and the sheath provided by the present application. The sheath can cooperate with the bottom disc and the bypass protrusion to fix the double-cavity cartridge bottle packaging material.

[0024] In some embodiments of the present application, the shape of the bottom disc of the bottle cap assembly of the packaging material is cylindrical or octagonal prism, preferably the shape of the bottom disc is octagonal prism, the sheath comprises a sheath body and a flange, the shape of the sheath is octagonal prism, the inner wall thereof is octagonal, the bypass protrusion of the double-cavity cartridge bottle of the packaging material is located at the vertex of the octagonal inner wall of the sheath; and the top of the inner wall of the sheath has protrusions in the horizontal direction, and the bottom disc of the bottle cap assembly of the packaging material is assembled by interference fit to further clamp the stopper and the double-cavity cartridge bottle with the bottom disc. By using the interference fit between the sheath and the bottom disc of the bottle cap assembly, the sheath and the bottle cap assembly exert pulling force on each other, so as to clamp the double-cavity cartridge bottle in the middle, which can make the stopper and the top cover more closely embedded with the bottle mouth opening and the bottle mouth respectively, and improve the sealing performance of the packaging material.

[0025] Compared with the prior art, the present application has at least one of the following technical effects:

[0026] 1. The present application provides a bottle cap assembly and a double-cavity cartridge bottle using the bottle cap assembly, which can integrate the pressing of the stopper and the pressing of the top cover for sealing in the freeze-drying machine.

[0027] 2. The application can improve the airtightness of the top plug and the bottle opening of the double-cavity carton bottle.

[0028] 3. The application can improve the sealing degree of the bottle cap assembly and the double-cavity carton bottle.

[0029] 4. The application can reduce the time cost and operation complexity required for sealing the double-cavity carton bottle in the freeze-drying process, improve the freeze-drying efficiency and freeze-dried product quality.

[0030] 5. The double-cavity carton bottle packaging material of the application can effectively maintain the rotation stop of the bottle cap and prevent the top plug from being cored, which helps the efficient use of the injection needle and the double-cavity carton bottle packaging material assembly. BRIEF DESCRIPTION OF DRAWINGS

[0031] The above and other objects, features and advantages of the present application will become more apparent from the following detailed description of embodiments of the present application, taken in conjunction with the accompanying drawings. The drawings provided below are for purposes of illustration only and are not intended to limit the present application. The same reference numbers in different drawings identify the same components or steps.

[0032] Figure 1 FIG. 1 illustrates a structural schematic diagram of the double-cavity carton bottle 1 and the top plug 2 of the present application.

[0033] Figure 2A FIG. 3 illustrates a structural schematic diagram of the top cap 3 of the present application.

[0034] Figure 2B FIG. 4 illustrates another structural schematic diagram of the top cap 3 of the present application.

[0035] Figure 3 FIG. 5 illustrates another structure of the top plug 2 and yet another structural schematic diagram of the top cap 3 of the present application.

[0036] Figure 4A FIG. 6 illustrates a structural schematic diagram of the top plug positioning point 303 of the present application.

[0037] Figure 4B FIG. 7 illustrates another structural schematic diagram of the top plug positioning point 303 of the present application.

[0038] Figure 5 FIG. 8 illustrates a structural schematic diagram of the upper end 30 of the present application.

[0039] Figure 6 FIG. 9 illustrates a structural schematic diagram of the maximum length, upper cut angle and lower cut angle of the protruding portion 304 of the present application.

[0040] Figure 7 FIG. 10 illustrates a structural schematic diagram of the double-cavity carton bottle packaging material assembly of the present application.

[0041] Reference Signs List

[0042] 1 - Double-chambered Cartridge 2 - Stopper 3 - Cap 4 - Sheath

[0043] 10 - Mouth 11 - Neck 12 - Body 13 - Inner Chamber

[0044] 20 - Cap 21 - Column 22 - Sealing Portion 30 - Upper End

[0045] 31 - Base 40 - Sheath Body 41 - Flange 100 - Mouth Opening

[0046] 120 - Bypass Protrusion 200 - Gap Portion 300 - Top Disc 301 - Thread

[0047] 302 - Opening 303 - Stopper Positioning Point 304 - Protrusion Portion 310 - First Indent

[0048] 400 - Second Indent DETAILED DESCRIPTION

[0049] As described above, the present application proposes a double-chambered cartridge package for injection, which includes the bottle cap assembly and the double-chambered cartridge 1 described above. It is to be noted that the double-chambered cartridge package for injection can include any combination formed and / or maintained by the combination of any one of the bottle cap assemblies and the double-chambered cartridge 1 proposed in the present application.

[0050] In the present application, a bottle cap assembly is also proposed, wherein the bottle cap assembly includes a stopper 2 and a cap 3 for sealing the double-chambered cartridge 1. The double-chambered cartridge 1 can be placed in a lyophilization holder and a sheath 4 used in the existing lyophilization process, and the double-chambered cartridge package can be fixed and placed upright or upside down in the lyophilization holder; the bottle cap assembly can be made of any material suitable for achieving the sealing function of the cap. The stopper 2 is positioned in the cap 3 for sealing the mouth 10 of the double-chambered cartridge 1; the cap 3 is used to press and fix the stopper 2 so that the stopper 2 seals the mouth 10 of the double-chambered cartridge 1; and the double-chambered cartridge 1 is sealed; wherein the process of pressing and fixing the stopper 2 in the cap 3 so that the stopper 2 seals the mouth 10 of the double-chambered cartridge 1 can include the following steps:

[0051] Pre-assembling the stopper 2 into the cap 3; and placing the cap 3 with the stopper 2 assembled thereon above the mouth 10 of the double-chambered cartridge 1 and pressing the cap 3 downward. The driving mode of pressing the cap 3 downward can be mechanical pressing, pneumatic driving, pneumatic clamp driving, or spring pressing, etc.

[0052] In the present application, the double-cavity card bottle 1 comprises an inner cavity 13, a bottle body 12, a bottle neck 11 and a bottle mouth 10, the center of the bottle mouth 10 is provided with a bottle mouth opening 100 connected with the inner cavity 13, the inner diameter of the bottle mouth opening 100 is smaller than the inner diameter of the bottle mouth 10 and the bottle neck 11; the outer wall of one side of the bottle body 12 has a bypass protrusion 120. Those skilled in the art can understand that the size of the inner cavity 13, the bottle body 12, the bottle neck 11 and the bottle mouth 10 of the double-cavity card bottle 1 can be adjusted to adapt to the size range of commonly used lyophilized supports, such as changing the vertical length of one or more parts of the double-cavity card bottle 1, changing the radial length of one or more parts of the double-cavity card bottle 1, etc., all of which do not deviate from the protection scope of the present application.

[0053] In the present application, the top plug 2 comprises a plug cap 20 and a plug column 21, the diameter of the plug column 21 can be equal to or slightly larger than the inner diameter of the bottle mouth opening 100, after the plug column 21 is embedded in the bottle mouth opening 100, the lower surface of the plug cap 20 is completely attached to 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 column 21 can be adjusted within the diameter range of the bottle mouth opening 100 after the plug column 21 is pressed under force, and the diameter of the plug column 21 can be slightly larger than the diameter of the bottle mouth opening 100 to ensure the tightness of the sealing.

[0054] In the present application, the top cover 3 comprises an upper end 30 and a bottom disc 31; the upper end 30 has a top disc 300, a thread 301 and an opening 302, the inner wall of the top cover 3 is attached to the bottle mouth 10; when the top cover 3 faces the bottle mouth 10, the top disc 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-cavity card bottle 1 is capped, the top disc 300 is tightly attached above the plug cap 20 to press the top plug 2. The opening 302 can discharge the sublimated moisture in the product, and the thread 301 is used for thread engagement with the injection needle.

[0055] It should be noted that the length of the bottom disc 31 in the vertical direction can be adjusted, so the bottom disc 31 can only attach to the connecting part of the bottle neck 11 and the bottle body 12, or additionally attach to at least part of the bottle body 12 to achieve better capping tightness and adapt to the size requirements of the top cover 3 in the lyophilization process. The shape of the bottom disc 31 can be set as a cylinder or a multi-prism to avoid the top cover 3 from slipping or relatively sliding with the double-cavity card bottle 1 under the action of rotational centrifugal force, which affects the sealing performance.

[0056] In particular, the center of the top disc 300 has a top disc opening, the circumferential lower edge to the upper edge of the top disc opening can have an inclination angle β in the vertical direction, and the circumferential upper edge of the top disc opening has a larger opening length than the circumferential lower edge; the circumferential edge surface of the top disc opening can be curved or flat.

[0057] In the present application, the top plug 2 can further comprise a sealing portion 22 protruding above the plug cap 20, the sealing portion 22 can be inserted into the top disc opening, when the top plug 2 is completely embedded into the bottle mouth 10, i.e. the double-chambered cartridge bottle 1 is completed to be press-plugged, the sealing portion 22 is embedded into the top disc opening and partially protrudes longitudinally above the top disc opening. It is understood by those skilled in the art that the sealing portion 22 can be slightly larger than the opening size of the circumferential lower edge of the top disc opening, during the process of pre-assembling the top plug 2 into the top cover 3, the top plug 2 needs to be fixed by the upper end 30, the surface of the sealing portion 22 can be slightly deformed to be inserted and embedded into the top disc opening from the circumferential lower edge of the top disc opening.

[0058] Therefore, during the process of pre-assembling the top plug 2 into the top cover 3, the sealing portion 22 can be embedded into the top disc opening, the edge portion thereof closely fits with the circumferential outer edge of the top disc opening and finally partially protrudes above the upper edge of the top disc opening. The radial length L of the sealing portion 22 can also be set to be relatively long, so as to improve the close fitting of the edge portion thereof with the circumferential outer edge of the top disc opening, so as to further prevent the top plug 2 from slipping out of the top disc 300. In addition, the size of β can also be adjusted, so that the circumferential lower edge of the top disc opening and the sealing portion 22 have a closer fitting with the circumferential upper edge of the top disc opening, so as to tightly surround the sealing portion 22 by the top disc opening.

[0059] In some embodiments, the radial length L of the sealing portion 22 can be 2.0 mm-5.0 mm, in particular, the radial length L of the sealing portion 22 can be 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm or 5.0 mm; preferably, the radial length L of the sealing portion 22 can be 3.0 mm-4.0 mm, in particular, the radial length L of the sealing portion 22 can preferably be 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm or 4.0 mm. The inclination angle β can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9° or 10°, etc.

[0060] In some embodiments, the circumferential lower edge opening length of the top disc opening can be 1.5mm-5.0mm, in particular, the circumferential lower edge opening length of the top disc opening can be 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm or 5.0mm; preferably, the circumferential lower edge opening length of the top disc opening can be 2.5mm-4.0mm, in particular, the circumferential lower edge opening length of the top disc opening can preferably be 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm or 4.0mm.

[0061] By setting the radial length L of the sealing portion 22 slightly larger than the circumferential lower edge opening length of the top disc opening, the sealing portion 22 is more fitted with the circumferential outer edge of the top disc opening, so that the top disc opening effectively fits and fixes the sealing portion 22 as a whole, and the circumferential edge provides further support on this basis, so that the whole top plug 2 does not slip off. Preferably, β is set to 0°, so that when the top disc opening has no inclination angle in the vertical direction, the sealing portion 22 can be well fixed, while avoiding excessive resistance when the sealing portion 22 is inserted into the top disc opening. In another case, when the top disc opening needs to have a certain inclination angle in the vertical direction to improve the limiting effect of the top disc 300 on the top plug 2, β can also be set to 5° to improve the fixing degree of the sealing portion 22, while not affecting the insertion and embedding of the sealing portion 22 into the top disc opening. Those skilled in the art can appropriately adjust the radial length L of the sealing portion 22, the inclination angle β and the circumferential lower edge opening length of the top disc opening based on the above parameter benchmarks according to the actual application of the bottle cap assembly, to adaptively adjust the fitting and fixing degree of the sealing portion 22 and the top disc 300.

[0062] 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, and the top plug 2 can be tightly fixed with the top cover 3 to achieve sealing due to the cooperation of the top plug positioning point 303 and the plug cap 21. 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 part 200 is left between the surface of the plug cap 20 and the inner wall of the upper end 30. In this way, when the top plug 2 is pressed tightly by the top cover 3, the plug cap 20 will not protrude upward in the middle of the top disc opening due to the expansion of the compressed volume of the plug cap 20 to the gap part 200 reserved around it. Therefore, when the injection needle, such as a micro fine needle (MFN), is inserted into the bottle mouth 10 from the middle of the plug cap 20, the plug cap 20 will not apply pressure to the inside of the needle at the insertion position, thereby avoiding coring, i.e. the plug cap 20 is cut to produce rubber fragments that fall into the needle and the inner cavity of the dual-chamber cartridge, and avoiding product contamination.

[0063] In some embodiments, the diameter of the plug cap 20 can range from 5.0 mm to 10.0 mm, and in particular, the diameter of the plug cap 20 can be 5.0 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm, 6.0 mm, 6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm, 7.0 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm, 7.9 mm, 8.0 mm, 8.1 mm, 8.2 mm, 8.3 mm, 8.4 mm, 8.5 mm, 8.6 mm, 8.7 mm, 8.8 mm, 8.9 mm, 9.0 mm, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm, 9.7 mm, 9.8 mm, 9.9 mm or 10.0 mm; preferably, the diameter of the plug cap 20 can range from 6.0 mm to 8.0 mm, and in particular, the diameter of the plug cap 20 can preferably be 6.0 mm, 6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm, 7.0 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm, 7.9 mm or 8.0 mm.

[0064] In some embodiments, the diameter of the upper end 30 of the top cover 3 can range from 5.0 mm to 10.0 mm, specifically, the diameter of the upper end 30 can be 5.0 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm, 6.0 mm, 6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm, 7.0 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm, 7.9 mm, 8.0 mm, 8.1 mm, 8.2 mm, 8.3 mm, 8.4 mm, 8.5 mm, 8.6 mm, 8.7 mm, 8.8 mm, 8.9 mm, 9.0 mm, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm, 9.7 mm, 9.8 mm, 9.9 mm or 10.0 mm; preferably, the diameter of the upper end 30 can range from 6.0 mm to 8.0 mm, specifically, the diameter of the upper end 30 can preferably be 6.0 mm, 6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm, 7.0 mm, 7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm, 7.6 mm, 7.7 mm, 7.8 mm, 7.9 mm or 8.0 mm.

[0065] More preferably, the diameter of the plug cap 20 can be configured as 7.0 mm, and the inner diameter of the upper end 30 of the top cover 3 that cooperates with the plug cap 20 can be configured as 7.3 mm, so that a gap part 200 with a length of 0.3 mm is left between the surface of the plug cap 20 and the inner wall of the upper end 30, and the gap part 200 can accommodate the increased volume of the plug cap 20 when the plug cap 20 is extruded during the assembly of the stopper 2 or the insertion of the injection needle, thereby avoiding the generation of upward pressure. It should be noted that in the bottle cap assembly according to the embodiments of the present application, those skilled in the art can appropriately adjust the diameter of the plug cap 20 and the diameter of the upper end 30 based on the above-mentioned parameter benchmarks according to the actual application of the bottle cap assembly, so as to adapt to the cooperation of the bottle cap assembly with the freeze-drying support of the freeze-dryer, the cooperation with the packaging sheath and / or the cooperation with the syringe. For example, the stability of the pre-assembly of the stopper 2 can be adjusted by appropriately adjusting the diameter of the plug cap 20; the more tightly sealed or more easily detached seal of the double-chamber carton bottle 1 can be maintained by appropriately adjusting the diameter of the upper end 30; and after the diameter of the plug cap 20 and the diameter of the upper end 30 are adjusted respectively, in order to appropriately avoid the influence of the extrusion of the 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 part 200, etc.

[0066] The stopper 2 can be stably positioned in the top cover 3 by inserting and fitting the sealing part 22 into the top disc opening during the pre-assembly of the top plug 2, and limiting the stopper 2 by the stopper positioning point 303. Therefore, in actual production, when external force is applied to the top cover 3, such as shaking, suspension, etc., the fixation of the top plug 2 in the top cover 3 will not be affected, thereby avoiding the top plug 2 from falling off the top cover 3 before the capping operation, ensuring the capping qualification rate after the freeze-drying is completed; in addition, the gap part 200 of the stopper cap 20 can also avoid core taking when cooperating with the injection needle, thereby ensuring the product quality and efficient use of packaging materials.

[0067] In the present application, the upper end 30 of the top cover 3 also has a stopper positioning point 303 protruding from the inner wall of the upper end 30 in the direction of the axis of the top cover 3, which is used to fix the top plug 2 embedded in the bottle mouth 10. Specifically, the stopper positioning point 303 extends radially along the upper end 30 and is uniformly arranged in the inner wall of the stopper positioning point 303, and the shape of the stopper positioning point 303 can be cylindrical or prismatic, in addition, the number and the interval length / arc between the plurality of stopper positioning points 303 can be adjusted to maintain the optimal fixation of the top plug 2.

[0068] In the present application, the number of stopper positioning points 303 is 4 or 5 or more. In particular, the number of stopper positioning points 303 can be even to maintain its symmetrical arrangement along the center of the upper end 30 to provide more stable fixation function for the top plug 2. Preferably, the number of stopper positioning points 303 is 4 or 8 to provide more stable fixation function for the top plug 2; more preferably, the number of stopper positioning points is 8 to provide the most stable fixation function for the top plug 2. The stopper positioning point 303 can also be used for positioning the top plug 2 before being pressed into the bottle mouth 10, and the top plug 2 is limited by the stopper positioning point 303 to avoid its independent slipping off the bottle mouth 10.

[0069] In the present application, the upper end 30 of the top cover 3 also has a protrusion 304 protruding from the inner wall of the upper end 30 in the direction of the axis of the top cover 3, and the top cover 3 can be limited by the protrusion 304 on the bottle mouth 10 before capping, so that the sublimation water in the inner cavity 13 can be discharged through the opening 302; therefore, the arrangement of the protrusion 304 helps to provide gas exchange and water discharge for the double-cavity 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 embedding of the top plug 2 into the bottle mouth 10, because the protrusion 304 is uniformly distributed on the inner wall of the upper end 30, and the top disc 300 can uniformly apply pressure to the entire surface of the stopper cap 20 pre-assembled into the upper end 30 during capping, therefore, the top plug 2 can be stably embedded into the bottle mouth 10.

[0070] In the present application, the number of protrusions 304 is 2 or more than 3; preferably, the maximum length (D) of the protrusion 304 protruding towards the axis direction of the top cover 3 can be 0.10mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, 0.15mm, 0.16mm, 0.17mm, 0.18mm, 0.19mm, 0.20mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm or 0.30mm. Specifically, D can be 0.15mm-0.30mm; further preferably, D can be 0.20mm-0.28mm, which can make the top cover 3 not easy to deform due to excessive pressure when the top cover 3 is pressed, and the sealing performance of the top cover 3 after being pressed is good and is not easy to slip off; more preferably, D can be 0.23mm-0.28mm, which can avoid the deformation of the top cover 3 due to pressure when the top cover 3 is pressed, and the sealing performance of the top cover 3 after being pressed is good and is not easy to slip off. It should be noted that when the material of the protrusion 304 is different, the value of D can be adjusted to achieve the optimal limiting of the top cover 3 before pressing and the optimal improvement of the fit between the upper end 30 and the double-cavity carton bottle 1. When the outer diameter of the bottle mouth 10 is 7.3mm, D is preferably 0.23mm, 0.25mm or 0.28mm, so that the protrusion 304 can provide the most stable fixation for the top cover 3.

[0071] In the present application, the shape of the protrusion 304 can be trapezoidal, semicircular, semi-elliptical or rectangular, preferably the shape of the protrusion 304 is trapezoidal. When the shape of the protrusion 304 is trapezoidal with the short side adjacent to the bottle mouth 10, the fit tightness of the upper end 30 and the bottle mouth 10 is relatively optimal, and the top cover 3 can be highly stably fitted on the double-cavity carton bottle 1 to maintain good sealing performance.

[0072] When the shape of the protrusion 304 is trapezoidal, the upper cut angle (θ) of the face of the protrusion 304 towards the axis direction of the top cover 3 and the side face thereof can be any angle between 0°-90°, further, θ can be 30°-45°, specifically, θ can be 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44° or 45°. It should be noted that when θ is less than 30°, the effect of the protrusion 304 on improving the fit tightness of the top cover 3 and the bottle mouth 10 can be significantly weakened; when θ is greater than 45°, the protrusion 304 can significantly hinder the pressing process, causing the top cover 3 to deform or even be damaged during the pressing process. Therefore, θ can be preferably any angle in the range of 30°-45°; more preferably, θ can be 30°, so that the protrusion 304 can provide better fit effect of the top cover 3 and the bottle mouth 10, and also does not adversely hinder the pressing process.

[0073] In addition, when the shape of the protrusion 304 is trapezoidal, the lower cut angle (a) of the surface of the protrusion 304 facing the axis direction of the top cover 3 and the side surface thereof can also be any angle between 0° and 90°. Since the pressure size of the capping process is mainly affected by the size of θ, when a and θ have the same value, the protrusion 304 can have the most stable axisymmetric structure and is not prone to deformation or damage during the capping process or storage process. Therefore, the present application further preferably a can be 30° to improve the use efficiency and anti-deformation ability of the protrusion 304. More preferably, θ and a of the protrusion 304 are both 30°, which will not cause structural damage to the top cover 3 during the capping process of the top cover 3, and at the same time can keep the top cover 3 and the double-chamber carton bottle 1 highly close, which can improve the capping efficiency and accuracy of the double-chamber carton bottle 1 in the freeze-drying process.

[0074] The present application further provides a double-chamber carton bottle package for injection, which comprises the above-mentioned another bottle cap assembly and the double-chamber carton bottle 1, and a double-chamber carton bottle package assembly for injection, which comprises the double-chamber carton bottle package for injection and a sheath 4 used in cooperation therewith. It should be noted that the double-chamber carton bottle package for injection can comprise any combination of the bottle cap assembly and the double-chamber carton bottle 1 which can be formed and / or maintained by any combination proposed in the present application.

[0075] The bottom disc 31 has a first notch 310 near the upper outer edge of the upper end 30, and the top end of the inner wall of the sheath 4 is stretched to form a protrusion in the horizontal direction and is limited on the first notch 310 of the bottom disc 31. The top cover 3 and the sheath 4 achieve interference fit, and the top plug 2 and the double-chamber carton bottle 1 are clamped in the middle by the opposite force. In addition, the bypass protrusion 120 of the bottle body 12 is clamped at the octagonal vertex of the inner wall of the sheath 4 and cannot slide relative to the inner wall of the sheath 4. In the above manner, when the double-chamber carton bottle package is placed in the sheath 4, the top cover 3 and the top plug 2 therein are fixed more tightly with the bottle mouth 10, effectively avoiding air leakage, rotation, falling off, etc.

[0076] In the present application, the shape of the bottom disc 31 is cylindrical or octagonal, and the sheath 4 comprises 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 carton bottle 1 are tightly fixed with each other. Since the bottle mouth 10, the bottle neck 11 and the bottle body 12 of the double-chamber carton bottle 1 are cylindrical, during the screwing and / or detaching of the injection needle with the top cover 3, the top cover 3 is forced to drive the double-chamber carton bottle 1 to co-rotate. When the shape of the top disc 31 is cylindrical, its smooth outer surface is difficult to be well limited by the inner wall of the sheath 4, and when the injection needle is screwed / detached, the top cover 3 may drive the entire double-chamber carton bottle 1 to co-rotate, so that the injection needle idles and cannot be fixed / detached with the top cover 3.

[0077] Therefore, the shape of the bottom disc 31 of the bottle cap assembly configured with the packaging assembly is an octagonal prism, and the shape of the sheath body 40 is an octagonal prism, so that the outer wall of the bottom disc 31 and the inner wall of the sheath body 40 are both octagonal, as shown in Figure 7 Thus, the bypass protrusion 120 of the double-chamber carton bottle 1 of the packaging assembly can be limited at the octagonal vertex of the inner wall of the sheath 4 (B-B), and the bottle body 12 will generate a large friction force with the inner wall of the bottom disc 31 during capping. When the top cap 3 is subjected to external force from an injection needle, the bottom disc 31 and the sheath 4 are fixedly connected due to the interference fit therebetween (A-A), so that the top cap 3 will not slip or slide relative to the double-chamber carton bottle 1, further stabilizing the whole packaging assembly, avoiding affecting the air tightness of the double-chamber carton bottle 1, and improving the use efficiency.

[0078] In particular, the lower end of the sheath 4 can also have an interference fit structure, and the lower end of the sheath body 40 can be provided with a second notch 400, which is buckled on the flange 41 by pressing, so that the sheath body 40 and the flange 41 are fixedly connected due to the interference fit therebetween (C-C). Thus, the fixing stability of the sheath body 40 can be improved, and the sheath body 40 can be prevented from rotating together with the packaging assembly.

[0079] Specifically, in some embodiments, the reconstituted freeze-dried product in the double-chamber carton bottle 1 is injected subcutaneously through an injection needle for the treatment of skin diseases or medical aesthetics. The hub of the injection needle has a threaded structure, which is engaged or removed by rotating the threaded structure of the hub with the threads 301 of the top cap 3 when the injection needle is installed on the top cap 3 for product injection or removed from the top cap 3. In this process, the bottom disc 31 of the top cap 3 is fixed and prevented from rotating by the octagonal inner wall of the sheath 4, and the bypass protrusion 120 of the double-chamber carton bottle 1 is also fixed and prevented from rotating by the vertex of the inner wall of the sheath 4. Therefore, by selecting the octagonal bottom disc 31 and cooperating with the sheath 4, the double-chamber carton bottle packaging assembly can be prevented from rotating when the injection needle is screwed / dismounted, so as to avoid idling when the sterile injection needle is screwed / dismounted, and improve the use efficiency of the double-chamber carton bottle packaging assembly.

[0080] At present, most of the freeze-dried products on the market use a vial as a drug container. Before injection, a sterile syringe is used to extract a reconstitution solvent from another container containing the reconstitution solvent, and then the reconstitution solvent is injected into the drug container for reconstitution, extraction and administration. The drug precision and use compliance are relatively poor. The bottle cap assembly and double-chamber carton bottle packaging of the present application can effectively use the front chamber to contain freeze-dried drugs and the rear chamber to contain reconstitution solvent. During use, the reconstitution solvent can be pushed through the bypass to flow into the front chamber to reconstitute the freeze-dried drugs, without the need for multiple extractions, thereby greatly facilitating the use convenience of the subjects or patients, and enabling the subjects or patients to self-inject.

[0081] In another aspect, the bottle cap assembly of the present application can also complete the capping and sealing of the double-cavity carton bottle in the freeze dryer, thereby maintaining the low moisture content of the freeze-dried product and maintaining the quality stability of the product. Therefore, the present application can use the bottle cap assembly and the double-cavity carton bottle to complete the preparation and storage of various pharmaceutical preparations, medical and cosmetic products such as insulin, growth factors, vaccines, chemotherapy drugs, hormone drugs, facial filler hyaluronic acid, water light needle, facial essence and customized perfume, etc., and improve the application prospect and application scope of the above-mentioned products prepared by the freeze-drying process.

[0082] Embodiment

[0083] The materials used in the experiment and the test method are generally and / or specifically described. The reagents or instruments not specified by the manufacturer are all conventional reagent products that can be obtained by purchase.

[0084] Embodiment 1

[0085] A bottle cap assembly includes a top plug 2 and a top cap 3 for sealing a double-cavity carton bottle 1. The structure of the top cap 3 is as shown in the figure. Figure 2A The double-cavity carton bottle 1 is sealed by the top plug 2 through the top cap 3, and the bottle opening 10 of the double-cavity carton bottle 1 is sealed through the top plug. Specifically,

[0086] First, the top plug 2 is limited inside the top cap 3 through the top plug positioning point 303, and the top cap 3 is placed on the bottle opening 10, so that the plug column 21 naturally faces the bottle opening 100, and the freeze-drying is carried out.

[0087] Then, after the freeze-drying is completed, the top plug 2 is pressed into the bottle opening 10 of the double-cavity carton bottle 1 through the top cap 3, and the top cap 3 includes an upper end 30 and a bottom disc 31. The upper end 30 has a top disc 300 in the center, a thread 301 and an opening 302 at the edge of the upper end 30; the bottom disc 31 is open at the bottom. After the top plug 2 is initially embedded in the bottle opening 10, the top cap 3 is pressed downward until the upper end 30 is completely fitted on the bottle opening 10. In this process, the inner wall of the upper end 30 is fitted with the bottle opening 10 and the bottle neck 11, and the inner wall of the bottom disc 31 is partially fitted with the bottle body 12.

[0088] The top disc 300 is a hollow cylindrical structure with a shortened middle part. During the process of pressing the top cap 3 downward by external force, the top plug 2 is pressed into the bottle opening 10 through the lower surface of the top disc 300, so that the top plug 2 is further embedded into the bottle opening 10 until the plug column 21 with a diameter slightly larger than the inner diameter of the bottle opening is completely embedded into the bottle opening 10 under the action of pressure, and the lower surface of the plug cap 20 is completely fitted with the upper surface of the bottle opening 10, so as to seal the double-cavity carton bottle 1 by using the top plug 2. No additional plug pressing device is needed to participate in the sealing, which reduces the additional process and time required for sealing the double-cavity carton bottle 1, and also avoids the influence of inaccurate sealing on the production efficiency of the freeze-drying process.

[0089] In particular, when the top cover 3 is arranged to press the top plug 2 to completely embed into the bottle mouth 10, the inner wall of the bottom disc 31 can also partially adhere to the top end of the bottle body 12; therefore, while the top cover 3 seals the bottle mouth opening 100 by using the top plug 2, the top cover 3 also seals the top plug 2 embedded into the bottle mouth, and seals the bottle mouth 10, the bottle neck 11 and at least a part of the bottle body 12 through the top plug 2, so as to realize the overall sealing of the double-cavity carton bottle 1.

[0090] The upper end 30 has a gap part 200 between the diameter of 7.3 mm and the diameter of 7.0 mm of the plug cap 20; the upper end 30 also has a top plug positioning point 303, as shown in Figure 5 、 Figure 4A and Figure 4B The top plug positioning point 303 is located below the top disc 300 and protrudes from the inner wall of the upper end 30 in the direction of the axis of the top cover 3. After the top plug 2 is completely embedded into the bottle mouth 10, the top plug positioning point 303 adheres to 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, so as to increase the friction between the plug cap 20 and the inner wall of the upper end 30, and prevent the top plug 2 from loosening or slipping out of the top cover 3 during the pre-assembly process due to the loose embedding. The number of the top plug positioning points 303 is four, which are evenly distributed on the inner wall of the upper end 30.

[0091] The upper end 30 also has a protruding part 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 into the bottle mouth 10, the protruding part 304 adheres to the outer wall of the bottle mouth 10, and the bottle mouth 10 is pressed by the protruding part 304 in the direction of the axis of the top cover 3, so as to increase the friction between the bottle mouth 10 and the inner wall of the upper end 30, and prevent the top cover 3 from slipping off after sealing due to the loose embedding, thereby improving the sealing performance of the double-cavity carton bottle 1. The maximum length of the protruding part 304 protruding from the inner wall of the upper end 30 is set to 0.20 mm, the shape of the protruding part 304 is set to trapezoidal, and the number of the protruding part 304 is two, which are distributed on both sides of the inner wall of the upper end 30, and the face of the protruding part 304 in the direction of the axis of the top cover 3 and the upper and lower cutting angles of the side face thereof are all 30°. The shape of the bottom disc 31 is cylindrical. The plug and cover sealing test of the bottle cap assembly shows that the adhesion of the top plug 2 and the top cover 3 is good, and the top plug 2 does not fall off from the top cover 3; the cover process does not cause the deformation of the top cover 3, and the cooperation and fixation of the top cover 3 and the double-cavity carton bottle 1 are good, and only occasionally fall off.

[0092] Example 2

[0093] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 was replaced with 0.23 mm, and the remaining structure and parameters were the same as in Example 1. The cap assembly underwent stopper sealing and capping sealing tests. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.23 mm, the capping process did not cause deformation of the top cap 3, and the top cap 3 did not fall off.

[0094] Example 3

[0095] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 was replaced with 0.25mm, and the remaining structure and parameters were the same as in Example 1. The cap assembly underwent stopper sealing and capping sealing tests. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.25mm, the capping process did not cause deformation of the top cap 3, and the top cap 3 did not fall off.

[0096] Example 4

[0097] The maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 was replaced with 0.28 mm, and the remaining structure and parameters were the same as in Example 1. The bottle cap assembly underwent stopper sealing and capping sealing tests. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off the top cap 3. After replacing the maximum length of the protrusion 304 protruding from the inner wall of the upper end 30 with 0.28 mm, the capping process did not cause deformation of the top cap 3, and the top cap 3 did not fall off.

[0098] Example 5

[0099] The structure of the top cap 3 of the bottle cap assembly in Example 3 is adjusted to increase the volume of the top cap 3, such as... Figure 2B As shown. Specifically, the base 31 in Embodiment 3 extends downward along the bottle body 12, so that the extended base 31 can seal at least a portion of the bottle body 12. It should be noted that the shape of the downwardly extending base 31 is set as an octagonal prism, and the structure of the adjusted top cover 3, except for the base 31, is the same as before the adjustment. The number of top stopper positioning points 303 is 8, which are evenly distributed on the inner wall of the upper end 30.

[0100] The bottle cap assembly was subjected to stopper sealing and capping sealing tests. It was found that the fit between the top stopper 2 and the top cap 3 was high, and the top stopper 2 did not slip off from the top cap 3. The capping process required a large amount of pressure, but it did not cause deformation or damage to the top cap 3. The fit between the top cap 3 and the bottle mouth 10 of the double-chamber cartridge bottle 1 was significantly improved, and it was not pulled out after a large force was applied.

[0101] Example 6

[0102] The structure of the top plug 2 and the top disc 300 of the top cover 3 of the bottle cap assembly in Example 5 was adjusted to improve the fixing tightness of the pre-assembly of the top plug 2 into the third top plug 7. Specifically, the top plug 2 was provided with a sealing portion 22 protruding axially upward on the upper surface of the plug cap 20, and the shape of the top disc opening was circular, with a lower edge diameter of 3.4 mm, and the shape of the sealing portion 22 was cylindrical, with a radial length L = 3.6 mm, as shown in Figure 3 The inclination angle β of the circumferential lower edge of the top disc opening to the upper edge thereof was 0°, and the other structures and parameters were the same as in Example 4.

Claims

1. A bottle cap assembly, characterized by, A double-cavity carton bottle for sealing, wherein, the bottle cap assembly comprises a top plug and a top cap; the top plug is positioned in the top cap for sealing the bottle mouth of the double-cavity carton bottle; the top cap is used to press and fix the top plug so that the top plug seals the bottle mouth of the double-cavity carton bottle; and the double-cavity carton bottle is sealed.

2. The bottle cap assembly of claim 1, wherein wherein, the double-cavity carton bottle comprises an inner cavity, a bottle body, a bottle neck, and a bottle mouth, the center of the bottle mouth is provided with a bottle mouth opening connected with the inner cavity, the inner diameter of the bottle mouth opening is smaller than the inner diameter of the bottle mouth and the bottle neck; one side outer wall of the bottle body has a bypass protrusion.

3. The bottle cap assembly of claim 2, wherein wherein, the top plug comprises a plug cap and a plug column, the diameter of the plug column is equal to or slightly larger than the inner diameter of the bottle mouth opening of the bottle mouth, after the plug column is embedded in the bottle mouth opening, the lower surface of the plug cap completely matches the upper surface of the bottle mouth.

4. The bottle cap assembly of claim 3, wherein wherein, the top cap comprises an upper end and a bottom disc; the upper end has a top disc, a thread, and an opening, the inner wall of the top cap matches the bottle mouth; the center of the top disc has a top disc opening, when the top cap moves to the bottle mouth, the top disc of the upper end presses the top plug to move into the bottle mouth, so that the top plug is embedded in the bottle mouth.

5. The bottle cap assembly of claim 4, wherein wherein, the top plug further comprises a sealing part protruding above the plug cap, the sealing part is inserted into the top disc opening of the top disc of the top cap, when the top plug is embedded in the bottle mouth, the sealing part longitudinally protrudes from the top disc opening of the top disc.

6. The bottle cap assembly of claim 4, wherein wherein, the upper end of the top cap further has a top plug positioning point, the top plug positioning point protrudes from the inner wall of the upper end towards the axis direction of the top cap, for fixing the top plug embedded in the bottle mouth.

7. The bottle cap assembly of claim 6, wherein wherein, the number of the top plug positioning points is 4 or 5 or more.

8. The bottle cap assembly of claim 4, wherein wherein, the upper end of the top cap further has a protruding part protruding from the inner wall of the upper end towards the axis direction of the top cap, for positioning the top plug before being pressed into the bottle mouth, and improving the matching degree of the upper end and the double-cavity carton bottle.

9. The bottle cap assembly of claim 8, wherein, wherein, the number of the protruding part is 2 or 3 or more; the maximum length of the protruding part protruding towards the axis direction of the top cap is 0.10mm-0.30mm.

10. The bottle cap assembly of claim 8, wherein wherein, the shape of the protruding part is trapezoidal, semicircular, semi-elliptical, or rectangular; when the shape of the protruding part is trapezoidal, the upper cutting angle of the surface of the protruding part towards the axis direction of the top cap and the side surface thereof is 30°-45°.

11. The bottle cap assembly of claim 10, wherein wherein, the shape of the protruding part is trapezoidal; the upper cutting angle of the surface of the protruding part towards the axis direction of the top cap and the side surface thereof is 30°.

12. The bottle cap assembly of claim 4, wherein wherein, the shape of the bottom disc is cylindrical or octagonal.

13. The bottle cap assembly of claim 12, wherein, wherein, the shape of the bottom disc is octagonal.

14. A dual chamber cartouche packaging material for injection, characterized in that It comprises the bottle cap assembly and the double-cavity carton bottle of any one of claims 1-13.

15. A dual chamber cartouche vial package assembly for injection, comprising: It comprises the double-cavity carton bottle package material and the sheath of claim 14.

16. The package assembly of claim 15, wherein, wherein, the shape of the bottom disc of the bottle cap assembly of the package material is octagonal, the sheath comprises a sheath body and a flange, the shape of the sheath is octagonal, the inner wall of the sheath body is octagonal, the bypass protrusion of the double-cavity carton bottle of the package material is located at the octagonal vertex of the inner wall of the sheath body; and ​ The top of the inner wall of the sheath body has a convexity in the horizontal direction, which is assembled with the bottom disc of the bottle cap assembly of the packaging material by interference fit, so as to further clamp the top plug and the double-cavity card bottle with the bottom disc.

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