Isolation plug for freeze-dried powder and ampoule

Abstract

The invention relates to the technical field of ampoules, in particular to an isolation plug for freeze-dried powder and an ampoule, the isolation plug is provided with a cavity with an opening in one end and forms the side wall of the isolation plug, the side wall of the isolation plug is provided with a hole part, a flanging structure is arranged close to the opening end of the isolation plug, and at least one notch is formed in the flanging structure; the isolation plug can be arranged on a freeze-drying container with a freeze-drying cavity and can move in the length direction of the freeze-drying container, so that the freeze-drying cavity is sealed or the freeze-drying cavity is communicated with the outside through the hole part. According to the isolation plug for the freeze-dried powder and the ampoule provided by the invention, a relatively sealed and sterile environment is provided for the freeze-drying cavity through the half isolation plug, water generated in the freeze-drying process can be discharged from the hole part in the side wall of the isolation plug, and in-situ plug pressing can be performed in a vacuum freeze-drying chamber to complete sealing; in addition, due to the arrangement of the flanging structure and the notches in the flanging structure, sleeving resistance is effectively reduced, and it is ensured that the semi-plug state is stable and reliable.

Description

Technical Field

[0001] This invention relates to the field of ampoule technology, and in particular to an isolating stopper and ampoule for freeze-dried powder. Background Technology

[0002] Lyophilized powder is a sterile powdered preparation produced by freezing a liquid drug under sterile conditions and then dehydrating it through vacuum sublimation. Maintaining the bioactivity of its core active ingredient—collagen—is a common challenge in this technological field. These protein components have poor stability in liquid environments and are prone to chemical degradation or physical denaturation, leading to loss of efficacy. Therefore, in the pharmaceutical field, to achieve long-term preservation, lyophilized powder is usually aliquoted from the solvent or relies on a continuous cold chain system at 2-8°C.

[0003] To resolve the conflict between maintaining activity and product shelf life (typically required to be 1-2 years), the cosmetics industry generally adopts pharmaceutical formulation methods, packaging lyophilized powder and solvent separately, storing them at low temperatures, and requiring consumers to dissolve and prepare the product before use. While this method delays activity decay to some extent, it has the following significant drawbacks: First, the active period of the dissolved product is drastically shortened, requiring consumers to use it within a limited time; otherwise, it easily leads to loss of activity and product waste. Second, the separate packaging structure is complex, production costs are high, and improper handling during preparation can easily cause imbalances or contamination, affecting the final efficacy and safety. Summary of the Invention

[0004] To address the inconvenience of separating freeze-dried powder and solvent in existing products, this invention provides an isolation stopper and ampoule for freeze-dried powder. The half-stop isolation stopper provides a relatively sealed and sterile environment for the freeze-drying chamber. Moisture generated during the freeze-drying process can be discharged through the holes on the side wall of the isolation stopper, and in-situ sealing can be achieved by pressing the stopper in the vacuum freeze-drying chamber. In addition, the flanged structure and the slits on it effectively reduce the resistance of the assembly and ensure that the half-stop state is stable and reliable.

[0005] The technical solution adopted by this invention to solve its technical problem is: An isolation plug for freeze-dried powder, the isolation plug having a cavity with one end open and forming a side wall of the isolation plug, the side wall of the isolation plug having a hole, and a flange structure near the open end of the isolation plug having at least one cut. The isolation plug can be disposed on the freeze-drying container and can move along the length of the freeze-drying container. The outer surface of the freeze-drying container is provided with a snap-fit ​​part. The inner wall of the isolation plug is provided with a first limiting part and a second limiting part in sequence from the opening end. A limiting groove is formed between the first limiting part and the second limiting part. The limiting groove of the inner wall of the isolation plug is adapted to the snap-fit ​​part on the outer surface of the freeze-drying container. When the isolation plug moves to the locking part and is placed in the limiting groove, the freeze-drying chamber of the freeze-drying container can be connected to the outside through the hole, so that the freeze-drying chamber is in a semi-sealed state; when the isolation plug continues to move to the second limiting part and passes the locking part, at this time, the locking part abuts against the inner side of the second limiting part, so that the freeze-drying chamber is in a sealed state.

[0006] Optionally, the cuts are arranged symmetrically in two places or circumferentially around the center of the isolation plug.

[0007] Optionally, the cut length is 1-2 mm.

[0008] Optionally, the cut is in the shape of an inverted V.

[0009] Optionally, the flange structure includes an integrally formed flange sidewall and an isolation ring, and the apex of the cut extends to the axial midpoint of the flange sidewall.

[0010] Optionally, a circular hole is provided at the apex of the cut.

[0011] Optionally, the diameter of the circular hole is 0.5-1 mm.

[0012] Optionally, the freeze-drying container includes a base and an inner tube, the hollow part of the inner tube is a freeze-drying chamber, one end of the inner tube into which the isolation plug is inserted forms a tube tip, the other end of the inner tube is fixed to the base, and the snap-fit ​​part is provided on the outer surface of the inner tube.

[0013] Optionally, a locking ring is provided on the base. The locking ring is located outside the inner tube and is concentric with the inner tube. One end of the locking ring is fixedly connected to the base, and the other end abuts against the opening end of the isolation plug in the freeze-drying chamber under sealed conditions. The locking ring has an open-loop structure with an opening that is easy to tear. The locking ring is fixedly connected to the base through several connection points.

[0014] Another object of the present invention is to provide an ampoule having a solvent chamber, an installation groove provided at the bottom opening of the ampoule, and an isolation plug for lyophilized powder as described above being provided in the installation groove.

[0015] The beneficial effects of this invention are: this invention provides an isolation stopper and ampoule for lyophilized powder. (1) The isolation plug of the half-plug provides a relatively sealed and sterile environment for the freeze-drying chamber, and the water generated during the freeze-drying process can be discharged from the hole on the side wall of the isolation plug. After the freeze-drying is completed, the in-situ plugging is completed directly in the freeze-drying chamber. The vacuum environment of the freeze-drying chamber can further improve the sealing effect to prevent external air and pollutants from entering the freeze-drying chamber, thereby ensuring the quality of the freeze-dried powder. (2) In order to ensure the sealing of the freeze-drying chamber, the isolation plug and the freeze-drying container are generally interference fit. By providing a flange structure at the open end of the isolation plug and symmetrically opening cuts on the flange structure, the isolation plug can be easily fitted onto the freeze-drying container, which significantly reduces the fitting resistance, improves the alignment accuracy, and ensures the stability of the half-plug state. (3) The packaging of the double-compartment ampoule is completed by pressing the isolation plug containing the lyophilized powder into the mounting groove at the bottom of the ampoule. The structure of the isolation plug, isolation ring, and sealing ring ensures the sealing of the solvent chamber and the lyophilized chamber, so that the solvent and the lyophilized powder do not interfere with each other during storage, thus ensuring the quality of the lyophilized powder. This isolation plug, which is pressed twice, simplifies the production process, improves the stability of the product, and effectively reduces the production cost. Attached Figure Description

[0016] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0017] Figure 1 This is an external schematic diagram of the freeze-drying container in this invention; Figure 2 This is a schematic diagram of the interior of the freeze-drying container in this invention; Figure 3 This is a schematic diagram of the internal structure of the isolation plug in this invention; Figure 4 This is a schematic diagram of the connection point of the locking ring in this invention; Figure 5 This is a schematic diagram of the interior of the half-plug state after the isolation plug and freeze-drying container are assembled in this invention; Figure 6 This is a schematic diagram of the internal state of the fully assembled isolation plug and freeze-drying container in this invention. Figure 7 This is a schematic diagram of the structure of the ampoule in this invention; Figure 8 This is a schematic diagram of the unused state of the ampoule in this invention; Figure 9 This is a schematic diagram illustrating the usage state of the ampoule in this invention; In the figure: 1. Freeze-drying container, 11. Freeze-drying chamber, 12. Snap-fit ​​part, 13. Inner tube, 14. Base, 141. Second wedge surface, 2. Isolation plug, 21. Hole, 22. First limiting part, 23. Second limiting part, 24. Limiting groove, 25. Flanged structure, 251. Flanged side wall, 252. Isolation ring, 2521. First wedge surface, 26. Cutout, 27. Round hole, 28. Sealing ring, 3. Locking ring, 31. Opening, 32. Connection point, 4. Ampoule, 41. Mounting groove. Detailed Implementation

[0018] The present invention will now be described in further detail. The embodiments described below are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0019] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0020] To address the inconvenience of using existing lyophilized powders and solvents for separate packaging, such as... Figure 1-9 As shown, the present invention provides an isolation plug 2 for freeze-dried powder. The isolation plug 2 has a cavity with one end open, forming a side wall of the isolation plug 2. A hole 21 is provided on the side wall of the isolation plug 2. The isolation plug 2 can be placed on the freeze-drying container 1 and can move along the length direction of the freeze-drying container 1, so as to seal the freeze-drying cavity 11 of the freeze-drying container 1 or to allow the freeze-drying cavity 11 of the freeze-drying container 1 to communicate with the outside through the hole 21. A flange structure 25 is provided near the opening end of the isolation plug 2, and at least one cut 26 is provided on the flange structure 25. A snap-fit ​​part 12 is provided on the outer surface of the freeze-drying container 1. A first limiting part 22 and a second limiting part 23 are sequentially provided on the inner wall of the isolation plug 2 from the opening end. A limiting groove 24 is formed between the first limiting part 22 and the second limiting part 23. The limiting groove 24 on the inner wall of the isolation plug 2 is adapted to the snap-fit ​​part 12 on the outer surface of the freeze-drying container 1.

[0021] This invention provides an isolation plug 2 for freeze-dried powder. The half-plug isolation plug 2 provides a relatively sealed and sterile environment for the freeze-drying chamber 11. The moisture generated during the freeze-drying process can be discharged from the hole 21 on the side wall of the isolation plug 2. After freeze-drying, the in-situ plugging is completed directly in the freeze-drying chamber. The vacuum environment of the freeze-drying chamber can further improve the sealing effect to prevent external air and contaminants from entering the freeze-drying chamber 11, thereby ensuring the quality of the freeze-dried powder.

[0022] Specifically, when the isolation plug 2 moves to the locking part 12 and is placed in the limiting groove 24 (due to the flange structure 25 and its cut 26, the first limiting part 22 on the isolation plug 2 does not contact the locking part 12 of the freeze-drying container 1 during the movement), the freeze-drying chamber 11 of the freeze-drying container 1 can be connected to the outside through the hole 21, so that the freeze-drying chamber 11 is in a semi-sealed state. The water sublimated during the freeze-drying process is discharged from the hole 21, which can effectively reduce the moisture content of the freeze-dried powder. When the isolation plug 2 continues to move to the second limiting part 23 and passes the locking part 12, at this time, the locking part 12 and the inner side of the second limiting part 23 abut against each other, so that the freeze-drying chamber 11 is in a sealed state. The vacuum environment of the freeze dryer can ensure the full sealing effect, that is, ensure the complete sealing of the freeze-drying chamber 11.

[0023] The isolating plug 2 is usually made of soft rubber, while the freeze-drying container 1 is made of acrylic. In the prior art, in order to ensure the sealing of the freeze-drying chamber 11, the isolating plug 2 and the freeze-drying container 1 are generally interference fit. The snap-fit ​​part 12 of the isolating plug 2 needs to pass through the first limiting part 22 and the second limiting part 23 in sequence (the snap-fit ​​part 12 in this invention does not need to pass through the first limiting part 22). This means that during the fitting process of the isolating plug 2 and the freeze-drying container 1, the snap-fit ​​part 12 not only needs to pass through the second limiting part 23, but also needs to pass through the first limiting part 22. This means that the isolating plug 2 and the freeze-drying container 1 need to be aligned very precisely during the fitting process. Otherwise, the isolating plug 2 is very likely to shift or not fit properly. This not only increases the difficulty of operation, but may also cause the isolating plug 2 to bounce during the pressing process, affecting the sealing effect and user experience.

[0024] To solve the above problems, the present invention provides a flanged structure 25 at the open end of the isolation plug 2 and symmetrically opens slits 26 on the flanged structure 25, so that the snap-fit ​​part 12 does not need to overcome the resistance of the first limiting part 22, and the isolation plug 2 can be easily fitted onto the freeze-drying container 1, which significantly reduces the fitting resistance, improves the alignment accuracy, and ensures the stability of the half-plug state.

[0025] The present invention preferably has four circumferentially arranged slits 26 with the center of the isolation plug 2 as the center; further preferably, two are arranged symmetrically, so as to further improve the balance and stability of the isolation plug 2 during the half-plugging process, which not only helps to evenly distribute the force during the assembly, but also avoids the problem of half-plugging state deviation caused by uneven force.

[0026] Furthermore, the present invention preferably has a cut 26 length of 1-2 mm.

[0027] The preferred flange structure 25 of the present invention includes an integrally formed flange sidewall 251 and an isolation ring 252. The apex of the cut 26 extends to the axial midpoint of the flange sidewall 251, ensuring that the cut 26 is in a reasonable position on the flange structure 25, avoiding the isolation plug 2 from being easily torn or failing due to the apex being too high, so that it can still maintain reliable performance in multiple uses.

[0028] To prevent stress concentration points from forming, the present invention preferably provides a circular hole 27 at the apex of the cut 26, which can effectively disperse the stress at the apex of the cut 26, reduce the risk of tearing of the isolation plug 2 during repeated use or under pressure, and thus extend the service life of the isolation plug 2.

[0029] Furthermore, the diameter of the circular hole 27 is preferably 0.5-1 mm.

[0030] In this invention, the hole portion 21 is preferably a single waist-shaped hole or a round hole formed on the side wall of the isolation plug 2, or waist-shaped holes or round holes symmetrically arranged on the side wall of the isolation plug 2, or a plurality of waist-shaped holes or round holes arranged circumferentially on the side wall of the isolation plug 2; the shape of the hole portion 21 is not limited, and can be single, two or more, depending on the usage requirements; in this invention, the hole portion 21 is preferably a waist-shaped hole symmetrically arranged on the side wall of the isolation plug 2.

[0031] Another objective of this invention is to provide an ampoule 4 having a solvent chamber, an opening at the bottom of the ampoule 4 and a mounting groove 41, wherein a freeze-dried powder isolation plug 2 as described above is disposed in the mounting groove 41; the freeze-dried powder and solvent are separated by the isolation plug 2, which facilitates subsequent mixing and use; the isolation plug 2 has chemical stability and will not react chemically with the freeze-dried powder and solvent, further ensuring the quality of the freeze-dried powder.

[0032] In this invention, the isolation ring 252 of the flanged structure 25 abuts against the outside of the bottom opening of the ampoule 4, and the outer surface of the isolation plug 2 is also provided with a sealing ring 28 that contacts the inner wall of the mounting groove 41; the isolation ring 252 can ensure that the isolation plug 2 is placed in place and ensures the sealing performance, while the sealing ring 28 can further improve the sealing performance.

[0033] Furthermore, the inner ring of the isolation ring 252 is provided with a first wedge surface 2521 recessed towards the solvent chamber side, and the base 14 is provided with a second wedge surface 141 that matches the first wedge surface 2521 on the side connected to the locking ring 3; after the locking ring 3 is torn off, the inner tube 13 is pushed into the bottle until the first wedge surface 2521 matches the second wedge surface 141, that is, pushed into place.

[0034] Because the present invention has a flanged structure 25 near the opening end of the isolation plug 2, and the flanged structure 25 has a cut 26 along the longitudinal direction of the isolation plug 2; it should be noted that these cuts 26 are not gaps formed by material loss, but opening structures formed by cutting process; due to the shape characteristics of the flanged structure 25 itself, the cut 26 presents an inverted V-shaped structure in its natural state. After the isolation plug 2 containing freeze-dried powder is pressed into the bottom of the ampoule 4, the two sides of the inverted V-shaped cut 26 will stick together and close under pressure, thereby achieving a reliable sealing effect.

[0035] Furthermore, the present invention preferably places the cut 26 at an angle of 30°-60° to the longitudinal direction of the isolation plug 2; this angle design can cause a larger overlap area on both sides of the cut 26 during the insertion of the ampoule 4, enhance the tightness of the contact surface, and thus further improve the sealing performance of the overall structure.

[0036] The preferred freeze-drying container 1 of the present invention includes a base 14 and an inner tube 13. The hollow part of the inner tube 13 is a freeze-drying chamber 11. One end of the inner tube 13 into which the isolation plug 2 is inserted forms a tube tip. The other end of the inner tube 13 is fixed to the base 14. The snap-fit ​​part 12 is provided on the outer surface of the inner tube 13. The tube tip is provided so that the closed end of the isolation plug 2 can be punctured when the ampoule 4 is used, so that the liquid in the ampoule 4 can be mixed with the powder in the inner tube 13.

[0037] Preferably, the base 14 of this invention is provided with a locking ring 3. The locking ring 3 is located outside the inner tube 13 and is concentric with the inner tube 13. One end of the locking ring 3 is fixedly connected to the base 14, and the other end abuts against the opening end of the isolation plug 2 in the sealed state of the freeze-drying chamber 11. The locking ring 3 has an open ring structure, forming an opening 31 that is easy to tear. The locking ring 3 and the base 14 are fixedly connected by several connection points 32. The setting of the locking ring 3 keeps the tube tip and the isolation plug 2 at a safe distance. When in use, the locking ring 3 is torn off and the inner tube 13 is pushed into the ampoule 4 until the isolation plug 2 is punctured.

[0038] This invention completes the packaging of the dual-compartment ampoule 4 by pressing the entire isolation plug 2 containing lyophilized powder into the mounting groove at the bottom of the ampoule 4. The flange structure 25 and its upper cut 26 enable convenient assembly between the isolation plug 2 and the lyophilized container 1 after insertion into the ampoule 4, while also achieving a good sealing effect. This ensures that the solvent and lyophilized powder do not interfere with each other during storage, guaranteeing the quality of the lyophilized powder. It simplifies the production process, improves product stability, and effectively reduces production costs.

[0039] The above description is illustrative only and not restrictive of the present invention. Those skilled in the art will understand that many modifications, variations or equivalents can be made without departing from the spirit and scope defined by the appended claims, and all such modifications, variations or equivalents will fall within the protection scope of the present invention.

Claims

1. A separator plug for lyophilized powder, characterized in that: The isolation plug (2) has a cavity with one end open and forms the side wall of the isolation plug (2). A hole (21) is provided on the side wall of the isolation plug (2). A flange structure (25) is provided near the opening end of the isolation plug (2). At least one cut (26) is provided on the flange structure (25). The isolation plug (2) can be disposed on the freeze-drying container (1) and can move along the length of the freeze-drying container (1). The outer surface of the freeze-drying container (1) is provided with a snap-fit ​​part (12). The inner wall of the isolation plug (2) is provided with a first limiting part (22) and a second limiting part (23) from the opening end. A limiting groove (24) is formed between the first limiting part (22) and the second limiting part (23). The limiting groove (24) of the inner wall of the isolation plug (2) is adapted to the snap-fit ​​part (12) on the outer surface of the freeze-drying container (1). When the isolation plug (2) moves to the locking part (12) and is placed in the limiting groove (24), the freeze-drying chamber (11) of the freeze-drying container (1) can communicate with the outside through the hole (21), so that the freeze-drying chamber (11) is in a semi-sealed state; when the isolation plug (2) continues to move to the second limiting part (23) and passes the locking part (12), at this time, the locking part (12) and the inner side of the second limiting part (23) abut against each other, so that the freeze-drying chamber (11) is in a sealed state.

2. A lyophilized powder isolation plug according to claim 1, characterized in that: The cuts (26) are symmetrically arranged in two places or are arranged circumferentially with the center of the isolation plug (2) as the center.

3. A lyophilized powder isolation plug according to claim 2, characterized in that: The length of the cut (26) is 1-2 mm.

4. A lyophilized powder isolation plug according to claim 2, characterized in that: The incision (26) is in the shape of an inverted V.

5. A lyophilized powder isolation plug according to claim 1, characterized in that: The flange structure (25) includes an integrally formed flange sidewall (251) and an isolation ring (252), and the apex of the cut (26) extends to the axial midpoint of the flange sidewall (251).

6. A lyophilized powder isolation plug according to claim 5, characterized in that: A circular hole (27) is provided at the apex of the cut (26).

7. A lyophilized powder isolation plug according to claim 6, characterized in that: The diameter of the circular hole (27) is 0.5-1mm.

8. A lyophilized powder isolation plug according to claim 1, characterized in that: The freeze-drying container (1) includes a base (14) and an inner tube (13). The hollow part of the inner tube (13) is a freeze-drying chamber (11). One end of the inner tube (13) into which the isolation plug (2) is inserted forms a tube tip. The other end of the inner tube (13) is fixed to the base (14). The snap-fit ​​part (12) is provided on the outer surface of the inner tube (13).

9. A lyophilized powder isolation plug according to claim 8, characterized in that: A locking ring (3) is provided on the base (14). The locking ring (3) is located outside the inner tube (13) and is concentric with the inner tube (13). One end of the locking ring (3) is fixedly connected to the base (14), and the other end abuts against the opening end of the isolation plug (2) in the freeze-drying chamber (11) under sealed condition. The locking ring (3) is an open ring structure, forming an opening (31) that is easy to tear. The locking ring (3) and the base (14) are fixedly connected by several connection points (32).

10. An ampoule having a stopper for lyophilized powder as described in any one of claims 1-9, characterized in that: The ampoule (4) has a solvent chamber, and the bottom opening of the ampoule (4) is provided with an installation groove (41) that can accommodate the isolation plug (2).

Images