Freeze-drying preparation redissolving device
By designing the hollow needle puncture part and shell connection of the lyophilized preparation redissolution device, a closed path is formed, which solves the problems of pollution, safety and slow dissolution speed during the redissolution of the lyophilized preparation, and achieves sterility, safety and high efficiency reconstitution effect.
Patent Information
- Application Number
- CN202420593011.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-03-26
- Publication Date
- 2025-01-07
- Estimated Expiration
- 2034-03-26
AI Technical Summary
The existing lyophilized preparation redissolution methods have risks of drug contamination, inconvenience in operation and safety hazards. Especially when used under sterile and dust-free conditions, it increases the pollution of environmental microorganisms and dust particles, and the slow redissolution speed leads to the lack of effective ingredients of the drug. Uniform, extreme pH.
A lyophilized preparation redissolution device is designed, and the shell one and the shell two are connected by a hollow needle puncture member to form a closed hollow fluid path. The tip of the hollow needle puncture member is provided with porous to increase the resolving solution and lyophilized powder. Contact area and accelerate redissolution process by pressure drive to ensure sterile state and safe operation.
It realizes sterility, safety and efficient dissolution of the redissolution process of lyophilized preparations, avoids external pollution, reduces the problems of excessive active ingredients of the drug and extreme pH caused by local infiltration, and improves the stability and safety of the drug.
Smart Images
Figure CN222304365U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical devices, and in particular to a freeze-dried preparation reconstitution device. Background Art
[0002] Freeze-dried preparations generally contain freeze-dried powder and corresponding reconstitution solution, which are respectively packaged in corresponding packaging containers and sealed with rubber stoppers. When using, the user first uses a syringe to take out the reconstitution solution, and then injects it into the container containing the freeze-dried powder to achieve freeze-dried powder reconstitution, and then mix it before use. However, this operation method has obvious defects:
[0003] First, when the operator extracts the reconstitution solution, the syringe needle punctures the rubber stopper of the reconstitution solution bottle, and the syringe needle is exposed to the air; when injecting the reconstitution solution, the syringe needle punctures the rubber stopper of the lyophilized powder bottle again, and the syringe needle and the reconstitution solution are exposed to the air again. Drugs, especially sterile preparations, have high requirements for environmental microorganisms and dust particles. The places where drug users use drugs, such as hospital wards and patients' homes, obviously do not have sterile and dust-free conditions. Using the above reconstitution method in such an environment increases the risk of environmental microorganisms and dust particles contaminating drugs, and reduces drug safety.
[0004] Secondly, the existing reconstitution method requires two needle insertion and withdrawal punctures, which is inconvenient to operate and sometimes operators are injured by the needle.
[0005] Therefore, it is of great significance to develop a convenient, safe and pollution-free freeze-dried preparation reconstitution device.
[0006] In view of this, the present utility model is proposed. Utility Model Content
[0007] In order to solve the above problems, the utility model provides a freeze-dried preparation reconstitution device, including a shell 1 and a shell 2, wherein an opening is provided at one end of the shell 1 to form an open end 13, and the shell 1 can be covered on the bottle mouth of the freeze-dried preparation, and a hollow needle-piercing member 14 is provided in the shell cavity on the opposite side of the open end 13, and the tip 141 of the hollow needle-piercing member faces the open end 13; an opening is provided at one end of the shell 2 to form an open end 23, and the shell 22 can be covered on the bottle mouth of the reconstitution solution, and a hollow needle-piercing member 24 is provided in the shell cavity on the opposite side of the open end 23, and the tip 241 of the hollow needle-piercing member faces the open end 23; the shell 1 and the shell 2 are connected back to back through the opposite side of the open end 13 of the shell 1 and the opposite side of the open end 23 of the shell 2, and the hollow needle-piercing member 14 and the hollow needle-piercing member 24 form a hollow fluid passage 3 at the connection between the shell 1 and the shell 2.
[0008] Some lyophilized preparations, such as fibrinogen, have a slow reconstitution speed. When using a syringe for reconstitution, a greater force is required to provide a faster spray speed for the reconstitution solution to impact the lyophilized powder and accelerate the dissolution of the lyophilized preparation. In order to solve this problem, the applicant further designed a lyophilized preparation reconstitution device, wherein the hollow inner diameter of the hollow needle-piercing member 14 is smaller than the hollow inner diameter of the hollow needle-piercing member 24; thereby, the reconstitution solution sprayed out of the hollow needle-piercing member 14 has a higher speed to impact the lyophilized loose body, and the impact force of the solution is used to accelerate the dissolution of the lyophilized preparation.
[0009] When some lyophilized preparations have a slow reconstitution speed, when a single needle is injected with the reconstitution solution, due to the small contact area between the reconstitution solution and the lyophilized powder and the slow reconstitution speed, the reconstitution solution cannot quickly dissolve the lyophilized powder evenly, resulting in partial infiltration of the lyophilized preparation during the reconstitution process. During partial infiltration, the local concentration of excipients and the active ingredients of the drug are extremely high, and the pH is extreme, which poses a challenge to the efficacy and stability of the drug. In order to solve this problem, the applicant further designed a lyophilized preparation reconstitution device, wherein the hollow needle-piercing member 14 is sealed at the tip 141 port, and the side wall of the tip 141 is provided with multiple holes; the multiple holes are evenly arranged horizontally around the side wall, and the reconstitution solution is sprayed at multiple points, which effectively increases the contact area between the reconstitution solution and the lyophilized powder, accelerates the dissolution rate of the lyophilized powder, and the multi-point spraying also reduces the degree of extreme excessive concentration of excipients and active ingredients of the drug during local infiltration, and alleviates the situation where the pH is extreme.
[0010] Preferably, the hollow needle-punched member is made of metal.
[0011] Preferably, the hollow needle-punched member is made of plastic.
[0012] Preferably, the shell 1 and the shell 2 are made of elastic material, and the shell 1 and the shell 2 are snap-fitted with the bottle mouth. The shell 1 and the shell 2 made of elastic material are easier to fit with the bottle mouth.
[0013] Since the mouths of freeze-dried preparation bottles on the market are mostly round and have a certain height, preferably, the inner cavities of shell 1 and shell 2 2 are cylindrical.
[0014] Preferably, the opening end 13 and the opening end 23 are sealed by a sterile film; after the opening end 13 and the opening end 23 are sealed by the sterile film, the sterility of the hollow needle-piercing component in direct contact with the liquid medicine is further ensured, thereby reducing the risk of liquid medicine contamination.
[0015] Preferably, the opposite sides of the opening end of shell 1 and the opposite sides of the opening end of shell 2 are connected in an integral manner.
[0016] Preferably, the opposite sides of the opening end of shell 1 and the opposite sides of the opening end of shell 2 are connected by a movable connection.
[0017] Preferably, the hollow needle-piercing member 14 and the hollow needle-piercing member 24 are fixedly connected to form a hollow fluid passage 3.
[0018] Preferably, the hollow needle-piercing member 14 and the hollow needle-piercing member 24 are integrally connected to form a hollow fluid passage 3.
[0019] Preferably, the hollow needle-piercing member 14 and the hollow needle-piercing member 24 are connected by threads to form a hollow fluid passage 3.
[0020] Preferably, the hollow needle-piercing member 14 and the hollow needle-piercing member 24 form a hollow fluid passage 3 by means of a plug-in connection.
[0021] Through the above technical scheme, the utility model produces the following beneficial effects:
[0022] (1) The entire freeze-dried preparation reconstitution process is carried out in a closed space, which is simple and easy, avoiding the risk of external contamination.
[0023] (2) The reconstitution process no longer requires a syringe, which avoids accidental injury from the injection needle and makes the reconstitution process safer.
[0024] (3) The inner diameter of the hollow space of the hollow needle-piercing member 14 is smaller than the inner diameter of the hollow space of the hollow needle-piercing member 24, so that the reconstituted solution sprayed out of the hollow needle-piercing member 14 has a higher speed to impact the lyophilized loose body, and utilizes the impact force of the solution to accelerate the dissolution of the lyophilized preparation.
[0025] (4) Multi-point spraying of the reconstitution solution effectively increases the contact area between the reconstitution solution and the lyophilized powder, accelerating the dissolution rate of the lyophilized powder. Multi-point spraying also reduces the concentration of excipients during local infiltration and the degree of extreme excess of active ingredients in the drug, thereby alleviating the situation where the pH value is extreme. BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Figure 1 This is a schematic diagram of the structure of Example 1.
[0027] 1. Shell 1; 2. Shell 2; 3. Hollow fluid passage; 13. Shell opening end 1; 23. Shell opening end 2; 14. Hollow needle-piercing member 1; 24. Hollow needle-piercing member 2; 141. Hollow needle-piercing member tip 1; 241. Hollow needle-piercing member tip 2; DETAILED DESCRIPTION
[0028] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and understandable, the present invention is further described in detail with reference to the accompanying drawings and embodiments.
[0029] like Figure 1As shown, the first embodiment of the freeze-dried preparation reconstitution device of the utility model:
[0030] A freeze-dried preparation reconstitution device, comprising a shell 1 and a shell 2, wherein an opening is provided at one end of the shell 1 to form an open end 13, the shell 1 can be covered on the bottle mouth of the freeze-dried preparation, a hollow needle-piercing member 14 is provided in the shell cavity on the opposite side of the open end 13, and the tip 141 of the hollow needle-piercing member faces the open end 13; an opening is provided at one end of the shell 2 to form an open end 23, the shell 22 can be covered on the bottle mouth of the reconstitution solution, a hollow needle-piercing member 24 is provided in the shell cavity on the opposite side of the open end 23, and the tip 241 of the hollow needle-piercing member faces the open end 23; the shell 1 and the shell 2 are connected through the open end of the shell 1 The opposite side of shell 1 13 and the opposite side of the opening end 23 of shell 2 are back-to-back connected, and the hollow puncture piece 14 and the hollow puncture piece 24 form a hollow fluid passage 3 at the connection between shell 1 and shell 2 by plug-in connection; the hollow puncture piece is made of metal; shell 1 and shell 2 are made of elastic material, and shell 1 and shell 2 are snap-fitted with the bottle mouth, which makes it easier to fit with the bottle mouth; the inner cavity of shell 1 and shell 2 is cylindrical, which matches the circular bottle mouth of freeze-dried preparations on the market; the opposite side of the opening end 13 of shell 1 and the opposite side of the opening end 23 of shell 2 are connected by snap-fitting.
[0031] When in use, first, cover the shell 22 at the mouth of the reconstitution solution bottle, and the hollow needle-piercing member 24 penetrates the bottle mouth and the bottle stopper; then cover the shell 11 at the mouth of the freeze-dried preparation bottle, and the hollow needle-piercing member 14 penetrates the bottle mouth and the bottle stopper; the reconstitution solution is on the top, the freeze-dried preparation is on the bottom, and the vertical placement is formed. By taking advantage of the fact that the pressure in the reconstitution solution bottle is greater than the pressure in the freeze-dried preparation bottle, the reconstitution solution is injected into the freeze-dried preparation bottle under pressure drive, thereby reconstituted the freeze-dried powder. The entire reconstitution process is carried out in a closed space, which is simple and easy, avoiding the risk of external contamination. Since the participation of the syringe is not required, the phenomenon of accidental injury by the injection needle is avoided, and the reconstitution process is safer.
[0032] Furthermore, in order to accelerate the dissolution of the freeze-dried preparation, the hollow inner diameter of the hollow needle-piercing member 14 is smaller than the hollow inner diameter of the hollow needle-piercing member 24; thereby, the reconstituted solution sprayed out of the hollow needle-piercing member 14 has a higher speed to impact the freeze-dried loose body, and utilize the impact force of the solution to accelerate the dissolution of the freeze-dried preparation.
[0033] Furthermore, in order to reduce the extreme concentration of auxiliary materials and active ingredients of drugs during local infiltration and alleviate the situation of extreme pH, the tip 141 of the hollow needle-piercing member 14 is sealed, and the side wall of the tip 141 is provided with multiple holes; the multiple holes are evenly arranged horizontally around the side wall.
[0034] Furthermore, in order to improve the sterility of the hollow needle-piercing member in direct contact with the liquid medicine, the shell walls of the shell 1 and the shell 2 are sealed except for the open ends, and the open ends 13 and 23 are sealed by a sterile film. After the open ends 13 and 23 are sealed by the sterile film, the sterility of the hollow needle-piercing member in direct contact with the liquid medicine is further ensured, reducing the risk of liquid medicine contamination.
Claims
1. A freeze-dried preparation reconstitution device, comprising a housing 1 (1) and a housing 2 (2), characterized in that: An opening is provided at one end of the shell (1) to form an open end (13). The shell (1) can be covered on the mouth of a freeze-dried preparation bottle. A hollow needle-piercing member (14) is provided in the shell cavity on the opposite side of the open end (13). The tip end (141) of the hollow needle-piercing member faces the open end (13). An opening is provided at one end of the shell (2) to form an open end (23). The shell (2) can be covered on the mouth of a reconstituted solution bottle. A hollow needle-piercing member (24) is provided in the shell cavity on the opposite side of the open end (23). The tip end of the hollow needle-piercing member (2) faces the open end (23). The shell (1) and the shell (2) are connected via the opposite side of the open end (13) of the shell (1) and the opposite side of the open end (23) of the shell (2). The hollow needle-piercing member (14) and the hollow needle-piercing member (24) form a hollow fluid passage (3) at the connection between the shell (1) and the shell (2).
2. The freeze-dried preparation reconstitution device according to claim 1, characterized in that: The hollow inner diameter of the hollow needle-piercing member 1 (14) is smaller than the hollow inner diameter of the hollow needle-piercing member 2 (24).
3. The freeze-dried preparation reconstitution device according to claim 2, characterized in that: The tip end (141) of the hollow needle-piercing member (14) is sealed, and the side wall of the tip end (141) is provided with multiple holes, which are evenly and horizontally arranged around the side wall.
4. The freeze-dried preparation reconstitution device according to claim 3, characterized in that: The hollow needle-pierced member is made of metal.
5. The freeze-dried preparation reconstitution device according to claim 3, characterized in that: The hollow needle-piercing member is made of plastic.
6. The freeze-dried preparation reconstitution device according to claim 4, characterized in that: The shell one (1) and the shell two (2) are made of elastic material, and the shell one (1) and the shell two (2) are snap-fitted with the bottle mouth.
7. The freeze-dried preparation reconstitution device according to claim 6, characterized in that: The inner cavities of the shell 1 (1) and the shell 2 (2) are cylindrical.
8. The freeze-dried preparation reconstitution device according to claim 7, characterized in that: The first opening end (13) and the second opening end (23) are sealed by a sterile film.
9. The freeze-dried preparation reconstitution device according to claim 7, characterized in that: The opposite sides of the opening end of the shell one (1) and the opposite sides of the opening end of the shell two (2) are connected in an integral manner.
10. The freeze-dried preparation reconstitution device according to claim 7, characterized in that: The opposite side of the opening end of the shell one (1) and the opposite side of the opening end of the shell two (2) are connected by a movable connection.