A closed system for the preparation of aqueous solutions of highly active compounds

Abstract

The utility model relates to a kind of water solution closed preparation system suitable for high-activity compound, it includes closed material accumulator, and the inside of lower port of closed material accumulator is provided with internal thread;Water solution preparation container, it includes container main body, stirring device;Stirring device includes stirring propeller and engine, and stirring propeller is set in the bottom in container main body, and engine is set in the side wall outside container main body, to drive stirring propeller;The outside of upper port of container main body is provided with the first outer thread matched with the internal thread of closed material accumulator;Feeding auxiliary, including inverted conical feeding port, feeding channel, and the outside of lower port of feeding channel is provided with the second outer thread matched with the internal thread of closed material accumulator, the utility model is closed by setting internal and external thread cooperation, and it is prevented to expose risk, by setting stirring propeller in bottom, stirring aqueous solution under closed condition is realized, realize semi-automation, it is simple, efficient, safe to operate.

Description

Technical Field

[0001] This utility model relates to the pharmaceutical field, and in particular to a closed-loop preparation system for aqueous solutions of highly active compounds. Background Technology

[0002] In the production of HP API (highly reactive API), the preparation of aqueous solutions (including solutions and suspensions) often involves one-step fluidized bed granulation. Since the entire process of HP API operation must be carried out in a closed container, the preparation of its aqueous solutions presents a challenge.

[0003] In current production processes, an intermediate container is typically transferred to a sealed isolator. Inside the isolator, dispensed HP API is added to the container, and the aqueous solution is prepared by manual stirring. After preparation, the intermediate container is removed from the isolator for cleaning and then transferred to the fluidized bed granulation process room. Finally, the HP API solution / suspension in the intermediate container is transferred to a container capable of being stirred.

[0004] This process is complex, time-consuming, and labor-intensive, and it also results in significant weight loss of HP API (especially for products with very small formulation sizes, such as ≤0.1mg), thus affecting the content of intermediate products. Losses occur during the transfer of the prepared solution to the mixing container (residue on the stirring spoon and glass walls), requiring repeated rinsing of the glass inner wall with aqueous solution. Furthermore, the solution transfer process is carried out in an exposed environment. When using a top-mounted stirrer for solution preparation, the container remains open, posing a risk of collapse and irreversible loss of solution. Throughout the entire process, there is a risk of exposure to highly reactive compounds.

[0005] In the prior art, utility model patent application number 202421514395.2 discloses an air-isolated stirring and dissolving device and a solution preparation and transfer device. However, this technical solution has two shortcomings, making it difficult to apply to the safe preparation of highly active compounds (HP APIs): 1. Insufficient Closed-Loop Operation: The process of removing highly active compounds (HP API) from their original packaging and adding them to the device's feeding hopper requires a strictly closed environment (such as an isolator) to avoid operator exposure risks. This existing technology does not address or resolve the closed-loop operation requirements for the initial unpacking and addition of materials, and therefore is unsuitable for the distribution and closed-loop feeding of highly active compounds.

[0006] 2. Vacuum Aspiration Risk: This existing technology employs a vacuum aspiration method. For highly reactive compounds, this method carries a significant risk: during the addition of solid materials or the preparation of solutions, there is a possibility of accidental aspiration and loss of valuable materials or solutions. Since highly reactive compounds are typically expensive to produce, such losses result in substantial cost waste. More importantly, if the operator fails to detect such accidental aspiration in a timely manner, it will directly lead to inaccurate content in the final intermediate product, severely impacting product quality.

[0007] Therefore, how to avoid the above-mentioned cumbersome operations as much as possible, thereby reducing the loss of HP API, and ensuring that the entire solution preparation process is carried out in a closed environment, has become a technical problem that needs to be solved in this field. Utility Model Content

[0008] To solve at least one of the above-mentioned technical problems, this utility model provides a closed-loop preparation system for aqueous solutions of highly active compounds, including a closed storage container, an internal thread provided on the inner side of the lower port of the closed storage container, a spring pressure valve provided in the channel of the closed storage container, and further comprising: An aqueous solution preparation container includes a container body and a stirring device; a valve is provided at the bottom of the container body; the stirring device includes a stirring propeller and an engine, the stirring propeller is located at the bottom inside the container body, and the engine is located on the side wall outside the container body to drive the stirring propeller; a first external thread is provided on the outer side of the upper port of the container body to mate with the internal thread of the sealed storage container. The feeding aid includes a feeding port and a feeding channel. The lower port of the feeding channel is provided with a second external thread that mates with the internal thread of the sealed storage device.

[0009] In some implementations, a viewing window is provided on the side wall of the container body.

[0010] In some implementations, the inner wall of the feeding aid is made of stainless steel.

[0011] In some implementations, the feed port is inverted conical in shape.

[0012] In some implementations, a support frame is also provided at the bottom of the container body, and a gasket is provided at the bottom of the support frame. Both the support frame and the gasket are made of stainless steel.

[0013] In some implementation schemes, the valve is a one-way valve.

[0014] In some implementations, the valve is also connected to a hose interface.

[0015] In some implementations, the sealed storage device also includes a spring-loaded pressure valve.

[0016] Compared with the prior art, the beneficial effects of this utility model are reflected in: 1. Direct feeding of HP API dry powder significantly reduces losses: HP API is only dispensed and stored in the isolator, eliminating the need for manual mixing with aqueous solution, thus minimizing HP API loss. The system uses a threaded feeding aid to transfer the dispensed HP API solid powder to a sealed storage container. The sealed storage container is directly connected to the aqueous solution preparation container to achieve direct feeding and mixing of dry powder. In other words, HP API does not need to be pre-dissolved or suspended and can be directly added to the aqueous solution preparation container in powder form. Furthermore, the inner wall of the feeding aid is made of stainless steel, reducing the friction between HP API and the inner wall and minimizing material loss during the transfer process.

[0017] 2. Completely closed-loop operation to eliminate exposure risks: In an isolated chamber, HP API is transferred to a sealed storage container via a feeding aid, and then transferred to an aqueous solution preparation container in a fluidized bed. This achieves a mixing-while-feeding preparation process, with all stages being completely closed (the sealed storage container is sealed to both the feeding aid and the aqueous solution preparation container). This ensures that there is no exposure risk to HP API throughout the entire preparation process, effectively protecting the health and safety of operators.

[0018] 3. Convenient and efficient operation, with a visible and controllable process: The system adopts threaded rotary docking (connecting the sealed storage container to the feeding auxiliary device and the sealed storage container to the aqueous solution preparation container), making the connection operation simple and reliable. Furthermore, the stirring process is semi-automated, with the external motor of the container body driving the internal stirring propeller. The viewing window on the side wall of the container allows for real-time observation of the solution preparation status, making the solution preparation process safer and more convenient.

[0019] 4. The system is stable and reliable, reducing the risk of accidents: The stirring propeller is set at the bottom of the container body, eliminating the need for manual opening and stirring. Furthermore, the bottom of the aqueous solution preparation container is equipped with a support frame and gaskets, which significantly improves the overall stability of the equipment. The container components of the entire system remain in a sealed connection during step-by-step and scenario-based operations, effectively eliminating the risk of irreversible material loss due to accidental collapse of container components.

[0020] The following will further explain the concept, specific structure and technical effects of this utility model in conjunction with the accompanying drawings, so as to fully understand the purpose, features and effects of this utility model. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the basic structure of the aqueous solution preparation container in the closed preparation system for aqueous solutions of highly active compounds, according to Embodiment 1 of this utility model.

[0022] Figure 2This is a schematic diagram of the basic structure of the feeding aid in a closed preparation system for aqueous solutions of highly active compounds, according to Embodiment 1 of this utility model.

[0023] Reference numerals: 10-Aqueous solution preparation container, 11-Container body, 12-Stirring device, 13-Feed channel, 111-Valve, 121-Stirring propeller, 122-Engine, 131-First external thread, 112-Viewing window, 113-Support frame, 1131-Gasket, 1111-Hose interface, 114-Handle, 20-Feeding aid, 21-Feeding port, 22-Feeding channel, 221-Second external thread. Detailed Implementation

[0024] In order to make the technical means, inventive features, objectives and effects of the utility model easy to understand, the utility model is further described in conjunction with specific illustrations, but the utility model is not limited to the following embodiments.

[0025] It should be noted that the structures, proportions, sizes, etc., shown in the accompanying drawings of this specification are only used to complement the content disclosed in the specification for those skilled in the art to understand and read, and are not intended to limit the conditions under which this utility model can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportional relationships, or adjustments to the size, without affecting the effects and purposes that this utility model can produce, should still fall within the scope of the technical content disclosed in this utility model.

[0026] Terms such as “comprising” and “including” indicate that, in addition to the components that are directly and explicitly stated in the specification and claims, the technical solution of this utility model does not exclude the presence of other components that are not directly or explicitly stated.

[0027] This invention provides a closed-loop preparation system for aqueous solutions of highly active compounds, mainly to solve the problems existing in the preparation of aqueous solutions of highly active compounds. A detailed description will follow with reference to the accompanying drawings: Example 1 This embodiment is a closed preparation system for aqueous solutions of highly active compounds, including a closed storage container, an internal thread provided on the inner side of the channel of the closed storage container, and a spring pressure valve provided in the channel of the storage container. The system also includes an aqueous solution preparation container 10 and a feeding aid 20. in, Figure 1The basic structural diagram of the aqueous solution preparation container 10 includes a container body 11, a stirring device 12, and a feed channel 13. A valve 111 is located at the bottom of the container body 11, with a hose interface 1111 connected to the other end of the valve 111. A viewing window 112 and a handle 114 are located on the side wall. The viewing window 112 is used to adjust the stirring speed in real time according to the stirring status, and the handle 114 facilitates lifting and transferring the aqueous solution preparation container. A stainless steel support frame with a stainless steel gasket 1131 is also provided at the bottom of the container body 11. 113, used to prevent tipping; the stirring device 12 includes a stirring propeller 121 and an engine 122. The stirring propeller 121 is disposed at the bottom inside the container body 11 for stirring in a closed state; the engine 122 is disposed on the side wall outside the container body 11 for driving the stirring propeller 121; the outer side of the feed channel 13 is provided with a first external thread 131 that mates with the internal thread on the inner side of the channel of the sealed storage container; the sealed storage container and the aqueous solution preparation container 10 are detachably sealed through the mating internal and external threads. Figure 2 The basic structural diagram of the feeding aid 20 includes an inverted conical feeding port 21 and a feeding channel 22. The outer side of the feeding channel 22 is provided with a second external thread 221 that mates with the internal thread on the inner side of the channel of the sealed storage device. The feeding aid 20 and the sealed storage device are detachably sealed through the mating internal and external threads.

[0028] This embodiment also provides a method for using a closed-loop preparation system for aqueous solutions of highly reactive compounds, including the following steps: First, HP API is added to the sealed storage container via a feeding aid 20 within the sealed isolator. Specifically, the feeding aid 20 and the sealed storage container are connected in a sealed manner via internal and external thread rotation to form a sealed feeding container assembly. The required amount of HP API is then slowly added to the sealed storage container through an inverted conical feeding port 21 using a stainless steel spoon. Since the entire feeding aid 20 is made of stainless steel with a smooth inner wall, the amount of HP API residue on the inner wall is minimized.

[0029] Next, the feeding auxiliary device 20 and the sealed storage device are rotated and separated. The sealed storage device is placed in a sealed bag and transferred out of the sealed isolator. After cleaning, it is transferred to the fluidized bed granulation room.

[0030] Finally, add a certain amount of purified water to the aqueous solution preparation container 10, turn on the engine 122 to drive the stirring propeller 121, and observe through the viewing window 112 to ensure that a water vortex is formed; connect the sealed storage container and the aqueous solution preparation container 10 in a sealed manner by rotating the internal and external threads. During the connection process, the HP API will slowly fall, forming an operation process of adding material and stirring at the same time. The sealed storage container and the aqueous solution preparation container 10 do not need to be separated after docking, forming a sealed preparation container combination; the stirring state of the solution can be observed through the viewing window 112, thereby adjusting the speed of the stirring propeller 121; after the aqueous solution is prepared, transfer the aqueous solution through the valve 111 and the hose interface 1111 connected to the valve by opening the valve 111.

[0031] It should be noted that the sealed storage device is a commercially available component and does not require an attached diagram. The working principle of its spring pressure valve is as follows: the external spiral rotation force (from the spiral force of the feeding channel of the feeding aid and the spiral force of the feeding channel of the aqueous solution preparation container) can push the spring pressure valve into the sealed storage device, gradually opening the valve. This allows the sealed storage device to be connected to the feeding aid and the aqueous solution preparation container to achieve a sealed state. When it is unscrewed, the spring pressure valve will return to its original position under the elastic deformation force, causing the spring pressure valve to close, thus achieving a sealed state inside the sealed storage device.

[0032] Example 2 In this embodiment, the sidewall of the container body 11 does not include the handle 114, and the rest is the same as in embodiment 1.

[0033] Example 3 In this embodiment, the valve 111 of the container body 11 is a single-way valve, and the rest is the same as in embodiment 1.

[0034] The preferred embodiments of this utility model have been described in detail above. It should be understood that those skilled in the art can make numerous modifications and variations based on the concept of this utility model without creative effort. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of this utility model through logical analysis, reasoning, or limited experimentation on the basis of existing technology should be within the scope of protection defined by the claims.

Claims

1. A closed-loop preparation system for aqueous solutions of highly reactive compounds, comprising a closed storage container, wherein the inner side of the channel of the closed storage container is provided with an internal thread, and the channel of the closed storage container is provided with a spring pressure valve, characterized in that, Also includes: An aqueous solution preparation container (10) includes a container body (11), a stirring device (12), and a feeding channel (13); a valve (111) is provided at the bottom of the container body (11); the stirring device (12) includes a stirring propeller (121) and an engine (122), the stirring propeller (121) is located at the bottom inside the container body (11), and the engine (122) is located on the side wall outside the container body (11) to drive the stirring propeller (121); the outer side of the feeding channel (13) is provided with a first external thread (131) that mates with the internal thread on the inner side of the channel of the sealed storage container. The feeding aid (20) includes a feeding port (21) and a feeding channel (22). The outer side of the feeding channel (22) is provided with a second external thread (221) that matches the internal thread on the inner side of the channel of the sealed storage device.

2. The closed-loop preparation system for aqueous solutions of highly active compounds according to claim 1, characterized in that, The container body (11) has a viewing window (112) on its side wall.

3. The closed-loop preparation system for aqueous solutions of highly reactive compounds according to claim 1, characterized in that, The inner wall of the feeding aid (20) is made of stainless steel.

4. The closed-loop preparation system for aqueous solutions of highly reactive compounds according to claim 1, characterized in that, The feed port (21) is an inverted cone shape.

5. The closed-loop preparation system for aqueous solutions of highly reactive compounds according to claim 1, characterized in that, The bottom of the container body (11) is also provided with a support frame (113), and the bottom of the support frame (113) is provided with a pad (1131).

6. The closed-loop preparation system for aqueous solutions of highly reactive compounds according to claim 5, characterized in that, The support frame (113) and the gasket (1131) are both made of stainless steel.

7. The closed-loop preparation system for aqueous solutions of highly reactive compounds according to claim 1, characterized in that, The valve (111) is a single-pass valve.

8. The closed-loop preparation system for aqueous solutions of highly reactive compounds according to claim 1, characterized in that, The valve (111) is also connected to a hose interface (1111).

9. The closed-loop preparation system for aqueous solutions of highly reactive compounds according to claim 1, characterized in that, The container body (11) is also provided with a handle (114) on its side wall.

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