A high-efficiency high-pressure homogenizer nanostructured liposome extrusion module

Abstract

The application relates to a high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, which comprises a connecting assembly, an extrusion assembly and a connecting pipe and a material pipe connected with the outlet of the high-pressure homogenizer; the extrusion assembly comprises a base, a filtering component, a cavity in sealed connection with the base and a cover structure, the cover structure is provided with a feeding port in communication with the material pipe, the cavity is provided with a channel in communication with the feeding port and used for passing a suspension, the base is provided with an embedded groove, the bottom of the embedded groove is provided with a containing space and a discharging port in communication with the containing space, the filtering component is installed in the embedded groove, the containing space is used for containing treated liquid and discharging the liquid from the discharging port, the extrusion module is directly connected with the outlet of the high-pressure homogenizer, no additional transfer pipeline is needed, residue and exposure problems in the material transfer process in traditional split-type equipment are avoided, and the material pollution risk is significantly reduced.

Description

Technical Field

[0001] This application relates to the field of liposome preparation technology, specifically to a high-efficiency high-pressure homogenizer nanostructured liposome extrusion module. Background Technology

[0002] As a commonly used nanomedicine carrier in the biomedical field, the uniformity of liposome particle size directly affects the drug's targeting, biocompatibility, and therapeutic effect. Therefore, it is necessary to refine the crude liposome suspension through a combination of high-pressure homogenization and membrane extrusion to obtain nano / submicron-sized particles that meet the requirements.

[0003] In current liposome preparation processes, the high-pressure homogenization unit and extrusion module are mostly set up independently, without forming a directly connected integrated structure. This means that the crude liposome suspension after primary high-pressure homogenization needs to be transferred to the extrusion module for further processing via additional pipelines. This separate design not only complicates the flow path structure and increases the risk of material residue and contamination, but may also affect the liposome processing effect due to pressure loss and flow rate fluctuations during the transfer process.

[0004] Therefore, it is necessary to improve the existing technology to overcome the aforementioned defects. Utility Model Content

[0005] In view of this, this application provides a high-efficiency high-pressure homogenizer nanostructured liposome extrusion module to solve at least one problem existing in the background art, comprising: A connecting assembly includes a connector, a connecting pipe, and a feed pipe that are connected to the outlet of a high-pressure homogenizer. One end of the connecting pipe extends into the connector and is secured by a first fastener, and the other end of the connecting pipe extends into the feed pipe and is secured by a second fastener. An extrusion assembly includes a base, a filtering component, a cavity sealed to the base, and a cover structure sealed to the cavity. The cover structure has an inlet communicating with the feed tube. The cavity has a channel communicating with the inlet and allowing the suspension to pass through. The base is provided with an embedding groove. The bottom of the embedding groove is provided with a receiving space and an outlet communicating with the receiving space. The filtering component is installed in the embedding groove and is used to process the lipid-containing suspension passing through the channel. The receiving space is used to hold the processed liquid and discharge it from the outlet.

[0006] Optionally, in the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, the filtration component includes a support plate embedded in the embedding groove, a sintered filter sheet stacked on the support plate, and a nanofiltration membrane covering the sintered filter sheet. The support plate is provided with a plurality of through holes communicating with the accommodating space. The suspension passing through the channel passes sequentially through the nanofiltration membrane and the sintered filter sheet and then enters the accommodating space through the plurality of through holes.

[0007] Optionally, in the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, the cross-sectional area of ​​the filtration component is larger than the cross-sectional area of ​​the channel.

[0008] Optionally, in the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, the bottom of the cavity includes a pressure-retaining part and a protrusion lower than the pressure-retaining part; The base is provided with a first mating part adapted to the pressing part and a second mating part lower than the first mating part. The second mating part is adapted to the protrusion. The pressing part simultaneously presses against the edge of the first mating part and the filter component, and a first sealing element is also provided between the protrusion and the second mating part.

[0009] Optionally, in the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, the cavity further includes a water-cooled cavity arranged around the channel. The water-cooled cavity is provided with a partition to divide the water-cooled cavity into an upper cavity and a lower cavity. The partition is provided with a perforation connecting the upper cavity and the lower cavity. The upper cavity is used to communicate with a cold water inlet, and the lower cavity is used to communicate with a water-cooled outlet.

[0010] Optionally, in the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, the cover structure includes an end cap, a locking member, and a screw connected to the upper end of the cavity. The end cap is provided with a vent hole. The locking member is partially located inside the end cap and there is a third sealing member between it and the end cap. The screw is threadedly connected to the locking member so that the vent hole communicates with or is isolated from the channel.

[0011] Optionally, in the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, the end cap is provided with a connection port connecting the vent hole and the channel, the upper end of the connection port is provided with a conical first mating surface, and the end of the screw is provided with a conical second mating surface adapted to the first mating surface.

[0012] Optionally, the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module further includes several fixing components, each including a fixing rod and a nut. The lower end of the fixing component is threadedly connected to the base, and the upper end of the fixing component passes through the cover structure. The nut is configured to rotate so that the cover structure applies downward pressure to the cavity and the base.

[0013] Optionally, the above-mentioned high-efficiency high-pressure homogenizer nanostructured liposome extrusion module further includes a back pressure regulating component, which includes a back pressure valve disposed at the discharge port for providing an independently adjustable and stable back pressure to the extrusion module.

[0014] Compared with existing technologies, this application has the following advantages: by directly connecting the extrusion module to the outlet of the high-pressure homogenizer, an integrated flow path for high-pressure homogenization and membrane extrusion refining is formed, eliminating the need for additional transfer pipelines. This avoids the problems of residue and exposure during material transfer in traditional split-type equipment, significantly reducing the risk of material contamination. At the same time, it reduces pressure loss and flow rate fluctuations, ensuring the continuity of liposome processing. Furthermore, by reducing redundant structures such as independent pipelines and connecting components, it not only reduces the overall manufacturing cost of the equipment but also significantly reduces the space occupied by the equipment, making it easier to arrange and install in industrial production. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the high-efficiency high-pressure homogenizer nanostructured liposome extrusion module shown in this embodiment; Figure 2 for Figure 1 A cross-sectional view of the high-efficiency high-pressure homogenizer nanostructured liposome extrusion module shown. Figure 3 for Figure 1 Another cross-sectional view of the high-efficiency high-pressure homogenizer nanostructured liposome extrusion module shown.

[0016] Reference numerals: 1-Connecting assembly, 11-Connector, 12-Connecting pipe, 13-Feed pipe, 14-First fastener, 15-Second fastener, 2-Extrusion assembly, 21-Base, 211-Embedded groove, 212-Accommodation space, 213-Outlet, 22-Filtering component, 221-Support plate, 222-Sintered filter sheet, 223-Nano filter membrane, 2211-Through hole, 23-Cavity, 231-Channel, 234-Water-cooled cavity, 2341-Upper Cavity, 2342-Lower cavity, 235-Partition plate, 2351-Perforation, 236-Cold water inlet, 237-Water cooling outlet, 24-Cover structure, 241-Feed inlet, 242-End cap, 2421-Ventilation hole, 2422-Connection port, 2423-First mating surface, 243-Locking component, 244-Screw, 2441-Second mating surface, 245-Third sealing component, 25-First sealing component, 3-Fixing component, 31-Fixing rod, 32-Nut. Detailed Implementation

[0017] The exemplary embodiments disclosed in this application will now be described in more detail. Numerous specific details are set forth in the following description to provide a more thorough understanding of this application. However, it will be apparent to those skilled in the art that this application can be implemented without one or more of these details. In other instances, to avoid confusion with this application, some technical features well-known in the art have not been described; that is, not all features of actual embodiments are described herein, nor are well-known functions and structures described in detail.

[0018] It should be understood that when an element or layer is referred to as "on," "adjacent to," "connected to," or "coupled to" other elements or layers, it may be directly on, adjacent to, connected to, or coupled to other elements or layers, or there may be intervening elements or layers. Conversely, when an element is referred to as "directly on," "directly adjacent to," "directly connected to," or "directly coupled to" other elements or layers, there are no intervening elements or layers. It should be understood that although the terms first, second, third, etc., may be used to describe various elements, components, areas, layers, and / or portions, these elements, components, areas, layers, and / or portions should not be limited by these terms. These terms are only used to distinguish one element, component, area, layer, or portion from another element, component, area, layer, or portion. Therefore, without departing from the teachings of this application, the first element, component, area, layer, or portion discussed below may be referred to as a second element, component, area, layer, or portion. And the discussion of a second element, component, area, layer, or portion does not imply that the first element, component, area, layer, or portion necessarily exists in this application.

[0019] Spatial relation terms such as “below,” “under,” “below,” “under,” “above,” “above,” etc., are used here for convenience to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms are intended to also include different orientations of devices in use and operation.

[0020] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of this application. When used herein, the singular forms “a,” “an,” and “ / the” are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “compose” and / or “comprising,” when used in this specification, identify the presence of features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups. When used herein, the term “and / or” includes any and all combinations of the associated listed items.

[0021] To fully understand this application, detailed steps and structures will be presented in the following description to illustrate the technical solution of this application. Preferred embodiments of this application are described in detail below; however, in addition to these detailed descriptions, this application may have other implementation methods.

[0022] Please refer to Figure 1-3 As shown in the preferred embodiment of this application, a high-efficiency high-pressure homogenizer nanostructured liposome extrusion module includes a connecting component 1 and an extrusion component 2. The connecting component 1 is used to connect to the outlet of the high-pressure homogenizer, and the extrusion component 2 is used to process the suspension flowing out of the high-pressure homogenizer outlet.

[0023] Specifically, the connecting assembly 1 includes a connector 11, a connecting pipe 12, and a material pipe 13 that connect to the outlet of the high-pressure homogenizer. One end of the connecting pipe 12 extends into the connector 11 and is fixed by a first fastener 14, while the other end extends into the material pipe 13 and is fixed by a second fastener 15. Both ends of the connecting pipe 12 extend into the connector 11 and the material pipe 13, respectively, forming a continuous material conveying channel to avoid interruption of material conveying. The rigid pipe design can withstand the high-pressure conditions output by the high-pressure homogenizer without deformation or breakage, ensuring the stability of material conveying. The first fastener 14 and the second fastener 15 respectively lock and fix the connection parts of the connecting pipe 12 and the connector 11, and the connecting pipe 12 and the material pipe 13, enhancing the connection sealing and preventing material leakage or the entry of outside air under high pressure.

[0024] The extrusion assembly 2 includes a base 21, a filter element 22, a cavity 23 sealed to the base 21, and a cover structure 24 sealed to the cavity 23. The cover structure 24 has an inlet 241 communicating with the feed tube 13. The cavity 23 has a channel 231 communicating with the inlet 241 and allowing the suspension to pass through. The base 21 is provided with an embedding groove 211. The bottom of the embedding groove 211 is provided with a receiving space 212 and an outlet 213 communicating with the receiving space 212. The filter element 22 is installed in the embedding groove 211 and is used to process the suspension containing lipid bodies that passes through the channel 231. The receiving space 212 is used to hold the processed liquid and discharge it from the outlet 213.

[0025] More specifically, the filtration component 22 includes a support plate 221 embedded in the embedding groove 211, a sintered filter sheet 222 stacked on the support plate 221, and a nanofiber filter membrane 223 covering the sintered filter sheet 222. The support plate 221 is provided with a plurality of through holes 2211 communicating with the accommodating space 212. The suspension passing through the channel 231 passes sequentially through the nanofiber filter membrane 223 and the sintered filter sheet 222, and then enters the accommodating space 212 through the plurality of through holes 2211. In this embodiment, the nanofiber filter membrane 223 is made of polycarbonate material with a pore size of 100 nm; the support plate 221 is made of hard alloy material; and the sintered filter sheet 222 is a porous ceramic filter sheet.

[0026] Understandably, by setting the support plate 221, support is provided for the sintered filter sheet 222 and the nanofiltration membrane 223, so as to avoid deformation of the nanofiltration membrane 223 or the sintered filter sheet 222 under high pressure; the sintered filter sheet 222 plays a role in pre-filtration and flow equalization, which can intercept large particulate impurities and make the suspension evenly contact the nanofiltration membrane 223, while the nanofiltration membrane 223 precisely controls the liposome particle size.

[0027] It should be noted that in this embodiment, the cross-sectional area of ​​the filter element 22 is larger than that of the channel 231, so that the suspension flowing out of the channel 231 can be fully spread on the surface of the filter element 22, avoiding local wear of the filter membrane or uneven distribution of liposome particle size caused by excessive local flow rate; at the same time, it increases the contact area between the suspension and the filter element 22, improves the processing efficiency per unit time, reduces the retention and pressure drop of the suspension in the channel 231, and ensures the continuity of the extrusion process.

[0028] Furthermore, the bottom of the cavity 23 includes a pressing part and a protruding part lower than the pressing part; the base 21 is provided with a first mating part adapted to the pressing part and a second mating part lower than the first mating part, the second mating part is adapted to the protruding part, the pressing part simultaneously presses against the edge of the first mating part and the filter component 22, and a first sealing member 25 is also provided between the protruding part and the second mating part.

[0029] Understandably, the aforementioned cavity 23 and base 21 are fitted together in a stepped manner to ensure the sealing and fixation of the filter element 22, preventing leakage of the suspension, ensuring the pressure stability of the liposome processing process, and improving the consistency of product quality.

[0030] Furthermore, the cavity 23 also includes a water-cooled cavity 234 arranged around the channel 231. A partition 235 is provided inside the water-cooled cavity 234 to divide the water-cooled cavity 234 into an upper cavity 2341 and a lower cavity 2342. A through hole 2351 is provided on the partition 235 to connect the upper cavity 2341 and the lower cavity 2342. The upper cavity 2341 is used to connect with the cold water inlet 236, and the lower cavity 2342 is used to connect with the water-cooled outlet 237.

[0031] Understandably, by using a partition 235 to divide the space into an upper chamber 2341 and a lower chamber 2342, cold water flows into the upper chamber 2341 and flows out of the lower chamber 2342 to form a circulating cooling path, which can uniformly and efficiently cool the suspension in the channel 231; avoid the oxidation, degradation or particle size loss of liposomes caused by frictional heat during high-pressure extrusion, and is especially suitable for the processing of heat-sensitive liposome materials, ensuring the bioactivity of liposomes and product stability.

[0032] Furthermore, the cover structure 24 includes an end cap 242 connected to the upper end of the cavity 23, a locking member 243, and a screw 244. The end cap 242 is provided with a vent hole 2421. The locking member 243 is partially located inside the end cap 242 and there is a third sealing member 245 between it and the end cap 242. The screw 244 is threadedly connected to the locking member 243 so that the vent hole 2421 can communicate with or be isolated from the channel 231.

[0033] Understandably, before processing the suspension, air in the channel 231 can be discharged through the vent 2421 to prevent air from mixing in and causing liposome aggregation or extrusion pressure fluctuations. During extrusion, the vent 2421 is closed to ensure the sealing of the cavity 23. The locking structure of the screw 244 is easy to operate and the ventilation status can be adjusted in real time, improving the operational flexibility and process controllability of the extrusion module. It is worth noting that in this embodiment, the end cap 242 is provided with a connection port 2422 connecting the vent 2421 and the channel 231. The upper end of the connection port 2422 is provided with a conical first mating surface 2423, and the end of the screw 244 is provided with a conical second mating surface 2441 adapted to the first mating surface 2423. The first conical mating surface 2423 and the second conical mating surface 2441 are adapted to each other, so that the first mating surface 2423 and the second mating surface 2441 can fit tightly together, thereby improving the sealing effect when the vent 2421 is separated from the channel 231, and preventing the suspension from leaking from the mating gap or air from entering under high pressure. On the other hand, the self-centering effect of the conical surface ensures that the screw 244 is accurately mated, reducing the difficulty of operation and reducing the wear of the mating surface.

[0034] Furthermore, the extrusion module also includes several fasteners 3, each including a fixing rod 31 and a nut 32. The lower end of the fastener 3 is threadedly connected to the base 21, and the upper end of the fastener 3 passes through the cover structure 24. The nut 32 is configured to rotate so that the cover structure 24 applies downward pressure to the cavity 23 and the base 21.

[0035] Understandably, the fasteners 3, through the cooperation of the fasteners 31 and the nuts 32, enable the cover structure 24 to apply uniform downward pressure to the cavity 23 and the base 21, ensuring that the sealing surfaces between the cavity 23 and the base 21, and between the cover structure 24 and the cavity 23, are tightly fitted, thus preventing leakage under high pressure. Furthermore, the assembly of the cover structure 24, the cavity 23, and the base 21 through the fasteners 3 facilitates the maintenance and replacement of various components in the entire extrusion module.

[0036] Furthermore, the extrusion module also includes a back pressure regulating component (not shown). The back pressure regulating component includes a back pressure valve installed at the discharge port 213, which is used to provide an independently adjustable and stable back pressure for the extrusion module. This allows for precise control of the back pressure within the extrusion module based on process parameters such as liposome particle size requirements and suspension viscosity, thus avoiding uneven liposome particle size caused by back pressure fluctuations. A stable back pressure environment allows the suspension to pass through the filter component 22 at a uniform speed, improving the consistency of liposome formation. At the same time, the independent regulation function of the back pressure valve is adaptable to the production of liposomes with different formulations and particle size requirements.

[0037] In this embodiment, the back pressure valve is set to a pressure range of 5-200 bar, and the high-pressure homogenizer operates at a pressure of 200-1500 bar.

[0038] The above is only one specific implementation of this application, and any other improvements made based on the concept of this application shall be considered within the scope of protection of this application.

Claims

1. A high-efficiency high-pressure homogenizer nanostructured liposome extrusion module, characterized in that, include: A connecting assembly includes a connector, a connecting pipe, and a feed pipe that are connected to the outlet of a high-pressure homogenizer. One end of the connecting pipe extends into the connector and is secured by a first fastener, and the other end of the connecting pipe extends into the feed pipe and is secured by a second fastener. An extrusion assembly includes a base, a filtering component, a cavity sealed to the base, and a cover structure sealed to the cavity. The cover structure has an inlet communicating with the feed tube. The cavity has a channel communicating with the inlet and allowing the suspension to pass through. The base is provided with an embedding groove. The bottom of the embedding groove is provided with a receiving space and an outlet communicating with the receiving space. The filtering component is installed in the embedding groove and is used to process the lipid-containing suspension passing through the channel. The receiving space is used to hold the processed liquid and discharge it from the outlet.

2. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 1, characterized in that, The filtration component includes a support plate embedded in the embedded groove, a sintered filter sheet stacked on the support plate, and a nanofiber membrane covering the sintered filter sheet. The support plate is provided with a plurality of through holes communicating with the accommodating space. The suspension passing through the channel passes sequentially through the nanofiber membrane and the sintered filter sheet and then enters the accommodating space through the plurality of through holes.

3. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 2, characterized in that, The cross-sectional area of ​​the filter element is larger than the cross-sectional area of ​​the channel.

4. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 1, characterized in that, The bottom of the cavity includes a pressing part and a protruding part lower than the pressing part; The base is provided with a first mating part adapted to the pressing part and a second mating part lower than the first mating part. The second mating part is adapted to the protrusion. The pressing part simultaneously presses against the edge of the first mating part and the filter component. A first sealing element is also provided between the protrusion and the second mating part.

5. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 1, characterized in that, The cavity also includes a water-cooled cavity surrounding the channel. A partition is provided inside the water-cooled cavity to divide it into an upper cavity and a lower cavity. The partition is provided with a perforation connecting the upper cavity and the lower cavity. The upper cavity is used to communicate with a cold water inlet, and the lower cavity is used to communicate with a water-cooled outlet.

6. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 1, characterized in that, The cover structure includes an end cap connected to the upper end of the cavity, a locking member, and a screw. The end cap is provided with a vent hole. The locking member is located inside the end cap and there is a third sealing member between it and the end cap. The screw is threadedly connected to the locking member so that the vent hole can communicate with or be isolated from the channel.

7. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 6, characterized in that, The end cap is provided with a connection port that connects the vent hole and the channel. The upper end of the connection port is provided with a tapered first mating surface, and the end of the screw is provided with a tapered second mating surface that matches the first mating surface.

8. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 1, characterized in that, The extrusion module also includes several fasteners, each including a fixing rod and a nut. The lower end of the fastener is threaded to the base, and the upper end of the fastener passes through the cover structure. The nut is configured such that rotating the nut causes the cover structure to apply downward pressure to the cavity and the base.

9. The high-efficiency high-pressure homogenizer nanostructured liposome extrusion module according to claim 1, characterized in that, The extrusion module also includes a back pressure regulating component, which includes a back pressure valve disposed at the discharge port for providing the extrusion module with a stable back pressure that can be independently adjusted.

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