Dual-channel temperature-controllable liposome extruder

Abstract

The utility model belongs to the field of extruders, and discloses a double-channel temperature-controllable liposome extruder. The device comprises a storage tank, the lower end of the storage tank is connected with a high-pressure pump through a discharging pipe, the high-pressure pump is connected with two extrusion units through pipelines, each extrusion unit comprises an extruder front section and an extruder rear section, a filter membrane is arranged between the extruder front section and the extruder rear section, a valve is arranged at an inlet of the extruder front section, and the valve is connected with the extruder front section. Through the parallel design of the double-channel extrusion units, the filter membrane can be replaced on line without shutdown, and the problem that a traditional liposome extruder needs to be shut down when the filter membrane is blocked is solved; the temperature and the pressure are accurately regulated and controlled, and the stirring paddle is used for mechanically stirring the liposome suspension, so that the liposome is always in a stable environment in the extrusion process, the quality stability and the particle size uniformity of the liposome are effectively guaranteed, and the problems in the aspects of temperature control precision, the stirring function of the storage tank and the like are solved.

Description

Technical Field

[0001] This utility model belongs to the field of extruder technology and relates to a dual-channel temperature-controlled liposome extruder. Background Technology

[0002] In the biomedical field, liposomes, as a highly promising drug delivery system, have shown broad application prospects in drug targeting and gene therapy. Liposomes can encapsulate drugs within themselves, forming vesicle structures similar to cell membranes. This effectively improves drug stability, prolongs drug circulation time in the body, enables targeted drug delivery, reduces toxic side effects on normal tissues, and enhances therapeutic efficacy.

[0003] Extrusion is a common method for preparing liposomes with uniform particle size. By applying a certain pressure, the liposome suspension is forced through a filter membrane with a specific pore size, thereby obtaining liposomes with a relatively uniform particle size distribution. However, traditional liposomes have the following problems.

[0004] During liposome extrusion, the presence of large particles or impurities in the liposome suspension, along with the aggregation of the liposomes themselves, can easily lead to membrane clogging. Once the membrane becomes clogged, the entire extrusion process must be stopped and the membrane replaced. This frequent downtime is particularly pronounced in large-scale liposome production, severely impacting production efficiency, causing significant delays, and consequently increasing both production and time costs.

[0005] The quality and stability of liposomes are extremely sensitive to temperature changes, and precise temperature control is crucial for the preparation of high-quality liposomes. However, traditional extruders struggle to achieve precise temperature control during the liposome extrusion process, resulting in significant temperature fluctuations. These temperature fluctuations can alter the physical and chemical properties of the liposome membrane, thereby affecting the liposome size and encapsulation efficiency. Liposomes of varying sizes will also exhibit different distributions and metabolic patterns in vivo, potentially failing to accurately reach the target tissue and reducing drug efficacy. Conversely, reduced encapsulation efficiency can lead to drug leakage, increasing drug toxicity and side effects, and compromising drug safety.

[0006] Furthermore, during the liposome extrusion process, a storage tank is used to hold the liposome suspension. Due to the lack of a stirring device, the liposome suspension is prone to aggregation in the storage tank, leading to uneven concentration. When the unevenly concentrated suspension enters the extruder, the quality of the extruded liposomes will be inconsistent, failing to meet the stringent requirements for high-quality drug production, such as liposome particle size and encapsulation efficiency, thus affecting the overall quality and efficacy of the drug formulation.

[0007] In summary, the problems of traditional liposome extruders, such as filter membrane clogging, temperature control accuracy, and mixing function of the storage tank, seriously limit the further development and application of liposomes in the biomedical field. Utility Model Content

[0008] The purpose of this invention is to provide a dual-channel temperature-controlled liposome extruder to address the shortcomings of the prior art.

[0009] This utility model is achieved by the following technical solution: A dual-channel temperature-controlled liposome extruder includes: a storage tank, the lower end of which is connected to a high-pressure pump via a discharge pipe, the high-pressure pump being connected to two extrusion units via pipes, each extrusion unit including a front section of the extruder and a rear section of the extruder, a filter membrane being provided between the front section of the extruder and the rear section of the extruder, and a valve being provided at the inlet of the front section of the extruder.

[0010] Furthermore, a temperature control jacket is provided on the outside of the storage tank, and the temperature control jacket is used to control the temperature of the storage tank.

[0011] Furthermore, a stirring motor is provided at the upper end of the storage tank, the output end of the stirring motor is connected to the stirring shaft, and multiple stirring paddles are fixedly connected to the lower end of the stirring shaft. The multiple stirring paddles and one end of the stirring shaft are fixedly installed inside the storage tank for stirring the liposome suspension in the storage tank.

[0012] Furthermore, a feed inlet is provided on one side of the stirring shaft, and the feed inlet is connected to the storage tank.

[0013] Furthermore, the lower end of the storage tank is connected to the ground via a support member, and the high-pressure pump is installed on the ground and located on one side of the storage tank.

[0014] Furthermore, the temperature control jacket is provided with an inlet and outlet, which supply the storage tank with hot and cold water from inside the temperature control jacket. A temperature sensor is provided at the inlet of the inlet and outlet.

[0015] Furthermore, a main valve is provided between the lower end of the storage tank and the discharge pipe, and a first quick-connect interface is provided between the main valve and the high-pressure pump, which detachably connects two adjacent discharge pipes.

[0016] Furthermore, a pressure gauge is installed between the valve and the front end of the extruder, and the pressure gauge is used to monitor the pressure of each extrusion unit.

[0017] Furthermore, the high-pressure pump is used to deliver the stirred liposome suspension to the extrusion unit at a constant pressure.

[0018] Furthermore, the filter membrane is a PC filter membrane.

[0019] Compared with the prior art, the present invention has the following beneficial technical effects:

[0020] This utility model discloses a dual-channel temperature-controlled liposome extruder. In the liposome production process, filter membrane clogging is a key issue restricting production efficiency and continuity. Traditional single-channel designs require machine shutdown for replacement once filter membrane clogging occurs, which seriously affects the production schedule. The parallel design of the dual-channel extrusion unit in this application enables online filter membrane replacement without stopping the machine, effectively avoiding downtime caused by filter membrane clogging, significantly reducing production interruption time, and making the production process smoother and more efficient.

[0021] This invention relates to a dual-channel temperature-controlled liposome extruder. The quality and performance of liposomes are extremely sensitive to temperature and pressure changes during extrusion; even minor fluctuations can lead to uneven liposome particle size, thus affecting the efficacy and safety of the drug. This application ensures that the liposomes remain in a stable environment throughout the extrusion process by precisely controlling temperature and pressure, effectively guaranteeing the quality stability and particle size uniformity of the liposomes.

[0022] This invention relates to a dual-channel temperature-controlled liposome extruder, in which a filter membrane is detachably installed between the front and rear sections of the extruder, reducing operational complexity, making maintenance more convenient, and reducing reliance on the professional skills of operators. Attached Figure Description

[0023] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the structure of a dual-channel temperature-controlled liposome extruder according to the present invention.

[0025] Figure label:

[0026] 1-Agitator motor; 2-Feed inlet; 3-Agitator shaft; 4-Storage tank; 5-Temperature control jacket; 6-Agitator paddle; 7-Temperature sensor; 8-Inlet / outlet; 9-Main valve; 10-Discharge pipe; 11-First quick connector; 12-High pressure pump; 13-Extruder front section; 14-Filter membrane; 15-Extruder rear section; 16-Pressure gauge; 17-Valve. Detailed Implementation

[0027] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of the present invention.

[0028] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this utility model are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the utility model described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, such as a process, method, system, product, or apparatus comprising a series of steps or units, are not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0029] The present invention will now be described in further detail with reference to the accompanying drawings:

[0030] Example 1

[0031] This utility model provides a dual-channel temperature-controlled liposome extruder, comprising: a storage tank 4, the lower end of which is connected to a high-pressure pump 12 via a discharge pipe 10, the high-pressure pump 12 being connected to two extrusion units via pipes, each extrusion unit including a front section 13 and a rear section 15 of the extruder, a filter membrane 14 being disposed between the front section 13 and the rear section 15 of the extruder, and a valve 17 being disposed at the inlet of the front section 13 of the extruder.

[0032] like Figure 1 As shown, the inlet end of the high-pressure pump 12 is connected to the discharge pipe 10, and the outlet end is connected to the pipeline. The high-pressure pump 12 is used to deliver the stirred liposome suspension to the extrusion unit at a constant pressure. The high-pressure pump 12 can be a plunger pump or a diaphragm pump. The corresponding flow rate and pressure are selected according to the actual production needs. In this embodiment, the high-pressure pump 12 is a high-performance plunger pump with a flow rate of 0-100 mL / min.

[0033] In this embodiment, there are two extrusion units. If there are three or four basic units, it is also within the protection range, but the minimum number is two. Each extrusion unit includes a valve 17, a pressure gauge 16, a front section 13 of the extruder, and a rear section 15 of the extruder connected in sequence. A filter membrane 14 is provided between the front section 13 of the extruder and the rear section 15 of the extruder. The outlet of the rear section 15 of the extruder is the extruder discharge port.

[0034] Each extrusion unit includes a filter membrane 14 and a pressure gauge 16, enabling rapid replacement and online monitoring of the filter membrane 14. The dual-path design allows two parallel pathways; while one pathway is operating, the other can be used for filter membrane 14 replacement or maintenance, ensuring the continuity of the extrusion process and significantly improving production efficiency. The filter membrane 14 is made of 50-200nm PC or other suitable materials for precise control of liposome particle size. The pressure gauge 16 monitors the pressure in each pathway, promptly detecting and responding to issues such as filter membrane clogging, facilitating timely intervention.

[0035] A stirring motor 1 is installed at the upper end of the storage tank 4. The output end of the stirring motor 1 is connected to the stirring shaft 3. One end of the stirring shaft 3 is installed inside the storage tank 4. Multiple stirring paddles 6 are installed at the lower end of the stirring shaft 3. This device ensures uniform concentration of suspension by mechanical stirring, prevents liposome particles from settling or aggregating, and ensures consistency of extruded raw materials.

[0036] A temperature control jacket 5 is installed on the outside of the storage tank 4, and an inlet / outlet 8 is installed on the outside of the temperature control jacket 5. The inlet / outlet 8 supplies hot and cold water to the storage tank 4 through the temperature control jacket 5 to control the temperature. A temperature sensor 7 is installed at the inlet of the inlet / outlet 8. The temperature sensor 7 achieves a temperature control accuracy of ±1℃, ensuring the temperature stability and uniformity of the liposome suspension before extrusion.

[0037] A main valve 9 is installed between the lower end of the storage tank 4 and the discharge pipe 10. A first quick-connect interface 11 is provided between the main valve 9 and the high-pressure pump 12. The first quick-connect interface 11 detachably connects two adjacent discharge pipes 10. The first quick-connect interface 11 makes the discharge unit more flexible. Different production needs may require discharge pipes 10 of different lengths or configurations. The first quick-connect interface 11 allows for easy combination and adjustment of the discharge pipes 10 to adapt to various production scenarios.

[0038] A feed inlet 2 is provided on one side of the stirring shaft 3, and the feed inlet 2 is connected to the storage tank 4. The stirring action of the stirring shaft 3 can immediately disperse and mix the incoming material. This uniform feeding method helps the material to quickly form a uniform liposome suspension in the storage tank 4, reducing local accumulation and precipitation, thereby improving the encapsulation rate of liposomes. Uniform encapsulation can ensure the effective encapsulation of drugs inside liposomes, improving drug stability and efficacy.

[0039] Working principle of a dual-channel temperature-controlled liposome extruder:

[0040] The liposome suspension is kept uniform and stable in the storage tank 4 by a temperature control jacket 5, a stirring shaft 3, and a stirring paddle 6. Then, a high-pressure pump 12 delivers the suspension to the extrusion unit at a constant pressure. The suspension passes through a dual-channel extrusion unit, where it forms liposomes with uniform particle size under the action of a filter membrane 14. If one filter membrane 14 malfunctions and needs replacement, the system can quickly switch to the other channel to continue operation, ensuring the continuity of the extrusion process and guaranteeing efficient liposome production.

[0041] This invention relates to a dual-path temperature-controlled liposome extruder, which can be flexibly adjusted and improved according to actual production needs. For example, an online particle size detection device can be added to monitor liposome particle size in real time, further optimizing the production process; the filter membrane 14 material can be optimized to improve its filtration performance and service life; and a high-pressure pump with a wider flow range can be selected to meet the needs of liposome production at different scales. This invention is applicable to the preparation of various liposomes, including traditional liposomes, targeted liposomes, and pH-sensitive liposomes, and has broad application prospects. It can be widely used in liposome drug research and development, production, and other fields, providing the biopharmaceutical industry with an efficient, precise, and reliable liposome extrusion device.

[0042] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of this utility model and not to limit it. Although the utility model has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of this utility model. Any modifications or equivalent substitutions that do not depart from the spirit and scope of this utility model should be covered within the protection scope of the claims of this utility model.

Claims

1. A dual-channel temperature-controlled liposome extruder, characterized in that: The system includes a storage tank (4), the lower end of which is connected to a high-pressure pump (12) via a discharge pipe (10). The high-pressure pump (12) is connected to two extrusion units via pipes. Each extrusion unit includes a front section (13) of an extruder and a rear section (15) of an extruder. A filter membrane (14) is provided between the front section (13) of the extruder and the rear section (15) of the extruder. A valve (17) is provided at the inlet of the front section (13) of the extruder.

2. The dual-channel temperature-controlled liposome extruder according to claim 1, characterized in that: A temperature control jacket (5) is provided on the outside of the storage tank (4), and the temperature control jacket (5) is used to control the temperature of the storage tank (4).

3. The dual-channel temperature-controlled liposome extruder according to claim 1, characterized in that: The upper end of the storage tank (4) is equipped with a stirring motor (1), the output end of the stirring motor (1) is connected to the stirring shaft (3), and the lower end of the stirring shaft (3) is fixedly connected with multiple stirring paddles (6). The multiple stirring paddles (6) and one end of the stirring shaft (3) are fixedly installed in the storage tank (4) for stirring the liposome suspension in the storage tank (4).

4. The dual-channel temperature-controlled liposome extruder according to claim 3, characterized in that: A feed inlet (2) is provided on one side of the stirring shaft (3), and the feed inlet (2) is connected to the storage tank (4).

5. The dual-channel temperature-controlled liposome extruder according to claim 1, characterized in that: The lower end of the storage tank (4) is connected to the ground through a support member, and the high-pressure pump (12) is set on the ground and located on one side of the storage tank (4).

6. The dual-channel temperature-controlled liposome extruder according to claim 2, characterized in that: The temperature control jacket (5) is provided with an inlet and outlet (8) on the outside. The inlet and outlet (8) provides temperature control to the storage tank (4) through the hot and cold water in the temperature control jacket (5). A temperature sensor (7) is provided at the inlet of the inlet and outlet (8).

7. The dual-channel temperature-controlled liposome extruder according to claim 1, characterized in that: A main valve (9) is provided between the lower end of the storage tank (4) and the discharge pipe (10). A first quick connector (11) is provided between the main valve (9) and the high-pressure pump (12). The first quick connector (11) detachably connects two adjacent discharge pipes (10).

8. The dual-channel temperature-controlled liposome extruder according to claim 1, characterized in that: A pressure gauge (16) is provided between the valve (17) and the front section (13) of the extruder, and the pressure gauge (16) is used to monitor the pressure of each extrusion unit.

9. The dual-channel temperature-controlled liposome extruder according to claim 3, characterized in that: The high-pressure pump (12) is used to deliver the stirred liposome suspension to the extrusion unit at a constant pressure.

10. The dual-channel temperature-controlled liposome extruder according to claim 1, characterized in that: The filter membrane (14) is a PC filter membrane.

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