External temperature control device for lipid nanoparticle preparation

Abstract

The utility model discloses an external temperature control device for lipid nanoparticle preparation, which comprises a cylindrical heat preservation cylinder, the heat preservation cylinder is formed by combining a first shell on the upper side and a second shell on the lower side, and pipe holes are formed in the corresponding side walls of the two sides of the heat preservation cylinder; the middle of the upper side of the first shell communicates with an air inlet pipe, the other end of the first shell is provided with a fan, and the output end of the fan is sequentially provided with a fan cavity and a heating cavity corresponding to the interior of the air inlet pipe. And air outlet holes are formed in the end sides of the first shell and the second shell. The heating and heat preservation device is used for heating and heat preservation of the feeding pipe or the discharging pipe, the temperature is controlled, the stability and consistency of ionizable cationic lipid, phospholipid, cholesterol and PEG lipid before and after being mixed with mRNA are improved, and the influence of the temperature on granulation is reduced.

Description

Technical Field

[0001] The utility model belongs to the technical field of biological preparation devices, in particular to an external temperature control device for preparing lipid nanoparticles. Background Art

[0002] In addition to inactivated antigens, a large portion of vaccine-type drugs is primarily mRNA. Through mRNA transcription in the human body, therapeutic target proteins are produced, thereby curing or preventing various diseases. The mRNA drug preparation process is generally as follows: E. coli is typically used as a carrier, which requires cultivation and then concentration through a hollow fiber column to obtain a high-concentration E. coli liquid. This is then fermented, alkaline lysed, and filtered to obtain a stock solution. The stock solution is then purified through a chromatography column to obtain a plasmid DNA template. The template is then enzymatically digested and transcribed in vitro to obtain mRNA, which is then processed through lipid nanoparticle (LNP) technology to finally produce the product.

[0003] LNP-mRNA is prepared by mixing ionizable cationic lipids, phospholipids, cholesterol, and PEG lipids with mRNA using microfluidic technology to form stable and efficiently delivered nanoparticles. During the LNP-mRNA preparation process, the pipeline is exposed to room temperature for a long time. However, studies have shown that the mixing process of lipid molecules and mRNA is sensitive to temperature, and temperature changes can affect the stability of the particles. Therefore, it is necessary to develop a device that can be placed externally on the preparation pipeline to insulate the pipeline and control the temperature conditions during the LNP-mRNA preparation process, thereby improving the stability and consistency of the particles. Utility Model Content

[0004] The purpose of the utility model is to provide an external temperature control device for lipid nanoparticle preparation, which is used to control the temperature conditions during the LNP-mRNA preparation process, thereby improving the stability and consistency of the particles.

[0005] In order to solve the above technical problems, the present invention is achieved through the following technical solutions:

[0006] An external temperature control device for preparing lipid nanoparticles, comprising a cylindrical heat-insulating cylinder, the heat-insulating cylinder being formed by combining an upper first shell and a lower second shell, the first shell and the second shell being openable, and having tube holes provided on corresponding side walls on both sides of the heat-insulating cylinder;

[0007] An air inlet pipe is connected to the middle portion of the upper side of the first shell, one end of the air inlet pipe is connected to the interior of the heat preservation tube, and the other end is provided with a fan, and a fan chamber and a heating chamber are sequentially provided in the air inlet pipe at the output end of the fan;

[0008] The first shell and the second shell are provided with air outlet holes at their end sides.

[0009] Furthermore, the first shell and the second shell are hingedly installed on the same side, the end side of the first shell has a hinge sleeve, and the corresponding end side of the second shell has a hinge shaft, so that the corresponding hinge sides of the first shell and the second shell are flipped open.

[0010] The first shell and the second shell have folding plates on their sides, which are used to improve the sealing performance by overlapping the folding plates after the first shell and the second shell are closed.

[0011] Furthermore, a winding roller is sleeved inside the heat-insulating cylinder, and the winding roller is a columnar structure with a spiral pipe groove opened on the side wall.

[0012] The end of the winding roller is provided with a roller shaft, the second shell is provided with a bracket for supporting the roller shaft, and the winding roller is detachably mounted on the bracket.

[0013] The utility model has the following beneficial effects: the device is installed at the front and rear ends of a lipid nanoparticle preparation device, wrapping the feed and discharge pipes to heat and insulate them, controlling the temperature to improve the stability and consistency of ionizable cationic lipids, phospholipids, cholesterol, and PEG lipids before and after mixing with mRNA, while reducing the impact of temperature on granulation. Specifically, air heating is performed through an insulation barrel. After the pipeline is introduced into the insulation barrel, the air inside the insulation barrel is heated, thereby heating the pipeline. This is suitable for use in relatively low room temperature environments. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions of the embodiments of the present utility model, the following briefly introduces the drawings required for describing the embodiments.

[0015] Figure 1 : Schematic diagram of the structure of the utility model in the closed state.

[0016] Figure 2 : Schematic diagram of the structure of the utility model in the open state.

[0017] Figure 3 : Schematic diagram of the structure of the utility model in the disassembled state.

[0018] In the accompanying drawings, the list of components represented by each number is as follows: first shell 1, second shell 2, pipe hole 21, air inlet pipe 3, fan 31, fan cavity 32, heating cavity 33, air outlet 22, hinged sleeve 10, hinged shaft 20, folding plate 23, winding roller 4, pipe groove 41, roller shaft 42, bracket 24. DETAILED DESCRIPTION

[0019] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0020] like Figure 1-2 : An external temperature control device for preparing lipid nanoparticles, comprising a cylindrical insulation cylinder, which is formed by merging a first shell 1 on the upper side and a second shell 2 on the lower side. The first shell 1 and the second shell 2 can be opened, and the corresponding side walls on both sides of the insulation cylinder are provided with tube holes 21; the first shell and the second shell both have inner grooves, which enclose the cylindrical inner cavity of the insulation cylinder, and the first shell and the second shell are arranged up and down, and semicircular notches are opened at the corresponding side tube hole positions. The corresponding notches of the upper and lower first shells and the second shells are merged to form a tube hole for the feed pipe or the discharge pipe of the lipid nanoparticle preparation equipment to enter the insulation cylinder, and the pipeline has a tube hole on one side to lead into the insulation cylinder and a tube hole on the other side to lead out.

[0021] An air intake pipe 3 is connected to the middle part of the upper side of the first shell 1. One end of the air intake pipe 3 is connected to the inside of the insulation tube, and the other end is provided with a fan 31. The output end of the fan 31 corresponds to the inside of the air intake pipe 3, and a fan cavity 32 and a heating cavity 33 are sequentially provided; the fan drives the blades in the fan cavity to drive the airflow to flow in one direction. After being heated in the heating cavity, the airflow is introduced into the inside of the insulation tube for heating the pipeline. A grid-shaped air intake slot is provided at the tail of the fan cavity.

[0022] Air outlet holes 22 are provided at the end sides of the first shell 1 and the second shell 2 .

[0023] This device is installed at the front and rear ends of the lipid nanoparticle preparation equipment, wrapping the feed and discharge pipes to heat and insulate them. This temperature control improves the stability and consistency of ionizable cationic lipids, phospholipids, cholesterol, and PEG lipids before and after mixing with mRNA, while reducing the impact of temperature on granulation. Specifically, air heating is performed through an insulation barrel. After the pipe is introduced into the insulation barrel, the air inside the barrel is heated, thereby heating the pipe. This is suitable for relatively low room temperature conditions.

[0024] like Figure 3 : The first shell 1 and the second shell 2 are hingedly installed on the same side. The end side of the first shell 1 has a hinge sleeve 10, and the corresponding end side of the second shell 2 has a hinge shaft 20, so that the corresponding hinged sides of the first shell 1 and the second shell 2 are flipped open.

[0025] The first shell 1 and the second shell 2 have folding plates 23 on their sides, which are used to improve the sealing performance by overlapping the folding plates 23 after the first shell 1 and the second shell 2 are closed.

[0026] The insulation cylinder is internally sleeved with a winding roller 4, which is a cylindrical structure with a spiral pipe groove 41 on its side wall. The pipe is wound around the winding roller to increase the length of the pipe in the insulation cylinder and improve the heating time.

[0027] The winding roller 4 has a roller shaft 42 at its end, and the second housing 2 has a bracket 24 that supports the roller shaft 42. The winding roller 4 is detachably mounted on the bracket 24. The winding roller can be removed, and the pipeline can be wound in the pipe groove, and then the entire assembly can be installed in the insulation cylinder, which improves the convenience of operation.

[0028] This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can better understand and utilize the present invention.

Claims

1. An external temperature control device for preparing lipid nanoparticles, characterized in that: The invention comprises a cylindrical heat-insulating cylinder, the heat-insulating cylinder being formed by combining an upper first shell (1) and a lower second shell (2), the first shell (1) and the second shell (2) being openable, and corresponding side walls on both sides of the heat-insulating cylinder being provided with tube holes (21); An air inlet pipe (3) is connected to the middle portion of the upper side of the first shell (1), one end of the air inlet pipe (3) is connected to the interior of the heat preservation tube, and the other end is provided with a fan (31), and a fan cavity (32) and a heating cavity (33) are sequentially provided inside the air inlet pipe (3) corresponding to the output end of the fan (31); and air outlet holes (22) are provided on the end sides of the first shell (1) and the second shell (2).

2. The external temperature control device for preparing lipid nanoparticles according to claim 1, characterized in that: The first shell (1) and the second shell (2) are hingedly mounted on the same corresponding side; the end side of the first shell (1) has a hinge sleeve (10), and the corresponding end side of the second shell (2) has a hinge shaft (20), so that the corresponding hinged sides of the first shell (1) and the second shell (2) can be flipped open.

3. The external temperature control device for preparing lipid nanoparticles according to claim 2, characterized in that: The first shell (1) and the second shell (2) have folding plates (23) on their sides, which are used to improve the sealing performance by overlapping the folding plates (23) after the first shell (1) and the second shell (2) are closed.

4. The external temperature control device for preparing lipid nanoparticles according to claim 1, characterized in that: A winding roller (4) is sleeved inside the heat-insulating cylinder. The winding roller (4) is a columnar structure, and a spiral pipe groove (41) is provided on the side wall.

5. The external temperature control device for preparing lipid nanoparticles according to claim 4, characterized in that: The end of the winding roller (4) has a roller shaft (42), the second shell (2) has a bracket (24) supporting the roller shaft (42), and the winding roller (4) is detachably mounted on the bracket (24).

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