Waveform microstructure mixing unit and application thereof

A hybrid unit and microstructure technology, applied in the field of microfluidics, can solve problems such as performance limitations, limited clinical translation and large-scale applications, and difficulty in scaling, and achieves the promotion of convective transport, diversification of applicable scenarios, and simple geometry. design effect

Pending Publication Date: 2022-05-27
SHANGHAI VITALGEN BIOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although SHMs are widely used in research laboratories, these mixers are difficult to process and have limited performance
SHM design is difficult to scale up and scale up, so it is limited in clinical translation and large-scale application

Method used

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  • Waveform microstructure mixing unit and application thereof
  • Waveform microstructure mixing unit and application thereof
  • Waveform microstructure mixing unit and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0204] Preparation of LNP samples;

[0205] In order to test the effect of the microfluidic chip of the present invention, various flow paths described in Table 1 were used to mix and prepare LNP samples. Specifically, by mixing the water phase (anionic long-chain natural polymer molecule in citric acid buffer solution, the molecular structure is similar to mRNA, the molecular weight is 15000Da, hereinafter referred to as "mRNA-like") and ethanol phase (lipid mixed solution ) were mixed at different flow rates in a 3:1 volume ratio to prepare LNP samples.

[0206] For the ethanol phase, SM-102 (8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-octanoic acid was prepared according to the concentrations shown in Table 2, respectively, 1-octyl nonyl ester), DSPC (distearoyl phosphatidyl choline), Cholesterol (cholesterol), DMG-PEG (distearoyl phosphatidyl ethanolamine-polyethylene glycol) ethanol stock solution, and a certain volume ratio The ratio is mixed to obtain the l...

Embodiment 1

[0214] Example 1. Comparison of Structural Mixing Units of Different Shapes

[0215] In this example, the mixing units numbered Y1, T1, S1, S2, and D-B1 in Table 1 were used to prepare the microfluidic chip. Y1 as Figure 8 shown, T1 as Figure 7 shown, S1 as Image 6 shown. The Lc of S2 and S1 is half of the Lc of S1, and other parameters are the same. D-B1 as Figure 5 shown in B.

[0216] In these five mixing units, the straight flow path in the inlet part of T1 is perpendicular to the straight flow path in the confluence part, while the other four are at a certain angle. In addition, Y1, T1, S1, and S2 use conventional rectangular cross-sections in the prior art, while D-B1 is the double-layer waveform mixing unit of the present invention.

[0217] The test method is as above " Preparation of LNPs Different flow rates were tried. Specifically, total flow rates of 1mL / min and 6mL / min were tried for all five mixing units. An additional 4mL was also tried for the onl...

Embodiment 2

[0224] Example 2. Scale-up of microstructured hybrid cells

[0225] In this embodiment, the hybrid cells numbered Y2, S3 and D-B4 in Table 1 are used as chips. These three chips are made by 200% proportional enlargement of the dimensions of Y1, S1 and D-B2 respectively. Proportional enlargement means that the length, width and height are all enlarged in the stated proportions. The angle between the entrance part and the confluence part of these three chips is the same. The difference is that Y2 is a straight line in the mixing part, S3 is a single-layer waveform mixing unit, and D-B4 is a double-layer waveform mixing unit.

[0226] The test method is as above " Preparation of LNPs ”. Different flow rates were tried. Specifically, 6 total flow rates were tried for each of the 3 mixing units: 1, 6, 12, 20, 24, 30 mL / min; also for both waveform mixing units 4 mL / min, which works well in Example 1. The statistical results of PDI, volume particle size and PDI of self-assembled ...

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Abstract

The invention relates to a waveform microstructure mixing unit. The invention also relates to a microfluidic device having such a unit, and to the use of said unit or device for the preparation of nanoparticles, such as lipid nanoparticles or self-assembled particles.

Description

technical field [0001] The invention relates to the field of microfluidics, in particular to a multi-layer waveform microstructure mixing unit and a mixing device having the mixing unit. The invention also relates to the use of the mixing unit and mixing device in the preparation of nanoparticles, such as lipid nanoparticles loaded with nucleic acid molecules. The mixing unit and mixing device of the present invention are particularly suitable for the preparation of self-assembly of lipid nanoparticles for use as medicines. Background technique [0002] Microfluidic technology has been applied to the preparation of nano-sized delivery vehicles, especially drug delivery vehicles, such as LNPs, polymer nanoparticles, liposomes, etc. [0003] Lipid nanoparticles (LNPs) are nanoparticles formed using lipids. At present, the technology of encapsulating nucleic acid such as mRNA with lipid nanoparticles has been used in the preparation of nucleic acid drugs and gene therapy. As...

Claims

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Application Information

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IPC IPC(8): B01J19/00B01L3/00A61J3/00
CPCB01J19/0093B01J19/0053B01L3/5027A61J3/00
Inventor 朱晰侯晨曦赵小平
Owner SHANGHAI VITALGEN BIOPHARMA CO LTD
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