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Nucleic acid lipid nano particle composition, pharmaceutical preparation containing same, and preparation method and application thereof

A technology of lipid nanoparticles and pharmaceutical preparations, applied in the field of biomedicine, can solve problems such as single large-scale clinical application of nucleic acid drug administration routes

Pending Publication Date: 2021-05-28
SUZHOU CUREMED BIOMEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The development of nucleic acid drugs provides effective means for the prevention and treatment of various diseases (including infectious diseases, tumors, diabetes, cardiovascular diseases, single-gene genetic diseases, etc.), but due to the instability of nucleic acid drugs at room temperature and the Factors such as a single pathway limit large-scale clinical applications

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  • Nucleic acid lipid nano particle composition, pharmaceutical preparation containing same, and preparation method and application thereof
  • Nucleic acid lipid nano particle composition, pharmaceutical preparation containing same, and preparation method and application thereof
  • Nucleic acid lipid nano particle composition, pharmaceutical preparation containing same, and preparation method and application thereof

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preparation example Construction

[0080] The present invention also provides a preparation method of the pharmaceutical preparation described in the second aspect, comprising the following steps:

[0081] The nucleic acid drug is mixed with the lipid carrier to prepare the drug-loaded lipid nanoparticle, and then an auxiliary material is added to form a pharmaceutical preparation.

[0082] In some specific embodiments of the present invention, for the preparation of dry powder, the present invention provides the following steps:

[0083] The nucleic acid drug and the lipid carrier are mixed to prepare a drug-loaded lipid nanoparticle solution, and then the aqueous solution of auxiliary materials is added, and the nucleic acid lipid nanoparticle dry powder is formed by spray drying.

[0084] In some specific embodiments of the present invention, when the nucleic acid drug is mixed with the lipid carrier, the mixing method is selected from microfluidic method, mechanical stirring method, high-pressure emulsion h...

Embodiment 1

[0094] DOTAP, DSPC, cholesterol and PEG-DMG with a total mass of 24.4 mg were dissolved in 1 mL of ethanol in a molar ratio of 50:38.5:10:1.5; 1 mg of mRNA was dissolved in 3 mL of citrate buffer (50 mM, pH=4.0 ), rapidly mixed with the above-mentioned ethanol solution by microfluidic technology, and then dialyzed to remove ethanol to obtain an LNP solution loaded with mRNA. Dissolve 1 g of mannitol in 46 mL of water to obtain an aqueous solution of excipients. After fully dissolving with the LNP solution, it is sprayed out of a spray drying tower at normal temperature, and a two-fluid atomization device is used to form a dry powder of nucleic acid lipid nanoparticles. Among them, the inlet air temperature is 45°C, the liquid flow rate is 0.3L / h, and the compressed air pressure is 0.2Mpa. The D50 of the dry powder particle size of this group is 5 μm.

Embodiment 2

[0096] DOTAP, DSPC, cholesterol and PEG-DMG with a total mass of 24.4 mg were dissolved in 1 mL of ethanol in a molar ratio of 50:38.5:10:1.5; 1 mg of mRNA was dissolved in 3 mL of citrate buffer (50 mM, pH=4.0 ), rapidly mixed with the above-mentioned ethanol solution by microfluidic technology, and then dialyzed to remove ethanol to obtain an LNP solution loaded with mRNA. Dissolve 1g of mannitol and 1g of lecithin in 46mL of water to obtain an aqueous solution of excipients. After fully dissolving with the LNP solution, spray it out through a freezing spray tower, use a two-fluid atomization device, and freeze-dry to form nucleic acid lipid nanoparticle dry powder. Among them, the temperature in the tower is -40°C, the liquid flow rate is 1L / h, and the compressed air pressure is 1Mpa.

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Abstract

The invention belongs to the field of biological medicine, and particularly relates to a nucleic acid lipid nano particle composition, a pharmaceutical preparation containing the same, and a preparation method and application thereof. The nucleic acid lipid nano particle composition comprises drug-loaded lipid nano particles and auxiliary materials, the mass ratio of the drug-loaded lipid nano particles to the auxiliary materials is (0.1-10): (90-99.9), the drug-loaded lipid nano particles comprise nucleic acid drugs and lipid carriers, the mass ratio of the nucleic acid drugs to the lipid carriers is 1: (2-30), the composition is good in stability, the nucleic acid drugs are not degraded due to too high temperature, the composition can be stored and transported at normal temperature, can be administered in various ways, and are quick in effect taking and high in bio-availability, large-scale production can be realized, the yield is high, and the repeatability is good.

Description

Technical field [0001] The invention belongs to the field of biomedicine, and specifically relates to a nucleic acid lipid nanoparticle composition, a pharmaceutical preparation containing the same, and a preparation method and application thereof. Background technique [0002] Research on lipid nanoparticles (LNP) began in the 1990s, and refers to solid natural or synthetic lipids or lipids (such as lecithin, triacylglycerol, etc.) with a particle size of 50 to 1000 nm. It is a solid colloidal drug delivery system made of a matrix and the drug is wrapped or embedded in a lipid or lipid core. [0003] In recent years, great progress has been made in LNP preparation technology, preparation materials and surface modification. It has huge potential in applications in the fields of anti-cancer, overcoming biological barriers, loading biological drugs and vaccine preparation. Compared with traditional liposomes, LNP has the following advantages: (1) The physical stability is gre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/51A61K31/7088A61K47/24A61K47/36A61K47/42A61K47/26A61K47/18A61K47/28
CPCA61K9/5123A61K9/5146A61K9/5161A61K9/5169A61K9/5192A61K31/7088A61K9/007A61K9/0019
Inventor 孙振华黄珂李英文赵亮高银佳刘羽平
Owner SUZHOU CUREMED BIOMEDICAL TECH CO LTD
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