Process for preparing solid lipide nano particle

Abstract

The invention provides a preparation method of solid lipid nano-particles, including the following steps: dissolve lipid which is insoluble in water into organic solvent which is acceptable by peopleand is mutually soluble with water to get an oil- phase lipid solution with a concentration of 0.05 to 50mg / ml; mix the oil-phase liquid in a micro-channel with a water-phase liquid which is a surfactant solution with a concentration 0.1-10mg / ml soluble in water; control the flowing speeds of the oil-phase liquid and the water-phase liquid respectively at 0.1 to 1m / s and 0.01 to 0.5m / s and controlthe speed ratio at 1:5 to 30:1; collect the liquid at the outlet of the micro-channel when the liquid flows inside the micro-channel are stable. In this way, solid lipid nanoparticle suspension can be obtained. With simple process and less steps, the invention avoids high-temperature high-pressure operation and can be easily produced in large-scale production; the particle size of the SLN is small and can be controlled within certain range.

Description

(1) Technical field [0001] The invention relates to a method for preparing solid lipid nanoparticles (SLN), especially a method for forming a water phase and an oil phase by using a microchannel with an inner tube or a branch tube, and then allowing the two phases to contact for mass transfer And prepare the method that obtains solid lipid nanoparticle. (2) Background technology [0002] Solid lipid nanoparticles are a nanoscale drug-carrying system, which is prepared from natural or synthetic solid lipids with high melting point that are physiologically compatible and biodegradable. Compared with traditional drug delivery systems (microemulsions, liposomes and polymer nanoparticles), SLN has the advantages of good physiological compatibility, stability, targeting, and slow and controlled release, and is suitable for oral and intravenous injection. , percutaneous drug delivery, pulmonary drug delivery, eye drug delivery and other drug routes, so it has broad application pro...

AI Technical Summary

Problems solved by technology

The high-pressure milk homogenization method is divided into heat homogenization method and cold homogenization method. Both methods require high-pressure homogenization and the steps are complicated. The former cannot handle heat-sensitive and unstable drugs, and the SLN obtained by the latter has a large particle size and a wide distribution range. The particle size of SLN is 200-1000nm; although the microemulsion method has simple preparation equipment and low energy consumption, the solid content of the obtained dispersion is low due to the microemulsion dilution and dispersion process, and a large amount of emulsifier and auxiliary emulsifier are required

There are also some other preparation methods, but there are obvious defects, such as the low concentration of the SLN dispersion obtained by the solvent emulsification diffusion method, which needs to be concentrated by means of ultrafiltration or freeze-drying; the ultrasonic dispersion method is easy to cause metal contamination, and is prone to micron grade particles; the solvent emulsification and evaporation method has the problem that the organic solvent is difficult to remove, which increases the toxicity of the drug

Generally speaking, the above methods also have the problem that it is difficult to precisely control the lipid solidification and precipitation process.