PHARMACEUTICAL COMPOSITION THAT COMPRISES A SOLUTION OF SILYMARIN IN A DEEP EUTECTIC SOLVENT OF NATURAL ORIGIN, METHODS OF OBTAINING AND USE IN MEDICINE
ES2861593
The invention falls within the field of Organic Chemistry and has its fundamental application in the pharmaceutical sector. It deals specifically with a deep eutectic solvent of natural origin (NADES, natural deep eutectic solvent) and the dissolution of milk thistle extract from the plant known as Silybum marianum in said NADES or other similar ones consisting mainly of glycerol, thus forming a composition ingestible pharmaceutical as obtained and presented. The synthesis of said solution takes place in a continuous method, which includes preparing NADES by mixing glycerol heated to a temperature below 65°C with a certain amount of water and arginine, under stirring. Once the NADES is obtained, it is mixed progressively and continuously with the milk thistle extract, stirring the complex until the complete dissolution of said extract in the NADES is achieved. This method allows the obtainable solution to be completely soluble in water and, therefore, its bioavailability and absorption inside organisms is guaranteed.

The technique presented in this document is based on the elaboration of a natural composition, without additives or emulsifiers, from the use of deep eutectic solvents of natural origin (NADES) based on glycerol, a natural and innocuous substance that can be ingested safely. quantum satis, usually marketed in its bidistilled form and, obviously (due to its application) food grade. Silymarin is a more or less standardized extract of milk thistle seeds, which contains a mixture of flavonolignans, thus including silibinin (silibin), isosilibinin, silicristin and silidianin, among other constituents (see definition in the Description of the invention section, which by reference is also integrated here as a definition of the invention), which act as active agents also independently of each other. Thus, this pharmaceutical composition, as described herein, can be prepared starting from the complete silymarin extract as a bioactive agent, as it is found and marketed, or using one or more of its molecules or active components as said active agent, as is the case silybin preferred. As for the deep eutectic solvent of natural origin, it preferably contains glycerin in an amount comprised between 75%-85% by weight of the total composition of NADES. Also preferably, the NADES comprises water, which improves its solvent properties. It should be noted that in this NADES, glycerol acts clearly as HBD, since it is the type of molecular relationship that it establishes with the other components (as we have said, arginine is a very rare exception in which both, glycerol and arginine, act doubly as HBD). HBD and HBQ). Therefore, this NADES also includes an additional compound that is a naturally occurring HBA, preferably an amino acid, which is more preferably selected from the group consisting of: arginine, betaine, choline chloride and citric acid.
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