Standardized plant extract, process for obtaining the same and uses thereof
The present invention refers to a process for obtaining a standardized extract having antinociceptive, anti-inflammatory and antipyretic properties, from at least one part of a plant of genus Aleurites . Furthermore, the present invention provides a pharmaceutical composition comprising an active ingredient of a pharmaceutically efficient quantity of standardized extract from at least one part of the plant of genus Aleurites . Finally, the present invention describes a method of treatment and use of the said extract, isolated or in a pharmaceutical composition, for the prevention, control or treatment of painful, inflammatory or febrile affections.
1. A method of obtaining a standardized extract of leaves of Aleurites moluccana , wherein the standardized extract is standardized to 2″-O-rhamnosylswertisin and wherein the standardized extract is obtained by the following steps:
(i) collecting, drying and subdividing leaves of Aleurites moluccana;
(ii) pre-extracting the leaves of step (i) with ethanol to provide a first extract;
(iii) extracting the first extract obtained in step (ii) with water and ethanol to provide a second extract;
(iv) filtering the second extract obtained in step (iii) to provide a third extract;
(v) concentrating the third extract obtained in step (iv) to provide a concentrated extract;
(vi) pasteurizing the concentrated extract at a temperature of approximately 95 degrees C. for approximately 3 minutes to provide a pasteurized extract; and
(vii) drying the pasteurized extract to provide a dried extract; wherein the dried extract is then qualitatively and quantitatively analyzed to determine the amount of 2″-O-rhamnosylswertisin by comparison with a marker, wherein the marker 2″-O-rhamnosylswertisin.
2. The method of claim 1 , wherein the leaves are collected in dry weather.
3. The method of claim 1 , wherein the pre-extracting step is performed by agitation at room temperature.
4. The method of claim 1 , wherein the ratio of water:ethanol in step (iii) is 2:8.
5. The method of claim 1 , wherein the ratio of water:ethanol in step (iii) is 3:7.
6. The method of claim 1 , wherein the ratio of water and ethanol:leaves of Aleurites moluccana in step (iii) is between approximately 1:1 and 20:1.
7. The method of claim 1 , wherein the ratio of water and ethanol:leaves of Aleurites moluccana in step (iii) is 10:1.
8. The method of claim 1 , wherein the concentrated extract obtained in step (v) contains approximately 20% to 50% of solids.
9. The method of claim 8 , wherein the drying step (vii) is performed by spray-drying, and wherein the spray-drying is performed in the presence of a drying adjuvant.
10. The method of claim 9 , wherein the drying adjuvant is selected from the group consisting of colloidal silicon dioxide, modified cassava starch, tricalcium phosphate, maltodextrin, cyclodextrins, microcrystalline cellulose, lactose or a combination thereof, and wherein the drying adjuvant is added in a proportion of approximately 10 to 40% in relation to the ratio of total solids in the concentrated extract.
11. The method of claim 1 , wherein the method optionally comprises a depigmentation step, step (viii), wherein the depigmentation is performed with active charcoal, adsorption resin or membrane ultrafiltration.
12. The method of claim 1 , wherein the ratio of water:ethanol in step (iii) is 4:6.
13. The method of claim 1 , wherein the ratio of water:ethanol in step (iii) 1:1.