| CPC A61K 9/1075 (2013.01) [A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01)] | 1 Claim |
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1. A method for producing an andrographolide carrier system for pharmaceutical composition, oral administration and other means, that allows for drug delivery of targeted- and controlled-release of andrographolide molecules, comprising:
(i) preparing a dispersed phase by dissolving andrographolide in ethanol in solvent in a mass ratio of andrographolide to ethanol of 6-10:8-12 by a stirrer at 300-500 rpm while heating to 40-60 degrees Celsius for 4-8 hours;
(ii) preparing an inner encapsulating carrier layer to protect active ingredient by heating liquid PEG (polyethylene glycol) to 60-80 degrees Celsius, with constant stirring for 15-30 minutes;
(iii) forming a protective encapsulating layer of the active agent by adding the inner encapsulating carrier layer to the dispersed phase, with further heating of the carrier-dispersed phase mixture to 40-60 degrees Celsius while stirring at 400-800 rpm for 30-60 minutes;
(iv) forming bonds to attach mucoadhesion enhancers onto the surface structure of the protective encapsulating layer by adding poly(acrylic acid) to the mixture in a mass ratio of 1-20:85-95, stirring at 400-800 rpm for 30-60 minutes to attach the poly (acrylic acid) onto the surface of the protective encapsulating layer, and then bringing the mixture to room temperature, slowly adding hydroxypropyl methylcellulose to the mixture in a mass ratio of 1-10:85-95, thereby increasing the expansion coefficient, adhesion force, and improving the release of adhesive poly(acrylic acid), and stirring vigorously the mixture until homogeneous;
(v) heating the mixture until the temperature reaches 50 degrees Celsius, adding Polysorbate 80 and PEG-40 hydrogenated castor oil in a mass ratio of 25-35:65-75, to the carrier-dispersed phase mixture obtained in step (iv) in a mass ratio of 40:60, with further stirring at 500-700 rpm under vacuum, wherein the reaction temperature is kept at 50-80 degrees Celsius for 1-2 hours, controlling the quality of the resulting product by water dissolution and transparency measurement, and then continue heating and measuring transparency every 30 minutes until transparency is observed to quench the reaction, then homogenizing the mixture by injection through a 30Mpa (300 bar) high pressure homogenizer;
(vi) filtering the product by injection through a nanofilter system before filling and packing, controlling quality of the resulting product by water dissolution and transparency measurement.
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