Abstract

The particle size and distribution have a significant impact on the bioavailability and stability of insoluble drugs. A scale-up microreactor system based on an ellipsoidal baffle mixer was proposed for the preparation and tuning of insoluble drug. As an important bioactive substance, apigenin was used as a representative of insoluble drugs and was subject to particle size regulation by this system. The effects of surfactant, flow rate ratio, flow rate and solvent concentration on apigenin particle size were studied by solvent/anti-solvent method experiments and the transport process of apigenin molecules in the microreactor was simulated numerically by computational fluid dynamics (CFD). Furthermore, the particle size regulation model of apigenin in the system was built by using the π theorem of fluid mechanics. Finally, under the conditions of optimal parameters, the minimum particle size of nano apigenin (D50) was 116 nm, the recovery was 95.3 % and the purity was increased by 0.88 %. This study demonstrates the feasibility of a highly efficient, high-throughput, particle size controllable preparation of nanomedicine.

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