RESUMO
OBJECTIVE: To prepare coenzyme Q10-γ-cyclodextrin nano-crystal suspension using high pressure homogeneous combining freeze-drying method, optimize the preparation technology, and evaluate the quality of the product. METHODS: Encapsulation efficiency and mean particle size of inclusion complex were used as indicators, and response surface method was performed for optimizing preparation process and formulations. The stability and transdermal performance in vitro of the inclusion complexes were investigated. RESULTS: The optimal technical parameters were as follows; the mass ratio of γ-cyclodextrin and drug, 7.76:1; ultrasonic temperature, 40℃; ultrasonic time, 28.33 min; homogeneous pressure, 40 MPa. Under such conditons, an average encapsulation efficiency of 48.39% and average particle size of 324 nm were obtained for the nano-crystal suspension. The transdermal experiment in vitro showed that the infiltration rate of inclusion was 5.68 μg·cm-2·h-1. CONCLUSION: The preparation method is simple and feasible. The product quality is stable. Moreover, it is easy to manufacture.