OBJECTIVE: To optimize preparation process of Genistein solid dispersions. METHODS: With the cumulative dissolution for 45 min and the time of 50% dissolution (t1/2) as index, single factor test and orthogonal test were used to investigate the effects of drugs and carrier ratio (m/m), melting temperature, mixing time, surfactants and mesh sieve on preparation process, and validated.The content of genistein was determined by HPLC. Chromatographic conditions were as follows as Diamonsil C18 column, mobile phase consisted of methanol-0.05% phosphoric acid (70 ∶ 30), detection wavelength 262 nm, column temperature 30 ℃, sample size 10 μl. RESULTS: Optimal preparation process was as follows as drugs and carrier ratio of 1 ∶ 9, melting temperature 75 ℃, mixing time 10 min, mesh sieve 40, no active agent. t1/2 of 3 batches of samples prepared by optimized preparation technology were 23.32, 23.10 and 23.28 min, and cumulative dissolution of them were 91.90%, 89.63% and 90.08%, respectively. CONCLUSIONS: Optimized preparation process is reliable, and Genistein solid dispersion is prepared successfully.
关键词
染料木素固体分散体正交试验制备工艺
Keywords
GenisteinSolid dispersionOrthogonal testPreparation process