Preparation And Pharmacokinetics Study Of Chaifu Granule

Objectives: To prepare the TCM compound of Chaifu Granule and to evaluate its pharmacokinetics.Methods: 14 Chinese herbs including Radix bupleuri, Spina gleditsiae, Rhizoma cyperi, Radix Curcumae, Radix paeoniae rubra, Scorpio, Radix angelicae sinensis, Radix scrophulariae, Pseudobulbus cremastrae seu pleiones, Rhizoma bolbostemmae, Bombyx batryticatus, Radix ranunculi ternati, Spica prunellae and Fructus citrus reticula were chosen to prepare Chaifu Granule for treatment of galactophore hyperplasia and chronic inflammatory mass. Active components of above herbs were extracted by different methods according to their physical and chemical characteristics. Essential oil of Radix bupleuri, Rhizoma cyperi, Radix angelicae sinensis, Radix Curcumae, Fructus citrus reticula were extracted by supercritical carbon dioxide extraction and then mixed byβ-cyclodextrin inclusion optimized by orthogonal test. Water extraction of Radix paeoniae rubra, Spica prunellae, Radix ranunculi ternati, Pseudobulbus cremastrae seu pleiones, Radix scrophulariae and Rhizoma bolbostemmae with extracting rate of Paeoniflorin and Ursolicacid as separating index were defecated by chitosan and extracting conditions were optimized by uniform experiment design. Active components of Bombyx batryticatus and Scorpio were extracted by alcohol extraction and transferred to powder with water extraction described above by spraying drying. At last, the powder were mixed withβ-cyclodextrin inclused essential oil to prepare Chaifu Granule. Quality standards, stability, pharmacokinetics and toxicology of this preparation were evaluated at the same time.Conclusions: Preparation and quality control methods are proved to be feasible and stable and pharmacokinetics and toxicology study offer theory basis for clinical application.