The Preparation Process And Study On Quality Standard Of Fufangzhuyu Granules

Objectives To study the combination of TCM and the extraction process of stasis granule, preparation technology and quality standardMethod 14 Chinese herbs including Cyperi rhizoma, Curcumae rhizoma, Spayganii rhizoma, Carthanmi flos and paeoniae radix rubra were chosen to prepare Fufangzhuyu Granule for the treatment of blood stasis symptom of disease of department of gynaecology, such as chronic adnexitis, dysmenorrhea, menstrual disorder disease. The prescription of the medicine has carried on the classification of different extraction methods according to the prescription of Chinese herbal medicine ingredients contained the physical and chemical properties and the related active ingredients of pharmacological effects. Essential oil of Cyperirhizoma, Curcumaerhizoma, Spayganiirhizoma, Angelicae sinensis radix, Chuan xiong rhizoma were extracted by supercritical carbon dioxide extraction and then mixed by the β-cyclodextrin inclusion technique with star designed to screen the best closure process.Water extraction of left after supercritical extraction liquid and residual medicine safflower and Carthanmi flos, paeoniae radix rubra, persicae semen, Linderae radix, with extracting rate of A hydroxy safflower yellowpigment were choesn water decoction extraction process optimization. Chitosan flocculating agent were used to purify water extraction liquid with the purification process by orthogonal design optimization. Then processed filtrate was condensed into a paste and choice of different materials and paste were mixed by selecting the best materials and the ratio of excipients to improve stability and hygroscopicity good particles.At last, the study of granules on the relevant quality standards is to determine the stability of the preparation.Conclusion Extraction process and the preparation process is simple and reasonable and feasible for clinical use and production quality control to provide quality assurance, but also provide reference for the establishment of the dosage form quality standards.