| Siwutang Prescription Granule, originated from the Traditional Chinese Medicine (TCM) formula Siwutang which is a primary formula for harmonizing nutrient Qi and defensive Qi and nourishing Qi and Blood in TCM, is a new concentrated granule for prescription according to the requirements in clinic, and is extracted and purified using modern techniques meeting the needs of the treatment based on differentiation and symptomatologic formulation. The nature, taste, channel tropism and actions keep consistent with the original formula Siwutang. This new formula gives attention to both symptomatologic modification of the formula and decocting compound prescription. In this project, we took a comprehensive, thorough and systemic research on preparing procedure, quality criteria, stability, main validating experiments of pharmacodynamics and safety value of Siwutang Prescription Granule in order to establish the quality criteria with standardization and supply the exemplification of preparing the concentrated prescription granules of TCM.Based on the principles of treatment based on differentiation, symptomatologic formulation and compound prescription decocting, we optimized the preparing procedure of Siwutang Prescription Granule, and established the quality criteria including the description and identification (TLC with standards of paeoniflorin, Radix Angelicae Sinensis, Ligusticum chuanxiong Hort. and Radix Rehmanniae Preparata.), tests (granularity, moisture content, dissolution, weight variation, determination of heavy metals, lead, cadmium, Arsenic arsenic, mercury and copper, pesticide residue and microbial limit), assay (paeoniflorin is not less than 6. 354 mg/g). We also did the stability research of the prescription granule. Main pharmacodynamical experiments were done to compare the prescription granule and standard decoction of Siwutang, of which the models are experimental Blood deficiency due to hemorrhage, Blood deficiency due to hemolysis, exhaustive swim exercise and dysmenorrhea with the indexes which are the embodiments of actions... |