The Righting Shengbai Particle Preparation Process And Quality Standards

Fuzheng Shenbai granules consist of Radix astragali. Radix codonopsis. Fructus schisandrae chinensis . Fructus psoraleae, Rhizoma atractylodis macrocephalae, Radix ophiopogonis. Radix Angelicae sisensis. Poria. Flos lonicerae.It has a good effect treating leucocyte decrease what chemotherapy leads to according to clinical experimentation for many years . The TCM formula is better combining the theory of TCM and the modern research and clinical experience into one.On the premise of reliable effect in clinic ,it's pharmacy was systematically studied so that setting up the foundation of the preparation standardization and the new medicine's report to higher body.The first in this study,extrative condition were researched by orthogonl design and the best preparation process were determined. In quality standards studies,the study on TLC identification method for Flos lonicerae. Fructus schisandrae chinensis . Radix ophiopogonis , Radix astragali was carried out.Then we established the content determination method of astragaloside. Determination the content of astragaloside and the content-limited by HPLC.We also studied the preliminary stability about three types of Fuzhengshenbai granules by room temperature and acceleration tests(40℃,75%).The result of experiment is below:The optimal preparation procedure : extraction time of Flos lonicerae . Fructus psoraleae. Radix Angelicae sisensis . Fructus schisandrae chinensis . Rhizoma atractylodis macrocephalae of prescription is 8 hours . Essential oil applies to the technology of β-cyclodextrin. Physic liquor after extraction concentrates to 0.5g/ml corresponding to the primitive medical material, then add 60% alcohol to make it sediment and rest 12 hours. The rest of prescription adopts imbitition to decocte 3 times and 12 time water every time for 2 hours.The experimental results have shown that the TLC spots of Flos lonicerae, Fructus schisandrae chinensis. Radix ophiopogonis. Radix astragali are very clear in the prepartion.and had repeatability.The content astragaloside is not lower than 41.6 μ g'g-1.the stabilities, sensitives, recoveries accord to the demands of qualitative analyses.These method can be used as a quality content method.The preliminary stability result has indicated that characters , indentification , test , content determination unchanged in six months.It showes that the quality of Fuzhengshenbai granules is stabilized.