title: [Alcohol-purification technology and its particle sedimentation process in manufactory of Fufang Kushen injection].
abstract: OBJECTIVE
  Fufang Kushen injection was selected as the model drug, to optimize its alcohol-purification process and understand the characteristics of particle sedimentation process, and to investigate the feasibility of using process analytical technology (PAT) on traditional Chinese medicine (TCM) manufacturing.
  
  
  METHODS
  Total alkaloids (calculated by matrine, oxymatrine, sophoridine and oxysophoridine) and macrozamin were selected as quality evaluation markers to optimize the process of Fufang Kushen injection purification with alcohol. Process parameters of particulate formed in the alcohol-purification, such as the number, density and sedimentation velocity, were also determined to define the sedimentation time and well understand the process.
  
  
  RESULTS
  The purification process was optimized as that alcohol is added to the concentrated extract solution (drug material) to certain concentration for 2 times and deposited the alcohol-solution containing drug-material to sediment for some time, i.e. 60% alcohol deposited for 36 hours, filter and then 80% -90% alcohol deposited for 6 hours in turn. The content of total alkaloids was decreased a little during the depositing process. The average settling time of particles with the diameters of 10, 25 microm were 157.7, 25.2 h in the first alcohol-purified process, and 84.2, 13.5 h in the second alcohol-purified process, respectively.
  
  
  CONCLUSIONS
  The optimized alcohol-purification process remains the marker compositions better and compared with the initial process, it's time saving and much economy. The manufacturing quality of TCM-injection can be controlled by process. PAT pattern must be designed under the well understanding of process of TCM production.
authors.affiliation: Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Xiaoqian
authors.initials: X
authors.lastname: Liu
authors.forename: Yan
authors.initials: Y
authors.lastname: Tong
authors.forename: Jinyu
authors.initials: J
authors.lastname: Wang
authors.forename: Ruizhen
authors.initials: R
authors.lastname: Wang
authors.forename: Yanxia
authors.initials: Y
authors.lastname: Zhang
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Wang
mesh_terms: D000438:Alcohols / Q000302:isolation & purification*; D000470:Alkaloids / Q000032:analysis; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D007267:Injections; D013678:Technology, Pharmaceutical
chemical_list: D000438:Alcohols; D000470:Alkaloids; D004365:Drugs, Chinese Herbal; C494416:kushen