title: Studies on the stability of salvianolic acid B as potential drug material.
abstract: BACKGROUND
  Salvianolic acid B (Sal B) is one of the major water-soluble compounds isolated from the roots of Salvia miltiorrhiza, which is widely used as a traditional Chinese medicine. Although much research on the general stability of Sal B has been undertaken and reported, there is still a need for further study of the stability required as a potential drug material.
  
  
  OBJECTIVE
  To study the stability of Sal B in the solid state and in normal saline (NS) solution during storage, as required in the ICH guidelines (2003) and Chinese Pharmacopoeia (2005).
  
  
  METHODS
  Sal B stability was analysed using the high-performance liquid chromatography (HPLC) method described in the Chinese Pharmacopoeia. HPLC coupled with time-of-flight mass spectrometry (HPLC-TOFMS) was applied for the separation and identification of the degradation products of Sal B.
  
  
  RESULTS
  In the solid state, Sal B packaged in aluminium foil bags was stable for 6 months under 'accelerated conditions' (40°C, 75% relative humidity, RH). However, solid Sal B degradation was observed under open exposure to stress conditions of high temperature (60°C) or high humidity (92.5 or 75% RH). In NS solution, Sal B underwent severe degradation under accelerated conditions. Through HPLC-TOFMS, nine degradation products were identified and the possible degradation pathway was deduced.
  
  
  CONCLUSIONS
  The results demonstrate that the potential drug material Sal B could be used in a solid formulation, but is not suitable for use as a liquid formulation.
authors.affiliation: School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang, 110016, China.
authors.forename: Li-Na
authors.initials: LN
authors.lastname: Zhou
authors.forename: Xin
authors.initials: X
authors.lastname: Zhang
authors.forename: Wei-Zhuo
authors.initials: WZ
authors.lastname: Xu
authors.forename: Xiao-Nan
authors.initials: XN
authors.lastname: Ma
authors.forename: Zhen
authors.initials: Z
authors.lastname: Jia
authors.forename: Ya-Ming
authors.initials: YM
authors.lastname: Zheng
authors.forename: Song
authors.initials: S
authors.lastname: You
mesh_terms: D001572:Benzofurans / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D006207:Half-Life; D006813:Humidity; D008027:Light; D013058:Mass Spectrometry / Q000379:methods; D018517:Plant Roots / Q000737:chemistry*; D027561:Salvia miltiorrhiza / Q000737:chemistry*; D013696:Temperature; D053630:Depsides
chemical_list: D001572:Benzofurans; D004365:Drugs, Chinese Herbal; C076944:salvianolic acid B; D053630:Depsides