title: [Using parallel line assay method based on quantitative responses in methodology evaluation for determining lumbrokinase potency in Rongshuan capsules].
abstract: OBJECTIVE
  To develop an assay methodology for determination of lumbrukinase potency in Rongshuan capsules.
  
  
  METHODS
  The agarose-fibrin plate assay methodology for determination of Lumbrukinase potency in Rongshuan capsules was studied including durability, specificity, linearity range, product's handling method, accuracy , repetitiveness, solution stability, recovery and statistical method. The method of parallel line assay based on quantitative responses in statistical methods for biological assays was used in the statistics of potency assay.
  
  
  RESULTS
  The durability and specificity of assay accord with the requirement; The linearity range was 12.5 to approximately 400 U, the RSD of accuracy tests was 3.2%, the RSD of repetitiveness tests was 8.3%, the solution is stable under 4 degrees C for 72 hours, the recovery rate was 97.0% and the RSD of recovery assays was 16.5%.
  
  
  CONCLUSIONS
  The agar-fibrin plate assay is rapidly, feasible, simple, convenient and accurate way for determining the Lumbrukinase potency. The method of parallel line assay based on quantitative responses in statistical methods for biological assays can control the error of determination.
authors.affiliation: Department of Pharmacology Shanxi Institute for Drug Control, Taiynan 030001, China. peizhid@126.com
authors.forename: Peizhi
authors.initials: P
authors.lastname: Dong
authors.forename: Jinhua
authors.initials: J
authors.lastname: Piao
authors.forename: Aihua
authors.initials: A
authors.lastname: Dang
authors.forename: Tingting
authors.initials: T
authors.lastname: Wang
authors.forename: Hong
authors.initials: H
authors.lastname: Zhang
authors.forename: Zhiwei
authors.initials: Z
authors.lastname: Zhang
mesh_terms: D000818:Animals; D001681:Biological Assay / Q000379:methods*; D002214:Capsules / Q000032:analysis; D010450:Endopeptidases / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis*
chemical_list: D002214:Capsules; D004364:Pharmaceutical Preparations; D010450:Endopeptidases; C083421:lumbrokinase