Study on preparation technology and quality standard of Kuijieling tablet

Objective: To study the prescription,preparation technology and quality standard of Kuijieling tablet.Methods: Single factor experiments were used to investigate the important factors affecting the process of tablet forming;the five herb medicine in this prescription were identified by thin layer chromatography(TLC) and atractylenolide Ⅰand atractylenolide Ⅲ were quantitatively determined by high performance liquid chromatography.Results: The formula for determining the core of Kuijieling was as follows:Disintegration agent was L-HPC and PVPP each 8%,the binder was 95% ethanol solution,and the lubricant was 0.25% magnesium stearate;spots in the TLC chromatogram for qualitative identification of the five herb medicine were clear and the resolution was high.AtractylenolideⅠshowed a good linear relationship in the range of 0.024 5-0.220 5 μg/mL and atractylenolide Ⅲ showed a good linear relationship in the range of 0.012 5-0.112 5 μg/mL.The results of the various examinations on Kuijieling colon specific tablets were all in line with the requirements of the Pharmacopoeia.Conclusions: The prescription process is scientific and reasonable.The established quality standard method is feasible.