Preparation and Quality Control of Shuansaitong Capsules / 中国药房

ABSTRACT

OBJECTIVE:To prepare Shuansaitong capsules and establish a method for its quality control.METHODS: Distillation method was applied to extract volatile oil from volatile oil-containing medical material and water decoction method was used to extract physic liquor from other medical material. Suitable quantity of excipients was added to prepare Shuansaitong capsules.Qualitative identifications of Ligusticum chuanxiong,Panax quinquefolium,Salvia miltiorrhiza,Angelica sisensis were performed by TLC,and the content of Gastrodin was determined by HPLC.RESULTS:The quality of Shuansaitong capsules was completely in conformity with the related requirements of China Pharmacopeia.The TLC spots were clear,well-separated,specific and free from interferonce of negative sample.The linear range of gastrodin was 0.1～0.5 ?g with a correlation coefficient of 0.999 5.The average recovery was 96.59% with RSD=0.47% (n=6).CONCLUSION:The preparation technology of Shuansaitong capsules is simple and the determination result was accurate,thus suitable for the preparation and quality control of Shuansaitong capsules.