栓塞通胶囊的制备及其质量标准研究  

Preparation and Quality Control of Shuansaitong Capsules

作　　者：郭文萍[1] 林新[1] 

机构地区：[1]河南三门峡市中心医院药剂科,三门峡市472000

出　　处：《中国药房》2008年第36期2825-2827,共3页China Pharmacy

摘　　要：目的:制备栓塞通胶囊并建立其质量标准。方法:采用蒸馏法提取含挥发油的药材,采用水煎煮法提取其它药材,加入适量辅料制备栓塞通胶囊;用薄层色谱(TLC)法对川芎、西洋参、丹参、当归作定性鉴别,用高效液相色谱法测定天麻素含量。结果:栓塞通胶囊符合《中国药典》对胶囊剂的质量要求;TLC鉴别斑点清晰,分离好,专属性强,阴性无干扰;天麻素进样量在0.1～0.5μg范围内与其峰面积积分值呈良好的线性关系(r=0.9995),平均回收率为96.59%,RSD=0.47%(n=6)。结论:该制备工艺简单,含量测定方法准确,可用于栓塞通胶囊的制备及其质量控制。OBJECTIVE： To prepare Shuansaitong capsules Distillation method was applied to extract volatile oil from volatile and establish a method for its quality control.METHODS： 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.

关 键 词：栓塞通胶囊 制备 薄层色谱法 高效液相色谱法 质量控制 

分 类 号：R283.65[医药卫生—中药学] R927.11[医药卫生—中医学]