复方紫归油的制备及质量控制  

Preparation and Quality Control of Compound Zigui Oil

作　　者：王琪[1] 马妍妍[1] 刘世萍[1] 

机构地区：[1]哈尔滨医科大学附属第一医院药学部,黑龙江哈尔滨150001

出　　处：《中国药业》2013年第13期34-35,共2页China Pharmaceuticals

摘　　要：目的制备复方紫归油并建立其质量控制方法。方法以大豆油为提取溶剂制备样品,采用薄层色谱法定性鉴别方中主药紫草和当归;对细菌、霉菌及酵母菌数计数方法及控制菌检查方法进行验证;同时建立其他相关质量控制指标。结果质量控制指标系统全面,薄层斑点清晰,重复性好。结论处方及制备工艺合理可行。质量控制方法可靠、全面,可用于本品的质量控制。Objective To prepare Compound Zigui Oil and to establish its quality control method.Methods Compound Zigui Oil was prepared with soybean oil as the extraction solvent.The counting methods of bacteria,fungi and yeast,and the control bacteria test were performed the verification.Arnebiae Radix and Angelicae Sinensis Radix in the prepration were identified by thin layer chromatography（TLC）,and the other quality control indexes were established.Results The quality control indexes were systematic and comprehensive.The obtained TLC spots were clear with good reproducibility.Conclusion The prescription and the preparation technology are rationa1 and feasible.The quality control method is reliable and comprehensive,and can be used for the quality controlof this product.

关 键 词：复方紫归油 质量控制 薄层色谱法 微生物限度 紫草 当归 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]