海生素冻干粉的质量控制及HPLC指纹图谱研究  

HPLC fingerprint and quality control of Haishengsu lyophilized powder isolated from Tegillarca granosa

作　　者：韩志武[1] 初晓[2] 郭申波[3] 刘秀荣 杨秀 厉云 陈守国 王春波[3] 

机构地区：[1]青岛大学医学院附属医院,山东青岛266003 [2]青岛市市立医院,山东青岛266011 [3]青岛大学医学院药理教研室,山东青岛266021 [4]青岛海生肿瘤医院,山东青岛266071

出　　处：《中国海洋药物》2005年第2期42-46,共5页Chinese Journal of Marine Drugs

基　　金：青岛市科技局科技三项经费项目(99青科技字028号)

摘　　要：目的建立海生素冻干粉的质量控制方法及其高效液相指纹图谱。方法用茚三酮反应和双缩脲反应对海生素冻干粉进行鉴别;用氮测定法测定海生素冻干粉中的氮含量,并用高效液相色谱法建立海生素冻干粉的高效液相指纹图谱。结果茚三酮反应和双缩脲反应呈阳性,海生素冻干粉中氮含量不低于6.0%,且各批次间样品的指纹图谱一致,冻干粉质量稳定。结论建立的方法分析快速、准确,可用于该制剂的质量控制。Objective To establish the quality control methods and HPLC fingerprint for Haishengsu lyophilized powder, a kind of extractions from Tegillarca granosa.Methods Biuret and Ninhydrin reactions were used for identification of the Haishengsu lyophilized powder. Nitrogen content in the Haishengsu lyophilized powder was determined by N 2 method (semi-trace method).HPLC was used to establish the fingerprint. Results The results of the biuret reaction and ninhydrin reaction were positive.Nitrogen content in the Haishengsu lyophilized powder was not less than 6.0%. And different batches of the Haishengsu lyophilized powder have the same dactylogram diagrams.Conclusion The method is convenient and accurate and suitable for the quality control of the Haishengsu lyophilized powder.

关 键 词：海生素冻干粉 高效液相色谱法 质量控制 指纹图谱 

分 类 号：R979.5[医药卫生—药品]