本文關鍵詞： 塞克硝唑 有關物質 電位滴定法 質量標準　出處：《中國藥房》2015年09期 　論文類型：期刊論文

【摘要】：目的:建立塞克硝唑的質量標準。方法:分別采用理化鑒別法、紫外光譜和紅外光譜對塞克硝唑進行鑒別;采用氣相色譜法(GC)、高效液相色譜法(HPLC)對殘留溶劑、有關物質等進行檢查;采用非水滴定法測定塞克硝唑的含量。結果:塞克硝唑理化鑒別的專屬性強,紫外光譜和紅外光譜鑒別方法均可行;按外標法以峰面積計算未檢測到殘留溶劑;以Agilent C18為色譜柱,甲醇-水(20∶80,V/V)為流動相,主峰能與相鄰雜質峰很好地分離;非水滴定法測得每1 ml的高氯酸滴定液(0.1 mol/L)相當于18.52mg的塞克硝唑(C7H11N3O3)。結論:本方法統(tǒng)一了塞克硝唑的性狀、鑒別、檢查與含量測定方法,可為其質量標準的修訂提供參考。
[Abstract]:Objective: to establish the quality standard of Seek nitrazole. Methods: physical and chemical identification, UV spectrum and infrared spectrum were used to identify Seek nidazole. The residual solvents and related substances were detected by gas chromatography (GC) and high performance liquid chromatography (HPLC). The content of Seek nitrazole was determined by non-aqueous titration. Results: Seek nitrazole had strong specificity in physical and chemical identification and could be identified by UV and IR spectra. No residual solvent was detected according to the peak area calculated by external standard method. Using Agilent C18 as chromatographic column and methanol-water 20: 80 V / V) as mobile phase, the main peak can be well separated from the adjacent impurity peak. The titration of perchloric acid per 1 ml is equal to 18.52 mg of Seek niazolium C _ 7H _ 11N _ 3O _ 3) by non-aqueous titration. Conclusion: this method unifies the character of Seek nitrazole. The methods of identification, inspection and content determination can provide reference for the revision of its quality standard.
【作者單位】： 湖南省腫瘤醫(yī)院;長沙市第一醫(yī)院;湖南省食品藥品檢驗院;湖南師范大學醫(yī)學院藥學系;
【分類號】：R927;O657
【正文快照】： 塞克硝唑(Secnidazole)化學名是1-(2-羥基丙基)-2-甲基-5-硝基咪唑,具有抗多種厭氧菌和原蟲的作用,特別是溶解宿主組織內阿米巴病、賈第鞭毛蟲等[1-2]。該藥由羅納普朗克樂安(Rhone-Poulenc Rorer)公司研制,于1980年在瑞士上市。我國塞克硝唑的現(xiàn)有質量標準為國家食品藥品監(jiān)督，

本文編號：1461807