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Bioequivalence Assessment of Two Simvastatin Tablets in Healthy Taiwanese Volunteers

【Update Date：2007-10-03】unit：

Isolation and Identification of a Sibutramine Analogue in a Healthy Food for Weight Loss

KUO-CHIH LAI1, YI-CHU LIU1, MU-CHANG TSENG1, YUN-LIAN LIN2 AND JER-HUEI LIN1*

1. Bureau of Food and Drug Analysis, Department of Health, Executive Yuan, 161-2, Kuen Yang St., Nangang, Taipei City 115, Taiwan, R.O.C.
2. National Research Institute of Chinese Medicine, 155-1, Sec. 2, Li Nung St., Beitou, Taipei City 112, Taiwan, R.O.C.

(Received: July 21, 2006; Accepted: October 10, 2006)

ABSTRACT

   A sibutramine analogue was detected and added illegally in known as the healthy food that can reduce weight.  The structure was determined as N-1-[1-(4-chlorophenyl) cyclobutyl]-3-methylbutyl-N-methylamine with the molecular formula C16H24NCl and molecular weight 265 Da.  The sample was desalted and extracted with water, further purified by a liquid-liquid partition method.  The structure was identified with a series of 1-D and 2-D NMR techniques, IR and FAB mass.  Comparing with the structure of sibutramine, a tertiary amine was substituted as a secondary amine.  This is one of the active metabolite of sibutramine.  Basic on the law, foods with any illegal additive such as synthetic chemical compound shall not be sold, manufactured, imported, processed, used, prepared, stored or transported.  Therefore, this sibutramine analogue has been included in the inspection list of illegal adulterants in Taiwan.

Key word: sibutramine analogue, adulterants, NMR, FAB mass