Abstract

A method for producing pharmaceutical drug substance from Nuphar lutea L. Smith that used orthophosphoric acid instead of the chlorinated solvent dichloroethane (DCE), which was used previously to produce lutenurine preparation, was developed. Furanoquinolizidine alkaloid salts containing immonium ions were shown to dominate lutenurine drug substances prepared by both technologies. NMR methods were used to establish the identity of the substance and to determine it quantitatively. The UV absorption maximum at 293 nm was characteristic of all alkaloids with immonium ions (S–CH=N+). The antimicrobial activity, toxicity, and physicochemical characteristics of substances prepared by the two different technologies were practically identical.

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