2010年美国FDA批准新药简析

Objective To study the constituents in Melicope pteleifolia. Methods Plant material was isolated with 80% EtOH. Compounds were separated with chromatographic methods and their structures were elucidated on the basis of spectral analysis (EI-MS, 1H-NMR, and 13C-NMR) and chemical evidence. Results Five compounds were isolated from petrol ether or ethyl acetate soluble fraction. Their structures were identified as 3,5,3'-trihydroxy- 4'-methoxy-7-(3-methylbut-2-enyloxy) flavone (pteleifolosin C, 1), 3,7-dimethoxyl kaempferol (kamatakenin, 2), vanillic acid (3), tricosanoic acid tetradecyl ester (4), and β-sitosterol (5), respectively. Conclusion Compound 1 is a new structure named pteleifolosin C. Compounds 2－4 are isolated from this plant for the first time．

Analysis of new drugs approved by FDA in 2010

The US Food and Drug Administration (FDA) approved 21 new drugs in 2010. In this article, the profile of some exciting products and the trends of drug R&D was provided. Among the FDA approvals, denosumab (Prolia?), dabigatran etexilate (Pradaxa?) and fingolimod (Gilenya?) are particularly mechanistically interesting or commercially exciting. In 2010, there was not increase in the overall number, but the proportion of orphan drugs and specialty care products increased significantly, and the proportion of biologics raised obviously too, which could suggest the change of focus and mode of drug R&D.