red clover USP28 原料标准.doc

?Red Clover consists of the dried inflorescence of Trifolium pratenseL.(Fam.Fabaceae).It contains not less than 0.5percent of isoflavones,calculated on the dried basis as the sum of daidzein,genistein,formononetin,and biochanin A. Packaging and storage— Preserve in a well-closed,light-resistant container,protected from moisture. Labeling— The label states the Latin binomial and,following the official name,the parts of the plant contained in the article. USP Reference standards á11?— USP Formononetin RS.USP Powdered Red Clover Extract RS. Botanic characteristics— Macroscopic— Red Clover inflorescences are ovoid with a rounded summit,mostly from 12to 34mm in length and width,usually on a very short stalk,shriveled,purplish,and more or less brown from drying,consisting of many papilionaceous flowers,crowded together and clothed at the base with broad,pointed,pale green ciliate stipules with darker veins.The flowers,which may or may not be accompanied by diminutive trifoliate leaves,are up to 15mm in length and have the following:five green,hairy,subulate calyx teeth,one longer than the other four;petals united into a more or less campanulate tube,somewhat recurved,and colorless with pinkish purple veins;diadelphous stamens;slender style;a faintly aromatic,somewhat tea-like odor;and a sweetish,then slightly bitter taste. Microscopic— Epidermis of calyx composed of polygonal cells with faintly striated cuticle and occasional anomocytic stomata on the outer epidermis only;abundant,uniseriate,covering trichomes with two small,thin-walled basal cells and a thick-walled tapering end cell,up to 1mm in length with a warty cuticle.Glandular trichomes are also present,particularly on the lower epidermis,each with a one-or two-celled stalk and a large,cylindrical head composed of several cells arranged in two rows.Epidermal cells of the corolla,papillose at the tip,are elongated with slightly wavy walls and a strongly striated cuticle;vascular strands of corolla and calyx are su