USP botanical monographs contain science-based quality standards that include multiple interrelated tests to provide a full quality characterization for each article in terms of its identity, purity, and content. USP develops pharmacopeial monographs for Traditional Herbal Medicines from different countries including Traditional Chinese Medicines. USP harmonizes botanical monographs to other pharmacopeias, such as European Pharmacopeia (EP) and Chinese Pharmacopeia (ChP), but USP monographs usually have more advantages in both methods and content specifications. In this work, we present USP monographs of Chinese skullcap root [1] and Coptis species rhizome [2].
USP monograph of Chinese skullcap root consists of the dried root of Scutellaria baicalensis Georgi. It contains multiple flavonoids including baicalin, baicalein, wogonoside and wogonin. Both HPLC and HPTLC analysis can identify and the HPLC can quantify the four flavonoids. Moreover, the monograph allows efficient differentiation between the Chinese and the American skullcap (Scutellaria lateriflora).
The USP monograph of Coptis species rhizome is represented by the dried rhizome of Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng & P.K.Hsiao, or Coptis teeta Wall.. The three species included in the USP monograph are in agreement with those of EP and ChP. However, according to USP monograph six alkaloids including berberine, palmatine, coptisine, epiberberine, jatrorrhizine, and columbamine can be determined by both HPLC and HPTLC, and the sum of the six alkaloids is requested to be NLT 9.0% and NMT 20%. In contrast in EP only berberine is specified; in ChP, four alkaloids are separately specified for C. chinensis, and berberine is only specified for C. deltoidea and C. Teeta.
References
[1] USP, Chinese Skullcap Root. Pharmacopeial Forum, 44 (2). Available at www.usp.org
[2] USP, Coptis Species Rhizome. Pharmacopeial Forum, 44 (5). Available at www.usp.org