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Research regarding the quality control of Hydrastis
canadensis (goldenseal) products
This information has been complied in order to facilitate
the research efforts of health care professionals and others. These
statements have not been evaluated by the Food and Drug Administration and
are not intended diagnose, treat, cure, prevent, mitigate, or prevent any
disease. The information is presented with the latest publications first.
This is an ongoing work so check back often as we will update these pages as
more information becomes available. Also see the anti-parasitic and
anti-diarrhea pages. Last Updated :
A New Glucosyl Feruloyl Quinic Acid as
a Potential Marker for Roots and Rhizomes of Goldenseal, Hydrastis
McNamara CE, Perry NB, Follett JM, Parmenter GA, Douglas JA.
J Nat Prod. 2004 Nov 29;67(11):1818-1822.
A new compound, 5-O-(4'-[beta-d-glucopyranosyl]-trans-feruloyl)quinic acid (GPFQ,
10), is reported from the medicinal plant goldenseal (Hydrastis canadensis).
A new HPLC method is described and used to show that GPFQ is a potential
marker for goldenseal roots (1.0% w/w) and rhizomes (2.3%). GPFQ was found
at much lower levels in stems (<0.1%) and could not be detected in leaves.
Neochlorogenic acid (9), which has not previously been reported from
goldenseal, and chlorogenic acid (6) reached their highest levels in leaves
(0.9% 9 and 0.5% 6). The main alkaloids, hydrastine (1) and berberine (2),
were highest in rhizomes (2.8% 1 and 4.6% 2), but palmatine (5) was not
found in genuine goldenseal.
Immunoquantitative analysis for
berberine and its related compounds using monoclonal antibodies in herbal
Kim JS, Tanaka H, Shoyama Y.
Analyst. 2004 Jan;129(1):87-91. Epub 2003 Dec
The monoclonal antibody (MAb) against berberine, a bioactive constituent of
Coptis japonica M., Phellodendron amurense R. and Hydrastis canadensis L.,
was produced and characterized. As immunogen, the derivative of berberine,
9-O-carboxymethyl berberrubine was synthesized and conjugated to carrier
protein, bovine serum albumin (BSA). In order to confirm its immunogenicity,
the ratio of hapten in berberine-BSA conjugate was determined by
matrix-assisted laser desorption/ionization time of flight mass spectrometry
(MALDI-TOF MS). After immunization, hybridomas secreting MAbs against
berberine were produced by fusing splenocytes with mouse myeloma cell line,
P3-X63-Ag8-653. After the screening, anti-berberine MAb 1D5-3B-7 was
obtained. Subsequently, a quantitative ELISA system for berberine and its
related compounds using the MAb was established and evaluated comparing with
HPLC method. The ELISA method described in this study can be available as an
analytical tool for quality control and standardization of medicinal plants
and its prescriptions containing berberine and its related compounds.
Chemical comparison of goldenseal (Hydrastis
canadensis L.) root powder from three commercial suppliers.
Weber HA, Zart MK, Hodges AE, Molloy HM, O'Brien BM, Moody
LA, Clark AP, Harris RK, Overstreet JD, Smith CS.
J Agric Food Chem. 2003 Dec 3;51(25):7352-8.
The characterization of herbal materials is a significant challenge to
analytical chemists. Goldenseal (Hydrastis canadensis L.), which has been
chosen for toxicity evaluation by NIEHS, is among the top 15 herbal
supplements currently on the market and contains a complex mixture of
indigenous components ranging from carbohydrates and amino acids to
isoquinoline alkaloids. One key component of herbal supplement production is
botanical authentication, which is also recommended prior to initiation of
efficacy or toxicological studies. To evaluate material available to
consumers, goldenseal root powder was obtained from three commercial
suppliers and a strategy was developed for characterization and comparison
that included Soxhlet extraction, HPLC, GC-MS, and LC-MS analyses. HPLC was
used to determine the weight percentages of the goldenseal alkaloids
berberine, hydrastine, and canadine in the various extract residues.
Palmatine, an isoquinoline alkaloid native to Coptis spp. and other common
goldenseal adulterants, was also quantitated using HPLC. GC-MS was used to
identify non-alkaloid constituents in goldenseal root powder, whereas LC-MS
was used to identify alkaloid components. After review of the
characterization data, it was determined that alkaloid content was the best
biomarker for goldenseal. A 20-min ambient extraction method for the
determination of alkaloid content was also developed and used to analyze the
commercial material. All three lots of purchased material contained
goldenseal alkaloids hydrastinine, berberastine, tetrahydroberberastine,
canadaline, berberine, hydrastine, and canadine. Material from a single
supplier also contained palmatine, coptisine, and jatrorrhizine, thus
indicating that the material was not pure goldenseal. Comparative data
for three commercial sources of goldenseal root powder are presented.
Method validation for determination of
alkaloid content in goldenseal root powder.
Weber HA, Zart MK, Hodges AE, White KD, Barnes SM, Moody LA,
Clark AP, Harris RK, Overstreet JD, Smith CS.
J AOAC Int. 2003 May-Jun;86(3):476-83.
A fast, practical ambient extraction methodology followed by isocratic
liquid chromatography (LC) analysis with UV detection was validated for the
determination of berberine, hydrastine, and canadine in goldenseal (Hydrastis
canadensis L.) root powder. The method was also validated for palmatine, a
major alkaloid present in the possible bioadulterants Coptis, Oregon grape
root, and barberry bark. Alkaloid standard solutions were linear over the
evaluated concentration ranges. The analytical method was linear for
alkaloid extraction using 0.3-2 g goldenseal root powder/100 mL extraction
solvent. Precision of the method was demonstrated using 10 replicate
extractions of 0.5 g goldenseal root powder, with percent relative standard
deviation for all 4 alkaloids < or = 1.6. Alkaloid recovery was determined
by spiking each alkaloid into triplicate aliquots of neat goldenseal root
powder. Recoveries ranged from 92.3% for palmatine to 101.9% for hydrastine.
Ruggedness of the method was evaluated by performing multiple analyses of
goldenseal root powder from 3 suppliers over a 2-year period. The method was
also used to analyze Coptis root, Oregon grape root, barberry bark, and
celandine herb, which are possible goldenseal bioadulterants. The
resulting chromatographic profiles of the bioadulterants were significantly
different from that of goldenseal. The method was directly transferred
to LC with mass spectrometry, which was used to confirm the presence of
goldenseal alkaloids tetrahydroberberastine, berberastine, canadaline,
berberine, hydrastine, and canadine, as well as alkaloids from the
bioadulterants, including palmatine, jatrorrhizine, and coptisine.
Variations in alkaloid content of
herbal products containing goldenseal.
Edwards DJ, Draper EJ.
J Am Pharm Assoc (Wash DC). 2003 May-Jun;43(3):419-23.
OBJECTIVE: To determine the concentration of hydrastine and berberine, the
primary alkaloids in herbal products containing goldenseal. DESIGN:
Descriptive comparison of 20 products purchased at local pharmacies or
health food stores; 17 products were labeled as containing goldenseal root
and 3 products contained goldenseal herb as the sole active herbal
ingredient. SETTING: Laboratory assessment of alkaloid content using
high-performance liquid chromatography. MAIN OUTCOME MEASURES: Comparisons
of hydrastine and berberine concentration, alkaloid ratio, and total
alkaloid content among products. RESULTS: Hydrastine concentration in
products labeled as containing goldenseal root ranged from 0 to 2.93%,
whereas berberine concentration varied from 0.82% to 5.86%. Median total
alkaloid concentration was 5.30%. Only 10 of 17 products met proposed United
States Pharmacopeia (USP) standards for the hydrastine and berberine content
of goldenseal root. Five products contained little or no hydrastine, unusual
berberine:hydrastine ratios, and additional peaks not observed with other
products. Alkaloid content in goldenseal root products was about fourfold
higher than in products labeled as containing goldenseal herb. CONCLUSION:
Alkaloid content of goldenseal products varies widely, with many products
failing to meet proposed USP standards. In addition, the chromatographic
pattern and alkaloid ratio for several products were atypical for
goldenseal. Given the current absence of regulation of the quality of
herbal products, pharmacists should take extra care to ensure that
substandard goldenseal products are not sold in their pharmacies.
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