The United States Pharmacopeial Convention (USP) is a nonprofit, scientific, standard-setting organization, and world leader in establishing quality, purity, and testing standards for medicines, foods, and dietary supplements. USP quality standards are used in more than 140 countries and are legally recognized by more than 40 countries. Currently, there is renewed interest in herbal medicines globally, and health policies are being implemented worldwide for the use of complementary and traditional medicine. In response, USP has developed a robust body of monographs that can be used to guide industry and regulators in ensuring the quality and safety of botanical ingredients used in dietary supplements and herbal medicines. Throughout the Pan American regions, there is a strong tradition of using botanicals as herbal medicines and, as in other regions, a growing desire for botanical dietary supplements. This underscores the need for public quality standards to ensure quality, reduce the flow of substandard and adulterated products, and ensure public health and safety. In April 2022, USP launched the Pan America Botanical Dietary Supplements and Herbal Medicines Expert Panel, with experts representing 12 different countries. The Expert Panel’s work focuses on developing quality control standards for the most important botanical ingredients used in the respective countries, ingredients that are also of global importance. This article provides an overview of the state of botanical dietary supplements and herbal medicines in different Pan American regions with a focus on the regulatory status of herbal products, the development of national quality and research initiatives, and policies related to agriculture conservation and sustainability, among other topics.
Saffron, the most expensive spice in the world, is comprised of the dried and dark red stigma of Crocus sativus L. flowers of the Iridaceae family. It is mainly used as a spice for imparting color, fragrance, and flavor to food but its medicinal and dyeing properties were also well known. In the USA, saffron products are used as dietary supplements for mood elevation, relaxation, weight loss, and to increase metabolism. The paper describes two analytical methods for the determination of crocetin esters, picrocrocin, safranal in saffron samples, and dietary supplements for inclusion in a monograph under development by the American Herbal Pharmacopoeia. Method validation showed satisfactory results in linearity, precision, and recovery. The content of picrocrocin, safranal, and crocetin esters ranged from 0.6–10.2%, 0.02–0.22%, and 2.8–25.6%, respectively, for thirty-seven stigma samples. Twenty-nine dietary supplements were analyzed. No saffron compounds were found in 16 (55%) of these products. Flower of Carthamus tinctorius and fruit of Gardenia jasminoides were the main adulterants detected in dietary supplements. Summarily, 60 compounds, including five standards were tentatively identified from saffron stigma, style, and petal samples using high-resolution mass spectrometry. Principle component analysis was used to discriminate between saffron stigma samples and dietary supplements. The results indicated that commercial products are of variable quality and the analytical method is suitable for quality assessment of a variety of both raw materials and finished dietary supplements.
A metabolomic ratio rule-based classification method was developed and programmed for automated metabolite profiling and differentiation of four major cinnamon species using ultra-high-performance liquid chromatography-high-resolution mass spectrometry (UHPLC-HRMS). The computational program identifies key cinnamon metabolites, including proanthocyanidins, cinnamaldehyde, and coumarin, from test samples through LC-MS data processing and assigns cinnamon species by critical metabolite ratios using a stepwise classification strategy. Further, 100% classification accuracy was achieved on the training sample set through critical ratio optimization, and over 95% accuracy was achieved on the validation sample set. The proposed cinnamon classification method exhibited superior accuracy compared to the metabolomic-based PLS-DA modeling method and offered great value for the authentication of cinnamon samples and evaluation of their potential health benefits.
INTRODUCTION:Pro-toxic dehydropyrrolizidine alkaloids are associated with liver disease in humans. The potential for long-term, low-level or intermittent exposures to cause or contribute to chronically-developing diseases is of international concern. Eupatorium perfoliatum is a medicinal herb referred to as boneset. While the presence of dehydropyrrolizidine alkaloids in some Eupatorium species is well-established, reports on Eupatorium perfoliatum are scant and contradictory.OBJECTIVE:To investigate the presence of dehydropyrrolizidine alkaloids in a survey of boneset samples and related alcoholic tinctures, and hot water infusions and decoctions.METHODS:Methanol, hot water or aqueous ethanol extracts of Eupatorium perfoliatum and three closely-related species were subjected to HPLC-ESI(+)MS and MS/MS analysis using three complementary column methods. Dehydropyrrolizidine alkaloids were identified from their MS data and comparison with standards.RESULTS:Forty-nine samples of Eupatorium perfoliatum were shown to contain dehydropyrrolizidine alkaloids (0.0002-0.07% w/w), the majority dominated by lycopsamine and intermedine, their N-oxides and acetylated derivatives. Alcoholic tinctures and hot water infusions and decoctions had high concentrations of the alkaloids. Different chemotypes, hybridisation or contamination of some Eupatorium perfoliatum samples with related species were suggested by the co-presence of retronecine- and heliotridine-based alkaloids.CONCLUSIONS:Sampling issues, low and high alkaloid chemotypes of Eupatorium perfoliatum or interspecies hybridization could cause the wide variation in dehydropyrrolizidine alkaloid concentrations or the different profiles observed. Concerns associated with dehydropyrrolizidine alkaloids provide a compelling reason for preclusive caution until further research can better define the toxicity and carcinogenicity of the dehydropyrrolizidine alkaloid content of Eupatorium perfoliatum. [Correction added on 12 July 2018, after first online publication: The 'Conclusions' section in the abstract has been added.].
The goal of this bulletin is to provide timely information and/or updates on issues of adulteration, substitution, potential interchangeable use, and mislabeling of Rhodiola rosea rhizome/root, in particular with other species from the genus Rhodiola, e.g., R. crenulata. The bulletin may serve as guidance for quality control personnel, the international herbal products industry, regulators, and extended natural products community in general. It is also intended to summarize the scientific data and analytical methods on the occurrence of species substitution and/or adulteration, the market situation, and economic and safety consequences for the consumer and the industry.
American Herbal Pharmacopoeia , American Herbal Pharmacopoeia , کتابخانه دیجیتال دانشگاه علوم پزشکی اصفهان