BOLDO - PEUMUS BOLDUS
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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.
Notes
- Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
- The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
Date
August 5, 2019
Proper name(s), Common name(s), Source material(s)
Proper name(s) | Common name(s) | Source material(s) | ||
---|---|---|---|---|
Proper name(s) | Part(s) | Preparation | ||
Peumus boldus |
|
Peumus boldus |
Leaf |
Dried |
References: Proper name: USDA 2019; Common names: McGuffin et al. 2000, Wiersema and León 1999; Source material: Blumenthal et al. 2000.
Route of Administration
Oral
Dosage Form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
- Traditionally used in Herbal Medicine to help relieve digestive disturbances (dyspepsia) (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Felter and Lloyd 1983; Wren 1907).
- Traditionally used in Herbal Medicine to stimulate digestion (Bradley 2006; Felter and Lloyd 1983).
The following combined use(s) or purpose(s) is/are also acceptable:
Traditionally used in Herbal Medicine to help relieve digestive disturbances (dyspepsia) and stimulate digestion (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Felter and Lloyd 1983; Wren 1907).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
150 - 5,000 milligrams of dried leaf, per day (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000)
Direction(s) for use
No statement required.
Duration(s) of Use
Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks (ESCOP 2003).
Risk Information
Caution(s) and warning(s)
- Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have kidney or liver disorders (Brinker 2010; Barnes et al. 2007; Bradley 2006).
Contraindication(s)
Do not use this product if you are pregnant or breastfeeding (Brinker 2010; Bradley 2006; Mills and Bone 2005).
Known adverse reaction(s)
No statement required.
Non-medicinal ingredients
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
Storage conditions
No statement required.
Specifications
- The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
- The medicinal ingredient must comply with the requirements outlined in the NHPID.
References Cited
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): Pharmaceutical Press; 2007.
- Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
- Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
- Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
- ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
- Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
- Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
- USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Peumus boldus Molina. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 31].
- Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
- Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
- Wren RC. Potter's Cyclopedia of Botanical Drugs and Preparations. London (UK): Potter and Clark; 1907.
References Reviewed
- Barnes J, Anderson LA, Philipson JD. Herbal Medicines: A Guide for Healthcare Professionals, 2nd edition. London (UK): The Pharmaceutical Press; 2002.
- BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.
- Bisset NG, Wichtl M, editors. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 2nd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2001.
- Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
- Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.