DONG QUAI - ANGELICA SINENSIS
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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
June 3, 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 | ||
Angelica sinensis |
|
Angelica sinensis |
Root |
|
References: Proper name: USDA 2019, McGuffin et al. 2000; Common names: USDA 2019, NS 2012, PPRC 2010, derMarderosian and Beutler 2009, Bensky et al. 2004, Chen and Chen 2004, McGuffin et al. 2000; Source material: PPRC 2010, Bensky et al. 2004, Chen and Chen 2004.
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)
Used in Traditional Chinese Medicine (TCM) to invigorate and harmonize/tonify the blood (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).
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 or preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
4.5 - 15 grams of dried/prepared root, per day (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).
Note
The term 'prepared root' refers to TCM methods of preparation for Dong quai root as specified by Bensky et al. 2004 [e.g. (Spray with rice wine) baked/fried until dried; (Spray with rice wine) baked/fried until dried and blackened; etc.].
Direction(s) for use
Avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy (NS 2012; Thorne 2004).
Duration(s) of Use
Consult a healthcare practitioner/health care provider/health care professional/doctor/physician for use beyond 6 months (NS 2012; Hirata et al. 1997).
Risk Information
Caution(s) and warning(s)
For all adults
Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking blood thinners/anticoagulants (Brinker 2018; NS 2012; WHO 2004).
For women only
- Consult a healthcare practitioner/health care provider/health care professional/doctor/ physician prior to use if you are breastfeeding (NS 2012).
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking birth control pills or hormone replacement therapy (HRT) (Brinker 2018; NS 2012).
- Stop use and consult a health care practitioner/health care provider/health care professional/doctor/physician if menstruation is delayed or absent, or if you experience increased menstrual bleeding time (Brinker 2018; NS 2012).
Contraindication(s)
For all adults
Do not use this product if you have diarrhea or hemorrhagic diseases (Bensky et al. 2004; Chen and Chen 2004; WHO 2004).
For women only
Do not use this product if you are pregnant or if you have hypermenorrhea/profuse menstrual flow/heavy periods (NS 2012; WHO 2004).
Known adverse reaction(s)
For women only
Stop use and consult a health care practitioner/health care provider/health care professional/ doctor/physician if you experience breast pain, discomfort and/or tenderness (Schumacher et al. 2007; Thorne 2004; Russell et al 2002).
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
Store in an airtight container in a cool, dry place protected from moisture (Ph.Eur. 2013; WHO 2004).
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
- Bensky D, Clavey, Stöger E, Gamble A. Chinese Herbal Medicine: MateriaMedica. 3rd edition. Seattle (WA): Eastland Press, Incorporated; 2004.
- Brinker 2018: Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions, 4th edition, including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications. [Accessed 2019 May 15]. Available from: https://www.eclecticherb.com/herb-contraindications-drug-interactions
- Chen JK, Chen TT. Chinese Medical Herbology and Pharmacology. Crampton L, editor. City of Industry (CA): Art of Medicine Press Inc.; 2004.
- derMarderosian A, Beutler JA, editors. The Review of Natural Products. [Dong quai: Date of issue April 2009]. St Louis (MO): Facts and Comparisons, Wolters Kluwer Health; Printed in 2008 and Updated to April 2012.
- Hirata JD, Swiersz LM, Zell B, Small R, Ettinger B. Does dong quai have estrogenic effects in postmenopausal women? A double-blind, placebo-controlled trial. Fertility and Sterility 1997;68(6):981-986.
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- NS 2012: Natural Standard. Dong quai (Angelica sinensis [Oliv.] Diels). Copyright 2012 [Internet]. [Accessed 2019 May 15]. Available from: http://www.naturalstandard.com
- NTP 2008: Chemical Information Review Document for Dong quai [CAS Nos. 308068-61-3 (root) and 299184-76-2 (extract)] Supporting Nomination for Toxicological Evaluation by the National Toxicology Program September 2008 [Internet]. [Accessed 2019 May 15]. Available from: http://ntp.niehs.nih.gov/ntp/noms/Support_Docs/Dong_quai090308.pdf
- PPRC 2010: Pharmacopoeia of the People's Republic of China 2010. English Edition. Compiled by The State Pharmacopoeia Commission of the P.R. China. Beijing (CN): China Medical Science Press; 2010.
- Russell L, Hicks GS, Low AK, Shepherd JM, Brown CA. Phytoestrogens: a viable option? The American Journal of the Medical Sciences 2002;324(4):185-188.
- Schumacher M, Guennoun R, Ghoumari A, Massaad C, Robert F, El-Etr M, Akwa Y, Rajkowski K, and Baulieu E. Novel perspectives for progesterone in Hormone Replacement Therapy, with special reference to the nervous system. Endocrine Reviews 2007;28:387-439.
- Thorne 2004: Thorne Research Inc. Monograph Angelica sinensis (Dong quai). Alternative Medicine Review 2004;9(4):429-433.
- USDA 2019: USDA, ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. Angelica sinensis (Oliv.) Diels. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 15]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
- WHO 2004: World Health Organization Monographs on Selected Medicinal Plants - Volume 2: Radix Angelicae Sinensis [Accessed 2019 May 15]. Available from: http://apps.who.int/medicinedocs/en/d/Js4927e/5.html#Js4927e.5
References Reviewed
- Chandler F, editor. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association; 2000.
- Cotran RS, Kumar V, Collins T. Pathologic Basis of Disease. 6th edition. Philadelphia (PA): W.B. Saunders Company; 1999.
- Dr. Duke's Phytochemical and Ethnobotanical Databases. Angelica sinensis [Internet]. [Accessed 2012 April 18]. Available from: http://www.ars-grin.gov/duke.
- European Commission. HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Directorate C - Scientific Opinions, C2 - Management of scientific committees; scientific co-operation and networks, Scientific Committee on Food. SCF/CS/FLAV/ FLAVOUR/30 Final 9 April 2003. Opinion of the Scientific Committee on Food on Isosafrole (expressed on 4 April 2003) [Internet]. [Accessed 2012 April 20]. Available from: http://ec.europa.eu/food/fs/sc/scf/out188_en.pdf
- Health Canada Drugs and Health Products, Guidance for industry - Product Monographs of Non- contraceptive Estrogen / Progestin-Containing Products. April 20, 2006 [Internet]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2012 April 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/hrt- ths/pm_mp_noncontracept-eng.php
- National Toxicology Program 2011. Report on carcinogens, Twelfth edition (2011). Safrole CAS No. 94-59-7 [Internet]. [Accessed 2012 April 20]. Available from: http://ntp.niehs.nih.gov/ntp/roc/twelfth/profiles/Safrole.pdf
- Tortora GJ, Grabowski SR. Principles of Anatomy and Physiology. 9th edition. Sudbury (MA). Biological Sciences Textbooks, Inc.; 2000.
- Upton R. Dong quai. In: Coates PM, Betz JM, Blackman MR, Cragg GM, Levine M, Moss J, White JD, editors. Encyclopedia of Dietary Supplements. Second Edition. New York (NY): Informa Healthcare; 2010. p. 208-216.
- Wu SJ, Ng LT, Lin CC. Antioxidant activities of some common ingredients of traditional chinese medicine, Angelica sinensis, Lycium barbarum and Poria cocos . Phytotherapy Research 2004;18(12):1008-1012.