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Drugs and Health Products

Monograph: 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: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. (iii) A claim for a traditional use must include either the term "Herbal Medicine" or "Traditional Chinese Medicine".

Date: 2012-11-27

NHPID Name

Angelica sinensis (USDA 2008)

Proper Name(s)

Angelica sinensis (Oliv.) Diels (Apiaceae) ( USDA 2009 , McGuffin et al. 2000 )

Common Name(s)

Source Material

Root ( PPRC 2010 , Bensky et al. 2004 , Chen and Chen 2004 )

Route Of Administration

Oral

Dosage Form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets. This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Used in Traditional Chinese Medicine (TCM) to invigorate and harmonize/tonify the blood  (PPRC 2010, Bensky et al. 2004, Chen and Chen 2004)

Dose(s)

Adults:

Preparation: Decoction

Dose(s): 4.5 - 15 Grams per day, dried root
Directions For Use: Avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy (NS 2012, Thorne 2004)

Preparation: Traditional Chinese Medicine

Dose(s): 4.5 - 15 Grams per day, prepared root
Directions For Use: Avoid prolonged exposure to sunlight, ultraviolet light (UV) or UV therapy (NS 2012, Thorne 2004)


Refer to Appendix 1 for the TCM method of preparation for Dong quai root.

Duration of use

For use beyond 6 months, consult a healthcare practitioner  (NS 2012, Hirata et al. 1997)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If menstruation is delayed or absent, or if you experience increased menstrual bleeding time, discontinue use and consult a health care practitioner  (NS 2012, Brinker 2010)
  • If you are breastfeeding, consult a healthcare practitioner prior to use  (NS 2012)
  • If you are taking birth control pills, consult a health care practitioner prior to use  (NS 2012, Brinker 2010)
  • If you are taking blood thinners/ anticoagulants, consult a health care practitioner prior to use  (NS 2012, Brinker 2010, WHO 2004)
  • If you are taking hormone replacement therapy (HRT), consult a health care practitioner prior to use  (NS 2012)
  • If you have family history of cancer, consult a healthcare practitioner prior to use  (NTP 2008, Schumacher et al. 2007)

Contraindication(s):
  • If you are pregnant, do not use this product  (NS 2012, WHO 2004)
  • If you have allergy/hypersensitivity to members of the Apiaceae/Umbelliferae family (anise, caraway, carrot, celery, dill, parsley), do not use this product  (NS 2012)
  • If you have diarrhoea or haemorrhagic diseases, do not use this product  (Bensky et al. 2004, Chen and Chen 2004, WHO 2004)
  • If you have hypermenorrhoea/ profuse menstrual flow/ heavy periods, do not use this product  (WHO 2004)

Known Adverse Reaction(s):
If you experience breast pain, discomfort and/or tenderness, discontinue use and consult a health care practitioner  (Schumacher et al. 2007, Thorne 2004, Russell et al. 2002)

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database 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 NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID). In addition, the medicinal ingredient may comply with the specifications outlined in the 'Angelica Sinensis Root for use in THM' and 'Processed Angelica Sinensis Root for use in THMP' monographs of the British Pharmacopoeia (BP) and in the 'Angelica sinensis radix' monograph of the European Pharmacopoeia (Ph. Eur.).

References cited

  • Bensky D, Clavey S, Stoger E, Gamble A. 2004. Chinese Herbal Medicine: Materia Medica, 3rd edition. Seattle (WA): Eastland Press.
  • BP 2012: British Pharmacopoeia 2012. Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2012.
  • Brinker 2010: Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions, 3rd 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. [Updated July 13, 2010; Accessed 2012 May 2]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • 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. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • NS 2012: Natural Standard. Dong quai (Angelica sinensis [Oliv.] Diels). Copyright 2012 [Internet]. [Accessed 2012 April 18]. 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 2012 April 20]. Available from: http://ntp.niehs.nih.gov/ntp/noms/Support_Docs/Dong_quai090308.pdf
  • Ph.Eur. 2013: European Pharmacopoeia. 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM); 2012.
  • 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.
  • 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 2009: USDA, ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Angelica sinensis (Oliv.) Diels. Last updated: 2009 December 3; Accessed 2012 November 27]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/taxgenform.pl?language=en
  • WHO 2004: World Health Organization Monographs on Selected Medicinal Plants - Volume 2: Radix Angelicae Sinensis [Accessed on November 15, 2011]. Available from: http://apps.who.int/medicinedocs/en/d/Js4927e/5.html#Js4927e.5.

References reviewed

  • Chandler F, editor. 2000. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.
  • 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.

Appendix 1:

TCM method of preparation for Dong quai root

Baked:

Slice fresh root, fry or bake the roots until dried (Bensky et al. 2004).

OR

Slice fresh root, fry or bake the roots until dried and blackened (Bensky et al. 2004).

OR

Slice fresh root. Spray with rice wine. Once the wine is absorbed, fry or bake the roots until dried and blackened (Bensky et al. 2004).

OR

Slice fresh root. Spray with rice wine. Once the wine is absorbed, fry or bake the roots until dried (Bensky et al. 2004).

Stir fried:

Slice the roots and stir bake with wine to dryness (PPRC 2010).