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Monograph: Amla - Phyllanthus emblica

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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.

Date: 2012-11-27

NHPID Name

Phyllanthus emblica (USDA 2008)

Proper Name(s)

Common Name(s)

Source Material

Fruit ( API 2001 [1990] , Khory and Katrak 1999[1903] )

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:

Dose(s)

Adults:

Antioxidant
Preparation: Powdered

Dose(s): not to exceed 6 Grams per day, powdered dry fruit
Directions For Use: Take 2 hours before or after taking other medications (Martindale 2008, HC 1994)

Laxative
Preparation: Powdered

Dose(s): 3 - 6 Grams per day, powdered dry fruit
Directions For Use: Allow at least 6 to 12 hours for laxative effect to occur (APhA 2002)

Rasayana; Amlapitta; Digestive tonic
Preparation: Powdered

Dose(s): 3 - 6 Grams per day, powdered dry fruit
Directions For Use: Take 2 hours before or after taking other medications (Martindale 2008, HC 1994)

Duration of use

Laxative:

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use
  • If you have or develop abdominal pain, nausea, fever or vomiting, consult a health care practitioner  (McGuffin et al. 1997, HC 1994)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
Antioxidant; Rasayana; Amlapitta; Digestive tonic:
Laxative effect may occur, in which case, discontinue use

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

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).

References cited

  • APhA 2002: Berardi RR, DeSimone EM, Newton GD, Oszko, MA, Popovich, NG, Rollins, CJ, Shimp LA, Tietze KJ. Handbook of Nonprescription Drugs: An interactive approach to self-care, 13th Edition. Washington (DC): American Pharmaceutical Association; 2002.
  • API 2001 [1990]. The Ayurvedic Pharmacopoeia of India, 1st edition, Part I, Volume I. Delhi (IN): The Controller of Publications; [Reprint of 1990 publication].
  • CPhA 2002: Repchinsky C, editor-in-chief. Patient Self-Care: Helping Patients Make Therapeutic Choices. 1st edition. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • Duke 1992: Dr. Duke's Phytochemical and Ethnobotanical Databases. Chemicals and their Biological Activities in: Phyllanthus emblica L. (Euphorbiaceae) -- Emblic, Myrobalan, 1992 [Internet]. [Accessed 2012 November 26]. Available from: http://www.ars-grin.gov/duke
  • Gogte VVM. Ayurvedic Pharmacology and Therapeutic Uses of Medicinal Plants. Mubai (IN): Bharatiya Vidya Bhavan; 2000.
  • HC 1994: Laxatives: General - Laxatives - Labelling Standard [Internet]. Ottawa (ON): Drugs and Health Products; Health Canada; 1994. [Accessed 2012 June 5]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxat-eng.php
  • ITIS 2011: Phyllanthus emblica [2011] Integrated Taxonomic Information System (ITIS) [Internet]. Accessed 2012 June 5]. Available from: http://www.itis.gov
  • Kapoor LD. 2001. Handbook of Medicinal Ayurvedic Medicinal Plants. Boca Raton (FL): CRC press LLC.
  • Khory RN, Katrak NN.1999 [1903]. Materia Medica of India and Their Therapeutics. Delhi (IN): Komal Prakashan; [Reprint of 1903 publication].
  • Martindale 2008: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2012. [Laxatives: latest modification: 31-Jul-2008; Accessed 2012 May 18]. Available from: http://www.medicinescomplete.com
  • Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2012. [Indian gooseberry: latest modification: 05-Dec-2011; Accessed 2012 May 18]. Available from: http://www.medicinescomplete.com
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Murthy KRS. 2004. Bhavaprakasha of Bhavmisra, Volume 1. Varanasi (IND): Chowkhamba Krishnadas Academy.
  • Paranjpe P. Indian Medicinal Plants: Forgotten Healers: A Guide to Ayurvedic Herbal Medicine. Delhi (IN): Chaukhamba Sanskrit Pratishthan; 2005.
  • Pray WS. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
  • Sudarshan SR. Encyclopaedia of Indian Medicine, Materia Medica - Herbal Drugs. Volume 4. Banglore (IN): Popular Prakashan; 2005.
  • USDA 2005: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Phyllanthus emblica L. Last updated: 25-Aug-2005; Accessed 2012 April 27]. Available from: http://www.ars-grin.gov/
  • Warrier PK, Nambiar VPK, Ramankutty C, editors. Indian Medicinal Plants: a compendium of 500 species. Volume 4. Chennai (IN): Orient Longman Private Limited; 2003
  • Williamson EM, editor. 2002. Major Herbs of Ayurveda. Edinburgh (GB): Churchill Livingstone.

References reviewed

  • Baliga MS, Dsouza JJ. Amla (Emblica officinalis Gaertn), a wonder berry in the treatment and prevention of cancer. European Journal of Cancer Prevention 2011;20(3):225-239.
  • 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 April 18]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Charoenteeraboon J, Ngamkitidechaku C, Soonthornchareonnon N, Jaijoy K, Sireeratowong S. Antioxidant activities of the standardized water extract from fruit of Phyllanthus emblica Linn. Songklanakarin Journal of Science and Technology 2010;32(6):599-604.
  • Chaudhuri RK. Emblica cascading antioxidant: a novel natural skin care ingredient. Skin pharmacology and applied skin physiology 2002;15(5):374-380.
  • Chen TS, Liou SY, Chang YL. Supplementation of Emblica officinalis (Amla) extract reduces oxidative stress in uremic patients. American Journal of Chinical Medicine 2009;37(1):19-25
  • Faccolia S. Cornucopia II A source book of edible plants. Vista (CA): Kampong Publications; 1998.
  • HC 2011: Health Canada. Canada Vigilance Adverse Reaction Online Database. Ottawa (ON): Marketed Health Products Directorate, Health Canada; 2011. [Accessed 2012 January 27]. Available from: http://webprod3.hc-sc.gc.ca/arquery-rechercheei/index-eng.jsp
  • Hiraganahalli BD, Chinampudur VC, Dethe S, Mundkinajeddu D, Pandre MK, Balachandran J, Agarwal A. Hepatoprotective and antioxidant activity of standardized herbal extracts. Pharmacognosy Magazine 2012;8(30):116-123.
  • Jain SK. DeFillips RA. Medicinal Plants of India. Volume 1. Algonac (MI): Reference Publications, Inc; 1991.
  • Khare CP, editor. Indian Herbal Remedies: Rational Western Therapy, Ayurvedic and Other Traditional Usage, Botany. Berlin (DE): Springer; 2004.
  • Manjunatha S, Jaryal AK, Bijlani RL, Sachdeva U, Gupta SK. Effect of Chyawanprash and vitamin C on glucose tolerance and lipoprotein profile. Indian Journal of Physiology and Pharmacology 2001;45(1):71-79
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Mishra LC, editor. Scientific Basis for Ayurvedia Therapies. Baton Roca (FL): CRC Press LLC; 2004.
  • NS 2012: Natural Standard. Amalaki (Phyllanthus emblica) Copyright 2012 [Internet]. [Accessed 2012 April 18]. Available from: http://www.naturalstandard.com.
  • Poltanov EA, Shikov AN, Dorman HJD, Pozharitskaya ON, Makarov VG, Tikhonov VP, Hiltunen R. Chemical and Antioxidant Evaluation of Indian Gooseberry (Emblica officinalis Gaertn., syn. Phyllanthus emblica L.) Supplements. Phytotherapy Research 2009;23:1309-1315.
  • Premila MS. Ayurvedic herbs: A clinical guide to the healing plants of traditional Indian medicine. New York (NY): The Haworth Press Inc; 2006.
  • Sabu MC, Kuttan R. Anti-diabetic activity of medicinal plants and its relationship with their antioxidant property. Journal of Ethanopharmacology 2002;81(2):155-169.
  • Sawant L, Pandita N, Prabhakar B. Determination of gallic acid in Phyllanthus emblica Linn. dried fruit powder by HPTLC. Journal of Pharmacy and BioAllied Sciences 2010;2(2):105-108.
  • Scartezzini P, Speroni E. Review on some plants of Indian traditional medicine with antioxidant activity. Journal of Ethnopharmacology 2000;71:23-42.