Monograph: Amylase, alpha-
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Date:
2019-04-29
NHPID name
alpha-Amylase ( Enzyme Nomenclature )Proper name(s)
4-alpha-D-glucan glucanohydrolase ( IUBMB 1961 )Common name(s)
- 1,4-alpha-D-glucan glucanohydrolase ( Unavailable )
- alpha-amylase ( IUBMB 1961 )
- Diastase ( Unavailable )
- Fungal diastase ( Unavailable )
- Taka-Diastase (Aspergillus) ( Unavailable )
Source material
- Aspergillus flavus var. oryzae - WHOLE (CABI 2012, Bisby et al. 2010, FCC 8)
- Aspergillus niger - WHOLE (CABI 2012, Bisby et al. 2010)
- Hordeum vulgare - SEED (USDA 2010, FCC 8)
- Rhizopus oryzae - WHOLE (CABI 2012, FCC 8)
Route Of administration
OralDosage 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:
Digestive enzyme. (NHPD 2012)Dose(s)
Adults:
Dose(s):
1
Directions for use:
Take with food/meal.
Dose(s):
1
Directions for use:
Swallow whole/Do not crush or chew.
- Dose unit information must include the quantities of both the enzyme preparation (mg or ml) and its enzymatic activity (FCC or USP units). When submitting by ePLA, please put the enzymatic activity quantity in the Quantity/Unit fields (field 77) and the quantity of enzyme preparation in mg or ml in the Additional Quantity/Unit fields.
- One alpha-amylase dextrinizing unit (DU) is defined as the quantity of alpha-amylase that will dextrinize soluble starch in the presence of an excess of beta-amylase at the rate of 1 g/h at 30ºC (FCC 8).
Duration of use
Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.Risk information
Statement(s) to the effect of:
Caution(s) and Warning(s): Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant, breastfeeding or have diabetes. Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs.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).
- Details of the manufacturing of the enzyme at the raw material stage should include fermentation medium, and the isolation process of the medicinal ingredient.
- The specifications must include testing for enzymatic activity of the medicinal ingredient at appropriate stages of formulation and manufacturing using the assay outlined in the current Food Chemicals Codex (FCC): alpha-AMYLASE ACTIVITY (NONBACTERIAL).
- Where published methods are not suitable for use, manufacturers will use due diligence to ensure that the enzymes remain active to the end of the shelf life indicated on the product label.
References cited
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Bisby F, Roskov Y, Orrell T, Nicolson D, Paglinawan L, Bailly N, Kirk P, Bourgoin T, Baillargeon G, Ouvrard D, editors. Species 2000 & ITIS Catalogue of Life, 15th March 2012 [Internet]. Reading (GB): Species 2000. [Source database Species Fungorum, 9.0, Sep 2010; Accessed 2012 March 28]. Available from: http://www.catalogueoflife.org
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CABI 2012: Centre for Agriculture and Bioscience International. Index Fungorum [Internet]. Wallingford (GB): CABI (Centre for Agriculture and Bioscience International); 2012. [Accessed 2012 March 30]. Available from: http://www.speciesfungorum.org
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CPS 2008: Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association; 2008.
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FCC 8: Food Chemicals Codex, Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
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Glade MJ, Kendra D, Kaminski MV. Improvement in protein utilization in nursing-home patients on tube feeding supplemented with an enzyme product derived from Aspergillus niger and bromelain. Nutrition 2001;17(4):348-350.
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IUBMB 1961: IUBMB Enzyme Nomenclature [Internet]. London (GB): Queen Mary, University of London. [alpha-amylase: CAS 9000-90-2, EC 3.2.1.1 created 1961; Accessed 2012 March 28]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/2/1/1.html
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Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2012. [Amylase: syn: EC 3.2.1.1 (alpha-amylase), CAS 9000-85-5 (bacterial alpha-amylase); 9000-90-2 (porcine alpha-amylase, pancreatic); latest modification 23 Sep 2011 ; Accessed 2012 March 28]. Available from: http://www.medicinescomplete.com
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USDA 2010: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. Beltsville (MD): National Germplasm Resources Laboratory. [Hordeum vulgare L: Last updated 04-Jan-2010; Accessed 2012 March 28]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
References reviewed
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Cichoke AJ. Pancreatic Enzymes. In: Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine, Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006 p. 1131-1146.
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Evidence for Quality of Finished Natural Health Products, Version 2.0 [Internet]. Ottawa (ON): Natural Health Products Directorate, Health Canada. 2007. [Accessed 2012 March 28]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php
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Natural Medicines Comprehensive Database. AbsorbAid Information. [Accessed 2012 March 28]. Available from: ttp://www.naturaldatabase.com/(S(opd4lu45015mm3553zs4sx55))/nd/Search.aspx?cs=&s=ND&pt=103&id=2738&fs=ND&searchid=22194785
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Nature's Sources. AbsorbAid® A natural Approach...Unlike Antacids and Acid Blockers. Frequently Asked Questions. [Accessed 2012 March 28]. Available from: http://www.naturessources.com/absorbaid_faq.asp