PORIA - WOLFIPORIA EXTENSA

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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)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s)	Common name(s)	Source material(s)
Proper name(s)	Common name(s)	Proper name(s)	Part(s)	Preparation
Wolfiporia extensa	Fu Ling Hoelen Indian bread Poria Sclerotium of tuckahoe	Wolfiporia extensa	Cultured mycelium Sclerotium/ mycelium	Dried

References: Proper name: CABI 2014, McGuffin et al. 2000; Common names: PPRC 2010, Bensky et al. 2004, Chen and Chen 2004, Hobbs 2003, McGuffin et al. 2000; Source materials: PPRC 2010, Bensky et al. 2004, Wasser 2002.

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 Herbal Medicine to support the immune system (Rios 2011; Hobbs 2003; Hoffmann 2003).
Source of fungal polysaccharides with immunomodulating properties (Hobbs 2003; Wasser 2002).
Used in Traditional Chinese Medicine (TCM) for small quantity of urination, dizziness and palpitation caused by phlegm-fluid retention, spleen deficiency, reduced food intake, sloppy stool, diarrhoea, disquietude of heart spirit, and insomnia (PPRC 2010).
Used in Traditional Chinese Medicine (TCM) to promote urination and leach out dampness (for urinary difficulty and cases of scanty urine due to damp-heat) (Bensky et al. 2004).
Used in Traditional Chinese Medicine (TCM) to promote urination to drain dampness, fortify the spleen, and calm the heart (PPRC 2010).
Used in Traditional Chinese Medicine (TCM) to strengthen the spleen and harmonize the middle burner: for spleen deficiency compounded by dampness with symptoms such as loss of appetite, diarrhoea, and epigastric distention (Bensky et al. 2004).
Used in Traditional Chinese Medicine (TCM) to strengthen the spleen and transform phlegm: for spleen deficiency with thin mucous in which phlegm moves upward with symptoms such as palpitations, headache, dizziness, and thick, greasy tongue coating (Bensky et al. 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)

Source of fungal polysaccharides

Methods of preparation: Dry, powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 grams of dried cultured mycelium/sclerotium/mycelium, per day (Hobbs 2003).

Methods of preparation: Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

Not to exceed 3.6 grams of dried cultured mycelium/sclerotium/mycelium per day and 40 % of polysaccharides (Hobbs 2003).

Method of preparation: Decoction

Not to exceed 18 grams of dried cultured mycelium/sclerotium/mycelium, per day (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003).

Method of preparation: Decoction standardized

Not to exceed 18 grams of dried cultured mycelium/sclerotium/mycelium per day and 40 % of polysaccharides (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003).

Herbal Medicine immune support

Methods of preparation: Dry, powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.6 - 3.6 grams of dried cultured mycelium/sclerotium/mycellium, per day (Hobbs 2003).

Methods of preparation: Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid Extract)

1.6 - 3.6 grams of dried cultured mycelium/sclerotium/mycellium per day and not to exceed 40 % of polysaccharides (Hobbs 2003).

Herbal Medicine immune support/Traditional Chinese Medicine (TCM)

Method of preparation: Decoction

9 - 18 grams of dried cultured mycelium/sclerotium/mycelium, per day (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003).

Method of preparation: Decoction standardized

9 - 18 grams of dried cultured mycelium/sclerotium/mycelium per day and not to exceed 40 % of polysaccharides (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003).

Direction(s) for use

Take before meals (Bensky et al. 2004).

Duration(s) of Use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.

Risk Information

Caution(s) and warning(s)

Traditional Chinese Medicine (TCM)

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have a yin deficiency, sunken spleen qi, or cold from deficiency with spermatorrhea (Bensky et al. 2004; Chen and Chen 2004).

Contraindication(s)

No statement required.

Known adverse reaction(s)

All products

Stop use if hypersensitivity/allergy occurs (Bensky et al. 2004).
Diuretic effect may occur (PPRC 2010).

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 a tightly closed, light-resistant container in a cool, dry place (PPRC 2010).

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 S, Toger E, Gamble A, editors. Chinese Herbal Medicine Materia Medica. 3^rd edition. Seattle (WA): Eastland Press Inc; 2004.
CABI 2014: Centre for Agriculture and Bioscience International. Index Fungorum [Internet]. Wallingford (GB): CABI (Centre for Agriculture and Bioscience International); 2014. [Accessed 2019 June 7]. Available from: http://www.speciesfungorum.org
Chen JK, Chen TT. Chinese Medical Herbology and Pharmacology. Crampton L, editor. City of Industry (CA): Art of Medicine Press Inc; 2004.
Hobbs C. Medicinal Mushrooms: An Exploration of Tradition, Healing & Culture. Summertown (TN): Book Publishing Company; 2003.
Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2^nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
PPRC 2010: Pharmacopoeia of the People's Republic of China 2010. Volume I. Beijing (PRC): Chinese Pharmacopoeia Commission; 2010.
Rios JL. Chemical constituents and pharmacological properties of Poria cocos. Planta Medica 2011;77(7):681-691.
Wasser SP. Medicinal mushrooms as a source of antitumor and immunomodulating polysaccharides. Applied Microbiology and Biotechnology 2002; 60(3):258-274.

References Reviewed

Albers R, Antoine JM, Bourdet-Sicard R, Calder PC, Gleeson M, Lesourd B, Samartín S, Sanderson IR, Van Loo J, Vas Dias FW, Watzl B. Markers to measure immunomodulation in human nutrition intervention studies. British Journal of Nutrition 2005;94(3):452-481.
Bisby FA, Roskov YR, Orrell TM, Nicolson D, Paglinawan LE, Bailly N, Kirk PM, Bourgoin T, Baillargeon G, Ouvrard D, editors. Species 2000 & ITIS Catalogue of Life, 22 December 2014 [Internet]. Reading (GB): Species 2010. [Accessed 2014 December 31]. Available from: http://www.catalogueoflife.org/col/details/species/id/17300121
Brinker 2010: Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions, 3^rd 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 2014 December 31]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
Brinker F. Herbal Contraindications and Drug Interactions: Plus Herbal Adjuncts with Medicines, expanded 4^th Edition. Sandy (OR): Eclectic Medical Publications; 2010.
Huang KC. The Pharmacology of Chinese Herbs. 2^nd edition. Boca Raton (FL): CRC Press; 1999.