Schisandra chinensis (Schisandra)

Date

December 1, 2011

Proper name(s)

Schisandra chinensis (NHPID)

Common name(s)

Schisandra
Chinese Magnoliavine
Wu Wei Zi

(NHPID)

Source material(s)

Dried fruit

Route(s) of Administration

Oral

Dosage form(s)

The acceptable pharmaceutical dosage forms suited to oral administration include, but are not limited to, chewables (e.g. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons. This labelling standard is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dose(s)

Oral:
Decoction and/or Aqueous (water) extracts
Up to 8g per day (QDE dose) (Greenlee et al. 2007)

Crude Preparations and/or Ethanolic extracts
4.5g per day (QDE dose) (Mills and Bone 2005)

Standardized Extracts

• 600 mg extract standardized to 5.6% deoxychizandrin (Fan et al. 2009)
• 1200 mg extract standardized to 0.8% Schisandrins (Amaryan et al. 2003)
• 20.4 ml extract standardized to 17.6% (w/v) Shisandrin (syn. Schisandrol A) and 10.5% (w/v) Schisandrin B (syn. Gamma-schisandrin) (Narimanian et al. 2005)

Reportedly Standardized Constituents and/or Markers

Schisandrins
Schisandrin (syn. Schisandrol A)
Schisandrin A (syn. Deoxyschisandrin)
Schisandrin B (syn. Gamma-schisandrin)
Note: Standardization is not required

(Amaryan et al. 2003; Narimanian et al. 2005; Fan et al. 2009)

Use(s) or Purpose(s)

To be provided by the applicant

Subpopulation

Adults

Duration of use

Decoction and/or Aqueous (water) extracts

• Up to 6g per day (QDE):
  No duration of use statement required
  (Bensky et al. 2004; PPRC 2005; Mills and Bone 2005; Chen and Chen 2004)
• 6-8g per day (QDE):
  Consult a health care practitioner for use beyond 4 months
  Greenlee et al. 2007

Crude Preparations and/or Ethanolic extracts

• 4.5g per day dried fruit (QDE):
  No duration of use statement required
  Mills and Bone 2005

Standardized Extracts

• 600 mg extract standardized to 5.6% deoxychizandrin:
  Consult a health care practitioner for use beyond 2 weeks.
  (Fan et al. 2009)
• 1200 mg extract standardized to 0.8% Schisandrins:
  Consult a health care practitioner for use beyond 1 month.
  (Narimanian et al. 2005)
• 20.4 ml extract standardized to 17.6% (w/v) Shisandrin and 10.5% (w/v) gamma-shisandrin:
  Consult a health care practitioner for use beyond 2 weeks
  (Amaryan et al. 2003)

Risk information

All Products:

Do not use if you are pregnant (Mills and Bone 2005; Brinker 2010)

Consult a health care practitioner prior to use if you are breastfeeding (Mills and Bone 2005)

Specifications

A Finished Product Specifications Form must accompany the application. The product must comply with the requirements of the most recent published version of the "Evidence for Quality of Finished Natural Health Products" guidance document.

Class specific information

N/A

Other Considerations

Schisandra contains ligans; thus, an anti-estrogenic effect is likely, however, the levels are unknown for relevance

Other standardizations have been previously licensed; however, upon further review, the evidence supporting these standardizations is insufficient.

References cited

• Amaryan, G., Astvatsatryan, V., Gabrielyan, E., Panossian, A., Panosyan, V., Wikman, G. Double-blind, placebo-controlled, randomized, pilot clinical trial of ImmunoGuard ® – a standardized fixed combination of Andrographis paniculata Nees, with Eleutherococcus senticosus Maxim, Schizandra chinensis Bail. And Glycyrrhiza glabra L. extracts in patients with Familial Mediterranean Fever. Phytomedicine 2003; 10:271-285
• Bensky, D., Clavey, S., Stöger, E. Gamble, A. Chinese Herbal Medicine Materia Medica 3^rd Edition. Seattle, Washington: Eastland Press Inc. 2004
• Chen, J.K., and Chen, T.T. Chinese Medicinal Herbology and Pharmacology. City of Industry, California: Art of Medicine Press, Inc. 2004.
• Chinese Pharmacopoeia Commission. Pharmacopoeia of the People’s Republic of China, Vol 1. Beijing, China: People’s Medical Publishing House. 2005
• Fan L., Mao XQ., Tao GY., et al. Effect of Schisandra chinensis extract and Ginkgo biloba extract on the pharmacokinetics of talinolol in healthy volunteers. Xenobiotica 2009; 39(3): 249-54
• Greenlee H., Atkinson, C., Stanczyk FZ. Lampe JW. A pilot and feasibility study on the effects of naturopathic botanical and dietary interventions on sex steroid hormone metabolism in premenopausal women. Cancer Epidemiol Biomarkers Prev 2007; 16(8): 1601-9
• Mills, S., and Bone, K. The Essential Guide to Herbal Safety. St. Lousi Missouri: Elsevier Inc. 2005
• Narimanian M, Badalyan M., Panosyan V., Gabrielyan E., Panossian A., Wikman G., Wagner H. Impact of Chisan® (ADAPT – 232) on the quality of life and its efficacy as an adjuvant in the treatment of acute non specific pneumonia. Phytomedicine, 2005; 12 (10): 723–729

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