Defined Organism Substance - Massa Medicata Fermentata

NHPID name:
Massa Medicata Fermentata

Reference:
CHIN_MED

Proper name(s):
Massa medicata fermentata

Common name(s):

Category:
Approved Herbal Substance Name
Monograph(s):
Traditional Chinese Medicine Ingredients

Schedule 1:
Extract

Source material(s):

Preparations:
Fermentation

Additional details

Detail:
As this ingredient is a Traditional Chinese Medicine (TCM) ingredient, it may only be used in accordance with the conditions of use outlined in Traditional Chinese Medicine (TCM) referenced texts (e.g. methods of preparations, source materials, doses, directions for use, durations of use, combinations of medicinal ingredients, risk statements, and the theory of TCM). Massa Medicata Fermentata must be prepared according to the State Drug Standard (SDS) Liu Shen Qu monograph WS3-B-3555-98 available at http://www.newdruginfo.com/ypbz/zybb/bbzl0109.htm (in Chinese). When submitting a Product Licence Application form including Massa Medicata Fermentata, all 7 ingredients of Massa Medicata Fermentata must be listed a source materials. Note that wheat bran and wheat flour can be represented as one source material (Triticum aestivum husk and seed).


Roles

Medicinal

Rationale:

Classified as an NHP under Schedule 1, item 2 (an extract) of the Natural Health Products Regulations.

Reference:  NNHPD
Restrictions:

General

Detail:
Artemisia species contain thujone. For adults, the upper limit for total daily intake of thujone from health products is 6 mg. Product licence applications for oral products should include a copy of a certificate of analysis or any other equivalent document demonstrating that the thujone content of a daily dose of the product is acceptable. Because thujone content of the herbal materials can vary, the thujone content should be determined for each batch during production of the product.

Reference:
EMA_THUJONE_2012


General

Detail:
In order to reduce toxicity, the seeds of Prunus armeniaca must be processed before use as medicinal ingredients in Massa Medicata Fermentata: The skin of Prunus armeniaca seeds must be removed and the seeds stir-baked in order to break down amygdalin, a cyanogenic glycoside.

Reference:
NNHPD