- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
Annex 4. A model structure for monographs on good agricultural practices for specific medicinal plants
The guidelines for cultivation of medicinal plants and quality control in Japan set out the recommendations for the cultivation of specific plants in a series of monographs.1 The monographs are structured along the following lines:
1. Name of medicinal plant:
(1) Japanese name of the medicinal plant
If no Japanese name for the medicinal plant has been established and the compendium name (see below for definition) has been used as equivalent to the plant name in Japan, the compendium name is given instead.
(2) Compendium name
The Japanese name for the medicinal plant material used for medicinal purposes (crude drug name)
(3) Scientific name
As defined in The Japanese Pharmacopoeia. For plants not included in The Japanese Pharmacopoeia, the established and widely used botanical name is given.
2. Part to be employed as the medicinal plant material
Description of the part of the medicinal plant used for medicinal purposes.
3. Characteristics of the medicinal plant
Description of the major morphological and botanical characteristics of the medicinal plant concerned.
4. Characteristics of the medicinal plant material and major production areas
(1) Characteristics of the medicinal plant material
As defined in The Japanese Pharmacopoeia or as widely acknowledged/recognized
(2) Major production areas of the medicinal plant material
The major cultivating sites in Japan and in other countries.
5. Characteristics of strain(s) for cultivation
(1) Morphological characteristics
(2) Ecological characteristics
(3) Composition of characteristic chemical ingredients of medicinal plant materials
(4) Preferred growing conditions
a) Climatic conditions
Indicated by code according to attached classifications showing:
- Daylight length
b) Soil conditions Indicated by code according to attached classifications showing:
- Soil type
- Soil conditions
suitability to fertile soil
c) Shade requirements
6. Cultivation methods
(1) Species and strains
(2) Propagation methods
a) Suitable cultivation conditions:
e) Care and management
f) Diseases and pests
g) Harvest method and procedure
h) After-harvest processing
i) Expected yield
7. Quality evaluation of the medicinal plant material
(1) National quality standard of the medicinal plant material
Defined as the quality and quantity standard given in The Japanese Pharmacopoeia or Japanese Standards for Herbal Medicines.
(2) Name of major chemical constituents
As indicators for quality evaluation.
(3) Chemical structure of selected major constituents
Drawings of chemical structures where appropriate.
8. Comparative summary table of the characteristics of different cultivated strains
Morphological characteristics of each strain being cultivated, including height, growth speed, morphology/shape of root, stem, leaf, flower, fruit and seed, resistance/tolerance to characteristic diseases/pests, and composition and quantitative indications of major chemical constituents of the medicinal plant material.
9. Cultivation calendar
A tabulated schedule of cultivating procedures for the medicinal plant, indicating the type of care and management work/actions and their timing during the entire cultivation process.
10. Background data and other information
(1) Origin of seed, medicinal plant, propagation material, etc.
(2) Cultivation for confirmation
To assess the appropriateness/suitability of cultivation and characteristics of seed/propagation material. Cultivation should be carried out according to the established cultivation method.
(3) Intended medical indication (s) of the medicinal plant material
(4) Names of Kampo formulae
(5) Photographs (5 - 10)
Of the medicinal plant and the medicinal plant material; also showing working methods/equipment as appropriate.
1Cultivation of medicinal plants and quality control, Vols. 1 - 10. Tokyo, Ministry of Health, Labour and Welfare Ed.. Yakuji Nippo, 1992 - 2001 (in Japanese) (17).
Geographical classification maps showing (1) warmth, (2) coldness, (3) daylight length and (4) soil type.