In contrast to kampo medicines, Japanese folk medicines generally use a
single Japanese herb, and its decoction has been taken orally for the treatment
without any theoretical basis.
Quality control
Kampo extract pharmaceutical preparations, such as the granule form, have
been quality controlled by good manufacturing practice (GMP) guidelines
since 1988.
The Japanese pharmacopoeia
The pharmacopoeia of Japan lists 165 raw herbs used in kampo formulations
and theJapanese Herbal Medicine Codexlists an additional 83 items.^4 For
each herbal material listed in these two documents, the plant origin, physical
properties and criteria for identification with respective testing methods are
rigorously specified. Eleven kampo formulae have also been introduced into
the Japanese pharmacopoeia. As natural plants, animal and mineral materials
have been used as the raw material of ingredients in the pharmaceutical
preparation, the quality control of these raw materials is required. This
control includes the selection of high-quality herbs and their quality control
including limits of contamination by pesticides and heavy metals, which are
evaluated by morphological and physicochemical methods.
Quality
Quality control of herbs must be conducted by a qualified person who has
special knowledge and experience with medicinal herbs. Preservation of
herbs is very important for quality control. Process control and quality
control for manufacturing of the final pharmaceutical preparation are also
carried out in Japan.
As kampo formulae and their component herbs (crude drugs) contain
multi-constituents, three-dimensional high-performance liquid chromatog-
raphy (HPLC) analysis has recently been developed to compare the overall
pattern of constituents through finger-printing analysis, in addition to the
qualitative and quantitative analysis of the particular constituents that are
specific in the herbs.
Evidence of effectiveness
Pharmacological studies
Although long-term clinical experiences suggest efficacy and safety, the
mechanisms of action and active principles of kampo medicines have yet to
be clarified scientifically.
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