Volume 7, Number 4 | Winter 2012

EditorialKey Issues for Quality Control of Natural Medicinal Products
Traditional medicines have been utilized worldwide. Key issues on using the medicines in a modern
medical care system are described below.
In general, a medicinal product consists of an active principle (active pharmaceutical ingredient: API) andadditives, and quality evaluation is made for them. An API plays a central role in a medicinal product. It
is evaluated from various points of view such as description, identification (e.g. UV, IR and qualitative
tests), pH, melting point, purity (e.g. clarity and color of solution, heavy metals, fingerprinting for relatedsubstances), loss of drying, residue of ignition, and assay in a Western medicine. On the other hand, all ofsuch test items cannot be adopted for traditional medicines because of special circumstances in naturalproducts. Under these circumstances, there are two premises in using traditional medicines in a modern
medical care system; i.e. (1) equivalency between modernized traditional medicines (e.g. extract products)
and ancient ones (e.g. decoction), and (2) quality evaluated by modern science.
(1) Modernized traditional medicines shall be assured equivalent to ancient ones. Historical facts ofmanufacturing processes from an era to another, adoption of manufacturing processes in classicaltexts, and confirmation of equivalency between modernized traditional medicines and ancient ones
can link the past with the present and can assure efficacy and safety of modernized traditional
medicines. In Japan, extract products, whose quality is equivalent to standard decoctions, have beenmarketed as Kampo extract products.
(2) Contaminants such as heavy metals, residual pesticides, and/or microorganism, and intentional
adulteration of active ingredients cause a number of human sufferings. Safety of traditional
medicines depends on quality of the products. Quality evaluation methods used for Western
medicines cannot directly be applied to modernized traditional medicines; thus, manufacturingcontrols as well as quality controls are absolutely required to obtain high-quality products.
In case of an extract product, what can be considered as an API? Is it a chemical compound, a natural raw
material, or extract? Extract is the answer in the case. Chemical compounds are ingredients of natural rawmaterials; natural raw materials are components of traditional formulas; and extract is an API of an extract
product. Quality of medicinal products depends on that of APIs and it is very important to control
manufacturing and quality of APIs; however, situations in natural medicines are complicated as shown
below.
Case A: Mixture of extracts individually obtained from raw botanical/animal/mineral materials
In this case, a finished product is considered a combination product, and “each extract” derived
from a raw botanical/animal/mineral material is an API. Quality assurance of each extract isimportant. An overall pattern of each extract should be strictly controlled.
Case B: Extract obtained from mixture of raw botanical/animal/mineral materials
In this case, a finished product can also be considered a combination product; however, “wholeextract” derived from raw botanical/animal/mineral materials is an API. An overall pattern of whole
extract should be strictly controlled.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

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Volume 7, Number 4 | Winter 2012

It is known that constituent profiles of extracts can be different between the above cases if natural materials
contain alkaloids. This is important in considering APIs. For these years, international standardization oftraditional medicines in East Asia including TCM, Kampo medicines and Korean medicines has been
facilitated; however, we have more than one way of thinking on APIs. Difference in manufacturing
processes requires different control items. We should bear in mind different targets in quality assurance oftraditional medicines.

Hiro Sasaki, Ph.D.
Visiting Scholar, Lifence General Institute
Assistant Secretary-General, The Japan Liaison of Oriental Medicine

2The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)