Volume 1, Special Edition | Current Kampo Medicine 2005

148 Prescriptions of Kampo Medicine in
Medical Insurance
Kampo or Chinese herbal medicinal preparations for ethicaluse are pharmaceutical Kampo products including classicalprescriptions of Chinese herbal extracts, pills, powders etc.
These are made through manufacturing processes involving theextraction of essences by boiling them down in water, recovery inpowder form, and the addition of excipients before theirconversion to pharmaceutical preparations. The term “ethicaluse” implies that these pharmaceutical preparations areregistered in the Drug Price List for National Health
Insurance(NHI). They can, therefore, be prescribed by Japanesephysicians at their discretion for daily medical use under thehealth insurance system. Kampo preparations have a long
historical background in Japan where traditional Chinese
herbal medicines have been used for more than ten centuries.
Today there is a heavy demand among the Japanese for theseprescriptions and the benefits they can offer, all covered under
the national health insurance system for ordinary medical use.
In 1976 the use of Chinese herbal preparations under thenational health insurance system was approved for the first time,
except for 6 formulations which were approved in 1967. Today,
148 registered formulations of Kampo prescriptions areavailable.

History of Chinese herbal preparations for ethical use
The development of ethical Kampo preparations waspossible because Chinese herbal medicines had already beencommercially available as extracts in the generalpharmaceutical market.
Research to develop extracts of Chinese medicinal herbs
was first initiated with 4 formulations of Minor Bupleurum
Decoction (xiao chai hu tang) etc. These were prepared forclinical trials by Takeshi Itakura in the 1940s. After World War
II, Hosono, Sakaguchi et al. of the Seikoen Hosono Clinic,
conducted further studies aimed at developing commercial
products from them in the 1950’s. Although the resulting
products attracted a highly favorable clinical evaluation they
were not actually marketed.
In the 1950’s, pharmaceutical scientists and manufacturers
began further research for the development of extract
preparations. A number of extract preparations made by certain
pharmaceutical companies made their way into the OTC market
around 1957, and were commercially promoted at drug stores.
Around that time, Chinese herbal medicines achieved a highdegree of popularity, with many people buying and taking these
old remedies in the guise of new drugs at pharmacies.
However, general practitioners did not accept these Kampo
preparations for prescription because they were not yet
approved for use under the national medical insurance scheme.
In 1967, 6 products supplied by Kotaro Kampo Pharmaceuticals
were accepted for registration in the NHI Drug Price List, butwere less successful in gaining widespread acceptance by thepublic. This was partly because they were not generally known
and partly because they had not been used within the Chinese
medicine establishment.

Chinese herbal preparations began to be available within thenational health insurance system in 1975, and 43 formulations
were approved for registration. Since then, thanks to the efforts of
the Japan Society for Oriental Medicine and of thepharmaceutical companies, they have gradually come to be widelyaccepted among general clinicians.
Many other Kampo
formulations were newly registered in the NHI Price List, so thatthe total of currently registered Kampo products is now 148.

Manufacturing Methods and Product Forms
Traditional Chinese herbal medicines are sold in various
product forms. Decoction is the most common, followed by pills
and powders. In Japan, Chinese herbal preparations are
manufactured by extracting them from a crude drug mixture
containing the relevant ingredients with hot water. The extract
is then isolated using spray dryers for ultimate conversion to thepharmaceutical preparations. The most commonly employed
excipient is lactose. Starch is also used, but less frequently.
The preparations are marketed in various forms:
Powders
Fine granules
CapsulesPillGranules
Tablets
Ointment

Of these forms, the first three are the most common on themarket. Pharmaceutical companies tend to prefer certain forms
for their proprietary products. For instance, Tsumura offers
granule preparations, and Kanebo fine granules. Somecompanies are presenting some of their products in tablets. Only
Kotaro employs the capsule form on a limited scale for its Coptis
Detoxification Decoction, Ephara, Aconite and Manchurian
Wildginger Decoction, etc.
These Kampo preparations are produced according tomanufacturing methods approved by the Ministry of Health,
Labor and Welfare; and are subject to strict regulatory control interms of concentration, composition and other quality
requirements.
Among the classical preparations preparations, for example
Angelica and Peony Powder or Cassia Twig and Tuckahoe Pill
were developed as powders or pills. Ethical Kampo preparations,even if their original form was a powder or pill, are without
exception preparations obtained as extracts from hot water. The
reason for this procedure is, that it eliminates bacteria or fungicontained in the crude drugs and markedly decreases theconcentration of heavy metals and pesticides. Microorganisms
and fungi are killed and the concentration of heavy metals andpesticides decreased during extraction to one tenth of theirinitial concentration.
The additional combination of chemical substances withextracted Chinese herbal essences is not performed, because it isrequired to maintain the purity of the contained essences. Inview of the need to ensure the purity of the essences contained in
the preparations, no crude powder admixture to the product isadmissible.

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

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