Development and optimization of a phytotherapeutic preparation based on traditional Japanese Kampo medicine against gastrointestinal disorders

Kampo (Japanese traditional medicine) is an integral part of the Japanese public health system. Kampo was developed in Japan based on works of ancient Chinese medicine and spurred enough innovations to be regarded as an independent tradition by 1600 AD. Since the 1960 s, traditional Kampo prescriptions – in contrast to TCM prescriptions standardised and invariable – were scientifically re-evaluated and approved as medicines. Presently, freeze-dried granules of 30% EtOH hot aqueous extracts of 148 Kampo prescriptions are covered by the Japanese health insurance. One of these is Shikunshito ( Panax ginseng root 4.0 g, Atractylodes lancea rhizome 4.0 g, Poria cocos sclerotium 4.0 g, Glycyrrhiza uralensis root 1.5 g, Ziziphus jujuba fruits 1.5 g, Zingiber officinale rhizome 3.5 g). It is commonly used against cachexia, stomach complaints, and nausea; traditionally as an aqueous decoction similar to TCM [1]. Here, a novel galenical for Shikunshito was developed in accordance with the EU directives for Traditional Herbal Medicinal Products (tHMPs). Numerous types of extracts were prepared and phytochemically compared to the traditional decoction, industrial-type 30% EtOH hot aqueous extracts, and a MeOH full extract using TLC and HPLC. Furthermore, a method was developed to reduce the content of simple oligosaccharides in the extract thus lowering the required daily dose for the patient. In contrast to the Japanese daily dose of 2.5 g extract granules 3 times daily (inacceptable for European patients), we were able to develop a novel dry extract for pelletizing, thus concentrating the common Japanese daily dose of secondary metabolites from Shikunshito in just 3 tablets per day (Convenience!). Due to the fact that Shikunshito is used in the EU in single prescription by Kampo practitioners since more than 15 years and since centuries in Japan without negative effects [1], the presented work opens the possibility to apply for its official registration as a phytopharmacon in Europe.