The formulations of traditional medicines used in China, India and Japan have been constructed to expect desirable treatment of diseases. The principles are based on the interaction of several crude drugs or several ingredients even in a single crude drug. Therefore, the apparent combined effects are equivalent to the sum of effects of those components which underwent addition, potentiation, subtraction and modulation. Here we provide hypothetical mathematical formulas to explain the theory of combinatorics, which successfully proved the pharmacological effects of processed single herbs and the basis of polyherbal therapies. The constructed formulas will contribute to designing new formulations together with seeking novel patterns of pharmacological actions of traditional medicines or with understanding of the mechanisms behind them.

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Anti-proliferative effect of Ginseng Radix on human premyelocytic leukemia cells (HL-60) was investigated. The 70% methanol extract (RG-ext) of Red Ginseng (steamed and dried roots of Panax ginseng C. A. MEYER) had superior activity to that (WG-ext) of White Ginseng (peeled and dried root of P. ginseng). Among major saponins of Ginseng Radix, ginsenoside-Rc (G-Rc) and -Rb₂ (G-Rb₂) exhibited significant activity, but ginsenoside-Rb₁ (G-Rb₁), -Rg₁ (G-Rg₁), -Rg₂ (G-Rg₂) and -Ro (G-Ro) were ineffective. (20S)-Ginsenoside-Rg₃ [(20S)-G-Rg₃] formed by the processing of Red Ginseng from the crude root of P. ginseng showed remarkable activity. Based on the morphological changes and the pattern of DNA fragmentation, RG-ext, (20S)-G-Rg₃, G-Rb₂, and G-Rc were found to induce apoptosis in HL-60 cells. Additionally, the effect of (20S)-G-Rg₃ was enhanced by treatment together with a water-soluble non-saponin fraction (RG-ext-W) obtained from RG-ext.

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Acute and subacute hepatotoxicity induced by barakol was investigated in mice. Blood clinical biochemistry parameters (serum AST, ALT, total bilirubin, cholesterol, triglyceride and glucose) and histopathological examination were used as criteria for liver injury. Mice were given barakol in a single dose (100, 200, 300 and 400 mg/kg, p.o.) and repeated doses (100, 200 and 300 mg/kg/day, p.o., 28 days) for acute and subacute toxicity studies, respectively. The acute and subacute hepatotoxic findings included the increase in total bilirubin, AST and ALT levels and the decrease in cholesterol, triglyceride and glucose concentrations which corresponded to the histopathological examination showing the hydropic swelling of hepatocytes, scattered degree of necrotic cells around central vein spreading to periportal zone and finally apoptotic cell death around centrilobular zone spreading to periportal area. The degree of the severity of barakol induced liver injury was dose and time dependent. The mechanism involved may be the induction of necrosis and apoptosis, resulting in the disturbance of normal liver cell function. The ultimate outcome of hepatotoxicity by barakol depended on the balance between the extent of liver cell damage and its repair. There were signs of liver regeneration and recovery in all doses of barakol treatment. Reduction of total cytochrome P450 content with unchanged protein expression of CYP 3A1 and 2E1, inhibition of mitochondrial respiration and hemolysis of red blood cells may be involved in barakol induced hepatotoxicity.

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Kshara Sutra is a medicated thread which is used in anal fistura surgical operations in Ayurveda, the Indian traditional Medicine. For the purpose of introducing Kshara Sutra therapy into Japan, which offers a better cure rate than modern surgery in India and Sri Lanka, we attempted the production of alternative Kshara Sutra by using Japanese plants and materials. We established the protocol of Kshara Sutra preparation including the use of the latex of the fig (Ficus carica L.) fruit as a binding agent instead of Snuhi (Euphorbia antiquorum L. or Euphorbia neliifolia L.), and red pepper tincture for induction of healing by granulation. In addition, we made Kshara, an alkali agent, from the plant of Achyranthes bidentata Bl. and used commercial turmeric powder and a suture with high water absorbency. This was the first Kshara Sutra in use in Japan and we named it “Kanazawa Sutra I”. and Its clinical examination is under way.

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No specific and effective treatment modality is available for patients with recurrent spontaneous abortion (RSA) who are positive for autoantibodies, and/or do not respond to the conventional allogeneic lymphocyte therapy. Sairei-to, a herbal formula, was tested to evaluate its efficacy in preventing abortion for those patients. All of 441 patients with RSA of precluded chromosomal abnormality was treated with Sairei-to before and after establishment of pregnancy. The efficacy was evaluated in the following three separate groups; Group 1 (228 patients with positive antinuclear antibodies (ANA) and/or anti-cardiolipin antibodies (ACA), Group 2 (79 patients with combined auto- and alloimmune RSA and Group 3 (134 patients with alloimmune RSA including 64 patients who did not respond to conventional alloimmunization therapy alone). In Group 1, relatively high live birth rates per pregnancy were achieved in autoimmune RSA at around 65%. In Group 2, relatively high live birth rates per pregnancy of 63 to 78% were observed in alloimmune RSA complicated with the autoantibodies. In Group 3, Sairei-to in addition to alloimmunization was successful even in alloimmune RSA which resisted against conventional alloimmunization alone with a comparably high live birth rate per pregnancy (66.7%) to that achieved in alloimmune RSA treated with alloimmunization alone (78.7%). Sairei-to is effective not only for patients with alloimmune RSA complicated with positive ANA and/or ACA but for patients with alloimmune RSA resisting against the conventional allogeneic lymphocyte therapy. Amendment of diagnostic criteria for alloimmune RSA was argued in view of T cell-mediated tolerance induction instead of B cell tolerance concept.

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[in Japanese]

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