Zingiber cassumunar Roxb. has been used for traditional medicine, but few studies have described its potential toxicity. In this study, the acute and chronic oral toxicity of Z. cassumunar extract granules were evaluated in Sprague-Dawley rats. The extract at a single dose of 5000 mg/kg body weight did not produce treatment related signs of toxicity or mortality in any of the animals tested during the 14-day observation period. However, a decrease in body weights was observed in treated males (P < 0.05). The weights of lung and kidney of treated females were increased (P < 0.05). Treated males were increased in spleen and epididymis weights (P < 0.05). In repeated dose 270-day oral toxicity study, the administration of the extracts at concentrations of 0.3, 3, 30, 11.25, 112.5, and 1,125 mg/kg body weight/day revealed no-treatment toxicity. Although certain endpoints among those monitored (i.e., organ weight, hematological parameters, and clinical chemistry) exhibited statistically significant effects, none was adverse. Gross and histological observations revealed no toxicity. Our findings suggest that the Z. cassumunar extract granules are well tolerated for both single and chronic administration. The oral no-observed-adverse-effect level (NOAEL) for the extract was 1,125 mg/kg body weight/day for males and females.

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Rhizomes of Zingiber cassumunar have been used for many years in traditional Thai medicine as an anti-inflammatory agent. The major bioactive component of this plant is Compound D [E-4-(3', 4'-dimethoxyphenyl)but-3-en-1-ol], which is a strong smooth muscle relaxant, and has antihistamine and anti-inflammatory actions. There is, however, incomplete information available for the pharmacokinetics of Compound D in mammals. In this study, we examined the pharmacokinetic profiles of Compound D in male Wistar rats. A standardized extract of Z. cassumunar containing 4 % w/w Compound D was administered intravenously at 25 mg/kg or by oral gavage at 25, 75, or 250 mg/kg to Wistar rats. Blood, tissues, urine, and feces were collected from 0 to 48 h after dosing and the level of Compound D was determined by liquid chromatography-tandem mass spectrometry. The concentration of Compound D ranged from 10-100 µg/L, reached a maximum approximately 0.15 h after oral dosing. Compound D exhibited an excellent tissue to plasma ratio, ranging from 1- to 1000 in several organs at 1-4 h after oral dosing. Less than 1 % of unchanged Compound D was excreted in the urine and feces. Further studies on tissue uptake and metabolite identification are required to obtain complete pharmacokinetic information and to develop appropriate dosing strategies of Compound D and the standardized extract of Z. cassumunar.

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Background/purpose The 3Mix-MP formulation (a mixture of metronidazole, ciprofloxacin, and minocycline; macrogol and propylene glycol) has been used to kill residual bacteria in dentin caries. This study aimed to investigate the dentin disinfection and cytotoxicity of a novel zinc oxide (ZnO) based medicament, Z-Mix. Materials and methods Z - Mix was prepared as a prefilled syringe of materials containing mainly ZnO, incorporated with amoxicillin, ciprofloxacin, and metronidazole (1 g% of each antibiotic). Drug penetration was measured at 24 hours and 72 hours. Streptococcus mutans , Lactobacillus acidophilus , or Enterococcus faecalis were inoculated into dentinal tubules for 30 days and were then subjected to Z-Mix or 0.2% chlorhexidine (CHX) for 48 hours. Viable bacteria in the dentin were determined using fluorescence staining. Their cytotoxicity against human dental pulp cells was assessed using an MTT assay. Results Z - Mix obviously diffused into dentinal tubules and the root apex, compared to the 3Mix-MP (P < 0.05). Fluorescence staining demonstrated a reduction of viable bacteria at 100 μm and 500 μm below infected cavities after treatment with Z-mix or CHX for 48 hours. Live and dead bacteria ratios indicated that Z-Mix exhibited markedly antimicrobial effects on inoculated bacteria in dentin samples (P < 0.05). There was no significant difference in the antimicrobial property between Z-Mix and CHX (P > 0.05). An acceptable level of cytotoxicity was observed in Z-Mix and its ingredients. Conclusion Z-Mix, a soft shapeable paste containing a mixture of three antibiotics, is successfully. It can penetrate to the root apex and exhibits antimicrobial properties.