This study was designed to elucidate the quantities of nutrients entrapped during cholesterol removal from cream by crosslinked b-cyclodextrin (b-CD, 4-12%, w ⁄ v) and to evaluate the amounts of the residual b-CD in cholesterol-removed cream treated by crosslinked b-CD. The content of lactose in the control cream (without the treatment by crosslinked b-CD) was 2.74%, and the amounts of lactose entrapped by crosslinked b-CD ranged from 0.00 to 0.03%. The total amounts of the entrapped short-chain free fatty acid (FFA) and free amino acid (FAA) ranged from 0.04 to 0.12 ppm and from 0.37 to 0.48 lmol ⁄ mL, respectively. The amounts of the entrapped water-soluble vitamins (L-ascorbic acid, niacin, thiamine and riboflavin) ranged from 0.01 to 0.05 ppm, from 0.01 to 0.05 ppm, from 0.00 to 0.04 ppm and from 0.02 to 0.05 ppm, respectively. The entrapped amounts of nutrients mentioned above were not remarkably affected by the concentrations of crosslinked b-CD (4-12%, w ⁄ v). The very small amounts of residual b-CD in the cholesterol-removed cream were measured (1.86-6.11 ppm). Based on the data obtained from the present study, it is concluded that the amounts of entrapped nutrients were negligible during cholesterol removal from cream by crosslinked b-CD, and the amounts of residual b-CD in cholesterolremoved cream were trace.
The root of Polygala tenuifolia Willdenow has been used for the treatment of insomnia, depression, and amnesia. However, the toxicological properties of the herb have been overlooked, because it has been used for a long time for various purposes. In this study, we evaluated the preclinical safety of the root extract in rats and beagle dogs. First, the acute oral toxicity was tested in both rats and dogs. In the rats, only one female of 2 g/kg died, but no treatment-related death or clinical and gross findings were observed after the administration. No toxicological changes or mortalities related to the test substance were also observed after the administration in the dogs. Although vomiting, discoloration, or hemorrhage was found in some dogs, there were no serious abnormalities. Second, the subchronic toxicity was investigated in the rats. Two animals were found dead in the female group of 1,000 mg/kg/day, but there were no abnormal findings associated with the test substance. There also were no adverse effects on the clinical signs, body weight, and hematological and biochemical findings. Therefore, our results showed that the acute or subchronic toxicity of the root extract of Polygala tenuifolia might not be toxic to rats and dogs.
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