目的：研究一种含木香超临界提取物软胶囊的安全性及对胃黏膜损伤保护作用。方法采用MTD法以20 g/kg BW进行小鼠急性毒性试验；以10、5、2.5 g/kg BW三个剂量进行小鼠骨髓微核及精子畸形试验；以5000、1000、200、40、8微克/皿5个剂量进行Ames试验；以0.83、0.625、0.417 g/kg BW三个剂量进行30 d喂养试验；以0.25、0.08、0.04 g/kg BW三个剂量进行胃黏膜损伤保护性研究。结果该软胶囊雌、雄性小鼠MTD＞20.0 g/kg BW，属无毒级；小鼠骨髓细胞微核试验、精子畸形试验及Ames试验结果均为阴性，无致突变性；30 d喂养试验未见任何异常表现；0.25，0.08 g/kg BW两个剂量组大鼠与模型对照组比较胃黏膜损伤面积明显降低（P<0.01），损伤抑制率明显增加（P<0.01）。结论该软胶囊未见毒性，且在一定剂量范围内对胃黏膜损伤有保护作用。%Objective To study the safety and protective effect to gastric mucosal damage of soft capsule including supercritical extract of Aucklandia. Methods Use the way of maximum tolerated dose 20 g/kg BW to do the acute toxicity test with mice;Use the dose of 10, 5, 2.5 g/kg BW to do marrow micronucleus and teratospermia test with mice;Use the dose of 5000, 1000, 200, 40, 8μg/dish to do the Ames test. Use the dose of 0.83, 0.625, 0.417 g/kg BW to do the 30 days feed test with rat;Use the dose of 0.25, 0.08, 0.04 g/kg BW to study protective effect after gastric mucosal damage with rat. Result The MTD of this soft capsule is over 20 g/kg BW, it is in non-toxic level. We get the negative result in marrow micronucleus and teratospermia test and Ames test, it means non-mutagenicity. Abnormal phenomenon were not be seen in the 30 days feed test. In the test of protective effect after gastric mucosal damage with rat, we can see obvious reduce of gastric mucosal damage area and marked increase of damage inhibition ratio with the dose of 0.25, 0.08 g/kg BW compared with model-control group. Conclusion This kind of soft capsule is safe and can protect the gastric mucosal damage with some range of dose.
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