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目的:研究从日香桂根茎中获得的一新活性成分(GH-0521)的急性毒性、亚急性毒性、镇痛、抗炎作用。方法:按照新药临床前毒理学研究指导原则,以小鼠为对象对GH-0521进行急性毒性、亚急性毒性试验。采用醋酸扭体试验、二甲苯耳廓肿胀试验进行镇痛、抗炎活性研究。结果:急性毒性试验:12h内GH-0521总给药剂量为5g/kg的情况下,连续观察14天,小鼠生理状况良好,体重增长正常,无死亡现象;解剖后未发现肉眼任何明显异常。亚急性毒性试验:3个GH-0521给药组连续给药(0.09g/kg,0.18g/kg和0.27g/kg)2周,小鼠生理状况良好,体重增长正常,无死亡现象,各项血常规和主要器官脏器系数也均未见明显异常。镇痛试验:3个GH-0521给药组(0.06g/kg,0.12g/kg和0.24g/kg),观察小鼠对醋酸引起痛反应的扭体次数,计算各组小鼠对痛反应的抑制率分别为25%、39%和13%。二甲苯耳廓肿胀试验:3个GH-0521给药组(0.06g/kg,0.12g/kg和0.24g/kg),观察各组对二甲苯引起耳廓肿胀的肿胀度,计算肿胀抑制率分别为28%、33%和36%。结论:从日香桂根茎中获得一新成分GH-0521,该成分经初步试验证明无明显急性毒性和亚急性毒性,且具有一定的镇痛抗炎效果。
Objective: To study the acute toxicity, subacute toxicity, analgesic and anti-inflammatory effects of a new active ingredient (GH-0521) derived from Rhizoma. Methods: According to the guidelines of preclinical toxicology study of new drugs, acute toxicity and subacute toxicity of GH-0521 were tested in mice. Acetic acid writhing test, xylene auricle swelling test for analgesic and anti-inflammatory activity. Results: Acute toxicity test: Under the condition that the total dose of GH-0521 was 5g / kg for 12h, the mice were observed for 14 days continuously. The mice were in good physical condition with normal weight gain and no death. No obvious abnormalities were found in the naked eye . Subacute toxicity test: Three GH-0521 groups were given continuous administration (0.09g / kg, 0.18g / kg and 0.27g / kg) for 2 weeks. The mice were in good physical condition with normal weight gain and no death. Blood routine and the main organ coefficient also showed no significant abnormalities. Analgesic test: The three GH-0521 groups (0.06g / kg, 0.12g / kg and 0.24g / kg) were used to observe the number of writhing induced by acetic acid in mice. The pain response The inhibition rates were 25%, 39% and 13%, respectively. Xylene auricle swelling test: three GH-0521 groups (0.06g / kg, 0.12g / kg and 0.24g / kg) were observed in each group of xylene swelling caused by auricle swelling degree, the calculation of swelling inhibition rate Respectively 28%, 33% and 36%. CONCLUSION: GH-0521, a new component of Rhizoma Digenoides rhizome, was obtained from the rhizome of Rhizoma Dioscoreae, which has been proved to have no obvious acute toxicity and subacute toxicity through preliminary tests and has some analgesic and anti-inflammatory effects.