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[目的]对院内制剂前列宁胶囊进行急性毒性及长期毒性试验研究,为临床用药提供参考。[方法]应用最大耐受量(MTD)试验测定法对前列宁胶囊进行小鼠急性毒性实验;大鼠长期毒性试验连续12周灌胃给药,处死半数动物,其余动物停药进行恢复期观察2周。观察大鼠饮食、活动、体重、大小便、进食量、外观体征等情况,并进行血液、生化、病理学等检查。[结果]急性毒性实验未见明显毒性反应,MTD为133g/kg,相当于推荐临床用药量折合0.75g/kg的178倍。长毒试验结果提示,前列宁胶囊高、中、低各剂量组动物均未出现严重中毒表现,各脏器无病理性变化。[结论]前列宁胶囊急性毒性和长期毒性试验未见明显毒副作用,表明在推荐临床剂量下使用,具有较高的安全系数。
[Objective] To study the acute toxicity and long-term toxicity test of Qianling capsule in hospital before hospitalization, and provide reference for clinical medication. [Method] The acute toxicity test of Qianliening Capsule was carried out by MTD test. Rats were given gavage for 12 weeks and half animals were sacrificed. The remaining animals were stopped and observed for convalescence 2 weeks. The rats were observed diet, activity, body weight, urine, food intake, appearance and other signs, and blood, biochemistry, pathology and other tests. [Result] There was no obvious toxic reaction in acute toxicity test. MTD was 133g / kg, equivalent to 178 times of the recommended clinical dosage of 0.75g / kg. Toxicity test results suggest that Qianleining capsule high, medium and low doses of each group of animals did not appear serious poisoning performance, no pathological changes in various organs. [Conclusion] Qianleining capsule acute toxicity and long-term toxicity test showed no obvious side effects, indicating that the recommended clinical dose, with a high safety factor.