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心力丸的毒性试验研究

Toxicologic Study on Xinli Pill
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摘要 目的观察心力丸对小鼠的最大耐受量(Maximal tolerance dose,MTD)和大鼠的长期毒性作用,为临床安全用药提供参考依据。方法(1)最大耐受量的测定采用心力丸以最大剂量单次灌胃,观察给药后小鼠所产生的急性毒性反应和死亡情况。(2)长期毒性试验观察3个剂量组(0.4、0.2、0.1g·kg-1·d-1)每天灌胃1次,每周给药6d,连续给药3个月对大鼠产生的毒性反应。结果(1)按40ml/kg灌胃16%的心力丸混悬液,未见异常情况。(2)连续给药3个月各组动物一般状况无明显异常。结论(1)心力丸的最大耐受量大于6.4g/kg,是临床日用量的1600倍。(2)心力丸在0.4g·kg-1·d-1,相当于临床最大日用量的100倍以下剂量是安全的。 Objective To observe the Maximal tolerance dose (MTD) and the long-period toxicity of Xinli Pill (XLP) in mice and rats respectively for establish nontoxic dose to providing reference in clinical medication safety. Methods (1) MTD of XLP was tested in mice. After the mice were administered with gastric infusion of XLP with maximum dose, the acute toxicity and mortality were observed. (2) The long-period toxicity was tested in rats. After 3 groups of rats (0.4, 0.2, 0.1 g·kg^-1·d^-1) were administered with gastric infusion one time, 6 days a week and the administration 3 consecutive months, the toxicity was observed. Results (1) According to 40 ml/kg perfusion with 16% of XPL suspension, no obvious abnormalities were observed. (2) After 3 consecutive administration, there was no obvious abnormalities on the general situation of the animals. Conclusion (1) The MTD of XLP was greater than 6.4 g/kg, that is 1600 times greater than the clinical daily dose. (2) XPL in the 0.4 g·kg^-1·d^-1 (equivalent to 100 times of the maximum daily dose) and the doses be low are all safe.
出处 《今日药学》 CAS 2009年第1期21-23,共3页 Pharmacy Today
关键词 心力丸 最大耐受量 长期毒性 Xinli pill maximal tolerance dose long-period toxicity
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参考文献1

  • 1袁伯俊,王治乔主编..新药临床前安全性评价与实践[M].北京:军事医学科学出版社,1997:237.

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