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[摘要]
目的 采用最大給藥量的方法觀察黃芪桂枝五物湯(浸膏)1日內(nèi)ig給予受試動(dòng)物后所產(chǎn)生的急性毒性反應(yīng),為多次重復(fù)給藥毒性試驗(yàn)的劑量、可能作用的靶器官和毒性反應(yīng)等指標(biāo)的設(shè)計(jì)及臨床劑量設(shè)計(jì)與觀察提供參考依據(jù)。方法 以受試物最大允許質(zhì)量濃度(0.6 g/mL)、小鼠最大給藥容積(40 mL/kg)1日內(nèi)ig給藥2次,連續(xù)觀察14 d內(nèi)有無毒性反應(yīng)及動(dòng)物死亡。結(jié)果 測(cè)得黃芪桂枝五物湯(浸膏)最大給藥量為48 g/kg(為臨床用量的218倍)。在此劑量下未見明顯毒性反應(yīng),14 d內(nèi)動(dòng)物無一死亡,大體解剖未見對(duì)臟器的毒性改變。結(jié)論 在本實(shí)驗(yàn)條件下,黃芪桂枝五物湯(浸膏)小鼠ig給藥的最大劑量為48 g/kg,未見該劑量對(duì)小鼠產(chǎn)生明顯的急性毒性。
[Key word]
[Abstract]
Objective Using the method with maximum amount of administration to observe the acute toxic reaction of Huangqi Guizhi Wuwu Decoction (extract) after the test animals were ig administered in one day, and to provide the reference for designing the index such as dosage of toxic test for repeated dosing, possibly functional target organ, and toxic reaction, as well as design and observation of clinical dosage. Methods Following the criterion of maximum acceptable concentration of test materials (0.6 g/mL) and maximum administration volume of mice (40 mL/kg), the mice were administrated twice per day, and there was no toxic reaction and none of the animals died during the next 14 d. Results Measured maximal dosage of Huangqi Guizhi Wuwu Decoction (extract) was 48 g/kg (218 times dosage more than that of clinical dosage). In this dose, there was no significant toxic reaction, and none of the animals died during 14 d and visceral organ had no changes by gross anatomy. Conclusion In the situation of this experiment, the optimized dosage of Huangqi Guizhi Wuwu Decoction is 48 g/kg to the mice, and the dosage could not produce the obvious acute toxic reaction.
[中圖分類號(hào)]
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