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Tytuł pozycji:

[Study on safety of Tibetan medicine zuotai and preliminary study on clinical safety of its compound dangzuo].

Tytuł :
[Study on safety of Tibetan medicine zuotai and preliminary study on clinical safety of its compound dangzuo].
Autorzy :
Li C
Wang DP
Duo J
Duojie LD
Chen XM
Du YZ
Yang HX
Zheng ZY
Yu MJ
Wei LX
Pokaż więcej
Źródło :
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica [Zhongguo Zhong Yao Za Zhi] 2014 Jul; Vol. 39 (13), pp. 2573-82.
Typ publikacji :
English Abstract; Journal Article; Research Support, Non-U.S. Gov't
Język :
Chinese
Imprint Name(s) :
Publication: Beijing : Zhongguo yao xue hui : Zhongguo Zhong yi yan jiu yuan Zhong yao yan jiu suo
Original Publication: [Beijing] : Zhongguo yao xue hui : [Zhongguo Zhong yi yan jiu yuan Zhong yao yan jiu suo, 1989-
MeSH Terms :
Drugs, Chinese Herbal/*toxicity
Adult ; Animals ; Clinical Trials as Topic ; Drugs, Chinese Herbal/analysis ; Drugs, Chinese Herbal/pharmacokinetics ; Female ; Humans ; Kidney/drug effects ; Liver/drug effects ; Male ; Medicine, Tibetan Traditional ; Mice ; Middle Aged ; Rats ; Rats, Wistar ; Young Adult
Substance Nomenclature :
0 (Drugs, Chinese Herbal)
Entry Date(s) :
Date Created: 20141004 Date Completed: 20141028 Latest Revision: 20141003
Update Code :
20210210
PMID :
25276985
Czasopismo naukowe
Zuotai (gTso thal) is a typical representative of Tibetan medicines containing heavy metals, but there is still lack of modem safety evaluation data so far. In this study, acute toxicity test, sub-acute toxicity test, one-time administration mercury distribution experiment, long-term mercury accumulative toxicity experiment and preliminary study on clinical safety of Compound Dangzuo were conducted in the hope of obtain the medicinal safety data of Zuotai. In the acute toxicity test, half of KM mice given the lethal dose of Zuotai were not died or poisoned, and LD50 was not found. The maximum tolerated dose of Zuotai was 80 g x kg(-1). In the subacute toxicity test, Zuotai could reduce ALT, AST, Crea levels in serums under low dose (13.34 mg x kg(-1) x d(-1)) and medium dose (53.36 mg x kg(-1) x d(-1)), with significant difference under low dose, and increase the levels of ALT, AST, MDA, Crea in serums under high dose (2 000 mg x kg(-1) x d(-1)); besides, the levels of BUN and GSH in serums reduced with the increase in dose of Zuotai, indicating a significant dose-effect relationship. In the one-time administration distribution experiment, the content of mercury in rat kidney, liver and lung increased after the one-time administration with Zuotai, with a significant dose-dependent relationship in kidney. In the long-term mercury accumulative toxicity experiment, KM mice were administered with equivalent doses of Zuotai for 4.5 months and then stopped drug administration for 1.5 months. Since the 2.5th month, they showed significant mercury accumulation in kidney, which gradually reduced after drug withdrawal, without significant change in mercury content in liver, spleen and brain and ALT, AST, TBIL, BUN and Crea in serum. At the 4.5th month after drug administration, KM mice showed slight structural changes in kidney, liver and spleen tissues, and gradually recovered to normal after drug withdrawal. Besides, no significant difference in weight gain was found between the Zuotai group and the control group. According to the findings of the clinical safety study of Dangzuo, after subjects administered Dangzuo under clinical dose for one month, their serum biochemical indicators, blood routine indicators and urine routine indicators showed no significant adverse change. This study proved that traditional Tibetan medicine Zuotai was slightly toxic, with a better safety in clinical combined administration and no adverse effects on bodies under the clinical dose and clinical medication cycle. However, long-term high-dose administration of Zuotai may have a certain effect on kidney.

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