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鼠类中藏丹参乙醇提取物的急毒和亚急毒研究。

Acute and subacute toxicity of ethanol extracts from Salvia przewalskii Maxim in rodents.

机构信息

Department of Pharmacology, School of Chemical Biology & Pharmaceutical Sciences, Capital Medical University, Youanmen, Beijing 100069, China.

出版信息

J Ethnopharmacol. 2010 Aug 19;131(1):110-5. doi: 10.1016/j.jep.2010.06.012. Epub 2010 Jun 16.

Abstract

AIM

The present investigation was carried out to evaluate the safety of the lipid-soluble ethanol extracts from rhizome of Salvia przewalskii Maxim (SPM) by determining its potential toxicity after acute and subacute administration in rodents.

MATERIALS AND METHODS

For the acute study, SPM extract was administered to mice in single doses given by gavage, intramuscular and intraperitoneal route. General behavior adverse effects and mortality were determined for up to 14 days. In the subacute study, the extract was administered orally at doses of 0, 50 and 250 mg/kg daily for 30 days to rats. Body weight, heart rate, blood pressure, biochemical and hematological parameters were determined at the end of 0, 15 and 30 days of daily administration.

RESULTS

In acute study, SPM extract caused dose-dependent general behavior adverse effects and mortality. The no-observed adverse effect levels (NOAEL) of the extract were 1723, 288 and 500 mg/kg, when given by gavage, intramuscular and intraperitoneal routes, respectively, and the lowest-observed adverse effect levels (LOAEL) were 1981, 840 and 781 mg/kg. Mortality increased with increasing doses, with LD(50) of 2547.8, 901.3 and 780.8 mg/kg for the oral, intramuscular and intraperitonal administration. In subacute study, daily oral administration of SPM extract for up to 30 days did not result in death or significant changes in the body weight, heart rate and blood pressure, hematological and mainly biological parameters. In biological analysis, some significant changes occurred, including total protein and albumin, glucose and triglycerides, indicating that SPM extract has lipid-modulating activity.

CONCLUSIONS

SPM extract was found to be low or non-toxic when acute toxicities and subacute toxicities in rodents. In view of the doses of the components consumed in traditional medicine, there is a wide margin of safety for the therapeutic use.

摘要

目的

本研究旨在通过测定脂溶性乙醇提取物(来源于藏药丹参 Salvia przewalskii Maxim 根茎)在啮齿动物体内的急性和亚急性给药后的潜在毒性,来评估其安全性。

材料和方法

在急性研究中,通过灌胃、肌肉内和腹腔内途径单次给予藏药丹参提取物,观察小鼠的一般行为不良反应和死亡率,时间长达 14 天。在亚急性研究中,以 0、50 和 250mg/kg 的剂量经口给予提取物,每天 1 次,连续 30 天,以评估大鼠的体重、心率、血压、生化和血液学参数。在每天给药 0、15 和 30 天后的第 30 天结束时进行这些参数的测定。

结果

在急性研究中,藏药丹参提取物引起了剂量依赖性的一般行为不良反应和死亡率。当通过灌胃、肌肉内和腹腔内途径给予时,提取物的无观察到不良效应水平(NOAEL)分别为 1723、288 和 500mg/kg,最低观察到不良效应水平(LOAEL)分别为 1981、840 和 781mg/kg。死亡率随着剂量的增加而增加,口服、肌肉内和腹腔内给药的 LD50 值分别为 2547.8、901.3 和 780.8mg/kg。在亚急性研究中,连续 30 天每天经口给予藏药丹参提取物不会导致死亡或体重、心率和血压、血液学和主要生物学参数的显著变化。在生物分析中,出现了一些显著变化,包括总蛋白和白蛋白、葡萄糖和甘油三酯,这表明藏药丹参提取物具有调节脂质的活性。

结论

藏药丹参提取物在啮齿动物体内的急性和亚急性毒性试验中表现出低毒性或非毒性。鉴于传统医学中所消耗的成分剂量,其治疗用途具有很大的安全性。

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