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. (c) 2010 Elsevier Ireland Ltd. All rights reserved.
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. (c) 2010 Elsevier Ireland Ltd. All rights reserved.
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