ACUTE AND SUB ACUTE SAFETY STUDIES OF HERBMED PLUS-A HERBAL FORMULATION IN LABORATORY ANIMALS
Keywords:
Herbmed plus, Safety profiles in animals, Swiss albino mice, Wistar rats, OECD and FDA guidelinesAbstract
Objective: To study Acute, sub-acute oral toxicity profile of Herbmed plus (HP) - A herbal formulation.
Methods: HP was derived from Crataeva nurvala Buch - Ham (Varun) bark, Musa paradisiaca Linn (Kadali/Banana) stem and roots, Achyranthes aspera Linn (Aghada) whole plant and Hordeum vulgare Linn (Yav) seeds. Above materials were converted into Varun bhavit kadali bhavit, kshars of Kadali, Aghada and Yav respectively and were mixed in certain proportions in GMP certified manufacturing facility to formulate HP capsules form remove soft gelatin. Acute and sub-acute safety profiles of HP was studied by OECD guidelines Number 423 and FDA guidelines in Swiss albino mice and Wistar rats respectively. For the acute study, HP was administered orally in a single dose of 2000mg/kg and for sub-acute study HP was administered orally using 90,180 and 450 mg/kg doses for 90 days.
Results: In an acute study there were no behavioral changes and mortality at 2000 mg/kg by the oral route in mice up to 14 days. In sub-acute study after administration of various doses of HP for 90 days to various groups; there was no significant difference in body weight, food consumption, hematology / enzyme profiles, relative organ weights and histological observations of vital organs in comparison to control animals.
Conclusion: The acute LD50 cut off for HP was found to be > 2000mg/kg in mice and No Observed Adverse Effect Level (NOAEL) for HP was found to be > 450 mg/kg by oral route for 90 days in Wistar rats.
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References
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