Acute and Sub-acute Safety Studies of a Herbal Formulation for Urolithiasis in Laboratory Animals | Chapter 12 | Novel Aspects on Pharmaceutical Research Vol. 1

 This study stated a preclinical acuteand sub-severe safety profiles of Hermed plus (HP) were examined in laboratory mammals. This is a very effective expression developed inside. We have systematically studied the effec  in Laboratory Animals  for allure behavioral changes or death if any, hematological  limits and found  no hepato or  renal toxicity guide the sub-chronic dermal  uncovering of  investigational product  in  the  mammals. The study was conducted in female Swiss light mice utilizing OECD guidelines Number 423.HP was derived from Crataeva nurvala Buch - Ham (Varun) bark, Musa paradisiaca Linn (Kadali / Banana) stem and ancestries, Achyranthes aspera Linn (Aghada) whole plant and Hordeum vulgare Linn (Yav) seeds. Above matters were converted into Varun bhavi, kadali bhavit, kshars of Kadali, Aghada and Yav individually and were mixed in sure proportions in GMP certified production facility to plan HP capsules form.Acute and sub-severe safety characterizations of HP was studied by OECD guidelines Number 423 and FDA directions in Swiss albino rodent and Wistar rats respectively. For the severe study, HP was administered verbally in a single dose of 2000mg/kg and for substitute-acute study HP was   executed  orally utilizing S90,180 and 450mg/kg doses for 90days.In the present substitute-acute study at termination the weights of internal organs like adrenals, heart, kidneys, liver, hate, lungs, organs/ ovaries were determined and were convinced into relative % organ weight and these were distinguished with control rats.In comparison to control mammals, the subacute oral medicine with 90 mg/kg, 180 mg/kg, and 450 mg/kg of HP for 90 days to various groups of rats revealed no mortality, no behavioural alterations, and current situation in blood sketch, biochemistry parameters, or characterizations of essential organs. Hence, the NOAEL for HP in male and female Wistar rats was persistent to be > 450 mg/kg when administered verbally for 90 days.

Author(s) Details:

Suresh Patankar,
ACE Hospital and Research Centre, 32/2a, Erandwana, Pune-411004 , India.

Arvind Mujumdar,
ACE Hospital and Research Centre, 32/2a, Erandwana, Pune-411004 , India.

Please see the link here: https://stm.bookpi.org/NAPR-V1/article/view/10424