Chronic toxicity study of Sameera Pannaga Rasa in Charle's foster albino rats

Sameera Pannaga Rasa (SPR) is a Kupi Pakwa Rasayana (a mercurial-arsenical formulation of Ayurveda prepared by specific pharmaceutical-controlled, indirect heat treatment [sand bath] in glass bottle) that contains Shodhita Parada (processed mercury), Shodhita Gandhaka (processed sulfur), Shodhita Haratala (processed arsenic trisulfide), Shodhita Somala (processed arsenic oxide) and Shodhita Manahshila (process arsenic disulfide) in equal quantity as ingredients. Parada, Haratala, Manahshila and Somala are highly potent minerals which are included in the Drug and Cosmetic Act 1940 under Schedule E1 because of their toxic nature in crude form.

In the present study, SPR was evaluated for safety profile through its chronic toxicity study in Charle's foster albino rats. The test drug was made into suspension in vehicle (4 ml honey and 7 ml distilled water). The test drug was administered orally once a day for 90 consecutive days in the dose of 11.25 (therapeutic dose [TED]), 56.25 (5 times TED) and 112.25 mg/kg (10 times TED). Animals were sacrificed on 91^st day and animals of recovery group were sacrificed on 121^st day. Parameters such as hematological, serum biochemical, and histopathology of various organs were studied.

Test drug at a higher dose level and recovery study showed no toxic effect in albino rats during chronic toxicity study.

SPR is found to have no toxic effect in albino rats during the repeated dose, oral, chronic toxicity study of 90 days, even at 10 times therapeutic equivalent dose (112.25 mg/kg) and even during recovery period of 1 month. It may be safety used at TED level.