Formulation, standardization and pharmacological studies of Saraswataristam: a polyhedral preparation.

Ayurvedic preparations achieved paramount importance in contemporary life owing to the safety and efficacy when compared with those of synthetic drugs. But due to lack of proper standardization at each stage from starting to culmination results in inferior quality and less demand. Saraswataristam, a fermented ayurvedic preparation, has been employed for treating central nervous system disorders and dermatological problems. Saraswataristam, containing Centella asiatica (L) urban (Umbelliferae) as the major ingredient is prepared as per the Ayurvedic Pharmacopoeial specifications, characterized and standardized for determining the quality, safety and efficacy of herbs used in it. Saraswataristam was prepared and subjected to phytochemical screening by FTIR analysis and HPTLC fingerprinting, heavy metal determination by AAS, determination of alcohol content, test for E. coli, S. aureus, aerobic bacteria, yeasts and mould, oral toxicity studies and anti-epileptic activity by MES method. The physico-chemical studies showed total ash content as 1.1%, extractive values and some trace elements such as Lead, Mercury, Cadmium and Arsenic with 3.1, 0.047, 0.17 and 0.46 ppm respectively and all values are found within the acceptable limits specified by WHO. FTIR and HPTLC studies showed the presence of asiaticoside in Saraswataristam, resulting in its chemical standardization. The formulation showed signs of dose dependent significant (P<0.001) reduction in various episodes of epileptic seizures in comparison with standard phenytoin, thereby making it biologically standardized. The physico-chemical and pharmacological analysis to standardize Saraswataristam confirmed its use as a safe anti-epileptic ayurvedic formulation.