Preclinical evaluation of Siddha Polyherbal formulation Pitha Kamalai Choornam for its Hepatoprotective activity in wistar albino rats

The trial drug Pitha Kamalai Choornam was selected from the text “Korakkar Maruththuvam” for the validation of safety, efficacy and its potency in hepatoprotective effect. The raw drugs were collected from the Ramasamy pillai shops, at Paris corner, Chennai. The raw drugs were authenticated by the Botanist and Proffesor in Gunapdam Department in Government Siddha Medical College, Arumbakkam, and Chennai-106. Various collections of Siddha and Modern science about the ingredients of the drug supported the fact of hepatoprotective activity. The shelf life of Choornam is mentioned in Siddha literature as 3 months. But the recent report has been published by the AYUSH and mentioned that the shelf life of Choornam is only 1 years. Physico-chemical Analysis: The pH of Pitha Kamalai Choornam was 5.63 which is acidic in nature. Acidic drugs are essential for Bioavailability and effectiveness. Acididic drugs are better absorbed in stomach. Hence, the drug does not produce any harmful effect to the mucus membrane of the GI tract. Choornam is one of the basic medicines in Siddha system. The medicines on this order have fine particle size and low moisture content. The fine particle size enhances the pharmacokinetic actions and the low moisture content indicates the longer shelf life period of the drug. Instrumental Analysis: Based on the results, Pitha Kamalai Choornam is preferably non-toxic to human in its therapeutic dose. The standardization of the drug was evaluated by chemical characterization with heavy metal analysis, functional group analysis, elemental analysis and determination of particle size by ICP-OES, FTIR, XRD and SEM respectively. ICP-OES reveals high concentration of K in Pitha Kamalai Choornam (44.801 mg/l). It also has physiologically important minerals like Na, Mg, P and Ca. In Pitha Kamalai Choornam the heavy metals like As, Cd, Pb and trace element like Ni were not detectable level. This reveals the safety of the drug. The FTIR results showed the presence of O-H Stretching and bend, C-H Stretching and bend, C=O Stretching as functional groups. The shift of C=O stretching frequency indicates a bounding of the calcium and oxygen nanoparticles through this group. XRD pattern of the trail drug Pitha Kamalai Choornam shows some good crystanility. The majar diffraction peaks are identified after XRD analysis. The crystalline may be due to the presence of the ingredients of the Pitha kamalai choornam. The SEM picture shown the presence of nanoparticle of size 1μm – 500 nm in the drug Pitha Kamalai Choornam. Further, the study shows that Pitha Kamalai Choornam is a kind of nanomedicine which favours the advantages of bio availability, better absorption and non toxic with minimal dose level. The Physico chemical analysis shows the presence of Calcium, phosphorus, sodium, magnesium which is physiologically important. In Pitha Kamalai Choornam the heavy metals like Arsenic, Cadmium, and Mercury were not detectable. This reveals the safety of the drug. Pharmacokinetic Aspect: The week acidic medicines were absorbed in alkaline medium. That is the Pitha Kamalai Choornam may be absorbed in small intestine. Toxicity Studies: From the acute toxicity study as per OECD guideline 423, it was concluded that the test drug Pitha Kamalai Choornam is a safest drug. No mortality was obtained. In Conclusion, no toxic effect was observed up to 400mg/kg of Pitha Kamalai Choornam treated over a period of 28 days (OECD 407). So, it can be concluded that the Pitha Kamalai Choornam can be prescribed for therapeutic use in human with the dosage recommendations of up to 100mg/kg body weight p.o. Hepatoprotective activity aginst CCl4 and Paracetamol: The present study showed that Pitha Kamalai Choornam produce protective action against the hepatotoxicity induced by CCl4 and paracetamol. The hepatoprotective role of Pitha Kamalai Choornam might be due to its chemical constituent. Pitha Kamalai Choornam produces antioxidant activity so this mechanism suggesting that the Pitha Kamalai Choornam may be useful to prevent the oxidative stress induced damage in liver. Hence Pitha Kamalai Choornam may be act as prophylactic as well as curative drug in treating hepato toxic conditions. Further studies needs to isolate the active constituents and also to evaluate the exact mechanism of action. Thus the author validated Pitha Kamalai Choornam as a new hepatoprotective drug which is cost effective and without any side effects