Quality control of an antipsoriatic ayurvedic herbal Formulation: Lajjalu Keram

Background: Psoriasis is an autoimmune disorder, which affects a large group of human population of world (3%). Till date, there is no treatment for psoriasis except some herbal drugs and its constituents. Since Ayurveda is the main traditional system of medicine in India, here, we have selected one ayurvedic formulation - Lajjalu Keram, which has been used since long for their quality control. Methods: Total microbial load of formulations were carried out for total fungal count and total bacterial count. Lajjalu Keram was also tested by high-performance liquid chromatographic (HPLC) for aflatoxins (B1, B2, G1, and G2), which showed its presence below the permissible limit; similarly, pesticides residues were analyzed using gas chromatography/mass spectrometry for organophosphates and organochlorides, which showed that pesticides were below detection limit (0.1 ppb). The content of heavy metals was analyzed using AAS, which demonstrated the presence of cadmium, lead, and arsenic below permissible limit, whereas mercury was found absent. Results: The result of quality control analysis showed the presence of alkaloids, tannins, carbohydrate, saponins, proteins and amino acids, lipid/fats, phenolic compounds, and flavonoids in formulation. The dermal toxicity (LD50) of Lajjalu Keram in Wistar rats was found more than 2000 mg/kg (safe for the management of psoriasis). Formulation was also analyzed for their composition of fatty acids. It was found to have 13 fatty acids, out of which, seven were saturated fatty acids (95.2%) and the rest were unsaturated fatty acids (3.27%). A rapid HPLC method for quantification of mimosine (an unusual amino acid present in formulation) has been developed and validated. The mimosine content in Lajjalu Keram was found to be 0.0070% w/w with % relative standard deviation of 0.41. Conclusion: The formulation afforded significant and better protection of carrageenan-induced rat paw edema (72.11% inhibition) as compared to control. The shelf life studies on antipsoriatic herbal formulations were carried out for 6 months at different time intervals. No significant variation in analysis parameters was observed on the storage of formulations up to 6 months. The assay of constituents using mean curve of sigma plot showed 44.2 month of shelf life for Lajjalu Keram.