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Introduction: Ayurvedic marine drugs derived from mollusc shells and coral are regularly used by Ayurvedic physicians to treat several disease conditions like acid peptic disease, irritable bowel syndrome, osteoporosis, etc. However, standard operating procedures for manufacturing these drugs and their complete characterization have not been published in the Ayurvedic Formulary and Ayurvedic Pharmacopeia of India to date. Methods: Present study describes the traditional manufacturing process and thorough characterization using classical and advanced analytical tools. The raw materials characters, in-process parameters, and finished product specifications have been elaborated to develop monographs. Especially, the identity and purity of raw coral and pearl were checked by Raman Spectroscopy and Energy Dispersive X-ray Fluorescence analysis. Results: In the finished product analysis, the X-Ray Diffraction study revealed that incineration after trituration with Aloe barbadensis leaf pulp or rose water converted the aragonite phase of calcium carbonate into calcite phase in mother pearl, cowry, and pearl while the calcite form of raw coral was retained. The prominent bands around 1390, 870, and 712 cm-1 detected by Fourier Transform-Infrared Spectroscopy and mass loss between 39-44% (w/w) revealed by thermogravimetric analysis confirmed the carbonate form of these calcium-based drugs. The finished products were very fine grayish-white powders constituted by irregularly shaped nano-micro particulate calcium carbonate exhibiting particle size between 600 nm (D10 value) to 1.2 µm (D90 value). Conclusion: The quality control and assurance achieved in this study may be further utilized by the pharmaceutical industries to manufacture quality marine drugs and conduct efficacy studies.
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BACKGROUND: Single herb Ayurvedic lipid-based formulations of Glycyrrhiza glabra are used as oral, nasal and topical applications for reducing radiotherapy induced side effects in oral cavity cancer patients. These formulations are reported to be de-glycyrrhized, thus minimizing adverse effects of glycyrrhizin on longer consumption. Being a proprietary formulation with specific ratio of herb, lipid and liquid media, there is a need of pharmaceutical standardization and stability study to be conducted for quality control and quality assurance. OBJECTIVE: Standardization of Yashtimadhu Ghrut (YG) and Yashtimadhu Taila (YT) based on pharmaceutical characters, safety tests, chromatographic analysis and stability study. MATERIAL AND METHODS: Two formulations viz., YG and YT were prepared using cow's ghee and sesame oil, respectively. Basic physicochemical analysis, Thin Layer Chromatography, High Pressure Liquid Chromatography of glabridin and 18-ß glycyrrhetinic acid, microbial load and heavy metal analysis were performed. Long term (0,3,6,9,12 months) as well as accelerated (0,3,6 months) stability study was conducted and extrapolated shelf-life was calculated for both the drugs. RESULT: Organoleptic and basic physicochemical characters were comparable for both the products while safety parameters were within permissible limits. Extrapolated shelf-life was deduced as 1.74 and 0.67 years for YG and YT, respectively. CONCLUSION: Single herb- G. glabra based lipid formulations were standardized and monographs were established. Shelf-life, though complying with classical Ayurvedic texts, indicates further research work with respect to pre-treatment of lipids and packaging systems for its enhancement.
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BACKGROUND: Ethno-medical claims indicate that leaf of Holoptelea integrifolia (Roxb.) Planch is being used in pain, inflammatory conditions by the Koya tribes. AIM: To evaluate and compare the anti-inflammatory and analgesic activity of leaves of H. integrifolia in powder and decoction forms. MATERIALS AND METHODS: The leaves of H. integrifolia were made into powder and decoction form using guidelines mentioned in Ayurvedic Pharmacopeia of India. The anti-inflammatory activity of test drug was evaluated against carrageenan and formalin induced paw edema and analgesic activity with formalin induced paw licking and tail flick response using Wistar albino rats. RESULTS: Administration of leaf powder showed insignificant inhibition of carrageenan induced paw edema at 1 h (21.62%) compared to the control group. Administration of decoction of leaves showed insignificant inhibition of carrageenan induced paw edema at 1 h (18.12%) and 3 h (9.78%). Administration of leaf powder decreased the paw edema at 24 h (37.65%) and 48 h (66.30%) while treatment with leaf decoction showed apparent decrease in paw edema at 24 h (13.68%) and 48 h (52.42%) but failed to reach at significant level of formalin induced paw edema in rats. The test drugs did not produce any effect on radiant heat induced pain in rats and formalin induced paw licking response. CONCLUSION: Leaf decoction of H. integrifolia has better anti-inflammatory activity than leaf powder while they have not shown significant analgesic effects in both the experimental models.