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INTRODUCTION
A traditional Ayurvedic composition, Panchatikta Ghrita Guggulu tablets are used to treat inflammatory conditions that impact the skin, bones, and joints. Guggulu (Commiphora wightii) and medicated Ghrita are blended with five Tikta (bitter) herbs-Guduchi (Tinospora cordifolia), Patola (Trichosanthes dioica), Kantakari (Solanum xanthocarpum), Vasa (Adhatoda vasica), and Neem (Azadirachta indica). The medicated ghee used to treat the diseases of Vataroga, Sandhigata Vata, Asthimajjagata Vata, and Kushta (Kariga, 2021).
To assess efficacy, purity, and safety in light of the growing demand for Ayurvedic medications, strong quality standards must be established. As a result, this study assessed the Panchatikta Ghrita Guggulu tablets for physicochemical characteristics, microbiological purity, heavy metal content, phytochemical composition, and antioxidant activity. This study was conducted to assess the phytochemical composition, quality, and safety of Panchatikta Ghrita Guggulu tablets.
MATERIALS AND METHODS
Materials
The Panchatikta Ghrita Guggulu tablets (Batch No. DU232404) were purchased from Shree Dhootapapeshwar Ltd., an Ayurvedic producer with GMP certification.
Methods
OM Pharmaceuticals Limited carried out heavy metal, physicochemical and microbiological safety analyses. The Central Research Facility, AYUSH-approved Drug Testing Laboratory for ASU Drugs, KAHER's Shri BMK Ayurveda Mahavidyalaya, Belagavi, was used to estimate antioxidant activity and total phenolic content.
Organoleptic Evaluation of Panchatikta Ghrita Guggulu tablet includes form, colour, taste, and odour. The following standard parameters were used to assess the Physicochemical parameters like pH (Government of India, 2008 Part II, Vol. 2 1st ed., p. 225), ash values (Government of India, 2008 Part II, Vol. 2 1st ed., p. 160), extractive values (Government of India, 2008 Part II, Vol. 2 1st ed., p. 160), TLC fingerprinting (Government of India, 2008 Part II, Vol. 2 1st ed., p. 164), hardness (Boshhiha AM, 2018), friability (Boshhiha AM, 2018), disintegration time (United States Pharmacopeia (USP), 2019), and loss on drying (Table 1). The Microbial Limit Test (Ministry of Health, Labour and Welfare, Japan. (n.d.)) was used to identify the overall microbial load and microbial contamination (Table 2). Heavy Metal Analysis (Pb, Hg, As, and Cd) was performed using AAS (Sardans, 2010). The Folin–Ciocalteu technique was used to calculate the total phenolic content, which was then represented as gallic acid equivalents (mg GAE/g). (Laoung-on J) Ascorbic acid was used as the standard in the DPPH radical scavenging experiment to assess antioxidant activity (Brand-Williams et al., 1995).
| Test | Observation | Limits |
|---|---|---|
| Loss on drying (105°C), | 4.24% w/w | Yellowish Brown to dark brown colour, round bioconvex coated tablet having SDL mark on one side |
| Friability | 0.00% w/w | Not more than 8% w/w |
| disintegration time | 28 min | Not more than 1% w/w |
| hardness | 4.8 kg/cm2 | Not less than 1.5 kg/cm2 |
| Thickness | 5.13 mm | 5.0 +/- 0.5 mm |
| pH (1% aqueous solution) | 6.07 | 5.0 – 7.0 |
| Ash | 22.62% w/w | Not more than 25% w/w |
| acid-insoluble ash | 2.25% w/w | Not more than 3% w/w |
| water-soluble extractive | 52.48% w/w | Not less than 35% w/w |
| alcohol- soluble Extractive | 27.12% w/w | Not less than 11% w/w |
| TLC fingerprinting | Complies | Unique fingerprints comparable to standard TLC |
| specified Micro-Organisms | Results |
|---|---|
| E. coli Absent | Absent/g |
| P. aeruginosa | Absent/g |
| Salmonella sp. | Absent/g |
| Staphylococcus sp. | Absent/g |
| Total Microbial Plate Count (TPC) | 2.1X103 c.f.u./g |
| Total Yeast and Mould Count (TYMC) | <10 c.f.u./g |
RESULTS
The results of the organoleptic and physicochemical parameters comply the standard guidelines. The results are tabulated in Table 1.
Microbial analysis of Panchatikta ghrita Guggulu tablet shows that the total bacterial and fungal counts were within API and WHO allowed limits, confirming the absence of hazardous infections by microbial analysis, the results were incorporated in Table 2.
Heavy metal analysis
Analysis of heavy metals showed that cadmium (<0.1 ppm), lead (0.374 ppm), mercury (0.21 ppm), and arsenic (0.34 ppm) were all within acceptable safety limits.
Total Phenolic Analysis
The extract's total phenolic content was 12.08 ± 0.32 mg GAE/g (Table 3).
| Extract | Concentrations (mg) | Mean Concentration Result | ||
|---|---|---|---|---|
| Hydro-alcoholic Extract (cold) | I | II | III | (12.08 ±0.32) mg GAE/g of Extract, GAE-Gallic Acid Equivalent |
| 12.42 | 12.05 | 11.78 |
A dose-dependent radical scavenging action was shown by antioxidant activity, with the highest inhibition (81.23%) occurring at 1000 μg/mL. Table 4 shows the results of the 2,2-Diphenyl-1-picrylhydrazyl (DPPH) assay used to assess the antioxidant activity of Panchatikta Ghrita Guggulu tablets (Table 4).
| Concentration μg/mL | % Radical Scavenging activity |
|---|---|
| 31.25 | 59.2 |
| 62.5 | 58.93 |
| 125 | 60.79 |
| 250 | 63.74 |
| 500 | 71.53 |
| 1000 | 81.23 |
DISCUSSION
Panchatikta Ghrita Guggulu tablets were found to fulfill acceptable requirements for Ayurvedic formulations based on the physicochemical parameters. Pharmaceutical stability and appropriateness for therapeutic use are indicated by low moisture content, sufficient hardness, and total disintegration within 28 min. TLC fingerprinting verified the components' genuineness, and extractive values point to a robust phytoconstituent profile.
The microbiological safety ensures by the absence of E. coli, Pseudomonas aeruginosa, Salmonella and Staphylococcus aureus. The formulation's safety for ingestion was confirmed by the total microbial and fungal counts, which were well within acceptable limits.
The measured heavy metals (Pb, Hg, As, and Cd) were found to be well within WHO and API requirements by heavy metal analysis. This assures that the formulation is safe for long-term therapeutic usage and free of toxicological hazards.
The presence of phenolic compounds, which are known for their anti-inflammatory, antioxidant, and free radical scavenging properties, was confirmed by the hydroalcoholic extract's total phenolic content of 12.08 ± 0.32 mg GAE/g extract.
The results of the DPPH showed a definite capacity for radical scavenging that was dose dependent. The effect increased significantly at increasing dosages (71.53% at 500 μg/mL and 81.23% at 1000 μg/mL), however modest activity was observed at lower concentrations (59–61% inhibition at 31.25–125 μg/mL).
The poly herbal formulation's phenolic chemicals, flavonoids, and bioactive phyto constituents work in concert to provide the reported antioxidant activity. These results corroborate the traditional claims made by Panchatikta Ghrita Guggulu in the treatment of degenerative and inflammatory disorders in which oxidative stress is a major factor.
CONCLUSION
The present study demonstrates that Panchatikta Ghrita Guggulu tablets meet all required safety, effectiveness, and quality standards. The pharmaceutical stability and safety of the formulation were validated by physicochemical, microbiological, and heavy metal studies. Its traditional medicinal uses in inflammatory and degenerative diseases are further supported by its high phenolic content and noteworthy antioxidant capability. In order to assure the safe integration of Ayurvedic medicines into contemporary healthcare systems, this thorough study emphasises the significance of strict quality control and scientific validation.