Preclinical safety evaluation of Tambira Parpam (தாம்பிர பற்பம்)

Tambira parpam is used for the treatment of Earl kuruku veekam (hepatomegaly), Nadukuvatham (Parkinson’s diseases), Maarpu selanthe (Breast tumour), Yonni putru (vaginal cancer), Gunmam (peptic ulcer), Pathavanmegam (filariasis) Naatpatta thalaivali (chronic headache) & etc as mentioned in the Siddha literature. The raw drugs were procured from farms and shops. They were identified and authenticated by Botanist, National Institute of Siddha. The Raw drugs were purified and the medicine was prepared as mentioned in the Siddha literature. On organoleptic examination, the finished product seems to be grey in colour and crystalline in nature. In physicochemical analysis of Tambira parpam, the pH was found to be in 8.97% with a loss on drying at 1050C of 1.9160 % w/w.Total Ash value, Acid insoluble Ash value, Water, and Alcohol Soluble Extractive values reveal the purity of the test drug. Qualitative Analysis of Tambira parpam demonstrates the presence of Chloride, Phosphate, Iron, and Alkaloids. Results of AAS confirm that the heavy metals were within the permissible limits in Tambira parpam, but copper content was present in 11.139 ppm level. SEM result confirms the presence of nano-sized, spherical shaped particles ranging between 10.17nm to 22.9μm, with a smooth surface in evenly distribution. Thermogravimetric analysis of Tambira Parpam Weight of the final residual matter was observed as 3.307 mg with 75.14% of residual volume. The X-ray diffraction pattern of Tambira Parpam result of the present XRD analysis it was concluded that the elemental composition of Tambira parpam confirms the presence of CuO at its stable state. Further, copper is the major component of the herbo-mineral formulation Tambira parpam in oxide form. Analysis of Tambira parpam by Fourier transform infrared spectroscopy (FTIR) revealed the Infrared absorption pattern of CuO stretching was observed in the region of 523.16 cm−1 to 691.53 cm−1 they a functional group of CuO, O-H group, Primary amino group and C=C group, CH2 Bending and CH2 deformation also observed in FTIR. This study also confirmed the presence of CuO in Tambira parpam. The toxicological evaluations were conducted as per OECD guidelines 423 & 407 for safety evaluation of Tambira parpam. In acute toxicity study, no signs of toxicity and mortality were observed throughout the study period up to the dose of 2000mg/kg body weight. Thus, the LD50 value of Tambira parpam was found to be greater than 2000 mg/kg body weight and classified as Category 5. In 28days Repeated dose Oral Toxicity Study, there was no significant changes in behavioral signs, food intake, water intake, Lipid Profile, Renal parameters hematological parameters (except WBC), and Hepatic parameters except that of SGOT and SGPT. The liver function test conducted at the end of the study, test groups (Low, Mid, High dose) revealed significant changes in level of liver parameters, when compared with control group animals. But the SGPT level of post retrieval animals were Normal limits compared to control group. There is no significant changes occurs in Satellite group. In Post retrieval group, both the Haematological and Hepatic parameters were observed in normal range. In organs of Control group, no abnormality was detected. The histopathological changes were noted in liver and renal tissue at the dose level mid and High dose treated group. At the same time the normal histological structure present in post retrieval group of animals. The above studies explained the qualitative of drug and presence of CuO in the study drug. They nanoparticles were also excises in the test drug by studding various analytical methods. From the safety study revealed that the high dose treated animals had some minimal pathological changes, but post retrieval animals had normal physiological parameters. So the drug may be eliminated after completion of the treatment period of the animals. These findings were crave the safety uses of the metallic preparation used in Siddha system of medicines. CONCLUSION: Tambira parpam had been used by Siddhars for long time to treat various diseases such as Peptic ulcer, Breast tumour, Parkinson’s diseases, hepatomegaly, vaginal cancer. Since Copper is present in Oxide form in Tambira parpam, which is observed by the quantitative analysis, the drug can be easily absorbed in intestine. Acute toxicity study shows that the test drug can be used up to the dose of 2000mg/kg bodyweight as a single dose. As per Siddha literature, the test drug was used as a minimal dose medicine. Though administration of 200 mg/kg b.wt and 400 mg/kg b.wt Tambira parpam produces mild elevation of WBC and SGPT in Group Mid and High dose group of animals, no notable abnormalities were observed in Satellite group of animals. Hence, we conclude that the dosage of Tambira parpam, 1.5mg twice a day narrated in Theran yemaha venba is a safer therapeutic dose for uses of human. The author hopes that this study will be a footprint to future research of Chronic toxicity study, Carcinogenicity, Teratogenicity regarding Tambira parpam