RESUMO
OBJECTIVES: Amirdha Gandhi Kukkil Vallathy (AGKV) is a herbo mineral Siddha formulation which has Sulphur, Kukkil, Seendhil and Serankottai as major ingredients and it is indicated for 80 types of Vatham diseases. Uthiravatha suronitham is one among the vatham diseases and it's clinical symptoms are correlated with Rheumatoid arthritis (RA). Since AGKV is a promising drug for RA, the safety of this drug has been validated by performing the acute and 28 days repeated oral dose toxicity study following the OECD guidelines 423 and 407. METHODS: The acute toxicity study has been performed by administering orally with a single dose of 300 and 2000â¯mg/kg body weight in rat models and the animals were observed for 14 consecutive days. Gross pathology was observed and animals were sacrificed at the end of the study. In 28 days repeated oral toxicity study, limit test has been carried out with a dose of 1,000â¯mg/kg body weight. RESULTS: No significant abnormality has been observed in the body weight, organ weight, biochemical parameters and histopathology studies. It has been revealed that this drug is safe upto 2000â¯mg/kg body weight in single dose study and 1,000â¯mg is a safer dose in the 28 days repeated oral toxicity study. CONCLUSIONS: The results of acute and 28 days repeated oral toxicity studies revealed no adverse effects in animals and hence this drug AGKV is safe and can be administered in human.
Assuntos
Artrite Reumatoide , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Ratos , Animais , Ratos Wistar , Minerais , Artrite Reumatoide/tratamento farmacológico , Peso CorporalRESUMO
OBJECTIVES: The knowledge of purification process is unique since it deals with various physical and chemical changes in the inherent toxic properties during the process and it renders a strong support in the art of medicine preparation in Siddha system of medicine. Semecarpus anacardium L. is listed under Schedule e (1) drugs and purification is mandatory before its administration in medicine preparation. The bioactive compounds present in the plant like alkaloids, terpenoids, flavonoids, saponins, glycosides, steroids enhance the medical efficacy and defense mechanisms of the plant. Hence an attempt has been made to reveal the chemical change, occurring during the purification process in Siddha system of medicine by evaluating the phytochemicals and anacardic acid which is responsible for forming blisters and dermatitis. METHODS: Five common methods were used to purify the Semecarpus anacardium nuts as per the Siddha classical texts. The quantification of phytochemicals and anacardic acid has been done in unpurified, intermediate and purified samples. RESULTS: Significant changes were observed in phytochemicals and anacardic acid quantity in unpurified and purified samples. The major reduction of anacardic acid from 5.62 % in S1 to below detectable limit (BDL) in S2, S3, S4, 0.24% in S5 and 3.32% in S6. There is mild to moderate change in the phytochemicals which will support the efficacy of the drug. CONCLUSIONS: With the results of phytochemicals, though all the purification methods have been evidenced to reduce the toxic nature, among the above five, the process II may be recommended for further research and medicine preparation.