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Nisha J.*, Elakkiyaa V., Deepalaxshmi N., Anbu N., Christian G. J., Visweswaran S. and Muthukumar N. J.


Siddha system of traditional medicine has versatile category of drugs which includes drugs for adults and children as well. Safety evaluation of Siddha formulations is of paramount importance as per the regulatory needs. In-vivo safety prediction using zebrafish embryo toxicity assay (ZFET) is a useful tool for systematic analysis of toxic concentration ranges of trial drugs and to detect whether compounds can affect the developing organs including skeletal makeup and neural networking. This protocol served as a basis for a zebrafish test to assess skeletal malformations during development. Chondrogenesis is already present at embryonic day 2 in zebrafish embryos, and supportive cartilage structures are present at the time of hatching. The main aim of the present investigation is to evaluate the embryo toxicity profiling of the siddha formulation Mudakkatran saaru (MS) using Zebrafish embryos. The concentration of the test drug ranging from 10μg to 320 μg/ml upon 24 to 96 hours post fertilization (HPF) exposure at 30 embryos per concentration. The results of the present investigation have clearly shown that there is no significant difference in movement analysis of the drugs treated groups (6.1 ± 1.322 to 7.667 ± 1.093 per min) with that of the control embryos with movement of 6.9 ± 1.094 per min. The data obtained from the present investigation reveals that there is no significant difference in heart rate of the drugs treated groups (125 ± 2.566 to 126.3 ± 1.701 beats/min) with that of the control embryos with heart rate of 125.8 ± 2.041 beats/ min. Further there was no abnormalities were detected in observed parameter’s such hatching rate, blood circulation, pigmentation, swimming pattern, balancing and morphogenesis. It was concluded from the results of the present investigation that siddha formulation Mudakkatran saaru was absolutely safe in developing embryos and didn’t alter any of the physiology of the developing fetus upon 24 to 96 HPF exposure.

Keywords: Siddha system, Safety evaluation, Mudakkatran saaru, Zebrafish embryos, Toxicity profiling, Developing embryos.

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