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. 2022 May 3;12(1):7127.
doi: 10.1038/s41598-022-11243-3.

Mutagenicity and safety pharmacology of a standardized antidiabetic polyherbal formulation

Fadzilah Adibah Abdul Majid  1 , Anis Fadhlina  2 , Hassan Fahmi Ismail  3 , Siti Nurazwa Zainol  4 , Archan Kumar Mamillapalli  5 , Vijayabalaji Venkatesan  5 , Rajesh Eswarappa  5 , Renuka Pillai  5
Affiliations

Mutagenicity and safety pharmacology of a standardized antidiabetic polyherbal formulation

Fadzilah Adibah Abdul Majid et al. Sci Rep. .

Abstract

Synacinn is a standardized polyherbal extract formulated for the treatment of diabetes mellitus and its complications. This study aims to assess the mutagenicity potential of Synacinn by Ames assay and in vivo bone marrow micronucleus (MN) test on Sprague Dawley rat. Human ether-a-go-go-related gene (hERG) assay and Functional Observation Battery (FOB) were done for the safety pharmacology tests. In the Ames assay, Dose Range Finding (DRF) study and mutagenicity assays (+/- S9) were carried out. For the MN test, a preliminary and definitive study were conducted. In-life observations and number of immature and mature erythrocytes in the bone marrow cells were recorded. The hERG assay was conducted to determine the inhibitory effect on hERG potassium channel current expressed in human embryonic kidney cells (HEK293). FOB tests were performed orally (250, 750, and 2000 mg/kg) on Sprague Dawley rats. Synacinn is non-mutagenic against all tested strains of Salmonella typhimurium and did not induce any clastogenicity in the rat bone marrow. Synacinn also did not produce any significant inhibition (p ≤ 0.05) on hERG potassium current. Synacinn did not cause any neurobehavioural changes in rats up to 2000 mg/kg. Thus, no mutagenicity, cardiotoxicity and neurotoxicity effects of Synacinn were observed in this study.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
TA100: fold increase in revertant colony count (vs vehicle control): plate incorporation method (DRF).
Figure 2
Figure 2
TA1537: fold increase in revertant colony count (vs vehicle control): mutagenicity assay 1 and 2.
Figure 3
Figure 3
TA1535: fold increase in revertant colony count (vs vehicle control): mutagenicity assay 1 and 2.
Figure 4
Figure 4
TA98: fold increase in revertant colony count (vs vehicle control): mutagenicity assay 1 and 2.
Figure 5
Figure 5
TA100: fold increase in revertant colony count (vs vehicle control): mutagenicity assay 1 and 2.
Figure 6
Figure 6
TA102: fold increase in revertant colony count (vs vehicle control): mutagenicity assay 1 and 2.
Figure 7
Figure 7
Rearing count of Sprague Dawley rats at predose and postdose. Data represent the mean of respective group measurements and are expressed as mean ± SEM.
Figure 8
Figure 8
Landing foot splay of Sprague Dawley rats at predose and postdose. Data represent the mean of respective group measurements and are expressed as mean ± SEM.
Figure 9
Figure 9
Total count of motor activity in Sprague Dawley rats at predose and postdose. Data represent the mean of respective group measurements and are expressed as mean ± SEM.
Figure 10
Figure 10
Ambulatory count of motor activity in Sprague Dawley rats at predose and postdose. Data represent the mean of respective group measurements and are expressed as mean ± SEM.
Figure 11
Figure 11
Forelimb and hindlimb grip strength of Sprague Dawley rats at predose and postdose. Data represent the mean of respective group measurements and are expressed as mean ± SEM.
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